HL 7 PUBLIC HEALTH WORKGROUP BIRTH DEFECTS IMPLEMENTATION

HL 7 PUBLIC HEALTH WORKGROUP BIRTH DEFECTS IMPLEMENTATION GUIDE BALLOT RECONCILIATION December 7, 2017

Conformance Statements Comment #18 (NEG) Commenter recommends to strike all conformance statements requiring the use of code. System. Name and Display. Name attributes. Forcing those values to be included just bloats the document. Disposition: Persuasive. We will delete all conformance statements on @codesystemname & @displayname. We will follow format in C-CDA STU R 2. 1. An example for the correction is illustrated below: 5. SHALL contain exactly one [1. . 1] code (CONF: 1137 -143) such that it a. SHALL contain exactly one [1. . 1] @code="29308 -4" Diagnosis (CONF: 1137 -144). b. SHALL contain exactly one [1. . 1] @code. System="2. 16. 840. 1. 113883. 6. 1" (Code. System: LOINC urn: oid: 2. 16. 840. 1. 113883. 6. 1) (CONF: 1137 -145). 2

Conventions Comment #20 (NEG) Commenter recommends to follow CDA IG conventions such as identification of source, status, and version of all templates. See Cytogenetics Section for example. Also see Father Information Section. These and many others are not C-CDA templates. Based on commenters recommendation, will be consistent and follow appropriate conventions. Disposition: Persuasive with Mod. We follow HL 7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes. In addition, we will correct spelling, “Cytogenertis section” to “Cytogenetics Section. ” 3

Conventions HL 7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2. 1 Draft Standard for Trial Use August 2015 Problem Section (entries optional) (V 3) [section: identifier urn: hl 7 ii: 2. 16. 840. 1. 113883. 10. 22. 2. 5: 2015 -08 -01 (open)] HL 7 CDA® R 2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries, Release 2 - US Realm Father Information Section [section: identifier urn: hl 7 ii: 2. 16. 840. 1. 113883. 10. 14. 96: 201515 -09 (open)] Birth Defects Diagnosis Section (entries required) [section: identifier urn: hl 7 ii: 2. 16. 840. 1. 113883. 10. 14. 2: 2014 -27 -10 (open)] 4

Birth Defects Diagnosis Concern Act Comment #23 (NEG) Commenter recommends that instead of creating new Acts, use existing Acts. In this case, use Problem Concern Act. Follow this logic throughout. The Problem Concern Act it too broad and conveys general problems, not birth defects. Therefore, we constrained the act to focus on birth defect problems. However, by making a change, we will need to include items like effective time, etc. Disposition: Persuasive with Mod. Will modify to imply the Problem Concern Act. Will also need to imply Problem Observation in the Birth Defects Diagnosis Template. 5

Birth Defects Diagnosis Concern Act HL 7 CDA® R 2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries, Release 2 - US Realm 1. SHALL contain exactly one [1. . 1] @class. Code="ACT" Act (Code. System: HL 7 Act. Class urn: oid: 2. 16. 840. 1. 113883. 5. 6 STATIC) (CONF: 1137 -121). 2. SHALL contain exactly one [1. . 1] @mood. Code="EVN" Event (Code. System: Act. Mood urn: oid: 2. 16. 840. 1. 113883. 5. 1001 STATIC) (CONF: 1137 -122). 3. SHALL contain exactly one [1. . 1] template. Id (CONF: 1137 -123) such that it. . . 5. SHALL contain exactly one [1. . 1] code (CONF: 1137 -125). a. This code SHALL contain exactly one [1. . 1] @code="CONC" Concern (CONF: 1137 -127). b. This code SHALL contain exactly one [1. . 1] @code. System="2. 16. 840. 1. 113883. 5. 6" (Code. System: HL 7 Act. Class urn: oid: 2. 16. 840. 1. 113883. 5. 6) (CONF: 1137 -128). … b. SHALL contain exactly one [1. . 1] Birth Defect Diagnosis Observation (identifier: urn: hl 7 ii: 2. 16. 840. 1. 113883. 10. 14. 4: 2014 -27 -10) (CONF: 1137137). HL 7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2. 1 Draft Standard for Trial Use August 2015 1. SHALL contain exactly one [1. . 1] @class. Code="ACT" (Code. System: HL 7 Act. Class urn: oid: 2. 16. 840. 1. 113883. 5. 6 STATIC) (CONF: 1198 -7469). 2. SHALL contain exactly one [1. . 1] @mood. Code="EVN" Event (Code. System: Act. Mood urn: oid: 2. 16. 840. 1. 113883. 5. 1001 STATIC) (CONF: 1198 -7470). 3. SHALL contain exactly one [1. . 1] template. Id (CONF: 1198 -7471) such that it … 5. SHALL contain exactly one [1. . 1] code (CONF: 1198 -7477). a. This code SHALL contain exactly one [1. . 1] @code="CONC" Concern (CONF: 1198 -19158). b. This code SHALL contain exactly one [1. . 1] @code. System="2. 16. 840. 1. 113883. 5. 6" (Code. System: HL 7 Act. Class urn: oid: 2. 16. 840. 1. 113883. 5. 6) (CONF: 1198 -32154). … b. SHALL contain exactly one [1. . 1] Allergy - Intolerance Observation (V 2) (identifier: urn: hl 7 ii: 2. 16. 840. 1. 113883. 10. 22. 4. 7: 2014 -06 -09) (CONF: 119814925). 6

Father Information Section Comment #38 (A-Q) Commenter asks if it is necessary to have a unique section for Father’s Information or can the information be captured via the Family History Section? Only minimum information about the Father (i. e. , SSID, race, and ethnicity) is needed. Not interested in collecting the history of father’s health conditions, etc. as part of birth defects reporting. The Family History Section is too robust and won’t be able to get this information. It would force reporting of more than what we need, including the problem value set. Currently Father Information Section constraints are more relaxed than the Family History Section, using a SHALL but the entries it contains are MAY. Whereas, Family History Observation is a SHALL. Disposition: Considered Question Answered. Yes, it is necessary to have a unique section for Father’s Information. Only minimum about the father is needed, not all that is needed with the Family History Section. 7

Newborn Delivery Information Section Comment #39 (NEG) Commenter stated that requiring the inclusion of the Newborn Delivery Information section may prove challenging to implement as this document is intended to be sent on children up to 12 years of age. It is extremely unlikely that information will be available for an older child if they have moved EHRs from where they were born. If the child moves from a different state then we will need to capture information no matter the age. We don’t want anyone to be able to “skip” the item, but rather allow a Null. Flavor. There are many other states that go up to age 12 (fetal alcohol (FASD)), as some are not diagnosed until later in childhood (>8 yrs. ). There are birth defects that are not diagnosed until later, thus we need to have an avenue to be able to collect that and understanding continuity of care. Consider developmental disorders, which are typically not diagnosed until the child is of school age. Disposition: Persuasive with Mod. We will add @null. Flavor for the Newborn Delivery Information section and to bind to null. Flavor code system. 8

Requirements as Separate Assets Comment #49 (A-S) Commenter suggested that having requirements is good, but it's better if you can put them in a separate asset (e. g. , a DAM) so they can support more than one technical specification. Followed pre-established criteria for producing and implementing a HL 7 CDA Implementation Guide as outlined in Quality of CDA IG: http: //wiki. hl 7. org/index. php? title=CDA_Implementation_Guide_Quality_Criteria Collaborated with a CDC SME at the onset of this project to assure that the Birth Defects IG was aligned with the published Birth & Fetal Death Report IG. In fact, we reference many section/entry templates from the Birth & Fetal Death Report IG. Disposition: Considered for Future Use. We may explore this approach, when producing another specification such as FHIR for Birth Defects reporting. Also if a DAM is considered, explore including in Vital Records DAM. 9