Standards Updates and Vocabulary Working Group

Purpose

The work group will recommend use of vocabulary and associated standards in support of interoperability of laboratory results.  Interoperability of laboratory results is defined as machine level recognition of which results are comparable and trendable. Lab orders and metadata associated with the order (e.g. ask at order entry questions) would be addressed insofar as coding an IVD (LIVD) by manufacturers would be helpful in recognizing comparability of lab results.

Scope

Currently In-Scope:

  • Vocabulary standards (SNOMED CT, LOINC, UCUM)

  • Supporting messaging/transport standards (HL7 v2 and FHIR)

  • Supporting identifier standards (device identifiers [UDI], test kit identifiers [reagent/lot], specimen container identifiers, GS1 supply chain identifiers [inventory], [blood bank] product identifiers)

  • Supporting information and data models (data elements, pre vs post coordination, order level metadata [ask at order entry question responses], clinical information, procedure/method metadata [e.g. antibody, point-of-care vs routine, processing steps, etc.])

  • Any and all laboratory tests utilized for clinical care or public health in the USA today except direct access testing (FDA approved and laboratory developed tests [LDTs]).

Currently Out-of-Scope:

  • Billing coding systems (CPT, HCPCS, PLA)

  • Experimental and/or research-only tests.

  • Non-laboratory data.

  • Implementation guidance.

  • Policy and regulations.

  • Translation from other languages to English.

  • Direct access testing (DAT) / consumer performed testing.

Call information

Every other Monday starting July 24 1:30 PM - 2:30 PM EST

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Meeting ID: 989 7283 9706
Passcode: shield

https://duke.zoom.us/j/98972839706?pwd=eDdhTUxDOGVDZTJ3K1gyZGRQbkZVQT09

Participants

Name

Organization

Role

Name

Organization

Role

Scott Campbell

UNMC

Co-Chair

Steering Committee member

Raj Dash

College of American Pathologists (CAP)

Co-Chair

Steering Committee member

Dan Rutz

Epic

Steering Committee member

Muktha Natrajan

CDC

 

Sandy Jones (Secondary)

CDC Cancer Surveillance

 

Anne Peruski (Secondary)

CDC

 

Andrea Pitkus

University of Wisconsin-Madison

Steering Committee member

Xavier Gansel

bioMérieux

Steering Committee member

Stan Huff

Graphite Health

Steering Committee member

John Snyder

NLM

Steering Committee member

Rob Hausam

Hausam Consulting

 

Marjorie Rollins

Regenstrief

Steering Committee member

Amy McCormick (secondary)

Epic

 

Nanguneri Nirmala

Tufts Medical Center

Steering Committee member

Mehdi Nassiri

Indiana University/Indiana University Health/Association for Molecular Pathology

Steering Committee member

Eza Hafeza

Regenstrief

Steering Committee member

Jim Case

Snomed International

Steering Committee member

Mary Kennedy

CAP

 

Projects

Project Name

[include link to the filled out project template file]

Brief Description

Priority

Project Name

[include link to the filled out project template file]

Brief Description

Priority

Xavier project around result codes - qualitative (all lab domains)

https://aphlinformatics.atlassian.net/wiki/download/attachments/1887437089/Shield Project Report Biomerieux 28Mar23.docx?api=v2

1

Xavier project around result codes - micro-organism

 

Xavier project around result codes - AST

 

Xavier project around result codes - microscopic and culture observations

 

Specimen CMT content / adoption

 

 

surgical synoptic reporting

 

 

Anatomic Pathology Structured Reporting (cancer pathology)

 

 

Structured genomics reporting (WGS, biomarkers, etc.)

 

 

Test naming conventions

 

 

Collected References:

presentation mentioned from L.J. (Joost) van Pelt, J.M.E.P. (Judith) Gillis “Exchanging laboratory results in the Netherlands: it should and it is possible, but with care!” at the last LOINC conference (2022 LOINC Conference - France) - must have LOINC 2022 registration to view, but has abstract