HIT Standards Committee Clinical Operations Workgroup Report Jamie Ferguson, Chair Kaiser Permanente John Halamka, Co-chair Harvard Medical School 20 August, 2009

2 Clinical Operations Workgroup Members Christopher Chute, Mayo Martin Harris, Cleveland Clinic Stan Huff, Intermountain Healthcare Kevin Hutchinson, Prematics Liz Johnson, Tenet Healthcare John Klimek, National Council of Prescription Drug Plans Wes Rishel, Gartner Nancy Orvis, Department of Defense Don Bechtel, Siemens Joyce Sensmeier, HIMSS John Halamka, Harvard Medical School Jamie Ferguson, Kaiser Permanente

3 Summary The workgroup clarified its descriptions, updated its documentation and refined its recommendations to address discussion points of the HIT Standards Committee and the HIT Policy Committee, as well as public comments Additional standards are recommended for vocabulary of detailed quality data elements and content exchange for quality measures

Addressing Public Comments p.1 Comments: Inadequate consideration of innovation –Response: Most innovations mentioned in comments are proprietary software, not standards. Some innovations would require changes in federal or state laws for medical records and/or other designated record sets. Also, changes to the standards will be considered in the future. Comments: Specific standards were not selected, e.g., ASTM Continuity of Care Record (CCR) –Response: The workgroup considered standards adopted by HHS in public processes, e.g., HITSP or CHI, as well as other standards that are widely accepted or used. Our recommendations to migrate to adopted standards over time offer the best path to achieving certification and the objectives and measures of meaningful use. Comments: Support HHS standards, e.g., HL7 CDA. –No response discussed.

Addressing Public Comments p.2 Comments: Alternative content exchange standards that have already been implemented should be selected –Response: Interoperability requires standardization, and the recommended timing of standards for 2013 allows implementers of alternative standards to gain value from existing implementations. Comments: The recommended alternatives to HITSP specifications should not be allowed in 2011 –Response: Complete nationwide implementation of the recommended standards is not feasible by Many HIT projects require more than two years time to be cost effective, and so as not to disrupt clinical operations. Also, the timeline allows value from existing HIT. This is reasonable and does not to pose an undue burden on meaningful users. Comments: A more complete list of HITSP specifications should be recommended for 2011 –The recommendations are sufficient for 2011 meaningful use.

Key Concept: Standards for Interoperability Clinical Operations is recommending standards for interoperability between entities, not within an entity Recommended standards should not apply to internal data capture, storage or uses – only to external representation and data exchange between entities Content should be able to be represented in the specified vocabularies and exchanged in the specified standards at the boundary between entities, regardless of how it is managed internally –Many methods may potentially be used to achieve interoperability standards, e.g., mapping, external services, or native data capture

Summary of Content Exchange Recommendations Primary content exchange standards: –Structured electronic documents: HL7 v.3 CDA, e.g., relevant CDA profile for consultation notes, or CCD for summary records –Clinical messaging: HL7 v.2.5.1, e.g., encounter, or lab results –Immunization queries and vaccination updates (only): HL7 v –Prescriptions: NCPDP Script v.10.x (ambulatory) and HL7 v (inpatient) –Eligibility, benefits, and referrals: ASC X12 v.4010A1, NCPDP Script v.5.1 and CAQH CORE Phase I and Phase II –Quality measure reporting: CMS PQRI Registry XML Specification

Summary of Vocabulary Recommendations Primary vocabulary standards: –Clinical problems and procedures: SNOMED CT –Drugs and Medication Allergies: RxNorm –Ingredient allergies: UNII –Laboratory tests: LOINC –Units of measure: UCUM –Administrative terminology: ASC X12 and NCPDP Script

Key Concept: 2013 Standards for 2011 Measures Clinical Operations WG is recommending standards for definitive 2013 implementation of the 2011 measures Standards for 2011 include certain limited alternatives Standards allowable during transition to the recommended standards not allowable for 2013 and beyond include: –Unstructured electronic documents for coordination of care, e.g., free text, PDF, or document images –Alternative legacy messaging implementations in some cases, e.g., alternative HL7 v2.x lab messaging –Legacy, local and proprietary coding systems (except quality measures where mapping to standards is recommended for 2011) For further information please see matrix handout

Next Steps Certification criteria must support the standards needed for meaningful use information exchange Some key standards are not ready to be recommended but may be ready prior to 2013 –QRDA for quality measure submissions –GIPSE for public health data exchange Standards Maintenance Processes –Vocabulary maintenance, e.g., SNOMED CT subset updates for terms used in retooled quality data elements –Updates to content exchange references, e.g., revised HITSP specifications and CMS PQRI specifications Additional 2013 and 2015 recommendations