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IHE Laboratory

IHE Laboratory. François Macary, AGFA Healthcare IHE Laboratory cochair. Laboratory Technical Framework. General scope: Ordering and performing clinical laboratory tests. In vitro testing Microbiology included. Anatomic pathology excluded.

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IHE Laboratory

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  1. IHE Laboratory François Macary, AGFA Healthcare IHE Laboratory cochair

  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. 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. 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) HL7 v2.5 + POCT1-A 2007 HL7 v3 CDA R2 2006

  5. Sharing Laboratory Reports: XD*-LAB

  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. 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: Hospital’s 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. Restrains: • CDA Release 2 from HL7 v3 normative edition • HL7 V3 Laboratory Result Event RMIM <entry> template based on a restriction of LAB “Result Event” RMIM. • LOINC subset of test codes, alternatively SNOMED CT Leverages: • 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)

  9. A CDA document is a kind of XML document Header: <ClinicalDocument> Body: <structuredBody> Entries contain structured and coded data to be integrated in the reader’s system <section> <text> • Human reader <section> <section> <entry>  machine Observation Substance administration Region of interest <section> Procedure Encounter Organizer <section> Observation multi-media

  10. Lab contextual data in the header(1) • 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? Level of confidentiality

  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. Lab contextual data in the header (3) In fulfillment of what order? • 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? What act? Preliminary or final report? Which lab performed the tests?

  13. Human-readable body: Two levels of sections Header • 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 <entry> 18767-4: Blood gas B O D Y Arterial blood gas pO2 (mm Hg) 85 pCO2 (mm Hg) 35 Mandatory <entry> 18719-5: Chemistry Electrolytes Na (mmol/l) 141 K (mmol/l) 4.4 Mandatory <entry> Glucose (g/L) 0.5 Mandatory <entry>

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

  15. Lab report structure CDA L1 Header Common + realm Spec. Top level “specialty” section template Source or Realm Spec. CDAL2 Leaf section template“Single specimen battery” Leaf sectiontemplate“Individual test” Leaf sectiontemplate“Challenge study (DFT)” Leaf sectiontemplate“Microbio-logy study” CDA L3 <entry> template

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

  17. Rendering of a single specimen battery (2) text block of the leaf section <renderMultimedia> <entry> <observationMedia> … </observationMedia> </entry>

  18. A possible rendering for microbiology

  19. Another possible rendering for microbiology

  20. 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 LOINC subset for test codes Restriction from 29000 codes down to 2600 Alternatively other terminologies may be used: SNOMED CT, national vocabs…

  21. Thank you. Questions…

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