Name | Organization |
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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 |
Agenda and Notes
Topic | Notes |
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Topic | Notes |
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Reviewing minutes from the last call - Action Item Follow up |
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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 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 |
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Chat:
Recording:
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