Neonatal Care Report publication draft with tracked changes

CDAR2L3_IG_NEONATALRPT_R1_D1_2010JAN_PUBDRAFT 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@gmail.com Co-Chair/Co-Editor Liora Alschuler Alschuler Associates, LLC liora@alschulerassociates.com Co-Chair Calvin Beebe Mayo Clinic cbeebe@mayo.edu Co-Chair Keith W. Boone GE Healthcare keith.boone@ge.com Primary Editor: Gay Giannone, MSN RN Alschuler Associates, LLC gay@alschulerassociates.com Co-Editor: Joy Kuhl, MBA, CPF Principal | Optimal Accords, LLC joy@optimalaccords.com Co-Editor: Michael A. Padula, MD Neonatologist, Clinical Informaticist 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.cho.org Jacqueline Kueser Vice President, Strategy/R&D Children’s Hospitals Corporation of America jacqueline.kueser@chca.com Co-Editor Co-Editor Kirk Elrod CHCA IT Liaison/Business Analyst Children’s Hospitals Corporation of America kirk.elrod@chca.com 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 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 2 January 2010 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 25 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 Seven (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. 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. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 3 January 2010 Revision History Rev Date By Whom Changes Final DSTU for ballot 12/11/2009 Et al Final draft for ballot submitted to HL7 Headquarters. Draft with tracked changes 3/17/2010 Et al Draft for publication with tracked changes posted for review prior to submission to HQ for publication Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 4 January 2010 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 1.6.1 Originator Responsibilities: General Case .......................................................... 12 1.6.2 Recipient Responsibilities: General Case ........................................................... 12 1.7 2 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 Package................................................................................. 15 1.9 Templates by Containment ...................................................................................... 15 DOCUMENT TEMPLATE ................................................................................................ 17 2.1 3 Use of Templates ..................................................................................................... 12 Neonatal Care Report .............................................................................................. 17 SECTION TEMPLATES .................................................................................................. 22 3.1 CCD Encounters section .......................................................................................... 22 3.1.1 4 Encounters section – NCR ................................................................................ 22 3.2 Acuity score data section ......................................................................................... 23 3.3 Patient data section ................................................................................................. 24 3.4 Patient data section – NCR....................................................................................... 25 3.5 Reporting parameters section .................................................................................. 27 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 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. 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Page 5 January 2010 4.4 Acuity data time organizer - day 7............................................................................ 33 4.5 Admission activity – neonatal................................................................................... 34 4.6 CCD Encounter activity ........................................................................................... 35 4.6.1 4.7 Neonatal ICU encounter activity ........................................................................ 35 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 ...................................................................................... 50 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 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. 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Page 6 January 2010 4.8.28 Head circumference .......................................................................................... 55 4.8.29 Heart rate ........................................................................................................ 56 4.8.30 Hemoglobin ...................................................................................................... 56 4.8.31 International normalized ratio (INR) .................................................................. 57 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 ............................................................................................. 60 4.8.38 Prothrombin time (PT) ...................................................................................... 60 4.8.39 Respiratory rate ............................................................................................... 60 4.8.40 Seizures ........................................................................................................... 61 4.8.41 Sodium serum .................................................................................................. 61 4.8.42 Systolic blood pressure ..................................................................................... 62 4.8.43 Urine output .................................................................................................... 62 4.8.44 White blood cell (leukocyte) count ..................................................................... 63 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 5 Neonatal ICU location ....................................................................................... 71 REFERENCES .............................................................................................................. 73 APPENDIX A — ACRONYMNS AND ABBREVIATIONS ......................................................... 74 APPENDIX B — TEMPLATES USED IN THIS GUIDE ........................................................... 76 APPENDIX C — SUMMARY OF VALUE SETS ...................................................................... 79 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. 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Page 7 January 2010 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: Acuity score 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 ........................................................................... 41 Figure 14: Typical laboratory 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 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 8 January 2010 Table of Tables Table 1: Contents of the DSTU Package ................................................................................ 15 Table 2: Templates by Containment ...................................................................................... 16 Table 3: Templates Organized Hierarchically ......................................................................... 76 Table 4: Summary of Value Sets ........................................................................................... 79 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 9 January 2010 1 INTRODUCTION 1.1 Purpose Over the previous few years, the Children’s Hospitals Neonatal Consortium (CHNC), a group of over 25 children’s hospital Neonatal Intensive Care Units (NICUs), 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 2008, 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. 1.2 Approach The CHNC core data set contains around 700 data elements; a subset of approximately 60 data elements are addressed in this Draft Standard, including 37 physiologic and laboratory elements for assessment of illness severity (4.1 Acuity indicator data generic organizer) and 21 base data elements (found throughout the header and body of the NCR, e.g. name, medical record number, birth weight and discharge head circumference). 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 Continuity of Care Document (CCD) and the Quality Reporting Document Architecture (QRDA). 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. 1.3 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 for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 10 January 2010 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. 1.3.1 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 NCR specification contains no additional constraints, that attribute remains optional for use in an NCR CDA instance. 1.3.2 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. 1.4 Audience The audience for this document includes software developers and implementers who wish to develop reporting capabilities within their electronic health record (EHR and Pediatric 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. 1.5 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, http://www.hl7.org/documentcenter/public/membership/HL7_Governance_and_Oper ations_Manual.pdf). 1.5.1 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. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 11 January 2010 1.5.2 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. 1.6 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. 1.6.1 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. 1.6.2 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). 1.7 Conventions Used in This Guide 1.7.1 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. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 12 January 2010 Figure 1: Template name and "conforms to" appearance Template name [<type of template>: templateId <XXXX.XX.XXX.XXX>] Description of the template will be here ..... 1. Conforms to <The template name> Template (templateId: XXXX<XX>XXX>YYY). 2. SHALL contain [1..1] @classCode = <AAA> <code display name> (CodeSystem: 123.456.789 <XXX> Class) STATIC (CONF:<number>). ....... 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. 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). SHALL Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 13 January 2010 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: http://wiki.hl7.org/index.php?title=CCD_Suggested_Enhancements. 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). 1.7.2 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 1.7.3 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 <ClinicalDocument mins=’urn:h17-org:v3’> ... </ClinicalDocument> XPath expressions are used in the narrative and conformance requirements to identify elements because they are familiar to many XML implementers. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 14 January 2010 1.8 Contents of the DSTU Package Table 1: Contents of the DSTU Package Filename Description CDAR2L3_IG_NEONATALRPT_ R1_D1_2010JAN_PUBDRAFT This guide NeonatalCareReport.xml The Neonatal Care Report sample cda.xsl A generic stylesheet for displaying the content of the sample document in HTML 1.9 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 templates are not included for ease of reading. This Table 2: 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. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 15 January 2010 Table 2: Templates by Containment Template OID Type 2.16.840.1.113883.10.20.17.1.1 document Neonatal Care Report 2.16.840.1.113883.10.20.17.2.1 2.16.840.1.113883.10.20.17.3.8 2.16.840.1.113883.10.20.17.2.5 section entry section Template Title Reporting parameters section Reporting parameters act 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 Head circumference 2.16.840.1.113883.10.20.17.2.3 entry section Acuity score data section entry Acuity indicator data generic organizer1 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 2.16.840.1.113883.10.20.17.3.59 The 44 clinical statement templates contained in the Acuity indicator data generic organizer template are not included in this chart for ease of reading. Please see the template itself. 1 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 16 January 2010 2 DOCUMENT TEMPLATE 2.1 Neonatal Care Report [ClinicalDocument: templateId 2.16.840.1.113883.10.20.17.1.1] 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. The NCR document contains 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 values that are unknown or not applicable at this point. The complete NCR sent after discharge will replace the initial document. Implementers should note that constraints 6, 7, and 9.b. below duplicate the CDA R2 base standard and are called out for emphasis; this NCR implementation requires no further constraints on them unless further constrained by a child constraint. 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). d. At least one name SHALL not have a valid/time/high indicating this was the name at the time of discharge. (CONF:4202). 2. This patient SHALL contain [1..1] administrativeGenderCode/@code, which SHALL be selected Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 17 January 2010 from ValueSet 2.16.840.1.113883.11.20.5.24 NCR gender DYNAMIC (CONF:4191). 3. This patient SHALL contain [1..1] birthTime (CONF:4195). a. This birthTime SHALL be precise at least to the day. (CONF:4240). 6. SHALL contain [1..*] author (CONF:4072). 7. SHALL contain [1..1] custodian (CONF:4075). a. This custodian SHALL be the reporting hospital. (CONF:4177). 8. 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. ii. iii. This associatedEntity SHALL contain [1..1] @classcode="PRS" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4089). This associatedEntity SHALL contain [1..1] code="MTH" (CodeSystem: 2.16.840.1.113883.5.111 HL7RoleCode) STATIC (CONF:4090). 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 contain the discharge date of the infant within its interval. (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). 9. 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. ii. iii. This parentDocument SHALL contain [1..1] @classCode="DOCCLIN" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4099). This parentDocument SHALL contain [1..1] @moodCode="EVN" (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:4100). This parentDocument SHALL contain [1..1] id (CONF:4101). 10. SHALL contain [1..1] componentOf (CONF:4104). a. This componentOf SHALL contain [1..1] encompassingEncounter (CONF:4105). i. ii. iii. This encompassingEncounter SHALL contain [1..1] id (CONF:4106). This encompassingEncounter SHALL contain [1..1] effectiveTime/low (CONF:4108). This encompassingEncounter SHALL contain [1..1] effectiveTime/high (CONF:4109). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 18 January 2010 iv. This encompassingEncounter SHALL contain [1..1] location (CONF:4234). 1. This location SHALL contain [1..1] healthCareFacility (CONF:4235). a. This healthCareFacility SHALL contain [1..*] id (CONF:4236). i. At least one id SHALL contain @root="2.16.840.1.113883.3.375" and SHALL contain @extension composed of a unique number assigned by CHNC (CONF:4237). 11. SHALL contain [1..1] component/structuredBody (CONF:4082). a. This component/structuredBody MAY contain [0..1] component (CONF:4130) such that it i. contain [1..1] Reporting parameters section (templateId:2.16.840.1.113883.10.20.17.2.1) (CONF:4131). SHALL b. This component/structuredBody SHALL contain [1..1] component (CONF:4132) such that it i. contain [1..1] Patient data section - NCR (templateId:2.16.840.1.113883.10.20.17.2.5) (CONF:4133). SHALL Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 19 January 2010 Figure 5: NCR document template example <realmCode code="US" /> <typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040" /> <templateId root="2.16.840.1.113883.10.20.17.1.1" />  <id root="cf18e3e1-aea7-4553-a087-b42a004dd27d" /> <code code="NCR-X" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Neonatal Care Report" /> <title>Neonatal Care Report</title> <effectiveTime value="200906261100" /> <confidentialityCode codeSystem="2.16.840.1.113883.5.25" code="N" /> <languageCode code="en-US" /> <recordTarget> <patientRole> ... <patient> <name use="L">  <given>Kari</given> <family>Kidd</family> <validTime> <low value="20090325" />  </validTime> </name> <name use="ASGN"> <given>Baby Girl</given> <family>Mumm</family> <validTime> <high value="20090325" />  </validTime> </name> <administrativeGenderCode code="1086007" codeSystem="2.16.840.1.113883.6.96" displayName="Female" /> <birthTime value="200903031537" /> </patient> </patientRole> </recordTarget> <author> ... </author>  <custodian> ... </custodian> <legalAuthenticator> ... </legalAuthenticator> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 20 January 2010  <participant typeCode="IND"> <associatedEntity classCode="PRS"> <code code="MTH" codeSystem="2.16.840.1.113883.5.111" /> addr> <postalCode>99999</postalCode> <useablePeriod value="20090625"/>  </addr> <associatedPerson> <name>  <given>Martha</given> <family>Mum</family> </name> </associatedPerson> </associatedEntity> </participant>  <relatedDocument typeCode="RPLC"> <parentDocument classCode="DOCCLIN" moodCode="EVN">  <id root="d619e9c0-d168-11de-8a39-0800200c9a66" /> <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="NCR-X" displayName="Neonatal Care Report" /> </parentDocument> </relatedDocument> <componentOf> <encompassingEncounter> <id extension="IN302902" root="1.1.2" />  <effectiveTime> <low value="200903031600" /> <high value="20090625" /> </effectiveTime> </encompassingEncounter> </componentOf> ... Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 21 January 2010 3 SECTION TEMPLATES 3.1 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 faceto-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). 3.1.1 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). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 22 January 2010 Figure 6: NCR encounters section example <section> <templateId root="2.16.840.1.113883.10.20.1.3" /> <templateId root="2.16.840.1.113883.10.20.17.2.2" /> <code code="46240-8" codeSystem="2.16.840.1.113883.6.1" displayName="Encounters" /> <title>Encounters</title> <text> ... </text> <entry typeCode="DRIV"> <encounter classCode="ENC" moodCode="EVN">  <templateId root="2.16.840.1.113883.10.20.1.21" />  <templateId root="2.16.840.1.113883.10.20.17.3.15" /> <id extension="IN302902" root="1.1.2" />  ... </encounter> </entry> </section> 3.2 Acuity score data section [section: templateId 2.16.840.1.113883.10.20.17.2.3] This section contains the templates that represent data elements whose variants are thought to be significant indicators of the severity of illness and of subsequent infant outcomes. Using organizers the data is grouped into three clinically significant periods of time: the first 12 hours of an admission, and the third and seventh days of an admission. 1. SHALL contain [1..1] code/@code=" 11283-9" Acuity Assessment (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:4205). 2. SHALL contain [1..1] title="ACUITY SCORE DATA" (CONF:4206). 3. SHALL contain [1..1] text (CONF:4207). 4. SHALL contain [1..1] templateId/@root="2.16.840.1.113883.10.20.17.2.3" (CONF:4165). 5. 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). 6. 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). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 23 January 2010 b. SHALL contain [1..1] Acuity data time organizer - day 3 (templateId:2.16.840.1.113883.10.20.17.3.61) (CONF:4171). 7. 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: Acuity score data section example <section> <templateId root="2.16.840.1.113883.10.20.17.2.3" /> <code code="11283-9" codeSystem="2.16.840.1.113883.6.1" displayName="Acuity assessment" /> <title>Acuity score data</title> <organizer moodCode="EVN" classCode="CLUSTER">  ... <effectiveTime> <low value="200903050001" /> <high value="200903052359" /> </effectiveTime> ... <organizer moodCode="EVN" classCode="CLUSTER">  --> 3.3 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" Patient data (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3865). 2. SHALL contain [1..1] title="PATIENT DATA" (CONF:3866). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 24 January 2010 3. SHALL contain [1..1] text (CONF:3867). 3.4 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 score data section (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 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 25 January 2010 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). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 26 January 2010 Figure 8: NCR patient data section example <component> <section> <templateId root="2.16.840.1.113883.10.20.17.2.4" /> <templateId root="2.16.840.1.113883.10.20.17.2.5" /> <code code="55188-7" codeSystem="2.16.840.1.113883.6.1" /> <title>Patient Data</title> <text> ... </text> <entry typeCode="DRIV"> <observation ... <templateId root="2.16.840.1.113883.10.20.17.3.1" /> <code code="47340003" codeSystem="2.16.840.1.113883.6.96" displayName="Birth weight" /> ... <entry typeCode="DRIV"> <observation ... <templateId root="2.16.840.1.113883.10.20.17.3.3" /> <code code="268477000" codeSystem="2.16.840.1.113883.6.96" displayName="Gestational age at birth" /> ... <component> <section> ... <title>Encounters</title> ... <component> <section> ... <title>Patient Data</title> ... </section> </component> </section> </component> 3.5 Reporting parameters section [section: templateId 2.16.840.1.113883.10.20.17.2.1] The reporting parameters section provides information about the reporting time interval, and may contain other information that provides context for the patient data being reported. The receiving organization may tell the reporting hospitals what information they want in this section. 1. SHALL contain [1..1] code/@code="55187-9" Reporting Parameters (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:4141). 2. SHALL contain [1..1] title="Reporting Parameters" (CONF:4142). 3. SHALL contain [1..1] text (CONF:4143). 4. SHALL contain [1..1] templateId/@root="2.16.840.1.113883.10.20.17.2.1" (CONF:3276). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 27 January 2010 5. SHALL contain [1..1] entry (CONF:3277) such that it a. SHALL contain [1..1] @typeCode="DRIV" Is derived from (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3278). b. SHALL contain [1..1] Reporting parameters act (templateId:2.16.840.1.113883.10.20.17.3.8) (CONF:3279). Figure 9: Reporting parameters section example <section> <templateId root="2.16.840.1.113883.10.20.17.2.1" /> <code code="55187-9" codeSystem="2.16.840.1.113883.6.1" /> <title>Reporting Parameters</title> <text> ... </text> <entry typeCode="DRIV"> <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.8" /> ... </act> </entry> </section> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 28 January 2010 4 CLINICAL STATEMENT TEMPLATES 4.1 Acuity indicator data generic organizer [organizer: templateId 2.16.840.1.113883.10.20.17.3.59] This template contains a collection of templates representing data elements whose variants are thought to be significant indicators of the severity of illness and of subsequent infant outcomes. Please navigate to the contained template to see its complete definition. For example, go to Oxygen administration (2.16.840.1.113883.10.20.17.3.17) to see the oxygen administration template representation including the recommended codes and terms. 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. 1. SHALL contain [1..1] @classCode="CLUSTER" Cluster (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4113). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:4114). 3. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:4115). 4. SHALL contain [2..2] component (CONF:3964) such that it a. SHALL contain [1..1] Arterial PaO2 Observation (templateId:2.16.840.1.113883.10.20.17.3.16) (CONF:3965). 5. SHALL contain [2..2] component (CONF:3966) such that it a. SHALL contain [1..1] Oxygen Administration (templateId:2.16.840.1.113883.10.20.17.3.17) (CONF:3967). 6. SHALL contain [1..1] component (CONF:3968) such that it a. SHALL contain [1..1] PaO2/FIO2 ratio (templateId:2.16.840.1.113883.10.20.17.3.18) (CONF:3969). 7. SHALL contain [2..2] component (CONF:3975) such that it a. SHALL contain [1..1] Mean airway pressure (templateId:2.16.840.1.113883.10.20.17.3.19) (CONF:3976). 8. SHALL contain [2..2] component (CONF:3977) such that it a. SHALL contain [1..1] PaCO2 Observation (templateId:2.16.840.1.113883.10.20.17.3.20) (CONF:3978). 9. SHALL contain [2..2] component (CONF:3979) such that it a. SHALL contain [1..1] Respiratory rate (templateId:2.16.840.1.113883.10.20.17.3.21) (CONF:3980). 10. SHALL contain [1..1] component (CONF:3981) such that it a. SHALL contain [1..1] Oxygenation index (templateId:2.16.840.1.113883.10.20.17.3.22) (CONF:3982). 11. SHALL contain [1..1] component (CONF:3983) such that it a. SHALL contain [1..1] Respiratory Severity Score (templateId:2.16.840.1.113883.10.20.17.3.23) (CONF:3984). 12. SHALL contain [1..1] component (CONF:3985) such that it Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 29 January 2010 a. SHALL contain [1..1] Nitric oxide administration (templateId:2.16.840.1.113883.10.20.17.3.24) (CONF:3986). 13. SHALL contain [1..1] component (CONF:3987) such that it a. SHALL contain [1..1] Respiratory or ventilatory support (templateId:2.16.840.1.113883.10.20.17.3.25) (CONF:3988). 14. SHALL contain [2..2] component (CONF:3989) such that it a. SHALL contain [1..1] Body temperature (templateId:2.16.840.1.113883.10.20.17.3.10) (CONF:3990). 15. SHALL contain [2..2] component (CONF:3991) such that it a. SHALL contain [1..1] Mean blood pressure (templateId:2.16.840.1.113883.10.20.17.3.26) (CONF:3992). 16. SHALL contain [2..2] component (CONF:3993) such that it a. SHALL contain [1..1] Systolic blood pressure (templateId:2.16.840.1.113883.10.20.17.3.27) (CONF:3994). 17. SHALL contain [2..2] component (CONF:3995) such that it a. SHALL contain [1..1] Diastolic blood pressure (templateId:2.16.840.1.113883.10.20.17.3.28) (CONF:3996). 18. SHALL contain [2..2] component (CONF:3997) such that it a. SHALL contain [1..1] Heart rate (templateId:2.16.840.1.113883.10.20.17.3.29) (CONF:3998). 19. SHALL contain [2..2] component (CONF:3999) such that it a. SHALL contain [1..1] Blood pH (templateId:2.16.840.1.113883.10.20.17.3.30) (CONF:4000). 20. SHOULD contain [0..2] component (CONF:4001) such that it a. SHALL contain [1..1] Blood gas base excess (templateId:2.16.840.1.113883.10.20.17.3.31) (CONF:4002). 21. SHOULD contain [0..2] component (CONF:4003) such that it a. SHALL contain [1..1] Blood gas base deficit (templateId:2.16.840.1.113883.10.20.17.3.32) (CONF:4004). 22. There SHALL only be 2 total results from base excess (templateId:2.16.840.1.113883.10.20.17.3.31) or base deficit (templateId:2.16.840.1.113883.10.20.17.3.32) (CONF:4005). 23. SHALL contain [1..1] component (CONF:4006) such that it a. SHALL contain [1..1] Lactic acid from serum/plasma (templateId:2.16.840.1.113883.10.20.17.3.33) (CONF:4007). 24. SHALL contain [1..1] component (CONF:4008) such that it a. SHALL contain [1..1] Calcium ionized (templateId:2.16.840.1.113883.10.20.17.3.34) (CONF:4009). 25. SHALL contain [1..1] component (CONF:4010) such that it a. SHALL contain [1..1] Calcium total serum (templateId:2.16.840.1.113883.10.20.17.3.35) (CONF:4011). 26. SHALL contain [2..2] component (CONF:4012) such that it a. SHALL contain [1..1] Sodium serum (templateId:2.16.840.1.113883.10.20.17.3.36) (CONF:4013). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 30 January 2010 27. SHALL contain [1..1] component (CONF:4049) such that it a. SHALL contain [1..1] Seizures (templateId:2.16.840.1.113883.10.20.17.3.54) (CONF:4050). 28. SHALL contain [2..2] component (CONF:4033) such that it a. SHALL contain [1..1] Hemoglobin (templateId:2.16.840.1.113883.10.20.17.3.46) (CONF:4034). 29. SHALL contain [2..2] component (CONF:4035) such that it a. SHALL contain [1..1] Blood urea nitrogen (BUN) (templateId:2.16.840.1.113883.10.20.17.3.47) (CONF:4036). 30. SHALL contain [1..1] component (CONF:4037) such that it a. SHALL contain [1..1] Creatinine observation (templateId:2.16.840.1.113883.10.20.17.3.48) (CONF:4038). 31. SHALL contain [1..1] component (CONF:4039) such that it a. SHALL contain [1..1] Aspartate aminotransferase (AST) (templateId:2.16.840.1.113883.10.20.17.3.49) (CONF:4040). 32. SHALL contain [1..1] component (CONF:4041) such that it a. SHALL contain [1..1] Alanine aminotransferase (ALT) (templateId:2.16.840.1.113883.10.20.17.3.50) (CONF:4042). 33. SHALL contain [1..1] component (CONF:4043) such that it a. SHALL contain [1..1] Bilirubin, total (templateId:2.16.840.1.113883.10.20.17.3.51) (CONF:4044). 34. SHALL contain [1..1] component (CONF:4031) such that it a. SHALL contain [1..1] International normalized ratio (INR) (templateId:2.16.840.1.113883.10.20.17.3.45) (CONF:4032). 35. SHALL contain [1..1] component (CONF:4047) such that it a. SHALL contain [1..1] Albumin observation (templateId:2.16.840.1.113883.10.20.17.3.53) (CONF:4048). 36. SHALL contain [1..1] component (CONF:4029) such that it a. SHALL contain [1..1] Activated partial thromboplastin time (templateId:2.16.840.1.113883.10.20.17.3.44) (CONF:4030). 37. SHALL contain [1..1] component (CONF:4051) such that it a. SHALL contain [1..1] Urine output (templateId:2.16.840.1.113883.10.20.17.3.55) (CONF:4052). 38. SHALL contain [1..1] component (CONF:4045) such that it a. SHALL contain [1..1] Bilirubin, conjugated (templateId:2.16.840.1.113883.10.20.17.3.52) (CONF:4046). 39. SHALL contain [2..2] component (CONF:4021) such that it a. SHALL contain [1..1] White blood cell (leukocytes) (templateId:2.16.840.1.113883.10.20.17.3.40) (CONF:4022). 40. SHALL contain [2..2] component (CONF:4015) such that it a. SHALL contain [1..1] Potassium serum (templateId:2.16.840.1.113883.10.20.17.3.37) (CONF:4016). 41. SHALL contain [2..2] component (CONF:4017) such that it Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 31 January 2010 a. SHALL contain [1..1] Bicarbonate serum (templateId:2.16.840.1.113883.10.20.17.3.38) (CONF:4018). 42. SHALL contain [1..1] component (CONF:4025) such that it a. SHALL contain [1..1] Fibrinogen level (templateId:2.16.840.1.113883.10.20.17.3.42) (CONF:4026). 43. SHALL contain [2..2] component (CONF:4019) such that it a. SHALL contain [1..1] Glucose serum (templateId:2.16.840.1.113883.10.20.17.3.39) (CONF:4020). 44. SHALL contain [1..1] component (CONF:4023) such that it a. SHALL contain [1..1] Platelets (templateId:2.16.840.1.113883.10.20.17.3.41) (CONF:4024). 45. SHALL contain [1..1] component (CONF:4027) such that it a. SHALL contain [1..1] Prothrombin time (PT) (templateId:2.16.840.1.113883.10.20.17.3.43) (CONF:4028). 46. SHALL contain [1..1] component (CONF:4053) such that it a. SHALL contain [1..1] Nothing by mouth (NPO) (templateId:2.16.840.1.113883.10.20.17.3.56) (CONF:4054). 47. SHALL contain [1..1] component (CONF:4055) such that it a. SHALL contain [1..1] Renal dialysis (renal replacement therapy) (templateId:2.16.840.1.113883.10.20.17.3.57) (CONF:4056). 48. SHALL contain [1..1] component (CONF:4057) such that it a. SHALL contain [1..1] Steroid treatment (systemic) (templateId:2.16.840.1.113883.10.20.17.3.58) (CONF:4058). 4.2 Acuity data time organizer - admission to 12 hours [organizer: templateId 2.16.840.1.113883.10.20.17.3.60] This organizer template groups the observations, findings, or values in the Acuity indicator data generic organizer (templateId 2.16.840.1.113883.10.20.17.3.59) into the time period from the admission through the first 12 hours of the admission. 1. Conforms to Acuity indicator data generic organizer Template (templateId: 2.16.840.1.113883.10.20.17.3.59). 2. SHALL contain [1..1] @classCode="CLUSTER" Cluster (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4059). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:4060). 4. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:4061). 5. SHALL contain [1..1] effectiveTime/low (CONF:4062). a. This effectiveTime/low SHALL be equal to the admission time and SHALL be accurate at least to the hour (CONF:4064). 6. SHALL contain [1..1] effectiveTime/high (CONF:4063). a. This effectiveTime/high SHALL be equal to the admission time plus 12 hours and SHALL be accurate at least to the hour (CONF:4065). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 32 January 2010 4.3 Acuity data time organizer - day 3 [organizer: templateId 2.16.840.1.113883.10.20.17.3.61] This organizer template groups the observations, findings, or values in the Acuity indicator data generic organizer (templateId 2.16.840.1.113883.10.20.17.3.59) into the time period of the third day of the admission. 1. Conforms to Acuity indicator data generic organizer Template (templateId: 2.16.840.1.113883.10.20.17.3.59). 2. SHALL contain [1..1] @classCode="CLUSTER" Cluster (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4116). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:4117). 4. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:4118). 5. SHALL contain [1..1] effectiveTime/low (CONF:4119). a. This effectiveTime/low day SHALL equal the third day after the day of admission and the minute SHALL equal 0001 (CONF:4120). 6. SHALL contain [1..1] effectiveTime/high (CONF:4121). a. This effectiveTime/high day SHALL equal the third day after the day of admission and the minute SHALL equal to 2359 (CONF:4122). 4.4 Acuity data time organizer - day 7 [organizer: templateId 2.16.840.1.113883.10.20.17.3.62] This organizer template groups the observations, findings, or values in the Acuity indicator data generic organizer (templateId 2.16.840.1.113883.10.20.17.3.59) into the time period of the seventh day of the admission. 1. Conforms to Acuity indicator data generic organizer Template (templateId: 2.16.840.1.113883.10.20.17.3.59). 2. SHALL contain [1..1] @classCode="CLUSTER" Cluster (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:4123). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:4124). 4. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:4125). 5. SHALL contain [1..1] effectiveTime/low (CONF:4126). a. This effectiveTime/low day SHALL equal the seventh day after the day of admission and the minute SHALL equal to 0001 (CONF:4127). 6. SHALL contain [1..1] effectiveTime/high (CONF:4128). a. This effectiveTime/high day SHALL equal the seventh day after the day of admission and the minute SHALL equal to 2359 (CONF:4129). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 33 January 2010 4.5 Admission activity – neonatal [act: templateId 2.16.840.1.113883.10.20.17.3.12] This admission act contains admission-related observation templates for body temperature and body weight. 1. SHALL contain [1..1] @classCode="ACT" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3298). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3299). 3. SHALL contain [1..1] code/@code="305056002" Admission procedure (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3301). 4. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3302). 5. SHALL contain [1..1] entryRelationship (CONF:3306) such that it a. SHALL contain [1..1] @typeCode="COMP" Refers to (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3304). b. SHALL contain [1..1] Body temperature (templateId:2.16.840.1.113883.10.20.17.3.10) (CONF:3305). 6. SHALL contain [1..1] entryRelationship (CONF:3303) such that it a. SHALL contain [1..1] @typeCode="COMP" Refers to (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3307). b. SHALL contain [1..1] Body weight (templateId:2.16.840.1.113883.10.20.17.3.11) (CONF:3308). Figure 10: Admission activity act example  <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.12" /> <code code="305056002" codeSystem="2.16.840.1.113883.6.96" displayName="Admission procedure" /> <statusCode code="completed" /> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> ... </observation> </entryRelationship> <entryRelationship typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> ... </observation> </entryRelationship> </act> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 34 January 2010 4.6 CCD Encounter activity [encounter: templateId 2.16.840.1.113883.10.20.1.21] This clinical statement represents the details of an encounter. 1. The value for "Encounter / @classCode" in an encounter activity SHALL be "ENC" 2.16.840.1.113883.5.6 ActClass STATIC. (CONF:577). 2. The value for "Encounter / @moodCode" in an encounter activity SHALL be "EVN" 2.16.840.1.113883.5.1001 ActMood STATIC. (CONF:578). 3. An encounter activity SHALL contain at least one Encounter / id. (CONF:579). 4. An encounter activity SHOULD contain exactly one Encounter / code. (CONF:580). 5. The value for "Encounter / code" in an encounter activity SHOULD be selected from ValueSet 2.16.840.1.113883.1.11.13955 EncounterCode 2.16.840.1.113883.5.4 ActCode DYNAMIC. (CONF:581). 6. An encounter activity MAY contain exactly one Encounter / effectiveTime, to indicate date, time, and/or duration of an encounter. (CONF:582). 7. An encounter activity MAY contain one or more Encounter / entryRelationship, whose value for "entryRelationship / @typeCode" SHALL be "RSON" "Has reason" 2.16.840.1.113883.5.1002 ActRelationshipType STATIC, where the target of the relationship represents the indication for the activity. (CONF:583). 8. An encounter activity MAY contain one or more Encounter / performer, used to define the practioners involved in an encounter. (CONF:584). 9. Encounter / performer MAY contain exactly one Encounter / performer / assignedEntity / code, to define the role of the practioner. (CONF:585). 10. An encounter activity MAY contain one or more patient instructions (templateId 2.16.840.1.113883.10.20.1.49). (CONF:586). 11. The value for "Encounter / entryRelationship / @typeCode" in an encounter activity MAY be "SUBJ" "Subject" 2.16.840.1.113883.5.1002 ActRelationshipType STATIC to reference an age observation (templateId 2.16.840.1.113883.10.20.1.38). (CONF:587). 12. An encounter activity SHALL contain one or more sources of information, as defined in section 5.2 Source. (CONF:588). 13. An encounter activity MAY contain one or more location participations (templateId 2.16.840.1.113883.10.20.1.45). (CONF:589). 4.6.1 Neonatal ICU encounter activity [encounter: templateId 2.16.840.1.113883.10.20.17.3.15] The neonatal ICU encounter contains selected data specific to each admission and discharge in an encounter. This template captures data for the current encounter being reported and may capture data from historical encounters. 1. Conforms to CCD Encounter activity Template (templateId: 2.16.840.1.113883.10.20.1.21). 2. SHALL contain [1..1] @classCode="ENC" Encounter (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3323). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3324). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 35 January 2010 4. SHALL contain [1..*] id (CONF:3325). a. The encounter that is the same encounter as the encompassingEncounter SHALL contain an encounter/id that equals the encompassingEncounter id (CONF:3330). 5. SHALL contain [1..1] code/@code="IMP" Inpatient encounter (CodeSystem: 2.16.840.1.113883.5.4 HL7ActCode) STATIC (CONF:3327). 6. SHOULD contain [0..1] effectiveTime/low (CONF:3329). 7. SHOULD contain [0..1] effectiveTime/high (CONF:3328). 8. SHALL contain [1..1] participant (CONF:3775). a. This participant SHALL contain [1..1] @typeCode="LOC" (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3776). b. This participant SHALL contain [1..1] Neonatal ICU location (templateId:2.16.840.1.113883.10.20.17.3.14) (CONF:3777). 9. SHALL contain [1..1] entryRelationship (CONF:3331) such that it a. SHALL contain [1..1] @typeCode="COMP" Component (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3332). b. SHALL contain [1..1] Admission activity - neonatal (templateId:2.16.840.1.113883.10.20.17.3.12) (CONF:3333). 10. SHALL contain [1..1] entryRelationship (CONF:3334) such that it a. SHALL contain [1..1] @typeCode="COMP" Component (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3335). b. SHALL contain [1..1] Discharge activity - Neonatal (templateId:2.16.840.1.113883.10.20.17.3.13) (CONF:3336). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 36 January 2010 Figure 11: Neonatal ICU encounter example <encounter classCode="ENC" moodCode="EVN">  <templateId root="2.16.840.1.113883.10.20.1.21" />  <templateId root="2.16.840.1.113883.10.20.17.3.15" /> <id extension="IN302902" root="1.1.2" />  <code code="IMP" codeSystem="2.16.840.1.113883.5.4" displayName="Inpatient encounter" /> <effectiveTime> <low value="200903031600" /> <high value="20090625" /> </effectiveTime>  <participant typeCode="LOC"> <templateId root="2.16.840.1.113883.10.20.1.45" /> <templateId root="2.16.840.1.113883.10.20.17.3.14" /> <participantRole classCode="SDLOC"> <code code="PEDNICU" codeSystem="2.16.840.1.113883.5.111" displayName="Neonatal ICU" /> </participantRole> </participant> <entryRelationship typeCode="COMP"> ... </entryRelationship> </encounter> 4.7 CCD Medication activity [substanceAdministration: templateId 2.16.840.1.113883.10.20.1.24] A medication activity is used to describe what is administered. Reconciliation of conflicting medication information from various sources is enabled both by indicating the source of information and by indicating whether the source is reporting intended or actual medication use. For instance, a physician may intend for a patient to be on a particular dose, but the patient may actually be taking a different dose; a pharmacy may fill a prescription for a particular dose only to then have the patient's physician lower the dose without notifying the pharmacy. Therefore, medication and supply activities can be expressed in either the "EVN" (event) mood or the "INT" (intent) mood. Medication activities in "INT" mood are not orders, but rather are reflections of what a clinician intends a patient to be taking. Medication activities in "EVN" mood reflect actual use. A pharmacy system will typically report what was actually filled, along with intended use. A physician will often report intended use. A patient or family member will typically report actual use. 1. The value for "SubstanceAdministration / @moodCode" in a medication activity SHALL be "EVN" or "INT" 2.16.840.1.113883.5.1001 ActMood STATIC. (CONF:1013). 2. A medication activity SHALL contain at least one SubstanceAdministration / id. (CONF:1014). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 37 January 2010 3. A medication activity SHOULD contain exactly one SubstanceAdministration / statusCode. (CONF:1015). 4. A medication activity SHOULD contain one or more SubstanceAdministration / effectiveTime elements, used to indicate the actual or intended start and stop date of a medication, and the frequency of administration. (See section 5.4.1 Dates and Times for additional details about time representation). (CONF:1016). 5. A medication activity SHOULD contain exactly one SubstanceAdministration / routeCode. (CONF:1017). 6. The value for "SubstanceAdministration / routeCode" in a medication activity SHOULD be selected from the HL7 RouteOfAdministration (2.16.840.1.113883.5.112) code system. (CONF:1018). 7. A medication activity SHOULD contain exactly one SubstanceAdministration / doseQuantity or SubstanceAdministration / rateQuantity. (CONF:1019). 8. A medication activity MAY contain exactly one SubstanceAdministration / maxDoseQuantity, which represents a maximum dose limit. (CONF:1020). 9. A medication activity MAY contain one or more SubstanceAdministration / performer, to indicate the person administering a substance. (CONF:1021). 10. A medication activity MAY have one or more associated consents, represented in the CCD Header as ClinicalDocument / authorization / consent. (CONF:1022). 11. A medication activity SHALL contain one or more sources of information, as defined in section 5.2 Source. (CONF:1023). 12. A medication activity MAY contain exactly one medication status observation. (CONF:1024). 13. A medication activity SHALL contain exactly one SubstanceAdministration / consumable, the target of which is a product template (CONF:1051). 14. A medication activity MAY contain exactly one medication series number observation. (CONF:2019). 4.7.1 Nitric oxide administration [substanceAdministration: templateId 2.16.840.1.113883.10.20.17.3.24] This template represents inhaled nitric oxide administered to a patient in parts per million. This guide uses route codes from the HITSP-endorsed Medication Route FDA Value Set. 1. Conforms to CCD Medication activity Template (templateId: 2.16.840.1.113883.10.20.1.24). 2. SHALL contain [1..1] @classCode="SBADM" Substance administration (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3414). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3415). 4. SHALL contain [1..1] statusCode (CONF:3416). 5. SHOULD contain [0..1] effectiveTime (CONF:3417). 6. SHALL contain [1..1] routeCode/@code="C38216" RESPIRATORY (INHALATION) (CodeSystem: 2.16.840.1.113883.3.26.1.1 FDA RouteOfAdministration) STATIC (CONF:3418). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 38 January 2010 7. SHALL contain [1..1] doseQuantity (CONF:3419). 8. SHALL contain [1..1] value (CONF:3420). a. This value SHALL contain [1..1] @unit="%" percent (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3421). 9. SHALL contain [1..1] consumable (CONF:3422). a. This consumable SHALL contain [1..1] manufacturedProduct (CONF:3423). i. This manufacturedProduct SHALL contain [1..1] manufacturedMaterial (CONF:3424). 1. This manufacturedMaterial SHALL contain [1..1] code/@code="562851" Nitric Oxide / Nitrogen Gas for Inhalation (CodeSystem: 2.16.840.1.113883.6.88 RxNorm) STATIC (CONF:3425). a. This code SHOULD contain [0..1] originalText (CONF:3426). Figure 12: Nitric oxide administration example  <substanceAdministration classCode="SBADM" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.1.24" />  <templateId root="2.16.840.1.113883.10.20.17.3.24" /> <id root="cdbd5b05-6cde-11db-9fe1-0800200c9a66" /> <statusCode code="completed" /> <effectiveTime value="200903032300" /> <routeCode code="C38216" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RESPIRATORY (INHALATION)" codeSystemName="FDA RouteOfAdministration" /> <doseQuantity value="20" unit="ppm" /> <consumable> <manufacturedProduct> <templateId root="2.16.840.1.113883.10.20.1.53" />  <manufacturedMaterial> <code code="562851" codeSystem="2.16.840.1.113883.6.88" displayName=" Nitric Oxide/Nitrogen Gas for Inhalation"> <originalText>Nitric Oxide</originalText> </code> </manufacturedMaterial> </manufacturedProduct> </consumable> </substanceAdministration> 4.7.2 Oxygen administration [substanceAdministration: templateId 2.16.840.1.113883.10.20.17.3.17] This template represents the percent or fraction of inspired oxygen administered to a patient. This guide uses route codes from the HITSP-endorsed Medication Route FDA Value Set. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 39 January 2010 1. Conforms to CCD Medication activity Template (templateId: 2.16.840.1.113883.10.20.1.24). 2. SHALL contain [1..1] @classCode="SBADM" Substance administration (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3357). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3358). 4. SHALL contain [1..1] statusCode (CONF:3360). 5. SHOULD contain [0..1] effectiveTime (CONF:3361). 6. SHALL contain [1..1] routeCode/@code="C38216" RESPIRATORY (INHALATION) (CodeSystem: 2.16.840.1.113883.3.26.1.1 FDA RouteOfAdministration) STATIC (CONF:3363). 7. SHALL contain [1..1] doseQuantity (CONF:3369). 8. SHALL contain [1..1] value (CONF:3370). a. This value SHALL contain [1..1] @unit="%" percent (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3371). 9. SHALL contain [1..1] consumable (CONF:3364). a. This consumable SHALL contain [1..1] manufacturedProduct (CONF:3365). i. This manufacturedProduct SHALL contain [1..1] manufacturedMaterial (CONF:3366). 1. This manufacturedMaterial SHALL contain [1..1] code/@code="7806" Oxygen (CodeSystem: 2.16.840.1.113883.6.88 RxNorm) STATIC (CONF:3367). a. This code SHOULD contain [0..1] originalText (CONF:3368). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 40 January 2010 Figure 13: Oxygen administration example <substanceAdministration classCode="SBADM" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.1.24" />  <templateId root="2.16.840.1.113883.10.20.17.3.17" /> <id root="cdbd5b05-6cde-11db-9fe1-0800200c9a68" /> <statusCode code="completed" /> <effectiveTime value="200903031607" /> <routeCode code="C38216" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RESPIRATORY (INHALATION)" codeSystemName="FDA RouteOfAdministration" /> <doseQuantity value="80" unit="%" /> <consumable> <manufacturedProduct> <manufacturedMaterial> <code code="7806" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm" displayName="Oxygen"> <originalText>Oxygen</originalText> </code> </manufacturedMaterial> </manufacturedProduct> </consumable> </substanceAdministration> 4.8 CCD Result observation [observation: templateId 2.16.840.1.113883.10.20.1.31] This clinical statement represents details of a lab, radiology, or other study performed on a patient. 1. The value for "Observation / @moodCode" in a result observation SHALL be "EVN" 2.16.840.1.113883.5.1001 ActMood STATIC. (CONF:800). 2. A result observation SHALL contain at least one Observation / id. (CONF:801). 3. A result observation SHALL contain exactly one Observation / statusCode. (CONF:802). 4. A result observation SHOULD contain exactly one Observation / effectiveTime, which represents the biologically relevant time (e.g. time the specimen was obtained from the patient). (CONF:803). 5. A result observation SHALL contain exactly one Observation / code. (CONF:804). 6. The value for "Observation / code" in a result observation SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem 2.16.840.1.113883.6.12). (CONF:805). 7. A result observation MAY contain exactly one Observation / methodCode if the method isn't inherent in Observation / code or if there is a need to further specialize the method in Observation / code. (CONF:806). 8. Observation / methodCode SHALL NOT conflict with the method inherent in Observation / code. (CONF:807). 9. A result observation SHALL contain exactly one Observation / value. (CONF:808). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 41 January 2010 10. Where Observation / value is a physical quantity, the unit of measure SHALL be expressed using a valid Unified Code for Units of Measure (UCUM) expression. (CONF:809). 11. A result observation SHOULD contain exactly one Observation / interpretationCode, which can be used to provide a rough qualitative interpretation of the observation, such as "N" (normal), "L" (low), "S" (susceptible), etc. Interpretation is generally provided for numeric results where an interpretation range has been defined, or for antimicrobial susceptibility test interpretation. (CONF:810). 12. A result observation SHOULD contain one or more Observation / referenceRange to show the normal range of values for the observation result. (CONF:811). 4.8.1 CDA XML patterns conforming to CCD Result observation The subsections below describe additional constraints that conform to the CCD Result observation template. Most of these result observations use the following pattern. Figure 14: Typical laboratory pattern for CCD-result observation conforming templates <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.1.31" />  <templateId root="2.16.840.1.113883.10.20.17.3.44" /> <id nullFlavor="NI" /> <code code="14979-9" codeSystem="2.16.840.1.113883.6.1" displayName="Coagulation surface induced Time PPP" /> <statusCode code="completed" /> <effectiveTime value="200903031800" /> <value xsi:type="PQ" value="33" unit="s" /> </observation> Non-laboratory NCR templates such as Birth weight or Gestational age at birth that conform to the CCD Result observation template do not include the effectiveTime element that is usually present in a lab result. Figure 15: Typical non-laboratory pattern for CCD-result observation conforming templates <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.1.31" />  <templateId root="2.16.840.1.113883.10.20.17.3.3" /> <code code="268477000" codeSystem="2.16.840.1.113883.6.96" displayName="Gestational age at birth" /> <statusCode code="completed" /> <value xsi:type="PQ" value="185" unit="d" /> </observation> The Arterial PaO2 observation requires a specimen element to represent the specimen type. The Blood gas base deficit, Blood gas base excess, and Blood gas pH observations may optionally follow this pattern to show specimen type. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 42 January 2010 Figure 16: Specimen type pattern for CCD-result observation conforming templates  <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.1.31" />  <templateId root="2.16.840.1.113883.10.20.17.3.16" /> <id nullFlavor="NI" /> <code code="11556-8" codeSystem="2.16.840.1.113883.6.1" displayName="Oxygen PPres Bld" /> <statusCode code="completed" /> <effectiveTime value="200903031607" /> <value xsi:type="PQ" value="55" unit="mm[Hg]" /> <specimen> <specimenRole> <id root="d5a9ef50-d05e-11dd-ad8b-0800200c9a66" /> <specimenPlayingEntity> <code code="122552005" codeSystem="2.16.840.1.113883.6.96" displayName="Arterial blood specimen" />  </specimenPlayingEntity> </specimenRole> </specimen> </observation> 4.8.2 Activated partial thromboplastin time [observation: templateId 2.16.840.1.113883.10.20.17.3.44] This observation represents an activated partial thromboplastin time result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3605). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3606). 4. SHALL contain [1..1] code/@code="14979-9" Coagulation surface induced Time PPP (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3607). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3608). 6. SHALL contain [1..1] value (CONF:3609). a. This value SHALL contain [1..1] @unit="s" seconds (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3610). 4.8.3 Alanine aminotransferase (ALT) [observation: templateId 2.16.840.1.113883.10.20.17.3.50] This observation represents an alanine aminotransferase (ALT) result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 43 January 2010 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3653). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3654). 4. SHALL contain [1..1] code/@code="1742-6" Alanine aminotransferase Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3655). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3656). 6. SHALL contain [1..1] value (CONF:3657). a. This value SHALL contain [1..1] @unit="U/L" Units per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3658). 4.8.4 Albumin observation [observation: templateId 2.16.840.1.113883.10.20.17.3.53] This observation represents an albumin result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3671). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3672). 4. SHALL contain [1..*] id (CONF:3673). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.11 Albumin DYNAMIC (CONF:3674). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3675). 7. SHOULD contain [0..1] effectiveTime (CONF:3676). 8. SHALL contain [1..1] value (CONF:3677). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3678). 4.8.5 Apgar at 1 minute [observation: templateId 2.16.840.1.113883.10.20.17.3.4] This observation represents the apgar score assigned to a neonate at 1 minute after birth. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3244). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3245). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.16 Apgar 1 minute post birth DYNAMIC (CONF:3246). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 44 January 2010 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3247). 6. MAY contain [0..1] effectiveTime (CONF:3255). 7. SHALL contain [1..1] value (CONF:3248). 4.8.6 Apgar at 5 minutes [observation: templateId 2.16.840.1.113883.10.20.17.3.5] This observation represents the apgar score assigned to a neonate at 5 minutes after birth. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3249). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3250). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.17 Apgar 5 minutes post birth DYNAMIC (CONF:3251). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3252). 6. MAY contain [0..1] effectiveTime (CONF:3254). 7. SHALL contain [1..1] value (CONF:3253). 4.8.7 Apgar score prolonged [observation: templateId 2.16.840.1.113883.10.20.17.3.6] This observation represents the apgar score assigned to a neonate after 5 minutes after birth. Typically, neonates are assigned additional apgar scores at 10, 15, and 20 minutes until the total score is 7 or greater. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3256). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3257). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.1 Apgar Summary Score (prolonged) DYNAMIC (CONF:3258). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3259). 6. MAY contain [0..1] effectiveTime (CONF:3260). 7. SHALL contain [1..1] value (CONF:3261). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 45 January 2010 4.8.8 Arterial PaO2 Observation [observation: templateId 2.16.840.1.113883.10.20.17.3.16] This observation represents a PaO2 (Arterial tension of oxygen) result from an arterial blood sample. NCR: The blood gas component values for a given time period are represented independently of other blood gas component values in the acuity data element reporting grouper. For example, the lowest or highest PaO2 value may or may not occur in the same blood gas from which another highest or lowest blood gas component is reported. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3343). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3344). 4. SHALL contain [1..*] id (CONF:3345). 5. SHALL contain [1..1] code/@code="11556-8" Oxygen PPres Bld (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3346). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3347). 7. SHOULD contain [0..1] effectiveTime (CONF:3348). 8. SHALL contain [1..1] value (CONF:3355). a. This value SHALL contain [1..1] @unit="mm[Hg]" millimeters of mercury (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3356). 9. SHALL contain [1..1] specimen (CONF:3350). a. This specimen SHALL contain [1..1] specimenRole (CONF:3351). i. This specimenRole SHOULD contain [0..1] id (CONF:3352). ii. This specimenRole SHALL contain [1..1] specimenPlayingEntity (CONF:3353). 1. This specimenPlayingEntity SHALL contain [1..1] code/@code="122552005" Arterial blood specimen (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3354). 4.8.9 Aspartate aminotransferase (AST) [observation: templateId 2.16.840.1.113883.10.20.17.3.49] This observation represents an aspartate aminotransferase (AST) result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3647). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3648). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 46 January 2010 4. SHALL contain [1..1] code/@code="1920-8" Aspartate aminotransferase Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3649). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3650). 6. SHALL contain [1..1] value (CONF:3651). a. This value SHALL contain [1..1] @unit="U/L" Units per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3652). 4.8.10 Bicarbonate serum [observation: templateId 2.16.840.1.113883.10.20.17.3.38] This observation represents a serum bicarbonate result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3563). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3564). 4. SHALL contain [1..1] code/@code="1963-8" Bicarbonate Ser (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3565). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3566). 6. SHALL contain [1..1] value (CONF:3567). a. This value SHALL contain [1..1] @unit="meq/L" Milliequivalents per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3568). 4.8.11 Bilirubin, conjugated [observation: templateId 2.16.840.1.113883.10.20.17.3.52] This observation represents a conjugated bilirubin result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3665). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3666). 4. SHALL contain [1..1] code/@code="15152-2" Bilirubin.glucuronidated Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3667). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3668). 6. SHALL contain [1..1] value (CONF:3669). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3670). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 47 January 2010 4.8.12 Bilirubin, total [observation: templateId 2.16.840.1.113883.10.20.17.3.51] This observation represents a total bilirubin result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3659). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3660). 4. SHALL contain [1..1] code/@code="1975-2" Bilirubin Ser/Plas TBIL (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3661). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3662). 6. SHALL contain [1..1] value (CONF:3663). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3664). 4.8.13 Birth head circumference [observation: templateId 2.16.840.1.113883.10.20.17.3.2] This observation represents a birth head circumference result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3232). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3233). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.19 Birth head circumference DYNAMIC (CONF:3234). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3235). 6. SHALL contain [1..1] value (CONF:3236). a. This value SHALL contain [1..1] @unit="cm" centimeter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3237). 4.8.14 Birth weight [observation: templateId 2.16.840.1.113883.10.20.17.3.1] This observation represents a birth weight. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3226). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 48 January 2010 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3227). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.15 Birth weight DYNAMIC (CONF:3228). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3229). 6. SHALL contain [1..1] value (CONF:3230). a. This value SHALL contain [1..1] @unit="g" gram (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3231). 4.8.15 Blood gas base deficit [observation: templateId 2.16.840.1.113883.10.20.17.3.32] This observation represents a blood gas base deficit result from any blood sample. NCR: The blood gas component values for a given time period are represented independently of other blood gas component values in the acuity data element reporting grouper. For example, the lowest or highest base deficit value may or may not occur in the same blood gas from which another highest or lowest blood gas component is reported. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3497). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3498). 4. SHALL contain [1..*] id (CONF:3499). 5. SHALL contain [1..1] code/@code="30318-0" Base deficit Bld (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3500). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3501). 7. SHOULD contain [0..1] effectiveTime (CONF:3502). 8. SHALL contain [1..1] value (CONF:3503). a. This value SHALL contain [1..1] @unit="mmol/L" millimoles per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3504). 9. MAY contain [0..1] specimen (CONF:3505). a. This specimen, if present, SHALL contain [1..1] specimenRole (CONF:3506). i. This specimenRole SHOULD contain [0..1] id (CONF:3507). ii. This specimenRole SHALL contain [1..1] specimenPlayingEntity (CONF:3508). 1. This specimenPlayingEntity SHALL contain [1..1] code (CONF:3509). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 49 January 2010 4.8.16 Blood gas base excess [observation: templateId 2.16.840.1.113883.10.20.17.3.31] This observation represents a blood gas base excess result from any blood sample. NCR: The blood gas component values for a given time period are represented independently of other blood gas component values in the acuity data element reporting grouper. For example, the lowest or highest base excess value may or may not occur in the same blood gas from which another highest or lowest blood gas component is reported. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3484). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3485). 4. SHALL contain [1..*] id (CONF:3486). 5. SHALL contain [1..1] code/@code="11555-0" Base excess Bld (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3487). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3488). 7. SHOULD contain [0..1] effectiveTime (CONF:3489). 8. SHALL contain [1..1] value (CONF:3490). a. This value SHALL contain [1..1] @unit="mmol/L" Milli-osmoles per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3491). 9. MAY contain [0..1] specimen (CONF:3492). a. This specimen, if present, SHALL contain [1..1] specimenRole (CONF:3493). i. This specimenRole SHOULD contain [0..1] id (CONF:3494). ii. This specimenRole SHALL contain [1..1] specimenPlayingEntity (CONF:3495). iii. This specimenRole SHALL contain [1..1] code (CONF:3496). 4.8.17 Blood pH [observation: templateId 2.16.840.1.113883.10.20.17.3.30] This observation represents a measure of the acidity or alkalinity of blood from any blood sample. NCR: The blood gas component values for a given time period are represented independently of other blood gas component values in the acuity data element reporting. For example, the lowest or highest pH value may or may not occur in the same blood gas from which another highest or lowest blood gas component is reported. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3471). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 50 January 2010 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3472). 4. SHALL contain [1..*] id (CONF:3473). 5. SHALL contain [1..1] code/@code="11558-4" pH Bld (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3474). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3475). 7. SHOULD contain [0..1] effectiveTime (CONF:3476). 8. SHALL contain [1..1] value (CONF:3477). a. This value SHALL contain [1..1] @unit="[pH]" pH (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3478). 9. MAY contain [0..1] specimen (CONF:3479). a. This specimen, if present, SHALL contain [1..1] specimenRole (CONF:3480). b. This specimen, if present, SHOULD contain [0..1] id (CONF:3481). c. This specimen, if present, SHALL contain [1..1] specimenPlayingEntity (CONF:3482). i. This specimenPlayingEntity SHALL contain [1..1] code (CONF:3483). 4.8.18 Blood urea nitrogen (BUN) [observation: templateId 2.16.840.1.113883.10.20.17.3.47] This observation represents a blood urea nitrogen (BUN) result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3633). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3634). 4. SHALL contain [1..*] id (CONF:3635). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.12 Blood Urea Nitrogen (BUN) DYNAMIC (CONF:3636). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3637). 7. SHOULD contain [0..1] effectiveTime (CONF:3638). 8. SHALL contain [1..1] value (CONF:3639). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3640). 4.8.19 Body temperature [observation: templateId 2.16.840.1.113883.10.20.17.3.10] This observation represents a body temperature. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 51 January 2010 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3286). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3287). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.2 Body temperature DYNAMIC (CONF:3288). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3289). 6. SHALL contain [1..1] value (CONF:3290). a. This value SHALL contain [1..1] @unit="cel" celcius (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3291). 4.8.20 Body weight [observation: templateId 2.16.840.1.113883.10.20.17.3.11] This observation represents a body weight result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3292). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3293). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.18 Body weight DYNAMIC (CONF:3294). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3295). 6. SHALL contain [1..1] value (CONF:3296). a. This value SHALL contain [1..1] @unit="g" gram (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3297). 4.8.21 Calcium ionized [observation: templateId 2.16.840.1.113883.10.20.17.3.34] This observation represents an ionized (unbound) calcium result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3518). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3519). 4. SHALL contain [1..*] id (CONF:3520). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.5 Ionized Calcium DYNAMIC (CONF:3521). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3522). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 52 January 2010 7. SHOULD contain [0..1] effectiveTime (CONF:3523). 8. SHALL contain [1..1] value (CONF:3524). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3525). 4.8.22 Calcium total serum [observation: templateId 2.16.840.1.113883.10.20.17.3.35] This observation represents a total serum calcium result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3539). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3540). 4. SHALL contain [1..1] code/@code="17861-6" Calcium Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3541). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3542). 6. SHALL contain [1..1] value (CONF:3543). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3544). 4.8.23 Creatinine observation [observation: templateId 2.16.840.1.113883.10.20.17.3.48] This observation represents a creatinine result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3641). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3642). 4. SHALL contain [1..1] code/@code="2160-0" Creatinine Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3643). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3644). 6. SHALL contain [1..1] value (CONF:3645). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3646). 4.8.24 Diastolic blood pressure [observation: templateId 2.16.840.1.113883.10.20.17.3.28] This observation represents a diastolic blood pressure. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 53 January 2010 NCR: The highest and lowest blood pressure component values for a given time period are represented independently of other blood pressure component values in the acuity data element reporting grouper. For example, the lowest mean blood pressure may or may not occur during the same reading where a lowest systolic or lowest diastolic reading occurred. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3456). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3457). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.21 Diastolic blood pressure DYNAMIC (CONF:3458). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3459). 6. SHALL contain [1..1] value (CONF:3460). a. This value SHALL contain [1..1] @unit="mm[Hg]" Millimeter of mercury (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3461). 4.8.25 Fibrinogen level [observation: templateId 2.16.840.1.113883.10.20.17.3.42] This observation represents a fibrinogen level result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3591). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3592). 4. SHALL contain [1..*] id (CONF:3593). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.8 Fibrinogen DYNAMIC (CONF:3594). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3595). 7. SHOULD contain [0..1] effectiveTime (CONF:3596). 8. SHALL contain [1..1] value (CONF:3597). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3598). 4.8.26 Gestational age [observation: templateId 2.16.840.1.113883.10.20.17.3.3] This observation represents the gestational age of an infant at birth; it is not the gestation of a pregnancy. Although gestational age of an infant is typically recorded in weeks plus days (e.g., 27 weeks and 3 days), the xsi:type PQ does not allow for mixed Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 54 January 2010 units. The gestational age must be represented in days; in this case 27 weeks and 3 days would be represented with 192 days. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3238). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3239). 4. SHALL contain [1..1] code/@code="412726003" Gestational age at birth (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3240). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3241). 6. SHALL contain [1..1] value (CONF:3242). a. This value SHALL contain [1..1] @unit="d" day (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3243). 4.8.27 Glucose serum [observation: templateId 2.16.840.1.113883.10.20.17.3.39] This observation represents a serum glucose result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3569). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3570). 4. SHALL contain [1..1] code/@code="2345-7" Glucose Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3571). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3572). 6. SHALL contain [1..1] value (CONF:3573). a. This value SHALL contain [1..1] @unit="mg/dL" Milligrams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3574). 4.8.28 Head circumference [observation: templateId 2.16.840.1.113883.10.20.17.3.9] This observation represents a head circumference. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3280). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3281). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 55 January 2010 4. SHALL contain [1..1] code/@code which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.25 Head circumference DYNAMIC (CONF:3282). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3283). 6. SHALL contain [1..1] value (CONF:3284). a. This value SHALL contain [1..1] @unit="cm" centimeter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3285). 4.8.29 Heart rate [observation: templateId 2.16.840.1.113883.10.20.17.3.29] This observation represents the beats per minute of the heart. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3465). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3466). 4. SHALL contain [1..1] code/@codewhich SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.25 Heart rate DYNAMIC (CONF:3467). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3468). 6. SHALL contain [1..1] value (CONF:3469). a. This value SHALL contain [1..1] @unit="/min" Per minute (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3470). 4.8.30 Hemoglobin [observation: templateId 2.16.840.1.113883.10.20.17.3.46] This observation represents a hemoglobin result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3619). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3620). 4. SHALL contain [1..*] id (CONF:3621). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.10 Hemoglobin DYNAMIC (CONF:3622). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3623). 7. SHOULD contain [0..1] effectiveTime (CONF:3624). 8. SHALL contain [1..1] value (CONF:3625). a. This value SHALL contain [1..1] @unit="g/dL" Grams per deciliter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3626). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 56 January 2010 4.8.31 International normalized ratio (INR) [observation: templateId 2.16.840.1.113883.10.20.17.3.45] This observation represents an international normalized ratio (INR) result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3611). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3612). 4. SHALL contain [1..*] id (CONF:3613). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.9 International Normalized Ratio (INR) DYNAMIC (CONF:3614). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3615). 7. SHOULD contain [0..1] effectiveTime (CONF:3616). 8. SHALL contain [1..1] value (CONF:3617). a. This value SHALL contain [1..1] @unit="s" seconds (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3618). 4.8.32 Lactic acid from serum/plasma [observation: templateId 2.16.840.1.113883.10.20.17.3.33] This observation represents a lactic acid measurement in serum or plasma. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3510). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3511). 4. SHALL contain [1..*] id (CONF:3512). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.4 Lactic acid/lactate DYNAMIC (CONF:3513). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3514). 7. SHOULD contain [0..1] effectiveTime (CONF:3515). 8. SHALL contain [1..1] value (CONF:3516). a. This value SHALL contain [1..1] @unit="mmol/L" millimoles per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3517). 4.8.33 Mean airway pressure [observation: templateId 2.16.840.1.113883.10.20.17.3.19] This observation represents the average pressure to which the lungs are exposed during the respiratory cycle while receiving measurable positive pressure respiratory support. Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 57 January 2010 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3377). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3378). 4. SHALL contain [1..1] code/@code="20056-8" Mean Airway Pressure (MAP) (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3379). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3380). 6. SHALL contain [1..1] value (CONF:3381). a. This value SHALL contain [1..1] @unit="cm[H2O]" Centimeters of water (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3382). 4.8.34 Mean blood pressure [observation: templateId 2.16.840.1.113883.10.20.17.3.26] This observation represents a mean blood pressure. NCR: The highest and lowest blood pressure component values for a given time period are represented independently of other blood pressure component values in the acuity data element reporting grouper. For example, the lowest mean blood pressure may or may not occur during the same reading where a lowest systolic or lowest diastolic reading occurred. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3444). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3445). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.22 Mean blood pressure DYNAMIC (CONF:3446). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3447). 6. SHALL contain [1..1] value (CONF:3448). a. This value SHALL contain [1..1] @unit="mm[Hg]" Millimeter of mercury (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3449). 4.8.35 PaCO2 Observation [observation: templateId 2.16.840.1.113883.10.20.17.3.20] This observation represents partial pressure of carbon dioxide in blood from any blood sample. NCR: The blood gas component values for a given time period are represented independently of other blood gas component values in the acuity data element reporting grouper. For example, the lowest or highest PaCO2 value may or may not occur in the same blood gas from which another highest or lowest blood gas component is reported Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 58 January 2010 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3383). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3384). 4. SHALL contain [1..*] id (CONF:3385). 5. SHALL contain [1..1] code/@code="11557-6" Carbon dioxide PPres Bld (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3386). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3387). 7. SHOULD contain [0..1] effectiveTime (CONF:3388). 8. SHALL contain [1..1] value (CONF:3389). a. This value SHALL contain [1..1] @unit="mm[Hg]" millimeters of mercury (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3390). 9. MAY contain [0..1] specimen (CONF:3391). a. This specimen, if present, SHALL contain [1..1] specimenRole (CONF:3392). i. This specimenRole SHOULD contain [0..1] id (CONF:3393). ii. This specimenRole SHALL contain [1..1] specimenPlayingEntity (CONF:3394). 1. This specimenPlayingEntity SHALL contain [1..1] code (CONF:3395). 4.8.36 Platelets [observation: templateId 2.16.840.1.113883.10.20.17.3.41] This observation represents a blood platelet result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3583). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3584). 4. SHALL contain [1..*] id (CONF:3585). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.7 Platelet DYNAMIC (CONF:3586). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3587). 7. SHOULD contain [0..1] effectiveTime (CONF:3588). 8. SHALL contain [1..1] value (CONF:3589). a. This value SHALL contain [1..1] @unit="10*3/uL" ThousandsPerMicroLiter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3590). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 59 January 2010 4.8.37 Potassium serum [observation: templateId 2.16.840.1.113883.10.20.17.3.37] This observation represents a serum potassium result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3557). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3558). 4. SHALL contain [1..1] code/@code="22760-3" Potassium Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3559). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3560). 6. SHALL contain [1..1] value (CONF:3561). a. This value SHALL contain [1..1] @unit="meq/L" Milliequivalents per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3562). 4.8.38 Prothrombin time (PT) [observation: templateId 2.16.840.1.113883.10.20.17.3.43] This observation represents a prothrombin time (PT) result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3599). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3600). 4. SHALL contain [1..1] code/@code="5902-2" Coagulation tissue factor induced time PPP (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3601). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3602). 6. SHALL contain [1..1] value (CONF:3603). a. This value SHALL contain [1..1] @unit="s" seconds (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3604). 4.8.39 Respiratory rate [observation: templateId 2.16.840.1.113883.10.20.17.3.21] This observation represents a patient's number of breaths per minute. NCR: If patient is apneic or breathing at a rate below ventilatory rate, it is understood that the value in documentation will likely be the ventilator rate. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 60 January 2010 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3396). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3397). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.23 Respiratory rate DYNAMIC (CONF:3398). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3399). 6. SHALL contain [1..1] value (CONF:3400). a. This value SHALL contain [1..1] @unit="/min" per minute (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3401). 4.8.40 Seizures [observation: templateId 2.16.840.1.113883.10.20.17.3.54] This observation represents presence of clinical or electroencephalographic (EEG) seizures. The possible values are: none, single, or multiple. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3685). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3686). 4. SHALL contain [1..1] code/@code="170707004" Fit frequency (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3687). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3688). 6. SHALL contain [1..1] value/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.13 Seizure frequency DYNAMIC (CONF:3689). 4.8.41 Sodium serum [observation: templateId 2.16.840.1.113883.10.20.17.3.36] This observation represents a serum sodium result. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3551). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3552). 4. SHALL contain [1..1] code/@code="42570-2" Sodium Ser/Plas (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3553). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3554). 6. SHALL contain [1..1] value (CONF:3555). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 61 January 2010 a. This value SHALL contain [1..1] @unit="meq/L" Milliequivalents per liter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3556). 4.8.42 Systolic blood pressure [observation: templateId 2.16.840.1.113883.10.20.17.3.27] This observation represents a systolic blood pressure. NCR: The highest and lowest blood pressure component values for a given time period are represented independently of other blood pressure component values in the acuity data element reporting grouper. For example, the lowest mean blood pressure may or may not occur during the same reading where a lowest systolic or lowest diastolic reading occurred. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3450). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3451). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.20 Systolic blood pressure DYNAMIC (CONF:3452). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3453). 6. SHALL contain [1..1] value (CONF:3454). a. This value SHALL contain [1..1] @unit="mm[Hg]" Millimeter of mercury (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3455). 4.8.43 Urine output [observation: templateId 2.16.840.1.113883.10.20.17.3.55] This observation represents the urine output in milliliters per kilogram per hour. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3699). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3700). 4. SHALL contain [1..1] code/@code="364202003" Measure of urine output (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3701). 5. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3702). 6. SHALL contain [1..1] value (CONF:3703). a. This value SHALL contain [1..1] @unit="mL/kg/h" Milliliters per kilogram per hour (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3704). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 62 January 2010 4.8.44 White blood cell (leukocyte) count [observation: templateId 2.16.840.1.113883.10.20.17.3.40] This observation represents the white blood cell (WBC) (leukocyte) count. 1. Conforms to CCD Result observation Template (templateId: 2.16.840.1.113883.10.20.1.31). 2. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3575). 3. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3576). 4. SHALL contain [1..*] id (CONF:3577). 5. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.6 White blood cell count DYNAMIC (CONF:3578). 6. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3579). 7. SHOULD contain [0..1] effectiveTime (CONF:3580). 8. SHALL contain [1..1] value (CONF:3581). a. This value SHALL contain [1..1] @unit="10*3/uL" ThousandsPerMicroLiter (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3582). 4.9 Discharge activity – Neonatal [act: templateId 2.16.840.1.113883.10.20.17.3.13] This discharge act contains discharge-related observation templates for head circumference and body weight. 1. SHALL contain [1..1] @classCode="ACT" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3309). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3310). 3. SHALL contain [1..1] code/@code="58000006" Discharge procedure (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3311). 4. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3312). 5. SHALL contain [1..1] entryRelationship (CONF:3313) such that it a. SHALL contain [1..1] @typeCode="COMP" Refers to (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3314). b. SHALL contain [1..1] Head circumference (templateId:2.16.840.1.113883.10.20.17.3.9) (CONF:3315). 6. SHALL contain [1..1] entryRelationship (CONF:3316) such that it a. SHALL contain [1..1] @typeCode="COMP" Refers to (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3317). b. SHALL contain [1..1] Body weight (templateId:2.16.840.1.113883.10.20.17.3.11) (CONF:3318). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 63 January 2010 Figure 17: Neonatal discharge activity example  <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.13" /> <code code="58000006" codeSystem="2.16.840.1.113883.6.96" displayName="Discharge procedure" /> <statusCode code="completed" /> <entryRelationship typeCode="COMP"> ... </entryRelationship> <entryRelationship typeCode="COMP"> ... </entryRelationship> </act> 4.10 Inborn/outborn [observation: templateId 2.16.840.1.113883.10.20.17.3.7] This observation represents whether an infant was born at the reporting hospital or some other location. If the negation indicator is true the infant was outborn (born at another location), if the negation indicator is false the infant was inborn (born at the reporting hospital. 1. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3262). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3263). 3. SHALL contain @negationInd (CONF:3264). 4. SHALL contain [1..1] code/@code="ASSERTION" (CodeSystem: 2.16.840.1.113883.5.4 HL7ActCode) STATIC (CONF:3265). 5. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3266). 6. SHALL contain [1..1] value/@code="169818001" Born before arrival (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3268). Figure 18: Inborn/outborn example <observation classCode="OBS" moodCode="EVN" negationInd="false"> <templateId root="2.16.840.1.113883.10.20.17.3.7" /> <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4" /> <statusCode code="completed" /> <value xsi:type="CD" code="169818001" codeSystem="2.16.840.1.113883.6.96" displayName="Born before arrival" /> </observation> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 64 January 2010 4.11 Nothing by mouth (NPO) [observation: templateId 2.16.840.1.113883.10.20.17.3.56] This observation represents whether a patient was taking nothing by mouth (NPO). If the patient was NPO the value of the negation indicator is set to "FALSE" and if the patient was taking (nutritive) feeds the negation indicator is set to "TRUE". NCR: NPO status in the NICU settings may include non-nutritive volumes for gastric stimulation. 1. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3705). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3706). 3. SHALL contain @negationInd (CONF:3707). 4. SHALL contain [1..1] code/@code="ASSERTION" (CodeSystem: 2.16.840.1.113883.5.4 HL7ActCode) STATIC (CONF:3708). 5. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3709). 6. SHALL contain [1..1] value/@code="182923009" NPO - Nothing by mouth (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3710). Figure 19: Nothing by mouth (NPO) example <observation classCode="OBS" moodCode="EVN" negationInd="false"> <templateId root="2.16.840.1.113883.10.20.17.3.56" /> <code code="182923009" codeSystem="2.16.840.1.113883.6.96" displayName="NPO - Nothing by mouth" /> </observation> 4.12 Oxygenation index [observation: templateId 2.16.840.1.113883.10.20.17.3.22] This observation represents the sum of the calculated value of (Mean Airway Pressure * FIO2*100)/PaO2. 1. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3402). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3403). 3. SHALL contain [1..1] code/@code="313558004" Oxygenation index measurement (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3404). 4. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3405). 5. SHALL contain [1..1] value (CONF:3406). a. This value SHALL contain [1..1] @unit="mm[Hg]" millimeters of mercury (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3407). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 65 January 2010 Figure 20: Oxygenation index example <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.22" /> <code code="313558004" codeSystem="2.16.840.1.113883.6.96" displayName="Oxygenation index measurement " /> <effectiveTime value="200903031620" /> <value xsi:type="PQ" value="11.6" unit="mm[Hg]" /> </observation> 4.13 PaO2/FIO2 ratio [observation: templateId 2.16.840.1.113883.10.20.17.3.18] This observation represents the ratio of PaO2 (Arterial tension of oxygen) to FIO2 (Fraction of inspired oxygen). NCR: This is recorded when the lowest PaO2 is recorded during the specified time interval. 1. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3372). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3373). 3. SHALL contain [1..1] code/@code="PaO2/FIO2-X" PaO2/FIO2 ratio (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3374). 4. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3375). 5. SHALL contain [1..1] value (CONF:3376). Figure 21: PaO2/FIO2 example <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.18" /> <code code="PaO2/FIO2-X" codeSystem="2.16.840.1.113883.6.1" displayName="PaO2/FIO2 ratio" /> <statusCode code="completed" /> <effectiveTime value="200903051607" /> <value xsi:type="REAL" value="257.1" /> </observation> 4.14 Renal dialysis (renal replacement therapy) [observation: templateId 2.16.840.1.113883.10.20.17.3.57] This observation represents whether or not a patient received any type of renal dialysis. If the negation indicator is true, the patient did NOT receive renal dialysis therapy. If the negation indicator is false, the patient did receive renal dialysis therapy. 1. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3711). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 66 January 2010 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3712). 3. SHALL contain @negationInd (CONF:3713). 4. SHALL contain [1..1] code/@code="ASSERTION" (CodeSystem: 2.16.840.1.113883.5.4 HL7ActCode) STATIC (CONF:3714). 5. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3715). 6. SHALL contain [1..1] value/@code="265764009" Renal dialysis (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3716). Figure 22: Renal dialysis example (did not occur) <observation classCode="OBS" moodCode="EVN" negationInd="true">  <templateId root="2.16.840.1.113883.10.20.17.3.57" /> <code code="265764009" codeSystem="2.16.840.1.113883.6.96" displayName="Renal dialysis" /> </observation> 4.15 Reporting parameters act [act: templateId 2.16.840.1.113883.10.20.17.3.8] The reporting parameters act provides information about the reporting time interval, and helps provide context for the patient data being reported to the receiving organization. The receiving organization may tell the reporting hospitals what information to include, such as dates representing the quarters of the year for which patient data is desired. 1. SHALL contain [1..1] @classCode="ACT" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3269). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3270). 3. SHALL contain [1..1] code/@code="252116004" Observation Parameters (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3272). 4. SHALL contain [1..1] effectiveTime (CONF:3273). a. This effectiveTime SHALL contain [1..1] low (CONF:3274). b. This effectiveTime SHALL contain [1..1] high (CONF:3275). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 67 January 2010 Figure 23: Reporting parameters act example <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.8" /> <code code="252116004" codeSystem="2.16.840.1.113883.6.96" displayName="Observation Parameters" /> <effectiveTime> <low value="20090601" />  <high value="20090831" />  </effectiveTime> </act> 4.16 Respiratory or ventilatory support [act: templateId 2.16.840.1.113883.10.20.17.3.25] This act represents the type of respiratory or ventilatory support a patient is receiving. The most general code 266700009 Ventilation assistance from the valueSet should be used with the negation indicator to represent that the patient did not receive ventilatory/respiratory assistance. 1. SHALL contain [1..1] @classCode="ACT" (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3427). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3428). 3. SHALL contain @negationInd (CONF:3429). 4. SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.3 Respiratory/Ventilatory Support Modes DYNAMIC (CONF:3430). 5. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3431). 6. MAY contain [0..1] entryRelationship (CONF:3432) such that it a. SHALL contain [1..1] @typeCode="COMP" Component (CodeSystem: 2.16.840.1.113883.5.1002 HL7ActRelationshipType) STATIC (CONF:3433). b. SHALL contain [1..1] observation (CONF:3434). i. This observation SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3435). ii. This observation SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3436). iii. This observation SHALL contain [1..1] code/@code="79063001" Gas flow rate (v) (CodeSystem: 2.16.840.1.113883.6.96 SNOMEDCT) STATIC (CONF:3437). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 68 January 2010 iv. This observation SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3438). v. This observation SHALL contain [1..1] value (CONF:3440). 1. This value SHALL contain [1..1] @unit="L/min" Liters per minute (CodeSystem: 2.16.840.1.113883.6.8 UCUM) STATIC (CONF:3441). 7. This act SHALL contain the entryRelationship representing gas flow rate if the act is representing nasal cannula support (CONF:4201). Figure 24: Respiratory or ventilatory support example <act classCode="ACT" moodCode="EVN" negationInd="false"> <templateId root="2.16.840.1.113883.10.20.17.3.25" /> <code code="59427005" codeSystem="2.16.840.1.113883.6.96" displayName="synchronized intermittent mandatory ventilation" /> <statusCode code="completed" /> </act> 4.17 Respiratory severity score [observation: templateId 2.16.840.1.113883.10.20.17.3.23] This observation represents the sum of the calculated value of (Mean Airway Pressure * FIO2). 1. SHALL contain [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3408). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3409). 3. SHALL contain [1..1] code/@code="RSS-X" Respiratory Severity Score (CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF:3410). 4. SHALL contain [1..1] statusCode/@code="completed" Completed (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3411). 5. SHALL contain [1..1] value (CONF:3412). Figure 25: Respiratory severity score example <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.17.3.23" /> <code code="RSS-X" codeSystem="2.16.840.1.113883.6.1" displayName="Respiratory Severity Score " /> <effectiveTime value="200903031620" /> <value xsi:type="REAL" value="5.12" /> </observation> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 69 January 2010 4.18 Steroid treatment (systemic) [substanceAdministration: templateId 2.16.840.1.113883.10.20.17.3.58] This template represents whether or not systemic steroids have been administered. The ingredient code N0000175576 Corticosteroid [EXT] from the NDF-RT code system in the valueSet should be used with the negation indicator to represent that the patient did not receive systemic steroids. 1. SHALL contain [1..1] @classCode="SBADM" Substance administration (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF:3717). 2. SHALL contain [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF:3718). 3. MAY contain @negationInd (CONF:3719). 4. SHALL contain [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF:3720). 5. MAY contain [0..1] effectiveTime (CONF:3721). 6. MAY contain [0..1] routeCode/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.3.88.12.3221.8.7 Medication Route FDA DYNAMIC (CONF:3723). 7. SHALL contain [1..1] consumable (CONF:3724). a. This consumable SHALL contain [1..1] manufacturedProduct (CONF:3725). i. This manufacturedProduct SHALL contain [1..1] manufacturedMaterial (CONF:3726). 1. This manufacturedMaterial SHALL contain [1..1] code/@code, which SHALL be selected from ValueSet 2.16.840.1.113883.11.20.5.14 Systemic steroids DYNAMIC (CONF:3727). Figure 26: Steroid treatment example  <substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="true"> <templateId root="2.16.840.1.113883.10.20.17.3.58" /> <statusCode code="completed" /> <consumable> <manufacturedProduct> <manufacturedMaterial> <code code="N0000175576" codeSystem="2.16.840.1.113883.3.26.1.5" displayName="Corticosteroid" codeSystemName="NDF-RT"> <originalText>Corticosteroid</originalText> </code> </manufacturedMaterial> </manufacturedProduct> </consumable> </substanceAdministration> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 70 January 2010 4.19 CCD Location participation [participant: templateId 2.16.840.1.113883.10.20.1.45] This clinical statement represents a location. 1. The value for "participant / @typeCode" in a location participation SHALL be "LOC" 2.16.840.1.113883.5.90 ParticipationType STATIC. (CONF:570). 2. A location participation SHALL contain exactly one participant / participantRole. (CONF:571). 3. The value for "participant / participantRole / @classCode" in a location participation SHALL be "SDLOC" "Service delivery location" 2.16.840.1.113883.5.110 RoleClass STATIC. (CONF:572). 4. Participant / participantRole in a location participation MAY contain exactly one participant / participantRole / code. (CONF:573). 5. The value for "participant / participantRole / code" in a location participation SHOULD be selected from ValueSet 2.16.840.1.113883.1.11.17660 ServiceDeliveryLocationRoleType 2.16.840.1.113883.5.111 RoleCode DYNAMIC. (CONF:574). 6. Participant / participantRole in a location participation MAY contain exactly one participant / participantRole / playingEntity. (CONF:575). 7. The value for "participant / participantRole / playingEntity / @classCode" in a location participation SHALL be "PLC" "Place" 2.16.840.1.113883.5.41 EntityClass STATIC. (CONF:576). 4.19.1 Neonatal ICU location [participant: templateId 2.16.840.1.113883.10.20.17.3.14] This template restricts the CCD location participation template to a Neonatal ICU. 1. Conforms to CCD Location participation Template (templateId: 2.16.840.1.113883.10.20.1.45). 2. SHALL contain [1..1] @typeCode="LOC" Location (CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType) STATIC (CONF:3319). a. This @typeCode SHALL contain [1..1] participantRole (CONF:3320). i. This participantRole SHALL contain [1..1] @classCode="SDLOC" Located entity (CodeSystem: 2.16.840.1.113883.5.110 HL7RoleClass) STATIC (CONF:3321). ii. This participantRole SHALL contain [1..1] code/@code="1040-5" Neonatal critical care unit (CodeSystem: 2.16.840.1.113883.6.259 HL7 HealthcareServiceLocation) STATIC (CONF:3322). Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 71 January 2010 Figure 27: Neonatal ICU location example  <participant typeCode="LOC"> <templateId root="2.16.840.1.113883.10.20.1.45" /> <templateId root="2.16.840.1.113883.10.20.17.3.14" /> <participantRole classCode="SDLOC"> <code code="PEDNICU" codeSystem="2.16.840.1.113883.5.111" displayName="Neonatal ICU" /> </participantRole> </participant> Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 72 January 2010 5 REFERENCES 1. HL7 Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD) A CDA implementation of ASTM E2369-05 Standard Specification for Continuity of Care Record© (CCR) April 01, 2007 available through HL7. 2. HL7 Implementation Guide for CDA Release 2 Quality Reporting Document Architecture (QRDA) Draft Standard for Trial Use March 2009. Available at: Quality Reporting Document Architecture (QRDA) 3. HL7 Implementation Guide for CDA Release 2 CDA for Public Health Case Reports (PHCR) Informative Standard October 2009. Available through HL7. 4. HL7 Implementation Guide for CDA Release 2: NHSN Healthcare Associated Infection (HAI) Reports, Release 2 Draft Standard for Trial Use January 2009 Available at: NHSN Healthcare Associated Infection (HAI) Reports 5. Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV, Shabo A, (Editors). HL7 Clinical Document Architecture, Release 2.0. ANSI-approved HL7 Standard; May 2005. Ann Arbor, Mich.: Health Level Seven, Inc. Available through HL7 or if an HL7 member with the following link: CDA Release 2 Normative Web Edition. 6. LOINC®: Logical Observation Identifiers Names and Codes, Regenstrief Institute. 7. SNOMED CT®: SNOMED Clinical Terms SNOMED International Organization. 8. Extensible Markup Language, www.w3.org/XML. 9. Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV, Shabo A., HL7 Clinical Document Architecture, Release 2. J Am Med Inform Assoc. 2006;13:3039. Available at: http://www.jamia.org/cgi/reprint/13/1/30. 10. Using SNOMED CT in HL7 Version 3; Implementation Guide, Release 1.5. Available through HL7 or if an HL7 member with the following link: Using SNOMED CT in HL7 Version 3 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 73 January 2010 APPENDIX A — ACRONYMNS AND ABBREV IATIONS ALT alanine aminotransferase AST aspartate aminotransferase ANSI American National Standards Institute ASTM American Society for Standards and Materials BUN blood urea nitrogen CCD Continuity of Care Document CDA Clinical Document Architecture CDS Core data set CHCA Child Health Corporation of America CHNC Children’s Hospitals Neonatal Consortium CONF Conformance CPT-4 Current Procedural Terminology, 4th Edition DRIV Is derived from DSTU Draft Standard for Trial Use EEG electroencephalogram EHR electronic health record ENC encounter EVN event FIO2 Fraction of inspired oxygen HAI Healthcare Associated Infection HITEP Health Information Technology Expert Panel HITSP Health Information Technology Standards Panel HL7 Health Level 7 ICU Intensive Care Unit IG Implementation Guide IMP Inpatient INT Intent INR International Normalized Ratio LOC location LOINC Logical Observation Identifiers Names and Codes NCR Neonatal Care Report Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 74 January 2010 NHSN National Healthcare Safety Network NICU Neonatal Intensive Care Unit NPO nothing by mouth OBS observation OID object identifier OTH Other PaO2 Arterial tension of oxygen PaCO2 Arterial tension of carbon dioxide pH Acidity (or basicity) of a solution PHCR Public Health Case Report PLC place PQ physical quantity PT prothrombin time QRDA Quality Reporting Document Architecture R2 Release 2 RIM Reference Information Model RSON reason SBADM substance administration SDLOC service delivery location SNOMED CT Systematized Nomenclature of Medicine--Clinical Terms SUBJ subject UCUM Unified Code for Units of Measure UNK Unknown VON Vermont Oxford Network WBC white blood cells XML Extensible Markup Language XSL Extensible Stylesheet Language XSI XML Schema Instance Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 75 January 2010 APPENDIX B — TEMPLATES USED IN THIS GUIDE The following table lists template hierarchically as they appear in this document. See the Templates by Containment table to see templates see the various groupings and organization of the templates as they would exist in an NCR CDA instance. Table 3: Templates Organized Hierarchically Template Title Template OID Document Templates Neonatal Care Report 2.16.840.1.113883.10.20.17.1.1 Section Templates CCD Encounters section NCR encounters section 2.16.840.1.113883.10.20.1.3 2.16.840.1.113883.10.20.17.2.2 Acuity score data section 2.16.840.1.113883.10.20.17.2.3 Patient data section 2.16.840.1.113883.10.20.17.2.4 Patient data section - NCR 2.16.840.1.113883.10.20.17.2.5 Reporting parameters section 2.16.840.1.113883.10.20.17.2.1 Clinical Statement Templates Acuity indicator data generic organizer 2.16.840.1.113883.10.20.17.3.59 Acuity data time organizer - admission to 12 hours 2.16.840.1.113883.10.20.17.3.60 Acuity data time organizer - day 3 2.16.840.1.113883.10.20.17.3.61 Acuity data time organizer - day 7 2.16.840.1.113883.10.20.17.3.62 Admission activity - neonatal 2.16.840.1.113883.10.20.17.3.12 CCD Encounter activity 2.16.840.1.113883.10.20.1.21 Neonatal ICU encounter activity CCD Medication activity 2.16.840.1.113883.10.20.17.3.15 2.16.840.1.113883.10.20.1.24 Nitric oxide administration 2.16.840.1.113883.10.20.17.3.24 Oxygen administration 2.16.840.1.113883.10.20.17.3.17 CCD Result observation 2.16.840.1.113883.10.20.1.31 Activated partial thromboplastin time 2.16.840.1.113883.10.20.17.3.44 Alanine aminotransferase (ALT) 2.16.840.1.113883.10.20.17.3.50 Albumin observation 2.16.840.1.113883.10.20.17.3.53 Apgar at 1 minute 2.16.840.1.113883.10.20.17.3.4 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 76 January 2010 Template Title Template OID Apgar at 5 minute 2.16.840.1.113883.10.20.17.3.5 Apgar score prolonged 2.16.840.1.113883.10.20.17.3.6 Arterial PaO2 Observation 2.16.840.1.113883.10.20.17.3.16 Aspartate aminotransferase (AST) 2.16.840.1.113883.10.20.17.3.49 Bicarbonate serum 2.16.840.1.113883.10.20.17.3.38 Bilirubin, conjugated 2.16.840.1.113883.10.20.17.3.52 Bilirubin, total 2.16.840.1.113883.10.20.17.3.51 Birth head circumference 2.16.840.1.113883.10.20.17.3.2 Birth weight 2.16.840.1.113883.10.20.17.3.1 Blood gas base deficit 2.16.840.1.113883.10.20.17.3.32 Blood gas base excess 2.16.840.1.113883.10.20.17.3.31 Blood pH 2.16.840.1.113883.10.20.17.3.30 Blood urea nitrogen (BUN) 2.16.840.1.113883.10.20.17.3.47 Body temperature 2.16.840.1.113883.10.20.17.3.10 Body weight 2.16.840.1.113883.10.20.17.3.11 Calcium ionized 2.16.840.1.113883.10.20.17.3.34 Calcium total serum 2.16.840.1.113883.10.20.17.3.35 Creatinine observation 2.16.840.1.113883.10.20.17.3.48 Diastolic blood pressure 2.16.840.1.113883.10.20.17.3.28 Fibrinogen level 2.16.840.1.113883.10.20.17.3.42 Gestational age 2.16.840.1.113883.10.20.17.3.3 Glucose serum 2.16.840.1.113883.10.20.17.3.39 Head circumference 2.16.840.1.113883.10.20.17.3.9 Heart rate 2.16.840.1.113883.10.20.17.3.29 Hemoglobin 2.16.840.1.113883.10.20.17.3.46 International normalized ratio (INR) 2.16.840.1.113883.10.20.17.3.45 Lactic acid from serum/plasma 2.16.840.1.113883.10.20.17.3.33 Mean airway pressure 2.16.840.1.113883.10.20.17.3.19 Mean blood pressure 2.16.840.1.113883.10.20.17.3.26 PaCO2 Observation 2.16.840.1.113883.10.20.17.3.20 Platelets 2.16.840.1.113883.10.20.17.3.41 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 77 January 2010 Template Title Template OID Potassium serum 2.16.840.1.113883.10.20.17.3.37 Prothrombin Time (PT) 2.16.840.1.113883.10.20.17.3.43 Respiratory rate 2.16.840.1.113883.10.20.17.3.21 Seizure frequency 2.16.840.1.113883.10.20.17.3.54 Sodium serum 2.16.840.1.113883.10.20.17.3.36 Systolic blood pressure 2.16.840.1.113883.10.20.17.3.27 Urine output 2.16.840.1.113883.10.20.17.3.55 White blood cell (leukocytes) 2.16.840.1.113883.10.20.17.3.40 Discharge activity - Neonatal 2.16.840.1.113883.10.20.17.3.13 Inborn/outborn 2.16.840.1.113883.10.20.17.3.7 Nothing by mouth (NPO) 2.16.840.1.113883.10.20.17.3.56 Oxygenation index 2.16.840.1.113883.10.20.17.3.22 PaO2/FIO2 ratio 2.16.840.1.113883.10.20.17.3.18 Renal dialysis (renal replacement therapy) 2.16.840.1.113883.10.20.17.3.57 Reporting parameters act 2.16.840.1.113883.10.20.17.3.8 Respiratory or ventilatory support 2.16.840.1.113883.10.20.17.3.25 Respiratory severity score 2.16.840.1.113883.10.20.17.3.23 Steroid treatment (systemic) 2.16.840.1.113883.10.20.17.3.58 Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 78 January 2010 APPENDIX C — SUMM ARY OF V ALUE SET S The following table summarizes the value sets used in this Neonatal Care Report Implementation Guide at the time of publishing. (Note: changes in display name and NOT code reflect a request in the display name change ONLY) Table 4: Summary of Value Sets valueSetOID Description code displayName codeSystem Code System Name A valueSet of SNOMED and LOINC codes for the 1 minute Apgar 169895004 Apgar at 1 minute 2.16.840.1.113883.6.96 SNOMED 48334-7 Apgar panel^1M post birth 2.16.840.1.113883.6.1 LOINC 169909004 Apgar at 5 minute 2.16.840.1.113883.6.96 SNOMED 48333-9 Apgar panel^5M post birth 2.16.840.1.113883.6.1 LOINC 169922007 Apgar at 10 minute 2.16.840.1.113883.6.96 SNOMED 48332-1 Apgar panel^10M post birth 2.16.840.1.113883.6.1 LOINC 443848000 Apgar at 15 minute 2.16.840.1.113883.6.96 SNOMED 443849008 Apgar at 20 minute 2.16.840.1.113883.6.96 SNOMED 169876006 Birth head circumference 2.16.840.1.113883.6.96 SNOMED 8290-9 Circumference.occipitalfrontalât birth 2.16.840.1.113883.6.1 LOINC (localValueSetName) 2.16.840.1.113883.11.20.5.16 Apgar 1 minute post birth 2.16.840.1.113883.11.20.5.17 Apgar 5 minutes post birth 2.16.840.1.113883.11.20.5.1 (Apgar Summary Score (prolonged)) 2.16.840.1.113883.11.20.5.19 (Birth head circumference) A valueSet of SNOMED and LOINC codes for the 5 minute Apgar A valueSet of SNOMED codes for the 10, 15 and 20 minute summary scores that are recorded in an extended neonatal resuscitation A valueSet of SNOMED and LOINC codes for birth head circumference valueSetOID Description code displayName codeSystem Code System Name A valueSet of SNOMED and LOINC codes for birth weight 47340003 Birth weight 2.16.840.1.113883.6.96 SNOMED 56056-5 Body weightât birth (reported) 2.16.840.1.113883.6.1 LOINC 8339-4 Body weightât birth (measured) 2.16.840.1.113883.6.1 LOINC (localValueSetName) 2.16.840.1.113883.11.20.5.15 (Birth weight) 2.16.840.1.113883.11.20.5.18 (Body weight) A valueSet of SNOMED and LOINC codes for measured body weight 27113001 Body weight 2.16.840.1.113883.6.96 SNOMED 3141-9 Body weight (measured) 2.16.840.1.113883.6.1 LOINC 2.16.840.1.113883.11.20.5.2 (Body temperature) A valueSet of applicable SNOMED body temperature codes for neonatal ICU 386725007 Body temperature 2.16.840.1.113883.6.96 SNOMED 8310-5 Body Temperature 2.16.840.1.113883.6.1 LOINC 276885007 Core body temperature 2.16.840.1.113883.6.96 SNOMED 415882003 Axillary temperature 2.16.840.1.113883.6.96 SNOMED 307047009 Rectal temperature 2.16.840.1.113883.6.96 SNOMED 364537001 Temperature of skin 2.16.840.1.113883.6.96 SNOMED 2.16.840.1.113883.11.20.5.21 (Diastolic blood pressure) A valueSet of SNOMED and LOINC codes for diastolic blood pressure 271650006 Diastolic blood pressure 2.16.840.1.113883.6.96 SNOMED 8462-4 Intravascular diastolic:Pres 2.16.840.1.113883.6.1 LOINC 2.16.840.1.113883.11.20.5.22 (Mean blood pressure) A valueSet of SNOMED and LOINC codes for mean blood pressure 6797001 Mean blood pressure 2.16.840.1.113883.6.96 SNOMED 8478-0 Intravascular mean:Pres 2.16.840.1.113883.6.1 LOINC 2.16.840.1.113883.11.20.5.20 (Systolic blood pressure) A valueSet of SNOMED and LOINC codes for systolic blood pressure 271649006 Systolic blood pressure 2.16.840.1.113883.6.96 SNOMED 8480-6 Intravascular systolic:Pres 2.16.840.1.113883.6.1 LOINC 2.16.840.1.113883.11.20.5.23 (Respiratory rate) A valueSet of SNOMED and LOINC codes for respiratory rate 86290005 Respiratory rate 2.16.840.1.113883.6.96 SNOMED 9279-1 Breaths:Nrat 2.16.840.1.113883.6.1 LOINC 2.16.840.1.113883.11.20.5.3 (Respiratory/Ventilatory Support Modes) A valueSet of applicable SNOMED procedure codes relating to types of ventilation 233573008 ECMO - Extracorporeal membrane oxygenation 2.16.840.1.113883.6.96 SNOMED 243153009 High frequency positive pressure ventilation 2.16.840.1.113883.6.96 SNOMED 243154003 High frequency jet 2.16.840.1.113883.6.96 SNOMED Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 80 January 2010 valueSetOID Description code displayName codeSystem Code System Name (localValueSetName) ventilation 2.16.840.1.113883.11.20.5.4 (Lactic acid/lactate) A valueSet of applicable lab LOINC lactate codes 2.16.840.1.113883.11.20.5.5 (Ionized Calcium) A valueSet of applicable lab LOINC ionized calcium codes Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. 243155002 High frequency oscillatory ventilation 2.16.840.1.113883.6.96 SNOMED 243147009 Controlled ventilation 2.16.840.1.113883.6.96 SNOMED 182687005 Intermittent positive pressure ventilation 2.16.840.1.113883.6.96 SNOMED 286813003 Pressure controlled SIMV 2.16.840.1.113883.6.96 SNOMED 59427005 Synchronized intermittent mandatory ventilation 2.16.840.1.113883.6.96 SNOMED 229312009 Nasal ventilation therapy 2.16.840.1.113883.6.96 SNOMED 47545007 CPAP - Continuous positive airway pressure therapy 2.16.840.1.113883.6.96 SNOMED 266700009 Ventilation assistance 2.16.840.1.113883.6.96 SNOMED 2524-7 Lactate Ser/Plas 2.16.840.1.113883.6.1 LOINC 32693-4 Lactate Bld 2.16.840.1.113883.6.1 LOINC 17863-2 Calcium.ionized [Mass/volume] in Serum or Plasma 17864-0 Calcium.ionized [Mass/volume] in Serum or Plasma by Ion-selective membrane electrode (ISE) 2.16.840.1.113883.6.1 38230-9 Calcium.ionized [Mass/volume] in Blood 2.16.840.1.113883.6.1 1994-3 Calcium.ionized [Moles/volume] in Blood 2.16.840.1.113883.6.1 1995-0 Calcium.ionized [Moles/volume] in Serum or Plasma 2.16.840.1.113883.6.1 12180-6 Calcium.ionized [Moles/volume] in Serum 2.16.840.1.113883.6.1 Page 81 January 2010 LOINC 2.16.840.1.113883.6.1 LOINC LOINC LOINC LOINC LOINC valueSetOID Description code displayName codeSystem (localValueSetName) Code System Name or Plasma by Ion-selective membrane electrode (ISE) 2.16.840.1.113883.11.20.5.6 (White blood cell count) 2.16.840.1.113883.11.20.5.7 (Platelet) 2.16.840.1.113883.11.20.5.8 (Fibrinogen) 2.16.840.1.113883.11.20.5.9 (International Normalized Ratio (INR)) A valueSet of applicable lab LOINC white count codes A valueSet of applicable lab LOINC platelet count codes A valueSet of applicable lab LOINC fibrinogen level codes A valueSet of applicable lab LOINC International Normalized Ratio (INR) codes Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. 47596-2 Calcium.ionized [Moles/volume] in Blood by Ion-selective membrane electrode (ISE) LOINC 2.16.840.1.113883.6.1 26464-8 Leukocytes [#/volume] in Blood 2.16.840.1.113883.6.1 6690-2 Leukocytes Bld Qn Automated count 2.16.840.1.113883.6.1 26515-7 Platelets Bld 2.16.840.1.113883.6.1 LOINC 49497-1 Platelets Bld Estimate 2.16.840.1.113883.6.1 LOINC 777-3 Platelets [#/volume] in Blood by Automated count LOINC LOINC LOINC 2.16.840.1.113883.6.1 30902-1 Fibrinogen [Mass/volume] in Platelet poor plasma by Heat denaturation 2.16.840.1.113883.6.1 LOINC 3255-7 Fibrinogen [Mass/volume] in Platelet poor plasma by Coagulation assay 2.16.840.1.113883.6.1 LOINC 55452-7 Fibrinogen in Platelet poor plasma 2.16.840.1.113883.6.1 LOINC 34714-6 INR in Blood by Coagulation assay 2.16.840.1.113883.6.1 LOINC Page 82 January 2010 valueSetOID Description code displayName codeSystem Code System Name 52129-4 INR in Platelet poor plasma by Coagulation assay --post heparin 2.16.840.1.113883.6.1 LOINC 6301-6 INR in Platelet poor plasma by Coagulation assay 2.16.840.1.113883.6.1 LOINC 46418-0 INR in Capillary blood by Coagulation assay 2.16.840.1.113883.6.1 LOINC A valueSet of applicable lab LOINC hemoglobin codes 718-7 Hemoglobin [Mass/volume] in Blood 2.16.840.1.113883.6.1 LOINC 20509-6 Hemoglobin [Mass/volume] in Blood by calculation 2.16.840.1.113883.6.1 LOINC A valueSet of applicable lab LOINC albumin codes 1751-7 Albumin [Mass/volume] in Serum or Plasma 2.16.840.1.113883.6.1 LOINC 2862-1 Albumin [Mass/volume] in Serum or Plasma by Electrophoresis 2.16.840.1.113883.6.1 LOINC 3094-0 Urea nitrogen [Mass/volume] in Serum or Plasma 2.16.840.1.113883.6.1 LOINC 6299-2 Urea nitrogen [Mass/volume] in Blood 2.16.840.1.113883.6.1 LOINC A valueSet of applicable SNOMED frequency qualifier codes 260413007 None 2.16.840.1.113883.6.96 SNOMED 50607009 Single 2.16.840.1.113883.6.96 SNOMED 255204007 Multiple 2.16.840.1.113883.6.96 SNOMED A valueSet of applicable systemic steroid medication codes N0000175576 Corticosteroid [EXT] 2.16.840.1.113883.3.26.1.5 ND FRT 3264 Dexamethasone 2.16.840.1.113883.6.88 RxNorm 5492 Hydrocortisone 2.16.840.1.113883.6.88 RxNorm 8640 Prednisone 2.16.840.1.113883.6.88 RxNorm 8638 Prednisolone 2.16.840.1.113883.6.88 RxNorm (localValueSetName) 2.16.840.1.113883.11.20.5.10 (Hemoglobin) 2.16.840.1.113883.11.20.5.11 (Albumin) 2.16.840.1.113883.11.20.5.12 (Blood Urea Nitrogen (BUN)) 2.16.840.1.113883.11.20.5.13 (Seizure frequency) 2.16.840.1.113883.11.20.5.14 (Systemic steroids) A valueSet of applicable lab LOINC BUN codes Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. All rights reserved. Page 83 January 2010 valueSetOID Description code displayName codeSystem Code System Name 6902 methylprednisolone 2.16.840.1.113883.6.88 RxNorm 1086007 Female 2.16.840.1.113883.6.96 SNOMED 10052007 Male 2.16.840.1.113883.6.96 SNOMED 37791004 Indeterminate 2.16.840.1.113883.6.96 SNOMED F Female 2.16.840.1.113883.5.1 HL7 AdministrativeGender M Male 2.16.840.1.113883.5.1 HL7 AdministrativeGender UN Undifferentiated 2.16.840.1.113883.5.1 HL7 AdministrativeGender (localValueSetName) 2.16.840.1.113883.11.20.5.24 (NCR gender) A valueSet of both the HL7 administrativeGender codes valueSet and HITSP foundations sex structure codes valueSet 2.16.840.1.113883.11.20.5.25 (Heart rate) A valueSet of SNOMED and LOINC codes for heart rate 364075005 Heart rate 2.16.840.1.113883.6.96 SNOMED 8867-4 Heart beat:NRat:Pt:XXX:Qn: 2.16.840.1.113883.6.1 LOINC 2.16.840.1.113883.11.20.5.26 Head circumference A valueSet of SNOMED and LOINC codes for heart rate 363812007 Head circumference 2.16.840.1.113883.6.96 SNOMED 8287-5 Circumference.occipitalfrontal 2.16.840.1.113883.6.1 LOINC Implementation Guide for CDA R2 NCR- US Realm Draft Standard for Trial Use Release 1 © 2010 Health Level Seven, Inc. 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