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To propose steps for creation of LIVD file entries for all IVD tests, available in a centralized repository

with or without mapping review.

Define the initial design and develop a sustainability and steady state plan for use of LIVD specifically and for other SHIELD standards in the future

Ultimate goal is to have data used in patient care, research public health be comparable - need to have support for the full data model for the complete meaning of the test

Items in scope:

• Current:

  • Produce a white paper that is citable with the requirements

  • Gather requirements for a LIVD file repository and develop related budget item for development

  • Develop a plan for steady state

    • operationally

      • Develop process to add and review new data elements

      • Develop process for submission, optional review and

• • • • feedback on content

      • Should include a QA process as part of the submission for either new data elements as well as content

    • financially

      • find a sustainable solution that retains free access to the data in LIDR

  • Develop and recommend a SHIELD endorsed standards implementation plan

    • Creation of LIVD Catalog by IVD Manufacturers - increase number of manufacturers creating catalog

• • • LAW adoption - increase number of instruments supporting IHE LAW

• • • Get more of the standards used in SHIELD as part of Recognized Consensus Standards: Medical Devices (fda.gov)

      • currently listed: LOINC, SNOMED, POCT1A

      • missing: UCUM, CLSI AUTO16 / LAW, IHE profiles

  • Identify mapping content applicable to a LIVD catalog for terminology alignment

• • (this WG definds the elements, the Vocab and Standards identifies the best approach)

    • Alignment of data elements supported in LIDR / LIVD with those already supported in LAW

    • Alignment of data elements in LIDR / LIVD needing support in LIS and EHR Systems

  • Identify which of the data elements are needed in the data flow and which are needed for reference within LIDR

    • evaluation against pre-analytical, analytical and post-analytical workflows

• Future:

  • Develop LIVD planning roadmap of supporting activities

  • Orders

    • for multi-targets

    • for additional information about clinical context

    • for tests requiring more than one instrument

  • other elements providing clinical context

  • lot numbers (may not be LIDR content, but needed for sending along with result - which WG does this go to?)

LIDR WG Parking Lot

Items out of scope:

• Harmonization of lab tests - this is important work for clinical interoperability, but is not terminology related, requires lab studies etc (we are interested in documenting the elements needed to better understand the test results)

• Information modeling (part of the standards and terminology workgroup) around how data from different tests are put to use in LIS / EHR-s data exchange (part of the IVD data hub working group work)

• Calculations not performed on the IVD instrument (e.g. Creatinine ratio) (this may be part of the standards and terminology working group)

• additional assessments made by humans (this may be part of the standards and terminology working group)

• lot numbers for reagents, preparation steps (stains / extraction kits / dilution etc) = no instance representation

Workplan

• Identify the elements for the MVP

  • what each use case needs

  • if elements are just in LIDR, or need to move with patient data

  • As part of MVP at minimum:

    • Name of ordered test (and identifier LOINC)

    • Name of performed test (result) (and identifier LOINC)

    • Type of Specimen (SNOMED CT)

    • Type of Specimen Source (SNOMED CT)

    • Type of Qualitative Result Value (SNOMED CT)

    • Type of Organism (Result Value) (SNOMED CT)

    • Units for Quantitative

• • • Result Value (UCUM)

    • Type of Equipment Identifier (UDI or other means to uniquely identify the kit - e.g. for LDTs)

    • Type of Test Kit Identifier (UDI or other means to uniquely identify the instrument used - e.g. for LDTs - but less likely)

    • Type of method used (SNOMED CT) - may help with automating LOINC assignment

    • LAW coverage of terminology

Declared Goals for LIDR

LIDR represents what labs SHOULD use, provide coding for ALL aspects of what needs to be reported, including units of measure, which MUST match what is in the package insert and provide consistent units of measure for calculations (if not part of the package insert)

Prior work:

https://aphlinformatics.atlassian.net/wiki/spaces/SLC

Hung Luu

UT Southwestern Medical Center

Working Group Co-Chair; SC liasion

Riki Merrick

Association of Public Health Laboratories

Working Group Co-Chair; SC liasion

Andrea Pitkus

University of Wisconsin-Madison

Steering Committee member

Xavier Gansel

Biomerieux

Steering Committee member

Rob Rae

CAP

Dan Rutz

Epic

Steering Committee member

Pam Banning

Solventum

Laurent LARDIN

Biomerieux

Amy McCormick

Epic

Sandy Jones

CDC Cancer Surveillance

Stan Huff

Graphite

Steering Committee member

Craig Collom

Steering Committee member

Marti Velezis

Sonrisa/FDA

Walter Sujanski

FDA

Observer

Raja Cholan

FDA

Observer

Russ Ott

FDA

Observer

Akila Namasivayam

FDA

Observer

Paul Rogers

FDA

Observer

Dong Wang

FDA

Observer

LIVD File Repository Requirements

Compile the requirements for LIDR - functional/policy/starting content/sustainability and develop and document the process for adding NEW

1

Additional data elements for LIVD file (e.g. UDI for equipment/ reagents, harmonization methods, UDIs for devices/kits/reagents

this is defining the WHAT elements are needed in LIDR - it will inform the requirements above, where we need to define the process of HOW to add new elements, when those are identified

2

Clinically relevant test definitions - what makes results “co-minglable”

How are results identified that are comparable (apples) or not comparable (oranges)

How is said identification mechanism implemented?

3