AALLC Style Guide



CDAR2_NCR_R1D1_2010JAN

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Neonatal Care Report (NCR)

Implementation Guide for CDA Release 2

(US Realm)

Based on HL7 CDA Release 2.0

Draft Standard for Trial use

First Ballot

January 2010

© 2010 Health Level Seven, Inc.

Ann Arbor, MI

All rights reserved.

|Co-Chair/Co-Editor: |Robert H. Dolin, MD |

| |Semantically Yours, LLC |

| |bobdolin@ |

|Co-Chair/Co-Editor |Liora Alschuler |

| |Alschuler Associates, LLC |

| |liora@ |

|Co-Chair |Calvin Beebe |

| |Mayo Clinic |

| |cbeebe@mayo.edu |

|Co-Chair |Keith W. Boone |

| |GE Healthcare |

| |keith.boone@ |

|Primary Editor: |Gay Giannone, MSN RN |

| |Alschuler Associates, LLC |

| |gay@ |

|Co-Editor: |Joy Kuhl, MBA, CPF |

| |Principal | Optimal Accords, LLC |

| |joy@ |

|Co-Editor: |Michael Padula, MD |

| |Neonatologist, Director, Neonatal IT |

| |The Children's Hospital of Philadelphia |

| |padula@email.chop.edu |

|Co-Editor: |Feliciano Yu, M.D. |

| |Information Technology Division |

| |Pediatrics Professor |

| |University of Alabama at Birmingham School of Medicine |

| |fyu@peds.uab.edu |

|Co-Editor: |Karna Murthy, MD |

| |Neonatologist, Children's Memorial Hospital |

| |Assistant Professor of Pediatrics, Northwestern University |

| |k-murthy@northwestern.edu |

|Co-Editor |David J. Durand, MD |

| |Director, Division of Neonatology |

| |Children's Hospital and Research Center Oakland |

| |ddurand@mail. |

|Co-Editor |Jacqueline Kueser |

| |Vice President, Strategy/R&D |

| |Children’s Hospitals Corporation of America |

| |jacqueline.kueser@ |

|Co-Editor | |

| |Kirk Elrod |

| |CHCA IT Liaison/Business Analyst |

| |Children’s Hospitals Corporation of America |

| |kirk.elrod@ |

|Current Working Group also includes: |Kate Conrad, Bobby George, Andy Spooner, David Muraco, Diane Ward, Celeste Milton, Jean|

| |Millar, Ann Watt, Shaun Shakib, Sandy Stuart, Brett Marquard, Jingdong (JD) Li, Anneke|

| |Goossen, William Goossen, Teresa Finitzo |

Acknowledgments

This guide was produced and developed through the efforts of the Neonatal Care Report (NCR) Project supported by the Children’s Hospitals Neonatal Consortium (CHNC), a group of over 21 children’s hospital Neonatal Intensive Care Units, in collaboration with the Child Health Corporation of America (CHCA), a business alliance of 43 leading children’s hospitals in North America.

CHNC and CHCA thank the Health Level 7 (HL7) Structured Documents Work Group for its support and sponsorship of this project within HL7, the Child Health Work Group for its participation, and the other volunteers throughout HL7 who contributed time and input into the effort.

Finally, we acknowledge the foundational work on HL7 Version 3 and the Reference Information Model (RIM), the HL7 domain committees, especially Patient Care, and the work done on Clinical Document Architecture (CDA) itself.

We also acknowledge the collaborative effort of the American Society for Standards and Materials (ASTM) and HL7, which produced the Continuity of Care Document (CCD). All these efforts were critical ingredients to the development of this Draft Standard for Trial Use (DSTU), and the degree to which the DSTU reflects these efforts will foster interoperability across the spectrum of health care.

SNOMED CT( is the registered trademark of the International Health Terminology Standard Development Organisation (IHTSDO). LOINC( is a registered United States trademark of Regenstrief Institute, Inc.

Revision History (delete low-level detail before submitting to ballot)

|Rev |Date |By Whom |Changes |

|New |11/16/2009 |Giannone/Kuhl |New |

|Draft1 |11/20/09 |Giannone |Tdb export added |

|First draft |11/30/2009 |Giannone/Hardy/Dolin |Tech edit/First QA completed |

|for posting | | | |

| | | | |

| | | | |

Table of Contents

1 Introduction 10

1.1 Purpose 10

1.2 Approach 10

1.3 Scope 10

1.3.1 Inheritance of Constraints 11

1.3.2 Future Work 11

1.4 Audience 11

1.5 Organization of This Guide 11

1.5.1 Templates 11

1.5.2 Vocabularies and Value Sets 12

1.6 Use of Templates 12

1.6.1 Originator Responsibilities: General Case 12

1.6.2 Recipient Responsibilities: General Case 12

1.7 Conventions Used in This Guide 12

1.7.1 Conformance Requirements 12

1.7.2 Keywords 14

1.7.3 XML Examples 14

1.8 Contents of the DSTU Ballot Package 15

1.9 Templates by Containment 15

2 Document Template 17

2.1 Neonatal Care Report 17

3 Section Templates 22

3.1 CCD Encounters section 22

3.1.1 Encounters section – NCR 22

3.2 Acuity data section – NCR 23

3.3 Patient data section 24

3.4 Patient data section – NCR 25

3.5 Reporting parameters section 27

4 Clinical Statement Templates 29

4.1 Acuity indicator data generic organizer 29

4.2 Acuity data time organizer - admission to 12 hours 32

4.3 Acuity data time organizer - day 3 33

4.4 Acuity data time organizer - day 7 33

4.5 Admission activity – neonatal 34

4.6 CCD Encounter activity 35

4.6.1 Neonatal ICU encounter activity 35

4.7 CCD Medication activity 37

4.7.1 Nitric oxide administration 38

4.7.2 Oxygen Administration 39

4.8 CCD Result observation 41

4.8.1 CDA XML patterns conforming to CCD Result observation 42

4.8.2 Activated partial thromboplastin time 43

4.8.3 Alanine aminotransferase (ALT) 43

4.8.4 Albumin observation 44

4.8.5 Apgar at 1 minute 44

4.8.6 Apgar at 5 minutes 45

4.8.7 Apgar score prolonged 45

4.8.8 Arterial PaO2 Observation 46

4.8.9 Aspartate aminotransferase (AST) 46

4.8.10 Bicarbonate serum 47

4.8.11 Bilirubin, conjugated 47

4.8.12 Bilirubin, total 48

4.8.13 Birth head circumference 48

4.8.14 Birth weight 48

4.8.15 Blood gas base deficit 49

4.8.16 Blood gas base excess 49

4.8.17 Blood pH 50

4.8.18 Blood urea nitrogen (BUN) 51

4.8.19 Body temperature 51

4.8.20 Body weight 52

4.8.21 Calcium ionized 52

4.8.22 Calcium total serum 53

4.8.23 Creatinine observation 53

4.8.24 Diastolic blood pressure 53

4.8.25 Fibrinogen level 54

4.8.26 Gestational age 54

4.8.27 Glucose serum 55

4.8.28 Head circumference 55

4.8.29 Heart Rate 56

4.8.30 Hemoglobin 56

4.8.31 International normalized ratio (INR) 56

4.8.32 Lactic acid from serum/plasma 57

4.8.33 Mean airway pressure 57

4.8.34 Mean blood pressure 58

4.8.35 PaCO2 Observation 58

4.8.36 Platelets 59

4.8.37 Potassium serum 59

4.8.38 Prothrombin time (PT) 60

4.8.39 Respiratory rate 60

4.8.40 Seizure frequency 61

4.8.41 Sodium serum 61

4.8.42 Systolic blood pressure 61

4.8.43 Urine output 62

4.8.44 White blood cell (leukocytes) 62

4.9 Discharge activity – Neonatal 63

4.10 Inborn/outborn 64

4.11 Nothing by mouth (NPO) 65

4.12 Oxygenation index 65

4.13 PaO2/FIO2 ratio 66

4.14 Renal dialysis (renal replacement therapy) 66

4.15 Reporting parameters act 67

4.16 Respiratory or ventilatory support 68

4.17 Respiratory severity score 69

4.18 Steroid treatment (systemic) 70

4.19 CCD Location participation 71

4.19.1 Neonatal ICU location 71

5 References 73

Appendix A — Acronymns and Abbreviations 74

Appendix B — Templates Used in This Guide 75

Appendix C — Summary of Value Sets 78

Table of Figures

Figure 1: Template name and "conforms to" appearance 13

Figure 2: Template-based conformance statements example 13

Figure 3: CCD conformance statements example 14

Figure 4: ClinicalDocument example 14

Figure 5: NCR document template example 20

Figure 6: NCR encounters section example 23

Figure 7: NCR acuity data section example 24

Figure 8: NCR patient data section example 27

Figure 9: Reporting parameters section example 28

Figure 10: Admission activity act example 34

Figure 11: Neonatal ICU encounter example 37

Figure 12: Nitric oxide administration example 39

Figure 13: Oxygen administration example 40

Figure 14: Typical pattern for CCD-result observation conforming templates 42

Figure 15: Typical non-laboratory pattern for CCD-result observation conforming templates 42

Figure 16: Specimen type pattern for CCD-result observation conforming templates 43

Figure 17: Neonatal discharge activity example 64

Figure 18: Inborn/outborn example 64

Figure 19: Nothing by mouth (NPO) example 65

Figure 20: Oxygenation index example 66

Figure 21: PaO2/FIO2 example 66

Figure 22: Renal dialysis example (did not occur) 67

Figure 23: Reporting parameters act example 68

Figure 24: Respiratory or ventilatory support example 69

Figure 25: Respiratory severity score example 69

Figure 26: Steroid treatment example 70

Figure 27: Neonatal ICU location example 72

Table of Tables

Table 1: Contents of the DSTU Ballot Package 15

Table 2: Templates by Containment 16

Table 3: Templates Organized Hierarchically 75

Table 5: Summary of Value Sets 78

Introduction

1. Purpose

Over the previous few years, the Children’s Hospitals Neonatal Consortium (CHNC), a group of over 21 children’s hospital Neonatal Intensive Care Units (NICUs), in collaboration with the Child Health Corporation of America (CHCA), developed a core data set of common data elements important to children’s hospital NICUs. CHNC is committed to developing tools to evaluate the effectiveness of tertiary neonatal intensive care in their unique patient population. Through the systematic collection and analyses of clinical data on infants admitted to children’s hospital NICUs, CHNC expects to spearhead benchmarking, quality improvement, and research initiatives that have not previously been possible in their patient population. In 2009, CHNC approached CHCA, a business alliance of 43 leading children’s hospitals in North America, to assist in creation of the database for this effort.

This project is intended to facilitate electronic extraction of a subset of the CHNC data set using a standard reporting specification in the form of a Neonatal Care Report (NCR) to support performance improvement and research. CHNC and CHCA envision this effort as a building block for more widespread use of the electronic medical record in place of manual data abstraction.

2. Approach

The CHNC core data set contains around 700 data elements. A subset of approximately 60 data elements are referenced in the NCR, including 37 acuity score data elements and 21 base data elements. Some of the data elements included in the NCR are known to correspond to Vermont Oxford Network (VON); others correspond to data collection sets mapped to national standards such as the Healthcare Associated Infection (HAI) reports for the National Healthcare Safety Network (NHSN).

Working with an initial portion of the data provides the opportunity to work with the data from the perspective of the underlying model and electronic format and to explore many design issues thoroughly. Taking this as an initial step ensures that the data set developers and standards community can reach consensus prior to the larger commitment of time that would be required to bring the full data set into standard format.

This project supports reusability and ease of data collection through a standard data representation harmonized with work developed through Health Information Technology Expert Panel (HITEP), balloted through Health Level Seven (HL7) and/or recognized by the Health Information Technology Standards Panel (HITSP).

This implementation guide (IG) specifies a standard for electronic submission of NCRs in a Clinical Document Architecture (CDA), Release 2 format.

3. Scope

This implementation guide is a conformance profile, as described in the Refinement and Localization section of the HL7 Version 3 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.

1. Inheritance of Constraints

As an annotation profile, portions of this implementation guide summarize or explain the base standard; therefore, not all requirements stated here are original to the implementation guide. Some originate in the base specification. Those requirements that do not add further constraints to the base standard and that can be validated through CDA.xsd may not have corresponding conformance statements.

Where no constraints are stated in this guide, NCR CDA instances are subject to and are to be created in accordance with the base CDA R2 specification. Where, for instance, the CDA R2 specification declares an attribute to be optional and the PHCR CDA specification contains no additional constraints, that attribute remains optional for use in an NCR CDA instance.

2. Future Work

The standard data submission format supported through this project represents a key, initial step in the move toward automation of data collection for quality monitoring and improvement in children’s hospitals NICUs. A natural follow-on to this work is a pilot project integrating the reporting into current workflow and information technology infrastructures. Other possible future work includes expansion of the NCR to include additional data elements.

4. Audience

The audience for this document includes software developers and implementers who wish to develop reporting capabilities within their electronic health record (EHR systems), and developers and analysts in receiving institutions who wish to process CDA NCR documents created according to this specification. The intended audience also includes neonatal experts and other children’s hospital providers.

5. Organization of This Guide

The requirements as laid out in the body of this document are subject to change per the policy on implementation guides (see section 13.02 “Draft Standard for Trial Use Documents” within the HL7 Governance and Operations Manual, ).

1. Templates

Templates are organized by document (see Document Template), by section (see Section Templates), and by clinical statements (see Clinical Statement Templates). Within a section, templates are arranged hierarchically, where a more specific template is nested under the more generic template that it conforms to. See Templates by Containment for a listing of the higher level templates by containment; the appendix Templates Used in This Guide includes a table of all of the templates Organized Hierarchically.

2. Vocabularies and Value Sets

Vocabularies recommended in this guide are from standard vocabularies. When SNOMED codes are used, rules defined in Using SNOMED CT in HL7 Version 3 are adhered to. In many cases, these vocabularies are further constrained into value sets for use within this guide. Value set names and OIDs are summarized in the table Summary of Value Sets. Each named value set in this summary table is stored in a template database that will be maintained by CHCA.

6. Use of Templates

When valued in an instance, the template identifier (templateId) signals the imposition of a set of template-defined constraints. The value of this attribute provides a unique identifier for the templates in question.

1. Originator Responsibilities: General Case

An originator can apply a templateId to assert conformance with a particular template.

In the most general forms of CDA exchange, an originator need not apply a templateId for every template that an object in an instance document conforms to. This implementation guide asserts when templateIds are required for conformance.

2. Recipient Responsibilities: General Case

A recipient may reject an instance that does not contain a particular templateId (e.g., a recipient looking to receive only CCD documents can reject an instance without the appropriate templateId).

A recipient may process objects in an instance document that do not contain a templateId (e.g., a recipient can process entries that contain Observation acts within a Problems section, even if the entries do not have templateIds).

7. Conventions Used in This Guide

1. Conformance Requirements

Conformance statements are grouped and identified by the name of the template, along with the templateId and the context of the template (e.g., ClinicalDocument, section, observation), which specifies the element under constraint. If a template is a specialization of another template, its first constraint indicates the more general template. In all cases where a more specific template conforms to a more general template, asserting the more specific template also implies conformance to the more general template. An example is shown below.

Figure 1: Template name and "conforms to" appearance

Template name

[: templateId ]

Description of the template will be here .....

1. Conforms to Template (templateId: XXXXXXX>YYY).

2. shall contain [1..1] @classCode = (CodeSystem:

123.456.789 Class) static (CONF:).

.......

The conformance verb keyword at the start of a constraint (shall, should, may, etc.) indicates business conformance, whereas the cardinality indicator (0..1, 1..1, 1..*, etc.) specifies the allowable occurrences within an instance. Thus, "may contain 0..1" and "should contain 0..1" both allow for a document to omit the particular component, but the latter is a stronger recommendation that the component be included if it is known.

The following cardinality indicators may be interpreted as follows:

0..1 as zero to one present

1..1 as one and only one present

2..2 as two must be present

1..* as one or more present

0..* as zero to many present

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. The use of shall requires that the component be valued with a member from the cited value set; however, in every case any HL7 "null" value such as other (OTH) or unknown (UNK) may be used.

Each constraint is uniquely identified (e.g., "CONF:605") by an identifier placed at or near the end of the constraint. These identifiers are not sequential as they are based on the order of creation of the constraint.

Figure 2: Template-based conformance statements example

1. SHALL contain [1..1] component/structuredBody (CONF:4082).

a. This component/structuredBody SHOULD contain [0..1] component (CONF:4130) such that it

i. SHALL contain [1..1] Reporting Parameters section (templateId:2.16.840.1.113883.10.20.17.2.1) (CONF:4131).

b. This component/structuredBody SHALL contain [1..1] component (CONF:4132) such that it

i. SHALL contain [1..1] Patient data section - NCR (templateId:2.16.840.1.113883.10.20.17.2.5) (CONF:4133).

CCD templates are included within this implementation guide for ease of reference. CCD templates contained within this implementation guide are formatted WITHOUT typical keyword and XML element styles. A WIKI site is available if you would like to make a comment to be considered for the next release of CCD: . The user name and password are: wiki/wikiwiki. You will need to create an account to edit the page and add your suggestion.

Figure 3: CCD conformance statements example

1. The value for “Observation / @moodCode” in a problem observation SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC. (CONF: 814).

2. A problem observation SHALL include exactly one Observation / statusCode. (CONF: 815).

3. The value for “Observation / statusCode” in a problem observation SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC. (CONF: 816).

4. A problem observation SHOULD contain exactly one Observation / effectiveTime, to indicate the biological timing of condition (e.g. the time the condition started, the onset of the illness or symptom, the duration of a condition). (CONF: 817).

2. Keywords

The keywords shall, shall not, should, should not, may, and need not in this document are to be interpreted as described in the HL7 Version 3 Publishing Facilitator's Guide:

• shall: an absolute requirement

• shall not: an absolute prohibition against inclusion

• should/should not: valid reasons to include or ignore a particular item, but must be understood and carefully weighed

• may/need not: truly optional; can be included or omitted as the author decides with no implications

3. XML Examples

XML samples appear in various figures in this document in a fixed-width 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 4: ClinicalDocument example

...

XPath expressions are used in the narrative and conformance requirements to identify elements because they are familiar to many XML implementers.

8. Contents of the DSTU Ballot Package

Table 1: Contents of the DSTU Ballot Package

|Filename |Description |

|CDAR2_NCR_R1D1_2010JAN.doc |This guide |

|NeonatalCareReport.xml |The Neonatal Care Report sample |

|cda.xsl |A generic stylesheet for displaying the content of the sample document in |

| |HTML |

9. Templates by Containment

The table below shows the Neonatal Case Report (NCR) templates organized by the document template and the section templates the document contains. In turn, it shows the sections and many of the clinical statement entry templates the sections contain. The 44 clinical statement templates contained in the Acuity indicator data generic organizer template are not included in this chart for ease of reading. This Templates by Containment table is placed before the template descriptions and conformance statements to provide an understanding of various groupings and organization of the templates as they would exist in an NCR CDA instance. To view all of the templates contained in the guide in hierarchical order, see the Templates Organized Hierarchically table.

Table 2: Templates by Containment

|Template OID |Type |Template Title |

|2.16.840.1.113883.10.20.17.1.1 |document |Neonatal Care Report |

|    2.16.840.1.113883.10.20.17.2.1 |section |Reporting parameters section |

|        2.16.840.1.113883.10.20.17.3.8 |entry | Reporting parameters act |

|    2.16.840.1.113883.10.20.17.2.5 |section |Patient data section - NCR |

|        2.16.840.1.113883.10.20.17.3.4 |entry | Apgar at 1 minute |

|        2.16.840.1.113883.10.20.17.3.5 |entry | Apgar at 5 minute |

|        2.16.840.1.113883.10.20.17.3.6 |entry | Apgar score prolonged |

|        2.16.840.1.113883.10.20.17.3.2 |entry | Birth head circumference |

|        2.16.840.1.113883.10.20.17.3.1 |entry | Birth weight |

|        2.16.840.1.113883.10.20.17.3.3 |entry | Gestational age |

|        2.16.840.1.113883.10.20.17.3.7 |entry | Inborn/outborn |

|        2.16.840.1.113883.10.20.17.2.2 |section | Encounters section NCR |

|            2.16.840.1.113883.10.20.17.3.15 |entry | Neonatal ICU encounter activity |

|                2.16.840.1.113883.10.20.17.3.14 |subentry | Neonatal ICU location |

|                2.16.840.1.113883.10.20.17.3.12 |entry | Admission activity - neonatal |

|                    2.16.840.1.113883.10.20.17.3.10 |entry | Body temperature |

|                    2.16.840.1.113883.10.20.17.3.11 |entry | Body weight |

|                2.16.840.1.113883.10.20.17.3.13 |entry | Discharge activity - Neonatal |

|                    2.16.840.1.113883.10.20.17.3.11 |entry | Body weight |

|                    2.16.840.1.113883.10.20.17.3.9 |entry | Head circumference |

|        2.16.840.1.113883.10.20.17.2.3 |section | Acuity data section - NCR |

| 2.16.840.1.113883.10.20.17.3.59 |entry | Acuity indicator data generic organizer[1] |

|            2.16.840.1.113883.10.20.17.3.60 |entry | Acuity data time organizer - admission to 12|

| | |hours |

|            2.16.840.1.113883.10.20.17.3.61 |entry | Acuity data time organizer - day 3 |

|            2.16.840.1.113883.10.20.17.3.62 |entry | Acuity data time organizer - day 7 |

Document Template

1 Neonatal Care Report

[ClinicalDocument: templateId 2.16.840.1.113883.10.20.17.1.1]

The CDA the Neonatal Care Report (NCR) constrains CDA to express the data elements identified by CHNC. This NCR CDA R2 document template defines the data elements that belong in the header of the NCR CDA document and prescribes the sections that belong in the NCR. Within the NCR document is an initial segment of data elements from the CHNC Neonatal Intensive Care Unit (NICU) Core Data Set (CDS). This NCR CDA will send these data elements from Neonatal Intensive Care providers to the CHNC database in standardized CDA format for analysis and performance improvement work.

A complete NCR is created and sent after an infant is discharged. An initial NCR may be created and sent shortly after the infant is born. Many data elements in this initial NCR will have null values for the many values that are unknown or not applicable at this point. The complete NCR sent after discharge will replace the first NCR document.

1. SHALL contain [1..1] realmCode="US" (CodeSystem: 2.16.840.1.113883.5.147 HL7 RealmOfUse) STATIC (CONF:4066).

2. SHALL contain [1..1] templateId/@root="2.16.840.1.113883.10.20.17.1.1" (CONF:4067).

3. SHALL contain [1..1] code/@code="NCR-X" Neonatal Care Report (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:4068).

4. SHALL contain [1..1] title (CONF:4069).

a. This title shall be valued with a case-insensitive, text string containing "Neonatal Care Report" (CONF:4083).

5. SHALL contain [1..1] recordTarget (CONF:4070).

a. This recordTarget SHALL contain [1..1] patientRole (CONF:4071).

i. This patientRole SHALL contain [1..*] id (CONF:4175).

1. Such ids shall have one id that is the infant's medical record number (CONF:4203).

ii. This patientRole SHALL contain [1..1] patient (CONF:4183).

1. This patient SHALL contain [1..*] name (CONF:4184) such that it

a. SHALL contain [1..1] given (CONF:4185).

b. SHALL contain [1..1] family (CONF:4186).

c. SHALL contain [1..1] validTime/low (CONF:4187).

2. This patient MAY contain [0..*] name (CONF:4202).

3. This patient SHALL contain [1..1] administrativeGenderCode/@code, which SHALL be selected from ValueSet 2.16.840.1.114443.1.1 HITSP foundations sex structure DYNAMIC (CONF:4191).

4. This patient SHALL contain [1..1] birthTime (CONF:4195).

6. SHALL contain [1..*] author (CONF:4072).

7. SHALL contain [1..1] custodian (CONF:4075).

a. This custodian SHALL contain [1..1] assignedCustodian (CONF:4177).

i. This assignedCustodian SHALL contain [1..1] representedCustodian (CONF:4178).

1. This representedCustodian SHALL contain [1..*] id (CONF:4179).

a. At least one id SHALL contain [1..1] @root="2.16.840.1.113883.3.375 " (CONF:4176).

b. This id SHALL contain @extension (CONF:4199).

i. This @extension shall be a unique number assigned by CHNC (CONF:4200).

8. SHOULD contain [0..1] legalAuthenticator (CONF:4077).

a. This legalAuthenticator, if present, SHALL contain [1..1] time (CONF:4078).

b. This legalAuthenticator, if present, SHALL contain [1..1] signatureCode="S" (CodeSystem: 2.16.840.1.113883.5.89 Participationsignature) STATIC (CONF:4079).

c. This legalAuthenticator, if present, SHALL contain [1..1] assignedEntity (CONF:4080).

i. This assignedEntity SHALL contain [1..1] id (CONF:4081).

9. SHALL contain [1..1] participant (CONF:4084) such that it

a. SHALL contain [1..1] @typeCode="IND" (CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType) STATIC (CONF:4085).

b. SHALL contain [1..1] associatedEntity (CONF:4088).

i. This associatedEntity SHALL contain [1..1] @classcode="PRS" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4089).

ii. This associatedEntity SHALL contain [1..1] code="MTH" (CodeSystem: 2.16.840.1.113883.5.111 HL7RoleCode) STATIC (CONF:4090).

iii. This associatedEntity SHALL contain [1..1] addr (CONF:4091).

1. This addr SHALL contain [1..1] postalCode (CONF:4095).

2. This addr SHALL contain [1..1] useablePeriod (CONF:4086).

a. This useablePeriod shall equal the discharge date of the infant (CONF:4087).

iv. This associatedEntity SHALL contain [1..1] associatedPerson (CONF:4092).

1. This associatedPerson SHALL contain [1..1] name (CONF:4093).

a. This name SHALL contain [1..1] family (CONF:4094).

10. MAY contain [0..1] relatedDocument (CONF:4096) such that it

a. SHALL contain [1..1] @typeCode="RPLC" (CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType) STATIC (CONF:4097).

b. SHALL contain [1..1] parentDocument (CONF:4098).

i. This parentDocument SHALL contain [1..1] @classCode="DOCCLIN" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4099).

ii. This parentDocument SHALL contain [1..1] @moodCode="EVN" (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:4100).

iii. This parentDocument SHALL contain [1..1] id (CONF:4101).

11. SHALL contain [1..1] componentOf (CONF:4104).

a. This componentOf SHALL contain [1..1] encompassingEncounter (CONF:4105).

i. This encompassingEncounter SHALL contain [1..1] id (CONF:4106).

1. This id shall be the "Data Processing (DP) Account number", a number unique to the visit (CONF:4107).

ii. This encompassingEncounter SHALL contain [1..1] effectiveTime/low (CONF:4108).

iii. This encompassingEncounter SHALL contain [1..1] effectiveTime/high (CONF:4109).

12. SHALL contain [1..1] component/structuredBody (CONF:4082).

a. This component/structuredBody MAY contain [0..1] component (CONF:4130) such that it

i. SHALL contain [1..1] Reporting parameters section (templateId:2.16.840.1.113883.10.20.17.2.1) (CONF:4131).

b. This component/structuredBody SHALL contain [1..1] component (CONF:4132) such that it

i. SHALL contain [1..1] Patient data section - NCR (templateId:2.16.840.1.113883.10.20.17.2.5) (CONF:4133).

Figure 5: NCR document template example

Neonatal Care Report

...

Kari

Kidd

Baby Girl

Mumm

...

...

...

addr>

99999

Martha

Mum

...

Section Templates

1 CCD Encounters section

[section: templateId 2.16.840.1.113883.10.20.1.3]

The CCD encounters section is used to list and describe 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.

1. The encounters section SHALL contain Section / code. (CONF:593).

2. The value for "Section / code" SHALL be "46240-8" "History of encounters" 2.16.840.1.113883.6.1 LOINC STATIC. (CONF:594).

3. The encounters section SHALL contain Section / title. (CONF:595).

4. Section / title SHOULD be valued with a case-insensitive language-insensitive text string containing "encounters". (CONF:596).

1 Encounters section – NCR

[section: templateId 2.16.840.1.113883.10.20.17.2.2]

This section contains administrative encounter information and selected data specific to each admission and discharge in an encounter. This section contains data for the current encounter being reported and may contain information about historical encounters.

1. Conforms to CCD Encounters section Template (templateId: 2.16.840.1.113883.10.20.1.3).

2. SHALL contain [1..1] templateId/@root="2.16.840.1.113883.10.20.17.2.2" (CONF:3337).

3. SHALL contain [1..1] title="Encounters" (CONF:3338).

4. SHALL contain [1..1] text (CONF:3339).

5. SHALL contain [1..*] entry (CONF:3340) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3341).

b. SHALL contain [1..1] Neonatal ICU encounter activity (templateId:2.16.840.1.113883.10.20.17.3.15) (CONF:3342).

Figure 6: NCR encounters section example

Encounters

...

...

2 Acuity data section – NCR

[section: templateId 2.16.840.1.113883.10.20.17.2.3]

The patient data section in the NCR contains data collected during a neonatal intensive care unit (NICU) inpatient stay. This section contains data that could be used in endorsed quality measures, and it may inform the creation of NICU quality measures. It contains significant basic data about the infant's birth and two subsections: an encounter section and an acuity assessment section.

1. SHALL contain [1..1] templateId/@root="2.16.840.1.113883.10.20.17.2.3" (CONF:4165).

2. SHALL contain [1..1] entry (CONF:4172) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4167).

b. SHALL contain [1..1] Acuity data time organizer - admission to 12 hours (templateId:2.16.840.1.113883.10.20.17.3.60) (CONF:4168).

3. SHALL contain [1..1] entry (CONF:4169) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4170).

b. SHALL contain [1..1] Acuity data time organizer - day 3 (templateId:2.16.840.1.113883.10.20.17.3.61) (CONF:4171).

4. SHALL contain [1..1] entry (CONF:4166) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4173).

b. SHALL contain [1..1] Acuity data time organizer - day 7 (templateId:2.16.840.1.113883.10.20.17.3.62) (CONF:4174).

Figure 7: NCR acuity data section example

Acuity Assesment

...

...

...

...

...

...

3 Patient data section

[section: templateId 2.16.840.1.113883.10.20.17.2.4]

The patient data section contains clinically significant patient data and may contain patient data elements and measure-specific grouping data elements as defined by particular measure(s).

1. SHALL contain [1..1] code/@code="55188-7" Clinical Information (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3865).

2. SHALL contain [1..1] title="PATIENT DATA" (CONF:3866).

3. SHALL contain [1..1] text (CONF:3867).

4 Patient data section – NCR

[section: templateId 2.16.840.1.113883.10.20.17.2.5]

The patient data section in the NCR contains data collected during a neonatal intensive care unit (NICU) inpatient stay. This section contains data that could be used in endorsed quality measures, and it may inform the creation of NICU quality measures. It contains significant basic data about the infant's birth and two subsections: an encounter section and an acuity assessment section.

1. Conforms to Patient data section Template (templateId: 2.16.840.1.113883.10.20.17.2.4).

2. SHALL contain [1..1] templateId/@root="2.16.840.1.113883.10.20.17.2.5" (CONF:4134).

3. SHALL contain [1..1] entry (CONF:4135) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4136).

b. SHALL contain [1..1] Encounters section - NCR (templateId:2.16.840.1.113883.10.20.17.2.2) (CONF:4137).

4. SHALL contain [1..1] entry (CONF:4138) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4139).

b. SHALL contain [1..1] Acuity data section - NCR (templateId:2.16.840.1.113883.10.20.17.2.3) (CONF:4140).

5. SHALL contain [1..1] entry (CONF:4144) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4145).

b. SHALL contain [1..1] Birth weight (templateId:2.16.840.1.113883.10.20.17.3.1) (CONF:4146).

6. SHALL contain [1..1] entry (CONF:4147) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4148).

b. SHALL contain [1..1] Birth head circumference (templateId:2.16.840.1.113883.10.20.17.3.2) (CONF:4149).

7. SHALL contain [1..1] entry (CONF:4150) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4151).

b. SHALL contain [1..1] Gestational age (templateId:2.16.840.1.113883.10.20.17.3.3) (CONF:4152).

8. SHALL contain [1..1] entry (CONF:4153) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4154).

b. SHALL contain [1..1] Apgar at 1 minute (templateId:2.16.840.1.113883.10.20.17.3.4) (CONF:4155).

9. SHALL contain [1..1] entry (CONF:4156) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4157).

b. SHALL contain [1..1] Apgar at 5 minute (templateId:2.16.840.1.113883.10.20.17.3.5) (CONF:4158).

10. MAY contain [0..*] entry (CONF:4159) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4160).

b. SHALL contain [1..1] Apgar score prolonged (templateId:2.16.840.1.113883.10.20.17.3.6) (CONF:4161).

11. SHALL contain [1..1] entry (CONF:4162) such that it

a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:4163).

b. SHALL contain [1..1] Inborn/outborn (templateId:2.16.840.1.113883.10.20.17.3.7) (CONF:4164).

Figure 8: NCR patient data section example

Patient Data

...

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