1. HIT Standards Committee Clinical Operations Workgroup Jamie Ferguson Kaiser Permanente John Halamka Harvard University February 24, 2010

2. 2 Clinical Operations WG Comments Recommendation: Broad Families of Standards Broad families of standards for each purpose in final rule: –NCPDP SCRIPT –HL7 version 2 –HL7 Clinical Document Architecture –Other Implementation guidance simultaneous with final rule –E.g., guidance letters, circulars, testing and certification programs –Specific topics: HL7 v.2.5.1 lab guide, CDC v.2.3.1, C32 CCD –Vocabulary: convenience subsets and value sets for Laboratory tests, Medications, Vaccinations, Problems, Procedures Consider minimum implementation guides in final rule

3. 3 Clinical Operations WG Comments Interoperability Request clarification of what is required inside the EHR vs. required only for interoperability at the borders –Problems, Laboratory Results, Medications, Immunizations –LOINC, SNOMED, RxNORM, CVX Recommend minimum vocabulary subset requirements for interfaces/interoperability to be mandated in certification and/or testing

4. 4 Clinical Operations WG Comments CCD/CCR Different documents may be best for different purposes –Not clear how to use CCR as a source for quality reporting CDA L2 vs. L3: –CMS NPRM for claim attachments used both CDA level 1/level 2 (“human decision variant”) and CDA level 3 (“computer decision variant”) –L2 implies no machine-readability, does that mean coded entries should be in narrative section?

5. 5 Clinical Operations WG Comments Vocabulary Publish convenience subsets and value sets –Frequency-based convenience subsets (“starter subsets”) –Quality measure value sets –Medical specialty convenience subsets Coordinate releases of adopted vocabulary standards on an integrated advance schedule Provide mechanisms for EHR users to easily implement vocabulary beyond convenience subsets Other recommendations –Stage 1: LOINC or SNOMED CT for vital signs –Stage 2: Medication allergies require vocabularies for ingredient, and clinical drug, and drug class

6. 6 Clinical Operations WG Comments Other Possible Inconsistencies CAQH CORE Phase 1 is only for X12 4010A1, yet appears to be required for use with X12 5010 Possible inconsistency with EO13410 requirements in federal contracts (e.g., OPM FEHB) and subregulatory requirements (e.g., CMS call letters) requiring recognized interoperability specifications to be used when procuring, updating or implementing relevant systems