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Digital Imaging and Communications in Medicine (DICOM)Supplement 164: Substance Administration ReportDICOM Standards Committee, Working Group 6 (Base Standard) Ad Hoc Group 1300 N. 17th Street, Suite 1752Rosslyn, Virginia 22209 USAStatus:DraftVERSION:Public Comment DraftNov 5, 2012Table of Contents TOC \o "1-5" \h \z Table of Contents PAGEREF _Toc403397548 \h 2DOCUMENT HISTORY PAGEREF _Toc403397549 \h 3Scope and Field of Application PAGEREF _Toc403397550 \h 5Limitations of Current Standard PAGEREF _Toc403397551 \h 5TO DO PAGEREF _Toc403397552 \h 6OPEN ISSUES PAGEREF _Toc403397553 \h 6CLOSED ISSUES PAGEREF _Toc403397554 \h 7Changes to NEMA Standards Publication PS 3.2-2011 PAGEREF _Toc403397555 \h 10Changes to NEMA Standards Publication PS 3.3-2011 PAGEREF _Toc403397556 \h 10A.35.X0 Defined Substance Administration SR Information Object Definition PAGEREF _Toc403397557 \h 11A.35.X0.1 Defined Substance Administration SR Information Object Description PAGEREF _Toc403397558 \h 11A.35.X4.2 Defined Substance Administration IOD Entity-Relationship Model PAGEREF _Toc403397559 \h 11A.35.X0.3 Defined Substance Administration SR IOD Module Table PAGEREF _Toc403397560 \h 11A.35.X0.3.1Defined Substance Administration SR IOD Content Constraints PAGEREF _Toc403397561 \h 11A.35.X1 Planned Substance Administration SR Information Object Definition PAGEREF _Toc403397562 \h 12A.35.X1.1 Planned Substance Administration SR Information Object Description PAGEREF _Toc403397563 \h 12A.35.X1.2 Planned Substance Administration SR IOD Entity-Relationship Model PAGEREF _Toc403397564 \h 13A.35.X1.3 Planned Substance Administration SR IOD Module Table PAGEREF _Toc403397565 \h 13A.35.X1.3.1Planned Substance Administration SR IOD Content Constraints PAGEREF _Toc403397566 \h 13A.35.X0 Performed Substance Administration SR Information Object Definition PAGEREF _Toc403397567 \h 14A.35.X0.1 Performed Substance Administration SR Information Object Description PAGEREF _Toc403397568 \h 14A.35.X0.2 Performed Substance Administration SR IOD Entity-Relationship Model PAGEREF _Toc403397569 \h 15A.35.X0.3 Performed Substance Administration SR IOD Module Table PAGEREF _Toc403397570 \h 15A.35.X0.3.1Performed Substance Administration SR IOD Content Constraints PAGEREF _Toc403397571 \h 15A.35.X3 Basic Performed Substance Administration Information Object Definition PAGEREF _Toc403397572 \h 16A.35.X3.1 Basic Performed Substance Administration Information Object Description PAGEREF _Toc403397573 \h 16A.35.X3.2 Basic Performed Substance Administration IOD Entity-Relationship Model PAGEREF _Toc403397574 \h 17A.35.X3.3 Basic Performed Substance Administration IOD Module Table PAGEREF _Toc403397575 \h 17A.35.X3.XBasic Substance Administration IOD Content Constraints PAGEREF _Toc403397576 \h 17A.35.X3.3.1Modality PAGEREF _Toc403397577 \h 17A.35.X3.3.2Radionuclide Code Sequence PAGEREF _Toc403397578 \h 17A.35.X3.3.3Radiopharmaceutical Code Sequence PAGEREF _Toc403397579 \h 18C.7.3.1.1General Series Attribute Descriptions PAGEREF _Toc403397580 \h 18Annex CINFORMATION MODULE DEFINITIONS (NORMATIVE) PAGEREF _Toc403397581 \h 18Changes to NEMA Standards Publication PS 3.3-2011 PAGEREF _Toc403397582 \h 18B.5Standard SOP classes PAGEREF _Toc403397583 \h 19I.4Media Storage Standard SOP Classes PAGEREF _Toc403397584 \h 20Changes to NEMA Standards Publication PS 3.6-2011 PAGEREF _Toc403397585 \h 21Changes to NEMA Standards Publication PS 3.16-2011 PAGEREF _Toc403397586 \h 24TID 1004Device Observer Identifying Attributes PAGEREF _Toc403397587 \h 25DEFINED Substance Administration SR IOD TEMPLATES PAGEREF _Toc403397588 \h 26TID xx16Defined Substance Administration PAGEREF _Toc403397589 \h 27Planned Substance Administration SR IOD TEMPLATES PAGEREF _Toc403397590 \h 28TID xx01Planned Substance Administration PAGEREF _Toc403397591 \h 29TID xx02Pre-Medication Context for Substance Administration PAGEREF _Toc403397592 \h 31TID xx03Patient Risk-Factor Context related to Imaging Agents PAGEREF _Toc403397593 \h 32TID xx05Substance Information PAGEREF _Toc403397594 \h 33TID xx06Substance Administration Consumables PAGEREF _Toc403397595 \h 35TID xx07Substance Administration Delivery Plan Template PAGEREF _Toc403397596 \h 36TID xx08Substance Administration Delivery Step Template PAGEREF _Toc403397597 \h 38TID xx09Substance Administration Delivery Phase Template PAGEREF _Toc403397598 \h 38Performed Substance Administration SR IOD TEMPLATES PAGEREF _Toc403397599 \h 40TID xx10Performed Substance Administration PAGEREF _Toc403397600 \h 42TID xx11Substance Administration Adverse Events PAGEREF _Toc403397601 \h 43TID xx15Radiopharmaceutical Substance Administration Data PAGEREF _Toc403397602 \h 44CID 9300Procedure Discontinuation Reasons PAGEREF _Toc403397603 \h 46CID xx1Substance Administration Adverse Events PAGEREF _Toc403397604 \h 46CID CXX10Intravenous Extravasation Symptoms PAGEREF _Toc403397605 \h 47CID xx2Temporal Periods Relating To Contrast Procedure PAGEREF _Toc403397606 \h 48CID xx3Substance Administration Syringe Type PAGEREF _Toc403397607 \h 48CID xx4Substance Administration Phase Type PAGEREF _Toc403397608 \h 49CID xx6Substance Administration Consumable PAGEREF _Toc403397609 \h 49CID xx7Temporal Periods Relating To Procedure PAGEREF _Toc403397610 \h 49CID xx8Substance Administration Mode PAGEREF _Toc403397611 \h 50CID xx9Substance Administration Risk-Factor Indications PAGEREF _Toc403397612 \h 50CID xx10Injector Head Type PAGEREF _Toc403397613 \h 51CID xx11Substance Administration Plan Type PAGEREF _Toc403397614 \h 51CID xx12Pre-Medication Agents for Substance Administration PAGEREF _Toc403397615 \h 51CID xx13GFR Measurements PAGEREF _Toc403397616 \h 52CID xx14GFR Measurement Methods PAGEREF _Toc403397617 \h 52CID CXX15Glomerular Filtration Rate Methods PAGEREF _Toc403397618 \h 53CID xx14Substance Administration Consumable Type PAGEREF _Toc403397619 \h 53CID xx16Administrable Substance Type PAGEREF _Toc403397620 \h 53CID xx15Substance Administration Completion Status PAGEREF _Toc403397621 \h 54Annex DDICOM Controlled Terminology Definitions (Normative) PAGEREF _Toc403397622 \h 54Changes to NEMA Standards Publication PS 3.17-2011 PAGEREF _Toc403397623 \h 62Annex XX Substance Administration Report Template (Informative) PAGEREF _Toc403397624 \h 63DOCUMENT HISTORYDocument Version DateContent012012/10/25Initial Version022013/01/22Implemented review comments clean up template structures.032013/02/04Implemented review comments042013/06/12Rename “Contrast Agent Administration” to “Substance Administration”Added Contrast Agent Admin. Plan SR IODAdded Extravasation detail table from supplement159Added Fasting Period Concept in Pre-Medication Context052013/08/12Renamed all concepts from “Contrast Administration” to “Substance Administration”Added new “Defined” SOP ClassRemoved Substance admin. Plan storage (no need to have template)06-142014/01/06Implemented review comments152014/04/01Added Annex DImplemented review comments162014/11/11Removed Planned, Defined, Basic IODs per WG06 review decision.Scope and Field of Application The supplement applies to all modalities in which radiographic, radiopharmaceutical or other imaging agents are introduced into a circulatory system in a controlled fashion (CT, MR, XA, NM, US).Following are the new SOP Classes introduced to describe administration events, flows, pressure, timings, physio-chemical attributes and pharmacological attributes of the agent administration and also consumables related to the administration. These SOP classes do not describe radioactivity or dosimetry administered. The Defined Substance Administration SR is for defining generic substance administration protocols for known generic study protocols. The idea is to enable build a generic or default substance administration protocols for known imaging study protocols, so as to be able to, further customize them easily. These objects are not patient specific; rather serve as a look up source for planning substance administration protocols.The Planned Substance Administration SR Storage SOP Class is intended for representing the plan or program to deliver imaging agent customized to a specific patient. Often, it is planned by the radiologists where the plan is tuned to the characteristics of a patient and needs of that procedure. The plan may be altered by the delivery system or a user based on a variety of factors.The Performed Substance Administration SR is for reporting the actual plan or program that was used to deliver the diagnostic imaging agent during a medical imaging study.In addition, the Basic Performed Substance Administration provides a summarized version of the performed substance administration. This is an attribute based class instead of a SR document. The primary use of this class is for communicating administration data to a modality system during an imaging studyThis supplement defines SOP Classes and IODs for persisting and communication of information relevant to the administration of imaging agents used in medical imaging examinations. Furthermore, the supplement is constructed so as to convey planned and delivered substance administration using manual methods or automated power-injector devices.Limitations of Current StandardLimited provision to record Planned Substance administration steps and detailed information pertaining to the injection of the prescribed imaging agents relative to the scheduled and planned injections. The current standard enables the encoding of some injection parameters like total substance volume, adminstration flow rates and ingredient however there is insufficient specifity in the existing IODs to enable the automated preperation of an injection device or fuller analysis of the injection steps for quality assurance and improvement activities. For instance, the collection of generated pressures, flow rate vectors, multi-phased infusions, and the persistance of events that may occur during the delivery of substance (eg: flow rate limiting due to high pressures).TO DO2Add “CM” part of Modality type, under Part-3 Section C.7.3.1.1.1. This is a new modality attribute value proposed, indicating a contrast agent administration.3Add explanatory information part of Part-17 describing Basic Performed Substance Administration SOP class4Add ‘fasting period’ concept part of pre-medication as patients might have to fast in case of oral contrast delivery.5How to add “Contrast Agent IE” into parts. What are the parts affected..?See Open Issue#56Ask WG-06 on putting plan into separate SR instance..Closed. See Closed Item#117Add templates from sup-159 – patient characteristics?8Fasting Period concept – Explain this concept clear in Pre-medication context. Additionally, add this concept part of Contrast Admin.OPEN ISSUES1Does the Basic Substance Administration need any additional attributes to make Q/R more effective?The design intent is that the pump will store the above SOP Instance directly to the modality.2Are the Enhanced Contrast/Bolus Module, Enhanced PET Isotope module and the Interventional modules sufficient for recording radio-pharmaceutical substance administration? (For PET/SPECT/Nucmed imaging)3Is UPC Code is the correct code to identify a consumable related to substance administration?4Is “DCID (xx13) GFR Measurements”, a comprehensive representation appropriate to convey GFR measurement and methods?5Is concept “Use of intra-arterial injection papaverine” limited to intra-arterial..?CLOSED ISSUES1Q: Should this supplement address the planned and delivered infusion data for radiopharmaceuticals at NM studies? A conceivable use-case is that a contrast agent administration SR object is created by a contrast dose manager containing the administered radiopharmaceutical data. This object is accessed by a radiopharma manager actor and it extracts the relevant data for population into a radiopharma administration dose report SR object.A: Yes. Look up Supplement 159 for dosimtery. This issue is closed2Q. It was discussed that the summary object (Basic Performed Substance Admin) could reference the detailed objects (contrast agent admin SR Objects) - Under General Series, how do we refer to detailed objects, from the summary object? A: Contrast Agent Admin SR has been eliminated. In case of such a need to refer “performed” instance, use explicit UID reference.This issue is Closed.3Q: In Basic Contrast Administration SOP, the series is under General Series Module C.7.3.1What is the value for modality attribute (0008,0060)? Do we assign a new modality value?A: Yes, there will be new value for all objects.4Q: Under module table of all new SOP definitions, “Synchronization” (C.7.4.2) module is included under “Frame Of Reference” IE. This module has Frame Of Reference UID as type 1 – which may not be available to the contrast infusion manager; Do we include a new module attribute table?A: Generate new UID for “Frame of Reference UID”.This issue is Closed.5Q: Similar to Issue 3, The Performed Substance Admin SOP could reference scheduled SOP instance? In this case, do we include this reference under series module?A: Either put an explicit UID reference in performed object or directly look up based on the Study UID. This issue is closed.6Q: What is the use of Contrast Agent Administration SR? Can we instead use Key-Objection-Selection SR document for this purpose?A: Originally, when proposed, the ‘Contrast Agent Administration SR’ is designed to hold various contexts like Patient risk-factor context, pre-medication contexts, other than the ‘Scheduled’ and ‘Performed’ Contrast Agent Admin. SR objects.This issue stands closed as ‘Contrast Agent Administration SR’ is eliminated.7Q: Design of Basic Performed Substance IOD: Treat it as SR (KOS Style) or treat it like standard tags, which require adding a new IE (Contrast/Bolus Agent IE).A: Adding a new Contrast/Bolus Agent IE. Closed.8To discuss: On a multiple injection per accession-number scenario, (where the injection is aborted for some reasons and redone again, or when a test injection is delivered before a main injection, etc.) there could be simply n “performed” objects – as we are not aggregating all of them under one “performed” object. What are the workflow implications? We want to ensure this point is clearly understood and handled before we finalize this design.A: Yes. Aggregated reporting is not considered. Closed9Could we add concept code values indicating if the contrast agent administration was completed or aborted. (this is for quick “Yes/No” indication to help consumer know if the injection was successful or not)Secondly, if we agree for the above, how does one add it under “Enhanced Contrast/Bolus Module” (C.7.6.4b of Part-3) “Basic Contrast Agent Admin. IOD”? - Should we go ahead and extend this module?A: Yes, we could flag Completed / Terminated / User Aborted, however cannot say successful.10Another workflow scenario question: As the “Basic Performed Substance Admin.” object is primarily meant for sending out to modality, the infusion manager that creates this object has to accurately obtain this Study UID? – how does one ensure this works especially when the modality is “site configured” to ignore sharing Study-UID coming from the worklist-server but generate one on its own?In other words, if the “Basic Performed Substance Admin.” object has a different Study-UID from that of the images cut by the modality, what is the impact?A: Question is Out of scope.11Substance Admin. Plan - Separate instance or just template?It was ideated to create another SOP for ‘Substance Administration Plan’, to be referenced under planned/performed objects – however it was then decided not to go in that direction (in Jun 2013 WG-06 meeting). Instead, will add “Defined” object, which is non-patient specific similar to hanging-protocol objects.12Should we create performed object if the agent was never administered but only attempted?Yes, Utilization of suites, inventory perspective we generate one. Make up your own StudyUID in case not if there is’nt one available. It’s up to the PACS to re-concile.13Work on Adverse Event Grade under adverse event template.Not a WG-06 question.14Should 7.4.2 Synchronization module be optional under Planned/Performed Substance Admin. IODs?It is mandatory in performed object, not required to add in planned object.15Design of Defined SR IOD – Add Defined Subst. Admin. IE?How does it affect ‘Contrast Agent IE’ under Basic-Performed Object change then? Should we change it to ‘Subst. Admin. IE’?Use ‘Substance Admin. IE’ in both defined and Basic sop modules.Make ‘Defined’ object using the same document IE without Patient/Study/Series IE.Add ‘Subst. Admin IE’ and use it in Basic object – See Enhanced Contrast/Bolus module attributes C.7.64b and Substance Administration module attributesClosed.16As an Infusion Manager, one who creates the Contrast Agent Admin. objects, how do we link to the related radioactivity/dosimetry objects (sup159) ? Do we share a common event UID and have it referred under use General Series module?If the answer is yes for the above question, how does one obtain the Event UID string?Closed.Ans: They are permitted to be same and how they are coordinated is out of scope of the document. If they are different, it seems tractable to find pairing on based on patient and time.17In relation to closed issue#1 – if we have decided to support data from radiopharmaceuticals, then what items from radiopharmaceutical template should be included? Sup159 has exhaustive details What data from supplement 159 related to radio-pharma administration needs inclusion?Closed. 18Consider renaming Contrast Agent Administration Reporting to Substance Administration Report?Yes. This would be a replacement for Substance Administration log. Need to include substance administration approval? – Wanted to clarify if this contradicts with the existing Substance Administration?19In a scenario when an injector is physically moved to from modality A to modality B (but still configured to modality A), how do we prevent/handle the issue of injector device sending report to the wrong destination (i.e., modality A)?Closed. Nothing could be done about it. Cannot be addressed in DICOM.20In the concept table CID xx12, one of the premedication component is listed as 'Dexamethasone sodium sulfate" - Please verify and confirm if this is right. (i.e., Is this Dexamethasone sodium phosphate?)Closed. Its Dexamethasone sodium sulfate - confirmed from ACR Manual of Contrast Media.21In Context table CID xx14 (Consumable type), do we add radiopharma explicitly?Closed. One can cover enough details of any consumable by specifying “Imaging Agent” as this is being invoked by TID xx6 “Substance Administration Consumables”.Changes to NEMA Standards Publication PS 3.2-2011Digital Imaging and Communications in Medicine (DICOM)Part 2: ConformanceItem #01: Add new SOP Classes in Table A.1-2Table A.1-2UID VALUESUID ValueUID NAMECategory…1.2.840.10008.5.1.4.1.1.88.X3Performed Substance Administration SRTransfer…Changes to NEMA Standards Publication PS 3.3-2011Part 3: Information Object DefinitionsItem#2: Add new SR IOD of PS 3.3 A.35:A.35.X0 Performed Substance Administration SR Information Object DefinitionA.35.X0.1 Performed Substance Administration SR Information Object DescriptionThe Performed Substance Administration SR IOD is used to convey the contrast medication that was delivered using manual methods or using automated power-injector devices, to a patient during a contrast study.A.35.X0.2 Performed Substance Administration SR IOD Entity-Relationship ModelThe E-R Model in Section A.1.2 of this Part applies to the Performed Substance Administration SR IOD. Table A.35.X0-1 specifies the Modules of the Performed Substance Administration SR IOD.A.35.X0.3 Performed Substance Administration SR IOD Module TableTable A.35.X0-1PERFORMED SUBSTANCE ADMINISTRATION SR IOD MODULESIEModuleReferenceUsagePatientPatientC.7.1.1MClinical Trial SubjectC.7.1.3UStudyGeneral StudyC.7.2.1MPatient StudyC.7.2.2UClinical Trial StudyC.7.2.3USeriesSR Document SeriesC.17.1MClinical Trial SeriesC.7.3.2UFrame of ReferenceSynchronizationC.7.4.2MEquipmentGeneral EquipmentC.7.5.1MEnhanced General EquipmentC.7.5.2MDocumentSR Document GeneralC.17.2MSR Document ContentC.17.3MSOP CommonC.12.1MA.35.X0.3.1Performed Substance Administration SR IOD Content ConstraintsA.35.X0.3.1.1Value TypeValue Type (0040,A040) XE "(0040,A040)" in the Content Sequence (0040,A730) XE "(0040,A730)" of the SR Document Content Module is constrained to the following Enumerated Values (see Table C.17.3-7 for Value Type definitions):TEXTCODENUMDATETIMEDATETIMEUIDREFPNAMECOMPOSITEIMAGEWAVEFORMCONTAINERA.35.X0.3.1.2Relationship ConstraintsRelationships between content items in the content of this IOD may be conveyed either by-value or by-reference. Table A.35.X-2 specifies the relationship constraints of this IOD. See Table C.17.3-8 for Relationship Type definitions.Table A.35.X-2RELATIONSHIP CONTENT CONSTRAINTS FOR EXTENSIBLE SR IODSource Value TypeRelationship Type (Enumerated Values)Target Value TypeCONTAINERCONTAINSTEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE1, IMAGE1, WAVEFORM1, CONTAINER (See below).TEXT, CODE, NUM, CONTAINERHAS OBS CONTEXTTEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE1CONTAINER, IMAGE1, WAVEFORM1, COMPOSITE1, NUMHAS ACQ CONTEXTTEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, CONTAINER.any typeHAS CONCEPT MODTEXT, CODE2TEXT, CODE, NUMHAS PROPERTIESTEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE1, WAVEFORM1, COMPOSITE1, CONTAINER.PNAMEHAS PROPERTIESTEXT, CODE, DATETIME, DATE, TIME, UIDREF, PNAMETEXT, CODE, NUMINFERRED FROMTEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE1, WAVEFORM1, COMPOSITE1, CONTAINER.Note:1. The SOP Classes to which an IMAGE, WAVEFORM or COMPOSITE Value Type may refer, is documented in the Conformance Statement for an application (see PS 3.2 and PS 3.4).2. The HAS CONCEPT MOD relationship is used to modify the meaning of the concept name of a parent node (or Source Content Item), with a modifier or qualifier in a child (target node) to provide a more descriptive explanation, a different coded language translation, or to define a post-coordinated concept.A.35.X0.3.1.3Content ConstraintsThe Performed Substance Administration SR IOD may refer to maximum of two different Substance administration Plan SR SOP instances, one indicating programmed plan and another delivered plan. In the case of manual administration of contrast agent, there shall be only one Substance administration Plan object, indicating the delivered plan.Add new IOD Definitions to PS 3.3:Annex CINFORMATION MODULE DEFINITIONS (NORMATIVE)Changes to NEMA Standards Publication PS 3.3-2011Digital Imaging and Communications in Medicine (DICOM)Part 4: Service Class SpecificationsAdd new SOP Class to PS 3.4 Annex B and I tables:B.5Standard SOP classesThe SOP Classes in the Storage Service Class identify the Composite IODs to be stored. Table B.5-1 identifies Standard SOP Classes.Table B.5-1STANDARD SOP CLASSESSOP Class NameSOP Class UIDIOD Specification(defined in PS 3.3)………Basic Text SR1.2.840.10008.5.1.4.1.1.88.11 XE "1.2.840.10008.5.1.4.1.1.88.11" Basic Text SREnhanced SR1.2.840.10008.5.1.4.1.1.88.22 XE "1.2.840.10008.5.1.4.1.1.88.22" Enhanced SRComprehensive SR1.2.840.10008.5.1.4.1.1.88.33 XE "1.2.840.10008.5.1.4.1.1.88.33" Comprehensive SRProcedure Log1.2.840.10008.5.1.4.1.1.88.40 XE "1.2.840.10008.5.1.4.1.1.88.33" Procedure LogMammography CAD SR1.2.840.10008.5.1.4.1.1.88.50 XE "1.2.840.10008.5.1.4.1.1.88.50" Mammography CAD SR IODKey Object Selection 1.2.840.10008.5.1.4.1.1.88.59 XE "1.2.840.10008.5.1.4.1.1.88.59" Key Object Selection DocumentChest CAD SR1.2.840.10008.5.1.4.1.1.88.65 XE "1.2.840.10008.5.1.4.1.1.88.65" Chest CAD SR IODX-Ray Radiation Dose SR1.2.840.10008.5.1.4.1.1.88.67 XE "1.2.840.10008.5.1.4.1.1.88.67" X-Ray Radiation Dose SRPerformed Substance Administration SR1.2.840.10008.5.1.4.1.1.88.xx3Performed Substance Administration SREncapsulated PDF Storage1.2.840.10008.5.1.4.1.1.104.1 XE "1.2.840.10008.5.1.4.1.1.104.1" Encapsulated PDF IOD…………I.4Media Storage Standard SOP ClassesThe SOP Classes in the Media Storage Service Class identify the Composite and Normalized IODs to be stored. The following Standard SOP Classes are identified in Table I.4-1Table I.4-1Media Storage Standard SOP ClassesSOP Class NameSOP Class UIDIOD Specification………Basic Text SR1.2.840.10008.5.1.4.1.1.88.11 XE “1.2.840.10008.5.1.4.1.1.88.11” Basic Text SREnhanced SR1.2.840.10008.5.1.4.1.1.88.22 XE “1.2.840.10008.5.1.4.1.1.88.22” Enhanced SRComprehensive SR1.2.840.10008.5.1.4.1.1.88.33 XE “1.2.840.10008.5.1.4.1.1.88.33” Comprehensive SRProcedure Log1.2.840.10008.5.1.4.1.1.88.40 XE "1.2.840.10008.5.1.4.1.1.88.40" Procedure LogMammography CAD SR1.2.840.10008.5.1.4.1.1.88.50 XE “1.2.840.10008.5.1.4.1.1.88.50” Mammography CAD SR IODKey Object Selection Document1.2.840.10008.5.1.4.1.1.88.59 XE "1.2.840.10008.5.1.4.1.1.88.59" Key Object Selection DocumentChest CAD SR1.2.840.10008.5.1.4.1.1.88.65 XE "1.2.840.10008.5.1.4.1.1.88.65" Chest CAD SR IODX-Ray Radiation Dose SR1.2.840.10008.5.1.4.1.1.88.67 XE "1.2.840.10008.5.1.4.1.1.88.67" X-Ray Radiation Dose SREncapsulated PDF Storage1.2.840.10008.5.1.4.1.1.104.1 XE "1.2.840.10008.5.1.4.1.1.104.1" Encapsulated PDF IODPerformed Substance Administration SR1.2.840.10008.5.1.4.1.1.88.xx3Performed Substance Administration SR………Changes to NEMA Standards Publication PS 3.6-2011Digital Imaging and Communications in Medicine (DICOM)Part 6: Data DictionaryAdd new SOP Class to PS 3.6 Table A-1:………...1.2.840.10008.5.1.4.1.1.88.1Text SR Storage – Trial (Retired)SOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.2Audio SR Storage – Trial (Retired)SOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.3Detail SR Storage – Trial (Retired)SOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.4Comprehensive SR Storage – Trial (Retired)SOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.11Basic Text SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.22Enhanced SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.33Comprehensive SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.40Procedure Log StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.50Mammography CAD SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.59Key Object Selection Document StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.65Chest CAD SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.67X-Ray Radiation Dose SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.88.xx3Performed Substance Administration SR StorageSOP ClassPS 3.41.2.840.10008.5.1.4.1.1.104.1Encapsulated PDF StorageSOP ClassPS 3.4…………Changes to NEMA Standards Publication PS 3.16-2011Digital Imaging and Communications in Medicine (DICOM)Part 16: Content Mapping ResourceModify TID 1004 as shownTID 1004Device Observer Identifying AttributesThis template (derived from the DICOM General Equipment Module of PS3.3) contains identifying (and optionally descriptive) attributes of devices that are observers.TID 1004DEVICE OBSERVER IDENTIFYING ATTRIBUTES Type: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1UIDREFEV (121012,DCM, “Device Observer UID”)1M2TEXTEV (121013,DCM, “Device Observer Name”)1UDefaults to value of Station Name (0008,1010) in General Equipment Module3TEXTEV (121014,DCM, “Device Observer Manufacturer”)1UDefaults to value of Manufacturer (0008,0070) in General Equipment Module4TEXTEV (121015,DCM, “Device Observer Model Name”)1UDefaults to value of Manufacturer’s Model Name (0008,1090) in General Equipment Module5TEXTEV (121016,DCM, “Device Observer Serial Number”)1UDefaults to value of Device Serial Number (0018,1000) in General Equipment Module6TEXTEV (121017,DCM, “Device Observer Physical Location during observation”)1U7CODEEV (113876, DCM, “Device Role in Procedure”)1-nUBCID (7445) Device Participating Roles8TEXTEV (newcode714, 99SUP164, “Device Observer Software Version”)1UContent Item DescriptionsRow 7If the device performing the observations has other roles, e.g., as the irradiating device in a dose report, this may be recorded here, if not implicit.Add new Section to Annex A of PS 3.16:TID xx02Pre-Medication Context for Substance AdministrationDetailed information on medications administered to the patient, prior to the Substance Administration.TID xx02 Pre-Medication Context For Substance AdministrationType: Extensible Order: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode525, 99SUP164, "Premedication Drugs”)11>CONTAINSCODEEV (newcode521, 99SUP164, ”Drug Product Identifier”)1-nUDCID (xx12) Pre-Medication Agents for Substance Administration2>>HAS PROPERTIESCODEEV (newcode522, 99SUP164, ”Equivalent Drug Code”)1-nU3>>HAS PROPERTIESTEXTEV (newcode523, 99SUP164, “Drug Name”)1-nU4>>HAS PROPERTIESNUMDCID (3410) Numeric Parameters of Drugs/Contrast1-nU5>>HAS PROPERTIESCODEEV (G-C340, SRT, “Route of Administration”)1 UDCID (11) Route of Administration6>HAS PROPERTIESNUMEV (newcode524, 99SUP164, ”Fasting Period”)1UUNITS = DT (h, UCUM, "h")Content Item DescriptionsRow 2Local national code equivalent for the drug in Row 1Row 3Describes drug name in text indicated in Row 1Row 6Fasting period in hours prior to substance administrationTID xx03Patient Risk-Factor Context related to Imaging AgentsTID xx03Patient Risk-Factor Context related to Imaging Agents Type: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode531, 99SUP164, ”Imaging-Agent Related Risk Factors”)1U2>CONTAINSCODEEV (F-01500, SRT, ”Risk factor”)1-nUDCID (xx09)Imaging Agent Risk-factor Indications3>CONTAINSNUMEV (newcode532, 99SUP164, “Serum Creatinine”)1-nUUNITS = DT( mg/dL,UCUM,”mg/dL”)4>>HAS OBS CONTEXTDATETIMEEV (121135, DCM, “Observation Date time”)1M5>CONTAINSNUMEV (F-70210, SRT, “Glomerular Filtration Rate“)1-nUUNITS = DT(mL/min/1.73m2, UCUM, “mL/min/1.73m2”)6>>HAS CONCEPT MODCODEEV (G-C036, SRT, “Measurement Method")1UDCID (xx14) GFR Measurement Methods7>>HAS CONCEPT MODCODEEV (121050, DCM, “Equivalent meaning of concept name”)1MDCID (xx13) GFR Measurements8>>HAS OBS CONTEXTDATETIMEEV (121135, DCM, “Observation Date time”)1MContent Item DescriptionsRow 3There may be multiple sCRs on record for the patient.. there are some clinical algorithms that assess the slope of the sCR (and/or eGFR) to ascertain whether a patient should receive contrast (Iodinated or Gadolinum) or if a reduced volume etc should be used.Row 5GFR measurement.Row 7If provided, the code shall represent the GFR measurement precoordinated with the method actually used for the measurement in row 5.TID xx05Substance InformationThis template describes the nature of a substance administered for the purpose of imaging.TID xx05 Substance InformationType: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode541, 99SUP164,“Substance Information”)1M2>CONTAINSTEXTEV (111546, DCM, “Used Substance Type”)1U3>CONTAINSCODEEV (111546, DCM, “Used Substance Type”)1MBCID (12) Radiographic Contrast Agent orBCID (25)Radiopharmaceuticals orBCID (3107) PETCardiologyRadiopharmaceuticals orBCID (3111) NuclearCardiologyRadiopharmaceutical or BCID (4021) PETRadiopharmaceutical4>HAS PROPERTIESCODEEV (newcode522, 99SUP164, “Equivalent Substance Code”)1-nU5>HAS PROPERTIESCODEEV (newcode544, 99SUP164, “Substance Class”)1MDCID (xx016) Administrable Substance Class6>CONTAINSCODEEV (G-C52F, SRT, “Active Ingredient”)1UDCID (13) Radiographic Contrast Agent Ingredient7>CONTAINSTEXTEV (newcode545$99SUP164,“Substance Manufacturer”)1U8>CONTAINSDATETIMEEV (newcode546, 99SUP164, “Substance Order Date”)1U9>CONTAINSNUMEV (newcode547,”99SUP164”, “Contrast Concentration”)1UUNITS = EV (mg/l, UCUM, “mg/l”)10>CONTAINSNUMEV (282258000, SRT, “Molarity”)1UUNITS = EV (mmol/l, UCUM,“ mmol/l” )11>CONTINSNUMEV (newcode548, 99SUP164, “Low Osmolarity”)DCID (230) Yes-No12>CONTAINSNUMEV (newcode549, 99SUP164, “Relaxivity”)1UUNITS = EV (mM^-1*sec^-1, UCUM, “mM^-1*sec^-1”)13>CONTAINSNUMEV (newcode550, 99SUP164, “Osmolality at 37C”)1UUNITS = EV (mOsm/kg, UCUM, “mOsmol/kg”)14>CONTAINSNUMEV (newcode551, 99SUP164, “Osmolarity at 37C”)1UUNITS = EV (mmol/L, UCUM,“ mmol/L” )15>CONTAINSNUMEV (newcode552, 99SUP164, “Viscosity at 37C”)1UUNITS = EV (mOsm/kg H20, “UCUM”, “mOsm/kg H20”)16>CONTAINSNUMEV (newcode553, 99SUP164, “Flush Concentration”)1UUNITS = EV (Mg/L, UCUM, “Mg/L”)17>CONTAINSCODEEV (G-C340, SRT, "Route of administration") 1UDCID (11) Route of Administration18>CONTAINSTEXTEV (CDXX24, $99SUP159, “Reagent Identifier”)1UIFF Row 5 =EV (123001, DCM, “Radiopharmaceutical”)19>CONTAINSCODEEV (C-B1000, SRT, “Diagnostic Radioisotope”)1UCIFF Row 5 =EV (123001, DCM, “Radiopharmaceutical”)BCID 18 (NM) or 4020 (PET)20>CONTAINSNUMEV (CDXX25, $99SUP159, “Radionuclide Half Life”)1UCIFF Row 5 =EV (123001, DCM, “Radiopharmaceutical”)Units = EV (s, UCUM, “seconds”)21>CONTAINSTEXTEV (CDXX26, $99SUP159, “Radionuclide Identifier”)1UIFF Row 5 =EV (123001, DCM, “Radiopharmaceutical”)Content Item DescriptionsRow 4Local equivalent drug code for Row 3Row 5Indicates whether the substance is radiopharmaceutical or contrast agent Row 6Mg/ml of active ingredientRow 7Substance or Imaging-Agent Manufacturer. Could be department for locally compounded items.Reagent manufacturer is noted in reagent parameters.Row 8Date-time the Contrast-Agent was ordered by the physician.Row 9Contrast Concentration, referring to the concentration of contrast type given in row 4Row 10One of: “Iodine”, “Gadolinium”, etcRow 12Relaxivity at 37C at B0 field strengthRow 21Identification for the radionuclide component of the radiopharmaceuticalTID xx06Substance Administration ConsumablesThese are consumable used in the course of a substance administration procedure.TID xx06 Substance Administration ConsumablesType: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode561, 99SUP164, “Substance Administration Consumable Information”)1U2>CONTAINSCODEEV (newcode562, 99SUP164, “Substance Consumable Type”)1-nUDCID (xx14) Substance Administration Consumable Type3>CONTAINSTEXTEV (121148, SRT, “Unit Serial Identifier”)1U4>CONTAINSTEXTEV (121149, DCM, “Lot identifier”)1U5>CONTAINSTEXTEV (newcode562, 99SUP164, “UPC Code”)1U6>CONTAINSTEXTEV (121145, SRT, ”Description of Material”)1U7>CONTAINSDATEEV (newcode563, 99SUP164, "Expiry Date")1U8>CONTAINSNUMEV (111467, DCM, “Needle Length”)1CIFF Row 2 Equals (newcode123, DCM, “Syringe”)UNITS = EV (cm, UCUM, ”centimeter”)9>CONTAINSNUMEV (122319, DCM,“Catheter Size”)1UUNITS = DCID (3510)Catheter Size Units10>CONTAINSTEXTEV (newcode564, 99SUP164, “Manufacturer Name”)1U11>CONTAINSCODEEV (newcode565, 99SUP164, “Syringe Type”)1CIFF Row 2 Equals (newcode123, DCM, “Syringe”)DCID (xx03) Substance Administration Injection Syringe Type12>>HAS PROPERTIESNUMEV (121146, DCM, “Quantity of material”)1UUnits = EV (1,UCUM,”no units”)13>CONTAINSTEXTEV (121147, DCM, "BillingCode")1UContent Item DescriptionsRow 3Serial ID of the substance consumableRow 4LOT identifier of the substanceRow 6Description about the substance material if anyRow 7Expiry date of SubstanceRow 8Needle Length of the catheter usedRow 10Syringe manufacturer nameRow 11See new CID for syringe type (Pre-filled or Empty)Row 12Syringe quantity numberTID xx07Substance Administration ProtocolThis template provides detailed information on Substance Administration protocol, both planned and delivered. A protocol consists of multiple steps of delivery; a step in turn consists of multiple phases.TID xx07 ParametersParameter NameParameter Usage$PlanType Coded term for Concept Name of a plan typeTID xx07 Substance Administration Delivery Protocol Type: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode571, 99SUP164, “Substance Delivery Procedure Plan”)1M2>CONTAINSCODEEV (newcode572, 99SUP164, “Protocol Type”)1M$PlanType3>INCLUDEDTID(xx08) “Substance Administration Delivery Step”1-nM$PlanType = $PlanType4>CONTAINSNUMEV (newcode573, 99SUP164, “Pressure Limit”)1UCIF TID xx01 Row 4 = EV (newcode081, DCM, “Automated Injection”) Or TID xx10 Row 8 = EV (newcode081, DCM, “Automated Injection”)UNITS = EV (kPa,UCUM, “kPa“)5>CONTAINSNUMEV (122094, DCM, “Rate of administration”)1UUNITS = EV (ml/S,UCUM, “ml/S“)6>CONTAINSWAVEFORMEV (newcode574, DCM, “Measurement Graph”)1-nMCIF TID xx10 Row 8 = EV (newcode081, DCM, “Automated Injection”) and Row 2 = EV (newcode113, DCM, “Delivered”)Content Item DescriptionsRow 1Plan Name /Title or simply a Plan number as textRow 2Scheduled –To be encoded while this plan is scheduled under “Planned Substance Administration Procedure SR IOD”Programmed – To be encoded if this plan is programed at the injector under “Performed Substance Administration Procedure SR IOD”.Delivered – To be encoded if this plan was used in actual delivery of drug to the patient, under “Performed Substance Administration Procedure SR IOD”.Row 6Generally, 3 waveform objects referenced: a. Flow-Rate vs Time, b. Pressure vs Time c. Volume vs TimeTID xx08Substance Administration Delivery Step TemplateThis template provides detailed information on Substance Administration delivery protocol. A protocol consists of multiple steps of delivery; a step in turn consists of multiple phases.TID xx08 ParametersParameter NameParameter Usage$PlanType Coded term for Concept Name of a plan typeTID xx08 Substance Administration Delivery Step TemplateType: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode581, 99SUP164, “Substance Delivery Procedure Step”)1Mx>CONTAINSCODEEV (newcode572, 99SUP164, “Plan Type”)1M$PlanType2>CONTAINSNUMEV (newcode582, 99SUP164, “Substance Delivery Step Number”)1MUnits = EV (1,UCUM,”no units”)3>CONTAINSNUMEV (newcode583, 99SUP164, “Injection Delay”)1MUNITS = EV (s, UCUM,“s”)4>CONTAINSNUMEV (newcode584, 99SUP164, "Scan Delay ")1MUNITS = EV (s, UCUM,“s”)5>INCLUDEDTID (xx09) “Substance Delivery Phase Template”1-nMContent Item DescriptionsRow 2Substance Delivery Step Number indicates a delivery step, it starts with 1 and increases monotonically by 1.TID xx09Substance Administration Delivery Phase TemplateThis template provides detailed information on Substance Administration delivery protocol. A plan may consist of multiple steps of delivery; a step in turn may consist of multiple phases.TID xx09 Substance Delivery Phase TemplateType: ExtensibleOrder: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode591, 99SUP164, “Substance Delivery Phase”)1M2>CONTAINSNUMEV (newcode592, 99SUP164, “Substance Delivery Phase Number”)1MUnits = EV (1,UCUM,”no units”)3>CONTAINSCODEEV (newcode593, 99SUP164, “Substance Delivery Phase Type”)1MDCID (xx04) Substance Administration Phase Type4>CONTAINSCODEEV (newcode544, 99SUP164, “Substance Type”)1MCIFF Row 3 equals(newcode061, DCM, “Administration”)DCID (xx16) Administrable Substance Type5>CONTAINSNUMEV (newcode594, 99SUP164, "Substance Flush Ratio")1MCIFF Row 3 equals(newcode061, DCM, “Administration”)UNITS = EV (%, UCUM, “%”)6>CONTAINSNUMEV (122091, DCM, “Volume Administered”1MCIFF Row 3 equals(newcode061, DCM, “Administration”)UNITS = EV (ml, UCUM,“ml”)7>CONTAINSNUMEV (122094, DCM, “Rate of administration”)1UCIFF Row 3 equals(newcode061, DCM, “Administration”)UNITS = EV (ml/s, UCUM “ml/s”)8>CONTAINSNUMEV (122095, DCM, “Duration of administration”)1UUNITS = EV (s, UCUM,“s”)9>CONTAINSDATETIMEEV (111526, DCM, “DateTime Started”1MCIFF TID xx07 Row 2 equals (newcode113, DCM, “Delivered”)10>CONTAINSDATETIMEEV (111527, DCM, “DateTime Ended”1MC IFF TID xx07 Row 2equals (newcode113, DCM, “Delivered”)11>CONTAINSNUMEV (newcode595, 99SUP164, “Initial Volume of Substance in Container”)1UCIFF Row 3 equals(newcode061, DCM, “Administration”)UNITS = EV (ml, UCUM,“ml”)12>CONTAINSNUMEV (newcode596, 99SUP164, “Residual Volume of Substance in Container”)1UCIFF Row 3 equals(newcode061, DCM, “Administration”)UNITS = EV (ml, UCUM,“ml”)13>CONTAINSNUMEV (newcode597, 99SUP164, “Rise Time")1MCIF Row 3 equals (newcode061, DCM, “Administration”)And IF TID xx07 Row 2 equals (newcode113, DCM, “Delivered”)UNITS = EV (s, UCUM,“s”)Content Item DescriptionsRow 2Substance Delivery Phase Number indicates a delivery phase, it starts with 1 and increases monotonically by 1.Row 5The ratio of volume of substance to volume of flushRow 9Date time of when the Substance delivery started for the current phaseRow 10Date time of when the Substance delivery ended for the current phasePerformed Substance Administration SR IOD TEMPLATESThe templates that comprise the Performed Substance Administration are interconnected as in Figure A-x.2TID xx10Performed Substance AdministrationTID 1005Procedure ContextTID 1003Person Observer Identifying AttributesTID xx05Substance InformationTID 1004Device Observer Identifying AttributesTID xx06Substance Administration ConsumablesTID xx07Substance Administration PlanTID xx11Adverse EventsTID xx02Pre-Medication ContextTID xx03Patient Risk-FactorsTID xx15Radiopharmaceutical Substance Administration Data?TID xx08Substance Administration Step?TID xx10Performed Substance AdministrationTID 1005Procedure ContextTID 1003Person Observer Identifying AttributesTID xx05Substance InformationTID 1004Device Observer Identifying AttributesTID xx06Substance Administration ConsumablesTID xx07Substance Administration PlanTID xx11Adverse EventsTID xx02Pre-Medication ContextTID xx03Patient Risk-FactorsTID xx15Radiopharmaceutical Substance Administration Data?TID xx08Substance Administration Step?Figure A.x-2: Performed Substance Administration SR IOD Template StructureTID xx10Performed Substance AdministrationThis template defines a container (the root) with subsidiary content items, each of which corresponds to a single Substance Administration delivered. There is a defined recording observer (the system or person responsible for planning the schedule).TID xx10 Performed Substance Administration Type: ExtensibleNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode601, DCM, “Performed Substance Administration Procedure Report”)1M2>INCLUDEDTID (1204) Language Designation1U3>CONTAINSTEXTEV (newcode602, DCM,“Summary Text")1U4>INCLUDEDTID(xx01) Pre-Medication1U5>INCLUDEDTID (xx03)Patient Risk-Factor Context related to Imaging Agents1U6>HAS OBS CONTEXTINCLUDEDTID (1002) Observer Context1-nMCIF Row 8 = EV (newcode081, DCM, “Automated Injection”)7>INCLUDEDTID (1005) Procedure Context1UxScreening purpose8>CONTAINSCODEEV (newcode500, 99SUP164, “Injection Mode”)1MDCID (xx08) Substance Administration Mode9>CONTAINSCODEEV (newcode712, 99SUP164, “Programmable Device”)1UDCID (230) Yes – No10>CONTAINSTEXTEV (newcode714, 99SUP164, “Device Observer Software Version”)1U11>CONTAINSCODEEV (newcode713, 99SUP164, “Injector Head Type”)1UDCID (xx10) Substance Administration Injector Head Type13>INCLUDEDTID (xx05) Substance Information1M14>INCLUDEDTID (xx06) Substance Administration Consumables1-nM15>INCLUDEDTID (xx07) Substance Administration Protocol1MCIFF TID xx05 Row 5 =EV (C-B0300, DCM, “Contrast Agent”)$PlanType = EV (newcodexxx, DCM, “Programmed”)16>INCLUDEDTID (xx07) Substance Administration Protocol1MCIFF TID xx05 Row 5 =EV (C-B0300, DCM, “Contrast Agent”)$PlanType = EV (newcode113, DCM, “Performed”)17>INCLUDEDTID(xx15) Radiopharmaceutical Substance Administration Data1UCIFF TID xx05 Row 5 =EV (123001, DCM, “Radiopharmaceutical”)18>INCLUDEDTID (xx11) Substance Administration Adverse Events1M19>CONTAINSCODEEV (newcode603,99SUP164, “Substance Administration Completion Status”)1MDCID (xx15) Substance Administration Completion StatusContent Item DescriptionsRow 3Describes a human readable text description of substance administrationRow 6Persons responsible and devices responsible for administering the substance. If an automated injector was used, it is recorded here.Row 7This is to provide context information so as to understand – what type of study is this plan intended for.Row 14Substance consumable informationRow 15Programmed plan, contains detailed steps of a delivery plan.Typically, there is only one delivery plan for a Planned Substance Administration SOP class, two for Performed Substance Administration SOP class, indicating both programmed and delivered delivery steps.Row 16Performed delivery plan, containing detailed steps for actual delivery of Substance TID xx11Substance Administration Adverse EventsThis general template provides detailed information on adverse events occurring to a patient as a reaction to administration of Substance.TID xx11 Substance Administration Adverse OutcomesType: ExtensibleNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (newcode701, 99SUP164,"Substance Administration Adverse Outcomes”)1M2>CONTAINSNUMEV (newcode702, 99SUP164,"Number Of Adverse Events”)1MUnits = EV (1,UCUM,”no units”)3>CONTAINSCODEEV (newcode703, DCM, “Substance Administration Adverse Events”)1-nMCIFF Row 2 > 0BDCID(9300) Procedure Discontinuation Reasons4>>HAS PROPERTIESCODEEV (newcode704, 99SUP164, “Adverse Event Severity”)1UBCID (3716) Severity5>>HAS PROPERTIESCODEEV (newcode705, 99SUP164,“Relative Time of Occurrence of Adverse Event”)UDCID (xxxx2) Temporal Periods Relating To Contrast Procedure6>>HAS PROPERTIESDATETIMEEV (newcode706, 99SUP164, “Adverse Event Observation Date Time”)1M7>CONTAINSNUMEV (CDXX16, $99SUP159, “Estimated Extravasation Activity”)1UIFF TID xx05 Row 5 =EV (123001, DCM, “Radiopharmaceutical”)Units = EV (MBq, UCUM, “megabecquerel”)8>CONTAINSNUMEV (CDXX16, $99SUP164, “Estimated Extravasation Volume”)1UUnits = EV (ml, UCUM, “ml”)9>>HAS PROPERTIESNUMEV (newcode707, 99SUP164, “Adverse Reaction Step”)1UUnits = EV (1,UCUM,”no units”)10>>HAS PROPERTIESNUMEV (newcode708, 99SUP164, “Adverse Reaction Phase”)1UUnits = EV (1,UCUM,”no units”)11>>HAS PROPERTIESTEXTEV (121106, DCM,“Comment”)1UContent Item DescriptionsRow 6Date and time when the adverse event was noted by the observer.Row 9Indicates the performed step number in this plan (as recorded in row 2 of TID xxx8) where an adverse reaction found to occur.Row 10Indicates the performed phase number (as recorded in row x of TID xxx7) in the step of this plan where an adverse reaction found to occur.Row 11For end user comments. Not to be used programmatically.TID xx15Radiopharmaceutical Substance Administration DataThe Radiopharmaceutical Substance Administration Data conveys the dose and assay and time information of a single radiopharmaceutical event. A Radiopharmaceutical Administration event is one radioactive pharmaceutical dispensed to a patient.TID xx15Radiopharmaceutical Substance Administration DATAType: Extensible Order: SignificantNLRel with ParentVTConcept NameVMReq TypeConditionValue Set Constraint1CONTAINEREV (CDXX05, $99SUP159, ”Radiopharmaceutical Administration”)1M2>CONTAINSCODEEV (123001, DCM, “Radiopharmaceutical”)1MBCID (25) Radiopharmaceuticals or BCID (3107) PET Cardiology Radiopharmaceuticals or BCID (3111) Nuclear Cardiology Radiopharmaceutical BCID (4021) PET Radiopharmaceutical3>CONTAINSUIDREFEV (CDXX12, $99SUP159, “Radiopharmaceutical Administration Event UID”)1MC4>CONTAINSTEXTEV (CDX111, $99SUP159, “Purpose of Administration ”)1M7>HAS PROPERTIESDATETIMEEV (123003, DCM, “Radiopharmaceutical Start Time”)1M8>HAS PROPERTIESDATETIMEEV (123004, DCM, “Radiopharmaceutical Stop Time”)1U9>CONTAINSNUMEV (CDXX17, $99SUP159, “Administered activity”)1MUnits = EV (MBq, UCUM, “megabecquerel”)10>CONTAINSNUMEV (123005, DCM, “Radiopharmaceutical Volume”)1UUnits = EV (cm3, UCUM, “cm3”)11>CONTAINSNUMEV (123007, DCM, “Radiopharmaceutical Specific Activity”)1UUnits = EV (Bq/mol, UCUM, “Bq/mol”)12>CONTAINSNUMEV (xxxx, 99SUP164, “Flush Delivered”)1UUnits = EV (ml, UCUM, “ml”)Content Item DescriptionsRow 3Unique identification of a single radiopharmaceutical administration event.Row 4Local description of the purpose of the administration of the radiopharmaceutical in the procedure (i.e. “Cardiac Stress Injection”, “Cardiac Rest Injection”) In order to facilitate the selection of the proper dose when querying the image archive, Series Description (0008,103E) should contain the same information as the Purpose of Administration. Row 6The estimated activity of extravasated radiopharmaceutical. This estimated value can be subtracted from administered activity for PET SUV calculations. Observation DateTime (0040,A032) shall be used to record the time of the estimate.Row 7The time the radiopharmaceutical was administered to the patient for imaging purposes. Row 9Total amount of radioactivity administered to the patient at Radiopharmaceutical Start Time. It is a computed field from the TID XXX6 Measured Activity Row 2, TID XXX6 Measured Activity Date Time Row 3, Radionuclide Half Life Row 15 and Radiopharmaceutical Start Time Row 7.Does not include estimated extravasation activity.Row 11Activity per unit mass of the radiopharmaceutical at Radiopharmaceutical Start TimeAdd the following CID’s to Part 16 Annex B:CID 9300Procedure Discontinuation ReasonsContext ID 9300Procedure Discontinuation ReasonsType: Extensible Version: 20110128Coding Scheme Designator(0008,0102)XE "(0008,0102)"Code Value(0008,0100)XE "(0008,0100)"Code Meaning (0008,0104)XE "(0008,0104)"DCM110526Resource pre-emptedDCM110527Resource inadequateDCM110528Discontinued Procedure Step rescheduledDCM110529Discontinued Procedure Step rescheduling recommendedInclude CID 9301 Modality PPS Discontinuation ReasonsInclude CID 9302 Media Import PPS Discontinuation ReasonsInclude CID xx1 Substance Administration Adverse EventsCID xx1Substance Administration Adverse EventsThe contrast reactions were obtained from ACR Manual of Contrast MediaContext ID xx1Substance Administration Adverse EventsType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode001Pressure limiting eventDCMnewcode002Flow-rate limiting eventDCMnewcode004Injection aborted by clinician operatorSRTF-52840Nausea, vomitingSRTF-5005EAltered tasteSRTF-400A9SweatingSRTF-24100CoughSRTF-A21A6ItchingSRTD0-71000Drug RashSRTF-03CCFFeels WarmSRTF-037ABPallorSRTF-24442Nasal CongestionSRTF-A2700HeadacheSRTD0-3002FDrug induced FlushingSRTF-01E6ESwelling: eyes, faceSRTDF-1147CDrug Induced DizzinessSRTF-03261ChillsSRTF-0B320AnxietySRTF-A4600ShakingSRTD3-31121Tachycardia-bradycardiaSRTF-20250BronchospasmSRTD3-02000HypertensionSRTD2-04460Laryngeal edemaSRTD0-2202BDiffuse inflammatory erythemaSRTD3-04006Drug-induced hypotensionSRTF-201B3DyspneaSRTD2-04460Laryngeal edema (severe or rapidly progressing)SRTDA-30000Epileptic convulsionsSRTD3-04003Chronic hypotensionDCMnewcode031UnresponsivenessDCMnewcode032Clinically manifest arrhythmiasSRTD2-60262Cardiopulmonary arrestInclude CID CXX10Intravenous Extravasation Symptoms (From Supplement 159)CID CXX10Intravenous Extravasation Symptoms This list of Extravasation Symptoms are taken from ACR NRDR-ICE Registry, IV Contrast Extravasation Reporting Form version 1.3 from NRDR.Context ID CXX10 Intravenous Extravasation SymptomsType: Extensible Version: yyyymmddCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)$99SUP159CDX127Decreased Perfusion $99SUP159CDX128Skin Induration $99SUP159CDX129Erythema $99SUP159CDX130Altered sensation $99SUP159CDX131No Signs or Symptoms$99SUP159CDX135Swelling Mild$99SUP159CDX136Swelling Moderate$99SUP159CDX137Swelling Severe$99SUP159CDX138Pain$99SUP159CDX139Skin Blistering or Ulceration$99SUP159CDX140Compartment Syndrome$99SUP159CDX141Other Extravasation SymptomAdd new CID for Radiosensitive Organs in Part 16:CID xx2Temporal Periods Relating To Contrast ProcedureContext ID xx2Temporal Periods Relating To Contrast ProcedureType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)SRTR-422A4After ProcedureSRTR-40FBADuring ProcedureSRTR-40FB9Before ProcedureDCM110514Procedure discontinued due toincorrect patient or procedurestep selected from modalitywork-listCID xx3Substance Administration Syringe TypeContext ID xx3Substance Administration Syringe TypeType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode051Pre-filledDCMnewcode052Empty (or Not Pre-filled)CID xx4Substance Administration Phase TypeContext ID xx4Substance Administration Phase TypeType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode061AdministrationDCMnewcode062Programmed HoldDCMnewcode063Manual PauseCID xx6Substance Administration ConsumableContext ID xx6Substance Administration ConsumablesType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCM121145Description of MaterialDCM121148Unit Serial IdentifierDCM121149Lot IdentifierCID xx7Temporal Periods Relating To ProcedureContext ID xx7Temporal Periods Relating To ProcedureType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)SRTR-422A4After ProcedureSRTR-40FBADuring ProcedureSRTR-40FB9Before ProcedureCID xx8Substance Administration ModeContext ID xx8Substance Administration ModeType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode081Automated InjectionDCMnewcode082Manual InjectionCID xx9Substance Administration Risk-Factor IndicationsFollowing risk factors are obtained from ACR Manual for Contrast MediaContext ID xx9Substance Administration Risk-factor IndicationsType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)SRTR-102B6History of renal failureSRTG-023FHistory of diabetesSRT195967001AsthmaSRTD3-29021Aortic StenosisSRTD3-13012Angina PectorisSRTG-026DHistory of congestive heart failureSRTG-0269History of HypertensionSRTD3-40300Pulmonary hypertensionSRTD3-21000CardiomyopathySRT48694002AnxietyDCMnewcode093ParaproteinemiasSRTM-97323MyelomaSRTP0-099F5History of Beta-blocking agents therapySRT448216007Carcinoma of the thyroidDCMnewcode097Use of intra-arterial injection papaverineDCM110503Patient allergic to media/contrastCID xx10Injector Head TypeContext ID xx10Injector Head TypeType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode101Dual Head InjectorDCMnewcode102Single Head InjectorCID xx11Substance Administration Plan TypeContext ID xx11Substance Administration Plan TypeType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode111PlannedDCMnewcode112ProgrammedDCMnewcode113DeliveredDCMnewcode114DefinedCID xx12Pre-Medication Agents for Substance AdministrationThe following list of pre-medication agents was obtained from ACR Manual of Contrast Media.Context ID xx12Pre-Medication Agents for Substance AdministrationType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)Trade Name(Informative)(From url)SRTC-37138PrednisoneSRTC-51450Diphenhydramine BenadrylSRTC-37128MethylprednisoloneSRTC-A01D1Methylprednisolone sodium succinate (Solu-Medrol)SRTC-A0173Hydrocortisone sodium succinate (Solu-Cortef)SRTC-913A4Dexamethasone sodium sulfate (Decadron)SRTC-51071H-1 AntihistamineSRTC-68050EphedrineCID xx13GFR MeasurementsContext ID xx13GFR MeasurementsType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)LN35591-7Cockroft-Gault Formula estimation of GFRLN62238-1CKD-EPI Formula estimation of GFRInclude CID CXX15Glomerular Filtration Rate Methods (From Supplement 159)CID xx14GFR Measurement MethodsContext ID xx14GFR Measurement MethodsType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcodex100Cockroft-Gault Formula estimation of GFRDCMnewcodex101CKD-EPI Formula estimation of GFRDCMnewcodex102Glomerular Filtration Rate (MDRD) DCMnewcodex103Glomerular filtration Rate non-black (MDRD)DCMnewcodex104Glomerular Filtration Rate black (MDRD)DCMnewcodex105Glomerular Filtration Rate female (MDRD)DCMnewcodex106Glomerular Filtration Rate Cystatin-based formula DCMnewcodex107Glomerular Filtration Rate Creatinine-based formula (Schwartz) DCMnewcodex108Creatinine Renal Clearance predicted by Cockroft-Gault FormulaDCMnewcodex109Glomerular filtration rate / 1.73 sq M. predicted by Creatinine based formula (CKD-EPI)Editorial: Modify CXX5 in sup 159CID CXX15Glomerular Filtration Rate MethodsContext ID CXX15Glomerular Filtration Rate MethodsType: Extensible Version: yyyymmddCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)LN33914‐3Glomerular Filtration Rate (MDRD) LN48642-3Glomerular filtration Rate non-black (MDRD)LN48643-1 Glomerular Filtration Rate black (MDRD)LN50044-7 Glomerular Filtration Rate female (MDRD)LN50210-4 Glomerular Filtration Rate Cystatin-based formula LN50384-7Glomerular Filtration Rate Creatinine-based formula (Schwartz) LN35591-7Creatinine Renal Clearance predicted by Cockroft-Gault FormulaLN62238-1Glomerular filtration rate / 1.73 sq M. predicted by Creatinine based formula (CKD-EPI)CID xx14Substance Administration Consumable TypeContext ID xx14Substance Administration Consumable TypeType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode121Imaging agentDCMnewcode122FlushSRTA-10150SyringeDCMnewcode124CartridgeCID xx16Administrable Substance ClassContext ID xx16Administrable Substance ClassType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCM123001xx53xt ID xxxx14 the substance is a radiopharmaceuticalSOP Instance directly to the modality.RadiopharmaceuticalDCMnewcode132FlushSRTC-B0300Contrast-AgentDCMnewcode133InterventionalCID xx15Substance Administration Completion StatusContext ID xx15Substance Administration Completion StatusType: Extensible Version: 2012xxxxCoding Scheme Designator(0008,0102)Code Value(0008,0100)Code Meaning (0008,0104)DCMnewcode141Substance administration completedDCMnewcode142Substance administration abortedDCMnewcode143Substance administration in progressAnnex DDICOM Controlled Terminology Definitions (Normative)This Annex specifies the meanings of codes defined in DICOM, either explicitly or by reference to another part of DICOM or an external reference document or standard.DICOM Code Definitions (Coding Scheme Designator “DCM” Coding Scheme Version “01”)Code Valuexe "(0008,0104)"Code MeaningDefinitionNotesnewcode001Pressure limiting event The Injector device detected a pressure at or above the programmed threshold.This event does not necessarily indicate occurrence of adverse reaction in a patient. newcode002Flow-rate limiting eventThe Injector device detected a flow-rate at or above the programmed threshold.This event does not necessarily indicate occurrence of adverse reaction in a patient. newcode004Injection aborted by clinician operatornewcode005Nausea, vomitingnewcode006Altered tastenewcode007Sweatsnewcode008Coughnewcode009Itchingnewcode010Rash, hivesnewcode011Warmthnewcode012Pallornewcode013Nasal stuffinessnewcode014Headachenewcode015Flushingnewcode016Swelling: eyes, facenewcode017Dizzinessnewcode018Chillsnewcode019Anxietynewcode020Shakingnewcode021Tachycardia/bradycardianewcode022Bronchospasm, wheezingnewcode023Hypertensionnewcode024Laryngeal edemanewcode025Generalized or diffuse erythemanewcode026Mild hypotensionnewcode027Dyspneanewcode028Laryngeal edema (severe or rapidly progressing)newcode029Convulsionsnewcode030Profound hypotensionnewcode031Unresponsivenessnewcode032Clinically manifest arrhythmiasnewcode033Cardiopulmonary arrestnewcode051Pre-filled SyringeThe syringe is pre-fillednewcode052Empty SyringeThe syringe is empty or not-prefillednewcode061AdministrationIndicates the administration state when fluid is being deliverednewcode062Programmed HoldFluid delivery is on hold until programmed time elapsesnewcode063Manual PauseFluid delivery paused manuallynewcode081Automated InjectionInjection involving power injectorsnewcode082Manual InjectionManual hand injectionnewcode097Use of intra-arterial injection papaverineThe patient previously received papaverine by intra-arterial injection.newcode111PlannedPlanned substance administration report newcode112ProgrammedProgrammed substance administration reportnewcode113DeliveredDelivered substance administration reportnewcode114DefinedDefined substance administration reporting object.newcode121Imaging agentSubstance administered orally or intravenously for diagnostic imaging purposenewcode122FlushSubstance used to flush imaging agent in diagnostic imaging.newcode123Syringenewcode124Cartridgenewcode133InterventionalAdministrable substance type is interventionalnewcode141Substance administration completedSubstance administration is completednewcode142Substance administration abortedSubstance administration is abortednewcode143Substance administration in progressSubstance administration is in progressnewcode499Defined Substance AdministrationContainer Defined Substance Administrationnewcode500Injection ModeMode of the substance administration referring to automated or manual mode of injection.newcode501Maximum Administered ActivityMaximum allowed radio activitynewcode502Minimum Administered ActivityMinimum allowed radio activitynewcode503Maximum Administered VolumeMaximum allowed amount of activity to be administerednewcode504Scheduled Administration TimeScheduled time of administrationnewcode505Uptake TimeRadiopharmaceutical administration uptake timenewcode511Planned Substance Administration Procedure ReportPatient specific substance administration plan prior to a studynewcode512Rationale for Administering SubstancePurpose for administering the substancenewcode513Scheduled Administered ActivityDesired radioactivity to be administered newcode521Drug Product IdentifierDrug product identification IDnewcode522Equivalent Drug CodeLocal national code equivalent for the drugnewcode523Drug NameOther name of the drugnewcode524Fasting PeriodFasting period prior to the substance administrationnewcode531Imaging-Agent Related Risk FactorsIndicates the report is about Imaging-Agent Related Risk Factorsnewcode532Serum CreatinineSerum Creatinine level observation result of the patient. Units in mg/dL.newcode533Glomerular Filtration RateGFR observation of the patient. GFR is equal to the total of the filtration rates of the functioning nephrons in the kidney. Units in mL/min/1.73m2, UCUM, “mL/min/1.73m2.newcode534Assessment MethodMethod used to assess GFRnewcode541Substance AdministrationSubstance administration reportingnewcode542SubstanceSubstance of interest being referred in the report.newcode543Substance CodeCode that uniquely identifies the substance that is being referred in the report.newcode544Substance TypeAdministrable substance typenewcode545Substance ManufacturerManufacturer of the substancenewcode546Substance Order DateDate and time when the substance was ordered for purchasenewcode547Contrast ConcentrationConcentration of active ingredient in the contrast substancenewcode548MolarityMolarity or molar concentration, is the number of moles of a substance per liter of solutionnewcode549RelaxivityRelaxivity of the contrast substancenewcode550Osmolality at 37CNumber of osmoles of solute per kilogram of solvent at 37Cnewcode551Osmolarity at 37CNumber of osmoles of solute per liter (L) at 37Cnewcode552Viscosity at 37CViscosity of contrast substance at 37C newcode553Flush ConcentrationConcentration of active ingredient in the flush substancenewcode561Substance Administration Consumable InformationReport is about Substance Administration Consumable Informationnewcode562Substance Consumable TypeType of consumablenewcode562UPC CodeUniversal Product Code IDnewcode563Expiry DateExpiry date of the consumablenewcode564Manufacturer NameManufacturer of the consumablenewcode565Syringe TypeType of syringe in administration of the substancenewcode571Substance Delivery Procedure PlanConsists of one or more substance administration delivery steps.newcode572Plan TypeType of substance administration plan that indicates the purpose of the plan. newcode573Pressure LimitMaximum allowed pressure while delivering the substance during power injectionnewcode574Measurement graphTwo dimensional graph points (x,y) often depicting measurement of pressure or flow rate of fluid against timenewcode591Substance Delivery PhaseConsists of one or more phases of substance deliverynewcode591Substance Delivery Phase NumberPhase number in the delivery process in order to identify a phase.newcode593Substance Delivery Phase TypeAdministration phase typenewcode594Substance Flush RatioRatio of substance and flushnewcode595Initial Volume of Substance in ContainerStarting volume of the substance before the administrationnewcode596Residual Volume of Substance in ContainerRemaining volume of the substance after the administrationnewcode597Rise timenewcode601Performed Substance Administration Procedure ReportReport consisting of detailed description of delivery of substance administration to a patientnewcode602Summary TextShort summary describing no the substance administrationnewcode603Substance Administration Completion StatusStatus of the substance administration completionnewcode701Substance Administration Adverse EventDescription of the adverse event occurring during or after administration of substancenewcode702Number Of Adverse EventsNumber of adverse events reportednewcode703Substance Administration Adverse EventsAdverse events occurred during or after the administration of substance to a patientnewcode704Adverse Event SeveritySeverity of adverse eventnewcode705Relative Time of Occurrence of Adverse EventTemporal periods relating to contrast procedurenewcode706Adverse Event Observation Date TimeObserved time of the adverse eventnewcode707Adverse Reaction StepStep number where the adverse event was observednewcode708Adverse Reaction PhasePhase number where the adverse event was observednewcode712Programmable DeviceIndicates if the injector device used to administer the imaging-agent is programmablenewcode714Device Observer Software VersionSoftware Version of the injector device usednewcode713Injector Head TypeNumber of injector heads (Single or dual)CDXX05Radiopharmaceutical Administration Event DataStructure to record information pertaining to the administration of a radiopharmaceuticalCDXX12Radiopharmaceutical Administration Event UIDUnique identification of a single radiopharmaceutical administration event. CDXX16Estimated Extravasation ActivityThe estimated percentage of administered activity lost at the injection site. The estimation includes extravasation, paravenous administration and leakage at the injection site.CDXX17Administered activityThe calculated activity at the Radiopharmaceutical Start Time when the radiopharmaceutical is administered to the patient. The residual activity (i.e. radiopharmaceutical not administered), if measured, is reflected in the calculated value. The estimated extravasation is not reflected in the calculated value.CDXX19Radiopharmaceutical Vial Unit Serial IdentifierIdentifies the Radiopharmaceutical Vial for multi-dose types. The Unit Serial Number record the identification for each individual dose. CDXX24Reagent IdentifierLot or Unit Serial number for the reagent component for the radiopharmaceutical. Following CDX codes are from supplement 159.CDXX25Radionuclide Half LifeHalf-life used in decay calculations. Expressed in seconds.CDXX26Radionuclide IdentifierLot or Unit Serial number for the radionuclide component for the radiopharmaceutical. CDXX27Procedure Discontinuation ReasonThe reason the procedure was discontinued after a product was administered.CDX111Purpose of AdministrationLocal description of the intended use for an example “Cardiac Stress Dose”. CDX131No Signs or SymptomsIntravenous Extravasation exhibits no signs or symptomsCDX132Multiple Procedure TypeProcedure report value for reports that contain more than administration events for different procedure types. ( PET and a NM administration event)CDX133Prescribing PhysicianPhysician that prescribed the radiopharmaceutical.CDX134Radiopharmaceutical AdministratingPerson that administered the radiopharmaceutical.CDX 135Swelling MildIntravenous Extravasation exhibits mild swellingCDX136Swelling ModerateIntravenous Extravasation exhibits moderate swellingCDX137Swelling SevereIntravenous Extravasation exhibits severe swellingCDX138PainIntravenous Extravasation causes pain or the patient reports pain from suspected extravasation.CDX139Skin Blistering or UlcerationIntravenous Extravasation exhibits skin blistering or ulcerationCDX140Compartment SyndromeIntravenous Extravasation exhibits compartment syndromeCDX141Extravasation visible in imageExtravasation, paravenous administration and leakage at the injection site, is visible in the images.Changes to NEMA Standards Publication PS 3.17-2011Digital Imaging and Communications in Medicine (DICOM)Part 17: Explanatory InformationAdd new Section to Annex XX of PS 3.17:Annex XX Substance Administration Report Template (Informative)XX.1 PURPOSE OF THIS ANNEXThis Annex describes the use of the Substance Administration Reporting. The substance administration report objects records the planned and performed delivery of contrasting agents. In addition, it also consists of a defined object that describes the desired substance administration protocol for known studies.A defined substance administration object is independent of a specific patient. Defined substance administration is typically specific to certain type of study.A planned substance administration object is intended for representing the plan or program to deliver contrast agent to the patient for a contrast study. It could be programmed at the time of schedule of a study or beginning of the study. Often, it is programmed at the power-Injector device console by the modality technician or radiologists. The plan may be altered by the delivery system or a user based on a variety of factors.A performed substance administration report object is for reporting the actual plan or program that was used to deliver the contrast agent during a medical imaging study. In addition, basic performed substance administration report object provides a summarized version of the performed substance administration. This is attribute based class instead of a SR document. The primary use of this class is for communicating administration data to a modality system during an imaging studyThe scope is intended to cover all modalities in which radiographic, radiopharmaceutical or other agents are introduced into a circulatory system in a controlled fashion (CT, MR, XA, NM, US)Following are some of the use cases that uses the above object for substance administration reporting.Figure xx-1 demonstrates the workflow of administration of contrast agent during an imaging study.Figure xx-1Figure xx-2 shows Data flows with Substance Administration SR Reporting (Referred as CDSR in the diagram)Figure xx-2Figure xx-3 shows the Case 1 – Manual Bolus Injection SystemFigure xx-3Case 2 – Manul Bolus Injection with input from DSS/Order Filler/ModalityFigure xx-4Case 3 – Automatic Infusion Pump – Contrast ReportingFigure xx-5Case 4 – Automatic infusion pump contrast reporting : Dispense and AdministrationFigure xx-6Case 5 – Automatic infusion pump contrast reporting : Dispense, administration and realtime check of dispensed product.Figure xx-7Use case 6 – Integration with CT / MRFigure xx-8Use case – Integration with CVFigure xx-9Use case 8 – Reporting Figure xx-10Use case 9 – ProtocolingThis use-case gives an example on how a planned object could be used. The radiologist uses the protocoling client in order to plan the contrast administration protocols specific to a patient. The protocoling client outputs the planned object into the infusion manager which is used by the technologist for contrast administration.39566851270635004131310912495 00 47472602038985003413760200215500470281024225251 001 4443095357187500 ................
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