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CDAR2_IG_CLONDATA_2013OCT HL7 Implementation Guide for CDA, Release 2Clinical Oncology Treatment Plan and SummaryOctober 2013HL7 Draft Standard for Trial Use (DSTU)Sponsored by:Structured Documents Working GroupAmerican Society for Clinical Oncology HIT Work GroupCopyright ? 2013 Health Level Seven International ? ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. Pat & TM Off.Use of this material is governed by HL7's IP Compliance PolicyPrimary Editor:Zabrina Gonzaga, MSN RNLantana Consulting GroupZabrina.gonzaga@Co-Editor:Liora AlschulerLantana Consulting Groupliora.alschuler@Primary Editor:Gaye Dolin, MSN RNLantana Consulting Groupgaye.dolin@Co-Editor:Suzanne MadduxAmerican Society of Clinical Oncologysuzanne.maddux@Co-Chair/ Co-EditorRobert H. Dolin, MDLantana Consulting Groupbob.dolin@Co-Editor:Jeff KanAmerican Society of Clinical OncologyJeff.Kan@Co-Chair:Calvin BeebeMayo Cliniccbeebe@mayo.eduCo-Editor:Yan HerasLantana Consulting Groupyan.heras@ Co-Chair:Austin KreislerSAIC Consultant to CDC/NHSN duz1@Co-editor:Eric ParapiniUniversity of Victoriaericp@uvic.ca Co-Chair:Brett MarquardRiver Rock Associatesbrett@Technical Editor:Adrienne GiannoneLantana Consulting Groupadrienne.giannone@ Co-Editor:Beau BannermanLantana Consulting Groupbeau.bannerman@Technical Editor:Diana WrightLantana Consulting Groupdiana.wright@ Co-Editor:Wendy ScharberRegistry Widgetswendy@ Technical Editor: Susan HardyLantana Consulting Groupsusan.hardy@ASCO Advisory Work Group: Kevin Hughes, Jeremy Warner, Peter Yu, Edward Ambinder, John Krauss, Lawrence Shulman, Deborah Mayer Sub Work Group Participants: Kevin Hughes, Jeremy Warner, Peter Yu, Edward Ambinder, John Krauss, Lawrence Shulman, Deborah Mayer, Mark Shafarman, Jeff Kan, Suzanne Maddux, Steven Chu, Grant Wood, Wendy Scharber, Chris Melo, Brian Drohan, Thomas Kuhn, Mark Roche, Joshua MannAcknowledgmentsThis guide was produced and developed through the efforts of a project supported by the American Society of Clinical Oncology and the HL7 Structured Documents Working Group. The HL7 Pharmacy Work Group provided advice and input to the representation of cancer related medication clinical statements. The HL7 Clinical Genomic Work Group provided recommendations in the Family History Section.This material contains content from SNOMED CT? (). SNOMED CT is a registered trademark of the International Health Terminology Standard Development Organisation (IHTSDO).This material contains content from LOINC? (). The LOINC table, LOINC codes, and LOINC panels and forms file are copyright ? 1995-2010, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and available at no cost under the license at .?? Contents TOC \o "1-3" 1Introduction PAGEREF _Toc369299492 \h 221.1Purpose PAGEREF _Toc369299493 \h 221.2Audience PAGEREF _Toc369299494 \h 221.3Approach PAGEREF _Toc369299495 \h 221.4CDA R2 PAGEREF _Toc369299496 \h 231.5Templated CDA PAGEREF _Toc369299497 \h 231.6Background PAGEREF _Toc369299498 \h 241.7Current Project PAGEREF _Toc369299499 \h 251.8Organization of This Guide PAGEREF _Toc369299500 \h 251.9Conformance Conventions Used in This Guide PAGEREF _Toc369299501 \h 261.9.1Errata or Enhancements PAGEREF _Toc369299502 \h 261.9.2Templates and Conformance Statements PAGEREF _Toc369299503 \h 261.9.3Open and Closed Templates PAGEREF _Toc369299504 \h 281.9.4Keywords PAGEREF _Toc369299505 \h 281.9.5Cardinality PAGEREF _Toc369299506 \h 281.9.6Vocabulary Conformance PAGEREF _Toc369299507 \h 291.9.7Null Flavor PAGEREF _Toc369299508 \h 301.9.8Unknown Information PAGEREF _Toc369299509 \h 321.9.9Asserting an Act Did Not Occur with a Reason PAGEREF _Toc369299510 \h 331.9.10Data Types PAGEREF _Toc369299511 \h 341.10XML Conventions Used in This Guide PAGEREF _Toc369299512 \h 351.11Content of the Package PAGEREF _Toc369299513 \h 362Document-Level Templates PAGEREF _Toc369299514 \h 372.1US Realm Header PAGEREF _Toc369299515 \h 372.1.1recordTarget PAGEREF _Toc369299516 \h 392.1.2author PAGEREF _Toc369299517 \h 512.1.3dataEnterer PAGEREF _Toc369299518 \h 552.1.4informant PAGEREF _Toc369299519 \h 562.1.5custodian PAGEREF _Toc369299520 \h 572.1.6informationRecipient PAGEREF _Toc369299521 \h 592.1.7legalAuthenticator PAGEREF _Toc369299522 \h 592.1.8authenticator PAGEREF _Toc369299523 \h 612.1.9participant (Support) PAGEREF _Toc369299524 \h 632.1.10inFulfillmentOf PAGEREF _Toc369299525 \h 652.1.11documentationOf/serviceEvent PAGEREF _Toc369299526 \h 652.1.12authorization/consent PAGEREF _Toc369299527 \h 682.1.13componentOf PAGEREF _Toc369299528 \h 692.2US Realm Address (AD.US.FIELDED) PAGEREF _Toc369299529 \h 692.3US Realm Date and Time (DTM.US.FIELDED) PAGEREF _Toc369299530 \h 702.4US Realm Patient Name (PTN.US.FIELDED) PAGEREF _Toc369299531 \h 712.5US Realm Person Name (PN.US.FIELDED) PAGEREF _Toc369299532 \h 732.6Clinical Oncology Treatment Plan and Summary PAGEREF _Toc369299533 \h 743Section-Level Templates PAGEREF _Toc369299534 \h 843.1Allergies Section (entries optional) PAGEREF _Toc369299535 \h 843.2Encounters Section (entries optional) PAGEREF _Toc369299536 \h 853.2.1Encounters Section BCTPS PAGEREF _Toc369299537 \h 863.3Family History Section PAGEREF _Toc369299538 \h 883.3.1Family History Section BCTPS PAGEREF _Toc369299539 \h 893.4Functional Status Section PAGEREF _Toc369299540 \h 903.4.1Functional Status Section BCTPS PAGEREF _Toc369299541 \h 943.5Medications Section (entries optional) PAGEREF _Toc369299542 \h 953.5.1Medications Section BCTPS PAGEREF _Toc369299543 \h 963.6Plan of Care Section PAGEREF _Toc369299544 \h 993.6.1Plan of Care Section BCTPS PAGEREF _Toc369299545 \h 1013.7Problem Section (entries optional) PAGEREF _Toc369299546 \h 1023.7.1Problem Section BCTPS PAGEREF _Toc369299547 \h 1033.8Procedures Section (entries optional) PAGEREF _Toc369299548 \h 1053.8.1Procedures Section BCTPS PAGEREF _Toc369299549 \h 1073.9Results Section (entries optional) PAGEREF _Toc369299550 \h 1083.9.1Results Section BCTPS PAGEREF _Toc369299551 \h 1103.10Vital Signs Section (entries optional) PAGEREF _Toc369299552 \h 1113.10.1Vital Signs Section BCTPS PAGEREF _Toc369299553 \h 1124Entry-Level Templates PAGEREF _Toc369299554 \h 1144.1Age Observation PAGEREF _Toc369299555 \h 1144.2Allergy Problem Act PAGEREF _Toc369299556 \h 1164.3Allergy Status Observation PAGEREF _Toc369299557 \h 1184.4Anthracyclines Lifetime Dose PAGEREF _Toc369299558 \h 1204.5Assessment Scale Observation PAGEREF _Toc369299559 \h 1234.6Assessment Scale Supporting Observation PAGEREF _Toc369299560 \h 1264.7B reast TNM Clinical Category PAGEREF _Toc369299561 \h 1284.8Breast TNM Metastasis Category PAGEREF _Toc369299562 \h 1324.9Breast TNM Node Category PAGEREF _Toc369299563 \h 1354.10Breast TNM Tumor Category PAGEREF _Toc369299564 \h 1384.11Caregiver Characteristics PAGEREF _Toc369300458 \h 1414.12Chemotherapeutic Drug Therapy Discontinued PAGEREF _Toc369300459 \h 1444.13Chemotherapy Protocol Reference PAGEREF _Toc369300460 \h 1484.14Cl inical Drug Trial PAGEREF _Toc369300999 \h 1514.15Drug Vehicle PAGEREF _Toc369301120 \h 1534.16Encounter Activities PAGEREF _Toc369301121 \h 1544.16.1Hospitalization With Reason PAGEREF _Toc369301122 \h 1574.17Encounter Diagnosis PAGEREF _Toc369301250 \h 1594.18Family History Death Observation PAGEREF _Toc369301251 \h 1614.19Family History Observation PAGEREF _Toc369301252 \h 1634.20Family History of Cancer None PAGEREF _Toc369301253 \h 1674.21Family History Organizer PAGEREF _Toc369301254 \h 1694.22Family History Pedigree PAGEREF _Toc369301255 \h 1744.23Health Status Observation PAGEREF _Toc369301256 \h 1764.24Highest Pressure Ulcer Stage PAGEREF _Toc369301257 \h 1794.25Immunization Medication Information PAGEREF _Toc369301258 \h 1804.26Indication PAGEREF _Toc369301259 \h 1824.27Instructions PAGEREF _Toc369301260 \h 1844.27.1Possible Side Effects PAGEREF _Toc369301261 \h 1864.28Last Menstrual Period PAGEREF _Toc369301262 \h 1894.29Medication Activity PAGEREF _Toc369301263 \h 1914.29.1Chemotherapy Medication Activity PAGEREF _Toc369301264 \h 1994.30Medication Dispense PAGEREF _Toc369301522 \h 202Medication Information PAGEREF _Toc369301523 \h 2064.31 PAGEREF _Toc369301524 \h 2064.32Medication Supply Order PAGEREF _Toc369301525 \h 2094.33Molecular Diagnostic Testing Organizer PAGEREF _Toc369301526 \h 2124.34Non-Medicinal Supply Activity PAGEREF _Toc369301527 \h 2144.35Number of Pressure Ulcers Observation PAGEREF _Toc369301528 \h 2164.36Plan of Care Activity Act PAGEREF _Toc369301529 \h 2194.36.1Plan of Care Radiation Activity PAGEREF _Toc369301530 \h 2204.37Plan of Care Activity Encounter PAGEREF _Toc369301531 \h 2224.38Plan of Care Activity Observation PAGEREF _Toc369301532 \h 2234.39Plan of Care Activity Procedure PAGEREF _Toc369301533 \h 2244.39.1Chemotherapy Regimen Plans PAGEREF _Toc369301534 \h 2254.39.2Plan of Care Activity Reconstruction Procedure PAGEREF _Toc369301535 \h 2294.40Plan of Care Activity Substance Administration PAGEREF _Toc369301536 \h 2314.40.1Chemotherapy Medication Activity Plan PAGEREF _Toc369301537 \h 2324.41Plan of Care Activity Supply PAGEREF _Toc369301538 \h 2364.42Post Treatment Disease Status PAGEREF _Toc369301539 \h 2374.43Precondition for Substance Administration PAGEREF _Toc369301540 \h 2394.44Pressure Ulcer Observation PAGEREF _Toc369301541 \h 2404.45Problem Concern Act (Condition) PAGEREF _Toc369301542 \h 2484.45.1Breast Cancer Concern Act PAGEREF _Toc369301543 \h 2494.46Problem Observation PAGEREF _Toc369301544 \h 2514.46.1Breast Cancer Diagnosis Observation PAGEREF _Toc369301545 \h 2544.46.2Cognitive Status Problem Observation PAGEREF _Toc369301546 \h 2584.46.3Functional Status Problem Observation PAGEREF _Toc369301547 \h 2624.46.4Neurotoxicity Impairment of ADLs PAGEREF _Toc369301548 \h 2654.47Problem Status PAGEREF _Toc369301549 \h 2684.48Procedure Activity Act PAGEREF _Toc369301550 \h 2704.48.1Radiation Therapy Care Completed PAGEREF _Toc369301551 \h 2764.49Procedure Activity Observation PAGEREF _Toc369301552 \h 2774.50Procedure Activity Procedure PAGEREF _Toc369301553 \h 2834.50.1Breast Cancer Procedures PAGEREF _Toc369301554 \h 2884.51Product Instance PAGEREF _Toc369301555 \h 2904.52Reaction Observation PAGEREF _Toc369301556 \h 2914.53Result Observation PAGEREF _Toc369301557 \h 2944.53.1Cardiac Function Observation PAGEREF _Toc369301558 \h 2964.53.2Cognitive Status Result Observation PAGEREF _Toc369301559 \h 2994.53.3Estrogen Receptor Status PAGEREF _Toc369301560 \h 3034.53.4Functional Status Result Observation PAGEREF _Toc369301561 \h 3064.53.5HER2 Receptor Status PAGEREF _Toc369301562 \h 3094.53.6Number of Lymph Nodes Positive PAGEREF _Toc369301563 \h 3124.53.7Number of Lymph Nodes Removed and Examined PAGEREF _Toc369301564 \h 3144.53.8Oncotype DX Score PAGEREF _Toc369301565 \h 3154.53.9Progesterone Receptor Status PAGEREF _Toc369301566 \h 3164.54Result Organizer PAGEREF _Toc369301567 \h 3194.54.1Cognitive Status Result Organizer PAGEREF _Toc369301568 \h 3204.54.2Functional Status Result Organizer PAGEREF _Toc369301569 \h 3224.54.3Lymph Node Sampling Result Organizer PAGEREF _Toc369301570 \h 3244.54.4Molecular Diagnostic Testing Organizer PAGEREF _Toc369301571 \h 3294.54.5Receptor Status Organizer PAGEREF _Toc369301572 \h 3304.55Service Delivery Location PAGEREF _Toc369301573 \h 3334.56Severity Observation PAGEREF _Toc369301574 \h 3364.57Substance or Device Allergy - Intolerance Observation PAGEREF _Toc369301575 \h 3404.57.1Allergy - Intolerance Observation PAGEREF _Toc369301576 \h 3444.58Vital Sign Observation PAGEREF _Toc369301577 \h 3494.58.1Body Height PAGEREF _Toc369301578 \h 3524.58.2Body Surface Area PAGEREF _Toc369301579 \h 3534.58.3Body Weight PAGEREF _Toc369301580 \h 3554.59Vital Signs Organizer PAGEREF _Toc369301581 \h 3574.59.1Vital Signs Organizer BCTPS PAGEREF _Toc369301582 \h 3595References PAGEREF _Toc369301583 \h 362Appendix A —Acronyms and Abbreviations PAGEREF _Toc369301584 \h 363Appendix B —Template IDs Used in this Guide PAGEREF _Toc369301585 \h 364Appendix C —Code Systems in This Guide PAGEREF _Toc369301586 \h 375Appendix D —Breast Cancer Adjuvant Treatment Plan and Summary Paper form PAGEREF _Toc369301587 \h 378Appendix E —Data Element Mapping Table PAGEREF _Toc369301588 \h 380Appendix F —Extensions to CDA R2 PAGEREF _Toc369301589 \h 386Appendix G —Previously Published Templates PAGEREF _Toc369301590 \h 388Appendix H —MIME Multipart/Related Messages PAGEREF _Toc369301591 \h 391MIME Multipart/Related Messages PAGEREF _Toc369301592 \h 391RFC-2557 MIME Encapsulation of Aggregate Documents, Such as HTML (MHTML) PAGEREF _Toc369301593 \h 391Referencing Supporting Files in Multipart/Related Messages PAGEREF _Toc369301594 \h 391Referencing Documents from Other Multiparts within the Same X12 Transactions PAGEREF _Toc369301595 \h 392Figures TOC \c "Figure" Figure 1: Templated CDA PAGEREF _Toc369301596 \h 24Figure 2: Constraints format example PAGEREF _Toc369301597 \h 27Figure 3: Constraints format – only one allowed PAGEREF _Toc369301598 \h 28Figure 4: Constraints format – only one like this allowed PAGEREF _Toc369301599 \h 29Figure 5: Binding to a single code PAGEREF _Toc369301600 \h 29Figure 6: XML expression of a single-code binding PAGEREF _Toc369301601 \h 29Figure 7: Translation code example PAGEREF _Toc369301602 \h 30Figure 8: nullFlavor example PAGEREF _Toc369301603 \h 30Figure 9: Attribute required PAGEREF _Toc369301604 \h 31Figure 10: Allowed nullFlavors when element is required (with xml examples) PAGEREF _Toc369301605 \h 31Figure 11: nullFlavor explicitly disallowed PAGEREF _Toc369301606 \h 31Figure 12: Unknown medication example PAGEREF _Toc369301607 \h 32Figure 13: Unkown medication use of anticoagulant drug example PAGEREF _Toc369301608 \h 32Figure 14: No known medications example PAGEREF _Toc369301609 \h 33Figure 15: Asserting an act did not occur with reason PAGEREF _Toc369301610 \h 34Figure 16: XML document example PAGEREF _Toc369301611 \h 35Figure 17: XPath expression example PAGEREF _Toc369301612 \h 35Figure 18: ClinicalDocument example PAGEREF _Toc369301613 \h 36Figure 19: US Realm Header example PAGEREF _Toc369301614 \h 39Figure 20: effectiveTime with time zone example PAGEREF _Toc369301615 \h 39Figure 21: recordTarget example PAGEREF _Toc369301616 \h 49Figure 22: Person author example PAGEREF _Toc369301617 \h 54Figure 23: Device author example PAGEREF _Toc369301618 \h 54Figure 24: dataEnterer example PAGEREF _Toc369301619 \h 56Figure 25: informant with assignedEntity example PAGEREF _Toc369301620 \h 57Figure 26: custodian example PAGEREF _Toc369301621 \h 58Figure 27: informationRecipient example PAGEREF _Toc369301622 \h 59Figure 28: legalAuthenticator example PAGEREF _Toc369301623 \h 61Figure 29: authenticator example PAGEREF _Toc369301624 \h 63Figure 30: participant example for a supporting person PAGEREF _Toc369301625 \h 65Figure 31: documentationOf example PAGEREF _Toc369301626 \h 67Figure 32: Consent example PAGEREF _Toc369301627 \h 69Figure 33: Clinical Oncology Treatment Plan and Summary document type example PAGEREF _Toc369301628 \h 79Figure 34: Patient information example PAGEREF _Toc369301629 \h 80Figure 35: author example PAGEREF _Toc369301630 \h 81Figure 36: Supporting person example PAGEREF _Toc369301631 \h 81Figure 37: Multi-disciplinary team of providers example PAGEREF _Toc369301632 \h 82Figure 38: Allergies Section example PAGEREF _Toc369301633 \h 85Figure 39: Encounters Section BCTPS example PAGEREF _Toc369301634 \h 87Figure 40: Family History Section BCTPS PAGEREF _Toc369301635 \h 90Figure 41: Functional Status Section BCTPS PAGEREF _Toc369301636 \h 95Figure 42: Medications Section BCTPS PAGEREF _Toc369301637 \h 98Figure 43: Plan of Care Section BCTPS PAGEREF _Toc369301638 \h 102Figure 44: Problem Section BCTPS Example PAGEREF _Toc369301639 \h 105Figure 45: Procedures Section BCTPS PAGEREF _Toc369301640 \h 108Figure 46: Results Section BCTPS example PAGEREF _Toc369301641 \h 111Figure 47: Vital Signs Section BCTPS example PAGEREF _Toc369301642 \h 113Figure 48: Age Observation example PAGEREF _Toc369301643 \h 115Figure 49: Allergy Problem Act example PAGEREF _Toc369301644 \h 118Figure 50: Allergy Status Observation example PAGEREF _Toc369301645 \h 120Figure 16: Anthracyclines Lifetime Dose PAGEREF _Toc369301646 \h 123Figure 52: Assessment Scale Observation example PAGEREF _Toc369301647 \h 126Figure 53: Assessment Scale Supporting Observation example PAGEREF _Toc369301648 \h 128Figure 19: Breast TNM Clinical Category PAGEREF _Toc369301649 \h 132Figure 20: Breast TNM Metastasis Category PAGEREF _Toc369301650 \h 135Figure 21: NullFlavor for Code Element PAGEREF _Toc369301651 \h 135Figure 22: Breast TNM Node Category PAGEREF _Toc369301652 \h 138Figure 23: Breast TNM Tumor Category PAGEREF _Toc369301653 \h 141Figure 59: Caregiver Characteristics example with assertion PAGEREF _Toc369301654 \h 143Figure 60: Caregiver Characteristics example without assertion PAGEREF _Toc369301655 \h 143Figure 25: Chemotherapeutic Drug Therapy Discontinued PAGEREF _Toc369301656 \h 148Figure 26: "OTH" for Other Values PAGEREF _Toc369301657 \h 148Figure 27: Chemotherapy Protocol Reference PAGEREF _Toc369301658 \h 151Figure 28: Clinical Drug Trial PAGEREF _Toc369301659 \h 153Figure 65: Drug Vehicle example PAGEREF _Toc369301660 \h 154Figure 30: Hospitalization With Reason PAGEREF _Toc369301661 \h 159Figure 67: Encounter Diagnosis example PAGEREF _Toc369301662 \h 161Figure 68: Family History Death Observation example PAGEREF _Toc369301663 \h 163Figure 69: Family History Observation example PAGEREF _Toc369301664 \h 167Figure 33: Family History of Cancer None PAGEREF _Toc369301665 \h 169Figure 71: Family History Organizer – history of cancer example PAGEREF _Toc369301666 \h 173Figure 35: Family History Pedigree PAGEREF _Toc369301667 \h 176Figure 73: Health Status Observation example PAGEREF _Toc369301668 \h 178Figure 74: Higheset Pressure Ulcer Stage example PAGEREF _Toc369301669 \h 180Figure 75: Immunization Medication Information example PAGEREF _Toc369301670 \h 182Figure 76: Indication example PAGEREF _Toc369301671 \h 184Figure 38: Possible Side Effects PAGEREF _Toc369301672 \h 189Figure 39: "OTH" For Other Value with Possible Side Effects PAGEREF _Toc369301673 \h 189Figure 40: Last Menstrual Period PAGEREF _Toc369301674 \h 191Figure 41: Chemotherapy Medication Activity example PAGEREF _Toc369301675 \h 202Figure 81: Medication Dispense example PAGEREF _Toc369301676 \h 205Figure 82: Medication Information example PAGEREF _Toc369301677 \h 209Figure 83: Medication Supply Order example PAGEREF _Toc369301678 \h 211Figure 42: Molecular Diagnostic Testing Organizer PAGEREF _Toc369301679 \h 214Figure 84: Non-Medicinal Supply Activity example PAGEREF _Toc369301680 \h 216Figure 85: Number of Pressure Ulcers Observation example PAGEREF _Toc369301681 \h 219Figure 86: Plan of Care Radiation Activity example PAGEREF _Toc369301682 \h 222Figure 87: Plan of Care Activity Encounter example PAGEREF _Toc369301683 \h 223Figure 88: Plan of Care Activity Observation example PAGEREF _Toc369301684 \h 224Figure 45: Chemotherapy Regimen Plans example PAGEREF _Toc369301685 \h 229Figure 90: Plan of Care Activity Reconstruction Procedure example PAGEREF _Toc369301686 \h 231Figure 91: Chemotherapy Medication Activity Plan example PAGEREF _Toc369301687 \h 235Figure 92: Plan of Care Activity Supply example PAGEREF _Toc369301688 \h 237Figure 93: Post Treatment Disease Status example PAGEREF _Toc369301689 \h 239Figure 94: Precondition for Substance Administration example PAGEREF _Toc369301690 \h 240Figure 95: Pressure Ulcer Observation example PAGEREF _Toc369301691 \h 247Figure 96: Breast Cancer Concern Act example PAGEREF _Toc369301692 \h 250Figure 97: Breast Cancer Diagnosis Observation example PAGEREF _Toc369301693 \h 257Figure 98: Cognitive Status Problem Observation example PAGEREF _Toc369301694 \h 261Figure 99: Functional Status Problem Observation example PAGEREF _Toc369301695 \h 264Figure 100: Neurotoxicity Impairment of ADLs example PAGEREF _Toc369301696 \h 267Figure 101: Problem Status example PAGEREF _Toc369301697 \h 270Figure 102: Radiation Therapy Care Completed example PAGEREF _Toc369301698 \h 277Figure 103: Procedure Activity Observation example PAGEREF _Toc369301699 \h 282Figure 104: Breast Cancer Procedures example PAGEREF _Toc369301700 \h 289Figure 105: Product Instance example PAGEREF _Toc369301701 \h 291Figure 106: Cardiac Function Observation example PAGEREF _Toc369301702 \h 299Figure 107: Cognitive Status Result Observation example PAGEREF _Toc369301703 \h 303Figure 108: Estrogen Receptor Status example PAGEREF _Toc369301704 \h 305Figure 109: Functional Status Result Observation example PAGEREF _Toc369301705 \h 308Figure 110:HER2 Receptor Status (FISH) example PAGEREF _Toc369301706 \h 312Figure 111: HER2 Receptor Status (IHC) example PAGEREF _Toc369301707 \h 312Figure 61: Number of Lymph Nodes Positive example PAGEREF _Toc369301708 \h 314Figure 62: Number of Lymph Nodes Removed and Examined PAGEREF _Toc369301709 \h 315Figure 63: Oncotype DX Score PAGEREF _Toc369301710 \h 316Figure 115: Progesterone Receptor Status example PAGEREF _Toc369301711 \h 318Figure 116 Cognitive Status Result Organizer example PAGEREF _Toc369301712 \h 322Figure 117: Functional Status Result Organizer example PAGEREF _Toc369301713 \h 324Figure 118: Lymph Node Sampling Result Organizer example PAGEREF _Toc369301714 \h 327Figure 119: Molecular Testing Organizer example PAGEREF _Toc369301715 \h 330Figure 120: Receptor Status Organizer example PAGEREF _Toc369301716 \h 332Figure 121: Service Delivery Location example PAGEREF _Toc369301717 \h 335Figure 122: Severity Observation example PAGEREF _Toc369301718 \h 340Figure 123: Allergy - Intolerance Observation example PAGEREF _Toc369301719 \h 349Figure 124: Body Height example PAGEREF _Toc369301720 \h 353Figure 125: Body Surface Area example PAGEREF _Toc369301721 \h 355Figure 126: Body Weight example PAGEREF _Toc369301722 \h 357Figure 127: Vital Signs Organizer BCTPS example PAGEREF _Toc369301723 \h 360Figure 128: BCTPS paper form PAGEREF _Toc369301724 \h 378Tables TOC \c "Table" Table 1: Content of the Package PAGEREF _Toc369301725 \h 37Table 2: Basic Confidentiality Kind Value Set PAGEREF _Toc369301726 \h 39Table 3: Language Value Set (excerpt) PAGEREF _Toc369301727 \h 39Table 4: Telecom Use (US Realm Header) Value Set PAGEREF _Toc369301728 \h 44Table 5: Administrative Gender (HL7) Value Set PAGEREF _Toc369301729 \h 44Table 6: Marital Status Value Set PAGEREF _Toc369301730 \h 45Table 7: Religious Affiliation Value Set (excerpt) PAGEREF _Toc369301731 \h 45Table 8: Race Value Set (excerpt) PAGEREF _Toc369301732 \h 46Table 9: Ethnicity Value Set PAGEREF _Toc369301733 \h 46Table 10: Personal Relationship Role Type Value Set (excerpt) PAGEREF _Toc369301734 \h 47Table 11: State Value Set (excerpt) PAGEREF _Toc369301735 \h 47Table 12: Postal Code Value Set (excerpt) PAGEREF _Toc369301736 \h 48Table 13: Country Value Set (excerpt) PAGEREF _Toc369301737 \h 48Table 14: Language Ability Value Set PAGEREF _Toc369301738 \h 49Table 15: Language Ability Proficiency Value Set PAGEREF _Toc369301739 \h 49Table 16: Healthcare Provider Taxonomy Value Set PAGEREF _Toc369301740 \h 54Table 17: IND Role classCode Value Set PAGEREF _Toc369301741 \h 65Table 18: PostalAddressUse Value Set PAGEREF _Toc369301742 \h 71Table 19: EntityNameUse Value Set PAGEREF _Toc369301743 \h 73Table 20: EntityPersonNamePersonPartQualifier Value Set PAGEREF _Toc369301744 \h 74Table 21: Clinical Oncology Treatment Plan and Summary Contexts PAGEREF _Toc369301745 \h 75Table 22: Clinical Oncology Treatment Plan and Summary Constraints Overview PAGEREF _Toc369301746 \h 75Table 23: Allergies Section (entries optional) Contexts PAGEREF _Toc369301747 \h 85Table 24: Allergies Section (entries optional) Constraints Overview PAGEREF _Toc369301748 \h 85Table 25: Encounters Section (entries optional) Contexts PAGEREF _Toc369301749 \h 86Table 26: Encounters Section (entries optional) Constraints Overview PAGEREF _Toc369301750 \h 87Table 27: Encounters Section BCTPS Contexts PAGEREF _Toc369301751 \h 87Table 28: Encounters Section BCTPS Constraints Overview PAGEREF _Toc369301752 \h 88Table 29: Family History Section Contexts PAGEREF _Toc369301753 \h 89Table 30: Family History Section Constraints Overview PAGEREF _Toc369301754 \h 89Table 31: Family History Section BCTPS Contexts PAGEREF _Toc369301755 \h 90Table 32: Family History Section BCTPS Constraints Overview PAGEREF _Toc369301756 \h 90Table 33: Functional Status Section Contexts PAGEREF _Toc369301757 \h 91Table 34: Functional Status Section Constraints Overview PAGEREF _Toc369301758 \h 93Table 35: Functional Status Section BCTPS Contexts PAGEREF _Toc369301759 \h 95Table 36: Functional Status Section BCTPS Constraints Overview PAGEREF _Toc369301760 \h 95Table 37: Medications Section (entries optional) Contexts PAGEREF _Toc369301761 \h 96Table 38: Medications Section (entries optional) Constraints Overview PAGEREF _Toc369301762 \h 97Table 39: Medications Section BCTPS Contexts PAGEREF _Toc369301763 \h 97Table 40: Medications Section BCTPS Constraints Overview PAGEREF _Toc369301764 \h 98Table 41: Plan of Care Section Contexts PAGEREF _Toc369301765 \h 100Table 42: Plan of Care Section Constraints Overview PAGEREF _Toc369301766 \h 100Table 43: Plan of Care Section BCTPS Contexts PAGEREF _Toc369301767 \h 102Table 44: Plan of Care Section BCTPS Constraints Overview PAGEREF _Toc369301768 \h 102Table 45: Problem Section (entries optional) Contexts PAGEREF _Toc369301769 \h 103Table 46: Problem Section (entries optional) Constraints Overview PAGEREF _Toc369301770 \h 104Table 47: Problem Section BCTPS Contexts PAGEREF _Toc369301771 \h 104Table 48: Problem Section BCTPS Constraints Overview PAGEREF _Toc369301772 \h 105Table 49: Procedures Section (entries optional) Contexts PAGEREF _Toc369301773 \h 106Table 50: Procedures Section (entries optional) Constraints Overview PAGEREF _Toc369301774 \h 107Table 51: Procedures Section BCTPS Contexts PAGEREF _Toc369301775 \h 108Table 52: Procedures Section BCTPS Constraints Overview PAGEREF _Toc369301776 \h 108Table 53: Results Section (entries optional) Contexts PAGEREF _Toc369301777 \h 109Table 54: Results Section (entries optional) Constraints Overview PAGEREF _Toc369301778 \h 110Table 55: Results Section BCTPS Contexts PAGEREF _Toc369301779 \h 111Table 56: Results Section BCTPS Constraints Overview PAGEREF _Toc369301780 \h 111Table 57: Vital Signs Section (entries optional) Contexts PAGEREF _Toc369301781 \h 112Table 58: Vital Signs Section (entries optional) Constraints Overview PAGEREF _Toc369301782 \h 113Table 59: Vital Signs Section BCTPS Contexts PAGEREF _Toc369301783 \h 113Table 60: Vital Signs Section BCTPS Constraints Overview PAGEREF _Toc369301784 \h 114Table 61: Age Observation Contexts PAGEREF _Toc369301785 \h 115Table 62: Age Observation Constraints Overview PAGEREF _Toc369301786 \h 115Table 63: AgePQ_UCUM Value Set PAGEREF _Toc369301787 \h 116Table 64: Allergy Problem Act Contexts PAGEREF _Toc369301788 \h 117Table 65: Allergy Problem Act Constraints Overview PAGEREF _Toc369301789 \h 117Table 66: ProblemAct statusCode Value Set PAGEREF _Toc369301790 \h 118Table 67: Allergy Status Observation Contexts PAGEREF _Toc369301791 \h 119Table 68: Allergy Status Observation Constraints Overview PAGEREF _Toc369301792 \h 120Table 69: Problem Status Value Set PAGEREF _Toc369301793 \h 121Table 70: Anthracyclines Lifetime Dose Contexts PAGEREF _Toc369301794 \h 121Table 71: Anthracyclines Lifetime Dose Constraints Overview PAGEREF _Toc369301795 \h 122Table 73: Assessment Scale Observation Contexts PAGEREF _Toc369301796 \h 124Table 74: Assessment Scale Observation Constraints Overview PAGEREF _Toc369301797 \h 125Table 75: Assessment Scale Supporting Observation Contexts PAGEREF _Toc369301798 \h 127Table 76: Assessment Scale Supporting Observation Constraints Overview PAGEREF _Toc369301799 \h 128Table 73: Breast TNM Clinical Category Contexts PAGEREF _Toc369301800 \h 129Table 74: Breast TNM Clinical Category Constraints Overview PAGEREF _Toc369301801 \h 130Table 75: Breast TNM Stage Group PAGEREF _Toc369301802 \h 132Table 76: Breast TNM Metastasis Category Contexts PAGEREF _Toc369301803 \h 133Table 77: Breast TNM Metastasis Category Constraints Overview PAGEREF _Toc369301804 \h 134Table 78: Breast TNM Metastasis Observation PAGEREF _Toc369301805 \h 135Table 79: Breast TNM Metastasis Category PAGEREF _Toc369301806 \h 135Table 80: Breast TNM Node Category Contexts PAGEREF _Toc369301807 \h 136Table 81: Breast TNM Node Category Constraints Overview PAGEREF _Toc369301808 \h 137Table 82: Breast TNM Node Observation PAGEREF _Toc369301809 \h 138Table 83: Breast TNM Node Category PAGEREF _Toc369301810 \h 138Table 84: Breast TNM Tumor Category Contexts PAGEREF _Toc369301811 \h 139Table 85: Breast TNM Tumor Category Constraints Overview PAGEREF _Toc369301812 \h 140Table 86: Breast TNM Tumor Observation PAGEREF _Toc369301813 \h 141Table 87: Breast TNM Tumor Category PAGEREF _Toc369301814 \h 141Table 92: Caregiver Characteristics Contexts PAGEREF _Toc369301815 \h 142Table 93: Caregiver Characteristics Constraints Overview PAGEREF _Toc369301816 \h 143Table 90: Chemotherapeutic Drug Therapy Discontinued Contexts PAGEREF _Toc369301817 \h 145Table 91: Chemotherapeutic Drug Therapy Discontinued Constraints Overview PAGEREF _Toc369301818 \h 146Table 92: Reason for Stopping Chemotherapy PAGEREF _Toc369301819 \h 148Table 93: Chemotherapy Protocol Reference Contexts PAGEREF _Toc369301820 \h 149Table 94: Chemotherapy Protocol Reference Constraints Overview PAGEREF _Toc369301821 \h 150Table 95: Clinical Drug Trial Contexts PAGEREF _Toc369301822 \h 152Table 96: Clinical Drug Trial Constraints Overview PAGEREF _Toc369301823 \h 153Table 101: Drug Vehicle Contexts PAGEREF _Toc369301824 \h 154Table 102: Drug Vehicle Constraints Overview PAGEREF _Toc369301825 \h 154Table 103: Encounter Activities Contexts PAGEREF _Toc369301826 \h 155Table 104: Encounter Activities Constraints Overview PAGEREF _Toc369301827 \h 156Table 105: EncounterTypeCode PAGEREF _Toc369301828 \h 158Table 102: Hospitalization With Reason Contexts PAGEREF _Toc369301829 \h 158Table 103: Hospitalization With Reason Constraints Overview PAGEREF _Toc369301830 \h 159Table 108: Encounter Diagnosis Contexts PAGEREF _Toc369301831 \h 160Table 109: Encounter Diagnosis Constraints Overview PAGEREF _Toc369301832 \h 161Table 110: Family History Death Observation Contexts PAGEREF _Toc369301833 \h 162Table 111: Family History Death Observation Constraints Overview PAGEREF _Toc369301834 \h 163Table 112: Family History Observation Contexts PAGEREF _Toc369301835 \h 164Table 113: Family History Observation Constraints Overview PAGEREF _Toc369301836 \h 164Table 114: Problem Type Value Set PAGEREF _Toc369301837 \h 166Table 115: Problem Value Set (excerpt) PAGEREF _Toc369301838 \h 167Table 112: Family History of Cancer None Contexts PAGEREF _Toc369301839 \h 168Table 113: Family History of Cancer None Constraints Overview PAGEREF _Toc369301840 \h 169Table 118: Family History Organizer Contexts PAGEREF _Toc369301841 \h 170Table 119: Family History Organizer Constraints Overview PAGEREF _Toc369301842 \h 171Table 120: Family Member Value Set PAGEREF _Toc369301843 \h 173Table 117: Family History Pedigree Contexts PAGEREF _Toc369301844 \h 175Table 118: Family History Pedigree Constraints Overview PAGEREF _Toc369301845 \h 176Table 123: Health Status Observation Contexts PAGEREF _Toc369301846 \h 177Table 124: Health Status Observation Constraints Overview PAGEREF _Toc369301847 \h 178Table 125: Health Status Value Set PAGEREF _Toc369301848 \h 179Table 126: Highest Pressure Ulcer Stage Contexts PAGEREF _Toc369301849 \h 180Table 127: Highest Pressure Ulcer Stage Constraints Overview PAGEREF _Toc369301850 \h 180Table 128: Immunization Medication Information Contexts PAGEREF _Toc369301851 \h 181Table 129: Immunization Medication Information Constraints Overview PAGEREF _Toc369301852 \h 181Table 130: Indication Contexts PAGEREF _Toc369301853 \h 183Table 131: Indication Constraints Overview PAGEREF _Toc369301854 \h 184Table 132: Instructions Contexts PAGEREF _Toc369301855 \h 185Table 133: Instructions Constraints Overview PAGEREF _Toc369301856 \h 186Table 134: Patient Education Value Set PAGEREF _Toc369301857 \h 187Table 132: Possible Side Effects Contexts PAGEREF _Toc369301858 \h 187Table 133: Possible Side Effects Constraints Overview PAGEREF _Toc369301859 \h 188Table 134: Chemotherapy Side Effects PAGEREF _Toc369301860 \h 189Table 135: Last Menstrual Period Contexts PAGEREF _Toc369301861 \h 190Table 136: Last Menstrual Period Constraints Overview PAGEREF _Toc369301862 \h 191Table 140: Medication Activity Contexts PAGEREF _Toc369301863 \h 192Table 141: Medication Activity Constraints Overview PAGEREF _Toc369301864 \h 193Table 142: MoodCodeEvnInt Value Set PAGEREF _Toc369301865 \h 198Table 143: Medication Route FDA Value Set (excerpt) PAGEREF _Toc369301866 \h 198Table 144: Body Site Value Set (excerpt) PAGEREF _Toc369301867 \h 199Table 145: Unit of Measure Value Set (excerpt) PAGEREF _Toc369301868 \h 199Table 146: Medication Product Form Value Set (excerpt) PAGEREF _Toc369301869 \h 200Table 144: Chemotherapy Medication Activity Contexts PAGEREF _Toc369301870 \h 200Table 145: Chemotherapy Medication Activity Constraints Overview PAGEREF _Toc369301871 \h 201Table 149: Medication Dispense Contexts PAGEREF _Toc369301872 \h 204Table 150: Medication Dispense Constraints Overview PAGEREF _Toc369301873 \h 204Table 151: Medication Fill Status Value Set PAGEREF _Toc369301874 \h 206Table 152: Medication Information Contexts PAGEREF _Toc369301875 \h 207Table 153: Medication Information Constraints Overview PAGEREF _Toc369301876 \h 208Table 154: Medication Clinical Drug Name Value Set PAGEREF _Toc369301877 \h 209Table 155: Medication Supply Order Contexts PAGEREF _Toc369301878 \h 210Table 156: Medication Supply Order Constraints Overview PAGEREF _Toc369301879 \h 210Table 154: Molecular Diagnostic Testing Organizer Contexts PAGEREF _Toc369301880 \h 213Table 155: Molecular Diagnostic Testing Organizer Constraints Overview PAGEREF _Toc369301881 \h 214Table 157: Non-Medicinal Supply Activity Contexts PAGEREF _Toc369301882 \h 215Table 158: Non-Medicinal Supply Activity Constraints Overview PAGEREF _Toc369301883 \h 216Table 159: Number of Pressure Ulcers Observation Contexts PAGEREF _Toc369301884 \h 217Table 160: Number of Pressure Ulcers Observation Constraints Overview PAGEREF _Toc369301885 \h 218Table 161: Pressure Ulcer Stage Value Set PAGEREF _Toc369301886 \h 219Table 162: Plan of Care Activity Act Contexts PAGEREF _Toc369301887 \h 220Table 163: Plan of Care Activity Act Constraints Overview PAGEREF _Toc369301888 \h 220Table 164: Plan of Care Radiation Activity Contexts PAGEREF _Toc369301889 \h 221Table 165: Plan of Care Radiation Activity Constraints Overview PAGEREF _Toc369301890 \h 221Table 166: Plan of Care moodCode (Act/Encounter/Procedure) Value Set PAGEREF _Toc369301891 \h 222Table 167: Plan of Care Activity Encounter Contexts PAGEREF _Toc369301892 \h 223Table 168: Plan of Care Activity Encounter Constraints Overview PAGEREF _Toc369301893 \h 223Table 169: Plan of Care Activity Observation Contexts PAGEREF _Toc369301894 \h 224Table 170: Plan of Care Activity Observation Constraints Overview PAGEREF _Toc369301895 \h 224Table 171: Plan of Care moodCode (Observation) Value Set PAGEREF _Toc369301896 \h 225Table 172: Plan of Care Activity Procedure Contexts PAGEREF _Toc369301897 \h 225Table 173: Plan of Care Activity Procedure Constraints Overview PAGEREF _Toc369301898 \h 226Table 173: Chemotherapy Regimen Plans Contexts PAGEREF _Toc369301899 \h 226Table 174: Chemotherapy Regimen Plans Constraints Overview PAGEREF _Toc369301900 \h 227Table 175: Planned moodCode (SubstanceAdministration/Supply) PAGEREF _Toc369301901 \h 229Table 177: Plan of Care Activity Reconstruction Procedure Contexts PAGEREF _Toc369301902 \h 230Table 178: Plan of Care Activity Reconstruction Procedure Constraints Overview PAGEREF _Toc369301903 \h 231Table 179: Breast Cancer Procedures Value Set PAGEREF _Toc369301904 \h 232Table 180: Plan of Care Activity Substance Administration Contexts PAGEREF _Toc369301905 \h 232Table 181: Plan of Care Activity Substance Administration Constraints Overview PAGEREF _Toc369301906 \h 233Table 182: Chemotherapy Medication Activity Plan Contexts PAGEREF _Toc369301907 \h 233Table 183: Chemotherapy Medication Activity Plan Constraints Overview PAGEREF _Toc369301908 \h 234Table 184: Plan of Care Activity Supply Contexts PAGEREF _Toc369301909 \h 237Table 185: Plan of Care Activity Supply Constraints Overview PAGEREF _Toc369301910 \h 237Table 186: Post Treatment Disease Status Contexts PAGEREF _Toc369301911 \h 238Table 187: Post Treatment Disease Status Constraints Overview PAGEREF _Toc369301912 \h 238Table 188: Disease Status Post Treatment Value Set PAGEREF _Toc369301913 \h 239Table 189: Precondition for Substance Administration Contexts PAGEREF _Toc369301914 \h 240Table 190: Precondition for Substance Administration Constraints Overview PAGEREF _Toc369301915 \h 240Table 191: Pressure Ulcer Observation Contexts PAGEREF _Toc369301916 \h 241Table 192: Pressure Ulcer Observation Constraints Overview PAGEREF _Toc369301917 \h 241Table 193: Pressure Point Value Set PAGEREF _Toc369301918 \h 246Table 194: TargetSite Qualifiers Value Set PAGEREF _Toc369301919 \h 247Table 195: Problem Concern Act (Condition) Contexts PAGEREF _Toc369301920 \h 249Table 196: Problem Concern Act (Condition) Constraints Overview PAGEREF _Toc369301921 \h 249Table 197: Breast Cancer Concern Act Contexts PAGEREF _Toc369301922 \h 250Table 198: Breast Cancer Concern Act Constraints Overview PAGEREF _Toc369301923 \h 251Table 199: Problem Observation Contexts PAGEREF _Toc369301924 \h 252Table 200: Problem Observation Constraints Overview PAGEREF _Toc369301925 \h 252Table 201: Breast Cancer Diagnosis Observation Contexts PAGEREF _Toc369301926 \h 255Table 202: Breast Cancer Diagnosis Observation Constraints Overview PAGEREF _Toc369301927 \h 256Table 203: Breast Cancer Value Set (excerpt) PAGEREF _Toc369301928 \h 258Table 204: Cognitive Status Problem Observation Contexts PAGEREF _Toc369301929 \h 259Table 205: Cognitive Status Problem Observation Constraints Overview PAGEREF _Toc369301930 \h 260Table 206: Functional Status Problem Observation Contexts PAGEREF _Toc369301931 \h 263Table 207: Functional Status Problem Observation Constraints Overview PAGEREF _Toc369301932 \h 263Table 208: Neurotoxicity Impairment of ADLs Contexts PAGEREF _Toc369301933 \h 266Table 209: Neurotoxicity Impairment of ADLs Constraints Overview PAGEREF _Toc369301934 \h 266Table 210: Problem Status Contexts PAGEREF _Toc369301935 \h 269Table 211: Problem Status Constraints Overview PAGEREF _Toc369301936 \h 270Table 212: Procedure Activity Act Contexts PAGEREF _Toc369301937 \h 271Table 213: Procedure Activity Act Constraints Overview PAGEREF _Toc369301938 \h 272Table 214: ProcedureAct statusCode Value Set PAGEREF _Toc369301939 \h 276Table 215: Act Priority Value Set Value Set PAGEREF _Toc369301940 \h 276Table 216: Radiation Therapy Care Completed Contexts PAGEREF _Toc369301941 \h 277Table 217: Radiation Therapy Care Completed Constraints Overview PAGEREF _Toc369301942 \h 277Table 218: Procedure Activity Observation Contexts PAGEREF _Toc369301943 \h 278Table 219: Procedure Activity Observation Constraints Overview PAGEREF _Toc369301944 \h 279Table 220: Procedure Activity Procedure Contexts PAGEREF _Toc369301945 \h 284Table 221: Procedure Activity Procedure Constraints Overview PAGEREF _Toc369301946 \h 284Table 222: Breast Cancer Procedures Contexts PAGEREF _Toc369301947 \h 289Table 223: Breast Cancer Procedures Constraints Overview PAGEREF _Toc369301948 \h 289Table 224: Product Instance Contexts PAGEREF _Toc369301949 \h 291Table 225: Product Instance Constraints Overview PAGEREF _Toc369301950 \h 291Table 226: Reaction Observation Contexts PAGEREF _Toc369301951 \h 292Table 227: Reaction Observation Constraints Overview PAGEREF _Toc369301952 \h 292Table 228: Result Observation Contexts PAGEREF _Toc369301953 \h 295Table 229: Result Observation Constraints Overview PAGEREF _Toc369301954 \h 295Table 230: Result Status Value Set PAGEREF _Toc369301955 \h 297Table 231: Cardiac Function Observation Contexts PAGEREF _Toc369301956 \h 297Table 232: Cardiac Function Observation Constraints Overview PAGEREF _Toc369301957 \h 298Table 233: Ejection Fraction Value Set PAGEREF _Toc369301958 \h 298Table 234: Cardiac Ejection Method Value Set PAGEREF _Toc369301959 \h 299Table 235: Cognitive Status Result Observation Contexts PAGEREF _Toc369301960 \h 300Table 236: Cognitive Status Result Observation Constraints Overview PAGEREF _Toc369301961 \h 301Table 237: Estrogen Receptor Status Contexts PAGEREF _Toc369301962 \h 304Table 238: Estrogen Receptor Status Constraints Overview PAGEREF _Toc369301963 \h 305Table 239: ObservationInterpretationDetected PAGEREF _Toc369301964 \h 306Table 240: Functional Status Result Observation Contexts PAGEREF _Toc369301965 \h 307Table 241: Functional Status Result Observation Constraints Overview PAGEREF _Toc369301966 \h 307Table 242: HER2 Receptor Status Contexts PAGEREF _Toc369301967 \h 310Table 243: HER2 Receptor Status Constraints Overview PAGEREF _Toc369301968 \h 311Table 244: Types of HER2 Tests PAGEREF _Toc369301969 \h 311Table 246: Number of Lymph Nodes Positive Contexts PAGEREF _Toc369301970 \h 313Table 247: Number of Lymph Nodes Positive Constraints Overview PAGEREF _Toc369301971 \h 314Table 248: Number of Lymph Nodes Removed and Examined Contexts PAGEREF _Toc369301972 \h 315Table 249: Number of Lymph Nodes Removed and Examined Constraints Overview PAGEREF _Toc369301973 \h 315Table 250: Oncotype DX Score Contexts PAGEREF _Toc369301974 \h 316Table 251: Oncotype DX Score Constraints Overview PAGEREF _Toc369301975 \h 316Table 252: Progesterone Receptor Status Contexts PAGEREF _Toc369301976 \h 317Table 253: Progesterone Receptor Status Constraints Overview PAGEREF _Toc369301977 \h 318Table 254: Types of Progesterone Receptor Test PAGEREF _Toc369301978 \h 319Table 254: Result Organizer Contexts PAGEREF _Toc369301979 \h 320Table 255: Result Organizer Constraints Overview PAGEREF _Toc369301980 \h 320Table 256: Cognitive Status Result Organizer Contexts PAGEREF _Toc369301981 \h 321Table 257: Cognitive Status Result Organizer Constraints Overview PAGEREF _Toc369301982 \h 322Table 258: Functional Status Result Organizer Contexts PAGEREF _Toc369301983 \h 323Table 259: Functional Status Result Organizer Constraints Overview PAGEREF _Toc369301984 \h 324Table 260: Lymph Node Sampling Result Organizer Contexts PAGEREF _Toc369301985 \h 325Table 261: Lymph Node Sampling Result Organizer Constraints Overview PAGEREF _Toc369301986 \h 326Table 262: Molecular Diagnostic Testing Organizer Contexts PAGEREF _Toc369301987 \h 330Table 263: Molecular Diagnostic Testing Organizer Constraints Overview PAGEREF _Toc369301988 \h 330Table 264: Receptor Status Organizer Contexts PAGEREF _Toc369301989 \h 331Table 265: Receptor Status Organizer Constraints Overview PAGEREF _Toc369301990 \h 332Table 266: Service Delivery Location Contexts PAGEREF _Toc369301991 \h 334Table 267: Service Delivery Location Constraints Overview PAGEREF _Toc369301992 \h 334Table 268: HealthcareServiceLocation PAGEREF _Toc369301993 \h 335Table 269: Severity Observation Contexts PAGEREF _Toc369301994 \h 337Table 270: Severity Observation Constraints Overview PAGEREF _Toc369301995 \h 338Table 271: Problem Severity Value Set PAGEREF _Toc369301996 \h 339Table 272: Observation Interpretation (HL7) Value Set PAGEREF _Toc369301997 \h 340Table 273: Substance or Device Allergy - Intolerance Observation Contexts PAGEREF _Toc369301998 \h 341Table 274: Substance or Device Allergy - Intolerance Observation Constraints Overview PAGEREF _Toc369301999 \h 341Table 275: Allergy/Adverse Event Type Value Set PAGEREF _Toc369302000 \h 345Table 276: Allergy - Intolerance Observation Contexts PAGEREF _Toc369302001 \h 345Table 277: Allergy - Intolerance Observation Constraints Overview PAGEREF _Toc369302002 \h 346Table 278: Vital Sign Observation Contexts PAGEREF _Toc369302003 \h 350Table 279: Vital Sign Observation Constraints Overview PAGEREF _Toc369302004 \h 351Table 280: Vital Sign Result Value Set PAGEREF _Toc369302005 \h 352Table 281: Body Height Contexts PAGEREF _Toc369302006 \h 353Table 282: Body Height Constraints Overview PAGEREF _Toc369302007 \h 353Table 283: Unit of Body Height Value Set PAGEREF _Toc369302008 \h 354Table 284: Body Surface Area Contexts PAGEREF _Toc369302009 \h 354Table 285: Body Surface Area Constraints Overview PAGEREF _Toc369302010 \h 355Table 286: Body Weight Contexts PAGEREF _Toc369302011 \h 356Table 287: Body Weight Constraints Overview PAGEREF _Toc369302012 \h 357Table 288: Unit Of Body Weight Value Set PAGEREF _Toc369302013 \h 358Table 289: Vital Signs Organizer Contexts PAGEREF _Toc369302014 \h 358Table 290: Vital Signs Organizer Constraints Overview PAGEREF _Toc369302015 \h 359Table 291: Vital Signs Organizer BCTPS Contexts PAGEREF _Toc369302016 \h 360Table 292: Vital Signs Organizer BCTPS Constraints Overview PAGEREF _Toc369302017 \h 360Table 293: Template List in Alphabetical Order by Type PAGEREF _Toc369302018 \h 365Table 294: Template List by Containments PAGEREF _Toc369302019 \h 368Table 295: List of Vocabularies PAGEREF _Toc369302020 \h 377Table 296: BCTPS Mapping Table PAGEREF _Toc369302021 \h 381Table 297: Templates Previously Published in C-CDA or QRDA Implementation Guides PAGEREF _Toc369302022 \h 389IntroductionPurposeThis document describes constraints on the Clinical Document Architecture Release 2 (CDA R2) header and body elements for the Clinical Oncology Treatment Plan and Summary document which is derived from the American Society of Clinical Oncology (ASCO) Breast Cancer Adjuvant Treatment Plan and Summary. Templates in this release of the implementation guide are specific to a Breast Cancer Treatment Plan and Summary (BCTPS). Standardization of information used in this form will promote interoperability; create information suitable for reuse in quality measurement, public health, research, and for reimbursement. This guide contains a library of CDA templates, and is compliant with the Consolidated CDA R2 cited in Final Rules for Stage 2 Meaningful Use and 45 CFR Part 170 – Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule.AudienceThe audience for this document includes software developers and implementers with reporting capabilities within their electronic health record (EHR) systems; developers and analysts in receiving institutions; and local, regional, and national health information exchange networks who wish to create or process Clinical Oncology Treatment Plan and Summary documents according to this specification. Business analysts and policy managers can also benefit from a basic understanding of the use of Clinical Document Architecture (CDA) templates across multiple implementation use cases. ApproachOverall, the approach taken here is consistent with balloted implementation guides for CDA. These publications view the ultimate implementation specification as a series of layered constraints. CDA itself is a set of constraints on the Health Level Seven (HL7) Reference Information Model (RIM) defined in the CDA R2 Refined Message Information Model (RMIM). Implementation guides such as this add constraints to CDA through conformance statements that further define and restrict the sequence and cardinality of CDA objects and the vocabulary sets for coded elements. This implementation guide is a conformance profile, as described in the “Refinement and Localization” section of the HL7 Version 3 Interoperability Standards. The base standard for this implementation guide is the HL7 Clinical Document Architecture, Release 2.0. As defined in that document, this implementation guide is both an annotation profile and a localization profile. It does not describe every aspect of CDA.The development of this guide includes a review and analysis of previously successfully balloted clinical exchange standards and published implementation guides for cancer treatment templates such as the Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, the HL7 Implementation Guide for CDA R2: Quality Reporting Document Architecture, DSTU Release 2 (QRDA), and the HL7 Implementation Guide for CDA Release 2.0, Consolidated CDA Templates, (US Realm). Templates were re-used wherever possible. CDA R2CDA R2 is “… a document markup standard that specifies the structure and semantics of ‘clinical documents’ for the purpose of exchange” [CDA R2, Section?1.1]. Clinical documents, according to CDA, have the following characteristics:PersistenceStewardshipPotential for authenticationContextWholenessHuman readabilityCDA defines a header that for classification and management and a document body that carries the clinical record. While the header metadata are prescriptive and designed for consistency across all instances, the body is highly generic, leaving the designation of semantic requirements to implementation.Templated CDACDA R2 can be constrained by mechanisms defined in the “Refinement and Localization” section of the HL7 Version 3 Interoperability Standards. The mechanism most commonly used to constrain CDA is referred to as “templated CDA”. In this approach, a library is created containing modular CDA templates such that the templates can be reused across any number of CDA document types, as shown in the following figure.Figure SEQ Figure \* ARABIC 1: Templated CDAThere are many different kinds of templates that might be created. Among them, the most common are:Document-level templates: These templates constrain fields in the CDA header, and define containment relationships to CDA sections. For example, a History-and-Physical document-level template might require that the patient’s name be present, and that the document contain a Physical Exam section.Section-level templates: These templates constrain fields in the CDA section, and define containment relationships to CDA entries. For example, a Physical-exam section-level template might require that the section/code be fixed to a particular LOINC code, and that the section contain a Systolic Blood Pressure observation.Entry-level templates: These templates constrain the CDA clinical statement model in accordance with real world observations and acts. For example, a Systolic-blood-pressure entry-level template defines how the CDA Observation class is constrained (how to populate observation/code, how to populate observation/value, etc.) to represent the notion of a systolic blood pressure.A CDA implementation guide (such as this one) includes reference to those templates that are applicable. On the implementation side, a CDA instance populates the template identifier (templateId) field where it wants to assert conformance to a given template. On the receiving side, the recipient can then not only test the instance for conformance against the CDA XML schema, but also test the instance for conformance against asserted templates. BackgroundElectronic health records (EHRs) often contain data that are not shared between providers or not captured for research, quality, or public health reporting. Disease-specific templates are required for the continuity of care for cancer patients and current templates lack the specificity needed for this population. ASCO’s strategy is to promote interoperability and information exchange among cancer care providers and patients. ASCO’s strategy for 2012 is to promote and improve delivery of care to cancer patients through improved exchange and interoperability of the clinical information most critical for that care. Though multiple types of breast cancer treatment forms are used to record treatment and plans, the scope of the data elements was derived from the ASCO Breast Adjuvant Treatment Plan and Summary form, which is a paper form that records demographic, general medical, family, treatment, and plan history for a patient with moderately advanced stage breast cancer. This particular subgroup of cancer patients is an ideal use case as most of the diagnostic and treatment approaches used in cancer are represented.Current ProjectThis project developed a high-priority set of clinical oncology templates for CDA. This document describes constraints on the CDA R2 header and body elements for the Clinical Oncology Treatment Plan and Summary document in the US Realm. The CDA document communicates a basic set of patient oncology-related information, including health status and treatment plans. It is utilized by health care providers as a summary of plan and treatment received at the time the record was created. It may not contain all the details to provide care, as it is not intended to be used when a patient is discharged or transferred from one facility to another, or to contain detailed specialty-specific information. The Clinical Oncology Treatment Plan and Summary document serves as a form of on-going communication to augment the coordination of care between health care providers while a patient is receiving care. Providers involved in the care of the patient may include the patient’s primary care provider, medical oncologist, surgical oncologist, and radiation oncologist.The project reuses information available in electronic health record systems through the development of cancer-specific data standards. The library of templates in this implementation guide ranges from detailed data elements, such as tumor stage, to sections, such as Plan of Care which can contain full notes from a report by a medical oncologist. The CDA architecture and use of a template library encourages greater capture and exchange of structured data. Standardization of information in this form promotes interoperability and creates information suitable for reuse in quality measurement, public health, research, and reimbursement Organization of This GuideThis guide includes a set of CDA templates and prescribes their use within a Clinical Oncology Treatment Plan and Summary document. The main chapters are:Chapter 2: Document Level Templates defines the document constraints that apply to Clinical Oncology Treatment Plan and Summary.Chapter 3: Section-Level Templates defines the section templates in Clinical Oncology Treatment Plan and Summary.Chapter 4: Entry-Level Templates Entry-Level Templates defines the entry template in Clinical Oncology Treatment Plan and Summary.Conformance Conventions Used in This GuideErrata or EnhancementsComments regarding errata or enhancements may be noted on the HL7 DSTU Comments page: . This implementation guide references several templates that have been balloted and published elsewhere. The Previously Published Templates appendix lists these templates.Templates and Conformance Statements Conformance statements within this implementation guide are presented as constraints from Trifolia Workbench. An algorithm converts constraints recorded in Trifolia to a printable presentation. Each constraint is uniquely identified by an identifier at or near the end of the constraint (e.g., CONF:7345). These identifiers are persistent but not sequential. Bracketed information following each template title indicates the template type (section, observation, act, procedure, etc.), the templateId, and whether the template is open or closed. Section and entry templates in the guide also include context tables and constraint overview tables. In the context tables, the "Used By" column indicates which documents or sections use this template, and the "Contains Entries" column indicates any entries that the template uses. Constraint overview tables summarize the constraints following the table. Value set tables, where applicable, and brief XML example figures are included with most explanations.A typical template, as presented in this guide, is shown in the Constraints format example figure below. The next sections describe specific aspects of conformance statements—open vs. closed statements, conformance verbs, cardinality, vocabulary conformance, containment relationships, and null flavors.16637023114000Figure SEQ Figure \* ARABIC 2: Constraints format exampleSeverity Observation[observation: templateId 2.16.840.1.113883.10.20.22.4.8(open)]Table xxx: Severity Observation ContextsUsed By:Contains Entries:Reaction Observation (optional)Allergy - Intolerance Observation (optional)Substance or Device Allergy - Intolerance Observation (required)This clinical statement represents the the gravity of the problem, such as allergy or reaction, …Table yyy: Severity Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.8']@classCode1..1SHALL73452.16.840.1.113883.5.6 (HL7ActClass) = OBS…SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:7345).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 ActMood) STATIC (CONF:7346).SHALL contain exactly one [1..1] templateId (CONF:7347) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.8" (CONF:10525).SHALL contain exactly one [1..1] code="SEV" Severity Observation (CodeSystem: 2.16.840.1.113883.5.4 ActCode) STATIC (CONF:7349). SHOULD contain zero or one [0..1] text (CONF:7350).This text, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:7351).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:7378).…Open and Closed TemplatesIn open templates, all of the features of the CDA R2 base specification are allowed except as constrained by the templates. By contrast, a closed template specifies everything that is allowed and nothing further may be included. Templates included in the Clinical Oncology Treatment Plan and Summary are open.KeywordsThe keywords shall, should, may, need not, should not, and shall not in this document are to be interpreted as described in the HL7 Version 3 Publishing Facilitator's Guide: shall: an absolute requirementshall not: an absolute prohibition against inclusionshould/should not: best practice or recommendation. There may be valid reasons to ignore an item, but the full implications must be understood and carefully weighed before choosing a different coursemay/need not: truly optional; can be included or omitted as the author decides with no implications Cardinality The cardinality indicator (0..1, 1..1, 1..*, etc.) specifies the allowable occurrences within a document instance. The cardinality indicators are interpreted with the following format “m…n” where m represents the least and n the most:0..1 zero or one 1..1 exactly one1..* at least one 0..* zero or more1..n at least one and not more than nWhen a constraint has subordinate clauses, the scope of the cardinality of the parent constraint must be clear. In the next figure, the constraint says exactly one participant is to be present. The subordinate constraint specifies some additional characteristics of that participant.Figure SEQ Figure \* ARABIC 3: Constraints format – only one allowed1. SHALL contain exactly one [1..1] participant (CONF:2777). a. This participant SHALL contain exactly one [1..1] @typeCode="LOC" (CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType) (CONF:2230).In the next figure, the constraint says only one participant “like this” is to be present. Other participant elements are not precluded by this constraint.Figure SEQ Figure \* ARABIC 4: Constraints format – only one like this allowed1. SHALL contain exactly one [1..1] participant (CONF:2777) such that it a. SHALL contain exactly one [1..1] @typeCode="LOC" (CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType) (CONF:2230).Vocabulary Conformance The templates in this document use terms from several code systems. These vocabularies are defined in various supporting specifications and may be maintained by other bodies, as is the case for the LOINC? and SNOMED CT? vocabularies.Note that value-set identifiers (e.g., ValueSet 2.16.840.1.113883.1.11.78 Observation Interpretation (HL7) DYNAMIC) do not appear in CDA submissions; they tie the conformance requirements of an implementation guide to the appropriate code system for validation. Value-set bindings adhere to HL7 Vocabulary Working Group best practices, and include both a conformance verb (shall, should, may, etc.) and an indication of dynamic vs. static binding. Value-set constraints can be static, meaning that they are bound to a specified version of a value set, or dynamic, meaning that they are bound to the most current version of the value set. A simplified constraint, used when the binding is to a single code, includes the meaning of the code, as follows.Figure SEQ Figure \* ARABIC 5: Binding to a single code 1. … code/@code="11450-4" Problem List (CodeSystem: 2.16.840.1.113883.6.1 LOINC).The notation conveys the actual code (11450-4), the code’s displayName (Problem List), the OID of the codeSystem from which the code is drawn (2.16.840.1.113883.6.1), and the codeSystemName (LOINC).HL7 Data Types Release 1 requires the codeSystem attribute unless the underlying data type is “Coded Simple” or “CS”, in which case it is prohibited. The displayName and the codeSystemName are optional, but recommended, in all cases. The above example would be properly expressed as follows.Figure SEQ Figure \* ARABIC 6: XML expression of a single-code binding<code code="11450-4" codeSystem="2.16.840.1.113883.6.1"/> <!-- or --><code code="11450-4" codeSystem="2.16.840.1.113883.6.1" displayName="Problem List" codeSystemName=”LOINC”/>A full discussion of the representation of vocabulary is outside the scope of this document; for more information, see the HL7 Version 3 Interoperability Standards, Normative Edition 2010 sections on Abstract Data Types and XML Data Types R1.There is a discrepancy in the implementation of translation code versus the original code between HL7 Data Types R1 and the convention agreed upon for this specification. The R1 data type requires the original code in the root. This implementation guide specifies the standard code in the root, whether it is original or a translation. This discrepancy is resolved in HL7 Data Types R2.Figure SEQ Figure \* ARABIC 7: Translation code example<code code='206525008’ displayName='neonatal necrotizing enterocolitis' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'> <translation code='NEC-1' displayName='necrotizing enterocolitis' codeSystem='2.16.840.1.113883.19'/></code>Null Flavor Information technology solutions store and manage data, but sometimes data are not available: an item may be unknown, not relevant, or not computable or measureable. In HL7, a flavor of null, or nullFlavor, describes the reason for missing data.?For example, if a patient arrives at an Emergency Department unconscious and with no identification, we would use a null flavor to represent the lack of information. The patient’s birth date would be represented with a null flavor of “NAV”, which is the code for “temporarily unavailable”. When the patient regains consciousness or a relative arrives, we expect to know the patient’s birth date.Figure SEQ Figure \* ARABIC 8: nullFlavor example<birthTime nullFlavor=”NAV”/> <!--coding an unknown birthdate-->Use null flavors for unknown, required, or optional attributes: NI No information. This is the most general and default null flavor.NA Not applicable. Known to have no proper value (e.g., last menstrual period for a male).UNK Unknown. A proper value is applicable, but is not known.ASKU Asked, but not known. Information was sought, but not found (e.g., the patient was asked but did not know).NAV Temporarily unavailable. The information is not available, but is expected to be available later.NASK Not asked. The patient was not asked.MSKThere is information on this item available but it has not been provided by the sender due to security, privacy, or other reasons. There may be an alternate mechanism for gaining access to this information.This above list contains those null flavors that are commonly used in clinical documents. For the full list and descriptions, see the nullFlavor vocabulary domain in the CDA normative edition. Any SHALL conformance statement may use nullFlavor, unless the attribute is required or the nullFlavor is explicitly disallowed. SHOULD and MAY conformance statement may also use nullFlavor.Figure SEQ Figure \* ARABIC 9: Attribute required1. SHALL contain exactly one [1..1] code/@code="11450-4" Problem List (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:7878) or 2. SHALL contain exactly one [1..1] effectiveTime/@value (CONF:5256).Figure SEQ Figure \* ARABIC 10: Allowed nullFlavors when element is required (with xml examples)1. SHALL contain at least one [1..*] id 2. SHALL contain exactly one [1..1] code 3. SHALL contain exactly one [1..1] effectiveTime<entry> <observation classCode="OBS" moodCode="EVN"> <id nullFlavor="NI"/> <code nullFlavor="OTH"> <originalText>New Grading system</originalText> </code> <statusCode code="completed"/> <effectiveTime nullFlavor="UNK"/> <value xsi:type="CD" nullFlavor="NAV"> <originalText>Spiculated mass grade 5</originalText> </value> </observation></entry>Figure SEQ Figure \* ARABIC 11: nullFlavor explicitly disallowed1. SHALL contain exactly one [1..1] effectiveTime (CONF:5256). a. SHALL NOT contain [0..0] nullFlavor (CONF:52580).Unknown InformationIf a sender wants to state that a piece of information is unknown, the following principles apply:1.If the sender doesn’t know an attribute of an act, that attribute can be null.Figure SEQ Figure \* ARABIC 12: Unknown medication example<entry> <text>patient was given a medication but I do not know what it was</text> <substanceAdministration moodCode="EVN" classCode="SBADM"> <consumable> <manufacturedProduct> <manufacturedLabeledDrug> <code nullFlavor="NI"/> </manufacturedLabeledDrug> </manufacturedProduct> </consumable> </substanceAdministration></entry>2.If the sender doesn’t know if an act occurred, the nullFlavor is on the act (detail could include specific allergy, drug, etc.).Figure SEQ Figure \* ARABIC 13: Unkown medication use of anticoagulant drug example<entry> <substanceAdministration moodCode="EVN" classCode="SBADM" nullFlavor="NI"> <text>I do not know whether or not patient received an anticoagulant drug</text> <consumable> <manufacturedProduct> <manufacturedLabeledDrug> <code code="81839001" displayName="anticoagulant drug" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> </manufacturedLabeledDrug> </manufacturedProduct> </consumable> </substanceAdministration></entry>3. If the sender wants to state ‘no known’, a negationInd can be used on the corresponding act (substanceAdministration, procedure, etc.)Figure SEQ Figure \* ARABIC 14: No known medications example<entry> <substanceAdministration moodCode="EVN" classCode="SBADM" negationInd=”true”> <text>No known medications</text> <consumable> <manufacturedProduct> <manufacturedLabeledDrug> <code code="410942007" displayName="drug or medication" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> </manufacturedLabeledDrug> </manufacturedProduct> </consumable> </substanceAdministration></entry>Asserting an Act Did Not Occur with a ReasonThe negationInd attribute, if true, specifies that the act indicated was observed to not have occurred (which is subtly but importantly different from having not been observed). NegationInd='true' is an acceptable way to make a clinical assertion that something did not occur, for example, "no gestational diabetes".A nested reason for the act not being done can be represented through the use of an entryRelationship clinical statement with an actRelationship type of “RSON”.Figure SEQ Figure \* ARABIC 15: Asserting an act did not occur with reason<entry> <substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="true"> <templateId root="2.16.840.1.113883.10.20.22.4.52"/> <statusCode code="completed"/> <effectiveTime nullFlavor="NI"/> <doseQuantity nullFlavor="NI"/> <consumable> <manufacturedProduct> <templateId root="2.16.840.1.113883.10.20.22.4.54"/> <!-- ******** Immunization Medication Information ******** --> <manufacturedMaterial> <code code="88" codeSystem="2.16.840.1.113883.6.59" displayName="Influenza virus vaccine" codeSystemName="CVX"> </code> </manufacturedMaterial> </manufacturedProduct> </consumable> <entryRelationship typeCode="RSON"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.24.3.88"/> <code code="410666004" codeSystem="2.16.840.1.113883.6.96" displayName="reason" codeSystemName="SNOMED CT"/> <value xsi:type="CD" code="275984001" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Immunization refused"/> </observation> </entryRelationship> </substanceAdministration></entry>Data TypesAll data types used in a CDA document are described in the CDA R2 normative edition. All attributes of a data type are allowed unless explicitly prohibited by this specification.XML Conventions Used in This GuideXPath Notation Instead of the traditional dotted notation used by HL7 to represent Reference Information Model (RIM) classes, this document uses XML Path Language (XPath) notation in conformance statements and elsewhere to identify the Extensible Markup Language (XML) elements and attributes within the CDA document instance to which various constraints are applied. The implicit context of these expressions is the root of the document. This notation provides a mechanism that will be familiar to developers for identifying parts of an XML document.Xpath statements appear in this document in a monospace font.XPath syntax selects nodes from an XML document using a path containing the context of the node(s). The path is constructed from node names and attribute names (prefixed by a ‘@’) and catenated with a ‘/’ symbol. Figure SEQ Figure \* ARABIC 16: XML document example<author> <assignedAuthor> ... <code codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT' code='17561000' displayName='Cardiologist' /> </assignedAuthor></author>In the above example, the code attribute of the code could be selected with the XPath expression in the next figure.Figure SEQ Figure \* ARABIC 17: XPath expression exampleauthor/assignedAuthor/code/@codeXML Examples and Sample DocumentsExtensible Mark-up Language (XML) examples appear in figures in this document in this monospace font. Portions of the XML content may be omitted from the content for brevity, marked by an ellipsis (...) as shown in the example below.Figure SEQ Figure \* ARABIC 18: ClinicalDocument example<ClinicalDocument xmls="urn:h17-org:v3"> ...</ClinicalDocument>Within the narrative, XML element (code, assignedAuthor, etc.) and attribute (SNOMED CT, 17561000, etc.) names also appear in this monospace font. This package includes complete sample documents as listed in the Content of the Package table below. Content of the PackageThe following files comprise this package.Table SEQ Table \* ARABIC 1: Content of the PackageFilenameDescriptionApplicabilityCDAR2_IG_CLONDATA_R1_2013OCT.docxThis implementation guideNormativeASCO_BCTPS.xmlThe sample CDA XML file that includes examples Oncology Treatment Plan and Summary specific templates discussed in this rmativeCDA.xslA CDA stylesheet for display of BCTPS instancesInformativeCancer_Treatment_Plan_and_Summary_(Breast).schISO schematron using XPath 1 to validate Oncology Treatment Plan and Summary CDA instances against implementation guide-specific constraints.?Informativevoc xml Here is some example text: Listing of value sets used in this implementation guide in XML formatInformativeDocument-Level TemplatesUS Realm Header [ClinicalDocument: templateId 2.16.840.1.113883.10.20.22.1.1(open)]This section describes constraints that apply to the header for all documents within the scope of this implementation guide. Header constraints specific to each document type are described in the appropriate document-specific section below.NBSHALL contain exactly one [1..1] realmCode="US" (CONF:16791).SHALL contain exactly one [1..1] typeId (CONF:5361).This typeId SHALL contain exactly one [1..1] @root="2.16.840.1.113883.1.3" (CONF:5250).This typeId SHALL contain exactly one [1..1] @extension="POCD_HD000040" (CONF:5251).SHALL contain exactly one [1..1] templateId (CONF:5252) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.1.1" (CONF:10036).SHALL contain exactly one [1..1] id (CONF:5363).This id SHALL be a globally unique identifier for the document (CONF:9991).SHALL contain exactly one [1..1] code (CONF:5253).This code SHALL specify the particular kind of document (e.g. History and Physical, Discharge Summary, Progress Note) (CONF:9992).SHALL contain exactly one [1..1] title (CONF:5254).Can either be a locally defined name or the display name corresponding to clinicalDocument/code (CONF:5255).SHALL contain exactly one [1..1] effectiveTime (CONF:5256).The content SHALL be a conformant US Realm Date and Time (DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4) (CONF:16865).SHALL contain exactly one [1..1] confidentialityCode, which SHOULD be selected from ValueSet HL7 BasicConfidentialityKind 2.16.840.1.113883.1.11.16926 STATIC 2010-04-21 (CONF:5259).SHALL contain exactly one [1..1] languageCode, which SHALL be selected from ValueSet Language 2.16.840.1.113883.1.11.11526 DYNAMIC (CONF:5372).MAY contain zero or one [0..1] setId (CONF:5261).If setId is present versionNumber SHALL be present (CONF:6380).MAY contain zero or one [0..1] versionNumber (CONF:5264).If versionNumber is present setId SHALL be present (CONF:6387).Table SEQ Table \* ARABIC 2: Basic Confidentiality Kind Value SetValue Set: HL7 BasicConfidentialityKind 2.16.840.1.113883.1.11.16926 STATIC 2010-04-21Code System(s):Confidentiality Code 2.16.840.1.113883.5.25 Description: This value sets contains codes that indicate the access rules for the entire document.Reference: (membership required)CodeCode SystemPrint NameN Confidentiality CodeNormalRConfidentiality CodeRestricted VConfidentiality CodeVery Restricted Table SEQ Table \* ARABIC 3: Language Value Set (excerpt)Value Set: Language 2.16.840.1.113883.1.11.11526 DYNAMICCode System(s):Internet Society Language 2.16.840.1.113883.1.11.11526Description:This value sets contains codes defined by Internet RFC 4646 (replacing RFC 3066). Please see ISO 639 language code set maintained by Library of Congress for enumeration of language codes. Specific Reference: CodeCode SystemPrint NameenInternet Society LanguageenglishfrInternet Society LanguagefrencharInternet Society Languagearabicen-USInternet Society LanguageEnglish, USes-USInternet Society LanguageSpanish, US…Figure SEQ Figure \* ARABIC 19: US Realm Header example<realmCode code="US"/> <typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040"/> <!-- US General Header Template --> <templateId root="2.16.840.1.113883.10.20.22.1.1"/> <!-- *** Note: The next templateId, code and title will differ depending on what type of document is being sent. *** --> <!-- conforms to the document specific requirements --> <templateId root="2.16.840.1.113883.10.20.22.1.2"/> <id extension="TT988" root="2.16.840.1.113883.19.5.99999.1"/> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="34133-9" displayName="Summarization of Episode Note"/> <title>Community Health and Hospitals: Health Summary</title> <effectiveTime value="201209150000-0400"/> <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25"/> <languageCode code="en-US"/> <setId extension="sTT988" root="2.16.840.1.113883.19.5.99999.19"/> <versionNumber value="1"/>Figure SEQ Figure \* ARABIC 20: effectiveTime with time zone example<!-- the syntax is "YYYYMMDDHHMMSS.UUUU[+|-ZZzz]" where digits can be omitted the right side to express less precision. --><effectiveTime value=”201107061227-08”/><!-- July 6, 2011, 12:27, 8 hours before UTC -->recordTargetThe recordTarget records the patient whose health information is described by the clinical document; it must contain at least one patientRole element. contain at least one [1..*] recordTarget (CONF:5266).Such recordTargets SHALL contain exactly one [1..1] patientRole (CONF:5267).This patientRole SHALL contain at least one [1..*] id (CONF:5268).This patientRole SHALL contain at least one [1..*] addr (CONF:5271).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10412).This patientRole SHALL contain at least one [1..*] telecom (CONF:5280).Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:5375).patientThis patientRole SHALL contain exactly one [1..1] patient (CONF:5283).This patient SHALL contain exactly one [1..1] name (CONF:5284).The content of name SHALL be a conformant US Realm Patient Name (PTN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1) (CONF:10411).This patient SHALL contain exactly one [1..1] administrativeGenderCode, which SHALL be selected from ValueSet Administrative Gender (HL7 V3) 2.16.840.1.113883.1.11.1 DYNAMIC (CONF:6394).This patient SHALL contain exactly one [1..1] birthTime (CONF:5298).SHALL be precise to year (CONF:5299).SHOULD be precise to day (CONF:5300).This patient SHOULD contain zero or one [0..1] maritalStatusCode, which SHALL be selected from ValueSet Marital Status Value Set 2.16.840.1.113883.1.11.12212 DYNAMIC (CONF:5303).This patient MAY contain zero or one [0..1] religiousAffiliationCode, which SHALL be selected from ValueSet Religious Affiliation Value Set 2.16.840.1.113883.1.11.19185 DYNAMIC (CONF:5317).This patient MAY contain zero or one [0..1] raceCode, which SHALL be selected from ValueSet Race Value Set 2.16.840.1.113883.1.11.14914 DYNAMIC (CONF:5322).This patient MAY contain zero or one [0..1] ethnicGroupCode, which SHALL be selected from ValueSet EthnicityGroup 2.16.840.1.114222.4.11.837 DYNAMIC (CONF:5323).guardianThis patient MAY contain zero or more [0..*] guardian (CONF:5325).The guardian, if present, SHOULD contain zero or one [0..1] code, which SHALL be selected from ValueSet PersonalRelationshipRoleType 2.16.840.1.113883.1.11.19563 DYNAMIC (CONF:5326).The guardian, if present, SHOULD contain zero or more [0..*] addr (CONF:5359).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10413).The guardian, if present, MAY contain zero or more [0..*] telecom (CONF:5382).The telecom, if present, SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:7993).The guardian, if present, SHALL contain exactly one [1..1] guardianPerson (CONF:5385).This guardianPerson SHALL contain at least one [1..*] name (CONF:5386).The content of name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10414).birthplaceThis patient MAY contain zero or one [0..1] birthplace (CONF:5395).The birthplace, if present, SHALL contain exactly one [1..1] place (CONF:5396).This place SHALL contain exactly one [1..1] addr (CONF:5397).This addr SHOULD contain zero or one [0..1] country, which SHALL be selected from ValueSet CountryValueSet 2.16.840.1.113883.3.88.12.80.63 DYNAMIC (CONF:5404).This addr MAY contain zero or one [0..1] postalCode, which SHALL be selected from ValueSet PostalCodeValueSet 2.16.840.1.113883.3.88.12.80.2 DYNAMIC (CONF:5403).If country is US, this addr SHALL contain exactly one [1..1] state, which SHALL be selected from ValueSet 2.16.840.1.113883.3.88.12.80.1 StateValueSet DYNAMIC (CONF:5402).languageCommunicationThis patient SHOULD contain zero or more [0..*] languageCommunication (CONF:5406).The languageCommunication, if present, SHALL contain exactly one [1..1] languageCode, which SHALL be selected from ValueSet Language 2.16.840.1.113883.1.11.11526 DYNAMIC (CONF:5407).The languageCommunication, if present, MAY contain zero or one [0..1] modeCode, which SHALL be selected from ValueSet LanguageAbilityMode Value Set 2.16.840.1.113883.1.11.12249 DYNAMIC (CONF:5409).The languageCommunication, if present, SHOULD contain zero or one [0..1] proficiencyLevelCode, which SHALL be selected from ValueSet LanguageAbilityProficiency 2.16.840.1.113883.1.11.12199 DYNAMIC (CONF:9965).The languageCommunication, if present, MAY contain zero or one [0..1] preferenceInd (CONF:5414).This patient MAY contain zero or more [0..*] sdtc:raceCode, where the @code SHALL be selected from ValueSet Race Value Set 2.16.840.1.113883.1.11.14914 DYNAMIC (CONF:7263).providerOrganizationThis patientRole MAY contain zero or one [0..1] providerOrganization (CONF:5416).The providerOrganization, if present, SHALL contain at least one [1..*] id (CONF:5417).Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:16820).The providerOrganization, if present, SHALL contain at least one [1..*] name (CONF:5419).The providerOrganization, if present, SHALL contain at least one [1..*] telecom (CONF:5420).Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:7994).The providerOrganization, if present, SHALL contain at least one [1..*] addr (CONF:5422).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10415).recordTarget Value SetsTable SEQ Table \* ARABIC 4: Telecom Use (US Realm Header) Value SetValue Set: Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMICCode System(s):AddressUse 2.16.840.1.113883.5.1119Description:An value set of codes that represent the type of telephone number. Reference: (membership required)CodeCode SystemPrint NameHPAddressUseprimary homeWPAddressUsework placeMCAddressUsemobile contactHVAddressUsevacation homeTable SEQ Table \* ARABIC 5: Administrative Gender (HL7) Value SetValue Set: Administrative Gender (HL7 V3) 2.16.840.1.113883.1.11.1 DYNAMICCode System(s): AdministrativeGender 2.16.840.1.113883.5.1Description: This value sets contains codes that includes concepts describing gender.Reference: (membership required)CodeCode SystemPrint NameFAdministrativeGenderFemaleMAdministrativeGenderMaleUNAdministrativeGenderUndifferentiatedTable SEQ Table \* ARABIC 6: Marital Status Value SetValue Set: HL7 Marital Status 2.16.840.1.113883.1.11.12212 DYNAMICCode System(s):MaritalStatus 2.16.840.1.113883.5.2Description: This value set contains codes that represent the status of a relationship with a significant other.Reference: (membership required)CodeCode SystemPrint NameA MaritalStatusAnnulled D MaritalStatusDivorced I MaritalStatusInterlocutory L MaritalStatusLegally Separated M MaritalStatusMarried P MaritalStatusPolygamous S MaritalStatusNever Married T MaritalStatusDomestic partner W MaritalStatusWidowed Table SEQ Table \* ARABIC 7: Religious Affiliation Value Set (excerpt)Value Set: HL7 Religious Affiliation 2.16.840.1.113883.1.11.19185 DYNAMICCode System(s):ReligiousAffiliation 2.16.840.1.113883.5.1076 Description:This value set contains codes that reflect spiritual faith affiliation.Reference: (membership required)CodeCode SystemPrint Name1026ReligiousAffiliationJudaism1020ReligiousAffiliationHinduism1041ReligiousAffiliationRoman Catholic Church…Table SEQ Table \* ARABIC 8: Race Value Set (excerpt)Value Set: Race 2.16.840.1.113883.1.11.14914 DYNAMICCode System(s):Race and Ethnicity - CDC 2.16.840.1.113883.6.238Description:This value set contains codes that include the 5 minimum categories for race specified by OMB along with a more detailed set of race categories used by the Bureau of Census. Reference: CodeCode SystemPrint Name1002-5Race and Ethnicity- CDCAmerican Indian or Alaska Native2028-9Race and Ethnicity- CDCAsian2054-5Race and Ethnicity- CDCBlack or African American2076-8Race and Ethnicity- CDCNative Hawaiian or Other Pacific Islander2106-3Race and Ethnicity- CDCWhite...Table SEQ Table \* ARABIC 9: Ethnicity Value SetValue Set: Ethnicity Group Value Set 2.16.840.1.114222.4.11.837 DYNAMICCode System(s):Race and Ethnicity - CDC 2.16.840.1.113883.6.238Description: This value set contains codes that represent whether or not a patient is of Hispanic or Latino descent. Reference: SystemPrint Name2135-2Race and Ethnicity Code SetsHispanic or Latino2186-5Race and Ethnicity Code SetsNot Hispanic or LatinoTable SEQ Table \* ARABIC 10: Personal Relationship Role Type Value Set (excerpt)Value Set: Personal Relationship Role Type 2.16.840.1.113883.1.11.19563 DYNAMICCode System(s):RoleCode 2.16.840.1.113883.5.111Description:This value set contains codes that represent types of personal relationships between two human beings.Reference: CodeCode SystemPrint NameHUSBRoleCodehusbandWIFERoleCodewifeFRNDRoleCodefriendSISINLAWRoleCodesister-in-law…Table SEQ Table \* ARABIC 11: State Value Set (excerpt)Value Set: StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMICCode System(s):FIPS 5-2 (State) 2.16.840.1.113883.6.92Description:This value set contains Codes for the Identification of the US States, the District of Columbia and the Outlying Areas of the United States, and includes Associated Areas Publication # 5-2, May, 1987Reference: CodeCode SystemPrint NameALFIPS 5-2 (State Alpha Codes)AlabamaAKFIPS 5-2 (State Alpha Codes)AlaskaAZFIPS 5-2 (State Alpha Codes)ArizonaARFIPS 5-2 (State Alpha Codes)Arkansas…Table SEQ Table \* ARABIC 12: Postal Code Value Set (excerpt)Value Set: PostalCodeValueSet 2.16.840.1.113883.3.88.12.80.2 DYNAMICCode System(s):US Postal Codes 2.16.840.1.113883.6.231Description:This value set contains postal (ZIP) code of an address in the United States.Reference: SystemPrint Name19009US Postal CodesBryn Athyn, PA92869-1736US Postal CodesOrange, CA32830-8413US Postal CodesLake Buena Vista, FL …Table SEQ Table \* ARABIC 13: Country Value Set (excerpt)Value Set: CountryValueSet 2.16.840.1.113883.3.88.12.80.63 DYNAMICCode System(s):ISO 3166-1 Country Codes: 1.0.3166.1Description:This value set contains codes that represent names of countries, territories, and defined of geographical areas.Reference: SystemPrint NameAWISO 3166-1 Country CodesArubaILISO 3166-1 Country CodesIsraelKZISO 3166-1 Country CodesKazakhstanUSISO 3166-1 Country CodesUnited States…Table SEQ Table \* ARABIC 14: Language Ability Value SetValue Set: HL7 LanguageAbilityMode 2.16.840.1.113883.1.11.12249 DYNAMICCode System(s):LanguageAbilityMode 2.16.840.1.113883.5.60Description:This value set contains codes that represent an individual’s language ability and method of expression.Reference: (members only)CodeCode SystemPrint NameESGN LanguageAbilityModeExpressed signed ESP LanguageAbilityModeExpressed spoken EWR LanguageAbilityModeExpressed written RSGN LanguageAbilityModeReceived signed RSP LanguageAbilityModeReceived spoken RWR LanguageAbilityModeReceived written Table SEQ Table \* ARABIC 15: Language Ability Proficiency Value SetValue Set: LanguageAbilityProficiency 2.16.840.1.113883.1.11.12199 DYNAMICCode System(s):LanguageAbilityProficiency 2.16.840.1.113883.5.61Description:This value set contains codes that represent the level of proficiency in a language.Reference: (members only)CodeCode SystemPrint NameELanguageAbilityProficiencyExcellentFLanguageAbilityProficiencyFairGLanguageAbilityProficiencyGoodPLanguageAbilityProficiencyPoorrecordTarget ExampleFigure SEQ Figure \* ARABIC 21: recordTarget example<recordTarget> <patientRole> <id extension="998991" root="2.16.840.1.113883.19.5.99999.2"/> <!-- Fake ID using HL7 example OID. --> <id extension="111-00-2330" root="2.16.840.1.113883.4.1"/> <!-- Fake Social Security Number using the actual SSN OID. --> <addr use="HP"> <!-- HP is "primary home" from codeSystem 2.16.840.1.113883.5.1119 --> <streetAddressLine>1000 Home Drive</streetAddressLine> <city>Blue Bell</city> <state>MA</state> <postalCode>02368</postalCode> <country>US</country> <!-- US is "United States" from ISO 3166-1 Country Codes: 1.0.3166.1 --> </addr> <telecom value="tel:(555)555-1212" use="HP"/> <!-- HP is "primary home" from HL7 AddressUse 2.16.840.1.113883.5.1119 --> <patient> <name use="L"> <!-- L is "Legal" from HL7 EntityNameUse 2.16.840.1.113883.5.45 --> <given>Eve</given> <!-- CL is "Call me" from HL7 EntityNamePartQualifier 2.16.840.1.113883.5.43 --> <family>Everywomen</family> </name> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/> <birthTime value="20050501"/> <maritalStatusCode code="M" displayName="Married" codeSystem="2.16.840.1.113883.5.2" codeSystemName="MaritalStatusCode"/> <religiousAffiliationCode code="1013" displayName="Christian (non-Catholic, non-specific)" codeSystemName="HL7 Religious Affiliation" codeSystem="2.16.840.1.113883.5.1076"/> <raceCode code="1966-1" displayName="Aleut" codeSystem="2.16.840.1.113883.6.238" codeSystemName="Race &amp; Ethnicity - CDC"/> <ethnicGroupCode code="2186-5" displayName="Not Hispanic or Latino" codeSystem="2.16.840.1.113883.6.238" codeSystemName="Race &amp; Ethnicity - CDC"/> <guardian> <code code="GRPRN" displayName="GrandParent" codeSystem="2.16.840.1.113883.5.111" codeSystemName="HL7 Role code"/> <addr use="HP"> <!-- HP is "primary home" from codeSystem 2.16.840.1.113883.5.1119 --> <streetAddressLine>1357 Amber Drive</streetAddressLine> <city>Beaverton</city> <state>OR</state> <postalCode>97867</postalCode> <country>US</country> <!-- US is "United States" from ISO 3166-1 Country Codes: 1.0.3166.1 --> </addr> <telecom value="tel:(816)276-6909" use="HP"/> <guardianPerson> <name> <given>Ralph</given> <family>Jones</family> </name> </guardianPerson> </guardian> <birthplace> <place> <addr> <city>Beaverton</city> <state>OR</state> <postalCode>97867</postalCode> <country>US</country> </addr> </place> </birthplace> <languageCommunication> <languageCode code="en"/> <modeCode code="ESP" displayName="Expressed spoken" codeSystem="2.16.840.1.113883.5.60" codeSystemName="LanguageAbilityMode"/> <preferenceInd value="true"/> </languageCommunication> </patient> <providerOrganization> <id root="2.16.840.1.113883.19.5.9999.1393"/> <name>Community Health and Hospitals</name> <telecom use="WP" value="tel: 555-555-5000"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> </providerOrganization> </patientRole></recordTarget>authorThe author element represents the creator of the clinical document. The author may be a device, or a person. SHALL contain at least one [1..*] author (CONF:5444).Such authors SHALL contain exactly one [1..1] time (CONF:5445).The content SHALL be a conformant US Realm Date and Time (DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4) (CONF:16866).Such authors SHALL contain exactly one [1..1] assignedAuthor (CONF:5448).This assignedAuthor SHALL contain exactly one [1..1] id (CONF:5449) such that itSHALL contain exactly one [1..1] @root (CONF:16786).If this assignedAuthor is an assignedPerson the assignedAuthor id SHALL contain exactly one [1..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:19521).This assignedAuthor SHOULD contain zero or one [0..1] code (CONF:16787).The code, if present, SHALL contain exactly one [1..1] @code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) 2.16.840.1.114222.4.11.1066 DYNAMIC (CONF:16788).This assignedAuthor SHALL contain at least one [1..*] addr (CONF:5452).The content SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:16871).This assignedAuthor SHALL contain at least one [1..*] telecom (CONF:5428).Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:7995).This assignedAuthor SHOULD contain zero or one [0..1] assignedPerson (CONF:5430).The assignedPerson, if present, SHALL contain at least one [1..*] name (CONF:16789).The content SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:16872).This assignedAuthor SHOULD contain zero or one [0..1] assignedAuthoringDevice (CONF:16783).The assignedAuthoringDevice, if present, SHALL contain exactly one [1..1] manufacturerModelName (CONF:16784).The assignedAuthoringDevice, if present, SHALL contain exactly one [1..1] softwareName (CONF:16785).There SHALL be exactly one assignedAuthor/assignedPerson or exactly one assignedAuthor/assignedAuthoringDevice (CONF:16790).Table SEQ Table \* ARABIC 16: Healthcare Provider Taxonomy Value SetValue Set: Healthcare Provider Taxonomy (HIPAA) 2.16.840.1.114222.4.11.1066 DYNAMICCode System(s):NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101 Description:This value set contains codes that represent health care professionals.Resources: SystemPrint Name122300000XNUCC Health Care Provider TaxonomyDentist 124Q00000XNUCC Health Care Provider TaxonomyDental Hygienist 126800000XNUCC Health Care Provider TaxonomyDental Assistant/Tech 133V00000XNUCC Health Care Provider TaxonomyDietitian, Registered 146L00000XNUCC Health Care Provider TaxonomyEMT/Paramedic 163W00000XNUCC Health Care Provider TaxonomyRegistered Nurse 163WI0500XNUCC Health Care Provider TaxonomyIVT Team Staff163WI0600XNUCC Health Care Provider TaxonomyInfection Control Professional163WX0106XNUCC Health Care Provider TaxonomyOccupational Health Professional164W00000XNUCC Health Care Provider TaxonomyLicensed Practical Nurse 167G00000XNUCC Health Care Provider TaxonomyPsychiatric Technician 183500000XNUCC Health Care Provider TaxonomyPharmacist 207PE0004XNUCC Health Care Provider TaxonomyOther First Responder227800000XNUCC Health Care Provider TaxonomyRespiratory Therapist/Tech227900000XNUCC Health Care Provider TaxonomyOther Student 246QM0706XNUCC Health Care Provider TaxonomyMedical Technologist 246RP1900XNUCC Health Care Provider TaxonomyPhlebotomist/IV Team 247100000XNUCC Health Care Provider TaxonomyRadiologic Technologist 261QD0000XNUCC Health Care Provider TaxonomyOther Dental Worker 261QP2000XNUCC Health Care Provider TaxonomyPhysical Therapist 261QR1100XNUCC Health Care Provider TaxonomyResearcher 332B00000XNUCC Health Care Provider TaxonomyCentral Supply363A00000XNUCC Health Care Provider TaxonomyPhysician Assistant 363L00000XNUCC Health Care Provider TaxonomyNurse Practitioner 364SC1501XNUCC Health Care Provider TaxonomyPublic Health Worker 367500000XNUCC Health Care Provider TaxonomyNurse Anesthetist367A00000XNUCC Health Care Provider TaxonomyNurse Midwife3747A0650XNUCC Health Care Provider TaxonomyAttendant/orderly376K00000XNUCC Health Care Provider TaxonomyNursing Assistant Figure SEQ Figure \* ARABIC 22: Person author example<author> <time value="20050329224411+0500"/> <assignedAuthor> <id extension="99999999" root="2.16.840.1.113883.4.6"/> <code code="200000000X" codeSystem="2.16.840.1.113883.6.101" displayName="Allopathic &amp; Osteopathic Physicians"/> <addr> <streetAddressLine>1002 Healthcare Drive </streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:555-555-1002"/> <assignedPerson> <name> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedAuthor></author>Figure SEQ Figure \* ARABIC 23: Device author example<author> <time value="20050329224411+0500"/> <assignedAuthor> <id extension="KP00017dev" root="2.16.840.1.113883.19.5"/> <addr> <streetAddressLine>21 North Ave.</streetAddressLine> <city>Burlington</city> <state>MA</state> <postalCode>02368</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:(555)555-1003"/> <assignedAuthoringDevice> <manufacturerModelName>Good Health Medical Device</manufacturerModelName > <softwareName>Good Health Report Generator</softwareName > </ assignedAuthoringDevice > </assignedAuthor></author>dataEntererThe dataEnterer element represents the person who transferred the content, written or dictated by someone else, into the clinical document. The guiding rule of thumb is that an author provides the content found within the header or body of the document, subject to their own interpretation, and the dataEnterer adds that information to the electronic system. In other words, a dataEnterer transfers information from one source to another (e.g., transcription from paper form to electronic system).MAY contain zero or one [0..1] dataEnterer (CONF:5441).The dataEnterer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:5442).This assignedEntity SHALL contain at least one [1..*] id (CONF:5443).Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:16821).This assignedEntity SHALL contain at least one [1..*] addr (CONF:5460).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10417).This assignedEntity SHALL contain at least one [1..*] telecom (CONF:5466).Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:7996).This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:5469).This assignedPerson SHALL contain at least one [1..*] name (CONF:5470).The content of name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10418).This assignedEntity MAY contain zero or one [0..1] code which SHOULD be selected from coding system NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101 (CONF:9944).Figure SEQ Figure \* ARABIC 24: dataEnterer example<dataEnterer> <assignedEntity> <id root="2.16.840.1.113883.4.6" extension="999999943252"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:555-555-1002"/> <assignedPerson> <name> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedEntity></dataEnterer>informantThe informant element describes the source of the information in a medical document.Assigned health care providers may be a source of information when a document is created. (e.g., a nurse's aide who provides information about a recent significant health care event that occurred within an acute care facility.) In these cases, the assignedEntity element is used.When the informant is a personal relation, that informant is represented in the relatedEntity element. The code element of the relatedEntity describes the relationship between the informant and the patient. The relationship between the informant and the patient needs to be described to help the receiver of the clinical document understand the information in the document.MAY contain zero or more [0..*] informant (CONF:8001).The informant, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8002).This assignedEntity SHALL contain at least one [1..*] id (CONF:9945).If assignedEntity/id is a provider then this id, SHOULD include zero or one [0..1] id where id/@root ="2.16.840.1.113883.4.6" National Provider Identifier (CONF:9946).This assignedEntity SHALL contain at least one [1..*] addr (CONF:8220).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10419).This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:8221).This assignedPerson SHALL contain at least one [1..*] name (CONF:8222).The content of name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10420).This assignedEntity MAY contain zero or one [0..1] code which SHOULD be selected from coding system NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101 (CONF:9947).Figure SEQ Figure \* ARABIC 25: informant with assignedEntity example<informant> <assignedEntity> <id extension="KP00017" root="2.16.840.1.113883.19.5"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:555-555-1002"/> <assignedPerson> <name> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedEntity></informant>custodianThe custodian element represents the organization that is in charge of maintaining the document. The custodian is the steward that is entrusted with the care of the document. Every CDA document has exactly one custodian. The custodian participation satisfies the CDA definition of Stewardship. Because CDA is an exchange standard and may not represent the original form of the authenticated document (e.g., CDA could include scanned copy of original), the custodian represents the steward of the original source document. The custodian may be the document originator, a health information exchange, or other responsible party. SHALL contain exactly one [1..1] custodian (CONF:5519).This custodian SHALL contain exactly one [1..1] assignedCustodian (CONF:5520).This assignedCustodian SHALL contain exactly one [1..1] representedCustodianOrganization (CONF:5521).This representedCustodianOrganization SHALL contain at least one [1..*] id (CONF:5522).Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:16822).This representedCustodianOrganization SHALL contain exactly one [1..1] name (CONF:5524).This representedCustodianOrganization SHALL contain exactly one [1..1] telecom (CONF:5525).This telecom SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:7998).This representedCustodianOrganization SHALL contain exactly one [1..1] addr (CONF:5559).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10421).Figure SEQ Figure \* ARABIC 26: custodian example<custodian> <assignedCustodian> <representedCustodianOrganization> <id extension="99999999" root="2.16.840.1.113883.4.6"/> <name>Community Health and Hospitals</name> <telecom value="tel: 555-555-1002" use="WP"/> <addr use="WP"> <streetAddressLine>1002 Healthcare Drive </streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> </representedCustodianOrganization> </assignedCustodian></custodian>informationRecipientThe informationRecipient element records the intended recipient of the information at the time the document is created. For example, in cases where the intended recipient of the document is the patient's health chart, set the receivedOrganization to be the scoping organization for that chart.MAY contain zero or more [0..*] informationRecipient (CONF:5565).The informationRecipient, if present, SHALL contain exactly one [1..1] intendedRecipient (CONF:5566).This intendedRecipient MAY contain zero or one [0..1] informationRecipient (CONF:5567).The informationRecipient, if present, SHALL contain at least one [1..*] name (CONF:5568).The content of name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10427).This intendedRecipient MAY contain zero or one [0..1] receivedOrganization (CONF:5577).The receivedOrganization, if present, SHALL contain exactly one [1..1] name (CONF:5578).Figure SEQ Figure \* ARABIC 27: informationRecipient example<informationRecipient> <intendedRecipient> <informationRecipient> <name> <given>Henry</given> <family>Seven</family> </name> </informationRecipient> <receivedOrganization> <name>Community Health and Hospitals</name> </receivedOrganization> </intendedRecipient></informationRecipient>legalAuthenticatorThe legalAuthenticator identifies the single person legally responsible for the document and must be present if the document has been legally authenticated. (Note that per the following section, there may also be one or more document authenticators.) Based on local practice, clinical documents may be released before legal authentication. This implies that a clinical document that does not contain this element has not been legally authenticated.The act of legal authentication requires a certain privilege be granted to the legal authenticator depending upon local policy. All clinical documents have the potential for legal authentication, given the appropriate credentials.Local policies may choose to delegate the function of legal authentication to a device or system that generates the clinical document. In these cases, the legal authenticator is a person accepting responsibility for the document, not the generating device or system.Note that the legal authenticator, if present, must be a person.SHOULD contain zero or one [0..1] legalAuthenticator (CONF:5579).The legalAuthenticator, if present, SHALL contain exactly one [1..1] time (CONF:5580).The content SHALL be a conformant US Realm Date and Time (DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4) (CONF:16873).The legalAuthenticator, if present, SHALL contain exactly one [1..1] signatureCode (CONF:5583).This signatureCode SHALL contain exactly one [1..1] @code="S" (CodeSystem: Participationsignature 2.16.840.1.113883.5.89 STATIC) (CONF:5584).The legalAuthenticator, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:5585).This assignedEntity SHALL contain at least one [1..*] id (CONF:5586).Such ids MAY contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:16823).This assignedEntity MAY contain zero or one [0..1] code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) 2.16.840.1.114222.4.11.1066 STATIC (CONF:17000).This assignedEntity SHALL contain at least one [1..*] addr (CONF:5589).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10429).This assignedEntity SHALL contain at least one [1..*] telecom (CONF:5595).Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:7999).This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:5597).This assignedPerson SHALL contain at least one [1..*] name (CONF:5598).The content of name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10430).Figure SEQ Figure \* ARABIC 28: legalAuthenticator example<legalAuthenticator> <time value="20090227130000+0500"/> <signatureCode code="S"/> <assignedEntity> <id extension="999999999" root="2.16.840.1.113883.4.6"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:555-555-1002"/> <assignedPerson> <name> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedEntity></legalAuthenticator>authenticatorThe authenticator identifies a participant or participants who attested to the accuracy of the information in the document.MAY contain zero or more [0..*] authenticator (CONF:5607).The authenticator, if present, SHALL contain exactly one [1..1] time (CONF:5608).The content SHALL be a conformant US Realm Date and Time (DTM.US.FIELDED) (2.16.840.1.113883.10.20.22.5.4) (CONF:16874).The authenticator, if present, SHALL contain exactly one [1..1] signatureCode (CONF:5610).This signatureCode SHALL contain exactly one [1..1] @code="S" (CodeSystem: Participationsignature 2.16.840.1.113883.5.89 STATIC) (CONF:5611).The authenticator, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:5612).This assignedEntity SHALL contain at least one [1..*] id (CONF:5613).Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:16824).This assignedEntity MAY contain zero or one [0..1] code (CONF:16825).The code, if present, MAY contain zero or one [0..1] @code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) 2.16.840.1.114222.4.11.1066 STATIC (CONF:16826).This assignedEntity SHALL contain at least one [1..*] addr (CONF:5616).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10425).This assignedEntity SHALL contain at least one [1..*] telecom (CONF:5622).Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:8000).This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:5624).This assignedPerson SHALL contain at least one [1..*] name (CONF:5625).The content of name SHALL be a conformant US Realm Person Name (PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10424).Figure SEQ Figure \* ARABIC 29: authenticator example<authenticator> <time value="20090227130000+0500"/> <signatureCode code="S"/> <assignedEntity> <id extension="999999999" root="2.16.840.1.113883.4.6"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom use="WP" value="tel:555-555-1002"/> <assignedPerson> <name> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedEntity></authenticator>participant (Support)The participant element identifies other supporting participants, including parents, relatives, caregivers, insurance policyholders, guarantors, and other participants related in some way to the patient. A supporting person or organization is an individual or an organization with a relationship to the patient. A supporting person who is playing multiple roles would be recorded in multiple participants (e.g., emergency contact and next-of-kin)MAY contain zero or more [0..*] participant (CONF:10003).The participant, if present, MAY contain zero or one [0..1] time (CONF:10004).Such participants, if present, SHALL have an associatedPerson or scopingOrganization element under participant/associatedEntity (CONF:10006).Unless otherwise specified by the document specific header constraints, when participant/@typeCode is IND, associatedEntity/@classCode SHALL be selected from ValueSet 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes STATIC 2011-09-30 (CONF:10007).Table SEQ Table \* ARABIC 17: IND Role classCode Value SetValue Set: INDRoleclassCodes 2.16.840.1.113883.11.20.9.33 STATIC 2011-09-30Code System(s):RoleClass 2.16.840.1.113883.5.110Description: This value set contains codes that represent types of support people. Reference: (members only)CodeCode SystemPrint NamePRSRoleClasspersonal relationshipNOKRoleClassnext of kinCAREGIVERRoleClasscaregiverAGNTRoleClassagentGUARRoleClassguarantorECONRoleClassemergency contactFigure SEQ Figure \* ARABIC 30: participant example for a supporting person<participant typeCode="IND"> <time xsi:type="IVL_TS"> <low value="19590101"/> <high value="20111025"/> </time> <associatedEntity classCode="NOK"> <code code="MTH" codeSystem="2.16.840.1.113883.5.111"/> <addr> <streetAddressLine>17 Daws Rd.</streetAddressLine> <city>Beaverton</city> <state>OR</state> <postalCode>97867</postalCode> <country>US</country> </addr> <telecom value="tel:(999)555-1212" use="WP"/> <associatedPerson> <name> <prefix>Mrs.</prefix> <given>Martha</given> <family>Jones</family> </name> </associatedPerson> </associatedEntity></participant>inFulfillmentOfThe inFulfillmentOf element represents orders that are fulfilled by this document.MAY contain zero or more [0..*] inFulfillmentOf (CONF:9952).The inFulfillmentOf, if present, SHALL contain exactly one [1..1] order (CONF:9953).This order SHALL contain at least one [1..*] id (CONF:9954).documentationOf/serviceEventA serviceEvent represents the main act, such as a colonoscopy or a cardiac stress study, being documented. In a continuity of care document, CCD, the serviceEvent is a provision of healthcare over a period of time. In a provision of healthcare serviceEvent, the care providers, PCP or other longitudinal providers, are recorded within the serviceEvent. If the document is about a single encounter, the providers associated can be recorded in the componentOf/encompassingEncounter.MAY contain zero or more [0..*] documentationOf (CONF:14835).The documentationOf, if present, SHALL contain exactly one [1..1] serviceEvent (CONF:14836).This serviceEvent SHALL contain exactly one [1..1] effectiveTime (CONF:14837).This effectiveTime SHALL contain exactly one [1..1] low (CONF:14838).This serviceEvent SHOULD contain zero or more [0..*] performer (CONF:14839).The performer, if present, SHALL contain exactly one [1..1] @typeCode (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:14840).The performer participant represents clinicians who actually and principally carry out the serviceEvent. In a transfer of care this represents the healthcare providers involved in the current or pertinent historical care of the patient. Preferably, the patient’s key healthcare care team members would be listed, particularly their primary physician and any active consulting physicians, therapists, and counselors (CONF:16753).The performer, if present, MAY contain zero or one [0..1] functionCode (CONF:16818).The functionCode, if present, SHOULD contain zero or one [0..1] @codeSystem, which SHOULD be selected from CodeSystem participationFunction (2.16.840.1.113883.5.88) STATIC (CONF:16819).The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:14841).This assignedEntity SHALL contain at least one [1..*] id (CONF:14846).Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:14847).This assignedEntity SHOULD contain zero or one [0..1] code (CONF:14842).The code, if present, SHALL contain exactly one [1..1] @code, which SHOULD be selected from CodeSystem NUCCProviderTaxonomy (2.16.840.1.113883.6.101) STATIC (CONF:14843).Figure SEQ Figure \* ARABIC 31: documentationOf example<documentationOf typeCode="DOC"> <serviceEvent classCode="PCPR"> <code code="73761001" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Colonoscopy"/> <effectiveTime> <low value="201209080000-0400"/> <high value="201209150000-0400"/> </effectiveTime> <performer typeCode="PRF"> <functionCode code="PP" displayName="Primary Care Provider" codeSystem="2.16.840.1.113883.12.443" codeSystemName="Provider Role"> <originalText>Primary Care Provider</originalText> </functionCode> <time> <low value="201209080000-0400"/> <high value="201209150000-0400"/> </time> <assignedEntity> <id extension="PseudoMD-1" root="2.16.840.1.113883.4.6"/> <code code="200000000X" displayName="Allopathic and Osteopathic Physicians" codeSystemName="Provider Codes" codeSystem="2.16.840.1.113883.6.101"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom value="tel:+1-555-555-5000" use="WP"/> <assignedPerson> <name> <prefix>Dr.</prefix> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> <representedOrganization> <id root="2.16.840.1.113883.19.5.9999.1393"/> <name>Community Health and Hospitals</name> <telecom value="tel:+1-555-555-5000" use="WP"/> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> </representedOrganization> </assignedEntity> </performer> </serviceEvent></documentationOf>authorization/consentThe header can record information about the patient’s consent.The type of consent (e.g., a consent to perform the related serviceEvent) is conveyed in consent/code. Consents in the header have been finalized (consent/statusCode must equal Completed) and should be on file. This specification does not address how Privacy Consent’ is represented, but does not preclude the inclusion of ‘Privacy Consent’.MAY contain zero or more [0..*] authorization (CONF:16792) such that itSHALL contain exactly one [1..1] consent (CONF:16793).This consent MAY contain zero or more [0..*] id (CONF:16794).This consent MAY contain zero or one [0..1] code (CONF:16795).The type of consent (e.g., a consent to perform the related serviceEvent) is conveyed in consent/code (CONF:16796).This consent SHALL contain exactly one [1..1] statusCode (CONF:16797).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:16798).Figure SEQ Figure \* ARABIC 32: Consent example<authorization typeCode="AUTH"> <consent classCode="CONS" moodCode="EVN"> <id root="629deb70-5306-11df-9879-0800200c9a66" /> <code codeSystem=" 2.16.840.1.113883.6.1" codeSystemName="LOINC" code="64293-4" displayName="Procedure consent"/> <statusCode code="completed"/> </consent></authorization>componentOfThe componentOf element contains the encompassing encounter for this document. The encompassing encounter represents the setting of the clinical encounter during which the document act(s) or ServiceEvent occurred. In order to represent providers associated with a specific encounter, they are recorded within the encompassingEncounter as participants.In a CCD the encompassingEncounter may be used when documenting a specific encounter and its participants. All relevant encounters in a CCD may be listed in the encounters section.MAY contain zero or one [0..1] componentOf (CONF:9955).The componentOf, if present, SHALL contain exactly one [1..1] encompassingEncounter (CONF:9956).This encompassingEncounter SHALL contain at least one [1..*] id (CONF:9959).This encompassingEncounter SHALL contain exactly one [1..1] effectiveTime (CONF:9958).US Realm Address (AD.US.FIELDED)[AD: templateId 2.16.840.1.113883.10.20.22.5.2 (open)]Reusable "address" template, designed for use in US Realm CDA Header.SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet PostalAddressUse 2.16.840.1.113883.1.11.10637 STATIC 2005-05-01 (CONF:7290).SHOULD contain zero or one [0..1] country, where the @code SHALL be selected from ValueSet CountryValueSet 2.16.840.1.113883.3.88.12.80.63 DYNAMIC (CONF:7295).SHOULD contain zero or one [0..1] state (ValueSet: StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMIC) (CONF:7293).State is required if the country is US. If country is not specified, its assumed to be US. If country is something other than US, the state MAY be present but MAY be bound to different vocabularies (CONF:10024).SHALL contain exactly one [1..1] city (CONF:7292).SHOULD contain zero or one [0..1] postalCode (ValueSet: PostalCodeValueSet 2.16.840.1.113883.3.88.12.80.2 DYNAMIC) (CONF:7294).PostalCode is required if the country is US. If country is not specified, its assumed to be US. If country is something other than US, the postalCode MAY be present but MAY be bound to different vocabularies (CONF:10025).SHALL contain at least one and not more than 4 streetAddressLine (CONF:7291).SHALL NOT have mixed content except for white space (CONF:7296).Table SEQ Table \* ARABIC 18: PostalAddressUse Value SetValue Set: PostalAddressUse 2.16.840.1.113883.1.11.10637 STATIC 2005-05-01Code System(s):AddressUse 2.16.840.1.113883.5.1119Description: This value set contains codes that represent different types of addresses.Reference: (members only)CodeCode SystemPrint NameBADAddressUsebad addressDIRAddressUsedirectHAddressUsehome addressHPAddressUseprimary homeHVAddressUsevacation homePHYSAddressUsephysical visit addressPSTAddressUsepostal addressPUBAddressUsepublicTMPAddressUsetemporaryWPAddressUsework placeUS Realm Date and Time (DTM.US.FIELDED)[TS: templateId 2.16.840.1.113883.10.20.22.5.4 (open)]The US Realm Clinical Document Date and Time datatype flavor records date and time information. If no time zone offset is provided, you can make no assumption about time, unless you have made a local exchange agreement.SHALL be precise to the day (CONF:10127).SHOULD be precise to the minute (CONF:10128).MAY be precise to the second (CONF:10129).If more precise than day, SHOULD include time-zone offset (CONF:10130).US Realm Patient Name (PTN.US.FIELDED)[PN: templateId 2.16.840.1.113883.10.20.22.5.1 (open)]The US Realm Patient Name datatype flavor is a set of reusable constraints that can be used for the patient or any other person. It requires a first (given) and last (family) name. If a patient or person has only one name part (e.g., patient with first name only) place the name part in the field required by the organization. Use the appropriate nullFlavor, "Not Applicable" (NA), in the other field.For information on mixed content see the Extensible Markup Language reference ().MAY contain zero or one [0..1] @use, which SHALL be selected from ValueSet EntityNameUse 2.16.840.1.113883.1.11.15913 STATIC 2005-05-01 (CONF:7154).SHALL contain exactly one [1..1] family (CONF:7159).This family MAY contain zero or one [0..1] @qualifier, which SHALL be selected from ValueSet EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7160).SHALL contain at least one [1..*] given (CONF:7157).Such givens MAY contain zero or one [0..1] @qualifier, which SHALL be selected from ValueSet EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7158).The second occurrence of given (given[2]) if provided, SHALL include middle name or middle initial (CONF:7163).MAY contain zero or more [0..*] prefix (CONF:7155).The prefix, if present, MAY contain zero or one [0..1] @qualifier, which SHALL be selected from ValueSet EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7156).MAY contain zero or one [0..1] suffix (CONF:7161).The suffix, if present, MAY contain zero or one [0..1] @qualifier, which SHALL be selected from ValueSet EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30 (CONF:7162).SHALL NOT have mixed content except for white space (CONF:7278).Table SEQ Table \* ARABIC 19: EntityNameUse Value Set Value Set: EntityNameUse 2.16.840.1.113883.1.11.15913 STATIC 2005-05-01Code System(s):EntityNameUse 2.16.840.1.113883.5.45Description:This value set contains codes that describe a persons name type.Reference: (members only)CodeCode SystemPrint NameAEntityNameUseArtist/StageABCEntityNameUseAlphabeticASGNEntityNameUseAssignedCEntityNameUseLicenseIEntityNameUseIndigenous/TribalIDEEntityNameUseIdeographicLEntityNameUseLegalPEntityNameUsePseudonymPHONEntityNameUsePhoneticREntityNameUseReligiousSNDXEntityNameUseSoundexSRCHEntityNameUseSearchSYLEntityNameUseSyllabicTable SEQ Table \* ARABIC 20: EntityPersonNamePersonPartQualifier Value SetValue Set: EntityPersonNamePartQualifier 2.16.840.1.113883.11.20.9.26 STATIC 2011-09-30Code System(s):EntityNamePartQualifier 2.16.840.1.113883.5.43Description: A value set of codes that further describe parts of a person’s name.Reference: (members only)CodeCode SystemPrint NameACEntityNamePartQualifieracademicADEntityNamePartQualifieradoptedBREntityNamePartQualifierbirthCLEntityNamePartQualifiercallmeINEntityNamePartQualifierinitialNBEntityNamePartQualifiernobilityPREntityNamePartQualifierprofessionalSPEntityNamePartQualifierspouseTITLEEntityNamePartQualifiertitleVVEntityNamePartQualifiervoorvoegselUS Realm Person Name (PN.US.FIELDED)[PN: templateId 2.16.840.1.113883.10.20.22.5.1.1 (open)]The US Realm Clinical Document Person Name datatype flavor is a set of reusable constraints that can be used for Persons.SHALL contain exactly one [1..1] name (CONF:9368).The content of name SHALL be either a conformant Patient Name (PTN.US.FIELDED), or a string (CONF:9371).Clinical Oncology Treatment Plan and Summary[ClinicalDocument: templateId 2.16.840.1.113883.10.20.30.1.1 (open)]Table SEQ Table \* ARABIC21: Clinical Oncology Treatment Plan and Summary ContextsUsed By:Contains Entries:Allergies Section (entries optional)Encounters Section BCTPSFamily History Section BCTPSFunctional Status Section BCTPSMedications Section BCTPSPlan of Care Section BCTPSProblem Section BCTPSProcedures Section BCTPSResults Section BCTPSVital Signs Section BCTPSThis document template conforms to the US Realm Header and contains additional constraints for the Clinical Oncology Treatment Plan and Summary. The sections in this document contain constraints for a Breast Cancer Treatment Plan and Summary (BCTPS), which is based on the Breast Cancer Adjuvant Treatment Plan and Summary form.Table SEQ Table \* ARABIC22: Clinical Oncology Treatment Plan and Summary Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueClinicalDocument[templateId/@root = '2.16.840.1.113883.10.20.30.1.1']templateId1..1SHALL19232@root1..1SHALL192332.16.840.1.113883.10.20.30.1.1code1..1SHALL19234@code1..1SHALL1923574156-1@codeSystem1..1SHALL270862.16.840.1.113883.6.1title1..1SHALL19236recordTarget1..1SHALL19237patientRole1..1SHALL19238id1..*SHALL19240telecom1..*SHALL19241providerOrganization1..1SHALL19692telecom1..*SHALL19693addr1..1SHALL19694legalAuthenticator1..1SHALL19695participant1..*SHALL19662associatedEntity1..1SHALL19663telecom1..*SHALL19664associatedPerson1..1SHALL19665name1..1SHALL19696family1..1SHALL19697given1..1SHALL19698documentationOf1..1SHALL19242serviceEvent1..1SHALL19243@classCode1..1SHALL19322PCPRperformer1..*SHALL19244assignedEntity1..1SHALL19245code1..1SHALL209552.16.840.1.114222.4.11.1066 (Healthcare Provider Taxonomy (HIPAA))addr1..1SHALL19699telecom0..*SHOULD19256assignedPerson0..1SHOULD19326name1..*SHALL19327family1..1SHALL19700given1..1SHALL19701component1..1SHALL19501structuredBody1..1SHALL19502component1..1SHALL19503section1..1SHALL23357component1..1SHALL25978section1..1SHALL25979component1..1SHALL25980section1..1SHALL25981component1..1SHALL26317section1..1SHALL26319component1..1SHALL26320section1..1SHALL26321component1..1SHALL26322section1..1SHALL26323component1..1SHALL26324section1..1SHALL26325component1..1SHALL26326section1..1SHALL26327component1..1SHALL26444section1..1SHALL26445component0..1MAY26446section1..1SHALL26447Conforms to US Realm Header template (2.16.840.1.113883.10.20.22.1.1).SHALL contain exactly one [1..1] templateId (CONF:19232) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.1.1" (CONF:19233).SHALL contain exactly one [1..1] code (CONF:19234).This code SHALL contain exactly one [1..1] @code="74156-1" Breast Cancer Treatment Plan and Summary (CONF:19235).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CONF:27086).The clinical document title describes the type of Oncology Treatment Plan and Summary. For example: “Breast Cancer Adjuvant Treatment Plan and Summary”. The document title should not conflict with the ClinicalDocument code or further document specification defined through the documentationOf/serviceEvent or an encompassingEncounter.SHALL contain exactly one [1..1] title (CONF:19236).SHALL contain exactly one [1..1] recordTarget (CONF:19237).This recordTarget SHALL contain exactly one [1..1] patientRole (CONF:19238).At least one patient ID would represent the patient medical record number (MRN).This patientRole SHALL contain at least one [1..*] id (CONF:19240).This patientRole SHALL contain at least one [1..*] telecom (CONF:19241).This patientRole SHALL contain exactly one [1..1] providerOrganization (CONF:19692).This providerOrganization SHALL contain at least one [1..*] telecom (CONF:19693).This providerOrganization SHALL contain exactly one [1..1] addr (CONF:19694).SHALL contain exactly one [1..1] legalAuthenticator (CONF:19695).The participant element element identifies supporting participants, including parents, relatives, caregivers, and other participants related in some way to the patient. In BCTPS, it is required to specify the contact person’s name and phone.SHALL contain at least one [1..*] participant (CONF:19662) such that itSHALL contain exactly one [1..1] associatedEntity (CONF:19663).This associatedEntity SHALL contain at least one [1..*] telecom (CONF:19664).This associatedEntity SHALL contain exactly one [1..1] associatedPerson (CONF:19665).This associatedPerson SHALL contain exactly one [1..1] name (CONF:19696).This name SHALL contain exactly one [1..1] family (CONF:19697).This name SHALL contain exactly one [1..1] given (CONF:19698).This documentationOf/serviceEvent represents the time period over which care was provided. It contains information about the providers involved in the cancer care of the patient during the period of care being summarized.SHALL contain exactly one [1..1] documentationOf (CONF:19242).This documentationOf SHALL contain exactly one [1..1] serviceEvent (CONF:19243).This serviceEvent SHALL contain exactly one [1..1] @classCode="PCPR" Care Provision (CONF:19322).This serviceEvent SHALL contain at least one [1..*] performer (CONF:19244).Such performers SHALL contain exactly one [1..1] assignedEntity (CONF:19245).This assignedEntity SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) 2.16.840.1.114222.4.11.1066 DYNAMIC (CONF:20955).This provider address represents the site where patient received treatment from this provider.This assignedEntity SHALL contain exactly one [1..1] addr (CONF:19699).This assignedEntity SHOULD contain zero or more [0..*] telecom (CONF:19256).This assignedEntity SHOULD contain zero or one [0..1] assignedPerson (CONF:19326).The assignedPerson, if present, SHALL contain at least one [1..*] name (CONF:19327).Such names SHALL contain exactly one [1..1] family (CONF:19700).Such names SHALL contain exactly one [1..1] given (CONF:19701).SHALL contain exactly one [1..1] component (CONF:19501).This component SHALL contain exactly one [1..1] structuredBody (CONF:19502).This structuredBody SHALL contain exactly one [1..1] component (CONF:19503) such that itSHALL contain exactly one [1..1] Allergies Section (entries optional) (templateId:2.16.840.1.113883.10.20.22.2.6) (CONF:23357).This structuredBody SHALL contain exactly one [1..1] component (CONF:25978) such that itSHALL contain exactly one [1..1] Medications Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.7) (CONF:25979).This structuredBody SHALL contain exactly one [1..1] component (CONF:25980) such that itSHALL contain exactly one [1..1] Family History Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.3) (CONF:25981).This structuredBody SHALL contain exactly one [1..1] component (CONF:26317) such that itSHALL contain exactly one [1..1] Problem Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.1) (CONF:26319).This structuredBody SHALL contain exactly one [1..1] component (CONF:26320) such that itSHALL contain exactly one [1..1] Procedures Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.4) (CONF:26321).This structuredBody SHALL contain exactly one [1..1] component (CONF:26322) such that itSHALL contain exactly one [1..1] Results Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.2) (CONF:26323).This structuredBody SHALL contain exactly one [1..1] component (CONF:26324) such that itSHALL contain exactly one [1..1] Vital Signs Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.5) (CONF:26325).This structuredBody SHALL contain exactly one [1..1] component (CONF:26326) such that itSHALL contain exactly one [1..1] Plan of Care Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.6) (CONF:26327).This structuredBody SHALL contain exactly one [1..1] component (CONF:26444) such that itSHALL contain exactly one [1..1] Functional Status Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.8) (CONF:26445).This structuredBody MAY contain zero or one [0..1] component (CONF:26446) such that itSHALL contain exactly one [1..1] Encounters Section BCTPS (templateId:2.16.840.1.113883.10.20.30.2.9 ) (CONF:26447).Figure SEQ Figure \* ARABIC 33: Clinical Oncology Treatment Plan and Summary document type example<ClinicalDocument> ... <realmCode code="US"/> <typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040"/> <!-- US Realm Header, consolidated CDA header template --> <templateId root="2.16.840.1.113883.10.20.22.1.1" assigningAuthorityName="HL7"/> <!-- Clinical Oncology Treatment Plan and Summary --> <templateId root="2.16.840.1.113883.10.20.30.1.1" assigningAuthorityName="HL7"/> <id root="04fc2b90-10e0-11e2-892e-0800200c9a66"/> <!-- ClinicalDocument code --> <code code="74156-1" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Breast Cancer Treatment Plan and Summary"/> <title>Breast Cancer Treatment Plan and Summary</title> <effectiveTime value="20130301"/> <confidentialityCode code="N"/> <languageCode code="en-US"/> ...</ClinicalDocument>Figure SEQ Figure \* ARABIC 34: Patient information example<recordTarget> <patientRole> <id root="1.2.1.173000" extension="2131823431"/> <addr use="HP"> ... </addr> <!-- patient cell --> <telecom value="tel:(781)555-1212" use="MC"/> <!-- patient email --> <telecom value="mailto:my.email@"/> <patient> <!-- patient name --> <name use="L"> <given>Eve</given> <family>Everywomen</family> </name> <!-- patient gender --> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/> <!-- patient date of birth --> <birthTime value="19670131"/> ... </patient> <providerOrganization> <id root="2.16.840.1.113883.19.5.9999.1393"/> <name>Cancer Clinic</name> <telecom use="WP" value="tel: 555-555-5000"/> <addr> ... </addr> </providerOrganization> </patientRole></recordTarget> Figure SEQ Figure \* ARABIC 35: author example<author> <time value="20130107224411+0500"/> <assignedAuthor> <id extension="99999999" root="2.16.840.1.113883.4.6"/> <code code="200000000X" codeSystem="2.16.840.1.113883.6.101" displayName="Cancer Associations PA"/> ... <telecom value="tel:(781)555-1200" use="WP"/> <assignedPerson> <name> <family>Nightengale</family> <given>Nancy</given> <suffix>AOCNP</suffix> </name> </assignedPerson> </assignedAuthor> </author> Figure SEQ Figure \* ARABIC 36: Supporting person example<!-- SUPPORT CONTACT --><participant typeCode="IND"> <associatedEntity classCode="NOK"> <code code="MTH" codeSystem="2.16.840.1.113883.5.111"/> <!-- SUPPORT CONTACT phone --> <telecom value="tel:(555)555-2006" use="WP"/> <!-- SUPPORT CONTACT name --> <associatedPerson> <name> <prefix>Mrs.</prefix> <given>Martha</given> <family>Mum</family> </name> </associatedPerson> </associatedEntity></participant>Figure SEQ Figure \* ARABIC 37: Multi-disciplinary team of providers example<documentationOf> <!-- Healthcare provider Information --> <serviceEvent classCode="PCPR"> <effectiveTime> <low value="20120320"/> <high value="20130102"/> </effectiveTime> <!--MEDICAL ONCOLOGIST --> <performer typeCode="PRF"> <assignedEntity> <id extension="12345" root="2.16.840.1.113883.4.6"/> <code code="207RH0000X" codeSystem="2.16.840.1.113883.6.101" codeSystemName="NUCC" displayName="Hematologist"/> <addr> ... </addr> <telecom value="tel:+1-301-975-3251" use="WP"/> <assignedPerson> <name> <prefix>Dr.</prefix> <given>Trudy</given> <family>Tumor</family> </name> </assignedPerson> </assignedEntity> </performer> <performer typeCode="PRF"> <!-- SURGICAL ONCOLOGIST--> <assignedEntity> <id extension="12345" root="2.16.840.1.113883.4.6"/> <code code="22086X0206X" codeSystem="2.16.840.1.113883.6.101" codeSystemName="NUCC" displayName="Surgical Oncology"/> <telecom value="tel:+1-301-975-3211" use="WP"/> <assignedPerson> <name> <prefix>Dr.</prefix> <given>Carl</given> <family>Cutter</family> </name> </assignedPerson> </assignedEntity> </performer> <performer typeCode="PRF"> <!-- RADIATION ONCOLOGIST--> <assignedEntity> <id extension="12345" root="2.16.840.1.113883.4.6"/> <code code="261QX0203X" codeSystem="2.16.840.1.113883.6.101" codeSystemName="NUCC" displayName="Radiation Oncology"/> <telecom value="tel:+1-301-975-3021" use="WP"/> <assignedPerson> <name> <prefix>Dr.</prefix> <given>Christine</given> <family>Curie</family> </name> </assignedPerson> </assignedEntity> </performer> <performer typeCode="PRF"> <!-- Primary Care Provider--> <functionCode code="PCP" codeSystem="2.16.840.1.113883.5.88"/> <assignedEntity> <id extension="12345" root="2.16.840.1.113883.4.6"/> <code code="1223G0001X" codeSystem="2.16.840.1.113883.6.101" codeSystemName="NUCC" displayName="General Practice"/> <telecom value="tel:+1-301-975-3251" use="WP"/> <assignedPerson> <name> <prefix>Dr.</prefix> <given>General</given> <family>Practice</family> </name> </assignedPerson> </assignedEntity> </performer> </serviceEvent></documentationOf>Section-Level Templates Allergies Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.6 (open)]Table SEQ Table \* ARABIC23: Allergies Section (entries optional) ContextsUsed By:Contains Entries:Clinical Oncology Treatment Plan and Summary (required)Allergy Problem ActThis section lists and describes any medication allergies, adverse reactions, idiosyncratic reactions, anaphylaxis/anaphylactoid reactions to food items, and metabolic variations or adverse reactions/allergies to other substances (such as latex, iodine, tape adhesives) used to assure the safety of health care delivery. At a minimum, it should list currently active and any relevant historical allergies and adverse reactions.Table SEQ Table \* ARABIC24: Allergies Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.6']templateId1..1SHALL7800@root1..1SHALL103782.16.840.1.113883.10.20.22.2.6code1..1SHALL15345@code1..1SHALL153462.16.840.1.113883.6.1 (LOINC) = 48765-2title1..1SHALL7802text1..1SHALL7803entry0..*SHOULD7804act1..1SHALL15444SHALL contain exactly one [1..1] templateId (CONF:7800) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.6" (CONF:10378).SHALL contain exactly one [1..1] code (CONF:15345).This code SHALL contain exactly one [1..1] @code="48765-2" Allergies, adverse reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15346).SHALL contain exactly one [1..1] title (CONF:7802).SHALL contain exactly one [1..1] text (CONF:7803).SHOULD contain zero or more [0..*] entry (CONF:7804) such that itSHALL contain exactly one [1..1] Allergy Problem Act (templateId:2.16.840.1.113883.10.20.22.4.30) (CONF:15444).Figure SEQ Figure \* ARABIC 38: Allergies Section example<section> <templateId root="2.16.840.1.113883.10.20.22.2.6"/> <code code="48765-2" displayName="Allergies, adverse reactions, alerts" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <title>Allergies</title> <text> ... </text> <entry typeCode> <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.30"/> <!-- Allergy Problem Act template --> ... </act> </entry></section>Encounters Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.22 (open)]Table SEQ Table \* ARABIC25: Encounters Section (entries optional) ContextsUsed By:Contains Entries:Encounter ActivitiesThis section lists and describes any healthcare encounters pertinent to the patient’s current health status or historical health history. An encounter is an interaction, regardless of the setting, between a patient and a practitioner who is vested with primary responsibility for diagnosing, evaluating, or treating the patient’s condition. It may include visits, appointments, as well as non-face-to-face interactions. It is also a contact between a patient and a practitioner who has primary responsibility for assessing and treating the patient at a given contact, exercising independent judgment. This section may contain all encounters for the time period being summarized, but should include notable encounters.Table SEQ Table \* ARABIC26: Encounters Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.22']templateId1..1SHALL7940@root1..1SHALL103862.16.840.1.113883.10.20.22.2.22code1..1SHALL15461@code1..1SHALL154622.16.840.1.113883.6.1 (LOINC) = 46240-8title1..1SHALL7942text1..1SHALL7943entry0..*SHOULD7951encounter1..1SHALL15465SHALL contain exactly one [1..1] templateId (CONF:7940) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.22" (CONF:10386).SHALL contain exactly one [1..1] code (CONF:15461).This code SHALL contain exactly one [1..1] @code="46240-8" Encounters (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15462).SHALL contain exactly one [1..1] title (CONF:7942).SHALL contain exactly one [1..1] text (CONF:7943).SHOULD contain zero or more [0..*] entry (CONF:7951) such that itSHALL contain exactly one [1..1] Encounter Activities (templateId:2.16.840.1.113883.10.20.22.4.49) (CONF:15465).Encounters Section BCTPS[section: templateId 2.16.840.1.113883.10.20.30.2.9 (open)]Table SEQ Table \* ARABIC27: Encounters Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (optional)Hospitalization With ReasonThis section contains encounters related to the patient's cancer treatment plan and summary. This section should describe inpatient encounters resulting from toxicity due to chemotherapy as well as other notable encounters.Table SEQ Table \* ARABIC28: Encounters Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.9 ']templateId1..1SHALL26309@root1..1SHALL263102.16.840.1.113883.10.20.30.2.9entry1..*SHALL26315encounter1..1SHALL26316Conforms to Encounters Section (entries optional) template (2.16.840.1.113883.10.20.22.2.22).SHALL contain exactly one [1..1] templateId (CONF:26309) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.9 " (CONF:26310).SHALL contain at least one [1..*] entry (CONF:26315) such that itSHALL contain exactly one [1..1] Hospitalization With Reason (templateId:2.16.840.1.113883.10.20.30.3.36) (CONF:26316).Figure SEQ Figure \* ARABIC 39: Encounters Section BCTPS example<section> <!-- C-CDA Encounters with entries optional section templateID --> <templateId root="2.16.840.1.113883.10.20.22.2.22"/> <!-- Encounters BCTPS section templateID --> <templateId root="2.16.840.1.113883.10.20.30.2.9"/> <code code="46240-8" codeSystem="2.16.840.1.113883.6.1"/> <title>ENCOUNTERS</title> <text> ... </text> <entry typeCode> <encounter classCode="ENC" moodCode="EVN"> <!-- C-CDA encounter activities TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.49"/> <!-- Hospitalization With Reason templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.36"/> ... </encounter> </entry></section>Family History Section [section: templateId 2.16.840.1.113883.10.20.22.2.15 (open)]Table SEQ Table \* ARABIC29: Family History Section ContextsUsed By:Contains Entries:Family History OrganizerThis section contains data defining the patient’s genetic relatives in terms of possible or relevant health risk factors that have a potential impact on the patient’s healthcare risk profile.Table SEQ Table \* ARABIC30: Family History Section Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.15']templateId1..1SHALL7932@root1..1SHALL103882.16.840.1.113883.10.20.22.2.15code1..1SHALL15469@code1..1SHALL154702.16.840.1.113883.6.1 (LOINC) = 10157-6title1..1SHALL7934text1..1SHALL7935entry0..*MAY7955organizer1..1SHALL15471SHALL contain exactly one [1..1] templateId (CONF:7932) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.15" (CONF:10388).SHALL contain exactly one [1..1] code (CONF:15469).This code SHALL contain exactly one [1..1] @code="10157-6" Family History (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15470).SHALL contain exactly one [1..1] title (CONF:7934).SHALL contain exactly one [1..1] text (CONF:7935).MAY contain zero or more [0..*] entry (CONF:7955) such that itSHALL contain exactly one [1..1] Family History Organizer (templateId:2.16.840.1.113883.10.20.22.4.45) ( (CONF:15471).Family History Section BCTPS[Section: templateId 2.16.840.1.113883.10.20.30.2.3 (open)]Table SEQ Table \* ARABIC31: Family History Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (required)Family History of Cancer NoneFamily History OrganizerFamily History PedigreeThis section contains the patient's family history (pedigree) information. It also allows assertion of no family history of cancer. The HL7 Family History (Pedigree) Model is required to be referenced as an external observation, and a nullFlavor can be sent if there is no pedigree available to point to. Non oncology family history may also be represented. Table SEQ Table \* ARABIC32: Family History Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.3']templateId1..1SHALL25967@root1..1SHALL259682.16.840.1.113883.10.20.30.2.3entry0..1MAY26011observation1..1SHALL26027entry1..1SHALL26759act1..1SHALL26760entry1..*SHALL26761organizer1..1SHALL26762Conforms to Family History Section template (2.16.840.1.113883.10.20.22.2.15).SHALL contain exactly one [1..1] templateId (CONF:25967) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.3" (CONF:25968).MAY contain zero or one [0..1] entry (CONF:26011) such that itSHALL contain exactly one [1..1] Family History of Cancer None (templateId:2.16.840.1.113883.10.20.30.3.11) (CONF:26027).SHALL contain exactly one [1..1] entry (CONF:26759) such that itSHALL contain exactly one [1..1] Family History Pedigree (templateId:2.16.840.1.113883.10.20.30.3.48) (CONF:26760).SHALL contain at least one [1..*] entry (CONF:26761) such that itSHALL contain exactly one [1..1] Family History Organizer (templateId:2.16.840.1.113883.10.20.22.4.45) (CONF:26762).Figure SEQ Figure \* ARABIC40: Family History Section BCTPS<section> <templateId root="2.16.840.1.113883.10.20.30.2.3"/> <code code="10157-6" displayName="History of family member diseases" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <title>FAMILY HISTORY</title> <text> ... </text> <entry> <observation classCode="OBS" moodCode="EVN" negationInd="true"> <!-- Family History of Cancer - None --> <templateId root="2.16.840.1.113883.10.20.30.3.11"/> ... </observation> </entry> <entry> <act classCode="ACT" moodCode="EVN"> <!-- CDA FAMILY HISTORY PEDIGREE TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.48"/> ... </act> </entry> <entry typeCode> <!-- mother --> <organizer moodCode="EVN" classCode="CLUSTER"> <!--C-CDA FAMILY HISTORY ORGANIZER TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.45"/> ... </organizer> </entry> <entry typeCode <!-- father --> <organizer moodCode="EVN" classCode="CLUSTER"> <!--C-CDA FAMILY HISTORY ORGANIZER TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.45"/> ... </organizer> </entry></section>Functional Status Section [section: templateId 2.16.840.1.113883.10.20.22.2.14 (open)]Table SEQ Table \* ARABIC33: Functional Status Section ContextsUsed By:Contains Entries:Assessment Scale ObservationCaregiver CharacteristicsCognitive Status Problem ObservationCognitive Status Result ObservationCognitive Status Result OrganizerFunctional Status Problem ObservationFunctional Status Result ObservationFunctional Status Result OrganizerHighest Pressure Ulcer StageNon-Medicinal Supply ActivityNumber of Pressure Ulcers ObservationPressure Ulcer ObservationThe Functional Status Section describes the patient’s physical state, status of functioning, and environmental status at the time the document was created. A patient’s physical state may include information regarding the patient’s physical findings as they relate to problems, including but not limited to:Pressure UlcersAmputationsHeart murmurOstomiesA patient’s functional status may include information regarding the patient relative to their general functional and cognitive ability, including:Ambulatory abilityMental status or competencyActivities of Daily Living (ADLs), including bathing, dressing, feeding, groomingHome or living situation having an effect on the health status of the patientAbility to care for selfSocial activity, including issues with social cognition, participation with friends and acquaintances other than family membersOccupation activity, including activities partly or directly related to working, housework or volunteering, family and home responsibilities or activities related to home and familyCommunication ability, including issues with speech, writing or cognition required for communicationPerception, including sight, hearing, taste, skin sensation, kinesthetic sense, proprioception, or balanceA patient’s environmental status may include information regarding the patient’s current exposures from their daily environment, including but not limited to:Airborne hazards such as second-hand smoke, volatile organic compounds, dust, or other allergensRadiationSafety hazards in home, such as throw rugs, poor lighting, lack of railings/grab bars, etc.Safety hazards at work, such as communicable diseases, excessive heat, excessive noise, etc.The patient's functional status may be expressed as a problem or as a result observation. A functional or cognitive status problem observation describes a patient’s problem, symptoms or condition. A functional or cognitive status result observation may include observations resulting from an assessment scale, evaluation or question and answer assessment.Any deviation from normal function displayed by the patient and recorded in the record should be included. Of particular interest are those limitations that would interfere with self-care or the medical therapeutic process in any way. In addition, a note of normal function, an improvement, or a change in functioning status may be included.Table SEQ Table \* ARABIC34: Functional Status Section Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.14']templateId1..1SHALL7920@root1..1SHALL103892.16.840.1.113883.10.20.22.2.14code1..1SHALL14578@code1..1SHALL145792.16.840.1.113883.6.1 (LOINC) = 47420-5title1..1SHALL7922text1..1SHALL7923entry0..*MAY14414organizer1..1SHALL14415entry0..*MAY14416organizer1..1SHALL14417entry0..*MAY14418observation1..1SHALL14419entry0..*MAY14420observation1..1SHALL14421entry0..*MAY14422observation1..1SHALL14423entry0..*MAY14424observation1..1SHALL14425entry0..*MAY14426observation1..1SHALL14427entry0..*MAY14580observation1..1SHALL14581entry0..*MAY14582observation1..1SHALL14583entry0..*MAY16777observation1..1SHALL16778entry0..*MAY16779observation1..1SHALL16780entry0..*MAY16781observation1..1SHALL16782SHALL contain exactly one [1..1] templateId (CONF:7920) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.14" (CONF:10389).SHALL contain exactly one [1..1] code (CONF:14578).This code SHALL contain exactly one [1..1] @code="47420-5" Functional Status (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:14579).SHALL contain exactly one [1..1] title (CONF:7922).SHALL contain exactly one [1..1] text (CONF:7923).MAY contain zero or more [0..*] entry (CONF:14414) such that itSHALL contain exactly one [1..1] Functional Status Result Organizer (templateId:2.16.840.1.113883.10.20.22.4.66) (CONF:14415).MAY contain zero or more [0..*] entry (CONF:14416) such that itSHALL contain exactly one [1..1] Cognitive Status Result Organizer (templateId:2.16.840.1.113883.10.20.22.4.75) (CONF:14417).MAY contain zero or more [0..*] entry (CONF:14418) such that itSHALL contain exactly one [1..1] Functional Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.67) (CONF:14419).MAY contain zero or more [0..*] entry (CONF:14420) such that itSHALL contain exactly one [1..1] Cognitive Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.74) (CONF:14421).MAY contain zero or more [0..*] entry (CONF:14422) such that itSHALL contain exactly one [1..1] Functional Status Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.68) (CONF:14423).MAY contain zero or more [0..*] entry (CONF:14424) such that itSHALL contain exactly one [1..1] Cognitive Status Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.73) (CONF:14425).MAY contain zero or more [0..*] entry (CONF:14426) such that itSHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14427).MAY contain zero or more [0..*] entry (CONF:14580) such that itSHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14581).MAY contain zero or more [0..*] entry (CONF:14582) such that itSHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14583).MAY contain zero or more [0..*] entry (CONF:16777) such that itSHALL contain exactly one [1..1] Pressure Ulcer Observation (templateId:2.16.840.1.113883.10.20.22.4.70) (CONF:16778).MAY contain zero or more [0..*] entry (CONF:16779) such that itSHALL contain exactly one [1..1] Number of Pressure Ulcers Observation (templateId:2.16.840.1.113883.10.20.22.4.76) (CONF:16780).MAY contain zero or more [0..*] entry (CONF:16781) such that itSHALL contain exactly one [1..1] Highest Pressure Ulcer Stage (templateId:2.16.840.1.113883.10.20.22.4.77) (CONF:16782).Functional Status Section BCTPS[section: templateId 2.16.840.1.113883.10.20.30.2.8 (open)]Table SEQ Table \* ARABIC35: Functional Status Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (required)Neurotoxicity Impairment of ADLsThis section describes the patient’s physical state, functioning status, and environmental status at the time the document was created. In particular, impairments to activities of daily living from neurotoxicity due to chemotherapy are noted within this section.Table SEQ Table \* ARABIC36: Functional Status Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.8']templateId1..1SHALL26375@root1..1SHALL263762.16.840.1.113883.10.20.30.2.8entry0..*MAY26440observation1..1SHALL26441Conforms to Functional Status Section template (2.16.840.1.113883.10.20.22.2.14).SHALL contain exactly one [1..1] templateId (CONF:26375) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.8" (CONF:26376).MAY contain zero or more [0..*] entry (CONF:26440) such that itSHALL contain exactly one [1..1] Neurotoxicity Impairment of ADLs (templateId:2.16.840.1.113883.10.20.30.3.37) (CONF:26441).Figure SEQ Figure \* ARABIC41: Functional Status Section BCTPS<section> <templateId root="2.16.840.1.113883.10.20.30.2.8"/> <code code="47420-5" codeSystem="2.16.840.1.113883.6.1"/> <title>FUNCTIONAL STATUS</title> <text> .... </text> <entry typeCode> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA FUNCTIONAL STATUS PROBLEM OBSERVATION TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.68"/> <!-- Neurotoxicity impairment of activities of daily living templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.37"/> ... </observation> </entry></section>Medications Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.1 (open)]Table SEQ Table \* ARABIC37: Medications Section (entries optional) ContextsUsed By:Contains Entries:Medication ActivityThe Medications Section defines a patient's current medications and pertinent medication history. At a minimum, the currently active medications are to be listed, with an entire medication history as an option. The section may also include a patient's prescription and dispense history.This section requires that there be either an entry indicating the subject is not known to be on any medications, or that there be entries summarizing the subject's medications.Table SEQ Table \* ARABIC38: Medications Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.1']templateId1..1SHALL7791@root1..1SHALL104322.16.840.1.113883.10.20.22.2.1code1..1SHALL15385@code1..1SHALL153862.16.840.1.113883.6.1 (LOINC) = 10160-0title1..1SHALL7793text1..1SHALL7794entry0..*SHOULD7795substanceAdministration1..1SHALL15984SHALL contain exactly one [1..1] templateId (CONF:7791) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.1" (CONF:10432).SHALL contain exactly one [1..1] code (CONF:15385).This code SHALL contain exactly one [1..1] @code="10160-0" History of medication use (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15386).SHALL contain exactly one [1..1] title (CONF:7793).SHALL contain exactly one [1..1] text (CONF:7794).SHOULD contain zero or more [0..*] entry (CONF:7795) such that itSHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15984).If medication use is unknown, the appropriate nullFlavor MAY be present (see unknown information in Section 1) (CONF:10076).Medications Section BCTPS[Section: templateId 2.16.840.1.113883.10.20.30.2.7 (open)]Table SEQ Table \* ARABIC39: Medications Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (required)Anthracyclines Lifetime DoseChemotherapeutic Drug Therapy DiscontinuedChemotherapy Medication ActivityMedication ActivityThis section contains therapies administered to the patient during cancer treatment. The specific chemotherapeutic agents are not specified, but attributes such as repeatNumber, to note the cycle, are constrained in the Chemotherapy Medication Activity Template. The total lifetime amount of drugs in the Anthracycline drug class that the patient has received up until the note was generated must be communicated.??The common side effects that are possible from the combination of agents the patient has received must be sent. Actual toxicities related to an agent are communicated in this section rather than the Allergies and Adverse Events Section since the toxicities are not allergies or typically unexpected and may not result in termination of the drug, but may result in adjustments in dose. If a drug is discontinued due to toxicities it should be noted in this section along with the reason why.Table SEQ Table \* ARABIC40: Medications Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.7']templateId1..1SHALL23764@root1..1SHALL237652.16.840.1.113883.10.20.30.2.7entry1..1SHALL25964substanceAdministration1..1SHALL25966entry0..* SHOULD27305substanceAdministration1..1SHALL27306entry0..*MAY27307observation1..1SHALL27308entry1..*SHALL27373substanceAdministration1..1SHALL27374Conforms to Medications Section (entries optional) template (2.16.840.1.113883.10.20.22.2.1).SHALL contain exactly one [1..1] templateId (CONF:23764) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.7" (CONF:23765).SHALL contain exactly one [1..1] entry (CONF:25964) such that itSHALL contain exactly one [1..1] Anthracyclines Lifetime Dose (templateId:2.16.840.1.113883.10.20.30.3.24) (CONF:25966).Any pertinent medications the patient is on should be communicated with the C-CDA Medication Activity template. Of particular interest are pre-chemotherapy regimen medications such as dexamethasone and hormone therapy such as Tamoxifen and Aromatase inhibitors.SHOULD contain zero or more [0..*] entry (CONF:27305) such that itSHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:27306).MAY contain zero or more [0..*] entry (CONF:27307) such that itSHALL contain exactly one [1..1] Chemotherapeutic Drug Therapy Discontinued (templateId:2.16.840.1.113883.10.20.30.3.43) (CONF:27308).SHALL contain at least one [1..*] entry (CONF:27373) such that itSHALL contain exactly one [1..1] Chemotherapy Medication Activity (templateId:2.16.840.1.113883.10.20.30.3.44) (CONF:27374).Figure SEQ Figure \* ARABIC42: Medications Section BCTPS<section> <templateId root="2.16.840.1.113883.10.20.30.2.7" /> <code code="10160-0" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="HISTORY OF MEDICATION USE" /> <title>MEDICATIONS</title> <text> ... </text> <entry> <substanceAdministration classCode="SBADM" moodCode="EVN"> <!-- ANTHRACYCLINES LIFETIME DOSE templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.24" /> ... </substanceAdministration> </entry> <entry> <substanceAdministration classCode="SBADM" moodCode="EVN"> <!-- Consolidated CDA Medication Activity templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.16" /> ... </substanceAdministration> </entry> <entry> <substanceAdministration classCode="SBADM" moodCode="EVN"> <!-- Consolidated CDA Medication Activity templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.16" /> .... </substanceAdministration> </entry> <entry> <observation classCode="OBS" moodCode="EVN"> <!-- Chemotherapeutic Drug Therapy Discontinued templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.43" /> ... </observation> </entry></section>Plan of Care Section [section: templateId 2.16.840.1.113883.10.20.22.2.10 (open)]Table SEQ Table \* ARABIC41: Plan of Care Section ContextsUsed By:Contains Entries:InstructionsPlan of Care Activity ActPlan of Care Activity EncounterPlan of Care Activity ObservationPlan of Care Activity ProcedurePlan of Care Activity Substance AdministrationPlan of Care Activity SupplyThe Plan of Care Section contains data that defines pending orders, interventions, encounters, services, and procedures for the patient. It is limited to prospective, unfulfilled, or incomplete orders and requests only, which are indicated by the @moodCode of the entries within this section. All active, incomplete, or pending orders, appointments, referrals, procedures, services, or any other pending event of clinical significance to the current care of the patient should be listed unless constrained due to privacy issues. The plan may also contain information about ongoing care of the patient and information regarding goals and clinical reminders. Clinical reminders are placed here to provide prompts for disease prevention and management, patient safety, and health-care quality improvements, including widely accepted performance measures. The plan may also indicate that patient education will be provided.Table SEQ Table \* ARABIC42: Plan of Care Section Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.10']templateId1..1SHALL7723@root1..1SHALL104352.16.840.1.113883.10.20.22.2.10code1..1SHALL14749@code1..1SHALL147502.16.840.1.113883.6.1 (LOINC) = 18776-5title1..1SHALL16986text1..1SHALL7725entry0..*MAY7726observation1..1SHALL14751entry0..*MAY8805observation1..1SHALL14752entry0..*MAY8807observation1..1SHALL14753entry0..*MAY8809observation1..1SHALL14754entry0..*MAY8811observation1..1SHALL14755entry0..*MAY8813observation1..1SHALL14756entry0..*MAY14695act1..1SHALL16751SHALL contain exactly one [1..1] templateId (CONF:7723) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.10" (CONF:10435).SHALL contain exactly one [1..1] code (CONF:14749).This code SHALL contain exactly one [1..1] @code="18776-5" Plan of Care (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:14750).SHALL contain exactly one [1..1] title (CONF:16986).SHALL contain exactly one [1..1] text (CONF:7725).MAY contain zero or more [0..*] entry (CONF:7726) such that itSHALL contain exactly one [1..1] Plan of Care Activity Act (templateId:2.16.840.1.113883.10.20.22.4.39) (CONF:14751).MAY contain zero or more [0..*] entry (CONF:8805) such that itSHALL contain exactly one [1..1] Plan of Care Activity Encounter (templateId:2.16.840.1.113883.10.20.22.4.40) (CONF:14752).MAY contain zero or more [0..*] entry (CONF:8807) such that itSHALL contain exactly one [1..1] Plan of Care Activity Observation (templateId:2.16.840.1.113883.10.20.22.4.44) (CONF:14753).MAY contain zero or more [0..*] entry (CONF:8809) such that itSHALL contain exactly one [1..1] Plan of Care Activity Procedure (templateId:2.16.840.1.113883.10.20.22.4.41) (CONF:14754).MAY contain zero or more [0..*] entry (CONF:8811) such that itSHALL contain exactly one [1..1] Plan of Care Activity Substance Administration (templateId:2.16.840.1.113883.10.20.22.4.42) (CONF:14755).MAY contain zero or more [0..*] entry (CONF:8813) such that itSHALL contain exactly one [1..1] Plan of Care Activity Supply (templateId:2.16.840.1.113883.10.20.22.4.43) (CONF:14756).MAY contain zero or more [0..*] entry (CONF:14695) such that itSHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:16751).Plan of Care Section BCTPS[section: templateId 2.16.840.1.113883.10.20.30.2.6 (open)]Table SEQ Table \* ARABIC43: Plan of Care Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (required)Chemotherapy Regimen PlansPlan of Care Activity Reconstruction ProcedurePlan of Care Radiation ActivityThis section contains information about planned radiation, chemotherapy, and reconstruction procedures for the patient. It is limited to prospective, unfulfilled or incomplete orders, and requests only, which are indicated by the @moodCode of the entries within this section.Table SEQ Table \* ARABIC44: Plan of Care Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.6']templateId1..1SHALL24087@root1..1SHALL262712.16.840.1.113883.10.20.30.2.6entry0..1 SHOULD24099procedure1..1SHALL24130entry0..1 SHOULD24101procedure1..1SHALL24131entry0..1SHOULD24103act1..1SHALL24132Conforms to Plan of Care Section template (2.16.840.1.113883.10.20.22.2.10).SHALL contain exactly one [1..1] templateId (CONF:24087) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.6" (CONF:26271).SHOULD contain zero or one [0..1] entry (CONF:24099) such that itSHALL contain exactly one [1..1] Chemotherapy Regimen Plans (templateId:2.16.840.1.113883.10.20.30.3.30) (CONF:24130).SHOULD contain zero or one [0..1] entry (CONF:24101) such that itSHALL contain exactly one [1..1] Plan of Care Activity Reconstruction Procedure (templateId:2.16.840.1.113883.10.20.30.3.31) (CONF:24131).SHOULD contain zero or one [0..1] entry (CONF:24103) such that itSHALL contain exactly one [1..1] Plan of Care Radiation Activity (templateId:2.16.840.1.113883.10.20.30.3.32) (CONF:24132).Figure SEQ Figure \* ARABIC43: Plan of Care Section BCTPS<section> <!-- Consolidated CDA Plan of Care section templateID --> <templateId root="2.16.840.1.113883.10.20.22.2.10" /> <!-- BCTPS Plan of Care section templateID --> <templateId root="2.16.840.1.113883.10.20.30.2.6" /> <code code="18776-5" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Treatment plan" /> <title>PLAN OF CARE</title> <text> ... </text> <entry> <procedure classCode="PROC" moodCode="INT"> <!-- Chemotherapy regimen plans template--> <templateId root="2.16.840.1.113883.10.20.30.3.30" /> <id root="2baf9dc1-6d92-4ed0-8b4a-ad556adb90fe" /> ... </procedure> </entry> <entry> <act moodCode="RQO" classCode="ACT"> <!-- Plan of Care Radiation Activity templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.32" /> ... </act> </entry> <entry> <procedure classCode="PROC" moodCode="INT"> <!-- Plan of Care Activity Reconstruction Procedure templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.31" /> ... </procedure> </entry></section>Problem Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.5 (open)]Table SEQ Table \* ARABIC45: Problem Section (entries optional) ContextsUsed By:Contains Entries:Problem Concern Act (Condition)This section lists and describes all relevant clinical problems at the time the document is generated. At a minimum, all pertinent current and historical problems should be listed.Table SEQ Table \* ARABIC46: Problem Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.5']templateId1..1SHALL7877@root1..1SHALL104402.16.840.1.113883.10.20.22.2.5code1..1SHALL15407@code1..1SHALL154082.16.840.1.113883.6.1 (LOINC) = 11450-4title1..1SHALL7879text1..1SHALL7880entry0..*SHOULD7881act1..1SHALL15505SHALL contain exactly one [1..1] templateId (CONF:7877) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.5" (CONF:10440).SHALL contain exactly one [1..1] code (CONF:15407).This code SHALL contain exactly one [1..1] @code="11450-4" Problem List (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15408).SHALL contain exactly one [1..1] title (CONF:7879).SHALL contain exactly one [1..1] text (CONF:7880).SHOULD contain zero or more [0..*] entry (CONF:7881).The entry, if present, SHALL contain exactly one [1..1] Problem Concern Act (Condition) (templateId:2.16.840.1.113883.10.20.22.4.3) (CONF:15505).Problem Section BCTPS[Section: templateId 2.16.840.1.113883.10.20.30.2.1 (open)]Table SEQ Table \* ARABIC47: Problem Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (required)Breast Cancer Concern ActLast Menstrual PeriodThis section contains a Breast Cancer Concern Act, which contains information specific to a breast cancer diagnosis such as tumor type, staging, and location. This section may include additional problem concern acts that represent information about the patient's comorbid conditions and and contain details pertaining to the patient’s last menstrual period.Table SEQ Table \* ARABIC48: Problem Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.1']templateId1..1SHALL19335@root1..1SHALL193362.16.840.1.113883.10.20.30.2.1entry1..*SHALL19456act1..1SHALL21929entry0..1MAY22074observation1..1SHALL22075Conforms to Problem Section (entries optional) template (2.16.840.1.113883.10.20.22.2.5).SHALL contain exactly one [1..1] templateId (CONF:19335) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.1" (CONF:19336).SHALL contain at least one [1..*] entry (CONF:19456) such that itSHALL contain exactly one [1..1] Breast Cancer Concern Act (templateId:2.16.840.1.113883.10.20.30.3.6) (CONF:21929).MAY contain zero or one [0..1] entry (CONF:22074) such that itSHALL contain exactly one [1..1] Last Menstrual Period (templateId:2.16.840.1.113883.10.20.30.3.34) (CONF:22075).Figure SEQ Figure \* ARABIC44: Problem Section BCTPS Example<component> <section> <!-- Problem Section BCTPS TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.2.1"/> <code code="11450-4" displayName="Problem Section" codeSystem="2.16.840.1.113883.6.1"/> <title>PROBLEMS</title> <text> .... </text> <entry> <act classCode="ACT" moodCode="EVN"> <!-- Breast Cancer Concern Act TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.6"/> .... </act> </entry> <entry> <!-- LAST MENSTRUAL PERIOD --> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.34"/> ... </entry> <entry> <!--CO MORBID CONDITIONS --> <act classCode="ACT" moodCode="EVN"> <!-- C-CDA PROBLEM CONCERN ACT (Condition)TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.3"/> ... </entryRelationship> </act> </entry> </section></component>Procedures Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.7 (open)]Table SEQ Table \* ARABIC49: Procedures Section (entries optional) ContextsUsed By:Contains Entries:Procedure Activity ActProcedure Activity ObservationProcedure Activity ProcedureThis section defines all interventional, surgical, diagnostic, or therapeutic procedures or treatments pertinent to the patient historically at the time the document is generated. The section is intended to include notable procedures, but can contain all procedures for the period of time being summarized. The common notion of “procedure” is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore this section contains procedure templates represented with three RIM classes: Act. Observation, and Procedure. Procedure act is for procedures the alter that physical condition of a patient (Splenectomy). Observation act is for procedures that result in new information about a patient but do not cause physical alteration (EEG). Act is for all other types of procedures (dressing change).The length of an encounter is documented in the documentationOf/encompassingEncounter/effectiveTime and length of service in documentationOf/ServiceEvent/effectiveTime.Table SEQ Table \* ARABIC50: Procedures Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.7']templateId1..1SHALL6270@root1..1SHALL62712.16.840.1.113883.10.20.22.2.7code1..1SHALL15423@code1..1SHALL154242.16.840.1.113883.6.1 (LOINC) = 47519-4title1..1SHALL17184text1..1SHALL6273entry0..*MAY6274procedure1..1SHALL15509entry0..1MAY6278observation1..1SHALL15510entry0..1MAY8533act1..1SHALL15511SHALL contain exactly one [1..1] templateId (CONF:6270) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.7" (CONF:6271).SHALL contain exactly one [1..1] code (CONF:15423).This code SHALL contain exactly one [1..1] @code="47519-4" History of Procedures (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15424).SHALL contain exactly one [1..1] title (CONF:17184).SHALL contain exactly one [1..1] text (CONF:6273).MAY contain zero or more [0..*] entry (CONF:6274) such that itSHALL contain exactly one [1..1] Procedure Activity Procedure (templateId:2.16.840.1.113883.10.20.22.4.14) (CONF:15509).MAY contain zero or one [0..1] entry (CONF:6278) such that itSHALL contain exactly one [1..1] Procedure Activity Observation (templateId:2.16.840.1.113883.10.20.22.4.13) (CONF:15510).MAY contain zero or one [0..1] entry (CONF:8533) such that itSHALL contain exactly one [1..1] Procedure Activity Act (templateId:2.16.840.1.113883.10.20.22.4.12) (CONF:15511).Procedures Section BCTPS[Section: templateId 2.16.840.1.113883.10.20.30.2.4 (open)]Table SEQ Table \* ARABIC51: Procedures Section BCTPS ContextsContained By:Contains:Clinical Oncology Treatment Plan and Summary (required)Breast Cancer ProceduresRadiation Therapy Care CompletedThis section contains information about breast-cancer-related procedures and treatments such as radiation therapy care.Table SEQ Table \* ARABIC52: Procedures Section BCTPS Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.4']templateId1..1SHALL23138@root1..1SHALL231392.16.840.1.113883.10.20.30.2.4entry1..*SHALL23135procedure1..1SHALL23137entry0..1SHOULD23189act1..1SHALL23190Conforms to Procedures Section (entries optional) template (2.16.840.1.113883.10.20.22.2.7).SHALL contain exactly one [1..1] templateId (CONF:23138) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.4" (CONF:23139).SHALL contain at least one [1..*] entry (CONF:23135) such that itSHALL contain exactly one [1..1] Breast Cancer Procedures (templateId:2.16.840.1.113883.10.20.30.3.12) (CONF:23137).SHOULD contain zero or one [0..1] entry (CONF:23189) such that itSHALL contain exactly one [1..1] Radiation Therapy Care Completed (templateId:2.16.840.1.113883.10.20.30.3.16) (CONF:23190).Figure SEQ Figure \* ARABIC45: Procedures Section BCTPS<section> <templateId root="2.16.840.1.113883.10.20.30.2.4" /> <code code="47519-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="HISTORY OF PROCEDURES"/> <title>PROCEDURES</title> <text> ... </text> <!-- BREAST CANCER PROCEDURES --> <entry typeCode> <procedure classCode="PROC" moodCode="EVN"> <!-- C-CDA PROCEDURE ACTIVITY PROCEDURE TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.14"/> <!-- Breast Cancer Procedures templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.12"/> ... </procedure> <!-- RADIATION THERAPY CARE COMPLETED --> <entry> <!-- NegationInd=false indicates the patient did have radiation therapy --> <act classCode="ACT" moodCode="EVN" negationInd="false"> <!-- C-CDA PROCEDURE ACTIVITY ACT TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.12"/> <!-- Radiation Therapy Care Completed TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.16"/> ... </act> </entry> <text /> </section>Results Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.3 (open)]Table SEQ Table \* ARABIC53: Results Section (entries optional) ContextsUsed By:Contains Entries:Result OrganizerThe Results Section contains the results of observations generated by laboratories, imaging procedures, and other procedures. The scope includes observations such as hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. The section often includes notable results such as abnormal values or relevant trends, and could contain all results for the period of time being documented.Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory.Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of a cardiac echocardiogram.Procedure results are typically generated by a clinician to provide more granular information about component observations made during a procedure, such as where a gastroenterologist reports the size of a polyp observed during a colonoscopy.Table SEQ Table \* ARABIC54: Results Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.3']templateId1..1SHALL7116@root1..1SHALL91362.16.840.1.113883.10.20.22.2.3code1..1SHALL15431@code1..1SHALL154322.16.840.1.113883.6.1 (LOINC) = 30954-2title1..1SHALL8891text1..1SHALL7118entry0..*SHOULD7119organizer1..1SHALL15515SHALL contain exactly one [1..1] templateId (CONF:7116) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.3" (CONF:9136).SHALL contain exactly one [1..1] code (CONF:15431).This code SHALL contain exactly one [1..1] @code="30954-2" Relevant diagnostic tests and/or laboratory data (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15432).SHALL contain exactly one [1..1] title (CONF:8891).SHALL contain exactly one [1..1] text (CONF:7118).SHOULD contain zero or more [0..*] entry (CONF:7119) such that itSHALL contain exactly one [1..1] Result Organizer (templateId:2.16.840.1.113883.10.20.22.4.1) (CONF:15515).Results Section BCTPS[Section: templateId 2.16.840.1.113883.10.20.30.2.2 (open)]Table SEQ Table \* ARABIC55: Results Section BCTPS ContextsUsed By:Contains Entries:Clinical Oncology Treatment Plan and Summary (required)Cardiac Function ObservationMolecular Diagnostic Testing OrganizerReceptor Status OrganizerThis section contains the result of observations for laboratory or diagnostic studies performed on patients with breast cancer (e.g., pre- and post-chemotherapy cardiac diagnostic studies, and hormone receptor status results).Table SEQ Table \* ARABIC56: Results Section BCTPS Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueSection[templateId/@root = '2.16.840.1.113883.10.20.30.2.2']templateId1..1SHALL23515@root1..1SHALL235162.16.840.1.113883.10.20.30.2.2entry1..*SHALL23517organizer1..1SHALL23518entry1..*SHALL23519observation1..1SHALL23520entry1..*SHALL26824organizer1..1SHALL26826Conforms to Results Section (entries optional) template (2.16.840.1.113883.10.20.22.2.3).SHALL contain exactly one [1..1] templateId (CONF:23515) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.2" (CONF:23516).SHALL contain at least one [1..*] entry (CONF:23517) such that itSHALL contain exactly one [1..1] Receptor Status Organizer (templateId:2.16.840.1.113883.10.20.30.3.17) (CONF:23518).SHALL contain at least one [1..*] entry (CONF:23519) such that itSHALL contain exactly one [1..1] Cardiac Function Observation (templateId:2.16.840.1.113883.10.20.30.3.21) (CONF:23520).SHALL contain at least one [1..*] entry (CONF:26824) such that itSHALL contain exactly one [1..1] Molecular Diagnostic Testing Organizer (templateId:2.16.840.1.113883.10.20.30.3.49) (CONF:26826).Figure SEQ Figure \* ARABIC 46: Results Section BCTPS example<section> <templateId root="2.16.840.1.113883.10.20.30.2.2" /> <code code="30954-2" codeSystem="2.16.840.1.113883.6.1"/> <title>RESULTS</title> <text> ... </text> <entry typeCode> <organizer classCode="CLUSTER" moodCode="EVN"> <!-- Result Organizer templateID from Consolidated CDA --> <templateId root="2.16.840.1.113883.10.20.22.4.1"/> <!-- MOLECULAR DIAGNOSTIC TESTING Organizer template --> <templateId root="2.16.840.1.113883.10.20.30.3.49"/> ... </organizer> </entry> <entry typeCode> <organizer classCode="CLUSTER" moodCode="EVN"> <!-- Result Organizer templateID from Consolidated CDA --> <templateId root="2.16.840.1.113883.10.20.22.4.1"/> <!-- Receptor status Organizer template ID --> <templateId root="2.16.840.1.113883.10.20.30.3.17"/> ... </organizer> </entry> <entry> <!-- consolidated CDA Result Observation templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Cardiac Function Observation templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.21"/> ... </entry></section>Vital Signs Section (entries optional) [section: templateId 2.16.840.1.113883.10.20.22.2.4 (open)]Table SEQ Table \* ARABIC57: Vital Signs Section (entries optional) ContextsUsed By:Contains Entries:Vital Signs OrganizerThe Vital Signs Section contains relevant vital signs for the context and use case of the document type, such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, and pulse oximetry. The section should include notable vital signs such as the most recent, maximum and/or minimum, baseline, or relevant trends.Vital signs are represented in the same way as other results, but are aggregated into their own section to follow clinical conventions.Table SEQ Table \* ARABIC58: Vital Signs Section (entries optional) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.22.2.4']templateId1..1SHALL7268@root1..1SHALL104512.16.840.1.113883.10.20.22.2.4code1..1SHALL15242@code1..1SHALL152432.16.840.1.113883.6.1 (LOINC) = 8716-3title1..1SHALL9966text1..1SHALL7270entry0..*SHOULD7271organizer1..1SHALL15517SHALL contain exactly one [1..1] templateId (CONF:7268) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.4" (CONF:10451).SHALL contain exactly one [1..1] code (CONF:15242).This code SHALL contain exactly one [1..1] @code="8716-3" Vital Signs (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15243).SHALL contain exactly one [1..1] title (CONF:9966).SHALL contain exactly one [1..1] text (CONF:7270).SHOULD contain zero or more [0..*] entry (CONF:7271) such that itSHALL contain exactly one [1..1] Vital Signs Organizer (templateId:2.16.840.1.113883.10.20.22.4.26) (CONF:15517).Vital Signs Section BCTPS[section: templateId 2.16.840.1.113883.10.20.30.2.5 (open)]Table SEQ Table \* ARABIC59: Vital Signs Section BCTPS ContextsUsed By:Contains Entries:Clinical Oncology Treatment Plan and Summary (required)Vital Signs Organizer BCTPSThis section contains height, weight, and body surface area findings.Table SEQ Table \* ARABIC60: Vital Signs Section BCTPS Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesection[templateId/@root = '2.16.840.1.113883.10.20.30.2.5']templateId1..1SHALL24842@root1..1SHALL248432.16.840.1.113883.10.20.30.2.5entry1..*SHALL24848organizer1..1SHALL24906Conforms to Vital Signs Section (entries optional) template (2.16.840.1.113883.10.20.22.2.4).SHALL contain exactly one [1..1] templateId (CONF:24842) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.2.5" (CONF:24843).SHALL contain at least one [1..*] entry (CONF:24848) such that itSHALL contain exactly one [1..1] Vital Signs Organizer BCTPS (templateId:2.16.840.1.113883.10.20.30.3.25) (CONF:24906).Figure SEQ Figure \* ARABIC 47: Vital Signs Section BCTPS example<section> <!—C-CDA Vital Signs Section with Coded Entries Optional templateID --> <templateId root="2.16.840.1.113883.10.20.22.2.4"/> <!-- BCTPS Vital Signs Section with Height weight and BSA Required --> <templateId root="2.16.840.1.113883.10.20.30.2.5"/> <code code="8716-3" displayName="Physical Findings - Vital signs" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"> <originalText>Vital Signs</originalText> </code> <title>VITAL SIGNS</title> <text> ... </text> <entry typeCode> <organizer classCode="CLUSTER" moodCode="EVN"> <!-- C-CDA VITAL SIGNS ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.26"/> <!-- Vital Signs Organizer BCTPS templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.25"/> ... </organizer> </entry></section>Entry-Level TemplatesAge Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.31 (open)]Table SEQ Table \* ARABIC61: Age Observation ContextsUsed By:Contains Entries:Problem Observation (optional)Family History Observation (optional)This Age Observation represents the subject's age at onset of an event or observation. The age of a relative in a Family History Observation at the time of that observation could also be inferred by comparing relatedSubject/subject/birthTime with observation/effectiveTime. However, a common scenario is that a patient will know the age of a relative when the relative had a certain condition or when the relative died, but will not know the actual year (e.g., "grandpa died of a heart attack at the age of 50"). Often times, neither precise dates nor ages are known (e.g., "cousin died of congenital heart disease as an infant").Table SEQ Table \* ARABIC62: Age Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.31']@classCode1..1SHALL76132.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL76142.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7899@root1..1SHALL104872.16.840.1.113883.10.20.22.4.31code1..1SHALL7615@code1..1SHALL167762.16.840.1.113883.6.96 (SNOMED-CT) = 445518008statusCode1..1SHALL15965@code1..1SHALL159662.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLPQ7617@unit1..1SHALLCS76182.16.840.1.113883.11.20.9.21 (AgePQ_UCUM)SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7613).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7614).SHALL contain exactly one [1..1] templateId (CONF:7899) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.31" (CONF:10487).SHALL contain exactly one [1..1] code (CONF:7615).This code SHALL contain exactly one [1..1] @code="445518008" Age At Onset (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:16776).SHALL contain exactly one [1..1] statusCode (CONF:15965).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:15966).SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7617).This value SHALL contain exactly one [1..1] @unit, which SHALL be selected from ValueSet AgePQ_UCUM 2.16.840.1.113883.11.20.9.21 DYNAMIC (CONF:7618).Table SEQ Table \* ARABIC63: AgePQ_UCUM Value SetValue Set: AgePQ_UCUM 2.16.840.1.113883.11.20.9.21 DYNAMICCode System(s):Unified Code for Units of Measure (UCUM) 2.16.840.1.113883.6.8Description:Description: A valueSet of UCUM codes for representing age value unitsCodeCode SystemPrint NameminUCUMMinutehUCUMHourdUCUMDaywkUCUMWeekmoUCUMMonthaUCUMYearFigure SEQ Figure \* ARABIC 48: Age Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.31"/> <!-- Age observation template --> <code code="445518008" codeSystem="2.16.840.1.113883.6.96" displayName="Age At Onset" /> <statusCode code="completed" /> <value xsi:type="PQ" value="57" unit="a" /></observation>Allergy Problem Act [act: templateId 2.16.840.1.113883.10.20.22.4.30 (open)]Table SEQ Table \* ARABIC64: Allergy Problem Act ContextsUsed By:Contains Entries:Allergies Section (entries optional) (optional)Allergy - Intolerance ObservationThis clinical statement act represents a concern relating to a patient's allergies or adverse events. A concern is a term used when referring to patient's problems that are related to one another. Observations of problems or other clinical statements captured at a point in time are wrapped in a Allergy Problem Act, or "Concern" act, which represents the ongoing process tracked over time. This outer Allergy Problem Act (representing the "Concern") can contain nested problem observations or other nested clinical statements relevant to the allergy concern.Table SEQ Table \* ARABIC65: Allergy Problem Act Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.22.4.30']@classCode1..1SHALL74692.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL74702.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7471@root1..1SHALL104892.16.840.1.113883.10.20.22.4.30id1..*SHALL7472code1..1SHALL7477@code1..1SHALL191582.16.840.1.113883.6.1 (LOINC) = 48765-2statusCode1..1SHALL7485@code1..1SHALL190862.16.840.1.113883.11.20.9.19 (ProblemAct statusCode)effectiveTime1..1SHALL7498entryRelationship1..*SHALL7509@typeCode1..1SHALL79152.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJobservation1..1SHALL14925SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7469).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7470).SHALL contain exactly one [1..1] templateId (CONF:7471) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.30" (CONF:10489).SHALL contain at least one [1..*] id (CONF:7472).SHALL contain exactly one [1..1] code (CONF:7477).This code SHALL contain exactly one [1..1] @code="48765-2" Allergies, adverse reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19158).SHALL contain exactly one [1..1] statusCode (CONF:7485).This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09 (CONF:19086).SHALL contain exactly one [1..1] effectiveTime (CONF:7498).If statusCode/@code="active" Active, then effectiveTime SHALL contain [1..1] low (CONF:7504).If statusCode/@code="completed" Completed, then effectiveTime SHALL contain [1..1] high (CONF:10085).SHALL contain at least one [1..*] entryRelationship (CONF:7509) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7915).SHALL contain exactly one [1..1] Allergy - Intolerance Observation (templateId:2.16.840.1.113883.10.20.22.4.7) (CONF:14925).Table SEQ Table \* ARABIC66: ProblemAct statusCode Value SetValue Set: ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09Code System(s): ActStatus 2.16.840.1.113883.5.14Description:This value set contains codes that represent the status of a problem or allergy concern.Reference: (members only)CodeCode SystemPrint NamecompletedActStatusCompletedabortedActStatusAbortedactiveActStatusActivesuspendedActStatusSuspendedFigure SEQ Figure \* ARABIC 49: Allergy Problem Act example<entry typeCode> <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.30"/> <id root="36e3e930-7b14-11db-9fe1-0800200c9a66"/> <code code="48765-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Allergies, adverse reactions, alerts" /> <statusCode code="active"/> <effectiveTime value="20060501"> <low value="20060501"/> </effectiveTime> <entryRelationship typeCode="SUBJ"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.7"/> . . . </act></entry>Allergy Status Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.28 (open)]Table SEQ Table \* ARABIC67: Allergy Status Observation ContextsUsed By:Contains Entries:Allergy - Intolerance Observation (optional)Substance or Device Allergy - Intolerance Observation (optional)This template represents the status of the allergy indicating whether it is active, no longer active, or is an historic allergy. There can be only one allergy status observation per alert observation.Table SEQ Table \* ARABIC68: Allergy Status Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.28']@classCode1..1SHALL73182.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL73192.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7317@root1..1SHALL104902.16.840.1.113883.10.20.22.4.28code1..1SHALL7320@code1..1SHALL191312.16.840.1.113883.6.1 (LOINC) = 33999-4statusCode1..1SHALL7321@code1..1SHALL190872.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCE73222.16.840.1.113883.3.88.12.80.68 (Problem Status Value Set)SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7318).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7319).SHALL contain exactly one [1..1] templateId (CONF:7317) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.28" (CONF:10490).SHALL contain exactly one [1..1] code (CONF:7320).This code SHALL contain exactly one [1..1] @code="33999-4" Status (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19131).SHALL contain exactly one [1..1] statusCode (CONF:7321).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19087).SHALL contain exactly one [1..1] value with @xsi:type="CE", where the @code SHALL be selected from ValueSet Problem Status Value Set 2.16.840.1.113883.3.88.12.80.68 DYNAMIC (CONF:7322).Table SEQ Table \* ARABIC69: Problem Status Value SetValue Set: Problem Status Value Set 2.16.840.1.113883.3.88.12.80.68Code System(s):SNOMED-CT 2.16.840.1.113883.6.96Description:A value set of codes that reflects the state of a problem. Reference: SystemPrint Name55561003SNOMED-CTActive73425007SNOMED-CTInactive413322009SNOMED-CTResolved* An inactive problem refers to one that is dormant, and may appear again in future.** A resolved problem refers to one that used to affect a patient, but no longer does.Figure SEQ Figure \* ARABIC 50: Allergy Status Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.28" /> <!-- Allergy status observation template --> <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Status" /> <statusCode code="completed" /> <value xsi:type="CE" code="55561003" codeSystem="2.16.840.1.113883.6.96" displayName="Active" /></observation>Anthracyclines Lifetime Dose[SubstanceAdministration: templateId 2.16.840.1.113883.10.20.30.3.24 (open)]Table SEQ Table \* ARABIC70: Anthracyclines Lifetime Dose ContextsContained By:Contains:Medications Section BCTPS (required)This clinical statement represents the total amount of drugs in the Anthracycline drug class that a patient has received in his or her lifetime.Table SEQ Table \* ARABIC71: Anthracyclines Lifetime Dose Constraints OverviewXPathCard.VerbData TypeCONF#Fixed ValuesubstanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.30.3.24']@classCode1..1SHALL236372.16.840.1.113883.5.6 (HL7ActClass) = SBADM@moodCode1..1SHALL236382.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL23639@root1..1SHALL236402.16.840.1.113883.10.20.30.3.24statusCode1..1SHALL23641@code1..1SHALL236422.16.840.1.113883.5.14 (ActStatus) = activeeffectiveTime1..1SHALLIVL_TS27315low1..1SHALL27316@nullFlavor1..1SHALL27317NINFhigh1..1SHALL27318doseQuantity1..1SHALL23645@unit1..1SHALL23646consumable1..1SHALL23647manufacturedProduct1..1SHALL27310manufacturedMaterial1..1SHALL27311code1..1SHALL27312@code1..1SHALL27313N0000007530@codeSystem1..1SHALL273142.16.840.1.113883.3.26.1.5 (NDFRT) = 2.16.840.1.113883.3.26.1.5SHALL contain exactly one [1..1] @classCode="SBADM" SubstanceAdministration (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23637).SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:23638).SHALL contain exactly one [1..1] templateId (CONF:23639) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.24" (CONF:23640).SHALL contain exactly one [1..1] statusCode (CONF:23641).This statusCode SHALL contain exactly one [1..1] @code="active" Active (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23642).In the absence of doseCheckQuantity as an attribute in CDA, this template uses the null value of "NINF" (negative infinity) to help to represent "From the beginning of time until this given date, this is the amount received".SHALL contain exactly one [1..1] effectiveTime (CONF:27315).This effectiveTime SHALL contain exactly one [1..1] low (CONF:27316).This low SHALL contain exactly one [1..1] @nullFlavor="NINF" negative infinity (CONF:27317).The effectiveTime/high is equal to the date the note is generated.This effectiveTime SHALL contain exactly one [1..1] high (CONF:27318).The doseQuantity/unit is not constrained.??Anthacyclines are usually ordered in mg/m2, and the maximum lifetime dose is often noted in mg/m2. However, what is most likely to be found in EHR is what was recorded on a Medication Administration Record (MAR), which is typically the actual mg (both are allowed).SHALL contain exactly one [1..1] doseQuantity (CONF:23645).This doseQuantity SHALL contain exactly one [1..1] @unit (CONF:23646).SHALL contain exactly one [1..1] consumable (CONF:23647).This consumable SHALL contain exactly one [1..1] manufacturedProduct (CONF:27310).This manufacturedProduct SHALL contain exactly one [1..1] manufacturedMaterial (CONF:27311).This manufacturedMaterial SHALL contain exactly one [1..1] code (CONF:27312).This code SHALL contain exactly one [1..1] @code="N0000007530" Anthracyclines (Structural Class) (CONF:27313).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.3.26.1.5" NDF-RT (CodeSystem: NDFRT 2.16.840.1.113883.3.26.1.5) (CONF:27314).Figure SEQ Figure \* ARABIC16: Anthracyclines Lifetime Dose<substanceAdministration classCode="SBADM" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.24" /> <statusCode code="active" /> <!-- Lifetime till observation--> <effectiveTime xsi:type="IVL_TS"> <!-- In the absence of doseCheckQuantity as an attribute in CDA this template uses the null value of negative infinity to help to represent "From the beginning of time until this given date, this is the amount received" --> <low nullFlavor="NINF"/> <!-- Date of observation or note generation --> <high value="20130301"/> </effectiveTime> <!-- Dose expressed here in mg. Though ordered in mg/m2, amd the max lifetime dose noted in mg/m2, what is most likely to be found in EHR is what was recorded on an MAR, which is typically the actual mg (both would be allowed)--> <doseQuantity value="137" unit="mg"/> <consumable> <manufacturedProduct classCode="MANU"> <manufacturedMaterial> <code codeSystem="2.16.840.1.113883.3.26.1.5" codeSystemName="NDF-RT" code="N0000007530" displayName="Anthracyclines (Structural Class)"/> </manufacturedMaterial> </manufacturedProduct> </consumable></substanceAdministration>Assessment Scale Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.69 (open)]Table SEQ Table \* ARABIC73: Assessment Scale Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)Functional Status Result Observation (optional)Cognitive Status Result Observation (optional)Functional Status Problem Observation (optional)Cognitive Status Problem Observation (optional)Assessment Scale Supporting ObservationAn assessment scale is a collection of observations that together yield a summary evaluation of a particular condition. Examples include the Braden Scale (assesses pressure ulcer risk), APACHE Score (estimates mortality in critically ill patients), Mini-Mental Status Exam (assesses cognitive function), APGAR Score (assesses the health of a newborn), and Glasgow Coma Scale (assesses coma and impaired consciousness.)Table SEQ Table \* ARABIC74: Assessment Scale Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.69']@classCode1..1SHALL144342.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL144352.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14436@root1..1SHALL144372.16.840.1.113883.10.20.22.4.69id1..*SHALL14438code1..1SHALL14439derivationExpr0..1MAY14637statusCode1..1SHALL14444@code1..1SHALL190882.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL14445value1..1SHALL14450interpretationCode0..*MAY14459translation0..*MAY14888author0..*MAY14460entryRelationship0..*SHOULD14451@typeCode1..1SHALL16741COMPobservation1..1SHALL16742referenceRange0..*MAY16799observationRange1..1SHALL16800text0..1SHOULD16801reference0..1SHOULD16802@value0..1MAY16803SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14434).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14435).SHALL contain exactly one [1..1] templateId (CONF:14436) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.69" (CONF:14437).SHALL contain at least one [1..*] id (CONF:14438).SHALL contain exactly one [1..1] code (CONF:14439).SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) identifying the assessment scale (CONF:14440).Such derivation expression can contain a text calculation of how the components total up to the summed score MAY contain zero or one [0..1] derivationExpr (CONF:14637).SHALL contain exactly one [1..1] statusCode (CONF:14444).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19088).Represents clinically effective time of the measurement, which may be when the measurement was performed (e.g., a BP measurement), or may be when sample was taken (and measured some time afterwards) SHALL contain exactly one [1..1] effectiveTime (CONF:14445).SHALL contain exactly one [1..1] value (CONF:14450).MAY contain zero or more [0..*] interpretationCode (CONF:14459).The interpretationCode, if present, MAY contain zero or more [0..*] translation (CONF:14888).MAY contain zero or more [0..*] author (CONF:14460).SHOULD contain zero or more [0..*] entryRelationship (CONF:14451) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CONF:16741).SHALL contain exactly one [1..1] Assessment Scale Supporting Observation (templateId:2.16.840.1.113883.10.20.22.4.86) (CONF:16742).The referenceRange/observationRange/text, if present, MAY contain a description of the scale (e.g. for a Pain Scale 1 to 10: 1 to 3 = little pain, 4 to 7= moderate pain, 8 to 10 = severe pain) MAY contain zero or more [0..*] referenceRange (CONF:16799).The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:16800).This observationRange SHOULD contain zero or one [0..1] text (CONF:16801).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:16802).The reference, if present, MAY contain zero or one [0..1] @value (CONF:16803).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:16804).Figure SEQ Figure \* ARABIC \* MERGEFORMAT 52: Assessment Scale Observation example<observation classCode="OBS" moodCode="EVN"> <!—Assessment Scale Observation --> <templateId root="2.16.840.1.113883.10.20.22.4.69"/> <id root="c6b5a04b-2bf4-49d1-8336-636a3813df0b"/> <code code="54614-3" displayName="Brief Interview for Mental Status" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <derivationExpr>Text description of the calculation</derivationExpr> <statusCode code="completed"/> <effectiveTime value="20120214"/> <!-- Summed score of the component values --> <value xsi:type="INT" value="7"/> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!-- ** Assessment scale supporting observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.86"/> ... </observation </entryRelationship> ...</observation>Assessment Scale Supporting Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.86 (open)]Table SEQ Table \* ARABIC75: Assessment Scale Supporting Observation ContextsUsed By:Contains Entries:Assessment Scale Observation (optional)An Assessment Scale Supporting observation represents the components of a scale used in an Assessment Scale Observation. The individual parts that make up the component may be a group of cognitive or functional status observations.Table SEQ Table \* ARABIC76: Assessment Scale Supporting Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.86']@classCode1..1SHALL167152.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL167162.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL16722@root1..1SHALL167232.16.840.1.113883.10.20.22.4.86id1..*SHALL16724code1..1SHALL19178@code1..1SHALL19179statusCode1..1SHALL16720@code1..1SHALL190892.16.840.1.113883.5.14 (ActStatus) = completedvalue1..*SHALL16754SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:16715).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:16716).SHALL contain exactly one [1..1] templateId (CONF:16722) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.86" (CONF:16723).SHALL contain at least one [1..*] id (CONF:16724).SHALL contain exactly one [1..1] code (CONF:19178).This code SHALL contain exactly one [1..1] @code (CONF:19179).Such that the @code SHALL be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) and represents components of the scale (CONF:19180).SHALL contain exactly one [1..1] statusCode (CONF:16720).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19089).SHALL contain at least one [1..*] value (CONF:16754).If xsi:type="CD" , MAY have a translation code to further specify the source if the instrument has an applicable code system and valueSet for the integer (CONF:14639) (CONF:16755).Figure SEQ Figure \* ARABIC 53: Assessment Scale Supporting Observation example<entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.86"/> <id root="f4dce790-8328-11db-9fe1-0800200c9a44"/> <code code="248240001" displayName="motor response" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED"/> <statusCode code="completed"/> <value xsi:type="INT" value="3"/> </observation> </entryRelationship> B reast TNM Clinical Category[act: templateId 2.16.840.1.113883.10.20.30.3.3 (open)]Table SEQ Table \* ARABIC73: Breast TNM Clinical Category ContextsContained By:Contains:Breast Cancer Diagnosis Observation (required)Breast TNM Metastasis CategoryBreast TNM Node CategoryBreast TNM Tumor CategoryThis clinical statement represents the overall TNM clinical stage of the patient's breast cancer which may contain details on the Tumor, Node, and Metastasis (TNM) categories.Table SEQ Table \* ARABIC74: Breast TNM Clinical Category Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.3']@classCode1..1SHALL220562.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL220572.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL19292@root1..1SHALL192932.16.840.1.113883.10.20.30.3.3id1..*SHALL24929code1..1SHALL21897@code1..1SHALL21898254326001@codeSystem1..1SHALL233512.16.840.1.113883.6.96effectiveTime1..1SHALL22077entryRelationship1..1SHALL21899@typeCode1..1SHALL21900COMPobservation1..1SHALL24907@classCode1..1SHALL249082.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL249092.16.840.1.113883.5.1001 (ActMood) = EVNcode1..1SHALL24910@code1..1SHALL2491121908-9@codeSystem1..1SHALL249122.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1statusCode1..1SHALL24913@code1..1SHALL249142.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD249152.16.840.1.113883.11.20.11.12 (Breast TNM Stage Group)entryRelationship1..1SHALL26213@typeCode1..1SHALL262142.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL26215entryRelationship1..1SHALL26216@typeCode1..1SHALL262172.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL26218entryRelationship1..1SHALL26219@typeCode1..1SHALL262202.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL26221SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:22056).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:22057).SHALL contain exactly one [1..1] templateId (CONF:19292) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.3" (CONF:19293).SHALL contain at least one [1..*] id (CONF:24929).SHALL contain exactly one [1..1] code (CONF:21897).This code SHALL contain exactly one [1..1] @code="254326001" TNM Breast Cancer Staging (CONF:21898).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CONF:23351).SHALL contain exactly one [1..1] effectiveTime (CONF:22077).SHALL contain exactly one [1..1] entryRelationship (CONF:21899) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CONF:21900).SHALL contain exactly one [1..1] observation (CONF:24907).This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:24908).This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:24909).This observation SHALL contain exactly one [1..1] code (CONF:24910).This code SHALL contain exactly one [1..1] @code="21908-9" Stage group clinical (CONF:24911).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:24912).This observation SHALL contain exactly one [1..1] statusCode (CONF:24913).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:24914).This observation SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Breast TNM Stage Group 2.16.840.1.113883.11.20.11.12 DYNAMIC (CONF:24915).This observation SHALL contain exactly one [1..1] entryRelationship (CONF:26213) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:26214).SHALL contain exactly one [1..1] Breast TNM Tumor Category (templateId:2.16.840.1.113883.10.20.30.3.5) (CONF:26215).This observation SHALL contain exactly one [1..1] entryRelationship (CONF:26216) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:26217).SHALL contain exactly one [1..1] Breast TNM Node Category (templateId:2.16.840.1.113883.10.20.30.3.7) (CONF:26218).This observation SHALL contain exactly one [1..1] entryRelationship (CONF:26219) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:26220).SHALL contain exactly one [1..1] Breast TNM Metastasis Category (templateId:2.16.840.1.113883.10.20.30.3.8) (CONF:26221).Table SEQ Table \* ARABIC75: Breast TNM Stage GroupValue Set: Breast TNM Stage Group 2.16.840.1.113883.11.20.11.12 This value set contains codes that categorizes the progression of cancer using theRoman Numeral systemReference: SystemPrint Name46333007SNOMED CTClinical stage I (finding) 46333007SNOMED CTClinical Stage IA (finding)786005SNOMED CTClinical Stage IB (finding)60333009SNOMED CTClinical stage II (finding)52774001SNOMED CTClinical Stage IIA (finding)17816005SNOMED CTClinical Stage IIB (finding)50283003SNOMED CTClinical stage III (finding)73082003SNOMED CTClinical Stage IIIA (finding)64062008SNOMED CTClinical Stage IIIB (finding)48105005SNOMED CTClinical Stage IIIC (finding)...Figure SEQ Figure \* ARABIC19: Breast TNM Clinical Category<entryRelationship typeCode="SPRT"> <act classCode="ACT" moodCode="EVN"> <!-- Breast TNM Stage TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.3"/> <id root="d3bcc512-d406-465c-a2b8-db2ace265681"/> <code codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="254326001" displayName="TNM Breast Cancer Staging"/> <effectiveTime value="20120112"/> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="21908-9" displayName="Stage group clinical"/> <statusCode code="completed"/> <effectiveTime> <low value="20120104"/> </effectiveTime> <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="46333007" displayName="clinical stage IA"/> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!-- BREAST TNM TUMOR (T) TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.5"/> ... </entryRelationship> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!--Node (N) STAGING TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.7"/> ... </observation> </entryRelationship> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!-- Metastasis (M) STAGING TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.8"/> ... </observation> </entryRelationship> </observation> </entryRelationship> </act> </entryRelationship>Breast TNM Metastasis Category[observation: templateId 2.16.840.1.113883.10.20.30.3.8 (open)]Table SEQ Table \* ARABIC76: Breast TNM Metastasis Category ContextsContained By:Contains:Breast TNM Clinical Category (required)This clinical statement represents the AJCC (American Joint Committee on Cancer) staging of metastasis (M) for breast cancer.Table SEQ Table \* ARABIC77: Breast TNM Metastasis Category Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.8']@classCode1..1SHALL218722.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL218732.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL21874@root1..1SHALL218752.16.840.1.113883.10.20.30.3.8id1..*SHALL22073code1..1SHALL218772.16.840.1.113883.11.20.11.25 (Breast TNM Metastasis Observation)statusCode1..1SHALL22047@code1..1SHALL220482.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL22080value1..1SHALLCD220492.16.840.1.113883.11.20.11.15 (Breast TNM Metastasis Category)SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:21872).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:21873).SHALL contain exactly one [1..1] templateId (CONF:21874) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.8" (CONF:21875).SHALL contain at least one [1..*] id (CONF:22073).SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Breast TNM Metastasis Observation 2.16.840.1.113883.11.20.11.25 DYNAMIC (CONF:21877).Note: The Breast TNM Metastasis Observation 2.16.840.1.113883.11.20.11.25 is a dynamically bound value set. As other members become available, they can be added to the value set. When a code is not yet available use a nullFlavor = “OTH”.SHALL contain exactly one [1..1] statusCode (CONF:22047).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:22048).SHALL contain exactly one [1..1] effectiveTime (CONF:22080).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Breast TNM Metastasis Category 2.16.840.1.113883.11.20.11.15 DYNAMIC (CONF:22049).Table SEQ Table \* ARABIC78: Breast TNM Metastasis ObservationValue Set: Breast TNM Metastasis Observation 2.16.840.1.113883.11.20.11.25This value set contains codes that represent breast TNM metastasis category for staging derived American Joint Committee Cancer where the integer represents the edition.Valueset Source: SystemPrint Name59522-3LOINCDerived American Joint Committee on Cancer-7 M descriptorTable SEQ Table \* ARABIC79: Breast TNM Metastasis CategoryValue Set: Breast TNM Metastasis Category 2.16.840.1.113883.11.20.11.15This value set contains codes that are part of the TNM classification system. The "M" represents metastases. The system is used to describe the spread of cancer to other parts of the body. Valueset Source: SystemPrint Name433411000124107SNOMED CTM0: No clinical or radiographic evidence of distant metastasis436201000124109SNOMED CTcM0(i+) as per American Joint Committee on Cancer 7th edition (finding)436201000124104SNOMED CTM1: Distant detectable metastasis found by clinical and radiographic means and/or histologically proven larger than 0.2 mm (finding)Figure SEQ Figure \* ARABIC20: Breast TNM Metastasis Category<observation classCode="OBS" moodCode="EVN"> <!-- Metastasis (M) STAGING TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.8"/> <id root="08eca3aa-e4a6-4dc3-9d59-1d452e5b6b20"/> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="59522-3" displayName="Derived American Joint Committee on Cancer-7 M descriptor "/> <statusCode code="completed"/> <effectiveTime> <low value="20120104"/> </effectiveTime> <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="436201000124104" displayName="M1: Distant detectable metastasis found by clinical and radiographic means and/or histologically proven larger than 0.2 mm"/> <reference typeCode="REFR"> <externalObservation classCode="OBS" moodCode="EVN"> <text mediaType="text"> <reference value=""/> </text> </externalObservation> </reference></observation>>Figure SEQ Figure \* ARABIC21: NullFlavor for Code Element<observation classCode="OBS" moodCode="EVN"> <!-- Metastasis (M) STAGING TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.8"/> <id root="08eca3aa-e4a6-4dc3-9d59-1d452e5b6b20"/> <code nullFlavor="OTH"> <originalText>Metastasis Category using the AJCC 6th edition</originalText> </code> <effectiveTime> <low value="20120104"/> </effectiveTime> <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="436201000124104" displayName="M1: Distant detectable metastasis found by clinical and radiographic means and/or histologically proven larger than 0.2 mm"/> </observation>Breast TNM Node Category[observation: templateId 2.16.840.1.113883.10.20.30.3.7 (open)]Table SEQ Table \* ARABIC80: Breast TNM Node Category ContextsContained By:Contains:Breast TNM Clinical Category (required)This clinical statement template represents the AJCC (American Joint Committee on Cancer) staging of lymph node (N) involvement for breast cancer.Table SEQ Table \* ARABIC81: Breast TNM Node Category Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.7']@classCode1..1SHALL218462.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL218472.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL21848@root1..1SHALL218492.16.840.1.113883.10.20.30.3.7id1..*SHALL22072code1..1SHALL218512.16.840.1.113883.11.20.11.24 (Breast TNM Node Observation)statusCode1..1SHALL22043@code1..1SHALL220442.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL22079value1..1SHALLCD220452.16.840.1.113883.11.20.11.14 (Breast TNM Node Category)SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:21846).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:21847).SHALL contain exactly one [1..1] templateId (CONF:21848) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.7" (CONF:21849).SHALL contain at least one [1..*] id (CONF:22072).SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Breast TNM Node Observation 2.16.840.1.113883.11.20.11.24 DYNAMIC (CONF:21851).Note: The Breast TNM Node Observation 2.16.840.1.113883.11.20.11.24 is a dynamically bound value set. As other members become available, they can be added to the value set. When a code is not yet available use a nullFlavor = “OTH”.SHALL contain exactly one [1..1] statusCode (CONF:22043).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:22044).SHALL contain exactly one [1..1] effectiveTime (CONF:22079).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Breast TNM Node Category 2.16.840.1.113883.11.20.11.14 DYNAMIC (CONF:22045).Table SEQ Table \* ARABIC82: Breast TNM Node ObservationValue Set: Breast TNM Node Observation 2.16.840.1.113883.11.20.11.24This value set contains codes that represent breast TNM node category for staging derived American Joint Committee Cancer where the integer represents the edition.Valueset Source: SystemPrint Name59525-6 LOINCDerived American Joint Committee on Cancer-7 N descriptorTable SEQ Table \* ARABIC83: Breast TNM Node CategoryValue Set: Breast TNM Node Category 2.16.840.1.113883.11.20.11.14This value set contains codes that are part of the TNM classification system. The "N" represents node. The system is used to categorize number, size and the extent of lymph node involvement. Valueset Source: SystemPrint Name436191000124102SNOMED CTNX: Regional lymph nodes cannot be assessed (finding)433441000124106SNOMED CTN0: No regional lymph node metastasis (finding)433451000124108SNOMED CTN1: Metastasis to movable ipsilateral level I, II axillary lymph node(s) (finding)433421000124104SNOMED CTN2 as per American Joint Committee on Cancer 7th edition (finding)436251000124100SNOMED CT N2a: Metastasis in ipsilateral level I, II axillary lymph nodes fixed to one another or to other structures (finding)434801000124109SNOMED CTN2b: Metastases only in clinically detected ipsilateral internal mammary nodes and in the absence of clinically evident level I, II axillary lymph node metastases (finding)433431000124101SNOMED CTN3 as per American Joint Committee on Cancer 7th edition (finding)436271000124105SNOMED CT N3a: Metastasis in ipsilateral infraclavicular lymph node(s) (finding)436271000124103SNOMED CT N3b: Metastasis in ipsilateral internal mammary lymph node(s) and axillary lymph node(s) (finding)436241000124102SNOMED CTN3c: Metastasis in ipsilateral supraclavicular lymph node(s) (finding)Figure SEQ Figure \* ARABIC22: Breast TNM Node Category<observation classCode="OBS" moodCode="EVN"> <!--Node (N) STAGING TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.7"/> <id root="7c77d6c1-2f29-448c-b76f-7287665c8540"/> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="59525-6" displayName="Derived American Joint Committee on Cancer-7 N descriptor "/> <statusCode code="completed"/> <effectiveTime> <low value="20120104"/> </effectiveTime> <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="433451000124108" displayName="N1: Metastasis to movable ipsilateral level I, II axillary lymph node(s) (finding)"/> <reference typeCode="REFR"> <externalObservation classCode="OBS" moodCode="EVN"> <text mediaType="text"> <reference value=""/> </text> </externalObservation> </reference></observation>Breast TNM Tumor Category[observation: templateId 2.16.840.1.113883.10.20.30.3.5 (open)]Table SEQ Table \* ARABIC84: Breast TNM Tumor Category ContextsContained By:Contains:Breast TNM Clinical Category (required)This clinical statement template represents the AJCC (Americn Joint Committee on Cancer)??staging of the tumor (T) for breast cancer.Table SEQ Table \* ARABIC85: Breast TNM Tumor Category Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.5']@classCode1..1SHALL218222.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL218232.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL19350@root1..1SHALL193512.16.840.1.113883.10.20.30.3.5id1..*SHALL22071code1..1SHALL218252.16.840.1.113883.11.20.11.23 (Breast TNM Tumor Observation)statusCode1..1SHALL22052@code1..1SHALL220532.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL22078value1..1SHALLCD220542.16.840.1.113883.11.20.11.13 (Breast TNM Tumor Category)SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:21822).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:21823).SHALL contain exactly one [1..1] templateId (CONF:19350) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.5" (CONF:19351).SHALL contain at least one [1..*] id (CONF:22071).SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Breast TNM Tumor Observation 2.16.840.1.113883.11.20.11.23 DYNAMIC (CONF:21825).Note: The Breast TNM Tumor Observation 2.16.840.1.113883.11.20.11.23 is a dynamically bound value set. As other members become available, they can be added to the value set. When a code is not yet available use a nullFlavor = “OTH”.SHALL contain exactly one [1..1] statusCode (CONF:22052).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:22053).SHALL contain exactly one [1..1] effectiveTime (CONF:22078).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Breast TNM Tumor Category 2.16.840.1.113883.11.20.11.13 DYNAMIC (CONF:22054).Table SEQ Table \* ARABIC86: Breast TNM Tumor ObservationValue Set: Breast TNM Tumor Observation 2.16.840.1.113883.11.20.11.23This value set contains codes that represent breast TNM tumor category for staging derived American Joint Committee Cancer where the integer represents the edition.Valueset Source: SystemPrint Name59528-0 LOINCDerived American Joint Committee on Cancer-7 T descriptor Table SEQ Table \* ARABIC87: Breast TNM Tumor CategoryValue Set: Breast TNM Tumor Category 2.16.840.1.113883.11.20.11.13This value set contains codes that are part of the TNM classification system. The "T" represents tumor. The system is used to categorize the size of the primary tumor and its infiltration into nearby tissues. Valueset Source: SystemPrint Name436181000124100SNOMED CTTX: Primary tumor cannot be assessed (finding)433371000124106SNOMED CTT0: No evidence of primary tumor (finding)369895002SNOMED CTT1: Breast tumor <= 2 cm in greatest dimension (finding)433381000124109SNOMED CTT1mi: Tumor <=1 mm in greatest dimension (finding)369897005SNOMED CTT1a: Breast tumor >0.1 cm but <= 0.5 cm in greatest dimension (finding)369898000SNOMED CTT1b: Breast tumor >0.5 cm but <= 1 cm in greatest dimension (finding)433391000124107SNOMED CTT1c: Tumor >10 mm but <=20 mm in greatest dimension (finding)369900003SNOMED CTT2: Breast tumor > 2 cm but <= 5 cm in greatest dimension (finding)369901004SNOMED CTT3: Breast tumor >5 cm in greatest dimension (finding)433401000124109SNOMED CTT4: Direct extension to chest wall and/or skin beyond dermis (finding)...Figure SEQ Figure \* ARABIC23: Breast TNM Tumor Category<observation classCode="OBS" moodCode="EVN"> <!-- BREAST TNM TUMOR (T) TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.5"/> <id root="2bbad97e-136c-4401-81bc-cfee14b31900"/> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="59528-0" displayName="Derived American Joint Committee on Cancer-7 T descriptor"/> <statusCode code="completed"/> <effectiveTime> <low value="20120104"/> </effectiveTime> <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="369900003" displayName="T2: Breast tumor greater than 2 cm but less than or equal to 5 cm in greatest dimension (finding)"/> <reference typeCode="REFR"> <externalObservation classCode="OBS" moodCode="EVN"> <text mediaType="text"> <reference value=""/> </text> </externalObservation> </reference></observation>Caregiver Characteristics [observation: templateId 2.16.840.1.113883.10.20.22.4.72 (open)]Table SEQ Table \* ARABIC92: Caregiver Characteristics ContextsUsed By:Contains Entries:Functional Status Section (optional)Functional Status Result Observation (optional)Cognitive Status Result Observation (optional)Functional Status Problem Observation (optional)Cognitive Status Problem Observation (optional)This clinical statement represents a caregiver’s willingness to provide care and the abilities of that caregiver to provide assistance to a patient in relation to a specific need.Table SEQ Table \* ARABIC93: Caregiver Characteristics Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.72']@classCode1..1SHALL142192.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL142202.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14221@root1..1SHALL142222.16.840.1.113883.10.20.22.4.72id1..*SHALL14223code1..1SHALL14230statusCode1..1SHALL14233@code1..1SHALL190902.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALL14599participant1..*SHALL14227time0..1MAY14830low1..1SHALL14831high0..1MAY14832participantRole1..1SHALL14228@classCode1..1SHALL14229INDSHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14219).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14220).SHALL contain exactly one [1..1] templateId (CONF:14221) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.72" (CONF:14222).SHALL contain at least one [1..*] id (CONF:14223).SHALL contain exactly one [1..1] code (CONF:14230).SHALL contain exactly one [1..1] statusCode (CONF:14233).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19090).SHALL contain exactly one [1..1] value (CONF:14599).Where the @code SHALL be selected from LOINC (codeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:14600).SHALL contain at least one [1..*] participant (CONF:14227).Such participants MAY contain zero or one [0..1] time (CONF:14830).The time, if present, SHALL contain exactly one [1..1] low (CONF:14831).The time, if present, MAY contain zero or one [0..1] high (CONF:14832).Such participants SHALL contain exactly one [1..1] participantRole (CONF:14228).This participantRole SHALL contain exactly one [1..1] @classCode="IND" (CONF:14229).Figure SEQ Figure \* ARABIC \* MERGEFORMAT 59: Caregiver Characteristics example with assertion<observation classCode="OBS" moodCode="EVN"> <!-- Caregiver Characteristics --> <templateId root="2.16.840.1.113883.10.20.22.4.72"/> <id root="c6b5a04b-2bf4-49d1-8336-636a3813df0c"/> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/> <statusCode code="completed"/> <value xsi:type="CD" code="422615001" codeSystem="2.16.840.1.113883.6.96" displayName="caregiver difficulty providing physical care"/> <participant typeCode="IND"> <participantRole classCode="CAREGIVER"> <code code="MTH" codeSystem="2.16.840.1.113883.5.111" displayName="Mother"/> </participantRole> </participant></observation>Figure SEQ Figure \* ARABIC \* MERGEFORMAT 60: Caregiver Characteristics example without assertion<observation classCode="OBS" moodCode="EVN"> <!-- Caregiver Characteristics --> <templateId root="2.16.840.1.113883.10.20.22.4.72"/> <id root="c6b5a04b-2bf4-49d1-8336-636a3813df0c"/> <code code=" 5267-7" codeSystem="2.16.840.1.113883.6.1" displayName=" ADL or IADL assistance from any caregiver” <statusCode code="completed"/> <value xsi:type="CD" code=" 422615001" codeSystem="2.16.840.1.113883.6.96" displayName="caregiver difficulty providing physical care"/> <participant typeCode="IND"> <participantRole classCode="CAREGIVER"> <code code="MTH" codeSystem="2.16.840.1.113883.5.111" displayName="Mother"/> </participantRole> </participant></observation>Chemotherapeutic Drug Therapy Discontinued[observation: templateId 2.16.840.1.113883.10.20.30.3.43 (open)]Table SEQ Table \* ARABIC90: Chemotherapeutic Drug Therapy Discontinued ContextsContained By:Contains:Medications Section BCTPS (optional)This clinical statement represents that chemotherapeutic drug therapy was stopped and the reason why it was discontinued. Table SEQ Table \* ARABIC91: Chemotherapeutic Drug Therapy Discontinued Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.43']@classCode1..1SHALL239062.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL239072.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL23908@root1..1SHALL239092.16.840.1.113883.10.20.30.3.43code1..1SHALL23910@code1..1SHALL239112.16.840.1.113883.5.4 (ActCode) = ASSERTION@codeSystem1..1SHALL270812.16.840.1.113883.5.4 (ActCode) = 2.16.840.1.113883.5.4statusCode1..1SHALL23912@code1..1SHALL239132.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL23914high1..1SHALL27405value1..1SHALLCD23916@code1..1SHALL23917274512008@codeSystem1..1SHALL270822.16.840.1.113883.6.96entryRelationship1..*SHALL23918@typeCode1..1SHALL239192.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSONobservation1..1SHALL23920@classCode1..1SHALL239212.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL239222.16.840.1.113883.5.1001 (ActMood) = EVNcode1..1SHALL27375@code1..1SHALL27376373832009@codeSystem1..1SHALL273772.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL23923@code1..1SHALL239242.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD239272.16.840.1.113883.11.20.11.11 (Reason for Stopping Chemotherapy)@nullFlavor0..1MAY274112.16.840.1.113883.5.1008 (HL7NullFlavor) = OTHoriginalText0..1MAY27412SHALL contain exactly one [1..1] @classCode="OBS" observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23906).SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:23907).SHALL contain exactly one [1..1] templateId (CONF:23908) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.43" (CONF:23909).SHALL contain exactly one [1..1] code (CONF:23910).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:23911).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:27081).SHALL contain exactly one [1..1] statusCode (CONF:23912).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23913).SHALL contain exactly one [1..1] effectiveTime (CONF:23914).This effectiveTime SHALL contain exactly one [1..1] high (CONF:27405).SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:23916).This value SHALL contain exactly one [1..1] @code="274512008" drug therapy discontinued (CONF:23917).This value SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CONF:27082).SHALL contain at least one [1..*] entryRelationship (CONF:23918).Such entryRelationships SHALL contain exactly one [1..1] @typeCode="RSON" has reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:23919).Such entryRelationships SHALL contain exactly one [1..1] observation (CONF:23920).This observation SHALL contain exactly one [1..1] @classCode="OBS" observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23921).This observation SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:23922).This observation SHALL contain exactly one [1..1] code (CONF:27375).This code SHALL contain exactly one [1..1] @code="373832009" reason for change in planned chemotherapy treatment (CONF:27376).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:27377).This observation SHALL contain exactly one [1..1] statusCode (CONF:23923).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23924).This observation SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Reason for Stopping Chemotherapy 2.16.840.1.113883.11.20.11.11 DYNAMIC (CONF:23927).This value MAY contain zero or one [0..1] @nullFlavor="OTH" other (CodeSystem: HL7NullFlavor 2.16.840.1.113883.5.1008) (CONF:27411).If the reason for chemotherapeutic drug discontinuation is not adequate through a term available in the value set, additional explanatory text can be provided in value/originalText.This value MAY contain zero or one [0..1] originalText (CONF:27412).Table SEQ Table \* ARABIC92: Reason for Stopping ChemotherapyValue Set: Reason for Stopping Chemotherapy 2.16.840.1.113883.11.20.11.11List of reason codes for stopping a chemotherapy treatment originating from ASCO's Quality Oncology Practice Initiative (QOPI). Valueset Source: SystemPrint Name419099009SNOMED CTdead (finding)62014003SNOMED CTadverse reaction to drug (disorder)182868002SNOMED CTtreatment stopped - alternative therapy undertaken (situation)399307001SNOMED CTlost to follow-up (finding)105480006SNOMED CTrefusal of treatment by patient (situation)182992009SNOMED CTtreatment completed (situation)399213007SNOMED CTtoxicity due to chemotherapy (disorder)373833004SNOMED CTchemotherapy changed - progressive disease during chemotherapy (finding)365550006SNOMED CTfinding of financial circumstances (finding)398192003SNOMED CTco-morbid conditions (finding)Figure SEQ Figure \* ARABIC25: Chemotherapeutic Drug Therapy Discontinued<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.43" /> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" /> <statusCode code="completed" /> <effectiveTime> <high /> </effectiveTime> <value code="274512008" codeSystem="2.16.840.1.113883.6.96" /> <entryRelationship typeCode="RSON"> <observation classCode="OBS" moodCode="EVN"> <code code="373832009" codeSystem="2.16.840.1.113883.6.96" /> <statusCode code="completed" /> <value nullFlavor="OTH"> <originalText /> </value> </observation> </entryRelationship></observation>Figure SEQ Figure \* ARABIC26: "OTH" for Other Values<entryRelationship typeCode="RSON"> <observation classCode="OBS" moodCode="EVN"> <code code="373832009" displayName="reason for change in planned chemotherapy treatment" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"></code> <statusCode code="completed"/> <effectiveTime> <low nullFlavor="NI"/> </effectiveTime> <value xsi:type="CD" nullFlavor="OTH"> <originalText>Severe shaking and cramping</originalText> </value> </observation></entryRelationship>Chemotherapy Protocol Reference[act: templateId 2.16.840.1.113883.10.20.30.3.50 (open)]Table SEQ Table \* ARABIC93: Chemotherapy Protocol Reference ContextsContained By:Contains:Chemotherapy Medication Activity (optional)Chemotherapy Medication Activity Plan (optional)This act references a cancer chemotherapy regimen protocol. The protocol referenced may contain information about other drugs in the regimen as well.Table SEQ Table \* ARABIC94: Chemotherapy Protocol Reference Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.50']@classCode1..1SHALL273412.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL273422.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL27328@root1..1SHALL273292.16.840.1.113883.10.20.30.3.50code1..1SHALL27330@code1..1SHALL2733169960004@codeSystem1..1SHALL273322.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL27333@code1..1SHALL273342.16.840.1.113883.5.14 (ActStatus) = completedreference1..1SHALL27335@typeCode1..1SHALL273362.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRexternalDocument1..1SHALL27337@classCode1..1SHALL273382.16.840.1.113883.5.6 (HL7ActClass) = DOCid1..1SHALL27339text0..1SHOULD27340SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:27341).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:27342).SHALL contain exactly one [1..1] templateId (CONF:27328) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.50" (CONF:27329).SHALL contain exactly one [1..1] code (CONF:27330).This code SHALL contain exactly one [1..1] @code="69960004" cancer chemotherapy regimen (CONF:27331).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:27332).SHALL contain exactly one [1..1] statusCode (CONF:27333).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:27334).SHALL contain exactly one [1..1] reference (CONF:27335).This reference SHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27336).This reference SHALL contain exactly one [1..1] externalDocument (CONF:27337).This externalDocument SHALL contain exactly one [1..1] @classCode="DOC" Document (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:27338).This act/id represents the identifier of the regimen protocol.This externalDocument SHALL contain exactly one [1..1] id (CONF:27339).This act/text should contain text naming the regimen and a hyperlink to an internal institution or external??protocol website.This externalDocument SHOULD contain zero or one [0..1] text (CONF:27340).Figure SEQ Figure \* ARABIC27: Chemotherapy Protocol Reference<act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.50" /> <code code="69960004" codeSystem="2.16.840.1.113883.6.96" displayName="cancer chemotherapy regimen" /> <statusCode code="completed" /> <reference typeCode="REFR"> <externalDocument classCode="DOC" moodCode="EVN"> <!--This would an identifier for the regimen protocol --> <id root="4e842410-8698-11e2-9e96-0800200c9a66" /> <!-- Could contain text naming the regimen and a link to an internal or external protocol website--> <text mediaType="text">TAC Regimen <reference value="" /></text> </externalDocument> </reference></act>Cl inical Drug Trial[act: templateId 2.16.840.1.113883.10.20.30.3.4 (open)]Table SEQ Table \* ARABIC95: Clinical Drug Trial ContextsContained By:Contains:Chemotherapy Medication Activity (optional)Chemotherapy Regimen Plans (optional)Chemotherapy Medication Activity Plan (optional)This clinical statement represents a treatment (e.g., chemotherapy administered) that is part of a clinical trial. Table SEQ Table \* ARABIC96: Clinical Drug Trial Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.4']@classCode1..1SHALL238592.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL238602.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL23861@root1..1SHALL238622.16.840.1.113883.10.20.30.3.4code1..1SHALL23876@code1..1SHALL23877185922005@codeSystem1..1SHALL262462.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL23863@code1..1SHALL238642.16.840.1.113883.5.14 (ActStatus) = completedSHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23859).SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:23860).SHALL contain exactly one [1..1] templateId (CONF:23861) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.4" (CONF:23862).SHALL contain exactly one [1..1] code (CONF:23876).This code SHALL contain exactly one [1..1] @code="185922005" clinical drug trials (CONF:23877).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:26246).SHALL contain exactly one [1..1] statusCode (CONF:23863).This statusCode SHALL contain exactly one [1..1] @code="completed" (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23864).Figure SEQ Figure \* ARABIC28: Clinical Drug Trial<act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.4" /> <code code="185922005" displayName="clinical drug trials" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" /> <statusCode code="completed" /></act>Drug Vehicle [participantRole: templateId 2.16.840.1.113883.10.20.22.4.24 (open)]Table SEQ Table \* ARABIC101: Drug Vehicle ContextsUsed By:Contains Entries:Medication Activity (optional)This template represents the vehicle (e.g. saline, dextrose) for administering a medication.Table SEQ Table \* ARABIC102: Drug Vehicle Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueparticipantRole[templateId/@root = '2.16.840.1.113883.10.20.22.4.24']@classCode1..1SHALL74902.16.840.1.113883.5.110 (RoleClass) = MANUtemplateId1..1SHALL7495@root1..1SHALL104932.16.840.1.113883.10.20.22.4.24code1..1SHALL19137@code1..1SHALL191382.16.840.1.113883.6.96 (SNOMED-CT) = 412307009playingEntity1..1SHALL7492code1..1SHALL7493name0..1MAY7494SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:7490).SHALL contain exactly one [1..1] templateId (CONF:7495) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.24" (CONF:10493).SHALL contain exactly one [1..1] code (CONF:19137).This code SHALL contain exactly one [1..1] @code="412307009" Drug Vehicle (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:19138).SHALL contain exactly one [1..1] playingEntity (CONF:7492).This playingEntity/code is used to supply a coded term for the drug vehicle.This playingEntity SHALL contain exactly one [1..1] code (CONF:7493).This playingEntity MAY contain zero or one [0..1] name (CONF:7494).This playingEntity/name MAY be used for the vehicle name in text, such as Normal Saline (CONF:10087).Figure SEQ Figure \* ARABIC 65: Drug Vehicle example<participantRole classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.24"/> <code code="412307009" displayName="drug vehicle" codeSystem="2.16.840.1.113883.6.96"/> <playingEntity classCode="MMAT"> <code code="324049125464" displayName="Normal Saline" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm"/> <name>Normal Saline</name> </playingEntity></participantRole>Encounter Activities [encounter: templateId 2.16.840.1.113883.10.20.22.4.49 (open)]Table SEQ Table \* ARABIC103: Encounter Activities ContextsUsed By:Contains Entries:Encounters Section (entries optional) (optional)Encounter DiagnosisIndicationService Delivery LocationThis clinical statement describes the interactions between the patient and clinicians. Interactions include in-person encounters, telephone conversations, and email exchanges.Table SEQ Table \* ARABIC104: Encounter Activities Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Encounter Activitiesencounter[templateId/@root = '2.16.840.1.113883.10.20.22.4.49']@classCode1..1SHALL87102.16.840.1.113883.5.6 (HL7ActClass) = ENC@moodCode1..1SHALL87112.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL8712@root1..1SHALL263532.16.840.1.113883.10.20.22.4.49encounterIDid1..*SHALL8713encounterTypecode0..1SHOULD87142.16.840.1.113883.3.88.12.80.32 (EncounterTypeCode)originalText0..1SHOULD8719reference0..1SHOULD15970@value0..1SHOULD15971encounterFreeTextTypereference/@value0..1SHOULD8720encounterDateTimeeffectiveTime1..1SHALL8715performer0..*MAY8725encounterProviderassignedEntity1..1SHALL8726code0..1MAY8727facilityLocationparticipant0..*MAY8738@typeCode1..1SHALL87402.16.840.1.113883.5.1002 (HL7ActRelationshipType) = LOCparticipantRole1..1SHALL14903reasonForVisitentryRelationship0..*MAY8722@typeCode1..1SHALL87232.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSONobservation1..1SHALL14899entryRelationship0..*MAY15492act1..1SHALL15973SHALL contain exactly one [1..1] @classCode="ENC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8710).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8711).SHALL contain exactly one [1..1] templateId (CONF:8712) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.49" (CONF:26353).SHALL contain at least one [1..*] id (CONF:8713).SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet EncounterTypeCode 2.16.840.1.113883.3.88.12.80.32 DYNAMIC (CONF:8714).The code, if present, SHOULD contain zero or one [0..1] originalText (CONF:8719).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15970).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15971).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15972).The originalText, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:8720).SHALL contain exactly one [1..1] effectiveTime (CONF:8715).MAY contain zero or more [0..*] performer (CONF:8725).The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8726).This assignedEntity MAY contain zero or one [0..1] code (CONF:8727).MAY contain zero or more [0..*] participant (CONF:8738) such that itSHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8740).SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:14903).MAY contain zero or more [0..*] entryRelationship (CONF:8722) such that itSHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8723).SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:14899).MAY contain zero or more [0..*] entryRelationship (CONF:15492) such that itSHALL contain exactly one [1..1] Encounter Diagnosis (templateId:2.16.840.1.113883.10.20.22.4.80) (CONF:15973).MAY contain zero or one [0..1] sdtc:dischargeDispositionCode, which SHALL be selected from ValueSet 2.16.840.1.113883.3.88.12.80.33 NUBC UB-04 FL17-Patient Status DYNAMIC or, if access to NUBC is unavailable, from CodeSystem 2.16.840.1.113883.12.112 HL7 Discharge Disposition. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the dischargeDispositionCode element (CONF:9929).Table SEQ Table \* ARABIC 105: EncounterTypeCodeValue Set: EncounterTypeCode 2.16.840.1.113883.3.88.12.80.32This value set contains the codes from Current Procedure and Terminology (CPT) designated for Evaluation and Management (99200 – 99607) Reference: (subscription to AMA Required)CodeCode SystemPrint Name99201CPT4Office or other outpatient visit (problem focused)99202 CPT4Office or other outpatient visit (expanded problem (expanded)99203CPT4Office or other outpatient visit (detailed)99204CPT4Office or other outpatient visit (comprehensive, (comprehensive - moderate)99205CPT4Office or other outpatient visit (comprehensive, comprehensive-high)...Hospitalization With Reason[encounter: templateId 2.16.840.1.113883.10.20.30.3.36 (open)]Table SEQ Table \* ARABIC102: Hospitalization With Reason ContextsContained By:Contains:Encounters Section BCTPS (required)IndicationThis clinical statement represents an inpatient hospitalization that occurred during cancer treatment. The HL7 encounter code "IMP" (inpatient) identifies an inpatient encounter. The HL7 actRelationship typeCode "RSON" (reason) captures the reason for the inpatient hospitalization with the Indications template.. Table SEQ Table \* ARABIC103: Hospitalization With Reason Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueencounter[templateId/@root = '2.16.840.1.113883.10.20.30.3.36']templateId1..1SHALL26330@root1..1SHALL263312.16.840.1.113883.10.20.30.3.36code1..1SHALL26333@code1..1SHALL264422.16.840.1.113883.5.4 (ActCode) = IMP@codeSystem1..1SHALL264432.16.840.1.113883.5.4entryRelationship1..1SHALL26346@typeCode1..1SHALL263472.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSONobservation1..1SHALL26374Conforms to Encounter Activities template (2.16.840.1.113883.10.20.22.4.49).SHALL contain exactly one [1..1] templateId (CONF:26330) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.36" (CONF:26331).SHALL contain exactly one [1..1] code (CONF:26333).This code SHALL contain exactly one [1..1] @code="IMP" Inpatient encounter (CodeSystem: ActCode 2.16.840.1.113883.5.4) (CONF:26442).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" actCode (CONF:26443).SHALL contain exactly one [1..1] entryRelationship (CONF:26346) such that itSHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:26347).SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:26374).Figure SEQ Figure \* ARABIC30: Hospitalization With Reason<encounter classCode="ENC" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.36" /> <code code="IMP" codeSystem="2.16.840.1.113883.5.4" code="IMP" displayName="Inpatient encounter"/> <effectiveTime> <!-- Dates of admission and discharge --> <low value="20121109"/> <high value="20121130"/> </effectiveTime> <!-- This states that the reason for admission was due to chemotherapy toxicity --> <entryRelationship typeCode="RSON"> <observation classCode="OBS" moodCode="EVN"> <!-- Consolidated CDA Indication template --> <templateId root="2.16.840.1.113883.10.20.22.4.19"/> <!-- Observation ID equals an ID on the problem list --> <id root="43faccd9-5b6e-45f3-b007-856e96b3d84d"/> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" /> <statusCode code="completed" /> <value xsi:type="CD" code="399213007" codeSystem="2.16.840.1.113883.6.96" displayName="toxicity due to chemotherapy"/> </observation> </entryRelationship></encounter>Encounter Diagnosis[act: templateId 2.16.840.1.113883.10.20.22.4.80 (open)]Table SEQ Table \* ARABIC108: Encounter Diagnosis ContextsUsed By:Contains Entries:Encounter Activities (optional)Problem ObservationThis template wraps relevant problems or diagnoses at the close of a visit or that need to be followed after the visit. If the encounter is associated with a Hospital Discharge, the Hospital Discharge Diagnosis must be used. This entry requires at least one Problem Observation entry.Table SEQ Table \* ARABIC109: Encounter Diagnosis Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.22.4.80']@classCode1..1SHALL148892.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL148902.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14895@root1..1SHALL148962.16.840.1.113883.10.20.22.4.80code1..1SHALL19182@code1..1SHALL191832.16.840.1.113883.6.1 (LOINC) = 29308-4entryRelationship1..*SHALL14892@typeCode1..1SHALL148932.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJobservation1..1SHALL14898SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14889).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14890).SHALL contain exactly one [1..1] templateId (CONF:14895) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.80" (CONF:14896).SHALL contain exactly one [1..1] code (CONF:19182).This code SHALL contain exactly one [1..1] @code="29308-4" Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19183).SHALL contain at least one [1..*] entryRelationship (CONF:14892) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14893).SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:14898).Figure SEQ Figure \* ARABIC 67: Encounter Diagnosis example<act classCode="ACT" moodCode="EVN"> <!—Encounter diagnosis act --> <templateId root="2.16.840.1.113883.10.20.22.4.80"/> <id root="5a784260-6856-4f38-9638-80c751aff2fb"/> <code code="29038-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName=" DIAGNOSIS"/> <statusCode code="active"/> <effectiveTime> <low value="20903003"/> </effectiveTime> <entryRelationship typeCode="SUBJ" > <observation classCode="OBS" moodCode="EVN" > <templateId root="2.16.840.1.113883.10.20.22.4.4"/> <!-- Problem Observation --> ... </observation> </entryRelationship></act>Family History Death Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.47 (open)]Table SEQ Table \* ARABIC110: Family History Death Observation ContextsUsed By:Contains Entries:Family History Observation (optional)This clinical statement records whether the family member is deceased.Table SEQ Table \* ARABIC111: Family History Death Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.47']@classCode1..1SHALL86212.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL86222.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL8623@root1..1SHALL104952.16.840.1.113883.10.20.22.4.47code1..1SHALL19141@code1..1SHALL191422.16.840.1.113883.5.4 (ActCode) = ASSERTIONstatusCode1..1SHALL8625@code1..1SHALL190972.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD86262.16.840.1.113883.6.96 (SNOMED-CT) = 419099009SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8621).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8622).SHALL contain exactly one [1..1] templateId (CONF:8623) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.47" (CONF:10495).SHALL contain exactly one [1..1] code (CONF:19141).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:19142).SHALL contain exactly one [1..1] statusCode (CONF:8625).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19097).SHALL contain exactly one [1..1] value="419099009" Dead with @xsi:type="CD" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:8626).Figure SEQ Figure \* ARABIC 68: Family History Death Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.47" /> <!-- Family history death observation template --> <id root="6898fae0-5c8a-11db-b0de-0800200c9a66" /> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" /> <statusCode code="completed" /> <value xsi:type="CD" code="419099009" codeSystem="2.16.840.1.113883.6.96" displayName="Dead"/></observation>Family History Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.46 (open)]Table SEQ Table \* ARABIC112: Family History Observation ContextsUsed By:Contains Entries:Family History Organizer (required)Age ObservationFamily History Death ObservationFamily History Observations related to a particular family member are contained within a Family History Organizer. The effectiveTime in the Family History Observation is the biologically or clinically relevant time of the observation. The biologically or clinically relevant time is the time at which the observation holds (is effective) for the family member (the subject of the observation).Table SEQ Table \* ARABIC113: Family History Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Family History Observa-tionobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.46']@classCode1..1SHALL85862.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL85872.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL8599@root1..1SHALL104962.16.840.1.113883.10.20.22.4.46id1..*SHALL8592code1..1SHALL85892.16.840.1.113883.3.88.12.3221.7.2 (Problem Type)statusCode1..1SHALL8590@code1..1SHALL190982.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime0..1SHOULD8593value1..1SHALLCD85912.16.840.1.113883.3.88.12.3221.7.4 (Problem Value Set)entryRelationship0..1MAY8675@typeCode1..1SHALL86762.16.840.1.113883.5.90 (HL7ParticipationType) = SUBJ@inversionInd1..1SHALL8677trueobservation1..1SHALL15526entryRelationship0..1MAY8678@typeCode1..1SHALL86792.16.840.1.113883.5.90 (HL7ParticipationType) = CAUSobservation1..1SHALL15527SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8586).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8587).SHALL contain exactly one [1..1] templateId (CONF:8599) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.46" (CONF:10496).SHALL contain at least one [1..*] id (CONF:8592).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:8589).SHALL contain exactly one [1..1] statusCode (CONF:8590).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19098).SHOULD contain zero or one [0..1] effectiveTime (CONF:8593).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:8591).MAY contain zero or one [0..1] entryRelationship (CONF:8675) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Subject (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8676).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:8677).SHALL contain exactly one [1..1] Age Observation (templateId:2.16.840.1.113883.10.20.22.4.31) (CONF:15526).MAY contain zero or one [0..1] entryRelationship (CONF:8678) such that itSHALL contain exactly one [1..1] @typeCode="CAUS" Causal or Contributory (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8679).SHALL contain exactly one [1..1] Family History Death Observation (templateId:2.16.840.1.113883.10.20.22.4.47) (CONF:15527).Table SEQ Table \* ARABIC114: Problem Type Value SetValue Set: Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Description:This value set contains codes that indicate the level of medical judgment used to determine the existence of a problem.References: SystemPrint Name404684003SNOMED-CTFinding409586006SNOMED-CTComplaint282291009SNOMED-CTDiagnosis64572001SNOMED-CTCondition248536006SNOMED-CTFinding of functional performance and activity418799008SNOMED-CTSymptom55607006SNOMED-CTProblem373930000SNOMED-CTCognitive function findingTable SEQ Table \* ARABIC 115: Problem Value Set (excerpt)Value Set: Problem 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMICCode System(s):SNOMED CT 2.16.840.1.113883.6.96Description:This value set contains codes that represent a patient’s medical, nursing, dental, social, preventative and psychiatric events and issues that are relevant to that patient’s healthcare (e.g., signs, symptoms, and defined conditions), problems and diagnoses. Limited to terms descending from the Clinical Findings (404684003) or Situation with Explicit Context (243796009) hierarchies.Reference: SystemPrint Name46635009SNOMED CTDiabetes mellitus type 1234422006SNOMED CTAcute porphyria31712002SNOMED CTPrimary biliary cirrhosis 302002000SNOMED CTDifficulty moving15188001SNOMED CTHearing loss48167000SNOMED CTAmnesia… Figure SEQ Figure \* ARABIC 69: Family History Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.46" /> <!-- Family History Observation template --> <id root="d42ebf70-5c89-11db-b0de-0800200c9a66" /> <code code="64572001" displayName="Condition" codeSystemName="SNOMED CT" codeSystem="2.16.840.1.113883.6.96" /> <statusCode code="completed" /> <effectiveTime value="1967" /> <value xsi:type="CD" code="22298006" codeSystem="2.16.840.1.113883.6.96" displayName="Myocardial infarction" /> <entryRelationship typeCode="CAUS"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.47" /> <!-- Family history death observation template --> ... </observation> </entryRelationship> <entryRelationship typeCode="SUBJ" <inversionInd="true"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.31" /> <!-- Age observation template --> ... </entryRelationship></observation>Family History of Cancer None[Observation: templateId 2.16.840.1.113883.10.20.30.3.11 (open)]Table SEQ Table \* ARABIC112: Family History of Cancer None ContextsContained By:Contains:Family History Section BCTPS (optional)This clinical statement asserts that the patient does not have a family history of cancer. Table SEQ Table \* ARABIC113: Family History of Cancer None Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.11']@classCode1..1SHALL260132.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL260142.16.840.1.113883.5.1001 (ActMood) = EVN@negationInd1..1SHALL26015truetemplateId1..1SHALL26016@root1..1SHALL260172.16.840.1.113883.10.20.30.3.11code1..1SHALL26018@code1..1SHALL26019ASSERTION@codeSystem1..1SHALL260202.16.840.1.113883.5.4text0..1SHOULD26021No family history of cancerstatusCode1..1SHALL26022@code1..1SHALL260232.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD26024@code1..1SHALL26025275937001@codeSystem1..1SHALL260262.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96SHALL contain exactly one [1..1] @classCode="OBS" observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:26013).SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:26014).SHALL contain exactly one [1..1] @negationInd="true" (CONF:26015).SHALL contain exactly one [1..1] templateId (CONF:26016) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.11" (CONF:26017).SHALL contain exactly one [1..1] code (CONF:26018).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CONF:26019).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" (CONF:26020).SHOULD contain zero or one [0..1] text="No family history of cancer" (CONF:26021).SHALL contain exactly one [1..1] statusCode (CONF:26022).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:26023).SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:26024).This value SHALL contain exactly one [1..1] @code="275937001" family history of cancer (CONF:26025).This value SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:26026).Figure SEQ Figure \* ARABIC33: Family History of Cancer None<observation classCode="OBS" moodCode="EVN" negationInd="true"> <templateId root="2.16.840.1.113883.10.20.30.3.11" /> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/> <text> No Family History of Cancer</text> <statusCode code="completed"/> <value xsi:type="CD" code="275937001" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="family history of cancer"/></observation>Family History Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.45 (open)]Table SEQ Table \* ARABIC118: Family History Organizer ContextsUsed By:Contains Entries:Family History Section (optional)Family History ObservationThe Family History Organizer associates a set of observations with a family member. For example, the Family History Organizer can group a set of observations about the patient’s father.Table SEQ Table \* ARABIC119: Family History Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Family History Organizerorganizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.45']@classCode1..1SHALL86002.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER@moodCode1..1SHALL86012.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL8604@root1..1SHALL104972.16.840.1.113883.10.20.22.4.45statusCode1..1SHALL8602@code1..1SHALL190992.16.840.1.113883.5.14 (ActStatus) = completedfamilyMemberDemographicssubject1..1SHALL8609relatedSubject1..1SHALL15244@classCode1..1SHALL152452.16.840.1.113883.5.41 (EntityClass) = PRScode1..1SHALL15246@code1..1SHALL152472.16.840.1.113883.1.11.19579 (Family Member Value Set)subject0..1SHOULD15248administrativeGenderCode1..1SHALL15974@code1..1SHALL159752.16.840.1.113883.1.11.1 (Administrative Gender (HL7 V3))birthTime0..1SHOULD15976familyMemberMedicalHistorycomponent1..*SHALL8607observation1..1SHALL16888SHALL contain exactly one [1..1] @classCode="CLUSTER" Cluster (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8600).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8601).SHALL contain exactly one [1..1] templateId (CONF:8604) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.45" (CONF:10497).SHALL contain exactly one [1..1] statusCode (CONF:8602).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19099).SHALL contain exactly one [1..1] subject (CONF:8609).This subject SHALL contain exactly one [1..1] relatedSubject (CONF:15244).This relatedSubject SHALL contain exactly one [1..1] @classCode="PRS" Person (CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:15245).This relatedSubject SHALL contain exactly one [1..1] code (CONF:15246).This code SHALL contain exactly one [1..1] @code, which SHOULD be selected from ValueSet Family Member Value Set 2.16.840.1.113883.1.11.19579 DYNAMIC (CONF:15247).This relatedSubject SHOULD contain zero or one [0..1] subject (CONF:15248).The subject, if present, SHALL contain exactly one [1..1] administrativeGenderCode (CONF:15974).This administrativeGenderCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Administrative Gender (HL7 V3) 2.16.840.1.113883.1.11.1 STATIC (CONF:15975).The subject, if present, SHOULD contain zero or one [0..1] birthTime (CONF:15976).The subject SHOULD contain zero or more [0..*] sdtc:id. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the id element (CONF:15249).The subject MAY contain zero or one sdtc:deceasedInd. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the deceasedInd element (CONF:15981).The subject MAY contain zero or one sdtc:deceasedTime. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the deceasedTime element (CONF:15982).The age of a relative at the time of a family history observation SHOULD be inferred by comparing RelatedSubject/subject/birthTime with Observation/effectiveTime (CONF:15983).SHALL contain at least one [1..*] component (CONF:8607).Such components SHALL contain exactly one [1..1] Family History Observation (templateId:2.16.840.1.113883.10.20.22.4.46) (CONF:16888).Table SEQ Table \* ARABIC120: Family Member Value SetValue Set: Family Member Value Set 2.16.840.1.113883.1.11.19579 DYNAMICCode System(s):RoleCode 2.16.840.1.113883.5.111Description:This value set contains codes that represent the familial relationship of a person to another (e.g., next of kin, or blood relations). This is a subset of the value set used for personal relationships.Reference: (members only)CodeCode SystemPrint NameADOPTRoleCodeadopted childAUNTRoleCodeauntCHILDRoleCodeChildCHLDINLAWRoleCodechild in-lawCOUSNRoleCodecousinDOMPARTRoleCodedomestic partnerFAMMEMBRoleCodeFamily MemberCHLDFOSTRoleCodefoster childGRNDCHILDRoleCodeGrandChildGRPRNRoleCodeGrandparentGPARNTRoleCodegrandparentGGRPRNRoleCodegreat grandparentHSIBRoleCodehalf-siblingMAUNTRoleCodeMaternalAuntMCOUSNRoleCodeMaternalCousinMGRPRNRoleCodeMaternalGrandparentMGGRPRNRoleCodeMaternalGreatgrandparentMUNCLERoleCodeMaternalUncleNCHILDRoleCodenatural childNPRNRoleCodenatural parentNSIBRoleCodenatural siblingNIENEPHRoleCodeniece/nephewPRNRoleCodeParentPRNINLAWRoleCodeparent in-lawPAUNTRoleCodePaternalAuntPCOUSNRoleCodePaternalCousinPGRPRNRoleCodePaternalGrandparentPGGRPRNRoleCodePaternalGreatgrandparentPUNCLERoleCodePaternalUncleSIBRoleCodeSiblingSIBINLAWRoleCodesibling in-lawSIGOTHRRoleCodesignificant otherSPSRoleCodespouseSTEPRoleCodestep childSTPPRNRoleCodestep parentSTPSIBRoleCodestep siblingUNCLERoleCodeuncleFigure SEQ Figure \* ARABIC 71: Family History Organizer – history of cancer example<entry typeCode> <!-- mother --> <organizer moodCode="EVN" classCode="CLUSTER"> <!--Consolidated CDA FAMILY HISTORY ORGANIZER TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.45"/> <statusCode code="completed"/> <entry typeCode> <!-- mother --> <organizer moodCode="EVN" classCode="CLUSTER"> <!--Consolidated CDA FAMILY HISTORY ORGANIZER TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.45"/> <statusCode code="completed"/> <!-- Example using HL7 Family Member Value Set. --> <subject> <relatedSubject classCode="PRS"> <code code="MTH" displayName="Mother" codeSystemName="HL7 FamilyMember" codeSystem="2.16.840.1.113883.5.111"> <translation code="9947008" displayName="Biological mother" codeSystemName="SNOMED" codeSystem="2.16.840.1.113883.6.96"/> </code> <subject> <sdtc:id root="2.16.840.1.113883.19.5.99999.2" extension="99999"/> <id xmlns="urn:hl7-org:sdtc" root="2.16.840.1.113883.19.5.99999.2" extension="1234"/> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/> <birthTime value="1930"/> </subject> </relatedSubject> </subject> <component> <observation classCode="OBS" moodCode="EVN"> <!--C-CDA FAMILY HISTORY OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.46"/> ... </observation> </component> </organizer> </entry> ... </organizer></entry>Family History Pedigree[Act: templateId 2.16.840.1.113883.10.20.30.3.48 (open)]Table SEQ Table \* ARABIC117: Family History Pedigree ContextsContained By:Contains:Family History Section BCTPS (required)This clinical statement contains the pedigree of the patient by pointing to the HL7 Pedigree Model as an external observation. If there is no pedigree available, a nullFlavor can be sent. Table SEQ Table \* ARABIC118: Family History Pedigree Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.48']@classCode1..1SHALL267432.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL267442.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL26745@root1..1SHALL267462.16.840.1.113883.10.20.30.3.48code1..1SHALL26747@code1..1SHALL2674810157-6@codeSystem1..1SHALL267492.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1reference1..1SHALL26750@typeCode1..1SHALL267512.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRexternalObservation1..1SHALL26752@classCode1..1SHALL267532.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL267542.16.840.1.113883.5.1001 (ActMood) = EVNid1..*SHALL26755text0..1SHOULD26756reference0..1SHOULD26757@value1..1SHALL26758SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:26743).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:26744).SHALL contain exactly one [1..1] templateId (CONF:26745) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.48" (CONF:26746).SHALL contain exactly one [1..1] code (CONF:26747).This code SHALL contain exactly one [1..1] @code="10157-6" History of family member diseases (CONF:26748).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:26749).SHALL contain exactly one [1..1] reference (CONF:26750) such that itSHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:26751).SHALL contain exactly one [1..1] externalObservation (CONF:26752).This externalObservation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:26753).This externalObservation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:26754).The id attribute??shall hold the ID of a pedigree instance.This externalObservation SHALL contain at least one [1..*] id (CONF:26755).This externalObservation SHOULD contain zero or one [0..1] text (CONF:26756).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:26757).The reference, if present, SHALL contain exactly one [1..1] @value (CONF:26758).Figure SEQ Figure \* ARABIC35: Family History Pedigree<act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.48" /> <code code="10157-6" displayName="History of family member diseases" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" /> <reference typeCode="REFR"> <externalObservation classCode="OBS" moodCode="EVN"> <!-- Example id --> <id root="2.16.840.1.113883.6.117" extension="299" assigningAuthorityName="Avon Center Appointment Number" /> <text mediaType="text">FamilyPedigreeModel <reference value="" /></text> </externalObservation> </reference></act>Health Status Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.5 (closed)]Table SEQ Table \* ARABIC123: Health Status Observation ContextsUsed By:Contains Entries:Problem Observation (optional)The Health Status Observation records information about the current health status of the patient.Table SEQ Table \* ARABIC124: Health Status Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.5']@classCode1..1SHALL90572.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL90722.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL16756@root1..1SHALL167572.16.840.1.113883.10.20.22.4.5code1..1SHALL19143@code1..1SHALL191442.16.840.1.113883.6.1 (LOINC) = 11323-3text0..1SHOULD9270reference0..1SHOULD15529@value0..1SHOULD15530statusCode1..1SHALL9074@code1..1SHALL191032.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD90752.16.840.1.113883.1.11.20.12 (HealthStatus)SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:9057).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:9072).SHALL contain exactly one [1..1] templateId (CONF:16756) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.5" (CONF:16757).SHALL contain exactly one [1..1] code (CONF:19143).This code SHALL contain exactly one [1..1] @code="11323-3" Health status (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19144).SHOULD contain zero or one [0..1] text (CONF:9270).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15529).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15530).SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15531).SHALL contain exactly one [1..1] statusCode (CONF:9074).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19103).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet HealthStatus 2.16.840.1.113883.1.11.20.12 DYNAMIC (CONF:9075).Table SEQ Table \* ARABIC125: Health Status Value SetValue Set: HealthStatus 2.16.840.1.113883.1.11.20.12 DYNAMICCode System(s):SNOMED-CT 2.16.840.1.113883.6.96Description:A value set contains codes that describe the state of the patient health status.Reference: SystemPrint Name81323004SNOMED-CTAlive and well313386006SNOMED-CTIn remission162467007SNOMED-CTSymptom free161901003SNOMED-CTChronically ill271593001SNOMED-CTSeverely ill21134002SNOMED-CTDisabled161045001SNOMED-CTSeverely disabled419099009SNOMED-CTDeceasedFigure SEQ Figure \* ARABIC 73: Health Status Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.5"/> <!-- Health status observation template --> <code code="11323-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Health status"/> <text> <reference value="#problems"/> </text> <statusCode code="completed"/> <value xsi:type="CD" code="81323004" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Alive and well"/></observation>Highest Pressure Ulcer Stage [observation: templateId 2.16.840.1.113883.10.20.22.4.77 (open)]Table SEQ Table \* ARABIC126: Highest Pressure Ulcer Stage ContextsUsed By:Contains Entries:Functional Status Section (optional)This observation contains a description of the wound tissue of the most severe or highest staged pressure ulcer observed on a patient.Table SEQ Table \* ARABIC127: Highest Pressure Ulcer Stage Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.77']@classCode1..1SHALL147262.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL147272.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14728@root1..1SHALL147292.16.840.1.113883.10.20.22.4.77id1..*SHALL14730code1..1SHALL14731@code1..1SHALL147322.16.840.1.113883.6.96 (SNOMED-CT) = 420905001value1..1SHALL14733SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14726).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14727).SHALL contain exactly one [1..1] templateId (CONF:14728) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.77" (CONF:14729).SHALL contain at least one [1..*] id (CONF:14730).SHALL contain exactly one [1..1] code (CONF:14731).This code SHALL contain exactly one [1..1] @code="420905001" Highest Pressure Ulcer Stage (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14732).SHALL contain exactly one [1..1] value (CONF:14733).Figure SEQ Figure \* ARABIC 74: Higheset Pressure Ulcer Stage example<entry typeCode><observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.77"/> <id root="08edb7c0-2111-43f2-a784-9a5fdfaa67f0"/> <code code="420905001" codeSystem="2.16.840.1.113883.6.96" displayName=" Highest Pressure Ulcer Stage"/> <statusCode code="completed"/> <value xsi:type="CD" code="421306004" codeSystem="2.16.840.1.113883.6.96" displayName="necrotic eschar"/> </observation></entry> Immunization Medication Information [manufacturedProduct: templateId 2.16.840.1.113883.10.20.22.4.54 (open)]Table SEQ Table \* ARABIC128: Immunization Medication Information ContextsUsed By:Contains Entries:Medication Supply Order (optional)Medication Dispense (optional)The Immunization Medication Information represents product information about the immunization substance. The vaccine manufacturer and vaccine lot number are typically recorded in the medical record and should be included if known.Table SEQ Table \* ARABIC129: Immunization Medication Information Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Immunization Medication InformationmanufacturedProduct[templateId/@root = '2.16.840.1.113883.10.20.22.4.54']@classCode1..1SHALL90022.16.840.1.113883.5.110 (RoleClass) = MANUtemplateId1..1SHALL9004@root1..1SHALL104992.16.840.1.113883.10.20.22.4.54id0..*MAY9005manufacturedMaterial1..1SHALL9006codedProductNamecode1..1SHALL90072.16.840.1.113883.3.88.12.80.22 (Vaccine Administered Value Set)freeTextProductNameoriginalText0..1SHOULD9008reference0..1SHOULD15555@value0..1SHOULD15556translation0..*MAYSET<PQR>9011lotNumberlotNumberText0..1SHOULD9014drugManufacturermanufacturerOrganization0..1SHOULD9012SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:9002).SHALL contain exactly one [1..1] templateId (CONF:9004) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.54" (CONF:10499).MAY contain zero or more [0..*] id (CONF:9005).SHALL contain exactly one [1..1] manufacturedMaterial (CONF:9006).This manufacturedMaterial SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Vaccine Administered Value Set 2.16.840.1.113883.3.88.12.80.22 DYNAMIC (CONF:9007).This code SHOULD contain zero or one [0..1] originalText (CONF:9008).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15555).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15556).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15557).This code MAY contain zero or more [0..*] translation (CONF:9011).Translations can be used to represent generic product name, packaged product code, etc (CONF:16887).This manufacturedMaterial SHOULD contain zero or one [0..1] lotNumberText (CONF:9014).SHOULD contain zero or one [0..1] manufacturerOrganization (CONF:9012).Figure SEQ Figure \* ARABIC 75: Immunization Medication Information example<manufacturedProduct classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.54"/> <!-- ******** Immunization Medication Information ******** --> <manufacturedMaterial> <code code="88" codeSystem="2.16.840.1.113883.12.292 " displayName="Influenza virus vaccine" codeSystemName="CVX"> <originalText> <referencevalue="#immi1"/> </originalText> <translation code="111" displayName="influenza, live, intranasal" codeSystemName="CVX" codeSystem=" 2.16.840.1.113883.12.292 " /> </code> <lotNumberText>1</lotNumberText> </manufacturedMaterial> <manufacturerOrganization> <name>Health LS - Immuno Inc.</name> </manufacturerOrganization></manufacturedProduct>Indication [observation: templateId 2.16.840.1.113883.10.20.22.4.19 (open)]Table SEQ Table \* ARABIC130: Indication ContextsUsed By:Contains Entries:Medication Activity (optional)Procedure Activity Procedure (optional)Procedure Activity Act (optional)Procedure Activity Observation (optional)Encounter Activities (optional)Hospitalization With Reason (required)The Indication Observation documents the rationale for an activity. It can do this with the id element to reference a problem recorded elsewhere in the document or with a code and value to record the problem type and problem within the Indication. For example, the indication for a prescription of a painkiller might be a headache that is documented in the Problems Section.Table SEQ Table \* ARABIC131: Indication Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.19']@classCode1..1SHALL74802.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL74812.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7482@root1..1SHALL105022.16.840.1.113883.10.20.22.4.19id1..1SHALL7483code1..1SHALL168862.16.840.1.113883.3.88.12.3221.7.2 (Problem Type)statusCode1..1SHALL7487@code1..1SHALL191052.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime0..1SHOULD7488value0..1SHOULDCD7489@nullFlavor0..1MAY15990@code0..1SHOULD159852.16.840.1.113883.3.88.12.3221.7.4 (Problem Value Set)SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7480).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7481).SHALL contain exactly one [1..1] templateId (CONF:7482) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.19" (CONF:10502).SHALL contain exactly one [1..1] id (CONF:7483).Set the observation/id equal to an ID on the problem list to signify that problem as an indication (CONF:16885).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:16886).SHALL contain exactly one [1..1] statusCode (CONF:7487).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19105).SHOULD contain zero or one [0..1] effectiveTime (CONF:7488).SHOULD contain zero or one [0..1] value with @xsi:type="CD" (CONF:7489).The value, if present, MAY contain zero or one [0..1] @nullFlavor (CONF:15990).If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:15991).The value, if present, SHOULD contain zero or one [0..1] @code, which SHOULD be selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:15985).Figure SEQ Figure \* ARABIC 76: Indication example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.19"/> <id root="db734647-fc99-424c-a864-7e3cda82e703" extension="45665"/> <code code="404684003" displayName="Finding" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <statusCode code="completed"/> <effectiveTime> <low value="20070103"/> </effectiveTime> <value xsi:type="CD" code="233604007" displayName="Pneumonia" codeSystem="2.16.840.1.113883.6.96"/></observation>Instructions [act: templateId 2.16.840.1.113883.10.20.22.4.20 (open)]Table SEQ Table \* ARABIC132: Instructions ContextsUsed By:Contains Entries:Medication Activity (optional)Medication Supply Order (optional)Procedure Activity Procedure (optional)Plan of Care Section (optional)Procedure Activity Act (optional)Procedure Activity Observation (optional)The Instructions template can be used in several ways, such as to record patient instructions within a Medication Activity or to record fill instructions within a supply order. The act/code defines the type of instruction. Though not defined in this template, a Vaccine Information Statement (VIS) document could be referenced through act/reference/externalDocument, and patient awareness of the instructions can be represented with the generic participant and the participant/awarenessCode.Table SEQ Table \* ARABIC133: Instructions Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.22.4.20']@classCode1..1SHALL73912.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL73922.16.840.1.113883.5.1001 (ActMood) = INTtemplateId1..1SHALL7393@root1..1SHALL105032.16.840.1.113883.10.20.22.4.20code1..1SHALL168842.16.840.1.113883.11.20.9.34 (Patient Education)text0..1SHOULD7395reference0..1SHOULD15577@value0..1SHOULD15578statusCode1..1SHALL7396@code1..1SHALL191062.16.840.1.113883.5.14 (ActStatus) = completedSHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7391).SHALL contain exactly one [1..1] @moodCode="INT" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7392).SHALL contain exactly one [1..1] templateId (CONF:7393) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.20" (CONF:10503).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Patient Education 2.16.840.1.113883.11.20.9.34 DYNAMIC (CONF:16884).SHOULD contain zero or one [0..1] text (CONF:7395).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15577).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15578).This @value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15579).SHALL contain exactly one [1..1] statusCode (CONF:7396).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19106).Table SEQ Table \* ARABIC134: Patient Education Value SetValue Set: Patient Education 2.16.840.1.113883.11.20.9.34 DYNAMICCode System(s): SNOMED-CG 2.16.840.1.113883.6.96Description: A value set of codes limited to terms descending from the Education (409073007) hierarchy.Reference: SystemPrint Name311401005SNOMED-CTPatient Education171044003SNOMED-CTImmunization Education243072006SNOMED-CTCancer EducationPossible Side Effects[act: templateId 2.16.840.1.113883.10.20.30.3.35 (open)]Table SEQ Table \* ARABIC132: Possible Side Effects ContextsContained By:Contains:Chemotherapy Regimen Plans (optional)This clinical statement represents the possible common side effects of breast cancer chemotherapy treatment. It does not seek to represent all possible side effects of any medication the patient may be on.Table SEQ Table \* ARABIC133: Possible Side Effects Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.35']@classCode1..1SHALL240272.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL240282.16.840.1.113883.5.1001 (ActMood) = INTtemplateId1..1SHALL24029@root1..1SHALL240302.16.840.1.113883.10.20.30.3.35code1..1SHALL24031@code1..1SHALL24032396080005@codeSystem1..1SHALL270832.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96entryRelationship1..*SHALL24033@typeCode1..1SHALL240342.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJobservation1..1SHALL24035code1..1SHALL24036@code1..1SHALL24037ASSERTION@codeSystem1..1SHALL270842.16.840.1.113883.5.4statusCode1..1SHALL24038@code1..1SHALL240392.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD240402.16.840.1.113883.11.20.11.9 (Chemotherapy Side Effects)Conforms to Instructions template (2.16.840.1.113883.10.20.22.4.20).SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:24027).SHALL contain exactly one [1..1] @moodCode="INT" intent (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:24028).SHALL contain exactly one [1..1] templateId (CONF:24029) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.35" (CONF:24030).SHALL contain exactly one [1..1] code (CONF:24031).This code SHALL contain exactly one [1..1] @code="396080005" medication side effects education (CONF:24032).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:27083).SHALL contain at least one [1..*] entryRelationship (CONF:24033) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:24034).SHALL contain exactly one [1..1] observation (CONF:24035).This observation SHALL contain exactly one [1..1] code (CONF:24036).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CONF:24037).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" (CONF:27084).This observation SHALL contain exactly one [1..1] statusCode (CONF:24038).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:24039).A value observation code of “OTH” is used to communicate side effects not listed in ValueSet table. In these instances, the original text would be sent.This observation SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHOULD be selected from ValueSet Chemotherapy Side Effects 2.16.840.1.113883.11.20.11.9 DYNAMIC (CONF:24040).Table SEQ Table \* ARABIC134: Chemotherapy Side EffectsValue Set: Chemotherapy Side Effects 2.16.840.1.113883.11.20.11.9 DYNAMICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Description: Possible common side effects of chemotherapyReference: SystemPrint Name278040002SNOMED CTloss of hair (finding)422587007SNOMED CTnausea (finding)386033004SNOMED CTneuropathy (disorder)165423001SNOMED CTred blood cell count low (finding)84229001SNOMED CTfatigue (finding)170951000SNOMED CTmenopause symptoms present (finding)415116008SNOMED CTplatelet count below reference range (finding)30238006SNOMED CTsecondary female infertility (disorder)236789001SNOMED CTsecondary male infertility (disorder)Figure SEQ Figure \* ARABIC38: Possible Side Effects<entry> <!-- Instructions template requires intent mood --> <act classCode="ACT" moodCode="INT"> <!-- C-CDA Instructions Template --> <templateId root="2.16.840.1.113883.10.20.22.4.20"/> <!-- Possible Side Effects Template --> <templateId root="2.16.840.1.113883.10.20.30.3.35"/> <code code="396080005" displayName="medication side effects education" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT"/> <statusCode code="completed"/> <entryRelationship typeCode="SUBJ"> <observation classCode="OBS" moodCode="DEF"> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/> <statusCode code="completed"/> <value xsi:type="CD" code="56317004" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="alopecia"/> </observation> </entryRelationship> </act></entry>Figure SEQ Figure \* ARABIC39: "OTH" For Other Value with Possible Side Effects<entryRelationship typeCode="SUBJ"> <!-- SHALL observation in definition mood --> <observation classCode="OBS" moodCode="DEF"> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/> <statusCode code="completed"/> <!-- Chemotherapy Side Effects --> <value xsi:type="CD"nullFlavor="OTH"> <originalText>Intolerance to high pitched noises</originalText> </observation></entryRelationship>Last Menstrual Period[observation: templateId 2.16.840.1.113883.10.20.30.3.34 (open)]Table SEQ Table \* ARABIC135: Last Menstrual Period ContextsContained By:Contains:Problem Section BCTPS (optional)This clinical statement represents the date of menstrual period of the patient. If known, the the first day of last menstrual period should be captured.??An effective time is required to determine if the menstrual period occured before or after treatment.Table SEQ Table \* ARABIC136: Last Menstrual Period Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.34']@classCode1..1SHALL219602.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL219612.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL21962@root1..1SHALL219632.16.840.1.113883.10.20.30.3.34id1..*SHALL22066code1..1SHALL21964@code1..1SHALL2196521840007@codeSystem1..1SHALL232372.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL21966@code1..1SHALL219672.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL22065value1..1SHALLTS21968SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:21960).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:21961).SHALL contain exactly one [1..1] templateId (CONF:21962) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.34" (CONF:21963).SHALL contain at least one [1..*] id (CONF:22066).SHALL contain exactly one [1..1] code (CONF:21964).This code SHALL contain exactly one [1..1] @code="21840007" Date of last menstrual period (CONF:21965).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:23237).SHALL contain exactly one [1..1] statusCode (CONF:21966).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:21967).SHALL contain exactly one [1..1] effectiveTime (CONF:22065).SHALL contain exactly one [1..1] value with @xsi:type="TS" (CONF:21968).Figure SEQ Figure \* ARABIC40: Last Menstrual Period<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.34" /> <id root="11f83a4d-344e-4c62-ac97-4ef857616562"/> <code code="21840007" codeSystem="2.16.840.1.113883.6.1" displayName="Date of last menstrual period"/> <statusCode code="completed"/> <effectiveTime value="20121128"/> <value xsi:type="TS" value="20121104"/></observation>Medication Activity [substanceAdministration: templateId 2.16.840.1.113883.10.20.22.4.16 (open)]Table SEQ Table \* ARABIC140: Medication Activity ContextsUsed By:Contains Entries:Reaction Observation (optional)Procedure Activity Procedure (optional)Medications Section (entries optional) (optional)Procedure Activity Act (optional)Procedure Activity Observation (optional)Medications Section BCTPS (optional)Drug VehicleIndicationInstructionsMedication DispenseMedication InformationMedication Supply OrderPrecondition for Substance AdministrationReaction ObservationA medication activity describes substance administrations that have actually occurred (e.g., pills ingested or injections given) or are intended to occur (e.g., "take 2 tablets twice a day for the next 10 days"). Medication activities in "INT" mood are reflections of what a clinician intends a patient to be taking. Medication activities in "EVN" mood reflect actual use.Medication timing is complex. This template requires that there be a substanceAdministration/effectiveTime valued with a time interval, representing the start and stop dates. Additional effectiveTime elements are optional, and can be used to represent frequency and other aspects of more detailed dosing regimens.Table SEQ Table \* ARABIC141: Medication Activity Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Medication ActivitysubstanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.22.4.16']@classCode1..1SHALL74962.16.840.1.113883.5.6 (HL7ActClass) = SBADM@moodCode1..1SHALL74972.16.840.1.113883.11.20.9.18 (MoodCodeEvnInt)templateId1..1SHALL7499@root1..1SHALL105042.16.840.1.113883.10.20.22.4.16id1..*SHALL7500deliveryMethodcode0..1MAY7506freeTextSigtext0..1SHOULD7501reference0..1SHOULD15977@value0..1SHOULD15978statusCode1..1SHALL7507effectiveTime1..1SHALL7508indicateMedicationStartedlow1..1SHALL7511indicateMedicationStoppedhigh1..1SHALL7512administrationTimingeffectiveTime0..1SHOULD7513@operator1..1SHALL9106ArepeatNumber0..1MAY7555routerouteCode0..1MAY75142.16.840.1.113883.3.88.12.3221.8.7 (Medication Route FDA Value Set)siteapproachSiteCode0..1MAYSET<CD>75152.16.840.1.113883.3.88.12.3221.8.9 (Body Site Value Set)dosedoseQuantity0..1SHOULD7516@unit0..1SHOULD75262.16.840.1.113883.1.11.12839 (UnitsOfMeasureCaseSensitive)rateQuantity0..1MAY7517@unit1..1SHALL75252.16.840.1.113883.1.11.12839 (UnitsOfMeasureCaseSensitive)doseRestrictionmaxDoseQuantity0..1MAYRTO<PQ, PQ>7518productFormadministrationUnitCode0..1MAY75192.16.840.1.113883.3.88.12.3221.8.11 (Medication Product Form Value Set)medicationInformationconsumable1..1SHALL7520manufacturedProduct1..1SHALL16085performer0..1MAY7522vehicleparticipant0..*MAY7523@typeCode1..1SHALL75242.16.840.1.113883.5.90 (HL7ParticipationType) = CSMparticipantRole1..1SHALL16086indicationentryRelationship0..*MAY7536@typeCode1..1SHALL75372.16.840.1.113883.5.1002 (HL7ActRelation-shipType) = RSONobservation1..1SHALL16087patientInstructionsentryRelationship0..1MAY7539@typeCode1..1SHALL75402.16.840.1.113883.5.1002 (HL7ActRelation-shipType) = SUBJ@inversionInd1..1SHALL7542trueact1..1SHALL16088orderInformationentryRelationship0..1MAY7543@typeCode1..1SHALL75472.16.840.1.113883.5.1002 (HL7ActRelation-shipType) = REFRsupply1..1SHALL16089fulfillmentInstructionsentryRelationship0..*MAY7549@typeCode1..1SHALL75532.16.840.1.113883.5.1002 (HL7ActRelation-shipType) = REFRsupply1..1SHALL16090reactionentryRelationship0..1MAY7552@typeCode1..1SHALL75442.16.840.1.113883.5.1002 (HL7ActRelationshipType) = CAUSobservation1..1SHALL16091precondition0..*MAY7546@typeCode1..1SHALL75502.16.840.1.113883.5.1002 (HL7ActRelation-shipType) = PRCNcriterion1..1SHALL16092SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7496).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:7497).SHALL contain exactly one [1..1] templateId (CONF:7499) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.16" (CONF:10504).SHALL contain at least one [1..*] id (CONF:7500).MAY contain zero or one [0..1] code (CONF:7506).SHOULD contain zero or one [0..1] text (CONF:7501).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15977).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15978).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15979).SHALL contain exactly one [1..1] statusCode (CONF:7507).SHALL contain exactly one [1..1] effectiveTime (CONF:7508) such that itSHALL contain exactly one [1..1] low (CONF:7511).SHALL contain exactly one [1..1] high (CONF:7512).SHOULD contain zero or one [0..1] effectiveTime (CONF:7513) such that itSHALL contain exactly one [1..1] @operator="A" (CONF:9106).SHALL contain exactly one [1..1] @xsi:type=”PIVL_TS” or “EIVL_TS” (CONF:9105).MAY contain zero or one [0..1] repeatNumber (CONF:7555).In "INT" (intent) mood, the repeatNumber defines the number of allowed administrations. For example, a repeatNumber of "3" means that the substance can be administered up to 3 times. In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a substance administration event means that the current administration is the 3rd in a series (CONF:16877).MAY contain zero or one [0..1] routeCode, which SHALL be selected from ValueSet Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:7514).MAY contain zero or one [0..1] approachSiteCode, where the @code SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:7515).SHOULD contain zero or one [0..1] doseQuantity (CONF:7516).The doseQuantity, if present, SHOULD contain zero or one [0..1] @unit, which SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:7526).Pre-coordinated consumable: If the consumable code is a pre-coordinated unit dose (e.g. "metoprolol 25mg tablet") then doseQuantity is a unitless number that indicates the number of products given per administration (e.g. "2", meaning 2 x "metoprolol 25mg tablet") (CONF:16878).Not pre-coordinated consumable: If the consumable code is not pre-coordinated (e.g. is simply "metoprolol"), then doseQuantity must represent a physical quantity with @unit, e.g. "25" and "mg", specifying the amount of product given per administration (CONF:16879).MAY contain zero or one [0..1] rateQuantity (CONF:7517).The rateQuantity, if present, SHALL contain exactly one [1..1] @unit, which SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:7525).MAY contain zero or one [0..1] maxDoseQuantity (CONF:7518).MAY contain zero or one [0..1] administrationUnitCode, which SHALL be selected from ValueSet Medication Product Form Value Set 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMIC (CONF:7519).SHALL contain exactly one [1..1] consumable (CONF:7520).This consumable SHALL contain exactly one [1..1] Medication Information (templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:16085).MAY contain zero or one [0..1] performer (CONF:7522).MAY contain zero or more [0..*] participant (CONF:7523) such that itSHALL contain exactly one [1..1] @typeCode="CSM" (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7524).SHALL contain exactly one [1..1] Drug Vehicle (templateId:2.16.840.1.113883.10.20.22.4.24) (CONF:16086).MAY contain zero or more [0..*] entryRelationship (CONF:7536) such that itSHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7537).SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:16087).MAY contain zero or one [0..1] entryRelationship (CONF:7539) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7540).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7542).SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:16088).MAY contain zero or one [0..1] entryRelationship (CONF:7543) such that itSHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7547).SHALL contain exactly one [1..1] Medication Supply Order (templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:16089).MAY contain zero or more [0..*] entryRelationship (CONF:7549) such that itSHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7553).SHALL contain exactly one [1..1] Medication Dispense (templateId:2.16.840.1.113883.10.20.22.4.18) (CONF:16090).MAY contain zero or one [0..1] entryRelationship (CONF:7552) such that itSHALL contain exactly one [1..1] @typeCode="CAUS" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7544).SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:16091).MAY contain zero or more [0..*] precondition (CONF:7546) such that itSHALL contain exactly one [1..1] @typeCode="PRCN" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7550).SHALL contain exactly one [1..1] Precondition for Substance Administration (templateId:2.16.840.1.113883.10.20.22.4.25) (CONF:16092).Medication Activity SHOULD include doseQuantity OR rateQuantity (CONF:7529).Table SEQ Table \* ARABIC142: MoodCodeEvnInt Value SetValue Set: MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATICCode System(s): ActMood 2.16.840.1.113883.5.1001Description: This value set contains codes that represent the state of occurrence of an event.Reference: (members only)CodeCode SystemPrint NameEVNActMoodEventINTActMoodIntentTable SEQ Table \* ARABIC 143: Medication Route FDA Value Set (excerpt)Value Set: Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMICCode System(s):National Cancer Institute (NCI) Thesaurus 2.16.840.1.113883.3.26.1.1Description:This value set contains codes that represent the Route of Administration based upon FDA Drug Registration and Listing Database (FDA Orange Book) which are used in FDA structured product and labelling (SPL). Reference: CodeCode SystemPrint NameC38229NCI ThesaurusINTRACAUDALC38276NCI ThesaurusINTRAVENOUSC38288NCI ThesaurusORALC38295NCI ThesaurusRECTAL…Table SEQ Table \* ARABIC 144: Body Site Value Set (excerpt)Value Set: Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMICCode System(s): SNOMED CT 2.16.840.1.113883.6.96Description: This value set contains codes descending from the SNOMED CT? Anatomical Structure (91723000) hierarchy or Acquired body structure (body structure) (280115004) or Anatomical site notations for tumor staging (body structure) (258331007) or Body structure, altered from its original anatomical structure (morphologic abnormality) (118956008) or Physical anatomical entity (body structure) (91722005) This indicates the anatomical site.Reference: SystemPrint Name361316009SNOMED CTentire embryonic artery38033009SNOMED CTamputation stump9550003SNOMED CTbronchogenic cyst302509004SNOMED CTheart…Table SEQ Table \* ARABIC 145: Unit of Measure Value Set (excerpt)Value Set: UCUM Units of Measure (case sensitive) 2.16.840.1.113883.1.11.12839 DYNAMICCode System(s): Unified Code for Units of Measure (UCUM) 2.16.840.1.113883.6.8Description: This value set contains codes that include all units of measure that are currently used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units. The focus is on electronic communication, as opposed to communication between humans.Reference: (members only)CodeCode SystemPrint Namemmol/kgUCUMMilliMolesPerKiloGramfLUCUMFemtoLiterug/mLUCUMMicroGramsPerMilliLiter…Table SEQ Table \* ARABIC 146: Medication Product Form Value Set (excerpt)Value Set: Medication Product Form 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMICCode System(s): National Cancer Institute (NCI) Thesaurus 2.16.840.1.113883.3.26.1.1Description: This is the physical form of the product as presented to the individual. For example: tablet, capsule, liquid or ointment. Reference: SystemPrint NameC42887NCI ThesaurusAEROSOLC42909NCI ThesaurusGRANULE, EFFERVESCENT C42998NCI ThesaurusTABLET …Chemotherapy Medication Activity[substanceAdministration: templateId 2.16.840.1.113883.10.20.30.3.44 (open)]Table SEQ Table \* ARABIC144: Chemotherapy Medication Activity ContextsContained By:Contains:Medications Section BCTPS (required)Chemotherapy Protocol ReferenceClinical Drug TrialReaction ObservationThis clinical statement represents needed elements and attributes when communicating chemotherapeutic medications. The specific chemotherapeutic agents are not specified, but attributes such as repeatNumber, to note the cycle, dose, and route are required. This template represents administered agents as the administration would be recorded in a Medication Administration Record (MAR); as such, the second recommended effectiveTime used to represent periodic intervals is not useful.Table SEQ Table \* ARABIC145: Chemotherapy Medication Activity Constraints OverviewXPathCard.VerbData TypeCONF#Fixed ValuesubstanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.30.3.44']@classCode1..1SHALL238452.16.840.1.113883.5.6 (HL7ActClass) = SBADM@moodCode1..1SHALL238462.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL23847@root1..1SHALL238482.16.840.1.113883.10.20.30.3.44statusCode1..1SHALL23849@code1..1SHALL238502.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALLIVL_TS26227low1..1SHALL26228high1..1SHALL26229repeatNumber1..1SHALL27319routeCode1..1SHALL238512.16.840.1.113883.3.88.12.3221.8.7 (Medication Route FDA)doseQuantity1..1SHALL23853@value1..1SHALL27320@unit1..1SHALL27321entryRelationship0..*MAY27322@typeCode1..1SHALL273232.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRact1..1SHALL27324entryRelationship0..*MAY27325@typeCode1..1SHALL273262.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL27327entryRelationship0..*MAY27343@typeCode1..1SHALL273452.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRact1..1SHALL27346Conforms to Medication Activity template (2.16.840.1.113883.10.20.22.4.16).SHALL contain exactly one [1..1] @classCode="SBADM" SubstanceAdministration (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23845).SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:23846).SHALL contain exactly one [1..1] templateId (CONF:23847) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.44" (CONF:23848).SHALL contain exactly one [1..1] statusCode (CONF:23849).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23850).SHALL contain exactly one [1..1] effectiveTime (CONF:26227) such that itSHALL contain exactly one [1..1] low (CONF:26228).SHALL contain exactly one [1..1] high (CONF:26229).SHALL contain exactly one [1..1] repeatNumber (CONF:27319).SHALL contain exactly one [1..1] routeCode, which SHALL be selected from ValueSet Medication Route FDA 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:23851).SHALL contain exactly one [1..1] doseQuantity (CONF:23853).This doseQuantity SHALL contain exactly one [1..1] @value (CONF:27320).This doseQuantity SHALL contain exactly one [1..1] @unit (CONF:27321).MAY contain zero or more [0..*] entryRelationship (CONF:27322) such that itSHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27323).SHALL contain exactly one [1..1] Clinical Drug Trial (templateId:2.16.840.1.113883.10.20.30.3.4) (CONF:27324).The Reaction Observation template represents reactions or toxicities to the chemotherapeutic drug. The reaction may or may not be expected and may or may not be a reason to discontinue or adjust the dose of an agent.MAY contain zero or more [0..*] entryRelationship (CONF:27325) such that itSHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27326).SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:27327).MAY contain zero or more [0..*] entryRelationship (CONF:27343) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27345).SHALL contain exactly one [1..1] Chemotherapy Protocol Reference (templateId:2.16.840.1.113883.10.20.30.3.50) (CONF:27346).Figure SEQ Figure \* ARABIC41: Chemotherapy Medication Activity example<substanceAdministration classCode="SBADM" moodCode="EVN"> <!-- Consolidated CDA Medication Activity templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.16"/> <!-- Chemotherapy Medication Activity 2.16.840.1.113883.10.20.30.3.44--> <templateId root="2.16.840.1.113883.10.20.30.3.44"/> <id root="39c22143-e9f2-42b7-b117-d1f0d454b0d9"/> <statusCode code="completed"/> <!-- Administered Over 1 hour on January 6, 2013 from 1300 to 1400--> <effectiveTime xsi:type="IVL_TS"> <low value="201301061300"/> <high value="201301061400"/> </effectiveTime> <repeatNumber value="1"/> <routeCode code="C38276" displayName="intravenous" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="National Cancer Institute (NCI) Thesaurus"/> <doseQuantity value="68.5" unit="mg"/> <consumable> <manufacturedProduct classCode="MANU"> <!-- SHALL Consolidated CDA Medication Information (manufacturedMaterial) --> <templateId root="2.16.840.1.113883.10.20.22.4.23"/> .... </manufacturedProduct> </consumable> <entryRelationship typeCode="REFR"> <act classCode="ACT" moodCode="EVN"> <!-- Chemotherapy Protocol Reference templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.50"/> ... </act> </entryRelationship> <entryRelationship typeCode="REFR"> <act classCode="ACT" moodCode="EVN"> <!-- Clinical Drug Trial templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.4"/> ... </act> </entryRelationship> <entryRelationship typeCode="MFST" inversionInd="true"> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA Reaction Observation templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.9"/> ... </observation> </entryRelationship></substanceAdministration>Medication Dispense [supply: templateId 2.16.840.1.113883.10.20.22.4.18 (open)]Table SEQ Table \* ARABIC149: Medication Dispense ContextsUsed By:Contains Entries:Medication Activity (optional)Immunization Medication InformationMedication InformationMedication Supply OrderThis template records the act of supplying medications (i.e., dispensing).Table SEQ Table \* ARABIC150: Medication Dispense Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Medication Dispensesupply[templateId/@root = '2.16.840.1.113883.10.20.22.4.18']@classCode1..1SHALL74512.16.840.1.113883.5.6 (HL7ActClass) = SPLY@moodCode1..1SHALL74522.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7453@root1..1SHALL105052.16.840.1.113883.10.20.22.4.18prescriptionNumberid1..*SHALL7454statusCode1..1SHALL74552.16.840.1.113883.3.88.12.80.64 (Medication Fill Status)dispenseDateeffectiveTime0..1SHOULD7456fillNumberrepeatNumber0..1SHOULD7457quantityDispensedquantity0..1SHOULD7458product0..1MAY7459manufacturedProduct1..1SHALL15607product0..1MAY9331manufacturedProduct1..1SHALL15608performer0..1MAY7461providerassignedEntity1..1SHALL7467addr0..1SHOULD7468orderInformationentryRelationship0..1MAY7473@typeCode1..1SHALL74742.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRsupply1..1SHALL15606SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7451).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7452).SHALL contain exactly one [1..1] templateId (CONF:7453) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.18" (CONF:10505).SHALL contain at least one [1..*] id (CONF:7454).SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet Medication Fill Status 2.16.840.1.113883.3.88.12.80.64 DYNAMIC (CONF:7455).SHOULD contain zero or one [0..1] effectiveTime (CONF:7456).SHOULD contain zero or one [0..1] repeatNumber (CONF:7457).In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd (CONF:16876).SHOULD contain zero or one [0..1] quantity (CONF:7458).MAY contain zero or one [0..1] product (CONF:7459) such that itSHALL contain exactly one [1..1] Medication Information (templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:15607).MAY contain zero or one [0..1] product (CONF:9331) such that itSHALL contain exactly one [1..1] Immunization Medication Information (templateId:2.16.840.1.113883.10.20.22.4.54) (CONF:15608).MAY contain zero or one [0..1] performer (CONF:7461).The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:7467).This assignedEntity SHOULD contain zero or one [0..1] addr (CONF:7468).The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10565).MAY contain zero or one [0..1] entryRelationship (CONF:7473) such that itSHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7474).SHALL contain exactly one [1..1] Medication Supply Order (templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:15606).A supply act SHALL contain one product/Medication Information or one product/Immunization Medication Information template (CONF:9333).Table SEQ Table \* ARABIC151: Medication Fill Status Value SetValue Set: Medication Fill Status 2.16.840.1.113883.3.88.12.80.64 DYNAMICCode System(s): ActStatus 2.16.840.1.113883.5.14Descriptions: This value set contains codes that represent the state fulfillment of a medication.Reference: (members only)CodeCode SystemPrint NameabortedActStatusAbortedcompletedActStatusCompletedFigure SEQ Figure \* ARABIC 81: Medication Dispense example<supply classCode="SPLY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.18"/> <id root="1.2.3.4.56789.1" extension="cb734647-fc99-424c-a864-7e3cda82e704"/> <statusCode code="completed"/> <effectiveTime value="20070103"/> <repeatNumber value="1"/> <quantity value="75"/> <product> <manufacturedProduct classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.23"/> <id root="2a620155-9d11-439e-92b3-5d9815ff4ee8"/> <manufacturedMaterial> <code code="573621" codeSystem="2.16.840.1.113883.6.88" displayName="Proventil 0.09 MG/ACTUAT inhalant solution"> <originalText> <reference value="#MedSec_1" /> </originalText> <translation code="573621" displayName="Proventil 0.09 MG/ACTUAT inhalant solution" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm" /> </code> </manufacturedMaterial> <manufacturerOrganization> <name>Medication Factory Inc.</name> </manufacturerOrganization> </manufacturedProduct> </product> <performer> <time nullFlavor="UNK" /> <assignedEntity> <id root="2.16.840.1.113883.19.5.9999.456" extension="2981823" /> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> <telecom nullFlavor="UNK" /> <assignedPerson> <name> <prefix>Dr.</prefix> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> <representedOrganization> <id root="2.16.840.1.113883.19.5.9999.1393" /> <name>Community Health and Hospitals</name> <telecom nullFlavor="UNK" /> <addr nullFlavor="UNK" /> </representedOrganization> </assignedEntity> </performer></supply>Medication Information[manufacturedProduct: templateId 2.16.840.1.113883.10.20.22.4.23 (open)]Table SEQ Table \* ARABIC152: Medication Information ContextsUsed By:Contains Entries:Medication Activity (required)Medication Supply Order (optional)Medication Dispense (optional)Chemotherapy Medication Activity (required)Chemotherapy Medication Activity Plan (required)The medication can be recorded as a pre-coordinated product strength, product form, or product concentration (e.g., “metoprolol 25mg tablet”, “amoxicillin 400mg/5mL suspension”); or not pre-coordinated (e.g., “metoprolol product”).Table SEQ Table \* ARABIC153: Medication Information Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Medication InformationmanufacturedProduct[templateId/@root = '2.16.840.1.113883.10.20.22.4.23']@classCode1..1SHALL74082.16.840.1.113883.5.110 (RoleClass) = MANUtemplateId1..1SHALL7409@root1..1SHALL105062.16.840.1.113883.10.20.22.4.23id0..*MAY7410manufacturedMaterial1..1SHALL7411codedProductNamecode1..1SHALL74122.16.840.1.113883.3.88.12.80.17 (Medication Clinical Drug Name Value Set)freeTextProductNameoriginalText0..1SHOULD7413reference0..1SHOULD15986@value0..1SHOULD15987codedBrandNametranslation0..*MAYSET<PQR>7414drugManufacturermanufacturerOrganization0..1MAY7416SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:7408).SHALL contain exactly one [1..1] templateId (CONF:7409) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.23" (CONF:10506).MAY contain zero or more [0..*] id (CONF:7410).SHALL contain exactly one [1..1] manufacturedMaterial (CONF:7411).This manufacturedMaterial SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Medication Clinical Drug Name Value Set 2.16.840.1.113883.3.88.12.80.17 DYNAMIC (CONF:7412).This code SHOULD contain zero or one [0..1] originalText (CONF:7413).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:15986).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15987).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15988).This code MAY contain zero or more [0..*] translation (CONF:7414).Translations can be used to represent generic product name, packaged product code, etc (CONF:16875).MAY contain zero or one [0..1] manufacturerOrganization (CONF:7416).Table SEQ Table \* ARABIC 154: Medication Clinical Drug Name Value SetValue Set: Medication Clinical Drug Name Value Set 2.16.840.1.113883.3.88.12.80.17Description: Shall contain RxNorm normal forms for concepts type of “Ingredient Name” or Generic Packs. The ingredient name concepts can be found in the RxNORM file RXCONSO.RRF selecting all terms where SAB=RXNORM (selecting the normal forms), and TTY=SCD (selecting the ingredient names) or TTY=GPCK (selecting the generic packs)References: SystemPrint Name798349RxNorm{1 (0.5 ML Acellular Pertussis Vaccine 0.936 MG/ML / Diphtheria Toxoid Vaccine 13.4 UNT/ML / Tetanus Toxoid Vaccine 10 UNT/ML Injectable Suspension) / 1 (0.5 ML Haemophilus influenzae b, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine763623RxNorm{1 (0.5 ML Chondroitin Sulfates 40 MG/ML / hyaluronate 30 MG/ML Prefilled Syringe) / 1 (0.55 ML hyaluronate 10 MG/ML Prefilled Syringe) } Pack790424RxNorm{1 (1 ML Epinephrine 1 MG/ML Prefilled Syringe) / 4 (Chlorpheniramine 2 MG Chewable Tablet) } Pack793885RxNorm{1 (120 ML Urea 100 MG/ML Medicated Shampoo) / 1 (85 ML Sulfacetamide 100 MG/ML Topical Lotion) } Pack...Figure SEQ Figure \* ARABIC 82: Medication Information example<manufacturedProduct classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.23"/> <id root="2a620155-9d11-439e-92b3-5d9815ff4ee8"/> <manufacturedMaterial> <code code="219483" codeSystem="2.16.840.1.113883.6.88" displayName="ProventilHFA"> <originalText> <reference value="#MedSec_1" /> </originalText> <translation code="219483" displayName="Proventil HFA" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm" /> </code> </manufacturedMaterial> <manufacturerOrganization> <name>Medication Factory Inc.</name> </manufacturerOrganization></manufacturedProduct>Medication Supply Order [supply: templateId 2.16.840.1.113883.10.20.22.4.17 (open)]Table SEQ Table \* ARABIC155: Medication Supply Order ContextsUsed By:Contains Entries:Medication Activity (optional)Medication Dispense (optional)Immunization Medication InformationInstructionsMedication InformationThis template records the intent to supply a patient with medications.Table SEQ Table \* ARABIC156: Medication Supply Order Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesupply[templateId/@root = '2.16.840.1.113883.10.20.22.4.17']@classCode1..1SHALL74272.16.840.1.113883.5.6 (HL7ActClass) = SPLY@moodCode1..1SHALL74282.16.840.1.113883.5.1001 (ActMood) = INTtemplateId1..1SHALL7429@root1..1SHALL105072.16.840.1.113883.10.20.22.4.17id1..*SHALL7430statusCode1..1SHALL7432effectiveTime0..1SHOULDIVL_TS15143high1..1SHALL15144repeatNumber0..1SHOULD7434quantity0..1SHOULD7436product0..1MAY7439manufacturedProduct1..1SHALL16093product0..1MAY9334manufacturedProduct1..1SHALL16094author0..1MAY7438entryRelationship0..1MAY7442@typeCode1..1SHALL74442.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL7445trueact1..1SHALL16095SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7427).SHALL contain exactly one [1..1] @moodCode="INT" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7428).SHALL contain exactly one [1..1] templateId (CONF:7429) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.17" (CONF:10507).SHALL contain at least one [1..*] id (CONF:7430).SHALL contain exactly one [1..1] statusCode (CONF:7432).SHOULD contain zero or one [0..1] effectiveTime (CONF:15143) such that itSHALL contain exactly one [1..1] high (CONF:15144).SHOULD contain zero or one [0..1] repeatNumber (CONF:7434).In "INT" (intent) mood, the repeatNumber defines the number of allowed fills. For example, a repeatNumber of "3" means that the substance can be supplied up to 3 times (or, can be dispensed, with 2 refills) (CONF:16869).SHOULD contain zero or one [0..1] quantity (CONF:7436).MAY contain zero or one [0..1] product (CONF:7439) such that itSHALL contain exactly one [1..1] Medication Information (templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:16093).MAY contain zero or one [0..1] product (CONF:9334) such that itSHALL contain exactly one [1..1] Immunization Medication Information (templateId:2.16.840.1.113883.10.20.22.4.54) (CONF:16094).A supply act SHALL contain one product/Medication Information or one product/Immunization Medication Information template (CONF:16870).MAY contain zero or one [0..1] author (CONF:7438).MAY contain zero or one [0..1] entryRelationship (CONF:7442).The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7444).The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7445).The entryRelationship, if present, SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:16095).Figure SEQ Figure \* ARABIC 83: Medication Supply Order example<supply classCode="SPLY" moodCode="INT"> <templateId root="2.16.840.1.113883.10.20.22.4.17" /> <id nullFlavor="NI" /> <statusCode code="completed" /> <effectiveTime xsi:type="IVL_TS"> <low value="20070103" /> <high nullFlavor="UNK" /> </effectiveTime> <repeatNumber value="1" /> <quantity value="75" /> <product> <manufacturedProduct classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.23" /> ... </manufacturedProduct> </product> <performer> <assignedEntity> <id extension="2981823" root="2.16.840.1.113883.19.5.9999.456" /> <addr> <streetAddressLine>1001 Village Avenue</streetAddressLine> <city>Portland</city> <state>OR</state> <postalCode>99123</postalCode> <country>US</country> </addr> </assignedEntity> </performer> <author> <time nullFlavor="UNK" /> <assignedAuthor> <id root="2a620155-9d11-439e-92b3-5d9815fe4de8" /> <addr nullFlavor="UNK" /> <telecom nullFlavor="UNK" /> <assignedPerson> <name> <prefix>Dr.</prefix> <given>Henry</given> <family>Seven</family> </name> </assignedPerson> </assignedAuthor> </author> <entryRelationship typeCode="SUBJ" inversionInd="true"> <act classCode="ACT" moodCode="INT"> <templateId root="2.16.840.1.113883.10.20.22.4.20" /> <!-- ** Instructions Template ** --> ... </act> </entryRelationship></supply>Molecular Diagnostic Testing Organizer[organizer: templateId 2.16.840.1.113883.10.20.30.3.49 (open)]Table SEQ Table \* ARABIC154: Molecular Diagnostic Testing Organizer ContextsContained By:Contains:Results Section BCTPS (required)Oncotype DX ScoreThis clinical statement represents results from molecular diagnostic tests used in the evaluation of patients with breast cancer. Table SEQ Table \* ARABIC155: Molecular Diagnostic Testing Organizer Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueorganizer[templateId/@root = '2.16.840.1.113883.10.20.30.3.49']templateId1..1SHALL26815@root1..1SHALL268162.16.840.1.113883.10.20.30.3.49id1..*SHALL27415code1..1SHALL26817@code1..1SHALL26818396927009@codeSystem1..1SHALL268192.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL26820@code1..1SHALL268212.16.840.1.113883.5.14 (ActStatus) = completedcomponent1..*SHALL26822observation1..1SHALL26823SHALL contain exactly one [1..1] templateId (CONF:26815) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.49" (CONF:26816).SHALL contain at least one [1..*] id (CONF:27415).SHALL contain exactly one [1..1] code (CONF:26817).This code SHALL contain exactly one [1..1] @code="396927009" molecular testing, diagnostic (CONF:26818).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:26819).SHALL contain exactly one [1..1] statusCode (CONF:26820).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:26821).SHALL contain at least one [1..*] component (CONF:26822) such that itSHALL contain exactly one [1..1] Oncotype DX Score (templateId:2.16.840.1.113883.10.20.30.3.18) (CONF:26823).Figure SEQ Figure \* ARABIC42: Molecular Diagnostic Testing Organizer<organizer> <templateId root="2.16.840.1.113883.10.20.30.3.49" /> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="396927009" displayName="molecular testing, diagnostic" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <statusCode code="completed"/> <component> <observation classCode="OBS" moodCode="EVN"> <!-- consolidated CDA Result Observation templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Oncotype DX Score templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.18"/> ... </component> </organizer>Non-Medicinal Supply Activity [supply: templateId 2.16.840.1.113883.10.20.22.4.50 (open)]Table SEQ Table \* ARABIC157: Non-Medicinal Supply Activity ContextsUsed By:Contains Entries:Functional Status Section (optional)Functional Status Result Observation (optional)Cognitive Status Result Observation (optional)Functional Status Problem Observation (optional)Cognitive Status Problem Observation (optional)Product InstanceThis template records non-medicinal supplies provided, such as medical equipmentTable SEQ Table \* ARABIC158: Non-Medicinal Supply Activity Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesupply[templateId/@root = '2.16.840.1.113883.10.20.22.4.50']@classCode1..1SHALL87452.16.840.1.113883.5.6 (HL7ActClass) = SPLY@moodCode1..1SHALL87462.16.840.1.113883.11.20.9.18 (MoodCodeEvnInt)templateId1..1SHALL8747@root1..1SHALL105092.16.840.1.113883.10.20.22.4.50id1..*SHALL8748statusCode1..1SHALL8749effectiveTime0..1SHOULDIVL_TS15498quantity0..1SHOULD8751participant0..1MAY8752@typeCode1..1SHALL87542.16.840.1.113883.5.90 (HL7ParticipationType) = PRDparticipantRole1..1SHALL15900SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8745).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8746).SHALL contain exactly one [1..1] templateId (CONF:8747) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.50" (CONF:10509).SHALL contain at least one [1..*] id (CONF:8748).SHALL contain exactly one [1..1] statusCode (CONF:8749).SHOULD contain zero or one [0..1] effectiveTime (CONF:15498).The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:16867).SHOULD contain zero or one [0..1] quantity (CONF:8751).MAY contain zero or one [0..1] participant (CONF:8752) such that itSHALL contain exactly one [1..1] @typeCode="PRD" Product (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8754).SHALL contain exactly one [1..1] Product Instance (templateId:2.16.840.1.113883.10.20.22.4.37) (CONF:15900).Figure SEQ Figure \* ARABIC 84: Non-Medicinal Supply Activity example<supply classCode="SPLY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.50"/> <!-- Non-medicinal supply activity template ******* --> <id root="2413773c-2372-4299-bbe6-5b0f60664446"/> <statusCode code="completed"/> <effectiveTime xsi:type="IVL_TS"> <high value="199911"/> </effectiveTime> <quantity value="2"/> <participant typeCode="PRD"> <participantRole classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.37"/> <!-- ******** Product instance template ******** --> ... </participantRole> </participant></supply>Number of Pressure Ulcers Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.76 (open)]Table SEQ Table \* ARABIC159: Number of Pressure Ulcers Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)This clinical statement enumerates the number of pressure ulcers observed in a particular stage.Table SEQ Table \* ARABIC160: Number of Pressure Ulcers Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.76']@classCode1..1SHALL147052.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL147062.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14707@root1..1SHALL147082.16.840.1.113883.10.20.22.4.76id1..*SHALL14709code1..1SHALL14767@code1..1SHALL147682264892003statusCode1..1SHALL14714@code1..1SHALL191082.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL14715value1..1SHALLINT14771author0..1MAY14717entryRelationship1..1SHALL14718@typeCode1..1SHALL147192.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJobservation1..1SHALL14720@classCode1..1SHALL147212.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL147222.16.840.1.113883.5.1001 (ActMood) = EVNvalue1..1SHALLCD147252.16.840.1.113883.11.20.9.35 (Pressure Ulcer Stage)SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14705).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14706).SHALL contain exactly one [1..1] templateId (CONF:14707) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.76" (CONF:14708).SHALL contain at least one [1..*] id (CONF:14709).SHALL contain exactly one [1..1] code (CONF:14767).This code SHALL contain exactly one [1..1] @code="2264892003" number of pressure ulcers (CONF:14768).SHALL contain exactly one [1..1] statusCode (CONF:14714).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19108).SHALL contain exactly one [1..1] effectiveTime (CONF:14715).SHALL contain exactly one [1..1] value with @xsi:type="INT" (CONF:14771).MAY contain zero or one [0..1] author (CONF:14717).SHALL contain exactly one [1..1] entryRelationship (CONF:14718).This entryRelationship SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14719).This entryRelationship SHALL contain exactly one [1..1] observation (CONF:14720).This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14721).This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14722).This observation SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Pressure Ulcer Stage 2.16.840.1.113883.11.20.9.35 STATIC (CONF:14725).Table SEQ Table \* ARABIC161: Pressure Ulcer Stage Value SetValue Set: Pressure Ulcer Stage 2.16.840.1.113883.11.20.9.35 STATICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Description: This value set contains codes represetning the stage of a pressure ulcer.Reference: SystemPrint Name421076008SNOMED-CTPressure Ulcer Stage 1420324007SNOMED-CTPressure Ulcer Stage 2421927004SNOMED-CTPressure Ulcer Stage 3420597008SNOMED-CTPressure Ulcer Stage 4421594008SNOMED-CTNonstageable pressureFigure SEQ Figure \* ARABIC 85: Number of Pressure Ulcers Observation example<entry typeCode> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.76"/> <id root="08edb7c0-2111-43f2-a784-9a5fdfaa67f0"/> <code code="2264892003" codeSystem="2.16.840.1.113883.6.96" displayName="number of pressure ulcers"/> <statusCode code="completed"/> <value xsi:type="INT" value="3"/> <entryRelationship typeCode="SUBJ"> <observation classCode="OBS" moodCode="EVN"> <value xsi:type="CD" code="421927004" codeSystem="2.16.840.1.113883.6.96" displayName="Pressure ulcer stage 3"/> </observation> </entryRelationship> </observation></entry>Plan of Care Activity Act [act: templateId 2.16.840.1.113883.10.20.22.4.39 (open)]Table SEQ Table \* ARABIC162: Plan of Care Activity Act ContextsUsed By:Contains Entries:Plan of Care Section (optional)This is the generic template for the Plan of Care Activity.Table SEQ Table \* ARABIC163: Plan of Care Activity Act Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.22.4.39']@classCode1..1SHALL85382.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL85392.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure))templateId1..1SHALL8544@root1..1SHALL105102.16.840.1.113883.10.20.22.4.39id1..*SHALL8546SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8538).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:8539).SHALL contain exactly one [1..1] templateId (CONF:8544) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.39" (CONF:10510).SHALL contain at least one [1..*] id (CONF:8546).Plan of Care Radiation Activity[act: templateId 2.16.840.1.113883.10.20.30.3.32 (open)]Table SEQ Table \* ARABIC164: Plan of Care Radiation Activity ContextsUsed By:Contains Entries:Plan of Care Section BCTPS (optional)This clinical statement represents a planned radiation therapy. It is a simple template to state that radiation care is planned. It does not provide details. More detail can be supplied with narrative in the Plan of Care BCTPS section/text.Table SEQ Table \* ARABIC165: Plan of Care Radiation Activity Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.32']@classCode1..1SHALL235372.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL235382.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure))templateId1..1SHALL23539@root1..1SHALL235402.16.840.1.113883.10.20.30.3.32id1..*SHALL23541code1..1SHALL23542@code1..1SHALL23543385798007@codeSystem1..1SHALL270872.16.840.1.113883.6.96 (SNOMED-CT) = 2.16.840.1.113883.6.96effectiveTime1..1SHALL23544Conforms to Plan of Care Activity Act template (2.16.840.1.113883.10.20.22.4.39).SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:23537).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:23538).SHALL contain exactly one [1..1] templateId (CONF:23539) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.32" (CONF:23540).SHALL contain at least one [1..*] id (CONF:23541).SHALL contain exactly one [1..1] code (CONF:23542).This code SHALL contain exactly one [1..1] @code="385798007" radiation therapy care (CONF:23543).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:27087).SHALL contain exactly one [1..1] effectiveTime (CONF:23544).Table SEQ Table \* ARABIC166: Plan of Care moodCode (Act/Encounter/Procedure) Value SetValue Set: Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30Code System(s): ActMood 2.16.840.1.113883.5.1001Description: A value set of codes that restrict the moodCode on an Act, Encounter or Procedure to the future.Reference: (members only)CodeCode SystemPrint NameINTActMoodIntentARQActMoodAppointment RequestPRMSActMoodPromisePRPActMoodProposalRQOActMoodRequestFigure SEQ Figure \* ARABIC 86: Plan of Care Radiation Activity example<act moodCode="RQO" classCode="ACT"> <!-- Plan of Care Activity Act templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.39"/> <!-- Plan of Care Radiation Activity templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.32"/> <!-- **** Plan of Care Activity Act template **** --> <id root="ab3365e3-97b1-4461-8a60-290d9228ea26"/> <code code="385798007" codeSystem="2.16.840.1.113883.6.96" displayName="radiation therapy care"/> <statusCode code="new"/> <effectiveTime value="20130205"/></act>Plan of Care Activity Encounter [encounter: templateId 2.16.840.1.113883.10.20.22.4.40 (open)]Table SEQ Table \* ARABIC167: Plan of Care Activity Encounter ContextsUsed By:Contains Entries:Plan of Care Section (optional)This is the template for the Plan of Care Activity Encounter.Table SEQ Table \* ARABIC168: Plan of Care Activity Encounter Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueencounter[templateId/@root = '2.16.840.1.113883.10.20.22.4.40']@classCode1..1SHALL85642.16.840.1.113883.5.6 (HL7ActClass) = ENC@moodCode1..1SHALL85652.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure))templateId1..1SHALL8566@root1..1SHALL105112.16.840.1.113883.10.20.22.4.40id1..*SHALL8567SHALL contain exactly one [1..1] @classCode="ENC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8564).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:8565).SHALL contain exactly one [1..1] templateId (CONF:8566) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.40" (CONF:10511).SHALL contain at least one [1..*] id (CONF:8567).Figure SEQ Figure \* ARABIC 87: Plan of Care Activity Encounter example<encounter moodCode="INT" classCode="ENC"> <templateId root="2.16.840.1.113883.10.20.22.4.40"/> <!-- Plan of Care Activity Encounter template --> <id root="9a6d1bac-17d3-4195-89a4-1121bc809b4d"/> <!-- ... --></encounter>Plan of Care Activity Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.44 (open)]Table SEQ Table \* ARABIC169: Plan of Care Activity Observation ContextsUsed By:Contains Entries:Plan of Care Section (optional)This is the template for the Plan of Care Activity Observation.Table SEQ Table \* ARABIC170: Plan of Care Activity Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.44']@classCode1..1SHALL85812.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL85822.16.840.1.113883.11.20.9.25 (Plan of Care moodCode (Observation))templateId1..1SHALL8583@root1..1SHALL105122.16.840.1.113883.10.20.22.4.44id1..*SHALL8584SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8581).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Observation) 2.16.840.1.113883.11.20.9.25 STATIC 2011-09-30 (CONF:8582).SHALL contain exactly one [1..1] templateId (CONF:8583) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.44" (CONF:10512).SHALL contain at least one [1..*] id (CONF:8584).Table SEQ Table \* ARABIC171: Plan of Care moodCode (Observation) Value SetValue Set: Plan of Care moodCode (Observation) 2.16.840.1.113883.11.20.9.25 STATIC 2011-09-30Code System(s): ActMood 2.16.840.1.113883.5.1001Description: A value set of codes that restrict the occurrence of an event to the future.Reference: (members only)CodeCode SystemPrint NameINTActMoodIntentGOLActMoodGoalPRMSActMoodPromisePRPActMoodProposalRQOActMoodRequestFigure SEQ Figure \* ARABIC 88: Plan of Care Activity Observation example<observation classCode="OBS" moodCode="RQO"> <templateId root="2.16.840.1.113883.10.20.22.4.44"/> <!-- Plan of Care Activity Observation template --> <id root="9a6d1bac-17d3-4195-89a4-1121bc809b4a" /> <code code="73761001" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Colonoscopy"/> <statusCode code="new"/> <effectiveTime> <center value="20120512"/> </effectiveTime></observation>Plan of Care Activity Procedure [procedure: templateId 2.16.840.1.113883.10.20.22.4.41 (open)]Table SEQ Table \* ARABIC172: Plan of Care Activity Procedure ContextsUsed By:Contains Entries:Plan of Care Section (optional)This is the template for the Plan of Care Activity Procedure.Table SEQ Table \* ARABIC173: Plan of Care Activity Procedure Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueprocedure[templateId/@root = '2.16.840.1.113883.10.20.22.4.41']@classCode1..1SHALL85682.16.840.1.113883.5.6 (HL7ActClass) = PROC@moodCode1..1SHALL85692.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure))templateId1..1SHALL8570@root1..1SHALL105132.16.840.1.113883.10.20.22.4.41id1..*SHALL8571SHALL contain exactly one [1..1] @classCode="PROC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8568).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:8569).SHALL contain exactly one [1..1] templateId (CONF:8570) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.41" (CONF:10513).SHALL contain at least one [1..*] id (CONF:8571).Chemotherapy Regimen Plans[procedure: templateId 2.16.840.1.113883.10.20.30.3.30 open)]Table SEQ Table \* ARABIC173: Chemotherapy Regimen Plans ContextsContained By:Contains:Plan of Care Section BCTPS (optional)Chemotherapy Medication Activity PlanClinical Drug TrialPossible Side EffectsThis clinical statement represents a Chemotherapy Regimen Plan that describes a patient’s future course of chemotherapy.??Complete coded modeling of the intricacies of chemo regimen plans/orders and timing are not intended to be reflected in the contained Medication activities.??Chemotherapy regimen details and timing are very complex.??Representation of the details is unlikely to be properly understood by a receiving EHR and could be dangerous and is beyond the scope of this template and plan summary. Section/text narrative in the Plan of Care BCTPS section should contain explicit and clear text describing the planned regimen.Table SEQ Table \* ARABIC174: Chemotherapy Regimen Plans Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueprocedure[templateId/@root = '2.16.840.1.113883.10.20.30.3.30']@classCode1..1SHALL240472.16.840.1.113883.5.6 (HL7ActClass) = PROC@moodCode1..1SHALL240482.16.840.1.113883.11.20.9.24 (Planned moodCode (SubstanceAdministration/Supply))templateId1..1SHALL24049@root1..1SHALL240502.16.840.1.113883.10.20.30.3.30id1..*SHALL24051code1..1SHALL24052@code1..1SHALL2405369960004@codeSystem1..1SHALL270882.16.840.1.113883.6.96originalText1..1SHALL24054statusCode1..1SHALL24055effectiveTime1..1SHALL24057low1..1SHALL24058high1..1SHALL24059entryRelationship0..*SHOULD24060@typeCode1..1SHALL240612.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPsubstanceAdministration1..1SHALL24062entryRelationship0..1MAY24066@typeCode1..1SHALL240672.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPact1..1SHALL24068entryRelationship0..*MAY24076@typeCode1..1SHALL240772.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPact1..1SHALL24078Conforms to Plan of Care Activity Procedure template (2.16.840.1.113883.10.20.22.4.41).SHALL contain exactly one [1..1] @classCode="PROC" procedure (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:24047).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Planned moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24 STATIC (CONF:24048).SHALL contain exactly one [1..1] templateId (CONF:24049) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.30" (CONF:24050).SHALL contain at least one [1..*] id (CONF:24051).SHALL contain exactly one [1..1] code (CONF:24052).This code SHALL contain exactly one [1..1] @code="69960004" cancer chemotherapy regimen (CONF:24053).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CONF:27088).The originalText element captures the name of the regimen plan. The regimen names are typically acronyms made up of the the first letters of the brand or clinical drug names that are part of the regimen. Regimens and their component drugs are variable and are not identified in standard code systems.This code SHALL contain exactly one [1..1] originalText (CONF:24054).Typically, a regimen plan in a plan summary would either be "new" or "active". An act/status of "new" indicates that the regimen is in the preparatory stages and may not yet be acted upon. An act/status of "active" indicates the regimen can be performed or is being performed. However, other actStatus codes could possibly be applicable.SHALL contain exactly one [1..1] statusCode (CONF:24055).The effectiveTime is represents when the regimen plan is expected to begin and end. SHALL contain exactly one [1..1] effectiveTime (CONF:24057).This effectiveTime SHALL contain exactly one [1..1] low (CONF:24058).This effectiveTime SHALL contain exactly one [1..1] high (CONF:24059).SHOULD contain zero or more [0..*] entryRelationship (CONF:24060) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:24061).SHALL contain exactly one [1..1] Chemotherapy Medication Activity Plan (templateId:2.16.840.1.113883.10.20.30.3.51) (CONF:24062).MAY contain zero or one [0..1] entryRelationship (CONF:24066) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:24067).SHALL contain exactly one [1..1] Clinical Drug Trial (templateId:2.16.840.1.113883.10.20.30.3.4) (CONF:24068).MAY contain zero or more [0..*] entryRelationship (CONF:24076) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:24077).SHALL contain exactly one [1..1] Possible Side Effects (templateId:2.16.840.1.113883.10.20.30.3.35) (CONF:24078).Table SEQ Table \* ARABIC175: Planned moodCode (SubstanceAdministration/Supply)Value Set: Planned moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24Description: A value set of codes that restrict a substance administration or supply to future occurence.Reference: (members only)CodeCode SystemPrint NameINTActMoodIntentPRMSActMoodPromisePRPActMoodProposalRQOActMoodRequestFigure SEQ Figure \* ARABIC45: Chemotherapy Regimen Plans example<procedure classCode="PROC" moodCode="INT"> <!-- Plan of Care Activity Procedure--> <templateId root="2.16.840.1.113883.10.20.22.4.41"/> <!-- Chemotherapy regimen plans template--> <templateId root="2.16.840.1.113883.10.20.30.3.30"/> <id root="2baf9dc1-6d92-4ed0-8b4a-ad556adb90fe"/> <code code="69960004" codeSystem="2.16.840.1.113883.6.96" displayName="cancer chemotherapy regimen"> <originalText>TAC chemotherapy regimen</originalText> </code> <!-- An act/status of "new" indicates that the regimen is in the preparatory stages and may not yet be acted upon. An act/status of "active" indicates the regimen can be performed or is being performed --> <statusCode code="active"/> <!-- Expected start and end dates of entire regimen planned dates (6 cycles of 21 days each - 126 days) --> <effectiveTime xsi:type="IVL_TS"> <low value="201301010001"/> <high value="201304302359"/> </effectiveTime> <entryRelationship typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="INT"> <!-- Consolidated CDA Plan of Care Activity Substance Administration --> <templateId root="2.16.840.1.113883.10.20.22.4.42"/> ... </substanceAdministration> </entryRelationship> <entryRelationship typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="INT"> <!-- Consolidated CDA Plan of Care Activity Substance Administration --> <templateId root="2.16.840.1.113883.10.20.22.4.42"/> <!-- Chemotherapy Medication Activity Plans --> <templateId root="2.16.840.1.113883.10.20.30.3.51"/> ... </substanceAdministration> </entryRelationship></procedure>Plan of Care Activity Reconstruction Procedure[procedure: templateId 2.16.840.1.113883.10.20.30.3.31 (open)]Table SEQ Table \* ARABIC177: Plan of Care Activity Reconstruction Procedure ContextsUsed By:Contains Entries:Plan of Care Section BCTPS (optional)This clinical statement represents a planned breast reconstruction procedure. It is a simple template to state what breast procedure is planned. It does not provide extensive details. More detail can be supplied with narrative in the Plan of Care BCTPS section/text.Table SEQ Table \* ARABIC178: Plan of Care Activity Reconstruction Procedure Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueprocedure[templateId/@root = '2.16.840.1.113883.10.20.30.3.31']@classCode1..1SHALL240792.16.840.1.113883.5.6 (HL7ActClass) = PROC@moodCode1..1SHALL240802.16.840.1.113883.11.20.9.23 (Plan of Care moodCode (Act/Encounter/Procedure))templateId1..1SHALL24081@root1..1SHALL240822.16.840.1.113883.10.20.30.3.31id1..*SHALL24083code1..1SHALL240842.16.840.1.113883.11.20.11.16 (Breast Cancer Procedures)effectiveTime1..1SHALL24086Conforms to Plan of Care Activity Procedure template (2.16.840.1.113883.10.20.22.4.41).SHALL contain exactly one [1..1] @classCode="PROC" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:24079).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (Act/Encounter/Procedure) 2.16.840.1.113883.11.20.9.23 STATIC 2011-09-30 (CONF:24080).SHALL contain exactly one [1..1] templateId (CONF:24081) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.31" (CONF:24082).SHALL contain at least one [1..*] id (CONF:24083).SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Breast Cancer Procedures 2.16.840.1.113883.11.20.11.16 Dynamic (CONF:24084).SHALL contain exactly one [1..1] effectiveTime (CONF:24086).Table SEQ Table \* ARABIC 179: Breast Cancer Procedures Value Set Value Set: Breast Cancer Procedures 2.16.840.1.113883.11.20.11.16 DYNAMICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Description: This value set contains codes that represent common breast cancer procedures performed.Reference: SystemPrint Name408469009SNOMED-CTbreast surgery79544006SNOMED-CTblock dissection of axillary lymph nodes396487001SNOMED-CTsentinel lymph node biopsy33496007SNOMED-CTbreast reconstruction384723003SNOMED-CTradical mastectomy172043006SNOMED-CTsimple mastectomy392022002SNOMED-CTlumpectomy234262008SNOMED-CTexcision of axillary lymph nodeFigure SEQ Figure \* ARABIC 90: Plan of Care Activity Reconstruction Procedure example<procedure classCode="PROC" moodCode="INT"> <templateId root="2.16.840.1.113883.10.20.30.3.31" "/> <id root="2e606db3-66dc-4abe-8771-5cee29739935"/> <code code="33496007" codeSystem="2.16.840.1.113883.6.96" displayName="Reconstruction of breast"/> <statusCode code="new"/> <effectiveTime value="20130305"/></procedure>Plan of Care Activity Substance Administration [substanceAdministration: templateId 2.16.840.1.113883.10.20.22.4.42 (open)]Table SEQ Table \* ARABIC180: Plan of Care Activity Substance Administration ContextsUsed By:Contains Entries:Plan of Care Section (optional)This is the template for the Plan of Care Activity Substance AdministrationTable SEQ Table \* ARABIC181: Plan of Care Activity Substance Administration Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValuesubstanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.22.4.42']@classCode1..1SHALL85722.16.840.1.113883.5.6 (HL7ActClass) = SBADM@moodCode1..1SHALL85732.16.840.1.113883.11.20.9.24 (Plan of Care moodCode (SubstanceAdministration/Supply))templateId1..1SHALL8574@root1..1SHALL105142.16.840.1.113883.10.20.22.4.42id1..*SHALL8575SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8572).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24 STATIC 2011-09-30 (CONF:8573).SHALL contain exactly one [1..1] templateId (CONF:8574) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.42" (CONF:10514).SHALL contain at least one [1..*] id (CONF:8575).Chemotherapy Medication Activity Plan[substanceAdministration: templateId 2.16.840.1.113883.10.20.30.3.51 (open)]Table SEQ Table \* ARABIC182: Chemotherapy Medication Activity Plan ContextsContained By:Contains:Chemotherapy Regimen Plans (optional)Chemotherapy Protocol ReferenceClinical Drug TrialMedication InformationReaction ObservationThis clinical statement represents needed elements and attributes when communicating planned chemotherapeutic medications. The specific chemotherapeutic agents are not specified, but attributes such as repeatNumber, to note the cycle, dose, and route are required.??Chemotherapy medication details and timing are very complex. Representation of the details is unlikely to be properly understood by a receiving EHR and could be dangerous and is beyond the scope of this template and plan summary. Section/text narrative in the Plan of Care BCTPS section should contain explicit and clear text describing the planned regimen.Table SEQ Table \* ARABIC183: Chemotherapy Medication Activity Plan Constraints OverviewXPathCard.VerbData TypeCONF#Fixed ValuesubstanceAdministration[templateId/@root = '2.16.840.1.113883.10.20.30.3.51']@classCode1..1SHALL273482.16.840.1.113883.5.6 (HL7ActClass) = SBADM@moodCode1..1SHALL273492.16.840.1.113883.11.20.9.24 (Planned moodCode (SubstanceAdministration/Supply))templateId1..1SHALL27350@root1..1SHALL273512.16.840.1.113883.10.20.30.3.51statusCode1..1SHALL27352effectiveTime1..1SHALLIVL_TS27354low1..1SHALL27355high1..1SHALL27356repeatNumber1..1SHALL27357routeCode1..1SHALL273582.16.840.1.113883.3.88.12.3221.8.7 (Medication Route FDA)doseQuantity1..1SHALL27360@value1..1SHALL27361@unit1..1SHALL27362consumable1..1SHALL27363manufacturedProduct1..1SHALL27413entryRelationship0..*MAY27364@typeCode1..1SHALL273652.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRact1..1SHALL27366entryRelationship0..*MAY27367@typeCode1..1SHALL273682.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL27369entryRelationship0..*MAY27370@typeCode1..1SHALL273712.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRact1..1SHALL27372Conforms to Plan of Care Activity Substance Administration template (2.16.840.1.113883.10.20.22.4.42).SHALL contain exactly one [1..1] @classCode="SBADM" SubstanceAdministration (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:27348).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Planned moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24STATIC (CONF:27349).SHALL contain exactly one [1..1] templateId (CONF:27350) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.51" (CONF:27351).Typically, a chemotherapeutic drug plan in a plan summary would either be "new" or "active". An act/status of "new" indicates that the regimen is in the preparatory stages and may not yet be acted upon. An act/status of "active" indicates the regimen can be performed or is being performed. However, other actStatus codes could possibly be applicable.SHALL contain exactly one [1..1] statusCode (CONF:27352).SHALL contain exactly one [1..1] effectiveTime (CONF:27354) such that itSHALL contain exactly one [1..1] low (CONF:27355).SHALL contain exactly one [1..1] high (CONF:27356).The repeatNumber represents the number of recommended chemotherapy drug cycles. In a substanceAdministration a substanceAdministration/moodCode in "INT" (intent) mood causes the repeatNumber to mean the number of intended administrations.SHALL contain exactly one [1..1] repeatNumber (CONF:27357).SHALL contain exactly one [1..1] routeCode, which SHALL be selected from ValueSet Medication Route FDA 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:27358).SHALL contain exactly one [1..1] doseQuantity (CONF:27360).This doseQuantity SHALL contain exactly one [1..1] @value (CONF:27361).This doseQuantity SHALL contain exactly one [1..1] @unit (CONF:27362).SHALL contain exactly one [1..1] consumable (CONF:27363).This consumable SHALL contain exactly one [1..1] Medication Information (templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:27413).MAY contain zero or more [0..*] entryRelationship (CONF:27364) such that itSHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27365).SHALL contain exactly one [1..1] Clinical Drug Trial (templateId:2.16.840.1.113883.10.20.30.3.4) (CONF:27366).The Reaction Observation template is used to represent reactions or toxicities to the chemotherapeutic drug. The reaction may or may not be expected and may or may not be a reason to discontinue or adjust the dose of an agent.MAY contain zero or more [0..*] entryRelationship (CONF:27367) such that itSHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27368).SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:27369).MAY contain zero or more [0..*] entryRelationship (CONF:27370) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:27371).SHALL contain exactly one [1..1] Chemotherapy Protocol Reference (templateId:2.16.840.1.113883.10.20.30.3.50) (CONF:27372).Figure SEQ Figure \* ARABIC 91: Chemotherapy Medication Activity Plan example<substanceAdministration classCode="SBADM" moodCode="INT"> <!-- Consolidated CDA Plan of Care Activity Substance Administration --> <templateId root="2.16.840.1.113883.10.20.22.4.42"/> <!-- Chemotherapy Medication Activity Plans --> <templateId root="2.16.840.1.113883.10.20.30.3.51"/> <id root="393083d6-01d1-423c-b253-3e2658241287"/> <statusCode code="active"/> <effectiveTime xsi:type="IVL_TS"> <!-- Starts 1 day after the dexamethasone dose and 1 hour after completion of Doxorubicin and Cyclophosphamide. Time is dependent on completion of the premedication (Dexamethasone) and the 2 other chemotherapeutics--> <low nullFlavor="NAV"/> <high nullFlavor="NAV"/> </effectiveTime> <!-- Over 1 hour --> <effectiveTime xsi:type="PIVL_TS" operator="A"> <phase> <width value="1" unit="h"></width> </phase> </effectiveTime> <!-- every 21 days (3 weeks)--> <effectiveTime xsi:type="PIVL_TS" institutionSpecified="true" operator="A"> <period value="21" unit="d"/> </effectiveTime> <!-- Number of recommended cycles (In "INT" (intent) mood, the repeatNumber defines the number of allowed administrations). --> <repeatNumber value="6" operator="A"/> <routeCode code="C38276" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Intravenous route" codeSystemName="FDA RouteOfAdministration"/> <doseQuantity value="75" unit="mg/m2"/> <consumable> <manufacturedProduct classCode="MANU"> <!-- Consolidated CDA Medication Information (manufacturedMaterial) --> <templateId root="2.16.840.1.113883.10.20.22.4.23"/> <manufacturedMaterial> <code code="72962" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RXNorm" displayName="Docetaxel"> <originalText>Docetaxel</originalText> </code> <!-- Brand Name --> <name>Taxotere</name> </manufacturedMaterial> </manufacturedProduct> </consumable></substanceAdministration>Plan of Care Activity Supply [supply: templateId 2.16.840.1.113883.10.20.22.4.43 (open)]Table SEQ Table \* ARABIC184: Plan of Care Activity Supply ContextsUsed By:Contains Entries:Plan of Care Section (optional)This is the template for the Plan of Care Activity Supply.Table SEQ Table \* ARABIC185: Plan of Care Activity Supply Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuesupply[templateId/@root = '2.16.840.1.113883.10.20.22.4.43']@classCode1..1SHALL85772.16.840.1.113883.5.6 (HL7ActClass) = SPLY@moodCode1..1SHALL85782.16.840.1.113883.11.20.9.24 (Plan of Care moodCode (SubstanceAdministration/Supply))templateId1..1SHALL8579@root1..1SHALL105152.16.840.1.113883.10.20.22.4.43id1..*SHALL8580SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8577).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet Plan of Care moodCode (SubstanceAdministration/Supply) 2.16.840.1.113883.11.20.9.24 STATIC 2011-09-30 (CONF:8578).SHALL contain exactly one [1..1] templateId (CONF:8579) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.43" (CONF:10515).SHALL contain at least one [1..*] id (CONF:8580).Figure SEQ Figure \* ARABIC 92: Plan of Care Activity Supply example<supply moodCode="INT" classCode="SPLY"> <templateId root="2.16.840.1.113883.10.20.22.4.43"/> <!-- ** Plan of Care Activity Supply ** --> <id root="9a6d1bac-17d3-4195-89c4-1121bc809b5d"/> <code .../></supply>Post Treatment Disease Status[Observation: templateId 2.16.840.1.113883.10.20.30.3.29 (open)]Table SEQ Table \* ARABIC186: Post Treatment Disease Status ContextsUsed By:Contains Entries:Breast Cancer Diagnosis Observation (required)This clinical statement represents the disease status of the patient after treatment.Table SEQ Table \* ARABIC187: Post Treatment Disease Status Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueObservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.29']@classCode1..1SHALL219342.16.840.1.113883.5.6 (HL7ActClass)@moodCode1..1SHALL219352.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL21932@root1..1SHALL219332.16.840.1.113883.10.20.30.3.29id1..*SHALL21936code1..1SHALL21937@code1..1SHALL21938128926000@codeSystem1..1SHALL233392.16.840.1.113883.6.96 (SNOMED-CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL21939@code1..1SHALL219402.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL21941value1..1SHALLCD219422.16.840.1.113883.10.20.30.4.1 (Disease Status Post Treatment)SHALL contain exactly one [1..1] @classCode (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:21934).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:21935).SHALL contain exactly one [1..1] templateId (CONF:21932) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.29" (CONF:21933).SHALL contain at least one [1..*] id (CONF:21936).SHALL contain exactly one [1..1] code (CONF:21937).This code SHALL contain exactly one [1..1] @code="405178006" Postprocedural recovery status (CONF:21938).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem:SNOMED-CT 2.16.840.1.113883.6.96) (CONF:23339).SHALL contain exactly one [1..1] statusCode (CONF:21939).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:21940).SHALL contain exactly one [1..1] effectiveTime (CONF:21941).A value observation code of “OTH” communicates side effects not listed in ValueSet table. In these instances, the original text would be sent.SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Disease Status Post Treatment 2.16.840.1.113883.10.20.30.4.1 DYNAMIC (CONF:21942).Table SEQ Table \* ARABIC188: Disease Status Post Treatment Value SetValue Set: Disease Status Post Treatment 2.16.840.1.113883.10.20.30.4.1 DYNAMICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Description: This value set contains codes that describe the state of a patient post treatment.Reference: SystemPrint Name414861001SNOMED-CTno evidence of recurrence of cancer (situation)58184002SNOMED-CTrecurrent disease (disorder)399056007SNOMED-CTcomplete therapeutic response (finding)Figure SEQ Figure \* ARABIC 93: Post Treatment Disease Status example<entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!-- Post Treatement Disease Status TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.29"/> <id nullFlavor="NI"/> <code code="405178006" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Postprocedural recovery status"/> <statusCode code="completed"/> <effectiveTime value="20120707"/> <value xsi:type="CD" code="58184002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="recurrent disease"/> </observation></entryRelationship> Precondition for Substance Administration [criterion: templateId 2.16.840.1.113883.10.20.22.4.25 (open)]Table SEQ Table \* ARABIC189: Precondition for Substance Administration ContextsUsed By:Contains Entries:Medication Activity (optional)A criterion for administration can be used to record that the medication is to be administered only when the associated criteria are met.Table SEQ Table \* ARABIC190: Precondition for Substance Administration Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valuecriterion[templateId/@root = '2.16.840.1.113883.10.20.22.4.25']templateId1..1SHALL7372@root1..1SHALL105172.16.840.1.113883.10.20.22.4.25code0..1SHOULD16854text0..1MAY7373value0..1SHOULDCD7369SHALL contain exactly one [1..1] templateId (CONF:7372) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.25" (CONF:10517).SHOULD contain zero or one [0..1] code (CONF:16854).MAY contain zero or one [0..1] text (CONF:7373).SHOULD contain zero or one [0..1] value with @xsi:type="CD" (CONF:7369).Figure SEQ Figure \* ARABIC 94: Precondition for Substance Administration example<precondition typeCode="PRCN"> <templateId root="2.16.840.1.113883.10.20.22.4.25" /> <criterion> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" /> <value xsi:type="CE" code="56018004" codeSystem="2.16.840.1.113883.6.96" displayName="Wheezing" /> </criterion></precondition>Pressure Ulcer Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.70 (open)]Table SEQ Table \* ARABIC191: Pressure Ulcer Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)The pressure ulcer observation contains details about the pressure ulcer such as the stage of the ulcer, location, and dimensions. If the pressure ulcer is a diagnosis, you may find this on the problem list. An example of how this would appear is in the Problem Section.Table SEQ Table \* ARABIC192: Pressure Ulcer Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.70']@classCode1..1SHALL143832.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL143842.16.840.1.113883.5.1001 (ActMood) = EVN@negationInd0..1MAY14385templateId1..1SHALL14387@root1..1SHALL143882.16.840.1.113883.10.20.22.4.70id1..*SHALL14389code1..1SHALL14759@code1..1SHALL147602.16.840.1.113883.5.4 (ActCode) = ASSERTIONtext0..1SHOULD14391reference0..1SHOULD14392@value1..1SHALL15585statusCode1..1SHALL14394@code1..1SHALL191112.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL14395value1..1SHALLCD143962.16.840.1.113883.11.20.9.35 (Pressure Ulcer Stage)@nullFlavor0..1MAY14397targetSiteCode0..*SHOULD14797@code1..1SHALL147982.16.840.1.113883.11.20.9.36 (Pressure Point )qualifier0..1SHOULD14799name1..1SHALL14800@code0..1SHOULD148012.16.840.1.113883.6.96 (SNOMED-CT) = 272741003value1..1SHALL14802@code0..1SHOULD148032.16.840.1.113883.11.20.9.37 (TargetSite Qualifiers )entryRelationship0..1SHOULD14410@typeCode1..1SHALL144112.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL14619@classCode1..1SHALL146852.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL146862.16.840.1.113883.5.1001 (ActMood) = EVNcode1..1SHALL14620@code1..1SHALL146212.16.840.1.113883.6.96 (SNOMED-CT) = 401238003value1..1SHALLPQ14622entryRelationship0..1SHOULD14601@typeCode1..1SHALL14602COMPobservation1..1SHALL14623@classCode1..1SHALL146872.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL146882.16.840.1.113883.5.1001 (ActMood) = EVNcode1..1SHALL14624@code1..1SHALL146252.16.840.1.113883.6.96 (SNOMED-CT) = 401239006value1..1SHALLPQ14626entryRelationship0..1SHOULD14605@typeCode1..1SHALL14606COMPobservation1..1SHALL14627@classCode1..1SHALL146892.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL146902.16.840.1.113883.5.1001 (ActMood) = EVNcode1..1SHALL14628@code1..1SHALL146292.16.840.1.113883.6.96 (SNOMED-CT) = 425094009value1..1SHALLPQ14630SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14383).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14384).Use negationInd="true" to indicate that the problem was not observed.MAY contain zero or one [0..1] @negationInd (CONF:14385).SHALL contain exactly one [1..1] templateId (CONF:14387) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.70" (CONF:14388).SHALL contain at least one [1..*] id (CONF:14389).SHALL contain exactly one [1..1] code (CONF:14759).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:14760).SHOULD contain zero or one [0..1] text (CONF:14391).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:14392).The reference, if present, SHALL contain exactly one [1..1] @value (CONF:15585).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15586).SHALL contain exactly one [1..1] statusCode (CONF:14394).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19111).SHALL contain exactly one [1..1] effectiveTime (CONF:14395).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Pressure Ulcer Stage 2.16.840.1.113883.11.20.9.35 STATIC (CONF:14396).This value MAY contain zero or one [0..1] @nullFlavor (CONF:14397).If the stage unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:14398).SHOULD contain zero or more [0..*] targetSiteCode (CONF:14797).The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHOULD be selected from ValueSet Pressure Point 2.16.840.1.113883.11.20.9.36 STATIC (CONF:14798).The targetSiteCode, if present, SHOULD contain zero or one [0..1] qualifier (CONF:14799).The qualifier, if present, SHALL contain exactly one [1..1] name (CONF:14800).This name SHOULD contain zero or one [0..1] @code="272741003" laterality (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14801).The qualifier, if present, SHALL contain exactly one [1..1] value (CONF:14802).This value SHOULD contain zero or one [0..1] @code, which SHOULD be selected from ValueSet TargetSite Qualifiers 2.16.840.1.113883.11.20.9.37 STATIC (CONF:14803).SHOULD contain zero or one [0..1] entryRelationship (CONF:14410) such that itSHALL contain exactly one [1..1] @typeCode="COMP" (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14411).SHALL contain exactly one [1..1] observation (CONF:14619).This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14685).This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14686).This observation SHALL contain exactly one [1..1] code (CONF:14620).This code SHALL contain exactly one [1..1] @code="401238003" Length of Wound (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14621).This observation SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:14622).SHOULD contain zero or one [0..1] entryRelationship (CONF:14601) such that itSHALL contain exactly one [1..1] @typeCode="COMP" (CONF:14602).SHALL contain exactly one [1..1] observation (CONF:14623).This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14687).This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14688).This observation SHALL contain exactly one [1..1] code (CONF:14624).This code SHALL contain exactly one [1..1] @code="401239006" Width of Wound (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14625).This observation SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:14626).SHOULD contain zero or one [0..1] entryRelationship (CONF:14605) such that itSHALL contain exactly one [1..1] @typeCode="COMP" (CONF:14606).SHALL contain exactly one [1..1] observation (CONF:14627).This observation SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14689).This observation SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14690).This observation SHALL contain exactly one [1..1] code (CONF:14628).This code SHALL contain exactly one [1..1] @code="425094009" Depth of Wound (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14629).This observation SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:14630).Table SEQ Table \* ARABIC193: Pressure Point Value SetValue Set: Pressure Point 2.16.840.1.113883.11.20.9.36 STATICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Definition: This value set contains codes that represent points on the body that are susceptible to pressure ulcer development. Reference: SystemPrint Name43631005SNOMED-CToccipital region structure23747009SNOMED-CTskin structure of chin91774008SNOMED-CTstructure of right shoulder7874003SNOMED-CTstructure of scapular region of back; 272741003 = laterality; 24028007 = right (qualifier value)368149001SNOMED-CTright elbow region structure368148009SNOMED-CTleft elbow region structure87141009SNOMED-CTsacral vertebra structure122495006SNOMED-CTthoracic spine structure122496007SNOMED-CT lumbar spine structure287579007SNOMED-CTright hip region structure387679003SNOMED-CTleft hip region structure396993003SNOMED-CTright posterior iliac crest396994009SNOMED-CTleft posterior iliac crest46862004SNOMED-CTbuttock structure;272741003 = laterality;7771000 = left6757004SNOMED-CTstructure of right knee82169009SNOMED-CTstructure of left knee76853006SNOMED-CTheel structure; 272741003 = laterality; 24028007 = right 182304008SNOMED-CTmedial aspect of ankle; 272741003 = laterality; 24028007 = right182305009SNOMED-CTlateral aspect of ankle; 272741003 = laterality; 24028007 = right43631005SNOMED-CToccipital region structure23747009SNOMED-CTskin structure of chin91774008SNOMED-CTstructure of right shoulder7874003SNOMED-CTstructure of scapular region of back; 272741003 = laterality; 24028007 = right (qualifier value)368149001SNOMED-CTright elbow region structure368148009SNOMED-CT left elbow region structure87141009SNOMED-CTsacral vertebra structure122495006SNOMED-CTthoracic spine structure122496007SNOMED-CT lumbar spine structure287579007SNOMED-CTright hip region structure387679003SNOMED-CTleft hip region structure396993003SNOMED-CTright posterior iliac crest396994009SNOMED-CTleft posterior iliac crest46862004SNOMED-CTbuttock structure;272741003 = laterality;7771000 = left6757004SNOMED-CTstructure of right knee82169009SNOMED-CTstructure of left knee76853006SNOMED-CTheel structure; 272741003 = laterality; 24028007 = right 182304008SNOMED-CTmedial aspect of ankle; 272741003 = laterality; 7771000 = left182305009SNOMED-CTlateral aspect of ankle; 272741003 = laterality;7771000 = left6685009SNOMED-CTstructure of right ankleTable SEQ Table \* ARABIC194: TargetSite Qualifiers Value SetValue Set: TargetSite Qualifiers 2.16.840.1.113883.11.20.9.37 STATICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Definition: this value set contains codes which may be combined with a Body Site code to further define a site location.Reference: SystemPrint Name255549009SNOMED-CTanterior7771000SNOMED-CTleft255561001SNOMED-CTmedial255551008SNOMED-CTposterior24028007SNOMED-CTrightFigure SEQ Figure \* ARABIC \* MERGEFORMAT 95: Pressure Ulcer Observation example<entry typeCode> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.70"/> <!-- Pressure Ulcer Observation in Plan of Care template --> <id root="e2292075-9183-4a25-b8c3-df8521130443"/> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/> <statusCode code="completed"/> <text> <reference value="#PULC1"/> </text> <effectiveTime value="20120328"/> <value xsi:type="CD" code="421927004" codeSystem="2.16.840.1.113883.6.96" displayName="Pressure ulcer stage 3"/> <targetSiteCode code="76552005" codeSystem="2.16.840.1.113883.6.96" displayName="skin structure of shoulder"/> <qualifier> <name code="272741003" displayName="Laterality"/> <value code="7771000" displayName="Left"/> </qualifier> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.70"/> <id root="737b4094-ebb1-41ed-8fcd-f3c53f649e3b"/> <code code="401239006" codeSystem="2.16.840.1.113883.6.96" displayName="Width of Wound"/> <statusCode code="completed"/> <value xsi:type="PQ" value="1" unit="[in_i]"/> </observation> </entryRelationship> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.70"/> <id root="737b4094-ebb1-41ed-8fcd-f3c53f649e3b"/> <code code=" 401238003" codeSystem="2.16.840.1.113883.6.96" displayName="Length of Wound"/> <statusCode code="completed"/> <value xsi:type="PQ" value="2" unit="[in_i]"/> </observation> </entryRelationship> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.70"/> <id root="737b4094-ebb1-41ed-8fcd-f3c53f649e3b"/> <code code="425094009" codeSystem="2.16.840.1.113883.6.96" displayName="Depth of Wound"/> <statusCode code="completed"/> <value xsi:type="PQ" value="0.5" unit="[in_i]"/> </observation> </entryRelationship>Problem Concern Act (Condition) [act: templateId 2.16.840.1.113883.10.20.22.4.3 (open)]Table SEQ Table \* ARABIC195: Problem Concern Act (Condition) ContextsUsed By:Contains Entries:Problem Section (entries optional) (optional)Problem ObservationObservations of problems or other clinical statements captured at a point in time are wrapped in a "Concern" act, which represents the ongoing process tracked over time. This allows for binding related observations of problems. For example, the observation of "Acute MI" in 2004 can be related to the observation of "History of MI" in 2006 because they are the same concern. The conformance statements in this section define an outer "problem act" (representing the “Concern”) that can contain a nested "problem observation" or other nested clinical statements.Table SEQ Table \* ARABIC196: Problem Concern Act (Condition) Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.22.4.3']@classCode1..1SHALL90242.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL90252.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL16772@root1..1SHALL167732.16.840.1.113883.10.20.22.4.3id1..*SHALL9026code1..1SHALL9027@code1..1SHALL191842.16.840.1.113883.5.6 (HL7ActClass) = CONCstatusCode1..1SHALL90292.16.840.1.113883.11.20.9.19 (ProblemAct statusCode)effectiveTime1..1SHALL9030low1..1SHALL9032high0..1SHOULD9033entryRelationship1..*SHALL9034@typeCode1..1SHALL90352.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJobservation1..1SHALL15980SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:9024).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:9025).SHALL contain exactly one [1..1] templateId (CONF:16772) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.3" (CONF:16773).SHALL contain at least one [1..*] id (CONF:9026).SHALL contain exactly one [1..1] code (CONF:9027).This code SHALL contain exactly one [1..1] @code="CONC" Concern (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:19184).SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09 (CONF:9029).The effectiveTime element records the starting and ending times during which the concern was active on the Problem List.SHALL contain exactly one [1..1] effectiveTime (CONF:9030).This effectiveTime SHALL contain exactly one [1..1] low (CONF:9032).This effectiveTime SHOULD contain zero or one [0..1] high (CONF:9033).SHALL contain at least one [1..*] entryRelationship (CONF:9034) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9035).SHALL contain exactly one [1..1] Problem Observation (templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15980).Breast Cancer Concern Act[act: templateId 2.16.840.1.113883.10.20.30.3.6 (open)]Table SEQ Table \* ARABIC197: Breast Cancer Concern Act ContextsContained By:Contains:Problem Section BCTPS (required)Breast Cancer Diagnosis ObservationThis clinical statement represents the breast cancer concern and contains the diagnosis of breast cancer which includes diagnosis detail and supporting observations such as breast cancer site, tumor type, and cancer staging.Table SEQ Table \* ARABIC198: Breast Cancer Concern Act Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.30.3.6']templateId1..1SHALL21814@root1..1SHALL218152.16.840.1.113883.10.20.30.3.6entryRelationship1..1SHALL21817@typeCode1..1SHALL218182.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJobservation1..1SHALL21819Conforms to Problem Concern Act (Condition) template (2.16.840.1.113883.10.20.22.4.3).SHALL contain exactly one [1..1] templateId (CONF:21814) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.6" (CONF:21815).SHALL contain exactly one [1..1] entryRelationship (CONF:21817) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:21818).SHALL contain exactly one [1..1] Breast Cancer Diagnosis Observation (templateId:2.16.840.1.113883.10.20.30.3.2) (CONF:21819).Figure SEQ Figure \* ARABIC 96: Breast Cancer Concern Act example<entry> <act classCode="ACT" moodCode="EVN"> <!-- Breast Cancer Concern Act TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.6" /> <id root="ec8a6ff8-ed4b-4f7e-82c3-e98e58b45de7" /> <code code="CONC" codeSystem="2.16.840.1.113883.5.6" displayName="Concern" /> <statusCode code="Completed" /> <effectiveTime> <low value="20120104" /> <high value="20120104" /> </effectiveTime> <entryRelationship typeCode="SUBJ"> <observation classCode="OBS" moodCode="EVN"> <!-- Breast Cancer Diagnosis Observation TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.2" /> <id root="4f5e6e60-e641-4e80-ac7b-cdea1029bcce" /> ... </observation> </entryRelationship> </act></entry>Problem Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.4 (open)]Table SEQ Table \* ARABIC199: Problem Observation ContextsUsed By:Contains Entries:Problem Concern Act (Condition) (required)Encounter Diagnosis (required)Age ObservationHealth Status ObservationProblem StatusA problem is a clinical statement that a clinician has noted. In health care it is a condition that requires monitoring or diagnostic, therapeutic, or educational action. It also refers to any unmet or partially met basic human need.A Problem Observation is required to be wrapped in an act wrapper in locations such as the Problem Section, Allergies Section, and Hospital Discharge Diagnosis Section, where the type of problem needs to be identified or the condition tracked. A Problem Observation can be a valid "standalone" template instance in cases where a simple problem observation is to be sent.The negationInd attribute, if true, specifies that the problem indicated was observed to not have occurred (which is subtly but importantly different from having not been observed). NegationInd='true' is an acceptable way to make a clinical assertion that something did not occur, for example, 'no diabetes'.Table SEQ Table \* ARABIC200: Problem Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Problem Observationobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.4']@classCode1..1SHALL90412.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL90422.16.840.1.113883.5.1001 (ActMood) = EVN@negationInd0..1MAY10139templateId1..1SHALL14926@root1..1SHALL149272.16.840.1.113883.10.20.22.4.4id1..*SHALL9043problemTypecode1..1SHALL90452.16.840.1.113883.3.88.12.3221.7.2 (Problem Type)problemNametext0..1SHOULD9185reference0..1SHOULD15587@value1..1SHALL15588statusCode1..1SHALL9049@code1..1SHALL191122.16.840.1.113883.5.14 (ActStatus) = completedproblemDateeffectiveTime0..1SHOULD9050low1..1SHALL15603high0..1SHOULD15604problemCodevalue1..1SHALLCD90582.16.840.1.113883.3.88.12.3221.7.4 (Problem Value Set)translation0..*MAY16749@code0..1MAY167502.16.840.1.113883.6.90 (ICD10CM)@nullFlavor0..1MAY10141ageAtOnsetentryRelationship0..1MAY9059@typeCode1..1SHALL90602.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL9069trueobservation1..1SHALL15590problemStatusentryRelationship0..1MAY9063@typeCode1..1SHALL90682.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL15591entryRelationship0..1MAY9067@typeCode1..1SHALL90642.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL15592SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:9041).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:9042).MAY contain zero or one [0..1] @negationInd (CONF:10139).Use negationInd="true" to indicate that the problem was not observed (CONF:16880).SHALL contain exactly one [1..1] templateId (CONF:14926) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.4" (CONF:14927).SHALL contain at least one [1..*] id (CONF:9043).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type 2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:9045).SHOULD contain zero or one [0..1] text (CONF:9185).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15587).The reference, if present, SHALL contain exactly one [1..1] @value (CONF:15588).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15589).SHALL contain exactly one [1..1] statusCode (CONF:9049).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19112).SHOULD contain zero or one [0..1] effectiveTime (CONF:9050).The effectiveTime, if present, SHALL contain exactly one [1..1] low (CONF:15603).This field represents the onset date (CONF:16882).The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:15604).This field represents the resolution date (CONF:16883).If the problem is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the existence of an high element within a problem does indicate that the problem has been resolved (CONF:16881).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:9058).This value MAY contain zero or more [0..*] translation (CONF:16749).The translation, if present, MAY contain zero or one [0..1] @code (CodeSystem: ICD10CM 2.16.840.1.113883.6.90 STATIC) (CONF:16750).This value MAY contain zero or one [0..1] @nullFlavor (CONF:10141).If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:10142).MAY contain zero or one [0..1] entryRelationship (CONF:9059) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9060).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9069).SHALL contain exactly one [1..1] Age Observation (templateId:2.16.840.1.113883.10.20.22.4.31) (CONF:15590).MAY contain zero or one [0..1] entryRelationship (CONF:9063) such that itSHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9068).SHALL contain exactly one [1..1] Problem Status (templateId:2.16.840.1.113883.10.20.22.4.6) (CONF:15591).MAY contain zero or one [0..1] entryRelationship (CONF:9067) such that itSHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9064).SHALL contain exactly one [1..1] Health Status Observation (templateId:2.16.840.1.113883.10.20.22.4.5) (CONF:15592).Breast Cancer Diagnosis Observation[observation: templateId 2.16.840.1.113883.10.20.30.3.2 (open)]Table SEQ Table \* ARABIC201: Breast Cancer Diagnosis Observation ContextsContained By:Contains:Breast Cancer Concern Act (required)Breast TNM Clinical CategoryPost Treatment Disease StatusThis clinical statement represents the diagnosis of breast cancer which includes diagnosis detail and supporting observations such as breast cancer site, tumor type, and cancer staging.Table SEQ Table \* ARABIC202: Breast Cancer Diagnosis Observation Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.2']templateId1..1SHALL19279@root1..1SHALL192802.16.840.1.113883.10.20.30.3.2id1..*SHALL22067code1..1SHALL21945@code1..1SHALL21946282291009@codeSystem1..1SHALL249422.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL26224@code1..1SHALL262252.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL22076value1..1SHALLCD271702.16.840.1.113883.3.526.3.389 (Breast Cancer)targetSiteCode1..*SHALL219252.16.840.1.113883.3.88.12.3221.8.9 (Body Site)qualifier0..*MAY22068name1..1SHALL22069value1..1SHALL22070entryRelationship1..1SHALL21926@typeCode1..1SHALL219272.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SPRTact1..1SHALL21928entryRelationship0..1MAY24939@typeCode1..1SHALL249402.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL24941Conforms to Problem Observation template (2.16.840.1.113883.10.20.22.4.4).SHALL contain exactly one [1..1] templateId (CONF:19279) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.2" (CONF:19280).SHALL contain at least one [1..*] id (CONF:22067).SHALL contain exactly one [1..1] code (CONF:21945).This code SHALL contain exactly one [1..1] @code="282291009" Diagnosis (CONF:21946).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:24942).SHALL contain exactly one [1..1] statusCode (CONF:26224).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:26225).The presence of an effective time low indicates the problem onset date.??The presence of an effective time high indicates the problem resolution date.SHALL contain exactly one [1..1] effectiveTime (CONF:22076).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Breast Cancer 2.16.840.1.113883.3.526.3.389 DYNAMIC (CONF:27170).SHALL contain at least one [1..*] targetSiteCode, which SHALL be selected from ValueSet Body Site 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:21925).Such targetSiteCodes MAY contain zero or more [0..*] qualifier (CONF:22068).The qualifier, if present, SHALL contain exactly one [1..1] name (CONF:22069).The qualifier, if present, SHALL contain exactly one [1..1] value (CONF:22070).SHALL contain exactly one [1..1] entryRelationship (CONF:21926) such that itSHALL contain exactly one [1..1] @typeCode="SPRT" Has support (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:21927).SHALL contain exactly one [1..1] Breast TNM Clinical Category (templateId:2.16.840.1.113883.10.20.30.3.3) (CONF:21928).MAY contain zero or one [0..1] entryRelationship (CONF:24939) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:24940).SHALL contain exactly one [1..1] Post Treatment Disease Status (templateId:2.16.840.1.113883.10.20.30.3.29) (CONF:24941).Table SEQ Table \* ARABIC203: Breast Cancer Value Set (excerpt)Value Set: Breast Cancer 2.16.840.1.113883.3.526.3.389 DYNAMICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96 ICD9CM 2.16.840.1.113883.6.2 ICD10CM 2.16.840.1.113883.6.90Description: This value set contains codes which list diagnoses related to breast cancer. Reference: SystemPrint Name109886000SNOMED-CTOverlapping malignant neoplasm of female breast (disorder)174.0ICD9CMMalignant neoplasm of nipple and areola of female breast174.1ICD9CMMalignant neoplasm of central portion of female breast174.2ICD9CMMalignant neoplasm of upper-inner quadrant of female breast188147009SNOMED-CTMalignant neoplasm of nipple and areola of female breast (disorder)188151006SNOMED-CTMalignant neoplasm of central part of female breast (disorder)188152004SNOMED-CTMalignant neoplasm of upper-inner quadrant of female breast (disorder)C50.011ICD10CMMalignant neoplasm of nipple and areola, right female breastC50.012ICD10CMMalignant neoplasm of nipple and areola, left female breastC50.019ICD10CMMalignant neoplasm of nipple and areola, unspecified female breast…Figure SEQ Figure \* ARABIC 97: Breast Cancer Diagnosis Observation example<entryRelationship typeCode="SUBJ"> <observation classCode="OBS" moodCode="EVN"> <!-- Breast Cancer Diagnosis Observation TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.2"/> <id root="4f5e6e60-e641-4e80-ac7b-cdea1029bcce"/> <code code="282291009" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="diagnosis"/> <statusCode code="completed"/> <!-- Date of diagnosis --> <effectiveTime> <low value="20120104"/> </effectiveTime> <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.2" codeSystemName="ICD-9" code="174.0" displayName="Malignant Neoplasm of Nipple and Areola of Female Breast"/> <targetSiteCode code="80248007" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="left breast (body structure)"/> <!—BREAST TNM CLINICAL CATGORY--> <entryRelationship typeCode="SPRT"> <act classCode="ACT" moodCode="EVN"> <!—BREAST TNM Stage TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.3"/> ... </act> </entryRelationship> <!-- POST TREATMENT DISEASE STATUS --> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!-- Post Treatement Disease Status TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.29"/> ... </observation> </entryRelationship> </observation> </entryRelationship> Cognitive Status Problem Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.73 (open)]Table SEQ Table \* ARABIC204: Cognitive Status Problem Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)Assessment Scale ObservationCaregiver CharacteristicsNon-Medicinal Supply ActivityA cognitive status problem observation is a clinical statement that describes a patient's cognitive condition, findings, or symptoms. Examples of cognitive problem observations are inability to recall, amnesia, dementia, and aggressive behavior. A cognitive problem observation is a finding or medical condition. This is different from a cognitive result observation, which is a response to a question that provides insight into the patient's cognitive status, judgment, comprehension ability, or response speed.Table SEQ Table \* ARABIC205: Cognitive Status Problem Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.73']@classCode1..1SHALL143192.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL143202.16.840.1.113883.5.1001 (ActMood) = EVN@negationInd0..1MAY14344templateId1..1SHALL14346@root1..1SHALL143472.16.840.1.113883.10.20.22.4.73id1..*SHALL14321code1..1SHALL14804@code0..1SHOULD148052.16.840.1.113883.6.96 (SNOMED-CT) = 373930000text0..1SHOULD14341reference0..1SHOULD15532@value0..1SHOULD15533statusCode1..1SHALL14323@code1..1SHALL190912.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime0..1SHOULD14324value1..1SHALLCD143492.16.840.1.113883.3.88.12.3221.7.4 (Problem Value Set)methodCode0..*MAY14693entryRelationship0..*MAY14331@typeCode1..1SHALL145882.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRsupply1..1SHALL14351entryRelationship0..*MAY14335@typeCode1..1SHALL145892.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL14352entryRelationship0..*MAY14467@typeCode1..1SHALL145902.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL14468Conforms to Problem Observation template (2.16.840.1.113883.10.20.22.4.4).SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14319).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14320).Use negationInd="true" to indicate that the problem was not observed.MAY contain zero or one [0..1] @negationInd (CONF:14344).SHALL contain exactly one [1..1] templateId (CONF:14346) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.73" (CONF:14347).SHALL contain at least one [1..*] id (CONF:14321).SHALL contain exactly one [1..1] code (CONF:14804).This code SHOULD contain zero or one [0..1] @code="373930000" Cognitive function finding (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14805).SHOULD contain zero or one [0..1] text (CONF:14341).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15532).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15533).SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15534).SHALL contain exactly one [1..1] statusCode (CONF:14323).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19091).SHOULD contain zero or one [0..1] effectiveTime (CONF:14324).The onset date SHALL be recorded in the low element of the effectiveTime element when known (CONF:14325).The resolution date SHALL be recorded in the high element of the effectiveTime element when known (CONF:14326).If the problem is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the existence of a high element within a problem does indicate that the problem has been resolved (CONF:14327).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:14349).MAY contain zero or more [0..*] methodCode (CONF:14693).MAY contain zero or more [0..*] entryRelationship (CONF:14331) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14588).SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14351).MAY contain zero or more [0..*] entryRelationship (CONF:14335) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14589).SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14352).MAY contain zero or more [0..*] entryRelationship (CONF:14467) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14590).SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14468).Figure SEQ Figure \* ARABIC \* MERGEFORMAT 98: Cognitive Status Problem Observation example<observation classCode="OBS" moodCode="EVN"> <!-- ** conforms to Problem observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.4"/> <templateId root="2.16.840.1.113883.10.20.22.4.73"/> <id root="08edb7c0-2111-43f2-a784-9a5fdfaa67f0"/> <code code="373930000" codeSystem="2.16.840.1.113883.6.96" displayName="Cognitive Function Finding"/> <text> <reference value="#COG2"/> </text> <statusCode code="completed"/> <effectiveTime> <low value="200704"/> <high value="200706"/> </effectiveTime> <value xsi:type="CD" code=" 371632003" codeSystem="2.16.840.1.113883.6.96" displayName="Comatose"/> </observation>Functional Status Problem Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.68 (open)]Table SEQ Table \* ARABIC206: Functional Status Problem Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)Assessment Scale ObservationCaregiver CharacteristicsNon-Medicinal Supply ActivityA functional status problem observation is a clinical statement that represents a patient’s functional performance and ability. Table SEQ Table \* ARABIC207: Functional Status Problem Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.68']@classCode1..1SHALL142822.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL142832.16.840.1.113883.5.1001 (ActMood) = EVN@negationInd0..1MAY14307templateId1..1SHALL14312@root1..1SHALL143132.16.840.1.113883.10.20.22.4.68id1..*SHALL14284code1..1SHALL14314@code0..1SHOULD143152.16.840.1.113883.6.96 (SNOMED-CT) = 248536006text0..1SHOULD14304reference0..1SHOULD15552@value0..1SHOULD15553statusCode1..1SHALL14286@code1..1SHALL191002.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime0..1SHOULD14287value1..1SHALLCD142912.16.840.1.113883.3.88.12.3221.7.4 (Problem Value Set)@nullFlavor0..1MAY14292methodCode0..1MAY14316entryRelationship0..*MAY14294@typeCode1..1SHALL145842.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRsupply1..1SHALL14317entryRelationship0..*MAY14298@typeCode1..1SHALL145862.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL14318entryRelationship0..*MAY14463@typeCode1..1SHALL145872.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL14464Conforms to Problem Observation template (2.16.840.1.113883.10.20.22.4.4).SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14282).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14283).Use negationInd="true" to indicate that the problem was not observed.MAY contain zero or one [0..1] @negationInd (CONF:14307).SHALL contain exactly one [1..1] templateId (CONF:14312) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.68" (CONF:14313).SHALL contain at least one [1..*] id (CONF:14284).SHALL contain exactly one [1..1] code (CONF:14314).This code SHOULD contain zero or one [0..1] @code="248536006" finding of functional performance and activity (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14315).SHOULD contain zero or one [0..1] text (CONF:14304).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15552).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15553).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15554).SHALL contain exactly one [1..1] statusCode (CONF:14286).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19100).SHOULD contain zero or one [0..1] effectiveTime (CONF:14287).The onset date SHALL be recorded in the low element of the effectiveTime element when known (CONF:14288).The resolution date SHALL be recorded in the high element of the effectiveTime element when known (CONF:14289).If the problem is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the existence of an high element within a problem does indicate that the problem has been resolved (CONF:14290).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:14291).This value MAY contain zero or one [0..1] @nullFlavor (CONF:14292).If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other code SHOULD be placed in the translation element (CONF:14293).MAY contain zero or one [0..1] methodCode (CONF:14316).MAY contain zero or more [0..*] entryRelationship (CONF:14294) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14584).SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14317).MAY contain zero or more [0..*] entryRelationship (CONF:14298) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14586).SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14318).MAY contain zero or more [0..*] entryRelationship (CONF:14463) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14587).SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14464).Figure SEQ Figure \* ARABIC \* MERGEFORMAT 99: Functional Status Problem Observation example<observation classCode="OBS" moodCode="EVN"> <!-- conforms to Problem observation --> <templateId root="2.16.840.1.113883.10.20.22.4.4"/> <!-- Functional status problem observation --> <templateId root="2.16.840.1.113883.10.20.22.4.68"/> <id root="08edb7c0-2111-43f2-a784-9a5fdfaa67f0"/> <code code="248536006" codeSystem="2.16.840.1.113883.6.96" displayName="Finding of Functional Performance and activity"/> <text> <reference value="#FUNC2"/> </text> <statusCode code="completed"/> <effectiveTime> <low value="200702"/> <high value="200704"/> </effectiveTime> <value xsi:type="CD" code=" 162891007" codeSystem="2.16.840.1.113883.6.96" displayName="dyspnea"/> <entryRelationship typeCode=" REFR"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.72"/> <!—Caregiver Characteristics --> ... </observation> </entryRelationship> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.69"/> <!— Assessment Scale Observation --> ... </observation> </entryRelationship> </observation>Neurotoxicity Impairment of ADLs[Observation: templateId 2.16.840.1.113883.10.20.30.3.37 (open)]Table SEQ Table \* ARABIC208: Neurotoxicity Impairment of ADLs ContextsUsed By:Contains Entries:Functional Status Section BCTPS (optional)This clinical statement associates neurotoxicity as the cause of a functional status observation. Table SEQ Table \* ARABIC209: Neurotoxicity Impairment of ADLs Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueObservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.37']@classCode1..1SHALL264212.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL264222.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL26438@root1..1SHALL264392.16.840.1.113883.10.20.30.3.37entryRelationship1..1SHALL26423@typeCode1..1SHALL264242.16.840.1.113883.5.1002 (HL7ActRelationshipType) = CAUS@inversionInd1..1SHALL26425trueobservation1..1SHALL26426@classCode1..1SHALL264272.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL264282.16.840.1.113883.5.1001 (ActMood) = EVNid1..*SHALL26429code1..1SHALL26430@code1..1SHALL26431ASSERTION@codeSystem1..1SHALL264322.16.840.1.113883.5.4statusCode1..1SHALL26433@code1..1SHALL264372.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD26434@code1..1SHALL264351946603@codeSystem1..1SHALL264362.16.840.1.113883.6.96Conforms to Functional Status Problem Observation template (2.16.840.1.113883.10.20.22.4.68).SHALL contain exactly one [1..1] @classCode="OBS" observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:26421).SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:26422).SHALL contain exactly one [1..1] templateId (CONF:26438) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.37" (CONF:26439).SHALL contain exactly one [1..1] entryRelationship (CONF:26423) such that itSHALL contain exactly one [1..1] @typeCode="CAUS" has etiology for (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:26424).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:26425).SHALL contain exactly one [1..1] observation (CONF:26426).This observation SHALL contain exactly one [1..1] @classCode="OBS" observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:26427).This observation SHALL contain exactly one [1..1] @moodCode="EVN" event (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:26428).This observation/id could reference the id of the detailed reaction observation in the chemo regimen or in Allergies/Adverse events section.This observation SHALL contain at least one [1..*] id (CONF:26429).This observation SHALL contain exactly one [1..1] code (CONF:26430).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CONF:26431).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" ActCode (CONF:26432).This observation SHALL contain exactly one [1..1] statusCode (CONF:26433).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:26437).This observation SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:26434).This value SHALL contain exactly one [1..1] @code="1946603" Neurotoxocity (CONF:26435).This value SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" SNOMED-CT (CONF:26436).Figure SEQ Figure \* ARABIC 100: Neurotoxicity Impairment of ADLs example<observation classCode="OBS" moodCode="EVN"> <!-- C-CDA FUNCTIONAL STATUS PROBLEM OBSERVATION TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.68"/> <!-- Neurotoxicity impairment of activities of daily living templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.37"/> <id root="0a2405dd-7629-40e4-abb7-8eb12432e450"/> <code codeSystem="2.16.840.1.113883.6.96" code="248536006" displayName="finding of functional performance and activity"/> <statusCode code="completed"/> <effectiveTime> <low value="20121109"/> </effectiveTime> <value xsi:type="CD" code="282207002" codeSystem="2.16.840.1.113883.6.96" displayName="Difficulty initiating walking"/> <entryRelationship typeCode="CAUS" inversionInd="true"> <observation classCode="OBS" moodCode="EVN"> <!-- This could also reference the id of the detailed reaction observation in the chemo regimen or in Allergies/Adverse events section --> <id root="ea3d6016-7d2c-450f-aa0c-e18f1bffbbe0"/> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/> <statusCode code="completed"/> <value xsi:type="CD" code="1946603" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Neurotoxocity"/> </observation> </entryRelationship> </observation> Problem Status [observation: templateId 2.16.840.1.113883.10.20.22.4.6 (open)]Table SEQ Table \* ARABIC210: Problem Status ContextsUsed By:Contains Entries:Problem Observation (optional)The Problem Status records whether the indicated problem is active, inactive, or resolved.Table SEQ Table \* ARABIC211: Problem Status Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.6']@classCode1..1SHALL73572.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL73582.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7359@root1..1SHALL105182.16.840.1.113883.10.20.22.4.6code1..1SHALL19162@code1..1SHALL191632.16.840.1.113883.6.1 (LOINC) = 33999-4text0..1SHOULD7362reference0..1SHOULD15593@value1..1SHALL15594statusCode1..1SHALL7364@code1..1SHALL191132.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLCD73652.16.840.1.113883.3.88.12.80.68 (Problem Status Value Set)SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7357).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7358).SHALL contain exactly one [1..1] templateId (CONF:7359) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.6" (CONF:10518).SHALL contain exactly one [1..1] code (CONF:19162).This code SHALL contain exactly one [1..1] @code="33999-4" Status (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19163).SHOULD contain zero or one [0..1] text (CONF:7362).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15593).The reference, if present, SHALL contain exactly one [1..1] @value (CONF:15594).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15595).SHALL contain exactly one [1..1] statusCode (CONF:7364).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19113).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem Status Value Set 2.16.840.1.113883.3.88.12.80.68 DYNAMIC (CONF:7365).Figure SEQ Figure \* ARABIC 101: Problem Status example<observation classCode="OBS" moodCode="EVN"> <!-- Status observation template --> <templateId root="2.16.840.1.113883.10.20.22.4.6"/> <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Status"/> <text> <reference value="#STAT1"/> </text> <statusCode code="completed"/> <value xsi:type="CD" code="55561003" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Active"/></observation>Procedure Activity Act [act: templateId 2.16.840.1.113883.10.20.22.4.12 (open)]Table SEQ Table \* ARABIC212: Procedure Activity Act ContextsUsed By:Contains Entries:Procedures Section (entries optional) (optional)IndicationInstructionsMedication ActivityService Delivery LocationThe common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g., splenectomy). This clinical statement represents any procedure that cannot be classified as an observation or a procedure according to the HL7 RIM. Examples of these procedures are a dressing change, teaching or feeding a patient or providing comfort measures.Table SEQ Table \* ARABIC213: Procedure Activity Act Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueact[templateId/@root = '2.16.840.1.113883.10.20.22.4.12']@classCode1..1SHALL82892.16.840.1.113883.5.6 (HL7ActClass) = ACT@moodCode1..1SHALL82902.16.840.1.113883.11.20.9.18 (MoodCodeEvnInt)templateId1..1SHALL8291@root1..1SHALL105192.16.840.1.113883.10.20.22.4.12id1..*SHALL8292code1..1SHALL8293originalText0..1SHOULD19186reference0..1MAY19187@value0..1MAY19188statusCode1..1SHALL82982.16.840.1.113883.11.20.9.22 (ProcedureAct statusCode)effectiveTime0..1SHOULD8299priorityCode0..1MAY83002.16.840.1.113883.1.11.16866 (Act Priority Value Set)performer0..*SHOULD8301assignedEntity1..1SHALL8302id1..*SHALL8303addr1..1SHALL8304telecom1..1SHALL8305representedOrganization0..1SHOULD8306id0..*SHOULD8307name0..*MAY8308telecom1..1SHALL8310addr1..1SHALL8309participant0..*MAY8311@typeCode1..1SHALL83122.16.840.1.113883.5.1002 (HL7ActRelationshipType) = LOCparticipantRole1..1SHALL15599entryRelationship0..*MAY8314@typeCode1..1SHALL83152.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP@inversionInd1..1SHALL8316trueencounter1..1SHALL8317@classCode1..1SHALL83182.16.840.1.113883.5.6 (HL7ActClass) = ENC@moodCode1..1SHALL83192.16.840.1.113883.5.1001 (ActMood) = EVNid1..1SHALL8320entryRelationship0..1MAY8322@typeCode1..1SHALL83232.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL8324trueact1..1SHALL15600entryRelationship0..*MAY8326@typeCode1..1SHALL83272.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSONobservation1..1SHALL15601entryRelationship0..*MAY8329@typeCode1..1SHALL83302.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPsubstanceAdministration1..1SHALL15602SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8289).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8290).SHALL contain exactly one [1..1] templateId (CONF:8291) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.12" (CONF:10519).SHALL contain at least one [1..*] id (CONF:8292).SHALL contain exactly one [1..1] code (CONF:8293).This code SHOULD contain zero or one [0..1] originalText (CONF:19186).The originalText, if present, MAY contain zero or one [0..1] reference (CONF:19187).The reference, if present, MAY contain zero or one [0..1] @value (CONF:19188).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:19189).This code in a procedure activity act SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:19190).SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:8298).SHOULD contain zero or one [0..1] effectiveTime (CONF:8299).MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet Act Priority Value Set 2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:8300).SHOULD contain zero or more [0..*] performer (CONF:8301).The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8302).This assignedEntity SHALL contain at least one [1..*] id (CONF:8303).This assignedEntity SHALL contain exactly one [1..1] addr (CONF:8304).This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:8305).This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:8306).The representedOrganization, if present, SHOULD contain zero or more [0..*] id (CONF:8307).The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:8308).The representedOrganization, if present, SHALL contain exactly one [1..1] telecom (CONF:8310).The representedOrganization, if present, SHALL contain exactly one [1..1] addr (CONF:8309).MAY contain zero or more [0..*] participant (CONF:8311).The participant, if present, SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8312).The participant, if present, SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15599).MAY contain zero or more [0..*] entryRelationship (CONF:8314).The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8315).The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8316).The entryRelationship, if present, SHALL contain exactly one [1..1] encounter (CONF:8317).This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8318).This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8319).This encounter SHALL contain exactly one [1..1] id (CONF:8320).Set the encounter ID to the ID of an encounter in another section to signify they are the same encounter (CONF:16849).MAY contain zero or one [0..1] entryRelationship (CONF:8322).The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8323).The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8324).The entryRelationship, if present, SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15600).MAY contain zero or more [0..*] entryRelationship (CONF:8326).The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8327).The entryRelationship, if present, SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15601).MAY contain zero or more [0..*] entryRelationship (CONF:8329).The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8330).The entryRelationship, if present, SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15602).Table SEQ Table \* ARABIC214: ProcedureAct statusCode Value SetValue Set: ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMICCode System(s): ActStatus 2.16.840.1.113883.5.14Description: This value set contains codes for use with a procedure activity.References: (members only)CodeCode SystemPrint NamecompletedActStatusCompletedactiveActStatusActiveabortedActStatusAbortedcancelledActStatusCancelledTable SEQ Table \* ARABIC215: Act Priority Value Set Value SetValue Set: Act Priority Value Set 2.16.840.1.113883.1.11.16866 DYNAMICCode System(s): ActPriority 2.16.840.1.113883.5.7Description: This value set contains codes that identify the importance of a procedure or act.Reference: (members only)CodeCode SystemPrint NameAActPriorityASAPCRActPriorityCallback resultsCSActPriorityCallback for schedulingCSPActPriorityCallback placer for schedulingCSRActPriorityContact recipient for schedulingELActPriorityElectiveEMActPriorityEmergencyPActPriorityPreoperativePRNActPriorityAs neededRActPriorityRoutineRRActPriorityRush reportingSActPriorityStatTActPriorityTiming criticalUDActPriorityUse as directedURActPriorityUrgentRadiation Therapy Care Completed[Act: templateId 2.16.840.1.113883.10.20.30.3.16 (open)]Table SEQ Table \* ARABIC216: Radiation Therapy Care Completed ContextsUsed By:Contains Entries:Procedures Section BCTPS (optional)This clinical statement records whether or not patient received radiation therapy. The details of the radiation therapy are not represented. If the patient's radiation therapy was not completed, then the effective time high would have a nullFlavor="NI". Table SEQ Table \* ARABIC217: Radiation Therapy Care Completed Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueAct[templateId/@root = '2.16.840.1.113883.10.20.30.3.16']@negationInd1..1SHALL24945templateId1..1SHALL23179@root1..1SHALL231802.16.840.1.113883.10.20.30.3.16code1..1SHALL23185@code1..1SHALL23186385798007@codeSystem1..1SHALL234452.16.840.1.113883.6.96 (SNOMED-CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL23183@code1..1SHALL231842.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL23181high1..1SHALL23182Conforms to Procedure Activity Act template (2.16.840.1.113883.10.20.22.4.12).NegationInd=true indicates the patient did not complete radiation therapy and a NegationInd=false means the patient did complete radiation therapy.SHALL contain exactly one [1..1] @negationInd (CONF:24945).SHALL contain exactly one [1..1] templateId (CONF:23179) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.16" (CONF:23180).SHALL contain exactly one [1..1] code (CONF:23185).This code SHALL contain exactly one [1..1] @code="385798007" Radiation therapy care (CONF:23186).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:23445).SHALL contain exactly one [1..1] statusCode (CONF:23183).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23184).SHALL contain exactly one [1..1] effectiveTime (CONF:23181).The value for the effective time represents the date the radiation therapy is completed. If the the radiation therapy was not completed, use nullFlavor=NI for effective time high.This effectiveTime SHALL contain exactly one [1..1] high (CONF:23182)Figure SEQ Figure \* ARABIC 102: Radiation Therapy Care Completed example<entry> <!-- NegationInd=false indicates the patient did have radiation therapy --> <act classCode="ACT" moodCode="EVN" negationInd="false"> <!-- C-CDA PROCEDURE ACTIVITY ACT TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.12"/> <!-- Radiation Therapy Care Completed TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.16"/> <id nullFlavor="NI"/> <code code="385798007" codeSystem="2.16.840.1.113883.6.96" displayName="radiation therapy care"/> <text>Radiation Therapy Care</text> <statusCode code="completed"/> <effectiveTime> <low value="20121201"/> <!-- If radiation therapy care was not completed, use nullFlavor=NI. --> <high value="20121221"/> </effectiveTime> </act></entry>Procedure Activity Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.13 (open)]Table SEQ Table \* ARABIC218: Procedure Activity Observation ContextsUsed By:Contains Entries:Procedures Section (entries optional) (optional)IndicationInstructionsMedication ActivityService Delivery LocationThe common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g., splenectomy). This clinical statement represents procedures that result in new information about the patient that cannot be classified as a procedure according to the HL7 RIM. Examples of these procedures are diagnostic imaging procedures, EEGs and EKGs.Table SEQ Table \* ARABIC219: Procedure Activity Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.13']@classCode1..1SHALL82822.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL82372.16.840.1.113883.11.20.9.18 (MoodCodeEvnInt)templateId1..1SHALL8238@root1..1SHALL105202.16.840.1.113883.10.20.22.4.13id1..*SHALL8239code1..1SHALL19197originalText0..1SHOULD19198reference0..1SHOULD19199@value0..1SHOULD19200statusCode1..1SHALL82452.16.840.1.113883.11.20.9.22 (ProcedureAct statusCode)effectiveTime0..1SHOULD8246priorityCode0..1MAY82472.16.840.1.113883.1.11.16866 (Act Priority Value Set)value1..1SHALL16846methodCode0..1MAYSET<CE>8248targetSiteCode0..*SHOULD8250@code1..1SHALL160712.16.840.1.113883.3.88.12.3221.8.9 (Body Site Value Set)performer0..*SHOULD8251assignedEntity1..1SHALL8252id1..*SHALL8253addr1..1SHALL8254telecom1..1SHALL8255representedOrganization0..1SHOULD8256id0..*SHOULD8257name0..*MAY8258telecom1..1SHALL8260addr1..1SHALL8259participant0..*MAY8261@typeCode1..1SHALL82622.16.840.1.113883.5.1002 (HL7ActRelationshipType) = LOCparticipantRole1..1SHALL15904entryRelationship0..*MAY8264@typeCode1..1SHALL82652.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP@inversionInd1..1SHALL8266trueencounter1..1SHALL8267@classCode1..1SHALL82682.16.840.1.113883.5.6 (HL7ActClass) = ENC@moodCode1..1SHALL82692.16.840.1.113883.5.1001 (ActMood) = EVNid1..1SHALL8270entryRelationship0..1MAY8272@typeCode1..1SHALL82732.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL8274trueact1..1SHALL15905entryRelationship0..*MAY8276@typeCode1..1SHALL82772.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSONobservation1..1SHALL15906entryRelationship0..*MAY8279@typeCode1..1SHALL82802.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPsubstanceAdministration1..1SHALL15907SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8282).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8237).SHALL contain exactly one [1..1] templateId (CONF:8238) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.13" (CONF:10520).SHALL contain at least one [1..*] id (CONF:8239).SHALL contain exactly one [1..1] code (CONF:19197).This code SHOULD contain zero or one [0..1] originalText (CONF:19198).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:19199).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:19200).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:19201).This @code SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12), ICD10 PCS (CodeSystem: 2.16.840.1.113883.6.4) (CONF:19202).SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:8245).SHOULD contain zero or one [0..1] effectiveTime (CONF:8246).MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet Act Priority Value Set 2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:8247).SHALL contain exactly one [1..1] value (CONF:16846).MAY contain zero or one [0..1] methodCode (CONF:8248).MethodCode SHALL NOT conflict with the method inherent in Observation / code (CONF:8249).SHOULD contain zero or more [0..*] targetSiteCode (CONF:8250).The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:16071).SHOULD contain zero or more [0..*] performer (CONF:8251).The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8252).This assignedEntity SHALL contain at least one [1..*] id (CONF:8253).This assignedEntity SHALL contain exactly one [1..1] addr (CONF:8254).This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:8255).This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:8256).The representedOrganization, if present, SHOULD contain zero or more [0..*] id (CONF:8257).The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:8258).The representedOrganization, if present, SHALL contain exactly one [1..1] telecom (CONF:8260).The representedOrganization, if present, SHALL contain exactly one [1..1] addr (CONF:8259).MAY contain zero or more [0..*] participant (CONF:8261).The participant, if present, SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8262).The participant, if present, SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15904).MAY contain zero or more [0..*] entryRelationship (CONF:8264).The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP" Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8265).The entryRelationship, if present, SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8266).The entryRelationship, if present, SHALL contain exactly one [1..1] encounter (CONF:8267).This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8268).This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8269).This encounter SHALL contain exactly one [1..1] id (CONF:8270).Set encounter/id to the id of an encounter in another section to signify they are the same encounter (CONF:16847).MAY contain zero or one [0..1] entryRelationship (CONF:8272) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8273).SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8274).SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15905).MAY contain zero or more [0..*] entryRelationship (CONF:8276) such that itSHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8277).SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15906).MAY contain zero or more [0..*] entryRelationship (CONF:8279) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8280).SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15907).Figure SEQ Figure \* ARABIC 103: Procedure Activity Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.13" /> <!-- Procedure Activity Observation --> <id extension="123456789" root="2.16.840.1.113883.19" /> <code code="274025005" codeSystem="2.16.840.1.113883.6.96" displayName="Colonic polypectomy" codeSystemName="SNOMED-CT"> <originalText> <reference value="#Proc1" /> </originalText> </code> <statusCode code="aborted" /> <effectiveTime value="20110203" /> <priorityCode code="CR" codeSystem="2.16.840.1.113883.5.7" codeSystemName="ActPriority" displayName="Callback results" /> <value xsi:type="CD" /> <methodCode nullFlavor="UNK" /> <targetSiteCode code="416949008" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Abdomen and pelvis" /> <performer> <assignedEntity> <id root="2.16.840.1.113883.19.5" extension="1234" /> <addr> <streetAddressLine>17 Daws Rd.</streetAddressLine> <city>Blue Bell</city> <state>MA</state> <postalCode>02368</postalCode> <country>US</country> </addr> <telecom use="WP" value="(555)555-555-1234" /> <representedOrganization> <id root="2.16.840.1.113883.19.5" /> <name>Community Health and Hospitals</name> <telecom nullFlavor="UNK" /> <addr nullFlavor="UNK" /> </representedOrganization> </assignedEntity> </performer> <participant typeCode="LOC"> <participantRole classCode="SDLOC"> <templateId root="2.16.840.1.113883.10.20.22.4.32" /> <!-- Service Delivery Location template --> ... </participantRole> </participant></observation>Procedure Activity Procedure [procedure: templateId 2.16.840.1.113883.10.20.22.4.14 (open)]Table SEQ Table \* ARABIC220: Procedure Activity Procedure ContextsUsed By:Contains Entries:Procedures Section (entries optional) (optional)Reaction Observation (optional)IndicationInstructionsMedication ActivityProduct InstanceService Delivery LocationThe common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g., splenectomy). This clinical statement represents procedures whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the patient. Examples of these procedures are an appendectomy, hip replacement, and a creation of a gastrostomy.Table SEQ Table \* ARABIC221: Procedure Activity Procedure Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueprocedure[templateId/@root = '2.16.840.1.113883.10.20.22.4.14']@classCode1..1SHALL76522.16.840.1.113883.5.6 (HL7ActClass) = PROC@moodCode1..1SHALL76532.16.840.1.113883.11.20.9.18 (MoodCodeEvnInt)templateId1..1SHALL7654@root1..1SHALL105212.16.840.1.113883.10.20.22.4.14id1..*SHALL7655code1..1SHALL7656originalText0..1SHOULD19203reference0..1SHOULD19204@value0..1SHOULD19205statusCode1..1SHALL76612.16.840.1.113883.11.20.9.22 (ProcedureAct statusCode)effectiveTime0..1SHOULD7662priorityCode0..1MAY76682.16.840.1.113883.1.11.16866 (Act Priority Value Set)methodCode0..1MAYSET<CE>7670targetSiteCode0..*SHOULD7683@code1..1SHALL160822.16.840.1.113883.3.88.12.3221.8.9 (Body Site Value Set)specimen0..*MAY7697specimenRole1..1SHALL7704id0..*SHOULD7716performer0..*SHOULD7718assignedEntity1..1SHALL7720id1..*SHALL7722addr1..1SHALL7731telecom1..1SHALL7732representedOrganization0..1SHOULD7733id0..*SHOULD7734name0..*MAY7735telecom1..1SHALL7737addr1..1SHALL7736participant0..*MAY7751@typeCode1..1SHALL77522.16.840.1.113883.5.1002 (HL7ActRelationshipType) = DEVparticipantRole1..1SHALL15911participant0..*MAY7765@typeCode1..1SHALL77662.16.840.1.113883.5.90 (HL7ParticipationType) = LOCparticipantRole1..1SHALL15912entryRelationship0..*MAY7768@typeCode1..1SHALL77692.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMP@inversionInd1..1SHALL8009trueencounter1..1SHALL7770@classCode1..1SHALL77712.16.840.1.113883.5.6 (HL7ActClass) = ENC@moodCode1..1SHALL77722.16.840.1.113883.5.1001 (ActMood) = EVNid1..1SHALL7773entryRelationship0..1MAY7775@typeCode1..1SHALL77762.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL7777trueact1..1SHALL15913entryRelationship0..*MAY7779@typeCode1..1SHALL77802.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSONobservation1..1SHALL15914entryRelationship0..*MAY7886@typeCode1..1SHALL78872.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPsubstanceAdministration1..1SHALL15915SHALL contain exactly one [1..1] @classCode="PROC" Procedure (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7652).SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:7653).SHALL contain exactly one [1..1] templateId (CONF:7654) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.14" (CONF:10521).SHALL contain at least one [1..*] id (CONF:7655).SHALL contain exactly one [1..1] code (CONF:7656).This code SHOULD contain zero or one [0..1] originalText (CONF:19203).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:19204).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:19205).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:19206).This code in a procedure activity SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12) or ICD10 PCS (CodeSystem: 2.16.840.1.113883.6.4) (CONF:19207).SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:7661).SHOULD contain zero or one [0..1] effectiveTime (CONF:7662).MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet Act Priority Value Set 2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:7668).MAY contain zero or one [0..1] methodCode (CONF:7670).MethodCode SHALL NOT conflict with the method inherent in Procedure / code (CONF:7890).SHOULD contain zero or more [0..*] targetSiteCode (CONF:7683).The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:16082).MAY contain zero or more [0..*] specimen (CONF:7697).The specimen, if present, SHALL contain exactly one [1..1] specimenRole (CONF:7704).This specimenRole SHOULD contain zero or more [0..*] id (CONF:7716).If you want to indicate that the Procedure and the Results are referring to the same specimen, the Procedure/specimen/specimenRole/id SHOULD be set to equal an Organizer/specimen/ specimenRole/id (CONF:7717).This specimen is for representing specimens obtained from a procedure (CONF:16842).SHOULD contain zero or more [0..*] performer (CONF:7718) such that itSHALL contain exactly one [1..1] assignedEntity (CONF:7720).This assignedEntity SHALL contain at least one [1..*] id (CONF:7722).This assignedEntity SHALL contain exactly one [1..1] addr (CONF:7731).This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:7732).This assignedEntity SHOULD contain zero or one [0..1] representedOrganization (CONF:7733).The representedOrganization, if present, SHOULD contain zero or more [0..*] id (CONF:7734).The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:7735).The representedOrganization, if present, SHALL contain exactly one [1..1] telecom (CONF:7737).The representedOrganization, if present, SHALL contain exactly one [1..1] addr (CONF:7736).MAY contain zero or more [0..*] participant (CONF:7751) such that itSHALL contain exactly one [1..1] @typeCode="DEV" Device (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7752).SHALL contain exactly one [1..1] Product Instance (templateId:2.16.840.1.113883.10.20.22.4.37) (CONF:15911).MAY contain zero or more [0..*] participant (CONF:7765) such that itSHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7766).SHALL contain exactly one [1..1] Service Delivery Location (templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15912).MAY contain zero or more [0..*] entryRelationship (CONF:7768) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7769).SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8009).SHALL contain exactly one [1..1] encounter (CONF:7770).This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7771).This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7772).This encounter SHALL contain exactly one [1..1] id (CONF:7773).Set the encounter ID to the ID of an encounter in another section to signify they are the same encounter (CONF:16843).MAY contain zero or one [0..1] entryRelationship (CONF:7775) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7776).SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:7777).SHALL contain exactly one [1..1] Instructions (templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15913).MAY contain zero or more [0..*] entryRelationship (CONF:7779) such that itSHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7780).SHALL contain exactly one [1..1] Indication (templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15914).MAY contain zero or more [0..*] entryRelationship (CONF:7886) such that itSHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7887).SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15915).Breast Cancer Procedures[Procedure: templateId 2.16.840.1.113883.10.20.30.3.12 (open)]Table SEQ Table \* ARABIC222: Breast Cancer Procedures ContextsUsed By:Contains Entries:Procedures Section BCTPS (required)Lymph Node Sampling Result OrganizerThis clinical statement represents procedures that are performed on a patient with breast cancer.Table SEQ Table \* ARABIC223: Breast Cancer Procedures Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueProcedure[templateId/@root = '2.16.840.1.113883.10.20.30.3.12']templateId1..1SHALL23112@root1..1SHALL231132.16.840.1.113883.10.20.30.3.12code1..1SHALL267252.16.840.1.113883.11.20.11.16 (Breast Cancer Procedures)statusCode1..1SHALL23128@code1..1SHALL231292.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL23130methodCode0..1MAY24962entryRelationship0..1SHOULD23131organizer1..1SHALL23132Conforms to Procedure Activity Procedure template (2.16.840.1.113883.10.20.22.4.14).SHALL contain exactly one [1..1] templateId (CONF:23112) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.12" (CONF:23113).SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Breast Cancer Procedures 2.16.840.1.113883.11.20.11.16 dynamic (CONF:26725).SHALL contain exactly one [1..1] statusCode (CONF:23128).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23129).SHALL contain exactly one [1..1] effectiveTime (CONF:23130).A methodCode may be used to describe the surgical method used in performing the procedure. Many breast cancer procedure codes are pre-coordinated with the method inherent in the code. If methodCode is used it should not conflict with the procedureCode.MAY contain zero or one [0..1] methodCode (CONF:24962).SHOULD contain zero or one [0..1] entryRelationship (CONF:23131).The entryRelationship, if present, SHALL contain exactly one [1..1] Lymph Node Sampling Result Organizer (templateId:2.16.840.1.113883.10.20.30.3.13) (CONF:23132).Figure SEQ Figure \* ARABIC 104: Breast Cancer Procedures example <procedure classCode="PROC" moodCode="EVN"> <!-- C-CDA PROCEDURE ACTIVITY PROCEDURE TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.14"/> <!-- Breast Cancer Procedures templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.12"/> <id root="e401f340-7be2-11db-9fe1-0800200c9a66"/> <code code="301796003" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Axillary lymph node procedure"/> <text>Axillary lymph node procedure</text> <statusCode code="completed"/> <effectiveTime value="20120430"/> <methodCode code="62471006" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="deep axillary lymphadenectomy"/> <targetSiteCode code="20437008" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="left axillary region(body structure)"/> <!-- LYMPH NODE SAMPLING RESULT ORGANIZER --> <entryRelationship typeCode="COMP"> <organizer classCode="CLUSTER" moodCode="EVN"> <!-- C-CDA RESULT ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.1"/> <!-- Lymph Node Sampling Result organizer templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.13"/> ...</organizer> </entryRelationship> </procedure> Product Instance [participantRole: templateId 2.16.840.1.113883.10.20.22.4.37 (open)]Table SEQ Table \* ARABIC224: Product Instance ContextsUsed By:Contains Entries:Procedure Activity Procedure (optional)Non-Medicinal Supply Activity (optional)This clinical statement represents a particular device that was placed in or used as part of a procedure or other act. This provides a record of the identifier and other details about the given product that was used. For example, it is important to have a record that indicates not just that a hip prostheses was placed in a patient but that it was a particular hip prostheses number with a unique identifier.The FDA Amendments Act specifies the creation of a Unique Device Identification (UDI) System that requires the label of devices to bear a unique identifier that will standardize device identification and identify the device through distribution and use. The UDI should be sent in the participantRole/id.Table SEQ Table \* ARABIC225: Product Instance Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueparticipantRole[templateId/@root = '2.16.840.1.113883.10.20.22.4.37']@classCode1..1SHALL79002.16.840.1.113883.5.110 (RoleClass) = MANUtemplateId1..1SHALL7901@root1..1SHALL105222.16.840.1.113883.10.20.22.4.37id1..*SHALL7902playingDevice1..1SHALL7903code0..1SHOULD16837scopingEntity1..1SHALL7905id1..*SHALL7908SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:7900).SHALL contain exactly one [1..1] templateId (CONF:7901) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.37" (CONF:10522).SHALL contain at least one [1..*] id (CONF:7902).SHALL contain exactly one [1..1] playingDevice (CONF:7903).This playingDevice SHOULD contain zero or one [0..1] code (CONF:16837).SHALL contain exactly one [1..1] scopingEntity (CONF:7905).This scopingEntity SHALL contain at least one [1..*] id (CONF:7908).Figure SEQ Figure \* ARABIC 105: Product Instance example<participantRole classCode="MANU"> <templateId root="2.16.840.1.113883.10.20.22.4.37" /> <!-- Product instance template --> <id root="742aee30-21c5-11e1-bfc2-0800200c9a66" /> <playingDevice> <code code="90412006" codeSystem="2.16.840.1.113883.6.96" displayName="Colonoscope" /> </playingDevice> <scopingEntity> <id root="eb936010-7b17-11db-9fe1-0800200c9b65" /> </scopingEntity></participantRole>Reaction Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.9 (open)]Table SEQ Table \* ARABIC226: Reaction Observation ContextsUsed By:Contains Entries:Medication Activity (optional)Allergy - Intolerance Observation (optional)Substance or Device Allergy - Intolerance Observation (optional)Chemotherapy Medication Activity (optional)Chemotherapy Medication Activity Plan (optional)Medication ActivityProcedure Activity ProcedureSeverity ObservationThis clinical statement represents an undesired symptom, finding, etc., due to an administered or exposed substance. A reaction can be defined with respect to its severity, and can have been treated by one or more interventions.Table SEQ Table \* ARABIC227: Reaction Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Reaction Observationobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.9']@classCode1..1SHALL73252.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL73262.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7323@root1..1SHALL105232.16.840.1.113883.10.20.22.4.9id1..1SHALL7329code1..1SHALL16851reactionFreeTexttext0..1SHOULD7330reference0..1SHOULD15917@value0..1SHOULD15918statusCode1..1SHALL7328@code1..1SHALL191142.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime0..1SHOULD7332low0..1SHOULD7333high0..1SHOULD7334reactionCodedvalue1..1SHALLCD73352.16.840.1.113883.3.88.12.3221.7.4 (Problem Value Set)entryRelationship0..*MAY7337@typeCode1..1SHALL73382.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON@inversionInd1..1SHALL7343trueprocedure1..1SHALL15920entryRelationship0..*MAY7340@typeCode1..1SHALL73412.16.840.1.113883.5.1002 (HL7ActRelationshipType) = RSON@inversionInd1..1SHALL7344truesubstanceAdministration1..1SHALL15921severityentryRelationship0..1SHOULD7580@typeCode1..1SHALL75812.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL10375trueobservation1..1SHALL15922SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7325).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7326).SHALL contain exactly one [1..1] templateId (CONF:7323) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.9" (CONF:10523).SHALL contain exactly one [1..1] id (CONF:7329).SHALL contain exactly one [1..1] code (CONF:16851).The value set for this code element has not been specified. Implementers are allowed to use any code system, such as SNOMED CT, a locally determined code, or a nullFlavor (CONF:16852).SHOULD contain zero or one [0..1] text (CONF:7330).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15917).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15918).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15919).SHALL contain exactly one [1..1] statusCode (CONF:7328).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19114).SHOULD contain zero or one [0..1] effectiveTime (CONF:7332).The effectiveTime, if present, SHOULD contain zero or one [0..1] low (CONF:7333).The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:7334).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC (CONF:7335).MAY contain zero or more [0..*] entryRelationship (CONF:7337) such that itSHALL contain exactly one [1..1] @typeCode="RSON" Has reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7338).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7343).SHALL contain exactly one [1..1] Procedure Activity Procedure (templateId:2.16.840.1.113883.10.20.22.4.14) (CONF:15920).This procedure activity is intended to contain information about procedures that were performed in response to an allergy reaction (CONF:16853).MAY contain zero or more [0..*] entryRelationship (CONF:7340) such that itSHALL contain exactly one [1..1] @typeCode="RSON" Has reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7341).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7344).SHALL contain exactly one [1..1] Medication Activity (templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15921).This medication activity is intended to contain information about medications that were administered in response to an allergy reaction (CONF:16840).SHOULD contain zero or one [0..1] entryRelationship (CONF:7580) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7581).SHALL contain exactly one [1..1] @inversionInd="true" TRUE (CONF:10375).SHALL contain exactly one [1..1] Severity Observation (templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:15922).Result Observation[observation: templateId 2.16.840.1.113883.10.20.22.4.2 (open)]Table SEQ Table \* ARABIC 228: Result Observation ContextsUsed By:Contains Entries:Result Organizer (required)This clinical statement represents details of a lab, radiology, or other study performed on a patient.The result observation includes a statusCode to allow recording the status of an observation. If a Result Observation is not completed, the Result Organizer must include corresponding statusCode. “Pending” results (e.g., a test has been run but results have not been reported yet) should be represented as “active” ActStatus.Table SEQ Table \* ARABIC229: Result Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.2']@classCode1..1SHALL71302.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL71312.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7136@root1..1SHALL91382.16.840.1.113883.10.20.22.4.2id1..*SHALL7137code1..1SHALL7133text0..1SHOULD7138reference0..1SHOULD15924@value0..1SHOULD15925statusCode1..1SHALL7134@code1..1SHALL148492.16.840.1.113883.11.20.9.39 (Result Status)effectiveTime1..1SHALL7140value1..1SHALL7143interpretationCode0..*SHOULD7147methodCode0..1MAYSET<CE>7148targetSiteCode0..1MAYSET<CD>7153author0..1MAY7149referenceRange0..*SHOULD7150observationRange1..1SHALL7151code0..0SHALL NOT7152SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7130).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7131).SHALL contain exactly one [1..1] templateId (CONF:7136) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.2" (CONF:9138).SHALL contain at least one [1..*] id (CONF:7137).SHALL contain exactly one [1..1] code (CONF:7133).SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:19211).Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or other constrained terminology named by the US Department of Health and Human Services Office of National Coordinator or other federal agency. Local and/or regional codes for laboratory results are allowed. The Local and/or regional codes SHOULD be sent in the translation element. See the Local code example figure (CONF:19212).SHOULD contain zero or one [0..1] text (CONF:7138).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15924).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15925).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15926).SHALL contain exactly one [1..1] statusCode (CONF:7134).This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Result Status 2.16.840.1.113883.11.20.9.39 STATIC (CONF:14849).SHALL contain exactly one [1..1] effectiveTime (CONF:7140).Represents clinically effective time of the measurement, which may be when the measurement was performed (e.g., a BP measurement), or may be when sample was taken (and measured some time afterwards) (CONF:16838).SHALL contain exactly one [1..1] value (CONF:7143).SHOULD contain zero or more [0..*] interpretationCode (CONF:7147).MAY contain zero or one [0..1] methodCode (CONF:7148).MAY contain zero or one [0..1] targetSiteCode (CONF:7153).MAY contain zero or one [0..1] author (CONF:7149).SHOULD contain zero or more [0..*] referenceRange (CONF:7150).The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:7151).This observationRange SHALL NOT contain [0..0] code (CONF:7152).Table SEQ Table \* ARABIC230: Result Status Value SetValue Set: Result Status 2.16.840.1.113883.11.20.9.39 STATICCode System(s): ActStatus 2.16.840.1.113883.5.14Description: This value set contains codes that represent the state of a result.Reference: SystemPrint NameabortedActStatusabortedactiveActStatusactivecancelledActStatuscancelledcompletedActStatuscompletedHeldActStatusheldsuspendedActStatussuspendedCardiac Function Observation[Observation: templateId 2.16.840.1.113883.10.20.30.3.21 (open)]Table SEQ Table \* ARABIC231: Cardiac Function Observation ContextsUsed By:Contains Entries:Results Section BCTPS (required)This clinical statement represents results from cardiac function tests. An effectiveTime is required and is used to infer whether a test was done prior to or after a treatment such as chemotherapy.Table SEQ Table \* ARABIC232: Cardiac Function Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueObservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.21']templateId1..1SHALL23497@root1..1SHALL262262.16.840.1.113883.10.20.30.3.21code1..1SHALL270992.16.840.1.113883.3.526.3.1134 (Ejection Fraction)statusCode1..1SHALL23501@code1..1SHALL235022.16.840.1.113883.5.14 (ActStatus) = Completedvalue1..1SHALLPQ23504methodCode1..1SHALL270982.16.840.1.113883.11.20.11.2 (Cardiac Ejection Method)Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:23497) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.21" (CONF:26226).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Ejection Fraction 2.16.840.1.113883.3.526.3.1134 DYNAMIC (CONF:27099).SHALL contain exactly one [1..1] statusCode (CONF:23501).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23502).SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:23504).SHALL contain exactly one [1..1] methodCode, which SHOULD be selected from ValueSet Cardiac Ejection Method 2.16.840.1.113883.11.20.11.2 DYNAMIC (CONF:27098).Table SEQ Table \* ARABIC233: Ejection Fraction Value SetValue Set: Ejection Fraction 2.16.840.1.113883.3.526.3.1134This value set contains codes that represent types of cardiac ejection observations.Resource: SystemPrint Name18044-8LOINCLeft ventricular Ejection fraction18043-0LOINCLeft ventricular Ejection fraction by US18044-8LOINCLeft ventricular Ejection fraction by US 2D single-plane ellipse18045-5LOINCLeft ventricular Ejection fraction by US 2D biplane ellipse18046-3LOINCLeft ventricular Ejection fraction by US 2D modified18047-1LOINCLeft ventricular Ejection fraction by US 2D modified biplane18048-9LOINCLeft ventricular Ejection fraction by US 2D modified single-plane18049-7LOINCLeft ventricular Ejection fraction by US.M-mode.Teichholz8806-2LOINCLeft ventricular Ejection fraction by 2D echo8807-0LOINCLeft ventricular Ejection fraction by 2D echo.visual estimate...Table SEQ Table \* ARABIC234: Cardiac Ejection Method Value SetValue Set: Cardiac Ejection Methods 2.16.840.1.113883.11.20.11.2Description: Thisethods used to measure cardiac ejection.Valueset Source: SystemPrint Name40701008SNOMED CTechocardiography 404221001SNOMED CTmultiple gated acquisition scanning Figure SEQ Figure \* ARABIC 106: Cardiac Function Observation example<entry> <!-- C-CDA Result Observation TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Cardiac Function Observation TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.21"/> <observation classCode="OBS" moodCode="EVN"> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="18044-8" displayName="Left ventricular Ejection fraction"/> <statusCode code="completed"/> <!-- C-CDA Result Observation requires effective time --> <effectiveTime value="20120430"/> <value xsi:type="PQ" value="76" unit="[%]"/> <methodCode code="404221001" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="multiple gated acquisition scanning"/> </observation></entry>Cognitive Status Result Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.74 (open)]Table SEQ Table \* ARABIC235: Cognitive Status Result Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)Cognitive Status Result Organizer (required)Assessment Scale ObservationCaregiver CharacteristicsNon-Medicinal Supply ActivityThis clinical statement contains details of an evaluation or assessment of a patient’s cognitive status. The evaluation may include assessment of a patient's mood, memory, and ability to make decisions. The statement, if present, will include supporting caregivers, non-medical devices, and the time period for which the evaluation and assessment were performed.This is different from a cognitive status problem observation, which is a clinical statement that describes a patient's cognitive condition, findings, or symptoms. Examples of cognitive problem observations are inability to recall, amnesia, dementia, and aggressive behavior. Table SEQ Table \* ARABIC236: Cognitive Status Result Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.74']@classCode1..1SHALL142492.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL142502.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14255@root1..1SHALL142562.16.840.1.113883.10.20.22.4.74id1..*SHALL14257code1..1SHALL14591@code0..1SHOULD145922.16.840.1.113883.6.96 (SNOMED-CT) = 373930000text0..1SHOULD14258reference0..1SHOULD15549@value0..1SHOULD15550statusCode1..1SHALL14254@code1..1SHALL190922.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL14261value1..1SHALL14263interpretationCode0..*SHOULD14264methodCode0..1MAYSET<CE>14265targetSiteCode0..1MAYSET<CD>14270author0..1MAY14266entryRelationship0..*MAY14272@typeCode1..1SHALL145932.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRsupply1..1SHALL14273entryRelationship0..*MAY14276@typeCode1..1SHALL145942.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRobservation1..1SHALL14277entryRelationship0..*MAY14469@typeCode1..1SHALL145952.16.840.1.113883.5.1002 (HL7ActRelationshipType) = COMPobservation1..1SHALL14470referenceRange0..*SHOULD14267observationRange1..1SHALL14268code0..0SHALL NOT14269Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:14249).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14250).SHALL contain exactly one [1..1] templateId (CONF:14255) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.74" (CONF:14256).SHALL contain at least one [1..*] id (CONF:14257).SHALL contain exactly one [1..1] code (CONF:14591).This code SHOULD contain zero or one [0..1] @code="373930000" Cognitive function finding (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:14592).SHOULD contain zero or one [0..1] text (CONF:14258).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15549).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15550).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15551).SHALL contain exactly one [1..1] statusCode (CONF:14254).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19092).Represents clinically effective time of the measurement, which may be the time the measurement was performed (e.g., a BP measurement), or may be the time the sample was taken (and measured some time afterwards).SHALL contain exactly one [1..1] effectiveTime (CONF:14261).SHALL contain exactly one [1..1] value (CONF:14263).If xsi:type=“CD”, SHOULD contain a code from SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:14271).SHOULD contain zero or more [0..*] interpretationCode (CONF:14264).MAY contain zero or one [0..1] methodCode (CONF:14265).MAY contain zero or one [0..1] targetSiteCode (CONF:14270).MAY contain zero or one [0..1] author (CONF:14266).MAY contain zero or more [0..*] entryRelationship (CONF:14272) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14593).SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14273).MAY contain zero or more [0..*] entryRelationship (CONF:14276) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14594).SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:14277).MAY contain zero or more [0..*] entryRelationship (CONF:14469) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14595).SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14470).SHOULD contain zero or more [0..*] referenceRange (CONF:14267).The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:14268).This observationRange SHALL NOT contain [0..0] code (CONF:14269).Figure SEQ Figure \* ARABIC \* MERGEFORMAT 107: Cognitive Status Result Observation example<observation classCode="OBS" moodCode="EVN"> <!-- ** conforms to Result observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!—Cognitive Status Result Oservation template --> <templateId root="2.16.840.1.113883.10.20.22.4.74"/> <id root="c6b5a04b-2bf4-49d1-8336-636a3813df0a"/> <code code="373930000" displayName="Cognitive function finding" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <text> <reference value="#COG1"/> </text> <statusCode code="completed"/> <effectiveTime value="200903111230"/> <value xsi:type="CD"/> <code code="61372001" displayName="Aggressive behavior" codeSystem=" 2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <interpretationCode code="HH" codeSystem="2.16.840.1.113883.5.83"/> <referenceRange> <observationRange> <text>Non Aggressive to Aggressive</text> </observationRange> </referenceRange></observation> Estrogen Receptor Status[Observation: templateId 2.16.840.1.113883.10.20.30.3.19 (open)]Table SEQ Table \* ARABIC237: Estrogen Receptor Status ContextsUsed By:Contains Entries:Receptor Status Organizer (required)This clinical statement represents the status of the estrogen receptors. If the estrogen status is positive, this indicates the presence of estrogen receptors, which increases the likelihood a patient will respond to hormonal therapy. Receptor status helps predict a patient's response to hormonal therapy and prognosis. The interpretationCode describes the value results as positive, negative, or indeterminate. The methodCode indicates the test performed to obtain the receptor status (e.g., immunohistochemistry).Table SEQ Table \* ARABIC238: Estrogen Receptor Status Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.19']templateId1..1SHALL23461@root1..1SHALL234622.16.840.1.113883.10.20.30.3.19code1..1SHALL23463@code1..1SHALL2346416112-5@codeSystem1..1SHALL234652.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1statusCode1..1SHALL23466@code1..1SHALL234672.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALL27102interpretationCode1..1SHALL270902.16.840.1.113883.1.11.20328 (ObservationInterpretationDetected)methodCode1..1SHALL27172@code0..1SHOULD27173117617002@codeSystem0..1SHOULD271742.16.840.1.113883.6.96 (SNOMED CT) = 2.16.840.1.113883.6.96Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:23461) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.19" (CONF:23462).SHALL contain exactly one [1..1] code (CONF:23463).This code SHALL contain exactly one [1..1] @code="16112-5" Estrogen Receptor [interpretation] in Tissue (CONF:23464).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:23465).SHALL contain exactly one [1..1] statusCode (CONF:23466).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23467).The ER status is usually resulted as either positive or negative which is represented in the interpretationCode. Sometimes a??percentage value such as 80% is also provided.??When there is no result value, a nullFlavor is sent in the observation value element.SHALL contain exactly one [1..1] value (CONF:27102).SHALL contain exactly one [1..1] interpretationCode, which SHALL be selected from ValueSet ObservationInterpretationDetected 2.16.840.1.113883.1.11.20328 DYNAMIC (CONF:27090).SHALL contain exactly one [1..1] methodCode (CONF:27172).This methodCode SHOULD contain zero or one [0..1] @code="117617002" immunohistochemistry procedure (IHC) (CONF:27173).This methodCode SHOULD contain zero or one [0..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED CT 2.16.840.1.113883.6.96) (CONF:27174).Table SEQ Table \* ARABIC239: ObservationInterpretationDetectedValue Set: ObservationInterpretationDetected 2.16.840.1.113883.1.11.20328This value set contains codes that represent the possible results of a test or sign in a clinical observation. Valueset Source: SystemPrint NameINDObservationInterpretationIndeterminateNEGObservationInterpretationNegativePOSObservationInterpretationPositiveFigure SEQ Figure \* ARABIC 108: Estrogen Receptor Status example<observation classCode="OBS" moodCode="EVN"> <!-- Estrogen Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.19"/> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="16112-5" displayName="Estrogen Receptor [interpretation] in Tissue" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <text> ER status </text> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="PQ" value="65" unit="%"/> <interpretationCode code="POS" codeSystem="2.16.840.1.113883.5.83" displayName="positive"/> <methodCode code="117617002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="immunohistochemistry procedure"/></observation> Functional Status Result Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.67 (open)]Table SEQ Table \* ARABIC240: Functional Status Result Observation ContextsUsed By:Contains Entries:Functional Status Section (optional)Functional Status Result Organizer (required)Assessment Scale ObservationCaregiver CharacteristicsNon-Medicinal Supply ActivityThis clinical statement represents details of an evaluation or assessment of a patient's functional status. The evaluation may include assessment of a patient's language, vision, hearing, activities of daily living, behavior, general function, mobility, and self-care status. The statement, if present, will include supporting caregivers, non-medical devices, and the time period for which the evaluation and assessment were performed.Table SEQ Table \* ARABIC241: Functional Status Result Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.67']@classCode1..1SHALL139052.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL139062.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL13889@root1..1SHALL138902.16.840.1.113883.10.20.22.4.67id1..*SHALL13907code1..1SHALL139082.16.840.1.113883.6.1 (LOINC)@code0..1SHALL264482.16.840.1.113883.6.1 (LOINC)text0..1SHOULD13926reference0..1SHOULD13927statusCode1..1SHALL13929@code1..1SHALL191012.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL13930value1..1SHALL13932interpretationCode0..*SHOULD13933methodCode0..1MAY13934targetSiteCode0..1MAY13935author0..1MAY13936entryRelationship0..1MAY13892@typeCode1..1SHALL14596REFRsupply1..1SHALL14218entryRelationship0..1MAY13895@typeCode1..1SHALL14597REFRobservation1..1SHALL13897entryRelationship0..1MAY14465@typeCode1..1SHALL14598COMPobservation1..1SHALL14466referenceRange0..*SHOULD13937observationRange1..1SHALL13938Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:13905).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:13906).SHALL contain exactly one [1..1] templateId (CONF:13889) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.67" (CONF:13890).SHALL contain at least one [1..*] id (CONF:13907).SHALL contain exactly one [1..1] code (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:13908).This code SHALL contain zero or one [0..1] @code, which SHOULD be selected from CodeSystem LOINC (2.16.840.1.113883.6.1) STATIC (CONF:26448).SHOULD contain zero or one [0..1] text (CONF:13926).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:13927).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:13928).SHALL contain exactly one [1..1] statusCode (CONF:13929).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19101).Represents clinically effective time of the measurement, which may be when the measurement was performed (e.g., a BP measurement), or may be when sample was taken (and measured some time afterwards) SHALL contain exactly one [1..1] effectiveTime (CONF:13930).SHALL contain exactly one [1..1] value (CONF:13932).If xsi:type=“CD”, SHOULD contain a code from SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96) (CONF:14234).SHOULD contain zero or more [0..*] interpretationCode (CONF:13933).MAY contain zero or one [0..1] methodCode (CONF:13934).MAY contain zero or one [0..1] targetSiteCode (CONF:13935).MAY contain zero or one [0..1] author (CONF:13936).MAY contain zero or one [0..1] entryRelationship (CONF:13892) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CONF:14596).SHALL contain exactly one [1..1] Non-Medicinal Supply Activity (templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:14218).MAY contain zero or one [0..1] entryRelationship (CONF:13895) such that itSHALL contain exactly one [1..1] @typeCode="REFR" refers to (CONF:14597).SHALL contain exactly one [1..1] Caregiver Characteristics (templateId:2.16.840.1.113883.10.20.22.4.72) (CONF:13897).MAY contain zero or one [0..1] entryRelationship (CONF:14465) such that itSHALL contain exactly one [1..1] @typeCode="COMP" has component (CONF:14598).SHALL contain exactly one [1..1] Assessment Scale Observation (templateId:2.16.840.1.113883.10.20.22.4.69) (CONF:14466).SHOULD contain zero or more [0..*] referenceRange (CONF:13937).The referenceRange, if present, SHALL contain exactly one [1..1] observationRange (CONF:13938).This observationRange SHALL NOT contain [0..0] code (CONF:13939).Figure SEQ Figure \* ARABIC \* MERGEFORMAT 109: Functional Status Result Observation example <observation classCode="OBS" moodCode="EVN"> <!-- ** conforms to Result observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Functional Status Result Oservation template --> <templateId root="2.16.840.1.113883.10.20.22.4.67"/> <id root="c6b5a04b-2bf4-49d1-8336-636a3813df0a"/> <code code="57251-1" displayName="Ambulation" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <text> <reference value="#FUNC1"/> </text> <statusCode code="completed"/> <effectiveTime value="200903111230"/> <value xsi:type="CD" code="371153006" displayName=" Independently able" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <interpretationCode code="B" codeSystem="2.16.840.1.113883.5.83"/> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> <!--Assessment Scale Observation --> <templateId root="2.16.840.1.113883.10.20.22.4.69"/> ... </observation> </entryRelationship> <entryRelationship typeCode="REFR"> <observation classCode="OBS" moodCode="EVN"> <!-- Caregiver Characteristics --> <templateId root="2.16.840.1.113883.10.20.22.4.72"/> ... </observation> </entryRelationship> <referenceRange> <observationRange> <text>Dependent to Independent</text> </observationRange> </referenceRange>... </observation>HER2 Receptor Status[Observation: templateId 2.16.840.1.113883.10.20.30.3.38 (open)]Table SEQ Table \* ARABIC242: HER2 Receptor Status ContextsUsed By:Contains Entries:Receptor Status Organizer (required)This clinical statement represents the human epidermal growth factor (HER2) status. The HER2 result aids in predicting a patient's response to HER2-directed therapy and overall prognostic survival. The interpretationCode describes the value results as positive, negative, or indeterminate.Table SEQ Table \* ARABIC243: HER2 Receptor Status Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.38']templateId1..1SHALL23525@root1..1SHALL235262.16.840.1.113883.10.20.30.3.38code1..1SHALL235272.16.840.1.113883.11.20.11.21 (Types of HER2 Tests)statusCode1..1SHALL23530@code1..1SHALL235312.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALL27100interpretationCode1..1SHALL268282.16.840.1.113883.1.11.20328 (ObservationInterpretationDetected)Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:23525) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.38" (CONF:23526).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Types of HER2 Tests 2.16.840.1.113883.11.20.11.21 DYNAMIC (CONF:23527).SHALL contain exactly one [1..1] statusCode (CONF:23530).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:23531).SHALL contain exactly one [1..1] value (CONF:27100).SHALL contain exactly one [1..1] interpretationCode, which SHALL be selected from ValueSet ObservationInterpretationDetected 2.16.840.1.113883.1.11.20328 DYNAMIC (CONF:26828).Table SEQ Table \* ARABIC244: Types of HER2 TestsValue Set: Types of HER2 Tests 2.16.840.1.113883.11.20.11.21This value set contains codes representing tests performed to detect the presence of a protein called human epidermal growth factor receptor 2 (HER2) in a patients that promotes cancer growth.Valueset Source: SystemPrint Name31150-6LOINCHER2 [Presence] in Tissue by Fluorescent in situ hybridization (FISH)72382-5LOINCHER2 [Units/volume] in Tissue by Immunoassay48675-3LOINCHER2 in Tissue by Fluorescent in situ hybridization (FISH) Nominal48676-1LOINCHER2 [interpretation] in Tissue32996-1LOINCHER2 [Mass/volume] in Serum42914-2LOINCHER2 [Mass/volume] in Serum by Immunoassay18474-7LOINCHER2 Ag [Presence] in Tissue by Immune stain42783-1LOINCERBB2 gene mutations found [Identifier] in Blood or Tissue by Molecular genetics method Nominal49683-6LOINCHER2/CEP17 [Ratio] in Tissue by Fluorescent in situ hybridization (FISH)72383-3LOINCHER2 [Presence] in Tissue by ImmunoassayFigure SEQ Figure \* ARABIC 110:HER2 Receptor Status (FISH) example<observation classCode="OBS" moodCode="EVN"> <!-- HER2 Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.38"/> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="31150-6" displayName="HER2 [Presence] in Tissue by Fluorescent in situ hybridization (FISH)" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <text> HER2 status (FISH)</text> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="PQ" value="4.25"/> <interpretationCode code="POS" codeSystem="2.16.840.1.113883.5.83" displayName="positive"/> </observation>Figure SEQ Figure \* ARABIC111: HER2 Receptor Status (IHC) example<observation classCode="OBS" moodCode="EVN"> <!-- HER2 Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.38"/> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="18474-7" displayName="HER2 Ag [Presence] in Tissue by Immune stain" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <text> HER2 Test (IHC)</text> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="PQ" value="3"/> <interpretationCode code="POS" codeSystem="2.16.840.1.113883.5.83" displayName="positive"/></observation>Number of Lymph Nodes Positive[Observation: templateId 2.16.840.1.113883.10.20.30.3.15 (open)]Table SEQ Table \* ARABIC246: Number of Lymph Nodes Positive ContextsContained By:Contains:Lymph Node Sampling Result Organizer (optional)This clinical statement represents of the number of lymph node that are positive for cancer.Table SEQ Table \* ARABIC247: Number of Lymph Nodes Positive Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.15']templateId1..1SHALL22175@root1..1SHALL221762.16.840.1.113883.10.20.30.3.15code1..1SHALL22177@code1..1SHALL2217844622-9@codeSystem1..1SHALL234422.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1value1..1SHALLINT22179Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:22175) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.15" (CONF:22176).SHALL contain exactly one [1..1] code (CONF:22177).This code SHALL contain exactly one [1..1] @code="44622-9" Regional lymph nodes containing metastases (CONF:22178).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:23442).SHALL contain exactly one [1..1] value with @xsi:type="INT" (CONF:22179).Figure SEQ Figure \* ARABIC61: Number of Lymph Nodes Positive example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.15" /> <id root="df9133b3-1adb-11e0-ac64-0800200c9a66"/> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="44622-9" displayName="Regional lymph nodes containing metastases"/> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="INT" value="3"/> <interpretationCode code="A" codeSystem="2.16.840.1.113883.5.83"/></observation>Number of Lymph Nodes Removed and Examined[observation: templateId 2.16.840.1.113883.10.20.30.3.14 (open)]Table SEQ Table \* ARABIC248: Number of Lymph Nodes Removed and Examined ContextsContained By:Contains:Lymph Node Sampling Result Organizer (optional)This clinical statement represents the number of lymph nodes examined.??Table SEQ Table \* ARABIC249: Number of Lymph Nodes Removed and Examined Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.14']templateId1..1SHALL22180@root1..1SHALL221812.16.840.1.113883.10.20.30.3.14code1..1SHALL22182@code1..1SHALL2218344621-1@codeSystem1..1SHALL234432.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1value1..1SHALLINT22184Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:22180) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.14" (CONF:22181).SHALL contain exactly one [1..1] code (CONF:22182).This code SHALL contain exactly one [1..1] @code="44621-1" Regional lymph nodes identified (CONF:22183).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:23443).SHALL contain exactly one [1..1] value with @xsi:type="INT" (CONF:22184).Figure SEQ Figure \* ARABIC62: Number of Lymph Nodes Removed and Examined<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.14" /> <id root="df9133b2-1adb-11e0-ac64-0800200c9a66"/> <code codeSystem="2.16.840.1.113883.6.1" code="44621-1" codeSystemName="LOINC" displayName="Regional lymph nodes identified"/> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="INT" value="6"/></observation> Oncotype DX Score[observation: templateId 2.16.840.1.113883.10.20.30.3.18 (open)]Table SEQ Table \* ARABIC250: Oncotype DX Score ContextsContained By:Contains:Molecular Diagnostic Testing Organizer (required)This clinical statement records the score of the oncotype diagnosis test which is a genomic test to determine the expression of the gene 21 panel. The test results assist providers in formulating a treatment plan and therapy for the patient. The score is recorded in the value as an integer.???? Table SEQ Table \* ARABIC251: Oncotype DX Score Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.18']templateId1..1SHALL23193@root1..1SHALL231942.16.840.1.113883.10.20.30.3.18code1..1SHALL23196@code1..1SHALL2319756780-0@codeSystem1..1SHALL234942.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1statusCode1..1SHALL23198@code1..1SHALL231992.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALLINT23201Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:23193) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.18" (CONF:23194).SHALL contain exactly one [1..1] code (CONF:23196).This code SHALL contain exactly one [1..1] @code="56780-0" CYP21A2 gene mutations tested for in Blood or Tissue by Molecular genetics method Nominal (CONF:23197).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:23494).SHALL contain exactly one [1..1] statusCode (CONF:23198).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23199).SHALL contain exactly one [1..1] value with @xsi:type="INT" (CONF:23201).Figure SEQ Figure \* ARABIC63: Oncotype DX Score<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.30.3.18" /> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="56780-0" displayName="CYP21A2 gene mutations tested for in Blood or Tissue by Molecular genetics method Nominal" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <text> ONCOTYPE DX </text> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="INT" value="22"/></observation>Progesterone Receptor Status[observation: templateId 2.16.840.1.113883.10.20.30.3.20 (open)]Table SEQ Table \* ARABIC252: Progesterone Receptor Status ContextsContained By:Contains:Receptor Status Organizer (required)This clinical statement represents the results of a progesterone receptor status test. If the progesterone status is positive, this indicates the presence of progesterone receptors which increases the likelihood a patient will respond to hormonal therapy. Receptor status helps predict a patient's response to hormonal therapy and prognosis. The interpretationCode describes the value results as positive, negative, or indeterminate.Table SEQ Table \* ARABIC253: Progesterone Receptor Status Constraints OverviewXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.20']templateId1..1SHALL23470@root1..1SHALL234712.16.840.1.113883.10.20.30.3.20code1..1SHALL234722.16.840.1.113883.11.20.11.22 (Types of Progesterone Receptor Tests)statusCode1..1SHALL23475@code1..1SHALL234762.16.840.1.113883.5.14 (ActStatus) = completedvalue1..1SHALL27101interpretationCode1..1SHALL270952.16.840.1.113883.1.11.20328 (ObservationInterpretationDetected)Conforms to Result Observation template (2.16.840.1.113883.10.20.22.4.2).SHALL contain exactly one [1..1] templateId (CONF:23470) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.20" (CONF:23471).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Types of Progesterone Receptor Tests 2.16.840.1.113883.11.20.11.22 DYNAMIC (CONF:23472).SHALL contain exactly one [1..1] statusCode (CONF:23475).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23476).The PR status is usually resulted as either positive or negative which is represented in the interpretationCode. Sometimes a??percentage value such as 30% is also provided.??When there is no result value, a nullFlavor is sent in the observation value element.SHALL contain exactly one [1..1] value (CONF:27101).SHALL contain exactly one [1..1] interpretationCode, which SHALL be selected from ValueSet ObservationInterpretationDetected 2.16.840.1.113883.1.11.20328 DYNAMIC (CONF:27095).Table SEQ Table \* ARABIC 254: Types of Progesterone Receptor TestValue Set: Types of Progesterone Receptor Tests 2.16.840.1.113883.11.20.11.22This value set contains codes that represent tests performed to determine the progesterone receptor (PR) status of a patient. This tests provide guidance in the treatment of patients with breast cancer.Valueset Source: SystemPrint Name16113-3LOINCProgesterone receptor [interpretation] in Tissue10861-3LOINCProgesterone receptor [Mass/mass] in Tissue31207-4LOINCProgesterone receptor [Moles/mass] in Tissue40557-1LOINCProgesterone receptor Ag [Presence] in Tissue by Immune stain14230-7LOINCProgesterone receptor/100 cells in Tissue by Immune stainFigure SEQ Figure \* ARABIC115: Progesterone Receptor Status example<observation classCode="OBS" moodCode="EVN"> <!-- Progesterone Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.20"/> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="40557-1" displayName="Progesterone receptor Ag [Presence] in Tissue by Immune stain" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/> <text> PR status (IHC)</text> <statusCode code="completed"/> <effectiveTime value="20120430"/> <value xsi:type="PQ" value="70" unit="%"/> <interpretationCode code="POS" codeSystem="2.16.840.1.113883.5.83" displayName="positive"/></observation>Result Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.1 (open)]Table SEQ Table \* ARABIC254: Result Organizer ContextsUsed By:Contains Entries:Results Section (entries optional) (optional)Result ObservationThis clinical statement identifies set of result observations. It contains information applicable to all of the contained result observations. Result type codes categorize a result into one of several commonly accepted values (e.g., “Hematology”, “Chemistry”, “Nuclear Medicine”). These values are often implicit in the Organizer/code (e.g., an Organizer/code of “complete blood count” implies a ResultTypeCode of “Hematology”). This template requires Organizer/code to include a ResultTypeCode either directly or as a translation of a code from some other code system.An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown.If any Result Observation within the organizer has a statusCode of ‘active’, the Result Organizer must also have as statusCode of ‘active’.Table SEQ Table \* ARABIC255: Result Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueorganizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.1']@classCode1..1SHALL71212.16.840.1.113883.5.6 (HL7ActClass)@moodCode1..1SHALL71222.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7126@root1..1SHALL91342.16.840.1.113883.10.20.22.4.1id1..*SHALL7127code1..1SHALL7128statusCode1..1SHALL7123@code1..1SHALL148482.16.840.1.113883.11.20.9.39 (Result Status)component1..*SHALL7124observation1..1SHALL14850SHALL contain exactly one [1..1] @classCode (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7121).SHOULD contain zero or one [0..1] @classCode="CLUSTER" Cluster (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) OR SHOULD contain zero or one [0..1] @classCode="BATTERY" Battery (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) (CONF:7165).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7122).SHALL contain exactly one [1..1] templateId (CONF:7126) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.1" (CONF:9134).SHALL contain at least one [1..*] id (CONF:7127).SHALL contain exactly one [1..1] code (CONF:7128).SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem 2.16.840.1.113883.6.12) (CONF:19218).Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or other constrained terminology named by the US Department of Health and Human Services Office of National Coordinator or other federal agency. Local and/or regional codes for laboratory results SHOULD also be allowed (CONF:19219).SHALL contain exactly one [1..1] statusCode (CONF:7123).This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Result Status 2.16.840.1.113883.11.20.9.39 STATIC (CONF:14848).SHALL contain at least one [1..*] component (CONF:7124) such that itSHALL contain exactly one [1..1] Result Observation (templateId:2.16.840.1.113883.10.20.22.4.2) (CONF:14850).Cognitive Status Result Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.75 (open)]Table SEQ Table \* ARABIC256: Cognitive Status Result Organizer ContextsUsed By:Contains Entries:Functional Status Section (optional)Cognitive Status Result ObservationThis clinical statement identifies a set of cognitive status result observations. It contains information applicable to all of the contained cognitive status result observations. A result organizer may be used to group questions in a Patient Health Questionnaire (PHQ). An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown.Table SEQ Table \* ARABIC257: Cognitive Status Result Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueorganizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.75']@classCode1..1SHALL143692.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER@moodCode1..1SHALL143712.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14375@root1..1SHALL143762.16.840.1.113883.10.20.22.4.75id1..*SHALL14377code1..1SHALL14378@code0..1SHOULD14697statusCode1..1SHALL14372@code1..1SHALL190932.16.840.1.113883.5.14 (ActStatus) = completedcomponent1..*SHALL14373observation1..1SHALL14381Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1).SHALL contain exactly one [1..1] @classCode="CLUSTER", which SHALL be selected from CodeSystem HL7ActClass (2.16.840.1.113883.5.6) STATIC (CONF:14369).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14371).SHALL contain exactly one [1..1] templateId (CONF:14375) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.75" (CONF:14376).SHALL contain at least one [1..*] id (CONF:14377).SHALL contain exactly one [1..1] code (CONF:14378).This code SHOULD contain zero or one [0..1] @code (CONF:14697).Should be selected from ICF (codeSystem 2.16.840.1.113883.6.254) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96) (CONF:14698).SHALL contain exactly one [1..1] statusCode (CONF:14372).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19093).SHALL contain at least one [1..*] component (CONF:14373) such that itSHALL contain exactly one [1..1] Cognitive Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.74) (CONF:14381).Figure SEQ Figure \* ARABIC 116 Cognitive Status Result Organizer example<organizer classCode="CLUSTER" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.75"/> <id root="9295dba4-df05-46bb-b94e-f2c4e4b156f8"/> <code code="d3" displayName="Communication" codeSystem="2.16.840.1.113883.6.254" codeSystemName="ICF"/> <statusCode code="completed"/> <component> <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Cognitive Status Result observation (Understanding Verbal Content) --> <templateId root="2.16.840.1.113883.10.20.22.4.74"/> ... </observation> </component> <component> <!-- ** conforms to Result observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <observation classCode="OBS" moodCode="EVN"> <!-- Cognitive Status Result observation(Expression of Ideas) --> <templateId root="2.16.840.1.113883.10.20.22.4.74"/> ... </observation> </component></organizer>Functional Status Result Organizer [organizer: templateId 2.16.840.1.113883.10.20.22.4.66 (open)]Table SEQ Table \* ARABIC258: Functional Status Result Organizer ContextsUsed By:Contains Entries:Functional Status Section (optional)Functional Status Result ObservationThis clinical statement identifies a set of functional status result observations. It contains information applicable to all of the contained functional status result observations. A functional status organizer may group self-care observations related to a patient's ability to feed, bathe, and dress.An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown.Table SEQ Table \* ARABIC259: Functional Status Result Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueorganizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.66']@classCode1..1SHALL143552.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER@moodCode1..1SHALL143572.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL14361@root1..1SHALL143622.16.840.1.113883.10.20.22.4.66id1..*SHALL14363code1..1SHALL14364@code0..1SHOULD14747statusCode1..1SHALL14358@code1..1SHALL191022.16.840.1.113883.5.14 (ActStatus) = completedcomponent1..*SHALL14359observation1..1SHALL14368Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1).SHALL contain exactly one [1..1] @classCode="CLUSTER", which SHALL be selected from CodeSystem HL7ActClass (2.16.840.1.113883.5.6) STATIC (CONF:14355).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:14357).SHALL contain exactly one [1..1] templateId (CONF:14361) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.66" (CONF:14362).SHALL contain at least one [1..*] id (CONF:14363).SHALL contain exactly one [1..1] code (CONF:14364).This code SHOULD contain zero or one [0..1] @code (CONF:14747).SHOULD be selected from ICF (codeSystem 2.16.840.1.113883.6.254) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96) (CONF:14748).SHALL contain exactly one [1..1] statusCode (CONF:14358).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19102).SHALL contain at least one [1..*] component (CONF:14359) such that itSHALL contain exactly one [1..1] Functional Status Result Observation (templateId:2.16.840.1.113883.10.20.22.4.67) (CONF:14368).Figure SEQ Figure \* ARABIC 117: Functional Status Result Organizer example<organizer classCode="CLUSTER" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.1"/> <!-- ** conforms to Result Organizer ** --> <templateId root="2.16.840.1.113883.10.20.22.4.66"/> <!-- Functional Status Result Organizer template --> <id root="9295dba4-df05-46bb-b94e-f2c4e4b156f8"/> <code code="d5" displayName="Self-Care" codeSystem="2.16.840.1.113883.6.254" codeSystemName="ICF"/> <statusCode code="completed"/> <component> <observation classCode="OBS" moodCode="EVN"> <!-- ** conforms to Result observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Functional Status Result observation(such as toileting) --> <templateId root="2.16.840.1.113883.10.20.22.4.67"/> ... </observation> </component> <component> <observation classCode="OBS" moodCode="EVN"> <!-- ** conforms to Result observation ** --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Functional Status Result observation(such as eating) --> <templateId root="2.16.840.1.113883.10.20.22.4.67"/> ... </observation> </component></organizer>Lymph Node Sampling Result Organizer[Organizer: templateId 2.16.840.1.113883.10.20.30.3.13 (open)]Table SEQ Table \* ARABIC260: Lymph Node Sampling Result Organizer ContextsUsed By:Contains Entries:Breast Cancer Procedures (optional)Number of Lymph Nodes PositiveNumber of Lymph Nodes Removed and ExaminedThis clinical statement represents the lymph nodes that were removed and examined and the number of those that were positive for pathology. This representation may include a reference to the full pathology report or details about each pathology finding.Table SEQ Table \* ARABIC261: Lymph Node Sampling Result Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueOrganizer[templateId/@root = '2.16.840.1.113883.10.20.30.3.13']@classCode1..1SHALL233142.16.840.1.113883.5.6 (HL7ActClass) = CLUSTERtemplateId1..1SHALL23315@root1..1SHALL233162.16.840.1.113883.10.20.30.3.13code1..1SHALL23324@code1..1SHALL23325178292004@codeSystem1..1SHALL233262.16.840.1.113883.6.96 (SNOMED-CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL23327@code1..1SHALL233282.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL23330specimen1..*SHALL23331specimenRole1..1SHALL23332id1..1SHALL23333specimenPlayingEntity0..1SHOULD23334code1..1SHALL23335@codeSystem1..1SHALL233362.16.840.1.113883.6.96 (SNOMED-CT)reference0..*MAY23337@typeCode1..1SHALL249482.16.840.1.113883.5.1002 (HL7ActRelationshipType) = REFRexternalDocument1..1SHALL24949id1..*SHALL24950code0..1MAY24957@code1..1SHALL2495834122-2@codeSystem1..1SHALL249592.16.840.1.113883.6.1 (LOINC) = 2.16.840.1.113883.6.1text0..1MAY24951@mediaType1..1SHALL24952reference0..1MAY24953@value1..1SHALL24968component0..1SHOULD23318observation1..1SHALL23320component0..1SHOULD23321observation1..1SHALL23323Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1).SHALL contain exactly one [1..1] @classCode="CLUSTER" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23314).SHALL contain exactly one [1..1] templateId (CONF:23315) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.13" (CONF:23316).SHALL contain exactly one [1..1] code (CONF:23324).This code SHALL contain exactly one [1..1] @code="178292004" Lymph node sampling (CONF:23325).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:23326).SHALL contain exactly one [1..1] statusCode (CONF:23327).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23328).SHALL contain exactly one [1..1] effectiveTime (CONF:23330).SHALL contain at least one [1..*] specimen (CONF:23331).Such specimens SHALL contain exactly one [1..1] specimenRole (CONF:23332).This specimenRole SHALL contain exactly one [1..1] id (CONF:23333).This specimenRole SHOULD contain zero or one [0..1] specimenPlayingEntity (CONF:23334).The specimenPlayingEntity, if present, SHALL contain exactly one [1..1] code (CONF:23335).This code SHALL contain exactly one [1..1] @codeSystem (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:23336).A reference may be made to additional information in a pathology report. MAY contain zero or more [0..*] reference (CONF:23337).The reference, if present, SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002) (CONF:24948).The reference, if present, SHALL contain exactly one [1..1] externalDocument (CONF:24949).This externalDocument SHALL contain at least one [1..*] id (CONF:24950).The code represents the type of document. Either a code and/or text description would be used to describe the external document.This externalDocument MAY contain zero or one [0..1] code (CONF:24957).The code, if present, SHALL contain exactly one [1..1] @code="34122-2" Pathology Note (CONF:24958).The code, if present, SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" LOINC (CodeSystem: LOINC 2.16.840.1.113883.6.1) (CONF:24959).This externalDocument MAY contain zero or one [0..1] text (CONF:24951).The text, if present, SHALL contain exactly one [1..1] @mediaType (CONF:24952).The text, if present, MAY contain zero or one [0..1] reference (CONF:24953).The reference, if present, SHALL contain exactly one [1..1] @value (CONF:24968).SHOULD contain zero or one [0..1] component (CONF:23318) such that itSHALL contain exactly one [1..1] Number of Lymph Nodes Removed and Examined (templateId:2.16.840.1.113883.10.20.30.3.14) (CONF:23320).SHOULD contain zero or one [0..1] component (CONF:23321) such that itSHALL contain exactly one [1..1] Number of Lymph Nodes Positive (templateId:2.16.840.1.113883.10.20.30.3.15) (CONF:23323).Figure SEQ Figure \* ARABIC 118: Lymph Node Sampling Result Organizer exampleentryRelationship typeCode="COMP"> <organizer classCode="CLUSTER" moodCode="EVN"> <!-- C-CDA RESULT ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.1"/> <!-- Lymph Node Sampling Result organizer templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.13"/> <id root="7d5a02b0-67a4-11db-bd13-0800200c9a66"/> <code codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="178292004" displayName="Lymph node sampling"/> <statusCode code="completed"/> <effectiveTime value="20120430"/> <specimen> <specimenRole> <id root="df9133b1-1adb-11e0-ac64-0800200c9a66"/> <specimenPlayingEntity> <!-- Specimen type --> <code codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" code="397436009" displayName="(a)specimen obtained by lymphadenectomy"/> </specimenPlayingEntity> </specimenRole> </specimen> <reference typeCode="REFR"> <externalDocument classCode="DOCCLIN" moodCode="EVN"> <id root="10021d19-5b29-4771-bce4-236109943dd4"/> <code code="34122-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Pathology Note"/> <text mediaType="Pathology/pdf"> <reference value="Pathology Note.10021d19-5b29-4771-bce4-236109943dd4.pdf" /> </text> </externalDocument> </reference> <!-- NUMBER OF LYMPH NODES REMOVED AND EXAMINED --> <component> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA RESULT OBSERVATION TemplateId --> <templateId root="2.16.840.1.113883.10.20.22.4.2" /> <!-- Number of Lymph Nodes Removed and Examined TemplateId --> <templateId root="2.16.840.1.113883.10.20.30.3.14"/> ... </observation> </component> <!-- NUMBER OF LYMPH NODES POSITIVE --> <component> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA RESULT OBSERVATION TemplateId --> <templateId root="2.16.840.1.113883.10.20.22.4.2" assigningAuthorityName="HL7 C-CDA"/> <!-- Number of Lymph Nodes Examined TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.15"/> ... </observation> </component> </organizer></entryRelationship>Molecular Diagnostic Testing Organizer[Organizer: templateId 2.16.840.1.113883.10.20.30.3.49 (open)]Table SEQ Table \* ARABIC262: Molecular Diagnostic Testing Organizer ContextsUsed By:Contains Entries:Results Section BCTPS (required)Oncotype DX ScoreThis clinical statement represents results from molecular diagnostic tests used in the evaluation of patients with breast cancer. Table SEQ Table \* ARABIC263: Molecular Diagnostic Testing Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueOrganizer[templateId/@root = '2.16.840.1.113883.10.20.30.3.49']templateId1..1SHALL26815@root1..1SHALL268162.16.840.1.113883.10.20.30.3.49code1..1SHALL26817@code1..1SHALL26818396927009@codeSystem1..1SHALL268192.16.840.1.113883.6.96 (SNOMED-CT) = 2.16.840.1.113883.6.96statusCode1..1SHALL26820@code1..1SHALL268212.16.840.1.113883.5.14 (ActStatus) = completedcomponent1..*SHALL26822observation1..1SHALL26823Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1).SHALL contain exactly one [1..1] templateId (CONF:26815) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.49" (CONF:26816).SHALL contain exactly one [1..1] code (CONF:26817).This code SHALL contain exactly one [1..1] @code="396927009" molecular testing, diagnostic (CONF:26818).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:26819).SHALL contain exactly one [1..1] statusCode (CONF:26820).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:26821).SHALL contain at least one [1..*] component (CONF:26822) such that itSHALL contain exactly one [1..1] Oncotype DX Score (templateId:2.16.840.1.113883.10.20.30.3.18) (CONF:26823).Figure SEQ Figure \* ARABIC 119: Molecular Testing Organizer example<organizer classCode="CLUSTER" moodCode="EVN"> <!-- Molecular Diagnostic Testing Organizer Template ID--> <templateId root="2.16.840.1.113883.10.20.30.3.49"/> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="396927009" displayName="molecular testing, diagnostic" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <statusCode code="completed"/> <component> <observation classCode="OBS" moodCode="EVN"> <!-- consolidated CDA Result Observation templateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Oncotype DX Score templateID --> <templateId root="2.16.840.1.113883.10.20.30.3.18"/> ... </component></organizer>Receptor Status Organizer[Organizer: templateId 2.16.840.1.113883.10.20.30.3.17 (open)]Table SEQ Table \* ARABIC264: Receptor Status Organizer ContextsUsed By:Contains Entries:Results Section BCTPS (required)Estrogen Receptor StatusHER2 Receptor StatusProgesterone Receptor StatusThis clinical statement represents a group of lab tests that are used to predict a patient's response to therapy.Table SEQ Table \* ARABIC265: Receptor Status Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueOrganizer[templateId/@root = '2.16.840.1.113883.10.20.30.3.17']templateId1..1SHALL23479@root1..1SHALL234802.16.840.1.113883.10.20.30.3.17code1..1SHALL23481@code1..1SHALL23482246113000@codeSystem1..1SHALL234832.16.840.1.113883.6.96 (SNOMED-CT)statusCode1..1SHALL23484@code1..1SHALL234852.16.840.1.113883.5.14 (ActStatus) = completedcomponent1..1SHALL23488observation1..1SHALL23489component1..1SHALL23490observation1..1SHALL23491component1..1SHALL23493observation1..1SHALL23536Conforms to Result Organizer template (2.16.840.1.113883.10.20.22.4.1).SHALL contain exactly one [1..1] templateId (CONF:23479) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.17" (CONF:23480).SHALL contain exactly one [1..1] code (CONF:23481).This code SHALL contain exactly one [1..1] @code="246113000" Receptor Status (CONF:23482).This code SHALL contain exactly one [1..1] @codeSystem (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96) (CONF:23483).SHALL contain exactly one [1..1] statusCode (CONF:23484).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:23485).SHALL contain exactly one [1..1] component (CONF:23488) such that itSHALL contain exactly one [1..1] Estrogen Receptor Status (templateId:2.16.840.1.113883.10.20.30.3.19) (CONF:23489).SHALL contain exactly one [1..1] component (CONF:23490) such that itSHALL contain exactly one [1..1] Progesterone Receptor Status (templateId:2.16.840.1.113883.10.20.30.3.20) (CONF:23491).SHALL contain exactly one [1..1] component (CONF:23493) such that itSHALL contain exactly one [1..1] HER2 Receptor Status (templateId:2.16.840.1.113883.10.20.30.3.38) (CONF:23536).Figure SEQ Figure \* ARABIC 120: Receptor Status Organizer example<organizer classCode="CLUSTER" moodCode="EVN"> <!-- C-CDA RESULT ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.1"/> <!-- Receptor status Organizer Template ID --> <templateId root="2.16.840.1.113883.10.20.30.3.17"/> <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/> <code code="246113000" displayName="Receptor Status" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <statusCode code="completed"/> <!-- ESTROGEN RECEPTOR STATUS --> <component> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA RESULT ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Estrogen Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.19"/> ... </observation> </component> <!-- PROGESTERONE RECEPTOR STATUS --> <component> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA RESULT ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- Progesterone Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.20"/> ... </observation> </component> <!-- HER2 RECEPTOR STATUS --> <component> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA RESULT ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.2"/> <!-- HER2 Receptor Status TemplateID --> <templateId root="2.16.840.1.113883.10.20.30.3.38"/> ... </observation> </component></organizer>Service Delivery Location [participantRole: templateId 2.16.840.1.113883.10.20.22.4.32 (open)]Table SEQ Table \* ARABIC266: Service Delivery Location ContextsUsed By:Contains Entries:Procedure Activity Procedure (optional)Procedure Activity Act (optional)Procedure Activity Observation (optional)Encounter Activities (optional)This clinical statement represents the location of a service event where an act, observation or procedure took place.Table SEQ Table \* ARABIC267: Service Delivery Location Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueparticipantRole[templateId/@root = '2.16.840.1.113883.10.20.22.4.32']@classCode1..1SHALL77582.16.840.1.113883.5.111 (RoleCode) = SDLOCtemplateId1..1SHALL7635@root1..1SHALL105242.16.840.1.113883.10.20.22.4.32code1..1SHALL168502.16.840.1.113883.1.11.20275 (HealthcareServiceLocation)addr0..*SHOULD7760telecom0..*SHOULD7761playingEntity0..1MAY7762@classCode1..1SHALL77632.16.840.1.113883.5.41 (EntityClass) = PLCname0..1MAY16037SHALL contain exactly one [1..1] @classCode="SDLOC" (CodeSystem: RoleCode 2.16.840.1.113883.5.111 STATIC) (CONF:7758).SHALL contain exactly one [1..1] templateId (CONF:7635) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.32" (CONF:10524).SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet HealthcareServiceLocation 2.16.840.1.113883.1.11.20275 STATIC (CONF:16850).SHOULD contain zero or more [0..*] addr (CONF:7760).SHOULD contain zero or more [0..*] telecom (CONF:7761).MAY contain zero or one [0..1] playingEntity (CONF:7762).The playingEntity, if present, SHALL contain exactly one [1..1] @classCode="PLC" (CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:7763).The playingEntity, if present, MAY contain zero or one [0..1] name (CONF:16037).Table SEQ Table \* ARABIC 268: HealthcareServiceLocationValue Set: HealthcareServiceLocation 2.16.840.1.113883.1.11.20275Description: This value set contains code representing a comprehensive classification of locations and settings where healthcare services are provided. This value set is based on the National Healthcare Safety Network (NHSN) location code system that has been developed over a number of years through CDC's interaction with a variety of healthcare facilities and is intended to serve a variety of reporting needs where coding of healthcare service locations is required. Specific URL PendingReference: SystemPrint Name1162-7HL7 HealthcareServiceLocation24-Hour observation area1184-1HL7 HealthcareServiceLocationAdministrative area1210-4HL7 HealthcareServiceLocationAdult Mixed Acuity Unit1099-1HL7 HealthcareServiceLocationAdult step down unit [post-critical care]1110-6HL7 HealthcareServiceLocationAllergy clinic1166-8HL7 HealthcareServiceLocationAmbulatory surgical setting1212-0HL7 HealthcareServiceLocationAny Age Mixed Acuity Unit1106-4HL7 HealthcareServiceLocationAssisted living area1145-2HL7 HealthcareServiceLocationBehavioral health clinic1185-8HL7 HealthcareServiceLocationBlood bank1195-7HL7 HealthcareServiceLocationBlood collection [Blood drive campaign]1147-8HL7 HealthcareServiceLocationBlood collection center1022-3HL7 HealthcareServiceLocationBone marrow transplant unit1026-4HL7 HealthcareServiceLocationBurn critical care unit1005-8HL7 HealthcareServiceLocationCardiac catheterization lab1112-2HL7 HealthcareServiceLocationCardiac rehabilitation center1113-0HL7 HealthcareServiceLocationCardiology clinic1186-6HL7 HealthcareServiceLocationCentral sterile supply1187-4HL7 HealthcareServiceLocationCentral trash area1095-9HL7 HealthcareServiceLocationCesarean section room/suite1011-6HL7 HealthcareServiceLocationClinical chemistry1010-8HL7 HealthcareServiceLocationClinical laboratory1148-6HL7 HealthcareServiceLocationContinence clinic1115-5HL7 HealthcareServiceLocationDermatology clinic1198-1HL7 HealthcareServiceLocationDialysis SCA...Figure SEQ Figure \* ARABIC 121: Service Delivery Location example<participantRole classCode="SDLOC"> <templateId root="2.16.840.1.113883.10.20.22.4.32" /> <!-- Service Delivery Location template --> <code code="1160-1" codeSystem="2.16.840.1.113883.6.259" codeSystemName="HealthcareServiceLocation" displayName="Urgent Care Center" /> <addr> <streetAddressLine>17 Daws Rd.</streetAddressLine> <city>Blue Bell</city> <state>MA</state> <postalCode>02368</postalCode> <country>US</country> </addr> <telecom nullFlavor="UNK" /> <playingEntity classCode="PLC"> <name>Community Health and Hospitals</name> </playingEntity></participantRole>Severity Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.8 (open)]Table SEQ Table \* ARABIC269: Severity Observation ContextsUsed By:Contains Entries:Reaction Observation (optional)Allergy - Intolerance Observation (optional)Substance or Device Allergy - Intolerance Observation (required)This clinical statement represents the gravity of the problem, such as allergy or reaction, in terms of its actual or potential impact on the patient. The Severity Observation can be associated with an Allergy Observation, Reaction Observation or both. When the Severity Observation is associated directly with an Allergy it characterizes the Allergy. When the Severity Observation is associated with a Reaction Observation it characterizes a Reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity.Table SEQ Table \* ARABIC270: Severity Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Severity Observationobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.8']@classCode1..1SHALL73452.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL73462.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7347@root1..1SHALL105252.16.840.1.113883.10.20.22.4.8code1..1SHALL19168@code1..1SHALL191692.16.840.1.113883.5.4 (ActCode) = SEVseverityFreeTexttext0..1SHOULD7350reference0..1SHOULD15928@value0..1SHOULD15929statusCode1..1SHALL7352@code1..1SHALL191152.16.840.1.113883.5.14 (ActStatus) = completedseverityCodedvalue1..1SHALLCD73562.16.840.1.113883.3.88.12.3221.6.8 (Problem Severity)interpretationCode0..*SHOULD9117@code0..1SHOULD160382.16.840.1.113883.1.11.78 (Observation Interpretation (HL7))SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7345).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7346).SHALL contain exactly one [1..1] templateId (CONF:7347) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.8" (CONF:10525).SHALL contain exactly one [1..1] code (CONF:19168).This code SHALL contain exactly one [1..1] @code="SEV" (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:19169).SHOULD contain zero or one [0..1] text (CONF:7350).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15928).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15929).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15930).SHALL contain exactly one [1..1] statusCode (CONF:7352).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19115).SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be selected from ValueSet Problem Severity 2.16.840.1.113883.3.88.12.3221.6.8 DYNAMIC (CONF:7356).SHOULD contain zero or more [0..*] interpretationCode (CONF:9117).The interpretationCode, if present, SHOULD contain zero or one [0..1] @code, which SHOULD be selected from ValueSet Observation Interpretation (HL7) 2.16.840.1.113883.1.11.78 DYNAMIC (CONF:16038).Table SEQ Table \* ARABIC271: Problem Severity Value SetValue Set: Problem Severity 2.16.840.1.113883.3.88.12.3221.6.8 DYNAMICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Description: This value set contains codes that indicate the level of the severity of a problem.References: SystemPrint Name255604002SNOMED-CTMild (qualifier value)371923003SNOMED-CTMild to moderate (qualifier value)6736007SNOMED-CTModerate (severity modifier) (qualifier value)371924009SNOMED-CTModerate to severe (qualifier value)24484000SNOMED-CTSevere (severity modifier) (qualifier value)399166001SNOMED-CTFatal (qualifier value)Table SEQ Table \* ARABIC272: Observation Interpretation (HL7) Value SetValue Set: ObservationInterpretation 2.16.840.1.113883.1.11.78 DYNAMICCode System(s): ObservationInterpretation 2.16.840.1.113883.5.83Description: This value set contains codes that represent a rough qualitative interpretation of the observation.CodeCode SystemPrint NameAObservationInterpretation AbnormalBObservationInterpretation betterCarrierObservationInterpretation CarrierDObservationInterpretation decreasedHXObservationInterpretation above high thresholdIObservationInterpretation intermediateINDObservationInterpretation IndeterminateLXObservationInterpretation below low thresholdMSObservationInterpretation moderately susceptibleNObservationInterpretation NormalNEGObservationInterpretation NegativePOSObservationInterpretation PositiveRObservationInterpretation resistentSObservationInterpretation susceptibleUObservationInterpretation increasedVSObservationInterpretation Very susceptibleWObservationInterpretation worseFigure SEQ Figure \* ARABIC 122: Severity Observation example<observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.8" /> <!-- ** Severity observation template ** --> <code code="SEV" displayName="Severity Observation" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode" /> <text> <reference value="#severity1" /> </text> <statusCode code="completed" /> <value xsi:type="CD" code="371924009" displayName="Moderate to severe" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" /> <interpretationCode code="S" displayName="susceptible" codeSystem="2.16.840.1.113883.5.83" codeSystemName="ObservationInterpretation"/></observation>Substance or Device Allergy - Intolerance Observation [observation: templateId 2.16.840.1.113883.10.20.24.3.90 (open)]Table SEQ Table \* ARABIC273: Substance or Device Allergy - Intolerance Observation ContextsUsed By:Contains Entries:Allergy Status ObservationReaction ObservationSeverity ObservationThis clinical statement represents that an allergy or adverse reaction to a substance or device exists or does not exist. The agent that is the cause of the allergy or adverse reaction is represented as a participant in the observation. Table SEQ Table \* ARABIC274: Substance or Device Allergy - Intolerance Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.24.3.90']@classCode1..1SHALL163032.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL163042.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL16305@root1..1SHALL163062.16.840.1.113883.10.20.24.3.90id1..*SHALL16307code1..1SHALL16345@code1..1SHALL163462.16.840.1.113883.5.4 (ActCode) = ASSERTIONstatusCode1..1SHALL16308@code1..1SHALL263542.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL16309value1..1SHALLCD16312@code1..1SHALLCS163172.16.840.1.113883.3.88.12.3221.6.2 (Allergy/Adverse Event Type Value Set)participant0..*SHOULD16318@typeCode1..1SHALL163192.16.840.1.113883.5.90 (HL7ParticipationType) = CSMparticipantRole1..1SHALL16320@classCode1..1SHALL163212.16.840.1.113883.5.110 (RoleClass) = MANUplayingEntity1..1SHALL16322@classCode1..1SHALL163232.16.840.1.113883.5.41 (EntityClass) = MMATcode1..1SHALL16324originalText0..1SHOULD16326reference0..1SHOULD16327@value0..1SHOULD16328translation0..*MAYSET<PQR>16330entryRelationship0..1MAY16333@typeCode1..1SHALL163352.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL16334trueobservation1..1SHALL16336entryRelationship0..*SHOULD16337@typeCode1..1SHALL163392.16.840.1.113883.5.1002 (HL7ActRelationshipType) = MFST@inversionInd1..1SHALL16338trueobservation1..1SHALL16340entryRelationship1..1SHALL16341@typeCode1..1SHALL163422.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL16343trueobservation1..1SHALL16344SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:16303).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:16304).SHALL contain exactly one [1..1] templateId (CONF:16305) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.24.3.90" (CONF:16306).SHALL contain at least one [1..*] id (CONF:16307).SHALL contain exactly one [1..1] code (CONF:16345).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:16346).SHALL contain exactly one [1..1] statusCode (CONF:16308).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14) (CONF:26354).SHALL contain exactly one [1..1] effectiveTime (CONF:16309).SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:16312).This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Allergy/Adverse Event Type Value Set 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC (CONF:16317).SHOULD contain zero or more [0..*] participant (CONF:16318).The participant, if present, SHALL contain exactly one [1..1] @typeCode="CSM" Consumable (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:16319).The participant, if present, SHALL contain exactly one [1..1] participantRole (CONF:16320).This participantRole SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:16321).This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:16322).This playingEntity SHALL contain exactly one [1..1] @classCode="MMAT" Manufactured Material (CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:16323).This playingEntity SHALL contain exactly one [1..1] code (CONF:16324).This code SHOULD contain zero or one [0..1] originalText (CONF:16326).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:16327).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:16328).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:16329).This code MAY contain zero or more [0..*] translation (CONF:16330).In an allergy to a specific medication the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.16 Medication Brand Name DYNAMIC or the ValueSet 2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug DYNAMIC (CONF:16325).In an allergy to a class of medications the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.18 Medication Drug Class DYNAMIC (CONF:16331).In an allergy to a food or other substance the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.20 Ingredient Name DYNAMIC (CONF:16332).MAY contain zero or one [0..1] entryRelationship (CONF:16333) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:16335).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:16334).SHALL contain exactly one [1..1] Allergy Status Observation (templateId:2.16.840.1.113883.10.20.22.4.28) (CONF:16336).SHOULD contain zero or more [0..*] entryRelationship (CONF:16337) such that itSHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:16339).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:16338).SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:16340).SHALL contain exactly one [1..1] entryRelationship (CONF:16341) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:16342).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:16343).SHALL contain exactly one [1..1] Severity Observation (templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:16344).Table SEQ Table \* ARABIC275: Allergy/Adverse Event Type Value SetValue Set: Allergy/Adverse Event Type Value Set 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMICCode System(s): SNOMED-CT 2.16.840.1.113883.6.96Definition: This value set contains codes that describe types of product and substance intolerances suffered by the patient.Reference: SystemPrint Name419199007SNOMED-CTAllergy to substance (disorder)416098002SNOMED-CTDrug allergy (disorder)59037007SNOMED-CTDrug intolerance (disorder)414285001SNOMED-CTFood allergy (disorder)235719002SNOMED-CTFood intolerance (disorder)420134006SNOMED-CTPropensity to adverse reactions (disorder)419511003SNOMED-CTPropensity to adverse reactions to drug (disorder)418471000SNOMED-CTPropensity to adverse reactions to food (disorder)418038007SNOMED-CTPropensity to adverse reactions to substance (disorder)Allergy - Intolerance Observation [observation: templateId 2.16.840.1.113883.10.20.22.4.7 (open)]Table SEQ Table \* ARABIC276: Allergy - Intolerance Observation ContextsUsed By:Contains Entries:Allergy Problem Act (required)Allergy Status ObservationReaction ObservationSeverity ObservationThis clinical statement represents that an allergy or adverse reaction exists or does not exist. The agent that is the cause of the allergy or adverse reaction is represented as a manufactured material participant playing entity in the allergy observation. While the agent is often implicit in the alert observation (e.g. “allergy to penicillin”), it should also be asserted explicitly as an entity. The manufactured material participant is used to represent natural and non-natural occurring substances.NOTE: The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), nor is it necessarily consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent.Table SEQ Table \* ARABIC277: Allergy - Intolerance Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueGreen Allergy Observationobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.7']@classCode1..1SHALL73792.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL73802.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7381@root1..1SHALL104882.16.840.1.113883.10.20.22.4.7id1..*SHALL7382code1..1SHALL15947@code1..1SHALL159482.16.840.1.113883.5.4 (ActCode) = ASSERTIONstatusCode1..1SHALL19084@code1..1SHALL190852.16.840.1.113883.5.14 (ActStatus) = completedadverseEventDateeffectiveTime1..1SHALL7387value1..1SHALLCD7390originalText0..1SHOULD7422reference0..1MAY15949@value0..1SHOULD15950adverseEventType@code1..1SHALL91392.16.840.1.113883.3.88.12.3221.6.2 (Allergy/Adverse Event Type Value Set)productparticipant0..1SHOULD7402@typeCode1..1SHALL74032.16.840.1.113883.5.90 (HL7ParticipationType) = CSMproductDetailparticipantRole1..1SHALL7404@classCode1..1SHALL74052.16.840.1.113883.5.110 (RoleClass) = MANUplayingEntity1..1SHALL7406@classCode1..1SHALL74072.16.840.1.113883.5.41 (EntityClass) = MMATproductCodedcode1..1SHALL7419productFreeTextoriginalText0..1SHOULD7424reference0..1SHOULD7425@value0..1SHOULD15952translation0..*MAYSET<PQR>7431entryRelationship0..1MAY7440@typeCode1..1SHALL79062.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL7446trueobservation1..1SHALL15954reactionentryRelationship0..*SHOULD7447@typeCode1..1SHALL79072.16.840.1.113883.5.1002 (HL7ActRelationshipType) = MFST@inversionInd1..1SHALL7449trueobservation1..1SHALL15955severityentryRelationship0..1SHOULD9961@typeCode1..1SHALL99622.16.840.1.113883.5.1002 (HL7ActRelationshipType) = SUBJ@inversionInd1..1SHALL9964trueobservation1..1SHALL15956Conforms to Substance or Device Allergy - Intolerance Observation template (2.16.840.1.113883.10.20.24.3.90).SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7379).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7380).SHALL contain exactly one [1..1] templateId (CONF:7381) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.7" (CONF:10488).SHALL contain at least one [1..*] id (CONF:7382).SHALL contain exactly one [1..1] code (CONF:15947).This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:15948).SHALL contain exactly one [1..1] statusCode (CONF:19084).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19085).SHALL contain exactly one [1..1] effectiveTime (CONF:7387).If it is unknown when the allergy began, this effectiveTime SHALL contain low/@nullFLavor="UNK" (CONF:9103).If the allergy is no longer a concern, this effectiveTime MAY contain zero or one [0..1] high (CONF:10082).SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:7390).This value SHOULD contain zero or one [0..1] originalText (CONF:7422).The originalText, if present, MAY contain zero or one [0..1] reference (CONF:15949).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15950).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15951).This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Allergy/Adverse Event Type Value Set 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC (CONF:9139).SHOULD contain zero or one [0..1] participant (CONF:7402) such that itSHALL contain exactly one [1..1] @typeCode="CSM" Consumable (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7403).SHALL contain exactly one [1..1] participantRole (CONF:7404).This participantRole SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:7405).This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:7406).This playingEntity SHALL contain exactly one [1..1] @classCode="MMAT" Manufactured Material (CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:7407).This playingEntity SHALL contain exactly one [1..1] code (CONF:7419).This code SHOULD contain zero or one [0..1] originalText (CONF:7424).The originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:7425).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15952).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15953).This code MAY contain zero or more [0..*] translation (CONF:7431).In an allergy to a specific medication the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.16 Medication Brand Name DYNAMIC or the ValueSet 2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug DYNAMIC (CONF:7421).In an allergy to a class of medications the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.18 Medication Drug Class DYNAMIC (CONF:10083).In an allergy to a food or other substance the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.20 Ingredient Name DYNAMIC (CONF:10084).MAY contain zero or one [0..1] entryRelationship (CONF:7440) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7906).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7446).SHALL contain exactly one [1..1] Allergy Status Observation (templateId:2.16.840.1.113883.10.20.22.4.28) (CONF:15954).SHOULD contain zero or more [0..*] entryRelationship (CONF:7447) such that itSHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7907).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7449).SHALL contain exactly one [1..1] Reaction Observation (templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:15955).SHOULD contain zero or one [0..1] entryRelationship (CONF:9961) such that itSHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9962).SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9964).SHALL contain exactly one [1..1] Severity Observation (templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:15956).Figure SEQ Figure \* ARABIC 123: Allergy - Intolerance Observation example<observation classCode="OBS" moodCode="EVN"> <!-- allergy observation template --> <templateId root="2.16.840.1.113883.10.20.22.4.7"/> <id root="4adc1020-7b14-11db-9fe1-0800200c9a66"/> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/> <statusCode code="completed"/> <effectiveTime> <low value="20060501"/> </effectiveTime> <value xsi:type="CD" code="419511003" displayName="Propensity to adverse reactions to drug" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"> <originalText> <reference value="#reaction2"/> </originalText> </value> <participant typeCode="CSM"> <participantRole classCode="MANU"> <playingEntity classCode="MMAT"> <code code="763049" displayName="Codeine 30mg/ml" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm"> <originalText> <reference value="#reaction2"/> </originalText> </code> </playingEntity> </participantRole> </participant> </observation>Vital Sign Observation[observation: templateId 2.16.840.1.113883.10.20.22.4.27 (open)]Table SEQ Table \* ARABIC278: Vital Sign Observation ContextsUsed By:Contains Entries:Vital Signs Organizer (required)Vital signs are represented as are other results, with additional vocabulary constraints.Table SEQ Table \* ARABIC279: Vital Sign Observation Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueobservation[templateId/@root = '2.16.840.1.113883.10.20.22.4.27']@classCode1..1SHALL72972.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL72982.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7299@root1..1SHALL105272.16.840.1.113883.10.20.22.4.27id1..*SHALL7300code1..1SHALL73012.16.840.1.113883.3.88.12.80.62 (Vital Sign Result Value Set)text0..1SHOULD7302reference0..1SHOULD15943@value0..1SHOULD15944statusCode1..1SHALL7303@code1..1SHALL191192.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL7304value1..1SHALLPQ7305interpretationCode0..1MAY7307methodCode0..1MAYSET<CE>7308targetSiteCode0..1MAYSET<CD>7309author0..1MAY7310SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7297).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7298).SHALL contain exactly one [1..1] templateId (CONF:7299) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.27" (CONF:10527).SHALL contain at least one [1..*] id (CONF:7300).SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Vital Sign Result Value Set 2.16.840.1.113883.3.88.12.80.62 DYNAMIC (CONF:7301).SHOULD contain zero or one [0..1] text (CONF:7302).The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15943).The reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15944).This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1) (CONF:15945).SHALL contain exactly one [1..1] statusCode (CONF:7303).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19119).SHALL contain exactly one [1..1] effectiveTime (CONF:7304).SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7305).MAY contain zero or one [0..1] interpretationCode (CONF:7307).MAY contain zero or one [0..1] methodCode (CONF:7308).MAY contain zero or one [0..1] targetSiteCode (CONF:7309).MAY contain zero or one [0..1] author (CONF:7310).Table SEQ Table \* ARABIC280: Vital Sign Result Value SetValue Set: Vital Sign Result Value Set 2.16.840.1.113883.3.88.12.80.62 DYNAMICCode System(s): LOINC 2.16.840.1.113883.6.1Definition: This value set contains codes representing types of vital sign results.References: SystemPrint Name8310-5LOINCBody Temperature8462-4LOINCBP Diastolic8480-6LOINCBP Systolic8287-5LOINCHead Circumference8867-4LOINCHeart Rate8302-2LOINCHeight8306-3LOINCHeight (Lying)2710-2LOINCO2 % BldC Oximetry9279-1LOINCRespiratory Rate3141-9LOINCWeight MeasuredBody Height [Observation: templateId 2.16.840.1.113883.10.20.30.3.26 (open)]Table SEQ Table \* ARABIC281: Body Height ContextsUsed By:Contains Entries:Vital Signs Organizer BCTPS (required)This clinical statement represents the the vertical height of an individual. Table SEQ Table \* ARABIC282: Body Height Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueObservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.26']@classCode1..1SHALL241072.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL241082.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL24862@root1..1SHALL248632.16.840.1.113883.10.20.30.3.26code1..1SHALL24113@code1..1SHALL241148302-2@codeSystem1..1SHALL241292.16.840.1.113883.6.1value1..1SHALLPQ24124@unit1..1SHALL241262.16.840.1.113883.11.20.11.18 (Unit Of Body Height)Conforms to Vital Sign Observation template (2.16.840.1.113883.10.20.22.4.27).SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:24107).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:24108).SHALL contain exactly one [1..1] templateId (CONF:24862) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.26" (CONF:24863).SHALL contain exactly one [1..1] code (CONF:24113).This code SHALL contain exactly one [1..1] @code="8302-2" Body height (CONF:24114).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" LOINC (CONF:24129).SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:24124).This value SHALL contain exactly one [1..1] @unit, which SHALL be selected from ValueSet Unit of Body Height 2.16.840.1.113883.11.20.11.18 DYNAMIC (CONF:24126).Table SEQ Table \* ARABIC283: Unit of Body Height Value SetValue Set: Unit of Body Height 2.16.840.1.113883.11.20.11.18 DYNAMICCode System(s): UCUM 2.16.840.1.113883.6.8Description: This value set contains codes that represent units of body heightReference: SystemPrint NamecmUCUMcm[in_i]UCUMinFigure SEQ Figure \* ARABIC 124: Body Height example<observation classCode="OBS" moodCode="EVN"> <!-- C-CDA VITAL SIGNS OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.27"/> <!-- Body Height template --> <templateId root="2.16.840.1.113883.10.20.30.3.26"/> <id root="c6f88321-67ad-11db-bd13-0800200c9a66"/> <code code="8302-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Height"/> <text> <reference value="#height1"/> </text> <statusCode code="completed"/> <effectiveTime value="20120407"/> <value xsi:type="PQ" value="152.4" unit="cm"/> <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/> </observation>Body Surface Area[Observation: templateId 2.16.840.1.113883.10.20.30.3.28 (open)]Table SEQ Table \* ARABIC284: Body Surface Area ContextsUsed By:Contains Entries:Vital Signs Organizer BCTPS (required)This clinical statement represesnts the calculated numerical quantity that represents the two-dimensional extent of the body surface relating height to weight.Table SEQ Table \* ARABIC285: Body Surface Area Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueObservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.28']@classCode1..1SHALL248642.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL248652.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL24868@root1..1SHALL248692.16.840.1.113883.10.20.30.3.28code1..1SHALL24872@code1..1SHALL248733140-1@codeSystem1..1SHALL259992.16.840.1.113883.6.1value1..1SHALLPQ24883@unit1..1SHALL248852.16.840.1.113883.6.8 (UCUM) = m2Conforms to Vital Sign Observation template (2.16.840.1.113883.10.20.22.4.27).SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:24864).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:24865).SHALL contain exactly one [1..1] templateId (CONF:24868) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.28" (CONF:24869).SHALL contain exactly one [1..1] code (CONF:24872).This code SHALL contain exactly one [1..1] @code="3140-1" BSA (Body Surface Area) (CONF:24873).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" LOINC (CONF:25999).SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:24883).This value SHALL contain exactly one [1..1] @unit="m2" (CodeSystem: UCUM 2.16.840.1.113883.6.8 STATIC) (CONF:24885).Figure SEQ Figure \* ARABIC 125: Body Surface Area example<observation classCode="OBS" moodCode="EVN"> <!-- C-CDA VITAL SIGNS OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.27"/> <!-- Body Surface Area TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.28"/> <id root="c6f88321-67ad-11db-bd13-0800200c9a66"/> <code code="3140-1" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="BSA (Body Surface Area)"/> <text> <reference value="#BSA1"/> </text> <statusCode code="completed"/> <effectiveTime value="20120407"/> <value xsi:type="PQ" value="1.31" unit="m2"/> <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/></observation> Body Weight[Observation: templateId 2.16.840.1.113883.10.20.30.3.27 (open)]Table SEQ Table \* ARABIC286: Body Weight ContextsUsed By:Contains Entries:Vital Signs Organizer BCTPS (required)This clinical statement represents the vertical force exerted by the mass of an individual as a result of gravity. Table SEQ Table \* ARABIC287: Body Weight Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed ValueObservation[templateId/@root = '2.16.840.1.113883.10.20.30.3.27']@classCode1..1SHALL235212.16.840.1.113883.5.6 (HL7ActClass) = OBS@moodCode1..1SHALL235222.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL24860@root1..1SHALL248612.16.840.1.113883.10.20.30.3.27code1..1SHALL23547@code1..1SHALL235483141-9@codeSystem1..1SHALL249472.16.840.1.113883.6.1value1..1SHALLPQ23558@unit1..1SHALL235602.16.840.1.113883.11.20.11.17 (Unit Of Body Weight)Conforms to Vital Sign Observation template (2.16.840.1.113883.10.20.22.4.27).SHALL contain exactly one [1..1] @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6) (CONF:23521).SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001) (CONF:23522).SHALL contain exactly one [1..1] templateId (CONF:24860) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.27" (CONF:24861).SHALL contain exactly one [1..1] code (CONF:23547).This code SHALL contain exactly one [1..1] @code="3141-9" Body weight Measured (CONF:23548).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" LOINC (CONF:24947).SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:23558).This value SHALL contain exactly one [1..1] @unit, which SHALL be selected from ValueSet Unit of Body Weight 2.16.840.1.113883.11.20.11.17 DYNAMIC (CONF:23560).Table SEQ Table \* ARABIC288: Unit Of Body Weight Value SetValue Set: Unit of Body Weight 2.16.840.1.113883.11.20.11.17 DYNAMICCode Sytem(s): UCUM 2.16.840.1.113883.6.8Description: This value set contains codes that represent units of mass for body weightReference: SystemPrint NamekgUCUMkg[lb_av]UCUMlbFigure SEQ Figure \* ARABIC 126: Body Weight example<observation classCode="OBS" moodCode="EVN"> <!-- C-CDA VITAL SIGNS OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.27"/> <!-- Body weight templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.27"/> <id root="0dec5daa-7095-41d1-be80-75bd58dff2fb"/> <code code="3141-9" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Weight Measured"/> <text> <reference value="#weight1"/> </text> <statusCode code="completed"/> <effectiveTime value="20120407"/> <value xsi:type="PQ" value="45" unit="kg"/> <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/></observation>Vital Signs Organizer[organizer: templateId 2.16.840.1.113883.10.20.22.4.26 (open)]Table SEQ Table \* ARABIC289: Vital Signs Organizer ContextsUsed By:Contains Entries:Vital Signs Section (entries optional) (optional)Vital Sign ObservationThe Vital Signs Organizer groups vital signs, which is similar to the Result Organizer, but with further constraints. An appropriate nullFlavor can be used when the organizer/code or organizer/id is unknown.Table SEQ Table \* ARABIC290: Vital Signs Organizer Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueorganizer[templateId/@root = '2.16.840.1.113883.10.20.22.4.26']@classCode1..1SHALL72792.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER@moodCode1..1SHALL72802.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL7281@root1..1SHALL105282.16.840.1.113883.10.20.22.4.26id1..*SHALL7282code1..1SHALL19176@code1..1SHALL191772.16.840.1.113883.6.96 (SNOMED-CT) = 46680005statusCode1..1SHALL7284@code1..1SHALL191202.16.840.1.113883.5.14 (ActStatus) = completedeffectiveTime1..1SHALL7288component1..*SHALL7285observation1..1SHALL15946SHALL contain exactly one [1..1] @classCode="CLUSTER" CLUSTER (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7279).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7280).SHALL contain exactly one [1..1] templateId (CONF:7281) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.26" (CONF:10528).SHALL contain at least one [1..*] id (CONF:7282).SHALL contain exactly one [1..1] code (CONF:19176).This code SHALL contain exactly one [1..1] @code="46680005" Vital signs (CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:19177).SHALL contain exactly one [1..1] statusCode (CONF:7284).This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19120).The effectiveTime represents clinically effective time of the measurement, which is most likely when the measurement was performed (e.g., a BP measurement).SHALL contain exactly one [1..1] effectiveTime (CONF:7288).SHALL contain at least one [1..*] component (CONF:7285) such that itSHALL contain exactly one [1..1] Vital Sign Observation (templateId:2.16.840.1.113883.10.20.22.4.27) (CONF:15946).Vital Signs Organizer BCTPS[organizer: templateId 2.16.840.1.113883.10.20.30.3.25 (open)]Table SEQ Table \* ARABIC291: Vital Signs Organizer BCTPS ContextsUsed By:Contains Entries:Vital Signs Section BCTPS (required)Body HeightBody Surface AreaBody WeightThis clinical statement represents a vital signs organizer that conforms to the C-CDA Vital Signs Organizer; this is required with vital signs observation entries. This vital signs organizer contains height, weight, and body surface area entries.Table SEQ Table \* ARABIC292: Vital Signs Organizer BCTPS Constraints OverviewNameXPathCard.VerbData TypeCONF#Fixed Valueorganizer[templateId/@root = '2.16.840.1.113883.10.20.30.3.25']@classCode1..1SHALL248892.16.840.1.113883.5.6 (HL7ActClass) = CLUSTER@moodCode1..1SHALL248902.16.840.1.113883.5.1001 (ActMood) = EVNtemplateId1..1SHALL24893@root1..1SHALL248942.16.840.1.113883.10.20.30.3.25code1..1SHALL24896@code1..1SHALL2489746680005@codeSystem1..1SHALL260002.16.840.1.113883.6.96component1..1SHALL24901observation1..1SHALL24902component1..1SHALL24903observation1..1SHALL24904component1..1SHALL24905observation1..1SHALL26001Conforms to Vital Signs Organizer template (2.16.840.1.113883.10.20.22.4.26).SHALL contain exactly one [1..1] @classCode="CLUSTER" CLUSTER (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:24889).SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:24890).SHALL contain exactly one [1..1] templateId (CONF:24893) such that itSHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.30.3.25" (CONF:24894).SHALL contain exactly one [1..1] code (CONF:24896).This code SHALL contain exactly one [1..1] @code="46680005" vital signs (CONF:24897).This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.96" SNOMED CT (CONF:26000).SHALL contain exactly one [1..1] component (CONF:24901) such that itSHALL contain exactly one [1..1] Body Height (templateId:2.16.840.1.113883.10.20.30.3.26) (CONF:24902).SHALL contain exactly one [1..1] component (CONF:24903) such that itSHALL contain exactly one [1..1] Body Weight (templateId:2.16.840.1.113883.10.20.30.3.27) (CONF:24904).SHALL contain exactly one [1..1] component (CONF:24905) such that itSHALL contain exactly one [1..1] Body Surface Area (templateId:2.16.840.1.113883.10.20.30.3.28) (CONF:26001).Figure SEQ Figure \* ARABIC 127: Vital Signs Organizer BCTPS example<entry typeCode> <organizer classCode="CLUSTER" moodCode="EVN"> <!-- C-CDA VITAL SIGNS ORGANIZER TemplateID --> <templateId root="2.16.840.1.113883.10.20.22.4.26"/> <!-- Vital Signs Organizer BCTPS templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.25"/> <id root="16f81685-cb5b-470b-9823-fca324968479"/> <code code="46680005" codeSystem="2.16.840.1.113883.6.96" displayName="Vital Signs" codeSystemName="SNOMED CT"> <originalText>Vital Signs</originalText> </code> <statusCode code="completed"/> <effectiveTime value="20120407"/> <component> <!-- BODY HEIGHT --> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA VITAL SIGNS OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.27"/> <!-- Body Height template --> <templateId root="2.16.840.1.113883.10.20.30.3.26"/> ... </observation> </component> <component> <!-- BODY WEIGHT --> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA VITAL SIGNS OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.27"/> <!-- Body weight templateID--> <templateId root="2.16.840.1.113883.10.20.30.3.27"/> ... </observation> </component> <component> <!-- BODY SURFACE AREA --> <observation classCode="OBS" moodCode="EVN"> <!-- C-CDA VITAL SIGNS OBSERVATION TemplateID--> <templateId root="2.16.840.1.113883.10.20.22.4.27"/> <!-- Body Surface Area TemplateID--> <templateId root="2.16.840.1.113883.10.20.30.3.28"/> ... </observation> </component> </organizer></entry>ReferencesHL7 Clinical Document Architecture (CDA Release 2). Clinical Document Architecture (CDA) Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, Release 1, August 2012. Clinical Genomics Work Group The Family History Standard – Implementation Guide (US Realm) December 2012. (must be an HL7 member)HL7 Version 3 Interoperability Standards, Normative Edition 2010. (must be an HL7 member)HL7 Version 3 Publishing Facilitator's Guide Implementation Guide for CDA R2: Quality Reporting Document Architecture, DSTU Release 2 (QRDA). and AbbreviationsAJCCAmerican Joint Committee on CancerBCTPS Breast Cancer Treatment Plan SummaryCCRContinuity of Care Record C-CDAHL7 Implementation Guide for CDA? Release 2: IHE Health Story Consolidation, Release 1.1 - US Realm (Consolidated CDA)CDAClinical Document ArchitectureCDC Centers for Disease Control and PreventionCRSCare Record SummaryDSTU Draft Standard for Trial Use EHRElectronic Health RecordEMRElectronic Medical RecordHER2Human Epidermal Growth FactorHL7Health Level SevenIGImplementation GuideLOINCLogical Observation Identifiers Names and CodesMAR Medication Administration RecordNHSN National Healthcare Safety NetworkOIDObject identifierPHIN VADS Public Health Information Network Vocabulary Access and Distribution System PHQPatient Health QuestionnaireQOPI Quality Oncology Practice InitiativeQRDAQuality Reporting Document ArchitectureR2Release 2RIM Reference Information Model RMIM Refined Message Information Model SDWG Structured Documents Working GroupSNOMED CTSystematized Nomenclature of Medicine, Clinical TermsTNMTumor Nodal MetastasisUDIUnique Device IdentificationVISVaccine Information StatementXML Extensible Mark-up LanguageTemplate IDs Used in this GuideThis appendix lists all templateIds used in this guide in alphabetical order and in containment order. Table SEQ Table \* ARABIC293: Template List in Alphabetical Order by TypeTemplate TitleTemplate TypetemplateIdClinical Oncology Treatment Plan and Summarydocument2.16.840.1.113883.10.20.30.1.1US Realm Headerdocument2.16.840.1.113883.10.20.22.1.1Allergies Section (entries optional)section2.16.840.1.113883.10.20.22.2.6Encounters Section (entries optional)section2.16.840.1.113883.10.20.22.2.22Encounters Section BCTPSsection2.16.840.1.113883.10.20.30.2.9 Family History Sectionsection2.16.840.1.113883.10.20.22.2.15Family History Section BCTPSsection2.16.840.1.113883.10.20.30.2.3Functional Status Sectionsection2.16.840.1.113883.10.20.22.2.14Functional Status Section BCTPSsection2.16.840.1.113883.10.20.30.2.8Medications Section (entries optional)section2.16.840.1.113883.10.20.22.2.1Medications Section BCTPSsection2.16.840.1.113883.10.20.30.2.7Plan of Care Sectionsection2.16.840.1.113883.10.20.22.2.10Plan of Care Section BCTPSsection2.16.840.1.113883.10.20.30.2.6Problem Section (entries optional)section2.16.840.1.113883.10.20.22.2.5Problem Section BCTPSsection2.16.840.1.113883.10.20.30.2.1Procedures Section (entries optional)section2.16.840.1.113883.10.20.22.2.7Procedures Section BCTPSsection2.16.840.1.113883.10.20.30.2.4Results Section (entries optional)section2.16.840.1.113883.10.20.22.2.3Results Section BCTPSsection2.16.840.1.113883.10.20.30.2.2Vital Signs Section (entries optional)section2.16.840.1.113883.10.20.22.2.4Vital Signs Section BCTPSsection2.16.840.1.113883.10.20.30.2.5Age Observationentry2.16.840.1.113883.10.20.22.4.31Allergy - Intolerance Observationentry2.16.840.1.113883.10.20.22.4.7Allergy Problem Actentry2.16.840.1.113883.10.20.22.4.30Allergy Status Observationentry2.16.840.1.113883.10.20.22.4.28Anthracyclines Lifetime Doseentry2.16.840.1.113883.10.20.30.3.24Assessment Scale Observationentry2.16.840.1.113883.10.20.22.4.69Assessment Scale Supporting Observationentry2.16.840.1.113883.10.20.22.4.86Body Heightentry2.16.840.1.113883.10.20.30.3.26Body Surface Areaentry2.16.840.1.113883.10.20.30.3.28Body Weightentry2.16.840.1.113883.10.20.30.3.27Breast Cancer Concern Actentry2.16.840.1.113883.10.20.30.3.6Breast Cancer Diagnosis Observationentry2.16.840.1.113883.10.20.30.3.2Breast Cancer Proceduresentry2.16.840.1.113883.10.20.30.3.12Breast TNM Clinical Categoryentry2.16.840.1.113883.10.20.30.3.3Breast TNM Metastasis Categoryentry2.16.840.1.113883.10.20.30.3.8Breast TNM Node Categoryentry2.16.840.1.113883.10.20.30.3.7Breast TNM Tumor Categoryentry2.16.840.1.113883.10.20.30.3.5Cardiac Function Observationentry2.16.840.1.113883.10.20.30.3.21Caregiver Characteristicsentry2.16.840.1.113883.10.20.22.4.72Chemotherapeutic Drug Therapy Discontinuedentry2.16.840.1.113883.10.20.30.3.43Chemotherapy Medication Activityentry2.16.840.1.113883.10.20.30.3.44Chemotherapy Medication Activity Planentry2.16.840.1.113883.10.20.30.3.51Chemotherapy Protocol Referenceentry2.16.840.1.113883.10.20.30.3.50Chemotherapy Regimen Plansentry2.16.840.1.113883.10.20.30.3.30Clinical Drug Trialentry2.16.840.1.113883.10.20.30.3.4Cognitive Status Problem Observationentry2.16.840.1.113883.10.20.22.4.73Cognitive Status Result Observationentry2.16.840.1.113883.10.20.22.4.74Cognitive Status Result Organizerentry2.16.840.1.113883.10.20.22.4.75Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Encounter Activitiesentry2.16.840.1.113883.10.20.22.4.49Encounter Diagnosisentry2.16.840.1.113883.10.20.22.4.80Estrogen Receptor Statusentry2.16.840.1.113883.10.20.30.3.19Family History Death Observationentry2.16.840.1.113883.10.20.22.4.47Family History Observationentry2.16.840.1.113883.10.20.22.4.46Family History of Cancer Noneentry2.16.840.1.113883.10.20.30.3.11Family History Organizerentry2.16.840.1.113883.10.20.22.4.45Family History Pedigreeentry2.16.840.1.113883.10.20.30.3.48Functional Status Problem Observationentry2.16.840.1.113883.10.20.22.4.68Functional Status Result Observationentry2.16.840.1.113883.10.20.22.4.67Functional Status Result Organizerentry2.16.840.1.113883.10.20.22.4.66Health Status Observationentry2.16.840.1.113883.10.20.22.4.5HER2 Receptor Statusentry2.16.840.1.113883.10.20.30.3.38Highest Pressure Ulcer Stageentry2.16.840.1.113883.10.20.22.4.77Hospitalization With Reasonentry2.16.840.1.113883.10.20.30.3.36Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Last Menstrual Periodentry2.16.840.1.113883.10.20.30.3.34Lymph Node Sampling Result Organizerentry2.16.840.1.113883.10.20.30.3.13Medication Activityentry2.16.840.1.113883.10.20.22.4.16Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Molecular Diagnostic Testing Organizerentry2.16.840.1.113883.10.20.30.3.49Neurotoxicity Impairment of ADLsentry2.16.840.1.113883.10.20.30.3.37Non-Medicinal Supply Activityentry2.16.840.1.113883.10.20.22.4.50Number of Lymph Nodes Positiveentry2.16.840.1.113883.10.20.30.3.15Number of Lymph Nodes Removed and Examinedentry2.16.840.1.113883.10.20.30.3.14Number of Pressure Ulcers Observationentry2.16.840.1.113883.10.20.22.4.76Oncotype DX Scoreentry2.16.840.1.113883.10.20.30.3.18Plan of Care Activity Actentry2.16.840.1.113883.10.20.22.4.39Plan of Care Activity Encounterentry2.16.840.1.113883.10.20.22.4.40Plan of Care Activity Observationentry2.16.840.1.113883.10.20.22.4.44Plan of Care Activity Procedureentry2.16.840.1.113883.10.20.22.4.41Plan of Care Activity Reconstruction Procedureentry2.16.840.1.113883.10.20.30.3.31Plan of Care Activity Substance Administrationentry2.16.840.1.113883.10.20.22.4.42Plan of Care Activity Supplyentry2.16.840.1.113883.10.20.22.4.43Plan of Care Radiation Activityentry2.16.840.1.113883.10.20.30.3.32Possible Side Effectsentry2.16.840.1.113883.10.20.30.3.35Post Treatment Disease Statusentry2.16.840.1.113883.10.20.30.3.29Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Pressure Ulcer Observationentry2.16.840.1.113883.10.20.22.4.70Problem Concern Act (Condition)entry2.16.840.1.113883.10.20.22.4.3Problem Observationentry2.16.840.1.113883.10.20.22.4.4Problem Statusentry2.16.840.1.113883.10.20.22.4.6Procedure Activity Actentry2.16.840.1.113883.10.20.22.4.12Procedure Activity Observationentry2.16.840.1.113883.10.20.22.4.13Procedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14Product Instanceentry2.16.840.1.113883.10.20.22.4.37Progesterone Receptor Statusentry2.16.840.1.113883.10.20.30.3.20Radiation Therapy Care Completedentry2.16.840.1.113883.10.20.30.3.16Reaction Observationentry2.16.840.1.113883.10.20.22.4.9Receptor Status Organizerentry2.16.840.1.113883.10.20.30.3.17Result Observationentry2.16.840.1.113883.10.20.22.4.2Result Organizerentry2.16.840.1.113883.10.20.22.4.1Service Delivery Locationentry2.16.840.1.113883.10.20.22.4.32Severity Observationentry2.16.840.1.113883.10.20.22.4.8Substance or Device Allergy - Intolerance Observationentry2.16.840.1.113883.10.20.24.3.90Vital Sign Observationentry2.16.840.1.113883.10.20.22.4.27Vital Signs Organizerentry2.16.840.1.113883.10.20.22.4.26Vital Signs Organizer BCTPSentry2.16.840.1.113883.10.20.30.3.25Table SEQ Table \* ARABIC294: Template List by ContainmentsTemplate TitleTemplate TypetemplateIdUS Realm Headerdocument2.16.840.1.113883.10.20.22.1.1Clinical Oncology Treatment Plan and Summarydocument2.16.840.1.113883.10.20.30.1.1Allergies Section (entries optional)section2.16.840.1.113883.10.20.22.2.6Allergy Problem Actentry2.16.840.1.113883.10.20.22.4.30Allergy - Intolerance Observationentry2.16.840.1.113883.10.20.22.4.7Allergy Status Observationentry2.16.840.1.113883.10.20.22.4.28Reaction Observationentry2.16.840.1.113883.10.20.22.4.9Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Procedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Product Instanceentry2.16.840.1.113883.10.20.22.4.37Service Delivery Locationentry2.16.840.1.113883.10.20.22.4.32Severity Observationentry2.16.840.1.113883.10.20.22.4.8Severity Observationentry2.16.840.1.113883.10.20.22.4.8Encounters Section BCTPSsection2.16.840.1.113883.10.20.30.2.9 Hospitalization With Reasonentry2.16.840.1.113883.10.20.30.3.36Indicationentry2.16.840.1.113883.10.20.22.4.19Family History Section BCTPSsection2.16.840.1.113883.10.20.30.2.3Family History of Cancer Noneentry2.16.840.1.113883.10.20.30.3.11Family History Organizerentry2.16.840.1.113883.10.20.22.4.45Family History Observationentry2.16.840.1.113883.10.20.22.4.46Age Observationentry2.16.840.1.113883.10.20.22.4.31Family History Death Observationentry2.16.840.1.113883.10.20.22.4.47Family History Pedigreeentry2.16.840.1.113883.10.20.30.3.48Functional Status Section BCTPSsection2.16.840.1.113883.10.20.30.2.8Neurotoxicity Impairment of ADLsentry2.16.840.1.113883.10.20.30.3.37Medications Section BCTPSsection2.16.840.1.113883.10.20.30.2.7Anthracyclines Lifetime Doseentry2.16.840.1.113883.10.20.30.3.24Chemotherapeutic Drug Therapy Discontinuedentry2.16.840.1.113883.10.20.30.3.43Chemotherapy Medication Activityentry2.16.840.1.113883.10.20.30.3.44Chemotherapy Protocol Referenceentry2.16.840.1.113883.10.20.30.3.50Clinical Drug Trialentry2.16.840.1.113883.10.20.30.3.4Medication Informationentry2.16.840.1.113883.10.20.22.4.23Reaction Observationentry2.16.840.1.113883.10.20.22.4.9Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Procedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Product Instanceentry2.16.840.1.113883.10.20.22.4.37Service Delivery Locationentry2.16.840.1.113883.10.20.22.4.32Severity Observationentry2.16.840.1.113883.10.20.22.4.8Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Reaction Observationentry2.16.840.1.113883.10.20.22.4.9Procedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Product Instanceentry2.16.840.1.113883.10.20.22.4.37Service Delivery Locationentry2.16.840.1.113883.10.20.22.4.32Severity Observationentry2.16.840.1.113883.10.20.22.4.8Plan of Care Section BCTPSsection2.16.840.1.113883.10.20.30.2.6Chemotherapy Regimen Plansentry2.16.840.1.113883.10.20.30.3.30Chemotherapy Medication Activity Planentry2.16.840.1.113883.10.20.30.3.51Chemotherapy Protocol Referenceentry2.16.840.1.113883.10.20.30.3.50Clinical Drug Trialentry2.16.840.1.113883.10.20.30.3.4Medication Informationentry2.16.840.1.113883.10.20.22.4.23Reaction Observationentry2.16.840.1.113883.10.20.22.4.9Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Procedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Product Instanceentry2.16.840.1.113883.10.20.22.4.37Service Delivery Locationentry2.16.840.1.113883.10.20.22.4.32Severity Observationentry2.16.840.1.113883.10.20.22.4.8Clinical Drug Trialentry2.16.840.1.113883.10.20.30.3.4Possible Side Effectsentry2.16.840.1.113883.10.20.30.3.35Plan of Care Activity Reconstruction Procedureentry2.16.840.1.113883.10.20.30.3.31Plan of Care Radiation Activityentry2.16.840.1.113883.10.20.30.3.32Problem Section BCTPSsection2.16.840.1.113883.10.20.30.2.1Breast Cancer Concern Actentry2.16.840.1.113883.10.20.30.3.6Breast Cancer Diagnosis Observationentry2.16.840.1.113883.10.20.30.3.2Breast TNM Clinical Categoryentry2.16.840.1.113883.10.20.30.3.3Breast TNM Metastasis Categoryentry2.16.840.1.113883.10.20.30.3.8Breast TNM Node Categoryentry2.16.840.1.113883.10.20.30.3.7Breast TNM Tumor Categoryentry2.16.840.1.113883.10.20.30.3.5Post Treatment Disease Statusentry2.16.840.1.113883.10.20.30.3.29Last Menstrual Periodentry2.16.840.1.113883.10.20.30.3.34Procedures Section BCTPSsection2.16.840.1.113883.10.20.30.2.4Breast Cancer Proceduresentry2.16.840.1.113883.10.20.30.3.12Lymph Node Sampling Result Organizerentry2.16.840.1.113883.10.20.30.3.13Number of Lymph Nodes Positiveentry2.16.840.1.113883.10.20.30.3.15Number of Lymph Nodes Removed and Examinedentry2.16.840.1.113883.10.20.30.3.14Radiation Therapy Care Completedentry2.16.840.1.113883.10.20.30.3.16Results Section BCTPSsection2.16.840.1.113883.10.20.30.2.2Cardiac Function Observationentry2.16.840.1.113883.10.20.30.3.21Molecular Diagnostic Testing Organizerentry2.16.840.1.113883.10.20.30.3.49Oncotype DX Scoreentry2.16.840.1.113883.10.20.30.3.18Receptor Status Organizerentry2.16.840.1.113883.10.20.30.3.17Estrogen Receptor Statusentry2.16.840.1.113883.10.20.30.3.19HER2 Receptor Statusentry2.16.840.1.113883.10.20.30.3.38Progesterone Receptor Statusentry2.16.840.1.113883.10.20.30.3.20Vital Signs Section BCTPSsection2.16.840.1.113883.10.20.30.2.5Vital Signs Organizer BCTPSentry2.16.840.1.113883.10.20.30.3.25Body Heightentry2.16.840.1.113883.10.20.30.3.26Body Surface Areaentry2.16.840.1.113883.10.20.30.3.28Body Weightentry2.16.840.1.113883.10.20.30.3.27Substance or Device Allergy - Intolerance Observationentry2.16.840.1.113883.10.20.24.3.90Allergy Status Observationentry2.16.840.1.113883.10.20.22.4.28Reaction Observationentry2.16.840.1.113883.10.20.22.4.9Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Procedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Activityentry2.16.840.1.113883.10.20.22.4.16Drug Vehicleentry2.16.840.1.113883.10.20.22.4.24Indicationentry2.16.840.1.113883.10.20.22.4.19Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Dispenseentry2.16.840.1.113883.10.20.22.4.18Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Informationentry2.16.840.1.113883.10.20.22.4.23Medication Supply Orderentry2.16.840.1.113883.10.20.22.4.17Immunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54Instructionsentry2.16.840.1.113883.10.20.22.4.20Medication Informationentry2.16.840.1.113883.10.20.22.4.23Precondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25Product Instanceentry2.16.840.1.113883.10.20.22.4.37Service Delivery Locationentry2.16.840.1.113883.10.20.22.4.32Severity Observationentry2.16.840.1.113883.10.20.22.4.8Severity Observationentry2.16.840.1.113883.10.20.22.4.8Code Systems in This GuideFor the user’s convenience, this table summarizes the vocabularies (code systems) used in this guide.Table SEQ Table \* ARABIC 295: List of VocabulariesNameOIDActCode2.16.840.1.113883.5.4ActMood2.16.840.1.113883.5.1001ActPriority2.16.840.1.113883.5.7ActStatus2.16.840.1.113883.5.14AddressUse2.16.840.1.113883.5.1119AdministrativeGender2.16.840.1.113883.5.1CDC Vaccine Code (CVX)2.16.840.1.113883.12.292ConfidentialityCode2.16.840.1.113883.5.25Country2.16.840.1.113883.3.88.12.80.63CPT42.16.840.1.113883.6.12EntityClass2.16.840.1.113883.5.41FDA RouteOfAdministration2.16.840.1.113883.3.26.1.1Healthcare Provider Taxonomy (HIPAA)2.16.840.1.113883.5.53HL7 HealthcareServiceLocation2.16.840.1.113883.6.259HL7ActClass2.16.840.1.113883.5.6HL7ActRelationshipType2.16.840.1.113883.5.1002HL7NullFlavor2.16.840.1.113883.5.1008HL7ParticipationType2.16.840.1.113883.5.90ICD10CM2.16.840.1.113883.6.90ICD9CM2.16.840.1.113883.6.2Language2.16.840.1.113883.6.121LanguageAbilityMode2.16.840.1.113883.5.60LanguageAbilityProficiency2.16.840.1.113883.5.61LOINC2.16.840.1.113883.6.1MaritalStatus2.16.840.1.113883.5.2NDFRT2.16.840.1.113883.3.26.1.5NUCCProviderTaxonomy2.16.840.1.113883.6.101ObservationInterpretation2.16.840.1.113883.5.83participationFunction2.16.840.1.113883.5.88Participationsignature2.16.840.1.113883.5.89Race & Ethnicity - CDC2.16.840.1.113883.6.238ReligiousAffiliation2.16.840.1.113883.5.1076RoleClass2.16.840.1.113883.5.110RoleCode2.16.840.1.113883.5.111RxNorm2.16.840.1.113883.6.88SNOMED CT2.16.840.1.113883.6.96UCUM2.16.840.1.113883.6.8USPostalCodes2.16.840.1.113883.6.231Breast Cancer Adjuvant Treatment Plan and Summary Paper formThe form below is copy of the American Society of Clinical Oncology’s Breast Cancer Adjuvant Treatement Plan and Summary form. This IG’s requirements were derived from this form with the design heuristic of what would ideally be available in an EHR.Figure SEQ Figure \* ARABIC 128: BCTPS paper form? 2009 American Society of Clinical Oncology. All rights reserved.Important caution: this is a summary document whose purpose is to review the highlights of the breast cancer chemotherapy treatment plan for this patient. This does not replace information available in the medical record, a complete medical history provided by the patient, examination and diagnostic information, or educational materials that describe strategies for coping with breast cancer and adjuvant chemotherapy in detail. Both medical science and an individual’s health care needs change, and therefore this document is current only as of the date of preparation. This summary document does not prescribe or recommend any particular medical treatment or care for breast cancer or any other disease and does not substitute for the independent medical judgment of the treating professional.? 2009 American Society of Clinical Oncology. All rights reserved.Important caution: this is a summary document whose purpose is to review the highlights of the breast cancer chemotherapy treatment plan for this patient. This does not replace information available in the medical record, a complete medical history provided by the patient, examination and diagnostic information, or educational materials that describe strategies for coping with breast cancer and adjuvant chemotherapy in detail. Both medical science and an individual’s health care needs change, and therefore this document is current only as of the date of preparation. This summary document does not prescribe or recommend any particular medical treatment or care for breast cancer or any other disease and does not substitute for the independent medical judgment of the treating professional.Data Element Mapping TableThe table below contains data elements from the American Society of Clinical Oncology’s Breast Cancer Adjuvant Treatment Plan and Summary form. This CDA implementation guide’s requirements were derived from this form with the design heuristic of what would ideally be available in an EHR. The table identifies the CDA template that represents the data element and provides an XPath indicating where exactly in that template the data element is captured.Table SEQ Table \* ARABIC 296: BCTPS Mapping TableOriginal Paper Form Data ElementXPathCDA TemplatePatient Name (text)/ClinicalDocument/recordTarget/patientRole/patient/nameClinical Oncology Treatment Plan and Summary2.16.840.1.113883.10.20.30.1.1Patient DOB (date)/ClinicalDocument/recordTarget/patientRole/patient/birthTimePractice Site/ClinicalDocument/recordTarget/patientRole/providerOrganizationMed Record Number (id)/ClinicalDocument/recordTarget/patientRole/idPatient Phone /ClinicalDocument/recordTarget/patientRole/telecomPatient CellPatient E-mailSupport Contact Name/ClinicalDocument/participant/associatedEntity/associatedPerson/nameSupport Contact Phone/ClinicalDocument/participant/associatedEntity/telecomSurgical Oncologist/ClinicalDocument/documentationOf/serviceEvent/performerMedical OncologistRadiation OncologistPrimary Care ProviderDate of Diagnosis (date)/.../observation/effectiveTime/lowBreast Cancer Diagnosis Observation2.16.840.1.113883.10.20.30.3.2Age of Diagnosis (temporal component derived from date of birth)/.../observation/effectiveTime/lowBreast Cancer Site (value set)/.../observation/targetSiteCodeFamily History Pedigree Model Pointer/…/act/reference/externalObservation/idFamily History Pedigree2.16.840.1.113883.10.20.30.3.48Family History - Relative (value set)/…/organizer/subject/relatedSubject/codeFamily History Organizer2.16.840.1.113883.10.20.22.4.45Family History - Diagnosis (value set)/…/observation/valueFamily History Observation2.16.840.1.113883.10.20.22.4.46Definitive Breast Surgery (date)/…/procedure/effectiveTimeBreast Cancer Procedures2.16.840.1.113883.10.20.30.3.12Breast Surgery Type (value set)/…/procedure/methodCodeBreast Cancer Procedures2.16.840.1.113883.10.20.30.3.12Notable Surgical Findings/comments?/…/section/textProcedures Section BCTPS2.16.840.1.113883.10.20.30.2.4Tumor Type (value set)/.../observation/valueBreast Cancer Diagnosis Observation2.16.840.1.113883.10.20.30.3.2# Lymph Nodes Removed /…/observation/valueNumber of Lymph Nodes Removed and Examined2.16.840.1.113883.10.20.30.3.14# Lymph Nodes Positive/…/observation/valueNumber of Lymph Nodes Positive2.16.840.1.113883.10.20.30.3.15Axillary Dissection (date)/…/observation/effectiveTimeBreast Cancer Procedures2.16.840.1.113883.10.20.30.3.12Sentinel Node Biopsy (date)T Stage (value set)/…/observation/valueBreast TNM Tumor Category2.16.840.1.113883.10.20.30.3.5N Stage (value set)/…/observation/valueBreast TNM Node Category2.16.840.1.113883.10.20.30.3.7M Stage (value set)/…/observation/valueBreast TNM Metastasis Category2.16.840.1.113883.10.20.30.3.8Stage (value set)/.../act/entryRelationship/observation/valueBreast TNM Clinical Category2.16.840.1.113883.10.20.30.3.3Oncotype DX Recurrence Score (int)/…/observation/valueOncotype DX Score2.16.840.1.113883.10.20.30.3.18ER Status (value set)/.../observation/interpretationCodeEstrogen Receptor Status2.16.840.1.113883.10.20.30.3.19PR Status (value set)/.../observation/interpretationCodeProgesterone Receptor Status2.16.840.1.113883.10.20.30.3.20HER2 Status (value set)/.../observation/interpretationCodeHER2 Receptor Status2.16.840.1.113883.10.20.30.3.38Major Comorbid Conditions/…/observation/valueProblem Observation2.16.840.1.113883.10.20.22.4.4Echocardiogram or MUGA Result (int)/…/observation/valueCardiac Function Observation2.16.840.1.113883.10.20.30.3.21Height (int)/…/observation/valueBody Height2.16.840.1.113883.10.20.30.3.26Pre-Treatment Weight (int) (temporal component derived)/…/observation/valueBody Weight2.16.840.1.113883.10.20.30.3.27Post-Treatment Weight (int) (temporal component derived)Pre-Treatment BSA (int)/…/observation/valueBody Surface Area2.16.840.1.113883.10.20.30.3.28Date Last Menstrual Period/…/observation/valueLast Menstrual Period2.16.840.1.113883.10.20.30.3.34Post-Chemo Date Last Menstrual Period (date) (temporal component derived)Name of Regimen (text)/…/procedure/code/originalTextChemotherapy Regimen Plans2.16.840.1.113883.10.20.30.3.30Regimen/Protocol Reference/…/substanceAdministration/entryRelationship/ act/reference/externalDocument/text/referenceChemotherapy Protocol Reference2.16.840.1.113883.10.20.30.3.50Treatment on Clinical Trial/…/act/codeClinical Drug Trial2.16.840.1.113883.10.20.30.3.4Pre-operative Chemo Administered(temporal component derived)/…/substanceAdministration/effectiveTimeChemotherapy Medication Activity2.16.840.1.113883.10.20.30.3.44Start Date of Chemo (date)/…/substanceAdministration/effectiveTime/lowEnd Date of Chemo (date)/…/substanceAdministration/effectiveTime/highChemotherapy Drug Name (code)/.../substanceAdministration/consumable/manufacturedProduct/manufacturedMaterial/codeRoute (value set)/.../substanceAdministration/routeCodeDose (int)/…/substanceAdministration/doseQuantitySchedule (limited - multiple effective times)/.../substanceAdministration/effectiveTimePost-Chemo Dose Reduction Needed (derived - calculated based on date)/…/substanceAdministration/doseQuantityChemotherapy Regimen Plans2.16.840.1.113883.10.20.30.3.30Post-Chemo Number of Chemo Cycles(temporal component derived)/../substanceAdministration/repeatNumberChemotherapy Medication Activity2.16.840.1.113883.10.20.30.3.44Possible Side Effects of this Regimen (value set)/.../act/entryRelationship/observation/valuePossible Side Effects2.16.840.1.113883.10.20.30.3.35Post-Chemo Anthracycline Administered/…/substanceAdministration/doseQuantityAnthracyclines Lifetime Dose2.16.840.1.113883.10.20.30.3.24Post-Chemo Serious Toxicities During Treatment(temporal component derived)/…/substanceAdministration/entryRelationship/@typeCodetypeCode="MFST"Reaction Observation2.16.840.1.113883.10.20.22.4.9Radiation Therapy Planned/…/act/codePlan of Care Radiation Activity2.16.840.1.113883.10.20.30.3.32Radiation Therapy Date Completed (date)/…/act/effectiveTimePost-Chemo Hospitalization for Toxicity During Treatment (temporal component derived)/.../encounter/entryRelationship/observation/valueHospitalization With Reason2.16.840.1.113883.10.20.30.3.36Post-Chemo Neurotoxicity that Impairs Activities of Daily Living (temporal component derived)/.../observation/entryRelationship/observation/valueNeurotoxicity Impairment of ADLs2.16.840.1.113883.10.20.30.3.37Reconstruction Planned /…/procedure/codePlan of Care Activity Reconstruction Procedure2.16.840.1.113883.10.20.30.3.31Reconstruction Date Completed (date)/…/procedure/effectiveTimeBreast Cancer Procedures2.16.840.1.113883.10.20.30.3.12Post-Chemo Reason for Stopping Chemotherapy/…/observation/valueIndication2.16.840.1.113883.10.20.22.4.19Post-Chemo Disease Status at End of Treatment (value set)/…/observation/valuePost Treatment Disease Status2.16.840.1.113883.10.20.30.3.29Endocrine Therapy (inferred - presence)/…/substanceAdministration/consumable/manufacturedProduct/manufacturedMaterial/codeMedication Activity2.16.840.1.113883.10.20.22.4.16Endocrine Therapy Start (date)/…/substanceAdministration/effectiveTime/lowEndocrine Therapy End (date)/…/substanceAdministration/effectiveTime/highTrastuzumab (Herceptin) Planned /…/procedure/codePre-trastuzumab Ejection Fraction (int)/…/observation/valueCardiac Function Observation2.16.840.1.113883.10.20.30.3.21Post-Chemo Trastuzumab (Herceptin) Prescribed /…/procedure/codePlan of Care Activity Substance Administration2.16.840.1.113883.10.20.22.4.42Post-Chemo Most Recent Ejection Fraction (temporal component derived)/…/observation/valueCardiac Function Observation2.16.840.1.113883.10.20.30.3.21Post-Chemo Planned or Completed Start Date of Trastuzumab Therapy (date)/…/substanceAdministration/effectiveTime/lowPlan of Care Activity Substance Administration2.16.840.1.113883.10.20.22.4.42Post-Chemo Planned or Completed End Date of Trastuzumab Therapy (date)/…/substanceAdministration/effectiveTime/highOncology Team Provider (value set)/ClinicalDocument/documentationOf/serviceEvent/performer/assignedEntity/codeClinical Oncology Treatment Plan and Summary2.16.840.1.113883.10.20.30.1.1Oncology Team Names (text)/.../performer/assignedEntity/assignedPerson/nameOncology Team Contact Fax/.../performer/assignedEntity/telecomOncology Team Phone/.../performer/assignedEntity/telecomPost-Chemo Survivorship Team Provider (text) (temporal component derived)/.../performer/assignedEntity/assignedPerson/namePre-treatment Comments (free text)/../section/text(any section template)Post-treatment Comments (free text)Extensions to CDA R2Where there is a need to communicate information for which there is no suitable representation in CDA R2, extensions to CDA R2 have been developed. These extensions are described above in the context of the section where they are used. This section serves to summarize the extensions and provide implementation guidance. Extensions created for this guide include:sdtc:raceCode - The raceCode extension allows for multiple races to be reported for a patient.sdtc:id - The id extension in the family history organizer on the related subject allows for unique identificiation of the family member(s).sdtc:deceasedInd - The deceasedInd extension (= “true” or “false”) in the family history organizer on the related subject is used inside to indicate if a family member is deceased.sdtc:deceasedTime - The deceasedTime extension in the family history organizer on the related subject allows for reporting the date and time a family member died.sdtc:birthTime – The birthTime extension allows for the birth date of any person to be recorded. The purpose of this extension is to allow the recording of the subscriber or member of a health plan in cases where the health plan eligibility system has different information on file than the provider does for the patient.sdtc:dischargeDispositionCode - The dischargeDispositionCode extension allows the provider to record a discharge disposition in an encounter activity. sdtc:valueSet – the valueSet extension allows the implementer to reference a particular value set from which a code was drawn.sdtc:valueSetVersion – the valueSetVersion extension allows the implementer to reference a specific version of a value set.To resolve issues that need to be addressed by extension, the developers of this guide chose to approach extensions as follows:An extension is a collection of element or attribute declarations and rules for their application to the CDA Release 2.0.A single namespace for all extension elements or attributes that may be used by this guide will be defined. The namespace for extensions created by the HL7 Structured Documents Working Group (formerly Stuctured Documents Technical Committee) shall be urn:hl7-org:sdtc. This namespace shall be used as the namespace for any extension elements or attributes that are defined by this implementation guide. Each extension element shall use the same HL7 vocabularies and data types used by CDA Release 2.0.Each extension element shall use the same conventions for order and naming as is used by the current HL7 tooling.An extension element shall appear in the XML where the expected RIM element of the same name would have appeared had that element not been otherwise constrained from appearing in the CDA XML schema.Previously Published TemplatesThe following templates were first published in other implementation guides and are re-used and republished in this guide. Enhancements or errata requested in these templates may be noted on the HL7 DSTU comments page . Specifically, these CDA templates are from HL7 Implementation Guide for CDA? Release 2: IHE Health Story Consolidation, Release 1.1 - US Realm (C-CDA) or HL7 Implementation Guide for CDA R2: Quality Reporting Document Architecture, DSTU Release 2 (QRDA). For more information on the reuse of templates, see the Templated CDA section in this document.Table SEQ Table \* ARABIC 297: Templates Previously Published in C-CDA or QRDA Implementation GuidesTemplate TitleTemplate TypetemplateIdPublished InUS Realm Headerdocument2.16.840.1.113883.10.20.22.1.1C-CDAAllergies Section (entries optional)section2.16.840.1.113883.10.20.22.2.6C-CDAEncounters Section (entries optional)section2.16.840.1.113883.10.20.22.2.22C-CDAFamily History Sectionsection2.16.840.1.113883.10.20.22.2.15C-CDAFunctional Status Sectionsection2.16.840.1.113883.10.20.22.2.14C-CDAMedications Section (entries optional)section2.16.840.1.113883.10.20.22.2.1C-CDAPlan of Care Sectionsection2.16.840.1.113883.10.20.22.2.10C-CDAProblem Section (entries optional)section2.16.840.1.113883.10.20.22.2.5C-CDAProcedures Section (entries optional)section2.16.840.1.113883.10.20.22.2.7C-CDAResults Section (entries optional)section2.16.840.1.113883.10.20.22.2.3C-CDAVital Signs Section (entries optional)section2.16.840.1.113883.10.20.22.2.4C-CDAAge Observationentry2.16.840.1.113883.10.20.22.4.31C-CDAAllergy - Intolerance Observationentry2.16.840.1.113883.10.20.22.4.7C-CDAAllergy Problem Actentry2.16.840.1.113883.10.20.22.4.30C-CDAAllergy Status Observationentry2.16.840.1.113883.10.20.22.4.28C-CDAAssessment Scale Observationentry2.16.840.1.113883.10.20.22.4.69C-CDAAssessment Scale Supporting Observationentry2.16.840.1.113883.10.20.22.4.86C-CDACaregiver Characteristicsentry2.16.840.1.113883.10.20.22.4.72C-CDACognitive Status Problem Observationentry2.16.840.1.113883.10.20.22.4.73C-CDACognitive Status Result Observationentry2.16.840.1.113883.10.20.22.4.74C-CDACognitive Status Result Organizerentry2.16.840.1.113883.10.20.22.4.75C-CDADrug Vehicleentry2.16.840.1.113883.10.20.22.4.24C-CDAEncounter Activitiesentry2.16.840.1.113883.10.20.22.4.49C-CDAEncounter Diagnosisentry2.16.840.1.113883.10.20.22.4.80C-CDAFamily History Death Observationentry2.16.840.1.113883.10.20.22.4.47C-CDAFamily History Observationentry2.16.840.1.113883.10.20.22.4.46C-CDAFamily History Organizerentry2.16.840.1.113883.10.20.22.4.45C-CDAFunctional Status Problem Observationentry2.16.840.1.113883.10.20.22.4.68C-CDAFunctional Status Result Observationentry2.16.840.1.113883.10.20.22.4.67C-CDAFunctional Status Result Organizerentry2.16.840.1.113883.10.20.22.4.66C-CDAHealth Status Observationentry2.16.840.1.113883.10.20.22.4.5C-CDAHighest Pressure Ulcer Stageentry2.16.840.1.113883.10.20.22.4.77C-CDAImmunization Medication Informationentry2.16.840.1.113883.10.20.22.4.54C-CDAIndicationentry2.16.840.1.113883.10.20.22.4.19C-CDAInstructionsentry2.16.840.1.113883.10.20.22.4.20C-CDAMedication Activityentry2.16.840.1.113883.10.20.22.4.16C-CDAMedication Dispenseentry2.16.840.1.113883.10.20.22.4.18C-CDAMedication Informationentry2.16.840.1.113883.10.20.22.4.23C-CDAMedication Supply Orderentry2.16.840.1.113883.10.20.22.4.17C-CDANon-Medicinal Supply Activityentry2.16.840.1.113883.10.20.22.4.50C-CDANumber of Pressure Ulcers Observationentry2.16.840.1.113883.10.20.22.4.76C-CDAPlan of Care Activity Actentry2.16.840.1.113883.10.20.22.4.39C-CDAPlan of Care Activity Encounterentry2.16.840.1.113883.10.20.22.4.40C-CDAPlan of Care Activity Observationentry2.16.840.1.113883.10.20.22.4.44C-CDAPlan of Care Activity Procedureentry2.16.840.1.113883.10.20.22.4.41C-CDAPlan of Care Activity Substance Administrationentry2.16.840.1.113883.10.20.22.4.42C-CDAPlan of Care Activity Supplyentry2.16.840.1.113883.10.20.22.4.43C-CDAPrecondition for Substance Administrationentry2.16.840.1.113883.10.20.22.4.25C-CDAPressure Ulcer Observationentry2.16.840.1.113883.10.20.22.4.70C-CDAProblem Concern Act (Condition)entry2.16.840.1.113883.10.20.22.4.3C-CDAProblem Observationentry2.16.840.1.113883.10.20.22.4.4C-CDAProblem Statusentry2.16.840.1.113883.10.20.22.4.6C-CDAProcedure Activity Actentry2.16.840.1.113883.10.20.22.4.12C-CDAProcedure Activity Observationentry2.16.840.1.113883.10.20.22.4.13C-CDAProcedure Activity Procedureentry2.16.840.1.113883.10.20.22.4.14C-CDAProduct Instanceentry2.16.840.1.113883.10.20.22.4.37C-CDAReaction Observationentry2.16.840.1.113883.10.20.22.4.9C-CDAResult Observationentry2.16.840.1.113883.10.20.22.4.2C-CDAResult Organizerentry2.16.840.1.113883.10.20.22.4.1C-CDAService Delivery Locationentry2.16.840.1.113883.10.20.22.4.32C-CDASeverity Observationentry2.16.840.1.113883.10.20.22.4.8C-CDASubstance or Device Allergy - Intolerance Observationentry2.16.840.1.113883.10.20.24.3.90QRDAVital Sign Observationentry2.16.840.1.113883.10.20.22.4.27C-CDAVital Signs Organizerentry2.16.840.1.113883.10.20.22.4.26C-CDAMIME Multipart/Related MessagesThe contents of this appendix were added in the event that implementers may want additional guidance when referencing external observations or documents.The following text is taken from the Claims Attachments Implementation Guide (AIS00000) in Section 2.4 . For up-to-date guidance, refer to the latest edition of that specification.MIME Multipart/Related MessagesAn attachment is comprised of the CDA document, including any supporting files necessary to render the attested content of the document. Two Internet request for comments (RFCs) are needed to properly construct the mime multipart message. When supporting files are needed, the collection of information shall be organized using a MIME multipart/related package constructed according to RFC 2557. Within the MIME package, supporting files must be encoded using Base-64. RFC-4648 should be used when encoding the contents of the MIME package using Base-64. Finally, RFC-2392 may be used to reference other content that appears in the same X12 transaction to use the same content to answer multiple questions for a single claim. Internet RFCs can be downloaded from the RFC editor page at MIME Encapsulation of Aggregate Documents, Such as HTML (MHTML)This RFC describes how to construct a MIME multipart/related package, and how URLs are resolved within content items of that package. RFC-2557 can be obtained at: MIME multipart/related package is made up of individual content items. Each content item has a MIME header identifying the item. Each content item is delimited from other content items using a string of application specified text. In addition, there must be an ending boundary. The actual content is recorded between these delimiter strings using a BASE-64 encoding of the content item. There is also a MIME header for the entire package.The first content item of a multipart/related message supporting attachments is the CDA document, containing the header and structured or non-structured body. Subsequent content items included in this package will contain additional content that appears within the body of the document. The CDA document will reference these additional content items by their URLs.Referencing Supporting Files in Multipart/Related Messages Because the CDA document and its supporting files may have already existed in a clinical information system, references may already exist within the CDA document to URLs that are not accessible outside of the clinical information system that created the document. When the CDA document is sent via attachments, these URLs may no longer be accessible by the receiving information system. Therefore, each content item that is referenced by a URL within the CDA document must be included as a content item in the MIME package. Each content item may specify the URL by which it is known using the Content-Location header. The receiver of this MIME package shall translate URL references according the RFC-2557. This will ensure resolution of the original URL to the correct content item within the MIME package. Thus, URL references contained within an original document need not be rewritten when the CDA package is transmitted. Instead, these URLs are simply supplied as the value of the Content-Location header in the MIME package.This capability allows for the same content item to be referred to more than once in a MIME multipart/related package without requiring the content item to be supplied twice. However, it does not allow a separate MIME multipart/related package to contain references to information sent in a previously recorded package. Referencing Documents from Other Multiparts within the Same X12 Transactions RFC-2392 is used when referencing content across MIME package boundaries, but still contained within the same X12 transaction (ST to SE). This can occur when the same document answers multiple questions for a single claim. Each component of a MIME package may be assigned a content identifier using the Content-ID header for the content item. For example, this header would appear as:Content-ID: <07EE4DAC-76C4-4a98-967E-F6EF9667DED1> This content identifier is a unique identifier for the content item, which means it must never be used to refer to any other content item. RFC-2392 defines the cid: URL scheme (http: and ftp: are two other URL schemes). This URL scheme allows for references by the Content-ID header to be resolved. The URL for the content item identified above would be:cid:07EE4DAC-76C4-4a98-967E-F6EF9667DED1 Receivers of the MIME multipart message must be able to resolve a cid: URL to the content item that it identifies. Senders must ensure that they only refer to items that have already been transmitted to the receiver by their cid: URL. Thus, this implementation guide prohibits forward URL references using the cid: URL scheme.Content items shall not be referenced across X12 transactions using the cid: URL scheme. For example, if the payer previously requested information using a 277, and the provider returned that information in a MIME multipart/related package in a 275, and then the payer requested additional information in another 277, the provider may not refer to the content item previously returned in the prior 275 transaction. ................
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