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Session 5: Laboratory

Session 5: Laboratory. IHE North America Webinar Series 2008 François Macary - GMSIH ( www.gmsih.fr ). Agenda. Overview of IHE Laboratory Domain Intra hospital integration profiles: Tests performed in laboratory ( LTW ) Device automation in laboratory ( LDA )

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Session 5: Laboratory

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  1. Session 5: Laboratory IHE North America Webinar Series 2008 François Macary - GMSIH (www.gmsih.fr)

  2. Agenda • Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  3. Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  4. Domain Scope [2004  2009] Ordering and performing laboratory tests in acute care settings • Tests on in vitro specimens … • … performed in lab as well as on the point of care • All lab specialties, including microbiology • Anatomic pathology excluded (domain “PAT” in IHE) Sharing laboratory reports within a community of care providers • Report produced by a clinical lab or a public health lab • for a patient and/or a non-human subject • published in a document sharing infrastructure (e.g. XDS) • as an electronic document (human readable & importable in DB) Will be extended to lab-to-lab workflows in next cycle [2009-2010]

  5. Organization of Lab Technical Framework • Volume 1 “Profiles” • Scope, use cases, dependencies, options, actors/transactions, process flows • Volume 2: “Transactions” • Messages, trigger events, sending & receiving responsibilities • Volume 3: “Transactions and Content” (XD-LAB) • Metadata for XDS, CDA r2 content modules for the lab report • Volume 4: “LOINC test codes subset”

  6. HL7 standard versions used Tests performed in lab - LTW Device automation in lab - LDA Point Of Care Testing - LPOCT Specimen container distribution - LBL Laboratory Code Sets Distribution - LCSD Intra hospital Messages: V2.5 & V2.5.1 Subset of LOINC test codes Sharing Laboratory Reports - XD-LAB Community Document: CDA R2 (V3)

  7. Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  8. Laboratory Testing Workflow profile (LTW) Care unit Laboratory Order mgmt. Automation Orders placed to lab Order Placer Work Orders Order Filler Device Auto-mation Manager Orders added by lab Device Order Result Tracker Test results Device Results CIS, EMR LIS LAS

  9. LTW: LIS with direct connection to the devices Care unit Laboratory Order mgmt. Automation Orders placed to lab Order Placer Order Filler Device Internal Automation Manager Orders added by lab Device Order Result Tracker Device Results CIS, EMR LIS with LAS embedded

  10. LTW: Actors and Transactions LTW [LAB-1]: Placer Order Management  [LAB-4]: Work Order Management Order Placer Order Filler Automation Manager  [LAB-2]: Filler Order Management (Reflex orders)  [LAB-5]: Test Results Management Order Result Tracker  [LAB-3]: Order Results Management LAB-1, LAB-2, LAB-4: OML / ORL LAB-3: ORU / ACK LAB 5: OUL / ACK All five transactions are mandatory and use v2.5 or v2.5.1 messages:

  11. LTW profile dependencies Security Patient administration LTW ATNA OP OF AM CT ORT PAM PDQ Profiles in IT Infrastructure TF

  12. LTW: Required actor grouping Each of OP, OF and ORT actors SHALL be grouped with: • Demographics/Encounter consumer actors from PAM or PDQ or both. • Secure Node actor from ATNA • Time Client actor from CT To obtain up to date patient demographic & encounter data To secure exchanges and access to healthcare data To synchronize applications

  13. LTW: Allowed actor grouping A CIS/EMR application MAY group OP and ORT actors, in which case, the flow of messages from OF to [OP / ORT] is simplified: Order Placer Order Result Tracker Order Filler New or corrected result ORU (Unsolicited Observations) LAB-3 OML (Order Status Change) LAB-1 Order Placer Order Result Tracker Order Filler New or corrected result ORU (Unsolicited Observations) LAB-3

  14. LTW: value proposition • Ward and Lab keep a consistent view of the lab requisition and its set of orders (append, replace, cancel, abort, status change) • Support for specimen collection & identification by ward, lab or third party • Orders on unidentified patients with later patient information reconciliation • Result messages (LAB-3) compatible with LAB to EHR result selected by HITSP, based on HL7 2.5.1 implementation guide « interoperable laboratory result reporting to EHR » (including microbio reporting requirements)

  15. Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  16. The Automation Manager splits a Work Order into steps Pre-analytical processor (e.g. aliquoter, centrifuge unit, robotic conveyer) Work Order (e.g. CRP, INR) Step 1 Step 2 IVD device (Analyzer) Step 3 Automation Manager (LIS or LAS) Post-analytical processor (e.g. robotic conveyer, storage)

  17. LDA workflow unit: Work Order Step (WOS) Laboratory automation LIS or LAS Lab Devices LTW LDA LAB-21: Download Pre or post processor OP LAB-22: Query LAB-1 LAB-4 Work Orders WOS LAB-26: Status change LAB-2 OF Automation Manager LAB-5 Test results WOS ORT LAB-3 LAB-21: Download LAB-22: Query Analyzer LAB-23: Test results

  18. LDA use cases: • WOS downloaded on Lab Device before specimen arrival • Query for WOS upon specimen id recognition on LD • Manual entry of WOS on LD (in case testing anticipates the registration of the order) • Rerun tests on the analyzer • Automatically triggered by first run (e.g. with dilution) • Decided by lab technician when verifying first results • Decided by lab clinical expert during clinical validation of the set of results • QC process • WOS on QC specimen downloaded on IVD device (analyzer) • QC WOS queried by IVD device • QC results uploaded to Automation Manager

  19. LDA Transactions Transactions:HL7 v2.5 messages: • LAB-21 – WOS download OML / ORL (*) • LAB-22 – WOS query QBP / RSP (*) • LAB-23 – Test results uploaded OUL / ACK • LAB-26 – WOS Status Change SSU / ACK (Specimen Status Update) (*) Rerun, dilution, reflex test conditions handled with TCD segment

  20. LTW + LDA: System architectures supported Systems:Actors grouping: LIS Order Filler AM AM LAS LD LAS AM Dev Dev Dev Dev Dev Dev LD LD LD LD LD LD

  21. LTW + LDA: Value proposition • Lab requisition id (ORC-4 – « placer group number ») shared by all systems (from CIS to IVD device). Thus the ward staff and lab staff speak of the same object. • Anticipated urgent testing before order registration, with later order/observation reconciliation • QC results consolidated on LIS and accessible from clinical validation of the patient results • The pathologist may trigger new runs from the clinical validation screen on the LIS.

  22. Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  23. LPOCT profile scope • Tests on in vitro specimens, performed on patient bedside or point of care • IVD devices operated by the ward staff or by the patients themselves • POCT process supervised by a clinical laboratory of the healthcare institution • Point of care results consolidated in the common EMR of the healthcare institution

  24. LPOCT goals • Obtain test results immediately for a quicker diagnostic or decision on patient treatment • Minimize quantity of blood drawn from the patient • Preserve a high level of quality in IVD testing (the reason why POCT process is supervised by a clinical laboratory)

  25. LPOCT workflow Historic access to any observations  Registration of POC order & observations CIS / EMR  Point of care observations Accepted observations  Care Unit A Immediate decision  Real time patient identity check POC testing devices POC Data Manager LIS Care Unit B Laboratory supervising the POCT process HIS

  26. LPOCT: Actors & Transactions Wards running point of care testing  [Lab-30]: Initiate poc testing POCRG POCDM  [Lab-32]: Accepted observation set POCT device  [Lab-31]: Produced observation set POC data mgr. Order Filler LIS Supervising laboratory

  27. LPOCT depends on [PAM | PDQ] Patient Administration Wards running point of care testing PAM supplier PDQ supplier Get patient demographics Demographics consumer  [Lab-30]: Initiate poc testing POCRG POCDM  [Lab-32]: Accepted observation set POCT device  [Lab-31]: Produced observation set POC data mgr. Order Filler LIS Supervising laboratory

  28. LPOCT depends on LTW Wards running point of care testing  [Lab-30]: Initiate poc testing POCRG POCDM  [Lab-32]: Accepted observation set POCT device  [Lab-31]: Produced observation set POC data mgr. LTW Order Placer  [LAB-1] or  [LAB-2]: Consolidate poct orders Order Filler (in LPOCT and LTW) LTW Order Result Tracker  [LAB-3]: Consolidate results LIS Supervising laboratory CIS

  29. LPOCT Transactions Transactions:POCT1-A Messages: • LAB-30 – Initial patient identity check OBS.R01 (optional, needs a persistent connection of poct device) • LAB-31 – Produced observation set OBS.R01 (patient results) OBS.R02 (QC results) • LAB-32 – Accepted observation set ORU^R30 (generate order) ORU^R31 (search for existing order)

  30. LPOCT + LTW + [PAM |PDQ]: Value proposition • POC patient results and orders consolidated together with lab orders and observations, on both LIS and EMR of the institution • POC QC results centralized on point of care data manager for a handy supervision by lab • Poc devices persistently connected MAY use the “Patient identity checking” option (leveraging PAM or PDQ) to secure the patient identification before testing.

  31. Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  32. (Robotized container delivery and labeling): LBL Medical examination Test order placed Specimen drawn Tests performed, results produced Clinical Ward Blood collection room Laboratory Uses HL7v2.5 messages: OML/ORL (push) QBP/RSP (pull) Robotic container selector, dispenser & barcoder, connected to LIS or CIS

  33. Agenda • Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  34. Laboratory Code Set Distribution: LCSD Code set Copy Copy Uses HL7v2.5 Master File messages: MFN^M08, MFN^M09, MFN^M10, MFN^M11 Owner of the common code set for batteries, tests and results Provide new release of the code set Orders (coded tests and batteries) Observations (coded tests and results) Consumer A of the common code set Consumer B

  35. Questions on intra hospital integration profiles? IHE NA Webinar Series 2008 – Session 5

  36. Agenda • Overview of IHE Laboratory Domain Intra hospital integration profiles: • Tests performed in laboratory (LTW) • Device automation in laboratory (LDA) • Point of care testing (LPOCT) • Robotized container delivery for specimen collection (LBL) • Code set distribution (LCSD) Community content profiles: • Sharing laboratory reports (XD-LAB)

  37. XD-LAB: Sharing laboratory reports as CDA R2 documents Hospital, Clinic, Physician, Clinical Lab, Public Health Lab Care Provider, Healthcare Institution, Disease Control Agency Document sharing infrastructure (XDS)

  38. Features of XD-LAB content profile • An XD-LAB report… • presents a set ofreleasablelaboratory results to be shared among various healthcare organizations, • is human-readable, • is derived from structured coded data embedded in the report and importable into the consumer’s system database, • supports continuity of care, • can support health monitoring and detection of outbreaks by public health agencies.

  39. XDS metadata bound to a lab report • XDSDocumentEntry Follows specification from PCC TF-2: 5.1.1.1 With these additional constraints: • classCode MAY be used by affinity domain to distinguish final lab reports from non-final ones • eventCodeList carries in addition, reportable conditions as well as non-human subject classification • formatCode = urn:ihe:lab:xd-lab:2008 (this is a CDA laboratory report) • parentDocumentRelationship constrained to “RPLC” (replacement only) • XDSSubmissionSet Follows specification from PCC TF-2: 5.1.1.2 • XDSFolder Follows specification from PCC TF-2: 5.1.1.3

  40. Structure of a CDA lab report <structuredBody> Contextual information: patient, encounter, author, authenticators… <ClinicalDocument> … Header B O D Y <section> 18719-5: Chemistry Up to two levels of sections. Each leaf section has its <text> block derived from a mandatory <entry> <section> Electrolytes Na (mmol/l) 141 K (mmol/l) 4.4 <entry> <section> Glucose (g/L) 0.5 <entry>

  41. Rendering of images or charts provided by IVD devices: In text block of the leaf section: <renderMultimedia> <entry> <observationMedia> … </observationMedia> </entry>

  42. 7 Templates for the header (CDA level 1) • The report itself • Non-human subject • Human patient paired with non-human subject • Intended recipients • Validator (authenticator) of the report and its content • Ordering Provider • Performing laboratory

  43. 2 Templates for the human-readable body (CDA level 2) • Laboratory Specialty <section>: contains either a <text> block or a set of Report Item sections. • Report Item <section>

  44. 12 Templates for the entries (CDA level 3) • Laboratory data processing entry • Specimen collection • Specimen received • Specimen site • Isolate organizer • Battery (panel) organizer • Observation • Annotation comment (defined by PCC TF-2: 6.4.4.6) • Notification organizer • Notifiable condition • Case identification • Outbreak identification

  45. More information on IHE Laboratory ? http://www.ihe.net/Technical_Framework (LAB TF 2.1 Final Text upcoming) http://wiki.ihe.net/index.php?title=Profiles#IHE_Laboratory_Profiles (profiles) http://wiki.ihe.net/index.php?title=Laboratory (lab domain activity) Francois.macary@gmsih.eu Thank you for your attention

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