Analysis of clinical specimens to obtain information about the health of a patient.

Data Element

Test Kit Unique Identifier
Description

Numeric or alphanumeric code representing a collection of materials necessary to perform diagnostic tests.

Comment

Support inclusion in V5 with phased implementation approach

APHL understands the importance of tracking this data 

However this data element will require some implementation planning in order to get to the expected full FDA defined UDI and its elements. While each laboratory tracks the tests they perform, documenting the UDI is not currently done in the LIS and creatiing a way to make that easiest for laboratories should be part of the plan - but given the timeline until USCDI versions are elevated for consideration for health IT certification APHL supports its inclusion now and proposes this approach:

Update definition to: Uniquely identifies the test reagent configuration that was used to obtain the Test Result Value. For FDA cleared/approved tests, a unique device identifier (UDI) should be available. At a minimum test name and manufacturer can be used to identify this element. Also acceptable is the Device Identifier (DI), which is contained within the unique device identifier (UDI) and can be retrieved from GUDID database (https://accessgudid.nlm.nih.gov/). Optimally the full UDI should be used, when available (can be formated as a barcode and/or human readable text).
 

Test Kit identifier should not be included in the final V5 USCDI

The at-Home test kits that have grown in popularity since the Covid 19 epeidemtic are not mature enough.

Few people particpate in the submission or Apps as they are currenlty fairly burdonsome wrt downloading, entering demogrpahic data and other information.

When the particpation in reporting using test kits become more common place, then this item could be reconsidered. Having particpated in the At-Home text kit IG development, we know this particular a ID element that is a UDI is not often available to be automatically derived via the apps, but UDI is described to be "if available - send" and remains a niche use case.

In addition, EHR systems (USCDI and US Core / C-CDA focus) are not prepared to receive UDIs from test-kits, and I question the value/add cost benefit ratio. Clinically what we should be focused on is getting the result available to clinicans via ease of use of Apps and willingness of EHRs to write results from certified apps.

DeviceName could replace the USCDI data Test kit UDI element and could be a starting point for future detail but  even this should not YET be in v5, but potentially be added to level 2 for eventual maturing into a future USCDI element v6 or beyond.

CAP Comment on Test Kit Unique Identifier

  • Data Class: Laboratory
  • Data Element: Test Kit Unique Identifier
  • CAP Comment: The College of American Pathologists (CAP) supports the elevation of this data element into USCDI, because the data element uniquely identifies the type of test that was used to obtain the Test Result Value. It should be specified that this Test Kit Unique Identifier data element is required to be sent if available and that the inclusion of this data element in USCDI does not imply a requirement of collection.

APHL Comments on ISA 2022

In order to better support the use of lab results from different laboratories in a patient’s record, research or for public health use for tests that are not harmonized against an international standard, this data element is essential to understanding equivalence of results and APHL supports inclusion of this data element in the Laboratory class of USCDI V4

Level 2 Data Element: Test Kit Unique Identifier

While valuable, IMO questions the capability of ONC certified HIT to store and exchange the Level 2 Data Element detailed in this submission While many of these data elements are implemented in CLIA for routine exchange between labs and state, tribal, local, or territorial (STLT) public health agencies, we request that this submission be reviewed thoroughly for implementation in ONC certified HIT.

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