2024-03-18 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

Andy Harris

alternate

Epic

Dan Rutz

primary

alternate

Biomerieux

Xavier Gansel

primary

alternate

Roche

Nick Decker

primary

Roche

Yue Jin

alternate

Healthcare Provider

Indiana University/Indiana University Health/Association for Molecular Pathology

Mehdi Nassiri, MD

primary

University of Wisconsin-Madison

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA

primary

UT Southwestern Medical Center

Hung Luu - regrets

primary

UNMC

Scott Campbell - regrets

primary

Tufts Medical Center

Nanguneri Nirmala

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

Stacy Lange

individual

Standards Organization

SNOMED International

James T. Case - regrets

primary

Monica Harry - regrets

alternate

Regenstrief Institute

Marjorie Rallins - regrets

primary

Eza Hafeza

alternate

HL7

Julia Skapik

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick

primary

Dari Shirazi

alternate

Graphite Health

Stan Huff - regrets

primary

alternate

CAP

Raj Dash - regrets

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

OPEN

primary

alternate

ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

alternate

FDA

 Keith Campbell

primary

 Victoria Derbyshire

alternate

Quorum evaluation (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business)

Currently we have 19 named members, so 2/3 = 12 (excluding chair and government members).

Open Meeting

Started 12:11 PM, ?? quorum reached

Follow up Items

• Special Topic calls:

  • Next dates:

    • March 12 - UK Experience

    • April 9th - open

    • May 14th - Netherlands

    • June 11th

  • Proposed:

    • Use of standards and reporting across the different systems used in Cancer and Pathology - ask CAP folks if interested / someone available (Scott offered)

Representing qualitative results

Qualitative result values (in OBX-5 or OBX-8):

• Always use OBX-8 (leave OBX-5 blank, if no quant, only qual) - would this approach be USCDI compliant - since Resultvalues is referencing qualitative values using SCT encoding

• Use OBX-5, unless reporting MIC, in which case also report R/I/S in OBX-8, else OBX-8 can add additional interpretation aspects

• In OBX-5 we use SCT, but in OBX-8 we use values from HL70078 = observationInterpretation = harmonized across all HL7 product families

• Background:

  • Antimicrobial resistance reporting - ABx represented in LOINC:

    • if quantitative result available - send numeric value in OBX-5 and interpretation of S/I/ R in OBX-8, using HL70078 codes, not

    • If only qualitative result, send coded interpretation in OBX-5 using SCT, not using OBX-8

    • CLSI has guidelines for certain organisms to include the numeric values and not for others

    • Looking for implementation experience with LIS vendors:

      • Can qualitative results e reported in either OBX-5 or OBX-8 or both?

      • Can SCT be used for OBX-8 in a scalable manner?

• Note that HL7 Europe is also working on that - I have asked if they can share their valuesets

Review Working Groups progress

Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid

• Laboratory Interoperability Data Registry (LIDR) Working Group

  • Working on the White Paper - plan to have draft for SC review by next call April 2, 2024 (for now)

• IVD Data Hub

  • call for additional members - looking for more input for real world data use - Vicky to see, if she can find someone or more

  •  

• Standards Updates and Vocabulary Working Group

  • Still looking for another Co-Chair!

  • See request for qualitative result reporting including antimocribial susceptibility testing

• Communications and Branding Working Group

  •  

Feedback on ONC published artifact - do we want to compile as SHIELD, or just as members?

• United States Core Data for Interoperability (USCDI) (including USCDI v5) due to ONC by April 15, 2024

• ONC January 2024 Health IT Standards Bulletin due to ONC by July 2024

  Information about the SVAP 2024 can be found at: = Standards Version Advancement Process

Discussion:

SC Votes so far: 3 in favor, rest not voted yet

Can prep confluence page to collect feedback:

• Test Kit Identifier and instrument identifier?

• Specimen condition acceptability - that needs fixing in V5

• suggest adding specimen reject reason

• Relabeling Tests and Panel/Test concepts to represent the Performed Test and the Ordered Test

• Relabeling Results/Values to Resultvalues - also suggest to further classify the categories of result values: quantitative with need for units of measure and qualitative with more specific value sets for ordinal vs nominal scale

• Healthcare facility aquired infection reporting coding is pre-coordinated into the organism name compared how the lab reports (often comes out of a special module in EHR-s, which remaps the information from the format in which it comes in from the lab = which is the organism and then the tested antibiotic and their susceptibility status)

• Clarifying the timestamps

Stacy Note:

• Would be helpful to have better names for lab tests that supports better understanding by patients - what is the same, what is different - on SHIELD radar

• Sometimes you get lab results from lab before the provider gets to see and comment / interpret it for the patient

  • this is related to the information blocking rule - there is not always enough information for the patient to understand the result values (examples would be age or sex related reference ranges, when they are applicable; sometimes also medication dependent, which is not knowable at the lab, but at the EHR-s);

  • providers can request that results are withheld for X amount of time for clinical reasons = harm prevention sceanrio; some of this could be set up for specific types of tests

  • Could we suggest to set up a system to track adverse events for releasing patient results without provider review - this would support acknowledgement that precision medicine is still a work in progress

  • Sara will check, if there is a central way to report HIT related incidents / patient happiness / usablility (often healthcare organizations have some ombudsman and do post-visit survey)

Next step: Review on 4/2 call and use 4/9 call for final review and vote, since no special topic call

ONC wants to thank folks for bringing all these thoughtful discussions as feedback back to USCDI developers

Roadmap section updates in response to ONC comments on the SHIELD roadmap

1. The roadmap mission section describes a broad vision of lab interoperability. However, the roadmap proposed solution is limited to the FDA use cases around In-vitro diagnostics (IVD) data, specifically populating the IVD data hub.  ONC suggests clearly describing the roadmap scope so the proposed solutions can be discussed within that context.

From last SC call: Nick will connect with Sara to get more context and then bring this to the IVD datahub group - then Nick will bring back here

2. The roadmap identifies training and education needs around using LOINC as a barrier to interoperability. ONC suggests clarifying how the roadmap addresses this barrier. ONC recognizes that terminologies require training and education, and replacing LOINC with another standard will not address the barrier.

Update from Standards and Vocab WG about re-write of this section?

3. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap.  ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).

Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an exampel implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

Looking for volunteer to tackle this re-write: For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption.

Next calls

All SHIELD:

General Updates: March 26, 2024

Special Topic: OPEN

SC: April 2, 2024

Adjourned

PM ET