1. September, 2005What IHE Delivers 1 IHE Laboratory François Macary, AGFA Healthcare IHE Laboratory cochair IHE Laboratory cochair

2. 2 Laboratory Technical Framework General scope: Ordering and performing clinical laboratory tests. In vitro testing Microbiology included. Anatomic pathology excluded. Sharing of laboratory reports (both ambulatory & acute care settings)

3. 3 Primary membership (sponsors & contributors) Biomedical scientists in professional societies SFIL (Fr) In discussion: CAP (US) National Healthcare IT bodies GMSIH (Fr) JAHIS (Jp) HIMSS (US) In discussion: CHCF (US) Contributing countries: France, Japan, Italy, UK, Germany, US Basically LIS & AM vendors, Analyzers manufacturers

4. 4 Summary of integration profiles Workflow Integration Profiles: Laboratory Scheduled Workflow (LSWF) Laboratory Information Reconciliation (LIR) Laboratory Device Automation (LDA) Laboratory Point Of Care Testing (LPOCT) Laboratory Code Sets Distribution (LCSD) Laboratory Specimen Label Workflow (LSL) Content Integration Profiles Sharing Laboratory Reports (XD*-LAB) 2007 HL7v2.5 + POCT1-A HL7 v3 CDA R2 2006

5. 5 Sharing Laboratory Reports: XD*-LAB

6. 6 Purpose Sharing laboratory reports Access to lab results in a patient-centric manner Retrieval of historical lab results by providers of care To improve coordination of care A content profile. A lab report: Presents a set of releasable laboratory results to be shared as historical information. Is human-readable, shared between care providers of various specialties and the patient (e.g. through a PHR) Contains machine readable coded entries (decision support, bio- surveillance)

7. 7 Value Proposition Use case 1: Hospital lab report [CIS RHIO EHRs] Most significant lab reports shared at discharge time. Use case 2: Private lab report [LIS RHIO / PHR] Final report shared by a private laboratory Use case 3: Lab report shared by physician [EHR PHR] Results received from a reference laboratory. Report shared by physician. Use case 4: Lab report automatically shared [LIS RHIO] A laboratory, systematically and automatically shares its final reports with a regional healthcare network. Use case 5: Hospitals cumulative report [CIS RHIO] At discharge time a hospital physician selects the most significant lab results and builds a cumulative report shared in a health info exchange.

8. 8 CDA Release 2 from HL7 v3 normative edition HL7 V3 Laboratory Result Event RMIM template based on a restriction of LAB Result Event RMIM. LOINC subset of test codes, alternatively SNOMED CT XDS (Cross Enterprise Document Sharing) XDR (Cross Enterprise Document Reliable Interchange) XDM (Cross Enterprise Document Media Interchange) DGS (Digital Signature) NAV (Notification of Document Availability) Leverages: Restrains:

9. 9 A CDA document is a kind of XML document Header: Body: Observation Substance administration Region of interest Procedure Encounter Organizer Observation multi-media Human reader machine Entries contain structured and coded data to be integrated in the readers system

10. 10 clinicalDocument/code Multi-disciplinary lab report (LOINC or SNOMED) Single discipline lab report (e.g. chemistry) (LOINC) recordTarget The patient effectiveTime Time the report was issued confidentialityCode Normal, restricted, very restricted interpreted by defined policies What kind of report? Who is the patient? When was the report produced? Lab contextual data in the header (1) Level of confidentiality

11. 11 Lab contextual data in the header (2) author A human (e.g. a physician) A system (e.g. LIS, EHR, …) custodian The organization operating the Content Creator legalAuthenticator The verifier of the report who legally authenticated it authenticator A verifier who is not he legal authenticator Author of the report Who assumes stewardship? Who signed the report? Who verified the report?

12. 12 Lab contextual data in the header (3) inFulfillmentOf/order the Order (Group) that was fulfilled participant typecode=REF The ordering physician for the lab act. documentationOf/serviceEvent The act documented serviceEvent/statusCode active = preliminary, completed = final serviceEvent/performer The fulfiller lab (person and organization) Who ordered the acts? In fulfillment of what order? Which lab performed the tests? What act? Preliminary or final report?

13. 13 Human-readable body: Two levels of sections A laboratory report has its results sorted by specialty sections. Within a specialty section, the results may be organized by reported item sections (battery, specimen study, individual test). The relationship between reported item and specialty is not constrained: Left up to the Document Source Actor. Each leaf section of the body is derived from a level 3 18767-4: Blood gas 18719-5: Chemistry Electrolytes Na (mmol/l) 141 K (mmol/l) 4.4 Glucose (g/L) 0.5 Arterial blood gas pO2 (mm Hg)85 pCO2 (mm Hg) 35 Header Mandatory BODYBODY

14. 14 A specialty section may also be itself a leaf section… 18725-2 MICROBIOLOGY STUDIES Urine study Direct examination Origin: mid-stram Color: straw Appearance:clear Microscopy Leukocyes:500 /mL … Header …According to the choice of the Document Source Actor. BODYBODY 18719-5: Chemistry Glucose (g/L) 0.5

15. 15 Lab report structure Header Common + realm Spec. Leaf section template Single specimen battery Top level specialty section template CDAL3 CDA L2 CDA L1 Leaf section template Individual test Leaf section template Challenge study (DFT) Leaf section template Microbio- logy study Source or Realm Spec. template

16. 16 Rendering of a single specimen battery (1) text block of the leaf section The current result from the current order (in documentationOf/serviceEvent ) Some previous results Specialty section

17. 17 Rendering of a single specimen battery (2) text block of the leaf section …

18. 18 A possible rendering for microbiology

19. 19 Another possible rendering for microbiology

20. 20 LOINC subset for test codes Chemistry ……………………………………………………………. Hematology ………………………………………………………..... Toxicology and drug monitoring ……………………………….. Virology and serology …………………………………………….. Parasitology and micology ………………….…………………… Bacteriology ………………………………………………………… Immunology and cell mark ……………………………………….. Patient and specimen findings ………………………………….. 873 tests 284 tests 194 tests 374 tests 158 tests 387 tests 278 tests 30 measures Alternatively other terminologies may be used: SNOMED CT, national vocabs…

21. September, 2005What IHE Delivers 21 Thank you. Questions…