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Session 5: Laboratory
IHE North America Webinar Series 2008IHE North America Webinar Series 2008
François Macary - GMSIH (François Macary - GMSIH (www.gmsih.fr) )
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 [2009-2010]
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 usedIntra
hospital
Co
mm
unity
Tests performed in lab - LTWDevice automation in lab - LDAPoint Of Care Testing - LPOCTSpecimen container distribution - LBL Laboratory Code Sets Distribution - LCSD
Sharing Laboratory Reports - XD-LAB
Document:Document:
CDA R2CDA R2(V3) (V3)
Messages:Messages:
V2.5V2.5&&
V2.5.1V2.5.1
Su
bset o
f LOIN
C te
st cod
es
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
Device
Device
LTW: LIS with direct connection to the devices
Laboratory
Order Filler
LIS with LAS embedded
Internal Automation
Manager
AutomationOrder mgmt.
Device
Device
Device
Order Placer
Order Result
Tracker
CIS, EMR
Orders placed to lab
Results
Orders added by lab
Care unit
LTW: Actors and Transactions
LTWLTW
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
SecurityLTWLTW
ATNAATNA
CTCT
PAMPAM
PDQPDQ
OF AMOP
ORT
Profiles in IT Infrastructure Profiles in IT Infrastructure TFTF
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 patientdemographic & 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 Placer Order Result Tracker Order Filler
New or corrected result
ORU (Unsolicited Observations)
OML (Order Status Change)
Order Placer Order Result Tracker Order 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 HL7 2.5.1 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 OrderWork Order(e.g. CRP, INR)(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
LDALDA
LDA workflow unit: Work Order Step (WOS)
LTWLTW
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
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 uploaded OUL / ACK
• LAB-26 – WOS Status Change SSU / ACK
(Specimen Status Update)
Transactions: HL7 v2.5 messages:
(*) Rerun, dilution, reflex test conditions handled with TCD segment
LTW + LDA: System architectures supported
LISLIS
LASLAS
DevDev DevDevDevDev DevDev
LASLAS
DevDev DevDev
Systems: Actors grouping:
Order Filler
AM
LD LDLD LD
AM
LD LD
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 observations Accepted 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 Wards running running point of care testingpoint of care testing
Supervising laboratorySupervising laboratory
POCT device
LIS
POC data mgr.
[Lab-30]: Initiate poc testing
[Lab-31]: Produced observation set
POCDM
Order Filler
POCRG
PDQPDQsuppliersupplier
PAMPAMsuppliersupplier
DemographicsDemographicsconsumerconsumer
Get patient demographics
LPOCT depends on [PAM | PDQ]
Wards Wards running running point of care testingpoint of care testing
Supervising laboratorySupervising laboratory
Patient AdministrationPatient 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
LTWOrder Placer
LTW Order Result
Tracker
LPOCT depends on LTW
Wards Wards running running point of care testingpoint of care testing
Supervising laboratorySupervising 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 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)
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
CopyCopy
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 5IHE 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
• XDSDocumentEntryFollows 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)
• XDSSubmissionSetFollows specification from PCC TF-2: 5.1.1.2
• XDSFolderFollows specification from PCC TF-2: 5.1.1.3
<structuredBody>
Structure of a CDA lab report
<section>
18719-5: Chemistry<section>
Electrolytes
Na (mmol/l) 141
K (mmol/l) 4.4
<section>
Glucose (g/L) 0.5
<ClinicalDocument> …
<entry>
<entry>
B
O
D
Y
Header
Up to two levels ofsections.Each leaf section has its <text> block derived from a mandatory <entry>
Contextual information: patient, encounter, author, authenticators…
Rendering of images or charts provided by IVD devices:
In text block of the leaf section:
<entry>
<observationMedia>
…
</observationMedia> </entry>
<renderMultimedia>
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 <section>: contains either a <text> block
or a set of Report Item sections.
• Report Item <section>
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
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)
Thank you for your attention