1. 1 Healthcare Information Technology Standards Panel Care Delivery - IS01 Electronic Health Record (EHR) Laboratory Results Reporting July 6, 2007

2. 2 Healthcare Information Technology Standards Panel Electronic Health Record (EHR) Laboratory Results Reporting  Scope –Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties  IS addresses lack of harmonization among data interoperability standards including vocabulary and laboratory and other messaging standards –IS accommodates both laboratory message transaction and document sharing paradigms –IS selects standards with wide coverage to address gaps and provide mapping between standards to address overlaps  HL7 and HITSP Lab WG are coordinating activities to complete a lab message implementation guide to meet the use case requirements. The guide is now being balloted by HL7.

3. 3 Healthcare Information Technology Standards Panel A. Identify/create lab result terminology B. Send results message to ordering clinician C. Patient ID cross-referencing D. Send results message to other authorized providers of care E. Structure lab result as lab report document F. Send document to repository, store, and register in data locator service (Note: data repository may be part of EHR or an independent actor) G. Notification of lab report availability H. Send report to authorized providers of care Use Case Scenario #1: Provide new lab results to ordering clinician, to other authorized providers and to data repositories. A G B D F C E H

4. 4 Healthcare Information Technology Standards Panel F. Send document to repository, store, and register in data locator service G. Notification of lab report availability I. Query data locator service for lab results location and retrieve from repository J. Query repository and retrieve lab report directly from repository K. Merge lab results into EHR L. View lab results from a web application Use Case Scenario #2: Query repository for retrieval of historical lab results F G J LK I

5. 5 Healthcare Information Technology Standards Panel Electronic Health Record (EHR) Laboratory Results Reporting

6. 6 Healthcare Information Technology Standards Panel IS01 Lab Results to EHR – Related Documents Overview Related DocumentsDocument Description TP13HITSP Transaction Package: Manage Sharing of Documents Transaction Package TP14HITSP Transaction Package: Send Lab Result Message to Ordering Clinician and Providers of Care Transaction Package T18HITSP Transaction: View Lab Result from a Web Application Transaction TP22HITSP Transaction Package: Patient ID Cross-Referencing Transaction Package T23HITSP Transaction: Patient Demographics Query Transaction T29HITSP Transaction: Notification of Document Availability Transaction C35HITSP Component: EHR Laboratory Result Terminology Component C36HITSP Component: Laboratory Result Message Component C37HITSP Component: Laboratory Report Document Component

7. 7 Healthcare Information Technology Standards Panel IS01 Lab Results to EHR  Specifies communication of a lab result to an EHR for the ordering clinician and/or other providers of care  Key Concepts: –Defines both an HL7 2.5.1 message and HL7 CDA R2 XML document for conveying the content of the report –Defines alternate actions for retrieval of lab result documents from a repository for web viewing of historical records –Either a v2 message or an XML document may fulfill the initial lab result and interpretation reporting from the lab; only XML documents are used for historical results.

8. 8 Healthcare Information Technology Standards Panel IS01 Lab Results to EHR  Pre- and Post-Conditions –Lab orders are a pre-condition, common meta-data is assumed  Constraints –Use of ISO OIDs for identifiers –Notification and distribution of results  Security and privacy –Deferred, to be integrated in next version  Gaps – Terminology standards for reporting laboratory results

9. 9 Healthcare Information Technology Standards Panel C36 – Lab Report Message  Defines constraints on an HL7 2.5.1 message specification to address the AHIC use case requirements  Does not include support for anatomic pathology  Refers to C35 for vocabulary and terminology support where HL7 is optional  Constrains data types and cardinality to meet AHIC requirements

10. 10 Healthcare Information Technology Standards Panel C37 Laboratory Report Document Structure  Constrains the use of the IHE XD*- Lab Profile which itself is a constrained implementation of the HL7 CDA R2 specification  Refers to C35 for terminology and vocabulary support  Key Concepts –Requires use of “Level 3” data encoding, e.g., fully computable results

11. 11 Healthcare Information Technology Standards Panel C35 EHR Lab Terminology  Specifies vocabulary for Laboratory Results data  LOINC for top 95% of routine tests reported in HEDIS, plus microbiology and cytology  SNOMED-CT for FDA SPL specified problem list subset  HL7 V2.5 Code Sets and HL7 V3.0 Code Sets  Key Concepts –Augments minimum vocabularies and terminologies required by base standard

12. 12 Healthcare Information Technology Standards Panel TP-13 – Manage Sharing of Documents  Defines the requirements for the registration, storage and retrieval of documents across repositories  Specifies a subset of transactions defined in the IHE Cross Document Sharing (XDS) Specification, Dec 2006 –ITI 14 Register Document Set –ITI 15 Provide & Register Document Set –ITI 18 Registry Stored Query –ITI 17 Retrieve Document  Key Concepts: Sharing of source attested documents, document content neutral, document registry, document repositories distributed or centralized. pkg TP13 «composite standard» IHE XDS +Register Document Set: ITI-14 +Provide & Register Document Set: ITI-15 +Query Registry: ITI-16 +Retrieve Document: ITI-17 «base standard» ISO 15000 ebRS «composite standard» IHE NAV «transaction package» Manage Sharing of Documents +docId = TP13 «transaction» Notification of Document Availability +docId = T29 uses constrains implements

13. 13 Healthcare Information Technology Standards Panel TP-13: Manage Sharing of Documents Querying for, retrieving, and submitting documents Doc Consumer Doc Index Query: Which docs ? Retrieve doc Soap Envelope Provide Document Doc Consumer Doc Repository Doc Source CDA Rel2 Lab V3  XDS = “FedEx” –A transport envelope, document format- and content- agnostic, with generic search and retrieve. Supports both push and pull models. Actors are not bound to any RHIO/NHIN architecture. CDA Rel2 Lab V3

14. 14 Healthcare Information Technology Standards Panel TP13 – Manage Sharing of Documents  Supports concept of affinity domains to scope interoperability  Gaps –An identified gap is the ability to share documents across communities, this is being discussed in a proposed IHE extension to Cross Document Sharing Profile (XDS) called Cross Community Access Profile (XCA) –An update to IS-01 is expected to support cross-affinity domain sharing of documents after final XCA is tested and refined

15. 15 Healthcare Information Technology Standards Panel T23 – Patient Demographics Query  Defines the methodology for obtaining a patient identity (or list of patient identities) that match a provided set of patient demographics  IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2):  ITI-21: Patient Demographics Query [§3.21.1]  Key Concepts – Patient Identity Demographics, HL7 Query/Response –Used to send initial results to non-ordering recipients, and for historical results

16. 16 Healthcare Information Technology Standards Panel TP22 – Patient Identity Cross-Referencing  Defines the methodology for identifying and cross-referencing different patient attributes for the same patient.  IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2): – ITI-8: Patient Identity Feed [§3.8.1] – ITI-9: Pix Query [§3.9.1]  Key Concepts –HL7 Query/Response –Used to send initial results to non- ordering recipients, and for historical results pkg TP22 «transaction package» Patient ID Cross-Referencing +docId = TP22 «composite standard» IHE PIX +Patient Id Feed: ITI-8 +PIX Query: ITI-9 «base standard» HL7 V2.5 Message constrains

17. 17 Healthcare Information Technology Standards Panel TP14 Send Lab Result  Defines the requirements for sending the HL7 2.5.1 Lab Message –Specific transport technology not constrained to allow NHIN flexibility; at a minimum defaults to HL7 specified methods  Uses C45 Acknowledgements –Specifies system acknowledgement behavior during message transmission –Processing example and additional detail on HL7 acknowledgements is expected in the final HL7 v.2.5.1 Lab Interoperability Implementation Guide.

18. 18 Healthcare Information Technology Standards Panel C45 – Acknowledgements  Reports status of messages sent using transactions and transaction packages  HL7 V2.5 Ack  Key Concepts: –Acknowledgements may be either for successful receipt or unsuccessful receipt  No constraints  Processing example and additional detail on HL7 acknowledgements is expected in the final HL7 v.2.5.1 Lab Interoperability Implementation Guide.

19. 19 Healthcare Information Technology Standards Panel C45 – Acknowledgements  Additional IS01 Constraints –May become obsolete as the HL7 Lab Message IG will specify internally  Gaps –Clarification of system vs. application acknowledgements, types of errors and system responsibilities

20. 20 Healthcare Information Technology Standards Panel T29 – Notification of Document Availability  Notifies a recipient that a document is available and provides the information needed to retrieve the document  IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2) Supplement for Notification of Document Availability (NAV)  Key Concepts: –Recommended a ‘publish and subscribe’ mechanism to IHE to make NAV a feasible tool

21. 21 Healthcare Information Technology Standards Panel TP18 View Lab Results via Web Application  Defines the ability to view a lab result using a web browser  Transform from CDA to any appropriate display format (HTML, XHTML, PDF, etc.)  Calls for a secure web connection for patient privacy

22. 22 Healthcare Information Technology Standards Panel TP18 View Lab Results via Web Application  Additional IS01 Constraints –No predefined style sheets required, follows HL7 CDA R2 for recipients responsibilities ( [§1.3.1]

23. 23 Healthcare Information Technology Standards Panel C44 – Secure Web Connection  Defines the use of IETF HTTPS to establish a secure web connection  Additional security and privacy constructs to be integrated into IS01 in next revision for deferred security requirements, e.g., authentication, role based access

24. 24 Healthcare Information Technology Standards Panel C44 – Secure Web Connection  Additional IS01 Constraints –Privacy deferred, to be implemented in next version