September, 2005What IHE Delivers 1 Francois Macary, Agfa HealthCare co-chair Lab Technical Committee co-chair Lab Technical Committee Sharing Laboratory.

1September, 2005 What IHE Delivers

Francois Macary, Agfa HealthCare Francois Macary, Agfa HealthCare

co-chair Lab Technical Committeeco-chair Lab Technical Committee

Sharing Laboratory ReportsSharing Laboratory ReportsXD-LABXD-LAB

2

Lab TF Integration ProfilesLab TF Integration ProfilesW

orkflowW

orkflowC

ontentC

ontent

Laboratory Scheduled Workflow (LSWF)Laboratory Information Reconciliation (LIR)Laboratory Device Automation (LDA)Laboratory Point Of Care Testing (LPOCT)Laboratory Code Sets Distribution (LCSD)Laboratory Barcode Labeling (LBL) -> 2007

Sharing Laboratory Reports (XD-LAB)V3:V3:

CDA CDA

V2.5V2.5

HL7HL7

Subset of LO

INC

test codesS

ubset of LOIN

C test codes

3

Lab TF Integration ProfilesLab TF Integration ProfilesW

orkflowW

orkflowC

ontentC

ontent

Laboratory Scheduled Workflow (LSWF)Laboratory Information Reconciliation (LIR)Laboratory Device Automation (LDA)Laboratory Point Of Care Testing (LPOCT)Laboratory Code Sets Distribution (LCSD)Laboratory Barcode Labeling (LBL) -> 2007

Sharing Laboratory Reports (XD-LAB)V3:V3:

CDA CDA

V2.5V2.5

HL7HL7

Subset of LO

INC

test codesS

ubset of LOIN

C test codesSharing Laboratory Reports

4

ScopeScope

Sharing laboratory reports Retrieval of historical lab results by the providers of care, in a patient-centric

manner

Main characteristics of a lab report: Presents a set of releasable laboratory results to be shared as “historical

information”. Usually a final report, shared once the lab order is completed. Occasionally a partial report may also be shared Human-readable, viewed by care providers (physicians, nurses,

pharmacists… and even the patient (e.g. through a PHR) Machine-processable (for decision support, bio-surveillance) The results must be represented in both formats

5

CISCIS

Use case 1: Hospital lab report [CIS Use case 1: Hospital lab report [CIS EHRs] EHRs]

At discharge time, a hospital physician selects the most significant laboratory At discharge time, a hospital physician selects the most significant laboratory reports produced during the patient stay, and issues these reports to an Affinity reports produced during the patient stay, and issues these reports to an Affinity Domain shared by a number of healthcare enterprises and primary care providers.Domain shared by a number of healthcare enterprises and primary care providers.

Lab Report Lab Report SourceSource

Lab Lab Report Report

ConsumerConsumer

XD*XD*

Discharge Discharge timetime

Lab Reports

HospitalHospital

Any care settingAny care settingor care provideror care provider

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LISLIS

Use case 2: Private lab report [LIS Use case 2: Private lab report [LIS PHR/EHR] PHR/EHR]

A private laboratory having signed a final report for a patient, sends this report in A private laboratory having signed a final report for a patient, sends this report in an electronic format to the patient record in the regional or national PHR.an electronic format to the patient record in the regional or national PHR.


XD*XD*

Lab Reportdocument

Private laboratoryPrivate laboratory

ReportReportSignedSigned


ConsumerConsumer


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Use case 3: Lab report published by a GPUse case 3: Lab report published by a GP

A physician reviews the results received from a reference laboratory for his A physician reviews the results received from a reference laboratory for his patient. The doctor, as requested by the patient, shares this laboratory report in patient. The doctor, as requested by the patient, shares this laboratory report in the patient’s personal health record in an electronic format.the patient’s personal health record in an electronic format.


ConsumerConsumer



XD*XD*

Lab Reportdocument

Ambulatory physician’s officeAmbulatory physician’s office

Results Results reviewedreviewed

8

Use case 4: Lab report automatically sharedUse case 4: Lab report automatically shared

A laboratory, systematically (with some degree of automatism) shares its final A laboratory, systematically (with some degree of automatism) shares its final reports with a regional healthcare network.reports with a regional healthcare network.

LISLIS


XD*XD*

Lab ReportDocument

LaboratoryLaboratory

ResultsResultscompletedcompleted


ConsumerConsumer


9

CISCIS

Use case 5: Hospital’s cumulative report [CIS Use case 5: Hospital’s cumulative report [CIS PHR] PHR]

At discharge time of an inpatient, a hospital physician selects the most significant At discharge time of an inpatient, a hospital physician selects the most significant lab results, produced by one or more laboratories of the healthcare enterprise lab results, produced by one or more laboratories of the healthcare enterprise during patient stay, and issues a cumulative report to the national PHR.during patient stay, and issues a cumulative report to the national PHR.



ConsumerConsumer

XD*XD*

Discharge Discharge timetime Cumulative

Lab Report

HospitalHospital


10

Dependencies of XD-LAB towards other profilesDependencies of XD-LAB towards other profiles

Content Creator

Content Consumer

Share a CDA lab report

XDSXDS XDRXDR XDMXDMor orDocument Document

sharing sharing infrastructureinfrastructure

Security Security infrastructureinfrastructure

ATNAATNA

CTCT

XD-LAB XD-LAB

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XD-LAB optionsXD-LAB options

Actor Options Domain, Volume,Section

Content Consumer

View Option (1)Document Import Option (1)Section Import Option (1)Discrete Data Import Option (1)

PCC TF-2: 3.1.1PCC TF-2: 3.1.2PCC TF-2: 3.1.3PCC TF-2: 3.1.4

Content Creator

No option

(1) The Content Consumer must support at least one of these options(1) The Content Consumer must support at least one of these options

12

A CDA Release 2 documentA CDA Release 2 document

<ClinicalDocument><ClinicalDocument>

<structuredBody> <structuredBody>

<section><section>

<text>

<entry>

The The headerheader delivers the context: delivers the context: patient, encounter, author, patient, encounter, author, cutodian, documented act…cutodian, documented act…

The The bodybody can be structured as a can be structured as a tree of nested sectionstree of nested sections

A A sectionsection may contain a may contain a narrative narrative blockblock for the human reader… for the human reader…

……and a number of entries and a number of entries containing machine-readable containing machine-readable coded data.coded data.

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Constrains the use of elements of the CDA header

Delivers guidelines for the layout of the structured body How to build the tree of sections How to organize the narrative block <text> ….. </text>

Mandates the structured & coded data <entry> ….. </entry> and defines a unique template for it. Aligned with HL7 V3 Laboratory result messages Compatible with HL7 v2.5 laboratory result messages

XD-LAB constrains CDA R2XD-LAB constrains CDA R2

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Key elements in the headerKey elements in the header

clinicalDocument/realmCode <realmCode code=“UV”> universal (no national extension) <realmCode code=“US”> US extension

clinicalDocument/code The kind of document: Either a multi-disciplinary lab report or a single

specialty lab report.

clinicalDocument/languageCode The main language used in the document (can be superseded by some

section) <languageCode code="en-US" codeSystem=" 2.16.840.1.113883.6.121"/>

Elements driven by the affinity domain:Elements driven by the affinity domain:

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<effectiveTime> = The time the current version was produced

<setId> = a common identifier to all versions of this document

<id> = unique id of the current instance

<versionNumber> = integer representing the current version

<relatedDocument typeCode=“RPLC”> (only replacement)

<parentDocument>

• <id> = the unique id of the replaced document

Replacing a lab report by a new version:Replacing a lab report by a new version:

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The <author> may be a system (e.g. the LIS)

The <custodian> is the organization in charge with stewardship of the report (replace, deprecate). It is the organization operating the Content Creator Actor (depending on the use case the laboratory, the hospital, the GP )

Authoring and stewardship:Authoring and stewardship:

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inFulfillmentOf/order = the request received by the laboratory

<participant typeCode=“REF”> = the ordering physician

informationRecipient/intendedRecipient = the list of the other intended recipents

Who and what this report is answering to:Who and what this report is answering to:

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documentationOf/serviceEvent = the main act documented by the report (e.g. the laboratory order) <performer> = the laboratory who performed the main part or the totality of

the tests reported in this document.

<legalAuthenticator> = the person who has verified and legally authenticated the report, and the organization represented by this person

<authenticator> = the other verifiers of the report (e.g. a biologist who performed the clinical validation of the results)

The main act: a lab orderThe main act: a lab order

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<recordTarget> = the patient

componentOf/encompassingEncounter = the encounter during which

the tests documented in this report were produced

The patient:The patient:

20

Same content binding as PCCSame content binding as PCC

Mapping between the metadata of XD* and the header of the CDA document (here the lab report), is defined in PCC TF, volume 2, section 4.1.1

21

The body is structured in two levels of sectionsThe body is structured in two levels of sections

Header

‘Reported Item’ section

‘Specialty’ section 18767-4: Blood gas18767-4: Blood gas

18719-5: Chemistry18719-5: Chemistry

Electrolytes

Na (mmol/l) 141

K (mmol/l) 4.4

Arterial blood gas

pO2 (mm Hg) 85

pCO2 (mm Hg) 35

<entry>

<entry>

Each section carrying results is derived from a mandatory

<entry> embedded at the end of the section.

This entry carries the coded & structured representation

of these results, to be imported by the consumer.

entry

22

At the international level, this profile is flexible At the international level, this profile is flexible regarding the organization of the bodyregarding the organization of the body

Possibility to use only one level of section, instead of two.

The profile provides a list of specialties but does not impose the relationship between specialties and tests

The narrative block (<text>…</text>) may appear only in a leaf section (which can be a specialty section without sub-section).

23

General rules of representation of lab General rules of representation of lab results in the human-readable bodyresults in the human-readable bodyDate/time of the observation (physiologic time = specimen collection)

Name of the analyte

Value (numeric, textual, coded, graphic, image)

Unit (if relevant)

Reference range (if known and relevant)

Interpretation code (if known and relevant)

Specimen type (if not implied by the test)

Testing method

Zero or more previous results, to facilitate the interpretation (trend)

Verifier, if it does not appear in the header

Subcontractor lab if this test was not performed by the performer declared in the header

24

4 templates for the leaf sections4 templates for the leaf sections

Single specimen battery

Individual test

Challenge study (dynamic function test)

microbiology

These templates are flexible: {paragraph, table, paragraph}These templates are flexible: {paragraph, table, paragraph}The examples shown, are not exclusive. The examples shown, are not exclusive.

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Example:Example:

Human readable <text> block

Current results Previous results

Specialty Specialty sectionsection

26

Embedded graphics or imagesEmbedded graphics or images

<entry> <observationMedia> …

</observationMedia> </entry>

<renderMultimedia>

27

Microbiology: rendering with table germ/antibioticMicrobiology: rendering with table germ/antibiotic

28

Microbiology: more traditional renderingMicrobiology: more traditional rendering

29

The coded & structured dataThe coded & structured data

Each leaf section SHALL contain one <entry> element at its end, below the <text> block.

The <text> block of the section SHALL be derived from the content of the <entry>

The <entry> conforms to a unique template defined in section 9.2 of the supplement.

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Usable coding systems in the <entry>Usable coding systems in the <entry>

HL7 vocabulary domains (e.g. specimen type, patient gender …)

SNOMED CT

For test codes: LOINC subset SNOMED CT National terminologies (e.g. in Japan)

31September, 2005 What IHE Delivers

Questions…Questions…

[email protected]@agfa.com

September, 2005What IHE Delivers 1 Francois Macary, Agfa HealthCare co-chair Lab Technical Committee co-chair Lab Technical Committee Sharing Laboratory.

Documents

lab order

lis lab report source

single specialty lab

multidisciplinary lab

partial report

hospital lab report

cda lab report xds xdrxdm

significant lab results