Mission and Responsibility

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

Co-Chairs: Wendy Rubinstein (FDA/CDRH), John Snyder (NLM), Riki Merrick (APHL)

High-Level Scope

Supporting the SHIELD goal: Identifying the same test the same way across the healthcare ecosystem

Items in scope:

• Current:

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

  • Develop a plan for steady state

  • Develop and recommend a LIVD planning strategic plan

    • Creation of LIVD Catalog by IVD Manufacturers - increase number of manufacturers creating catalog (Ed H.)

    • LAW adoption - increase number of instruments supporting IHE LAW (Ed H.)

    • Alignment of LAW/LIVD with Hospital System protocols (Ed H.)

  • Identify mapping content applicable to a LIVD catalog for terminology alignment (Ed H.)

    • Identifier of Test Performed (LOINC)

    • Type of Specimen (SNOMED CT)

    • Type of Qualitative Result (SNOMED CT)

    • Units for Quantitative results (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 assigment

    • LAW coverage of terminology

• Future:

  • Develop LIVD planning roadmap of supporting activities

• Out of Scope for LIVD but In Scope for SHIELD

  • Expand capacity, develop a work plan to create SHIELD standards for all IVD

  • Semantic Interoperability Standards workflow plan

• COMMENTS from Sam: I think we need to decide what needs to be included in the LIVD files, not limited to only what LOINC should be used, but other important identifiers of a test to allow expandability within the realm of interoperability (instrument identifier (RM: we have that), calibration/standardization (RM: for those tests that can be standardized at the kind level – meaning all tests from that manufacturer with that model number use this calibration kit (or one of them) then we could add, but if that is at the instance/sample level when the test is used, then it doesn’t belong in the LIVD file, but we would need to figure out where in the HL7 message these elements should be sent) , test kit identifiers (RM: we have that), lab identifier (RM:what do you mean here? The LIVD file is used by each lab when they set up their catalog – so the lab identifier is added in the catalog and all the downstream standards) , etc). We should also decide (standardize) where in the HL7 messages the LOINC and other data elements are needed to allow interoperability (RM: see the use case list with the suggested standards to use = and the standards list = of course if we identify NEW elements, we will need to update these standards!).

Items out of scope:

• Harmonization of lab tests - this is important work for clinical interoperability, but is not terminology related, requires lab studies etc

Timeline

Due date Sep 1 for the strategic plan

To be developed (3 year plan) TBD

Interested Parties

Strategies and action items for each strategy

• #1 Provide LIVD files from as many manufacturers as possible for a set of priority tests

  • Develop the list of high volume tests with hich impact on patient safety, if not properly identified when merged in flowsheets with help from CAP and AACC (work with Implementation Committee)

  • Identify all manufacturers of those tests and reach out to IVD vendors via IICC

• #2 Develop and recommend a LIVD Planning Strategic Plan

  • LIVD FILE repositiory (LIDR) development

  • Calibration to universal standard for this type of test (vendor levels)

  • Create the process to identify and then add new elements to the LIVD file format and the LIDR repository

  • Identify elements needed for the LIVD file vs elements that need to be included in IHE LAW / LOI / LRI other data exchange use cases

Action Steps to achieve goal

• #1 Document the requirements for the repository (see: )

  §  Identify the governance structure for changes to the LIVD file / repository / review process and associated tooling

  ·       Members of this committee need to be sure we have the technical expertise as well as leadership

  §  Identify the hosting site (this will need long term funding support) – this should be open and free access

  §  Identify the review team (this will need long term funding support)

  §  Agree on the submission, review and publication process

  §  Identify what would be the minimal viable product for the first step and then create an improvement plan over time (this should be well enough defined that someone with more expertise on building a repository could come up with a budget for operations)

  §  Develop a plan to incrementally grow the LIVD repository - see Strategy #1

• #2 Expand use of data elements that are needed for complete clinical interoperability

§ Update the USCDI to include ALL elements listed in the LIVD file

·       Timeframe 6 months?

§  Work with LIS vendors to accommodate new data elements for IVD test kit ID and IVD instrument ID (and any others we identify)and make it available for export

·       Timeframe 1 year or so

§  Work with EHR-s vendors to accommodate receipt of new data elements for IVD test kit ID and IVD instrument ID (and any others we identify)

·       Timeframe 1 year or so

• #3 Expand LIVD file format to support clinical interoperability

  • value sets for specimen types, units of measure and codification of method

    §  Requires clarification for use of SNOMED CT content outside member countries (is not an issue in the US, but IVD manufactures operate worldwide, so need to ensure that either all codes used are in the Global Patient Summary (GPS) set or get specific agreement with SNOMED International

  • additional elements that may support automatic LOINC determination

  • Additional elements that indicate international harmonization has happened (and potentially other elements like QC or prep steps that may affect result comparability across institutions)

    §  Requires work with HL7 OO WG (project already exists):

    ·       participation in 2 connectathons

    ·       A new STU ballot

    ·       Timeframe 9 – 12 months

• #4 Expand use of FDA UDI (or other forms of uniquely identifying the IVD test kit and the IVD instrument

  §  Ensure that IVD manufacturers request UDI as part of their FDA submission

  §  Timeframe???

  UDI is a strict FDA guidance (here), so the answer to the above question has to be found in the UDI regulation. Need an FDA expert who will, elaborate far better than we would ever do!

• #5 Expand other SHIELD standards to accomodate the new elements for support of clinical interoperability

§  Requires work with HL7 OO WG (project already exists):

·       A new STU ballot

·       Timeframe 9 – 12 months

Metrics and Milestones

LIVD file specific:

§  Number of IVD manufacturers that use LIVD file to provide LOINC mappings for their tests

§  Number of IVD manufacturers that have UDI for their test kits and instruments

§  Number of laboratories that use LIVD file content to build their catalogs

§  Percentage of labs that have mapped the same test to the same LOINC as in LIVD file

§  Number of IVD vendors that have UDI for

their instruments (percentage of all instruments available in US)

their test kits (percentage of all instruments available in US)

Other SHIELD standards spacific:

§  Number of IVD manufacturers & systems offering HL7 (any) interfaces / IHE LAW (CLSI AUTO16) connectivity interface

§  Number of laboratories that have implemented HL7 (any) interfaces / IHE LAW (CLSI AUTO16) interfaces for their IVD/LIS connections

§  Number of LIS vendors that have implemented HL7 (any) interfaces / IHE LAW (CLSI AUTO16) and LOI and LRI (and ELR R1 maybe)

§  Number of EHR-s vendors that have implemented LOI and LRI

Milestones for first 2 years:

Complete the list of priority IVD that have high volume and are clinically sensitive

LIVD Expansion review process guidelines evaluated by SHIELD FOR LOINC, SNOMED CT, and unique device identfication (preferrably UDI)