Francois Macary, Agfa HealthCare

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Sharing Laboratory ReportsXD-LAB

• Francois Macary, Agfa HealthCare
• co-chair Lab Technical Committee

2
Lab TF Integration Profiles
Workflow
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) -gt 2007
Content
Sharing Laboratory Reports (XD-LAB)
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Lab TF Integration Profiles
Workflow
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) -gt 2007
Content
Sharing Laboratory Reports (XD-LAB)
Sharing Laboratory Reports
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Scope

• 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

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Use case 1 Hospital lab report CIS ?EHRs
At discharge time, a hospital physician selects
the most significant laboratory 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.
XD
CIS
Hospital
Lab Report Source
Lab Report Consumer
Lab Reports
Any care setting or care provider
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Use case 2 Private lab report LIS ? PHR/EHR
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.
XD
LIS
Lab Report Source
Lab Report Consumer
Lab Reportdocument
Any care setting or care provider
Private laboratory
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Use case 3 Lab report published by a GP
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 the patients personal
health record in an electronic format.
XD
Lab Report Consumer
Lab Report Source
Results reviewed
Lab Reportdocument
Any care setting or care provider
Ambulatory physicians office
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Use case 4 Lab report automatically shared
A laboratory, systematically (with some degree of
automatism) shares its final reports with a
regional healthcare network.
XD
LIS
Lab Report Source
Lab Report Consumer
Resultscompleted
Lab ReportDocument
Any care setting or care provider
Laboratory
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Use case 5 Hospitals cumulative report CIS ?
PHR
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 during patient stay,
and issues a cumulative report to the national
PHR.
XD
CIS
Hospital
Lab Report Source
Lab Report Consumer
Cumulative Lab Report
Any care setting or care provider
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Dependencies of XD-LAB towards other profiles
XD-LAB
Share a CDA lab report
Content Creator
Content Consumer
Document sharing infrastructure
XDS
XDR
XDM
or
or
Security infrastructure
ATNA
CT
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XD-LAB options
(1) The Content Consumer must support at least
one of these options
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A CDA Release 2 document
The header delivers the context patient,
encounter, author, cutodian, documented act
ltClinicalDocumentgt
ltstructuredBodygt
The body can be structured as a tree of nested
sections
ltsectiongt
ltsectiongt
lttextgt
A section may contain a narrative block for the
human reader and a number of entries containing
machine-readable coded data.
ltentrygt
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XD-LAB constrains CDA R2

• 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 lttextgt ..
  lt/textgt
• Mandates the structured coded data ltentrygt ..
  lt/entrygt and defines a unique template for it.
• Aligned with HL7 V3 Laboratory result messages
• Compatible with HL7 v2.5 laboratory result
  messages

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Key elements in the header
Elements driven by the affinity domain

• clinicalDocument/realmCode
• ltrealmCode codeUVgt universal (no national
  extension)
• ltrealmCode codeUSgt 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)
• ltlanguageCode code"en-US" codeSystem"
  2.16.840.1.113883.6.121"/gt

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Key elements in the header
Replacing a lab report by a new version

• lteffectiveTimegt The time the current version
  was produced
• ltsetIdgt a common identifier to all versions of
  this document
• ltidgt unique id of the current instance
• ltversionNumbergt integer representing the
  current version
• ltrelatedDocument typeCodeRPLCgt (only
  replacement)
• ltparentDocumentgt
• ltidgt the unique id of the replaced document

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Key elements in the header
Authoring and stewardship

• The ltauthorgt may be a system (e.g. the LIS)

• The ltcustodiangt 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 )

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Key elements in the header
Who and what this report is answering to

• inFulfillmentOf/order the request received by
  the laboratory
• ltparticipant typeCodeREFgt the ordering
  physician
• informationRecipient/intendedRecipient the list
  of the other intended recipents

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Key elements in the header
The main act a lab order

• documentationOf/serviceEvent the main act
  documented by the report (e.g. the laboratory
  order)
• ltperformergt the laboratory who performed the
  main part or the totality of the tests reported
  in this document.
• ltlegalAuthenticatorgt the person who has
  verified and legally authenticated the report,
  and the organization represented by this person
• ltauthenticatorgt the other verifiers of the
  report (e.g. a biologist who performed the
  clinical validation of the results)

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Key elements in the header
The patient

• ltrecordTargetgt the patient
• componentOf/encompassingEncounter the encounter
  during which the tests documented in this report
  were produced

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Same 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

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The body is structured in two levels of sections
Header
18767-4 Blood gas
Arterial blood gas pO2 (mm Hg) 85
pCO2 (mm Hg) 35
ltentrygt
entry
Each section carrying results is derived from a
mandatory ltentrygt embedded at the end of the
section. This entry carries the coded
structured representation of these results, to be
imported by the consumer.
18719-5 Chemistry
Electrolytes Na (mmol/l) 141
K (mmol/l) 4.4
ltentrygt
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At the international level, this profile is
flexible regarding 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 (lttextgtlt/textgt) may appear
  only in a leaf section (which can be a specialty
  section without sub-section).

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General rules of representation of lab results in
the human-readable body

• Date/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

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4 templates for the leaf sections

• Single specimen battery
• Individual test
• Challenge study (dynamic function test)
• microbiology

These templates are flexible paragraph, table,
paragraph The examples shown, are not exclusive.
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Example
Specialty section
Human readable lttextgt block
Previous results
Current results
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Embedded graphics or images
ltrenderMultimediagt
ltentrygt ltobservationMediagt lt/observationMediagt
lt/entrygt
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Microbiology rendering with table germ/antibiotic
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Microbiology more traditional rendering
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The coded structured data

• Each leaf section SHALL contain one ltentrygt
  element at its end, below the lttextgt block.
• The lttextgt block of the section SHALL be derived
  from the content of the ltentrygt
• The ltentrygt conforms to a unique template defined
  in section 9.2 of the supplement.

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Usable coding systems in the ltentrygt

• HL7 vocabulary domains (e.g. specimen type,
  patient gender )
• SNOMED CT
• For test codes
• LOINC subset
• SNOMED CT
• National terminologies (e.g. in Japan)

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• Questions

Francois.macary_at_agfa.com