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|The following schematron asserts are untested, but seem easily testable:|
|In the Physician Reading Study Performer (V2) template (urn:hl7ii:2.16.840.1.1138184.108.40.206.2.1:2014-06-09):|
d. The id SHOULD include zero or one [0..1] id where id/@root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:1098-32135).
It seems like we could clean up d. and standardize the templating a bit.
In the Diagnostic Imaging Report template:
If the DICOM Object Catalog section SHALL come first, then why not list it before the Findings section?
|In the Mental Stagus Organizer (V3) template (urn:hl7ii:2.16.840.1.1138220.127.116.11.4.75:2015-08-01):|
a. The Organizer SHALL have at least one of code or effectiveTime (CONF:1198-32426).
Why does this exist? We already know the organizer SHALL have a code because of CONF:1198-14378, so I can't see a circumstance in which this statement ever does anything.
|Typo (should be entryRelationship):|
12. SHALL contain at least one [1..*] entryRelationships (CONF:1098-32782).
Note that this isn't tested in the schematron either, presumably because it was looking for an "entryRelationships" element. We should fix this in Trifolia and I think (hope?) that'll give us the schematron fix for free.
|The schematron has the following assert for CONF:1098-7508:|
<sch:assert id="a-1098-7508-c" test="cda:effectiveTime[@xsi:type='IVL_TS']">SHALL contain exactly one [1..1] effectiveTime (CONF:1098-7508) such that it</sch:assert>
IVL_TS certainly does seem like the most likely @xsi:type to have for the first effectiveTime here (in contrast with the second, which the IG says SHALL have type PIVL_TS or EIVL_TS), but the IG itself never mentions the first effectiveTime's type, so this seems strange.
|Currently the CDA R2.0 specification and the C-CDA IG don't provide a way to semantically convey that the patient or an individual (a relatedPerson) is the Custodian of the information.||2021|
|Priyaranjan Tokachichu||The schematron rule considers "assignedPerson or representedOrganizaton" logic, but not "assignedPerson or (assignedAuthoringDevice and representedOrganization)". This results in schematron failure of "author/assignedAuthor" in the header that has "assignedPerson" and "representedOrganization" (which is valid based on implied meaning of (CONF:1198-8457)).||2016|
|The Planned Intervention Act (V2) contains text in the template description that is logically correct due to the intent of the section to contain only planned events: “All interventions referenced in a Planned Intervention Act must have moodCodes indicating that that are planned (have not yet occurred).”|
So, any moodCode OTHER THAN "EVN".
|The current Payer Section "REQUIRES" (SHALL 1..*) a prior authorization. There will not always be an authorization every time coverage is used/communicated in the Payer Section.||1945|
|Encounter Diagnosis (V3)|
[act: identifier urn:hl7ii:2.16.840.1.113818.104.22.168.4.80:2015-08-01 (open)]
This template wraps relevant problems or diagnoses at the close of a visit or that need to be followed after the visit. If the encounter is associated with a Hospital Discharge, the Hospital Discharge Diagnosis must be used. This entry requires at least one Problem Observation entry.
|@sueann svaby||SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Social History Type urn:oid:2.16.840.1.113822.214.171.124.80.60 DYNAMIC (CONF:1198-8558).|
a. If @codeSystem is not LOINC, then this code SHALL contain at least one [1..*] translation, which SHOULD be selected from CodeSystem LOINC (urn:oid:2.16.840.1.113883.6.1) (CONF:1198-32951).
|Encounter Diagnosis (V3)|
[act: identifier urn:hl7ii:2.16.840.1.1138126.96.36.199.4.80:2015-08-01 (open)]
The template is missing a binding for statusCode.
Figure 144 shows a statusCode of "active". This provides the wrong guidance.
|Please REMOVE/DEPRECATE this commentIn the errata release from June 2019,Figure 162 is wrong and needs to be updated to use the correct Code System OID for CVX 2.16.840.1.1137188.8.131.520.6. It currently shows as 2.16.840.1.113762.12.292|
|Care Plan (V2)|
[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.1138184.108.40.206.1.15:2015-08-01 (open)]
The CDA Care Plan represents an instance of this dynamic Care Plan at a point in time. The CDA document itself is NOT dynamic.
Key differentiators between a Care Plan CDA and CCD (another “snapshot in time” document): There are 2 required sections:
o Health Concerns o Interventions
There are 2 optional sections:
o Goals o Outcomes
• Provides the ability to identify patient and provider priorities with each act • Provides a header participant to indicate occurrences of Care Plan review A care plan document can include entry references from the information in these sections to the information (entries) in other sections.
Please see Volume 1 of this guide to view a Care Plan Relationship diagram and story board.
|Smoking Status - Meaningful Use (V2) (urn:hl7ii:2.16.840.1.1138220.127.116.11.4.78:2014-06-09)|
. This value SHALL contain exactly one [1..1] @code, which SHALL be selected from ValueSet Smoking Status urn:oid:2.16.840.1.113818.104.22.168.38 DYNAMIC (CONF:1098-14817).
|We have trouble adding new Social History Observations when the US Gov't identifies the observation using LOINC. We really should be using LOINC in the code ("the question").|
I recommend creating a Grouping Value Set that combines the original set of concepts using SNOMEDCT (Social History Type (SNOMEDCT)) and then agree to put all new/additional social history observation codes in the Social History Type (LOINC) value set. Use the existing OID for the new Grouping VS and make two new value sets for the parts of the grouping VS.
|On page 392, Section 3.61.1, the last three sentences of the text read as follows:|
"Procedure act is for procedures that alter the physical condition of a patient (e.g., splenectomy). Observation act is for procedures that result in new information about a patient but do not cause physical alteration (e.g., EEG). Act is for all other types of procedures (e.g., dressing change)."
This is different from the wording on page 390, Section 3.61 Procedures Section (entries optional) (V2). Updated language is in the proposed section below.
|1793||3.41 Immunization Medication Information (V2) includes SHALL have a manufactureMaterial where this code MAY contain zero or more [0..*] translation, which MAY be selected from ValueSet Vaccine Clinical Drug urn:oid:2.16.840.1.113722.214.171.1240.8 DYNAMIC (CONF:1098-31543).|
|3.41 Immunization Medication Information (V2) includes SHALL have a manufactureMaterial where this code MAY contain zero or more [0..*] translation, which MAY be selected from ValueSet Vaccine Clinical Drug urn:oid:2.16.840.1.1137126.96.36.1990.8 DYNAMIC (CONF:1098-31543).||1790|
|SHOULD contain exactly one [1..1] effectiveTime (CONF:1098-32943) such that it|
a. SHALL contain exactly one [1..1] @operator="A" (CONF:1098-32945).
b. SHALL contain exactly one [1..1] @xsi:type="PIVL_TS" or "EIVL_TS" (CONF:1098-32946).
|We have seen real-world implementation defects where planned future encounters appear in the Encounters section rather than the Plan of Treatment section where they should be. I think some developers are just querying their database encounter tables for all encounters for a particular patient and sticking everything in the Encounters section regardless of whether they are past or future. Let's introduce a new conformance rule to ensure each Encounter activity ends before the document header effectiveTime.|
|In section 3.81 Procedure Activity Procedure (V2) the Procedure.code (CONF:1098-7656) doesn't mention HCPCS as a possible code system. I think that code system should be explicitly listed because it is in common use in the US realm along with CPT-4. There are many procedures which are in HCPCS but not in CPT-4.|
This @code SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12) or ICD10 PCS (CodeSystem: 2.16.840.1.113883.6.4) or CDT-2 (Code System: 2.16.840.1.113883.6.13) (CONF:1098-19207).
|The value set for statusCode for Medication Supply Order (v2) include several codes that are incompatible with the equivalent statusCodes in the FHIR US Core profile for MedicationRequest (http://hl7.org/fhir/STU3/valueset-medication-request-status.html).||1776|
|The statusCode for Immunizations in the Immunization Activity (v3) allows for all values in the ActStatus urn:oid:2.16.840.1.1138188.8.131.5233:||1775|
|The value set for status of Result Observation (V3) [Result Status urn:oid:2.16.840.1.1138184.108.40.206.39 STATIC] is broadly incompatible with the FHIR US Core value sets for Observation status (http://hl7.org/fhir/valueset-observation-status.html) and DiagnosticReport status (http://hl7.org/fhir/valueset-diagnostic-report-status.html). Here are the values for reference:||1774|
|The ProcedureAct statusCode urn:oid:2.16.840.1.1138220.127.116.11.22 STATIC 2014-04-23 used for statusCode in the Procedure Activity Procedure (V2) template currently has 4 values:||1773|
|In the Goal Observation template, the status is currently hardcoded to "active":||1772|
|The C-CDA 2.1 Problem Value Set (urn:oid:2.16.840.1.113818.104.22.168.3221.7.4) allows only terms descending from the Clinical Findings (404684003) or Situation with Explicit Context (243796009) hierarchies.||1768|
|Currently the Personal and Legal Relationship Role Type Value set (2.16.840.1.113822.214.171.124.1) is missing some (about 10) concepts needed to align with the corresponding Value set used in FHIR RelatedPerson.Relationship.||1765|
|Template Improvement Request:||1764|
|New feature request||1762||SHALL contain exactly one [1..1] componentOf (CONF:1198-8386).|
a. This componentOf SHALL contain exactly one [1..1] encompassingEncounter (CONF:1198-8387).
|Smoking Status - Meaningful Use (V2)|
[observation: identifier urn:hl7ii:2.16.840.1.1138126.96.36.199.4.78:2014-06-09 (open)]
|Immunizations Section (entries required) (V3)|
[section: identifier urn:hl7ii:2.16.840.1.1138188.8.131.52.2.2.1:2015-08-01 (open)]
|1757||In order to stay aligned with FHIR, the Birth Sex entry template needs to be modified to use the same value set for birth sex.|
The value set is being established now in VSAC. We believe the OID will be OID: 2.16.840.1.1137184.108.40.2061.24.
|Page 85-86: "There are 2 required sections: Health Concerns and Interventions|
There are 2 optional sections: Goals and Outcomes"
|Interventions Section (V3)|
[section: identifier urn:hl7ii:2.16.840.1.1138220.127.116.11.2.3:2015-08-01 (open)]
|Currently the infulfillmentOF/order in the header doesn't seem to allow for the semantics to indicate when the document contains information about the initiation of an order. It only seems to permit indicating when a document contains information about the fulfillment of an order. Where would I index in the header information about evidence within the document indicating an order was placed?||1642|
|This template represents the patient's home environment including, but not limited to, type of residence (trailer, single family home, assisted living), living arrangement (e.g., alone, with parents), and housing status (e.g., evicted, homeless, home owner).||1638|
|This sdtc:dischargeDispositionCode SHOULD contain exactly [0..1] codeSystem, which SHOULD be either CodeSystem: NUBC 2.16.840.1.113883.6.301.5 OR CodeSystem: HL7 Discharge Disposition 2.16.840.1.113883.12.112 (CONF:1198-32377).||1626||Because LOINC has deprecated the code 52521-1 the examples for Care Plan document should use the replacement code of 18776-5, and the sample code in the value set should be fixed to use 18776-5.|
Duplicate to 1625 - made this by mistake and couldn't figure out how to delete it.
|Because LOINC has deprecated the code 52521-2 the examples for Care Plan document should use the replacement code of 18776-5, and the sample code in the value set should be fixed to use 18776-5.||1623|
|Health Status Evaluations and Outcomes Section|
[section: identifier urn:oid:2.16.840.1.113818.104.22.168.2.61 (open)]
This template represents observations regarding the outcome of care from the interventions used to treat the patient. These observations represent status, at points in time, related to established care plan goals and/or interventions.
|There is a general need to do an overall clean-up the C-CDA IG to go through all value set definitions and make sure that the source information is correct.|
As we have improved the availability of value set definitions and expansions in VSAC, the source may have changed from PHINVADS or some other organization.
|@Eric Parapini||In the template Immunization Activity Act (V3) (TemplateId: 2.16.840.1.113822.214.171.124.4.52:2015-08-01) there is an entryRelationship to the Instruction (V2) template (TemplateId: 2.16.840.1.1138126.96.36.199.4.20:2014-06-09). ||1606|
|@Eric Parapini||I would like to request the LOINC code "80791-7" Nutrition and dietetics Plan of care note be added to the Care Plan Document Type value set (urn:oid:2.16.840.1.1137188.8.131.529.10)||1605|
|In the latest errata version (CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_Vol2_2018MAYwith_errata.pdf) on page128 (2.1.8 above number 4) that "Preferred code is 18748-4 LOINC Diagnostic Imaging Report" but per LOINC, that code will be deprecated in December 2018||1603|
|From the C-CDA Companion Guide Note Activity Template (Page 92 - 9(c)(ii)(1)):|
The playingEntity, if present, SHALL contain zero or more [0..*] US Realm Person Name (PN.US.FIELDED) (identifier: urn:oid:2.16.840.1.1138184.108.40.206.5.1.1) (CONF:3250-16929).
|Allergy & intolerance template (2.16.840.1.1138220.127.116.11.4.7), substance reactant binding (CONF:1098-7419)|
The bound value set is very large, making it difficult to support for both entry and validation.
|1525||SHOULD contain zero or one [0..1] performer="PRF" Performer (CodeSystem: HL7ParticipationType urn:oid:2.16.840.1.113883.5.90 STATIC) (CONF:1198-8961) such that it||1516|
|Number of Pressure Ulcers Observation (V3)|
[observation: identifier urn:hl7ii:2.16.840.1.113818.104.22.168.4.76:2015-08-01 (open)]
This template represents the number of pressure ulcers observed at a particular stage.
|1515||@George Dixon||Clinical Documentation Request we are unable to support. Medication Administration- Ability to display an administered dose with a cumulative dose. Use Case - For a given treatment timeframe when ordering and administering chemotherapy medications related to their toxicity it is important to know the patient's running dosage received. Depending on the clinical environments management of visits (acute versus repeat outpatient treatments) this may be within an encounter or across encounters for a given period of time. Need communicate most recent dose(s), Cumulative interval (low/high) and cumulative dose.||1513|
|Table 400: Health Insurance Type|
Code System OID is wrong
ALSO WRONG IN THE LIST OF CODES SYSTEMS USED IN THE IG
|Value Set: HealthcareServiceLocation urn:oid:2.16.840.1.113822.214.171.12475|
A comprehensive classification of locations and settings where healthcare services are provided. This value set is based on the National Healthcare Safety Network (NHSN) location code system that has been developed over a number of years through CDC's interaction with a variety of healthcare facilities and is intended to serve a variety of reporting needs where coding of healthcare service locations is required.
|Currently in the Patient Generated Document Header|
13. MAY contain zero or more [0..*] documentationOf (CONF:1198-28710).
The code should be selected from a value set established by the document-level template for a specific type of Patient Generated Document.
|@Berge,Ruth||The link in section 1.1.17 Progress Note (v3) in Table 49 (Progress Note (V3) Context) for " Allergies and Intolerances Section (entries optional) (V3) " goes to 2.4.1 Allergies and Intolerances Section (entries required) (V3). This is also true for the link in Table 53: Referral Note (V2) Constraints Overview . In Table 53 the Allergies section is assigned CONF# 1198- 30625. On page 195, in the details for Allergies there is another link that also goes to the wrong Allergies and Intolerance Section.||1470|
|This comment refers back to decisions made in Errata 1338.|
Given a proposed alternative constraint was not provided/proposed by Regenstrief in time to be included in the September errata update for C-CDA R2.1, I supported leaving the errata change as had been proposed and implemented in the US Realm header template draft C-CDA R2.1 errata release (shown below):
|Value Set X_ActRelationshipDocument is a new value set that came into existence during the C-CDA R2.1 Errata Update. It needs to be added to the CCDA Value Set Summary sheet maintained in the HL7 SDWG Workgroup Documents area.||1430|
|SHALL contain exactly one [1..1] templateId (CONF:81-8531) such that it|
a. SHALL contain exactly one [1..1] @root="2.16.840.1.1138126.96.36.199.1.2"
|3.34 Goal Observation|
MAY contain zero or one [0..1] value (CONF:1098-32743).
|Section 3.23, page 483:|
Table 272: EncounterTypeCode
Value Set: EncounterTypeCode urn:oid:2.16.840.1.1138188.8.131.52.80.32
This value set includes only the codes of the Current Procedure and Terminology designated for Evaluation and Management (99200 – 99607) (subscription to AMA Required
Value Set Source: http://www.amacodingonline.com/
|@Hyde,Linda||Value Set Links in IG|
A number of the links for value sets in the IG either no long work or point to the wrong location. For example several value set links send you to the VTSL Browser (veterinary service extension); the link for the country value set is no longer valid.
|@Hyde,Linda||Wound Measurements Value set 2.16.840.1.1138184.108.40.206.2.5 (dynamic)|
IG table says 'A value set of SNOMED-CT codes to capture the dimensions of a wound' but the value set is using LOINC codes.
|@Hyde,Linda||Procedure Value set 2.16.840.1.1138220.127.116.11.80.28 (dynamic)|
This value set is referenced in the IG but does not appear in the list of value sets in the appendix or as it's own table. It appears in the section for 'performer for the value of service event code' pg 169,182. Value set covers all values under the 71388002 Procedure. It is in VSAC and in the R2.1 Value Set Download from VSAC.
|@Hyde,Linda||Pressure Point Value Set 2.16.840.1.113818.104.22.168.36 (static)|
VSAC and Trifolia only have one code in common. Trifolia codes are for the site 'structure' and VSAC for 'skin structure of'. The IG value set table contains the same codes as Trifolia. The purpose of this value set is to identify the areas of the body generally associated with pressure ulcers so it would seem that 'skin structure of' would be the more appropriate concepts to use.
|@Hyde,Linda||Planned moodcode (Observation)Value set 2.16.840.1.113822.214.171.124.25 (static)|
VSAC contains code for GOL (goal). This code is not in the IG table. It is in the ActMood table.
|@Hyde,Linda||ParticipationFunction Value set 2.16.840.1.1138126.96.36.19967 (static)|
There are new codes in the ParticipationFunction code system that are not in VSAC.
|@Hyde,Linda||Observation Interpretation (HL7)Value set 2.16.840.1.1138188.8.131.52 (static)|
1. There is a new version of ObservationInterpretation with additional codes that are not in VSAC and several codes in VSAC that are now deprecated.
2. Code system name in IG is HITSP-CS-83 but in VSAC it is ObservationInterpretation. IG should be updated
|@Hyde,Linda||INDRoleClassCodes Value set. 2.16.840.1.1138184.108.40.206.33|
The implementation contains references to both static and dynamic for this value set. Pages 62,97,144,157 refer to this value set as STATIC, however on page 204 it is listed as DYNAMIC.
|@Hyde,Linda||EntityPersonNamePartQualifier Value Set 2.16.840.1.1138220.127.116.11.26(static)|
LS legal status)code is not in VSAC. In the original version of the code system it was include but in a separate level. All the codes under _ PersonNamePartQualifier are in VSAC.
|@Hyde,Linda||Entity Name Use Value Set 2.16.840.1.113818.104.22.16813 (static)|
All values of the EntityNameUse code system are in VSAC except OR (official registry).This code was not in the original code system but is in V3.
|@Hyde,Linda||Allergy and Intolerance Type Value Set 2.16.840.1.113822.214.171.124.3221.6.2 (dynamic)|
<!-- ************************ ENCOUNTERS *********************** -->
I think there is a problem with the sample CCD file C-CDA_R2-1_CCD.xml included in this package.
|doseQuanity/@unit and administrationUnitCode/@code are a confusing set of elements, but I will do my best pulling from the base definitions:||1370|
|In the Comment Activity template (2.16.840.1.1138126.96.36.199.4.64):|
5. SHALL contain exactly one [1..1] text (CONF:81-9430).
a. This text SHALL contain exactly one [1..1] reference (CONF:81-15967).(expand HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes Companion Guide, Release 2 STU - US Realm )
|The Note Types Value Set (urn:oid:2.16.840.1.1138188.8.131.52.68) version 20191017 is missing three note types specific in USCDI v1:||1996|
|In Appendix C, I read the Provenance - Author Participation template as saying you can use the same trick as in the standard C-CDA Author Participation template to reference an author already defined elsewhere in the document:|
The assignedAuthor/id may be set equal to (a pointer to) an id on a participant elsewhere in the document (header or entries) or a new author participant can be described here.
Table 9 of the Companion Guide recommends the LOINC codes 11502-2 for Laboratory Narrative notes and 11526-1 for Pathology Narrative notes. However, these codes aren't actually included in the Note Types value set (urn:oid:2.16.840.1.1138184.108.40.206.68) as required by the Notes Section and Note Activity templates in Appendix A. Likewise, although no specific LOINC code is recommended for Imaging Narrative notes, the value set doesn't include any codes from the value set recommended for imaging notes in Table 8 (urn:oid:220.127.116.11.4.1.12009.10.2.5).
|For the UDI information, can we get clarification on whether it is possible to send other information when we do not have the DI information?|
Appendix B UDI
Figure 1: Unique Device Identifier (UDI) Organizer Template ID root is incorrect
<input type="checkbox" id="minutesID" name="minutes" value="Approved" style="font-size:20px"> <label for="minutesID" style="font-size:20px">Minutes Approved by Consensus</label><br>
This is to approve minutes via general consent. "You have received the minutes. Are there any corrections to the minutes? (pause) Hearing none, if there are no objections, the minutes are approved as printed."