Session 5: Laboratory IHE North America Webinar Series 2008 François Macary - GMSIH (

Agenda 1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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 [ ]

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”

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

1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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

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

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

LTW profile dependencies Patient administration Security LTW ATNA CT PAM PDQ OFAM OP ORT Profiles in IT Infrastructure TF

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

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 PlacerOrder Result TrackerOrder Filler New or corrected result ORU (Unsolicited Observations) OML (Order Status Change) Order PlacerOrder Result TrackerOrder Filler New or corrected result ORU (Unsolicited Observations) LAB-3 LAB-1 LAB-3

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 HL implementation guide « interoperable laboratory result reporting to EHR » (including microbio reporting requirements)

1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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

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

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

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

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

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.

1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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

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)

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

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

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

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

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

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.

1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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

Agenda 1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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

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

Agenda 1.Overview of IHE Laboratory Domain Intra hospital integration profiles: 2.Tests performed in laboratory (LTW) 3.Device automation in laboratory (LDA) 4.Point of care testing (LPOCT) 5.Robotized container delivery for specimen collection (LBL) 6.Code set distribution (LCSD) Community content profiles: 7.Sharing laboratory reports (XD-LAB)

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

Features of XD-LAB content profile An XD-LAB report… –presents a set of releasable laboratory 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.

XDS metadata bound to a lab report XDSDocumentEntry Follows specification from PCC TF-2: 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: XDSFolder Follows specification from PCC TF-2:

Structure of a CDA lab report : Chemistry Electrolytes Na (mmol/l) 141 K (mmol/l) 4.4 Glucose (g/L) 0.5 … BODYBODY Header Up to two levels of sections. Each leaf section has its block derived from a mandatory Contextual information: patient, encounter, author, authenticators…

Rendering of images or charts provided by IVD devices: In text block of the leaf section: …

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

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

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: ) Notification organizer Notifiable condition Case identification Outbreak identification

More information on IHE Laboratory ? (LAB TF 2.1 Final Text upcoming) (profiles) (lab domain activity) Thank you for your attention