IHE Laboratory

1
IHE Laboratory

• François Macary, AGFA Healthcare
• IHE Laboratory cochair

2
Laboratory Technical Framework

• General scope
• Ordering and performing clinical laboratory
  tests.
• In vitro testing
• Microbiology included.
• Anatomic pathology excluded.
• Sharing of laboratory reports (both ambulatory
  acute care settings)

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Primary membership (sponsors contributors)

• Biomedical scientists in professional societies
• SFIL (Fr)
• In discussion CAP (US)
• National Healthcare IT bodies
• GMSIH (Fr)
• JAHIS (Jp)
• HIMSS (US)
• In discussion CHCF (US)
• Contributing countries
• France, Japan, Italy, UK, Germany, US
• Basically LIS AM vendors, Analyzers
  manufacturers

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Summary of integration profiles

• Workflow Integration Profiles
• Laboratory Scheduled Workflow (LSWF)
• Laboratory Information Reconciliation (LIR)
• Laboratory Device Automation (LDA)
• Laboratory Point Of Care Testing (LPOCT)
• Laboratory Code Sets Distribution (LCSD)
• Laboratory Specimen Label Workflow (LSL)
• Content Integration Profiles
• Sharing Laboratory Reports (XD-LAB)

HL7 v2.5
POCT1-A
2007
HL7 v3 CDA R2
2006
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Sharing Laboratory Reports XD-LAB
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Purpose

• Sharing laboratory reports
• Access to lab results in a patient-centric manner
• Retrieval of historical lab results by providers
  of care
• To improve coordination of care
• A content profile. A lab report
• Presents a set of releasable laboratory results
  to be shared as historical information.
• Is human-readable, shared between care providers
  of various specialties and the patient (e.g.
  through a PHR)
• Contains machine readable coded entries (decision
  support, bio-surveillance)

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Value Proposition

• Use case 1 Hospital lab report CIS ? RHIO ?
  EHRs
• Most significant lab reports shared at discharge
  time.
• Use case 2 Private lab report LIS ? RHIO / PHR
• Final report shared by a private laboratory
• Use case 3 Lab report shared by physician EHR ?
  PHR
• Results received from a reference laboratory.
  Report shared by physician.
• Use case 4 Lab report automatically shared LIS
  ? RHIO
• A laboratory, systematically and automatically
  shares its final reports with a regional
  healthcare network.
• Use case 5 Hospitals cumulative report CIS ?
  RHIO
• At discharge time a hospital physician selects
  the most significant lab results and builds a
  cumulative report shared in a health info
  exchange .

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Restrains

• CDA Release 2 from HL7 v3 normative edition
• HL7 V3 Laboratory Result Event RMIM
• ltentrygt template based on a restriction of LAB
  Result Event RMIM.
• LOINC subset of test codes, alternatively SNOMED
  CT

Leverages

• XDS (Cross Enterprise Document Sharing)
• XDR (Cross Enterprise Document Reliable
  Interchange)
• XDM (Cross Enterprise Document Media Interchange)
• DGS (Digital Signature)
• NAV (Notification of Document Availability)

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A CDA document is a kind of XML document
Header ltClinicalDocumentgt
Body ltstructuredBodygt
Entries contain structured and coded data to be
integrated in the readers system
ltsectiongt

• lttextgt
• Human reader

ltsectiongt
ltsectiongt
ltentrygt ? machine


Observation
Substance administration
Region of interest
ltsectiongt
Procedure
Encounter
Organizer
ltsectiongt
Observation multi-media
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Lab contextual data in the header (1)
What kind of report?

• clinicalDocument/code
• Multi-disciplinary lab report (LOINC or SNOMED)
• Single discipline lab report (e.g. chemistry)
  (LOINC)
• recordTarget
• The patient
• effectiveTime
• Time the report was issued
• confidentialityCode
• Normal, restricted, very restricted
• interpreted by defined policies

Who is the patient?
When was the report produced?
Level of confidentiality
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Lab contextual data in the header (2)

• author
• A human (e.g. a physician)
• A system (e.g. LIS, EHR, )
• custodian
• The organization operating the Content Creator
• legalAuthenticator
• The verifier of the report who legally
  authenticated it
• authenticator
• A verifier who is not he legal authenticator

Author of the report
Who assumes stewardship?
Who signed the report?
Who verified the report?
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Lab contextual data in the header (3)
In fulfillment of what order?

• inFulfillmentOf/order
• the Order (Group) that was fulfilled
• participant typecodeREF
• The ordering physician for the lab act.
• documentationOf/serviceEvent
• The act documented
• serviceEvent/statusCode
• active preliminary, completed final
• serviceEvent/performer
• The fulfiller lab (person and organization)

Who ordered the acts?
What act?
Preliminary or final report?
Which lab performed the tests?
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Human-readable body Two levels of sections
Header

• A laboratory report has its results sorted by
  specialty sections.
• Within a specialty section, the results may be
  organized by reported item sections (battery,
  specimen study, individual test).
• The relationship between reported item and
  specialty is not constrained Left up to the
  Document Source Actor.
• Each leaf section of the body is derived from a
  level 3 ltentrygt

18767-4 Blood gas
B O D Y
Arterial blood gas pO2 (mm Hg) 85
pCO2 (mm Hg) 35
Mandatory ltentrygt
18719-5 Chemistry
Electrolytes Na (mmol/l) 141
K (mmol/l) 4.4
Mandatory ltentrygt
Glucose (g/L) 0.5
Mandatory ltentrygt
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A specialty section may also be itself a leaf
section
Header
B O D Y
18719-5 Chemistry
Glucose (g/L) 0.5
ltentrygt
According to the choice of the Document Source
Actor.
18725-2 MICROBIOLOGY STUDIES Urine study Direct
examination Origin mid-stram Color
straw Appearance clear Microscopy Leukocyes 500
/mL
ltentrygt
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Lab report structure
Header Common realm Spec.
CDA L1
Top level specialty section template
Source or Realm Spec.
CDAL2
Leaf section templateSingle specimen battery
Leaf sectiontemplateIndividual test
Leaf sectiontemplateChallenge study (DFT)
Leaf sectiontemplateMicrobio-logy study
CDA L3
ltentrygt template
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Rendering of a single specimen battery (1)
Specialty section
text block of the leaf section
Some previous results
The current result from the current order (in
documentationOf/serviceEvent)
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Rendering of a single specimen battery (2)
text block of the leaf section
ltrenderMultimediagt
ltentrygt ltobservationMediagt lt/observationMediagt
lt/entrygt
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A possible rendering for microbiology
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Another possible rendering for microbiology
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LOINC subset for test codes

• Chemistry .
• Hematology .....
• Toxicology and drug monitoring ..
• Virology and serology ..
• Parasitology and micology .
• Bacteriology
• Immunology and cell mark ..
• Patient and specimen findings ..

• 873 tests
• 284 tests
• 194 tests
• 374 tests
• 158 tests
• 387 tests
• 278 tests
• 30 measures

Alternatively other terminologies may be used
SNOMED CT, national vocabs
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Thank you.

• Questions