session 5: laboratory ihe north america webinar series 2008 françois macary - gmsih ()

Session 5: Laboratory

IHE North America Webinar Series 2008IHE North America Webinar Series 2008

François Macary - GMSIH (François Macary - GMSIH (www.gmsih.fr) )

http://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)

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

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)

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.

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]



Patient AdministrationPatient Administration

POCT device

LIS

POC data mgr.

[Lab-32]:




POCDM

Order Filler (in LPOCT and LTW)

POCRG

LTWOrder Placer

LTW Order Result

Tracker

LPOCT depends on LTW



POCT device

CIS

LIS

POC data mgr.

[Lab-32]:




[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.

(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










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










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)

[email protected]

Thank you for your attention

http://www.ihe.net/Technical_Framework

http://wiki.ihe.net/index.php?title=Profiles#IHE_Laboratory_Profiles

http://wiki.ihe.net/index.php?title=Laboratory

mailto:[email protected]

session 5: laboratory ihe north america webinar series 2008 françois macary - gmsih ()

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