1 ONC s Laboratory Results Interface (LRI) and Laboratory Orders Interface (LOI) Implementation Guides and LIS-EHR Data Exchange Pathology Informatics 2015 May 6, 2015 Pittsburgh, PA Walter H. Henricks, M.D. Cleveland Clinic
2 Notice of Faculty Disclosure In accordance with ACCME guidelines, any individual in a position to influence and/or control the content of this ASCP CME activity has disclosed all relevant financial relationships within the past 12 months with commercial interests that provide products and/or services related to the content of this CME activity. The individual below has responded that he/she has no relevant financial relationship(s) with commercial interest(s) to disclose: Walter Henricks, MD
3 Outline and Objectives Describe LRI and LOI and place in regulatory context Describe LRI and LOI relevance to laboratories Examine ONC's proposed rule for 2015 Edition of Health IT Certification Criteria
4 What is the Relevance of the LOI, LRI, edos Implementation Guides to Laboratories? They will determine what the future looks like for laboratory information exchange and LIS interfaces. They are woven into the fabric of ONC s emerging, broader framework of Health IT, which will encompass LISs and other aspects of laboratory information use. Laboratories will need to ensure that their systems and interfaces are compliant. The IGs will continue to evolve and expand.
5 Context for LOI, LRI, edos IGs HITECH Act Meaningful Use EHR Standards and Certification Criteria ONC Standards and Interoperability (S&I) Framework
6 ARRA (American Recovery and Reinvestment Act) includes HITECH (Health Information Technology for Economic and Clinical Health Act) implemented in CMS Rule - EHR Incentive Program ( Meaningful Use ; MU) - HOW providers and hospitals must use EHRs alignment ONC Rule - EHR Standards and Certification Criteria (SCC) - WHAT EHRs must be able to do Walter H. Henricks, M.D. (ONC = Office of the National Coordinator for Health Information Technology in HHS)
7 Brief Regulatory History of EHRs July 2010: Stage 1 MU; 2011 Edition SCC Sept. 2012: Stage 2 MU; 2014 Edition SCC Sept. 2014: CEHRT Flexibility Rule Allowed for delays in EHRs meeting 2014 Edition Sept. 2014: 2014 Edition SCC Release 2 Added flexibility; promoted interoperability; set stage for 2015 Edition SCC March 30, 2015: Proposed Rules Stage 3 MU and 2015 Edition SCC MU=Meaningful Use; SCC=Standards and Certification Criteria CEHRT=Certified Electronic Health Record Technology Walter H. Henricks, M.D.
8 ONC Health IT Certification Criteria incorporated by reference Content exchange standards for exchanging electronic health information LRI LRI Public Health LOI edos (others CDA, etc.) Vocabulary standards for representing electronic health information LOINC SNOMED-CT UCUM (Unified Code for Units of Measure) (others RxNorm, etc.)
9 How great is this? Walter H. Henricks, M.D.
10 ONC Standards and Interoperability Framework Public and private sector community effort Adopted by ONC to enable harmonized interoperability specifications Creation of tools, services, and guidance to facilitate exchange of health information Set of integrated functions, processes, and tools Specific initiatives focused on real world challenges (e.g. lab orders)
11 Each S&I Initiative has a Wiki Walter H. Henricks, M.D.
12 The Path to S&I IG Walter H. Henricks, M.D. S&I Initiatives (Laboratory) LRI LRI PH LOI edos EHR-S Health IT developers Gov t agencies Consulting groups Professional societies Participants Commercial labs Individuals, etc. - Artifacts Phases Charter - HL7 Ballot Use cases Implementation Guide (IG) Pilots Evaluation
13 S&I and HL7 Collaboration to Create IGs S&I Implementation Guide HL7 Balloting Process Comment period for HL7 members and paying non-members Ballot reconciliation HL7+S&I HL7 Implementation Guide published HL7 Version Implementation Guide: S&I Framework Lab Results Interface, Release 1 US Realm
15 Laboratory Results Initiative (LRI) Implementation Guide (IG) Requirements, specifications, standards, and implementation guidance for electronic reporting of laboratory test results to ambulatory care providers Use Cases directed at reporting between LIS and EHR Balloted and approved through HL7 HL7 V2.5.1 ORU^R01 Message as basis for IG
16 LRI Context Diagram Walter H. Henricks, M.D.
17 OBX Segment Table in HL7 IG Walter H. Henricks, M.D.
18 Value Sets for Interpretive Codes in HL7 IG Walter H. Henricks, M.D.
19 LRI IG Vocabulary Standards LOINC vocabulary required where a LOINC code is available For receivers, SNOMED CT vocabulary required for certain Microbiology related results For senders, SNOMED CT recommended UCUM (Unified Code for Units of Measure) recommended
20 Laboratory Orders Initiative (LOI) Implementation Guide (IG) Requirements, specifications, standards, and implementation guidance for electronic ordering of laboratory tests in ambulatory settings Use Case directed at test ordering between EHR-S and LIS HL7 V2.5.1 OML^O21 Message as basis for IG
21 LOI Context Diagram Walter H. Henricks, M.D.
22 LOI IG Order Entry Challenges Addressed Add on test orders Cancel test request by provider Cancel test by laboratory Ask at Order Entry responses Information needed for interpretation of results Data required for state/federal agency mandates Information at time of specimen collection (e.g. fasting)
23 LOI IG Vocabulary Standards LOINC vocabulary where a LOINC code is available AND provided by the laboratory SNOMED-CT strongly recommended UCUM recommended
24 LOINC in LOI IG Test order consisting of both the laboratory s local order code and the corresponding LOINC order code: Test order using only the laboratory s local order code:
25 Laboratory Test Compendium Framework (edos) Implementation Guide (IG) Standardized means of electronically communicating a laboratory s Directory of Services (edos) Defined format to deliver laboratory test menu offerings and related information to systems that support electronic laboratory ordering, results reporting, and other functionality Support of initial edos build for each new client and ongoing maintenance updates Laboratory = Compendium Producer EHR (or other system) = Compendium Consumer
26 edos works in concert with LRI and LOI: Several elements in the laboratory s test compendium are subsequently used in the lab order and lab result
27 edos Context Diagram Walter H. Henricks, M.D.
28 Laboratory Test Compendium Framework (edos) IG Expectations for Exchange Complete edos delivered to initialize an interface. Delivery of complete edos available at any time upon request. Delivery of edos, full or partial, should be automated process between Compendium Producer and Consumer edos to be processed by Consumer upon receipt
29 Laboratory Test Compendium Framework (edos) IG Vocabulary Standards Laboratory s local test code to be used to identify orderable test in its edos LOINC as standard alternate vocabulary to identify an orderable test. Performing laboratory determines applicable LOINC order code. If no applicable LOINC code, local code may be only code defined in edos. SNOMED CT recommended UCUM recommended
30 Proposed Rule Federal Register March 30, 2015 Walter H. Henricks, M.D.
31 ONC Health IT Certification Criteria incorporated by reference Content exchange standards for exchanging electronic health information LRI LRI Public Health LOI edos (others CDA, etc.) Vocabulary standards for representing electronic health information LOINC SNOMED-CT UCUM (Unified Code for Units of Measure) (others RxNorm, etc.)
32 Proposed ONC 2015 Edition marks a shift that has implications for laboratories Walter H. Henricks, M.D.
33 ONC 2015 Edition Marks Significant Shift EHR, EHR Technology Health IT EHR Module Health IT Module The term health IT is reflective of the scope of ONC s authority and represents a broad range of technology... Our proposals would permit other types of health IT (e.g., laboratory information systems (LISs)), to receive appropriate attribution and not be referenced by a certificate with EHR in it.
34 (a)(2) Computerized Provider Order Entry Laboratory HL7 v2.5.1 Implementation Guide: Laboratory Orders from EHR, Release 2 (LOI IG) HL7 v2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework, Release 2, v1.2 (edos IG) LOINC v2.50 or newer LOI R2 IG test requisition information specified in CLIA (42 CFR ) required in message Therefore, inclusion of this standard for certification may also facilitate laboratory compliance with CLIA.
35 (b)(4) Incorporate Laboratory Tests and Values/Results (b)(5) Transmission of Laboratory Test Reports HL7 v2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 2 (LRI IG) More specific requirements for display of information included in a test report. which would also assist with laboratory compliance with CLIA. Reference ranges, critical values, delays, corrected reports LOINC v2.50 or newer
36 (f)(3) Transmission to Public Health Agencies reportable laboratory tests and values/results HL7 v2.5.1 Implementation Guide: Electronic Reporting to Public Health, Release 2 LOINC v2.50 or newer SNOMED-CT September 2014 release
37 Other Pearls from (proposed) ONC 2015 Edition framework [that is ]open and accessible to more types of health IT Emphasis on interoperability Supports Stage 3 MU (e)(1) (View, download, and transmit to 3rd party) VDT We seek to ensure that the test reports that are delivered by providers to patients through the VDT capabilities adhere to the CLIA test reporting requirements.
38 One more thing EHR-S Functional Requirements IG Definition of EHR system functional requirements related to the receipt of laboratory results compliant with the LRI Release 2. Additional requirements as set forth in CLIA as well as clinical best practices beyond the scope of LRI Release 2. ONC seeking comment in the proposed rule
39 Summary ONC s (proposed) 2015 Edition Health IT Certification Criteria signal a shift to broader framework of Health IT, which will encompass LISs and other aspects of laboratory information use. LRI, LOI, edos are key elements of ONC s 2015 Edition These efforts will determine the future for laboratory information exchange and LIS interfaces. IGs will continue to evolve and expand. Laboratories will need to ensure that their systems and interfaces are compliant.
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