2024-01-22 LIDR WG Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Sandy Jones

CDC

Stan Huff

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Marti Velezis

 Sonrisa / FDA

Walter Sujansky

FDA

Susan Downer

JMC

Ralf Herzog

Roche

Cornelia Felder

Roche

Daniel Golson

JMC

Andrea Prada

JMC

Maria Sagat

 CAP

Raja Cholan

FDA

Russ Ott

FDA

Akila Namasivayam

FDA

Reviewing minutes from the last call - Action Item Follow up

• Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary

  • Review operational definition of “equivalence”

• Outreach to Dr. DeBaca

  • Hung will check for more info and maybe see, if she could participate in SHIELD

• Hung is still working on the examples

• Waiting for response from Ed

• Keep updating the googlesheet: Potassium LIVD data

• Have LIVD File Repository Requirements

  Have draft budget (for setting up a web-based database and yearly maintenance): https://aphlinformatics.atlassian.net/wiki/download/attachments/915407143/LIDR - Budget.xlsx?api=v2

• Sign up for sections to provide draft content on the LIDR White Paper

• Review LIDR Use Cases and sign up to lead one of these

Call Schedule

Riki out on travel 1/15 and 1/22; at HL7 WGM 1/29

No call 1/15, Hung will run 1/22 and 1/29

Review LIDR White Paper

No comments yet

LIDR Elements Discussion

• LIDR should contain all the information necessary to unambiguously represent how a test is done, but different use cases dictate what is required to be sent

• Should each entry of LIDR (a row) be represented by a unique identifier? How would that identifier be coded and transmitted?

• How do we represent a test kit UDI as multiple reagents may be involved in the processing and process of obtaining the result

• Some elements are relevant for all or most use cases and there are things in the process that may differ from lab to lab, but are not important or relevant in any use case (UDI of glass slides, lysing reagents)

• What is relevant may vary from test to test (method, specimen source)

LIDR Elements:

IVD Test Ordered: (LOINC) To identify the test ordered (e.g., high-sensitive troponin I, comprehensive metabolic panel, 24-hour urine creatinine) in a standardized manner regardless of local codes and naming conventions.

IVD Test Performed: (LOINC) To identify test analyte/observable in a standardized manner regardless of local codes and naming conventions.

Specimen information

o Specimen type (SNOMED CT®) at minimum

o Specimen source site (SNOMED CT®) – the actually collected from site will not be in LIDR, in LIDR I assume this will be part of a pre-coordinated specimen type, though potentially it could be represented as allowable source sites for this test, if that is more efficient

o Specimen source site topography (SNOMED CT®) – this will be on instance data only, not in LIDR

o Specimen collection method (SNOMED CT®) – the actually used method will not be in LIDR, in LIDR I assume this will be part of a pre-coordinated specimen type.

from the LIDR white paper, those are test package insert content (thus known from the manufacturer) and not transactional data from the lab setting presenting specimen data for a given performed test – agreed, hence the added qualifications

Results

o Quantitative results need to include units of measure (UCUM)

o Qualitative result value set (SNOMED CT®)

Test kit identification – A single entry that conveys information on the manufacturer of the reagent kit and method. Not intended as an exhaustive catalog of reagents used in the process of testing. (Unique Identification for the test kit could be UDI for FDA-approved tests or another unique identification system for other types of tests such as EUA and LDTs.) This can be in the package insert to allow for a guaranteed match between the test being set up in the laboratory and the entry in LIDR commercially available tests (not LDTs).

Equipment identification.- A single entry that conveys information on the manufacturer of the instrument from which the result is derived. Not intended to be an exhaustive catalog of instruments used in the process of testing.  (Unique identification for the instrument should be its UDI.)

I would not assume that a single entry may convey all these information: Hardware / firmware / Software / system elements (reader & analyzer, etc.) may be represented by more than one UDI. – agreed – we will have to take a closer look at the different patterns that might emerge for this and might have to be more clear as to which instrument parts need to be represented in LIDR

Harmonization indicator for assays that have undergone successful manufacturer harmonization with calibration to an internationally certified and standardized material

If the intention is to describe which tests were calibrated with the same internationally certified and standardized material, this information is likely NOT in the scope of what IVD system manufacturers may be able to deliver. – I guess I don’t understand too much about how this currently works, but if we are going to include such an indicator we need to get better educated to understand how to represent this content.

ACTION ITEMS

Please see the action items at top of this page - Next deliverable is White paper outline by end of this year

And we need to prioritize the use cases, so that we can finalize the requirements for the first phase of LIDR, which need to be included in the White paper

Next call

Monday 1/29/2024 9 - 10 AM ET

Adjourned