Laboratory

CSTE Comment - v5

CSTE supports collection of more granular laboratory data to support case adjudication and reporting as well as patient deduplication and linking of data from cases to ELR, which can be critical. The variables we recommend be added to USCDI v5 include:

Name of testing/performing laboratory and associated identifiers (CLIA)(HIGH PRIORITY)
Name of ordering provider and submitter
Address of testing/performing laboratory 
Accession number at testing laboratory (HIGH PRIORITY for matching purposes)
Date the test was ordered
Date the test was performed (needs to be reconciled with results date/timestamp)
Specimen collection date and time (HIGH PRIORITY) (Needs to be reconciled with Test Date=Clinically relevant time)
Test result value (needs to be reconciled with values/results in USCDI V1 and V2), units, reference range and interpretation (HIGH PRIORITY)
Abnormal flag (HIGH PRIORITY)
Test kit identifier

Dates and times are critical to evaluating the timeliness of reporting - it is a major indicator for the performance of public health surveillance systems and without this information it is unknown how data exchange is impacting the ability for public health to respond in a timely fashion. Although the date and time data are generated by the system, in practice it has been observed that availability of this data to Public Health Departments is sparse for use in timeliness analysis
 

ACLA Comment on Test Kit Unique Identifier for Draft USCDI v5

The American Clinical Laboratory Association (ACLA) appreciates the opportunity to comment on the data element, Test Kit Unique Identifier.

This is not currently supported by most laboratories and would impact technology and operational aspects of their business.  We suggest that ONC work with FDA, CMS/CLIA, public health agencies, laboratories, and instrument manufacturers to establish a practical roadmap.

Additionally, inclusion of this data element would be problematic for laboratory developed tests (LDTs) because they have generally not been regulated as devices and do not currently have UDIs.  FDA’s proposed rule to regulate LDTs as devices would not require the adoption of UDIs for LDTs prior to 2 years after the final rule (likely April 2026).  Until then, there is no mechanism for obtaining UDIs for LDTs not regulated as devices, and multiple devices with multiple device identifiers may be used in the performance of an LDT.

APPLICABLE VOCABULARY STANDARD(S)

Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. Where an applicable vocabulary standard has not been identified, this field will remain empty.

ACLA comments:

ACLA suggests “preferred”  replace “required”  under the heading “Applicable Vocabulary Standard(s), or please clarify what is meant by “required” when a standard value (e.g., UDI) does not exist. Test Unique Kit Identifiers are not always available, and UDI is not implementable in every circumstance. 

CDC's comment for USCDI Draft v5

For public health, as the standard develops, this will be an important field for understanding how to analyze laboratory data in the context of test performance details. We agree with the earlier comments from APHL for this data element. 

SHIELD Community Comment

On behalf of the SHIELD Community I am submitting this comment:

#1 - Definitions between USCDI and USCDI+ MUST be the same for this data element for the same use case

• #2 - 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). 
•  
• #3 - Response to specific feedback requested In the ONC Standards Bulletin (https://www.healthit.gov/sites/default/files/page/2024-01/Standards_Bulletin_2024-1.pdf) = ONC seeks feedback on the new Test Kit Unique Device Identifier data element that would be added to the Laboratory data class, including in what scenarios this data element would be useful and what experience health IT developers have exchanging this element.": 
  • a) would need to also define requirements for storage in the LIS
  • b) when the test kit identifier is added to the results - options are:
    •  - provided it via IVD instrument interface as described in IHE LAW = CLSI AUTO-16
    •  - scan a barcode on the test kit package (data labels that are standardized and systemized reduce the burden of entering and risk of introducing transcription errors when doing this manually) - this is agnostic to where the scanning happens (can be at LIS or middleware or IVD instrument)
    •  - assigned to the test in the LIS set up (this would only be at the level of DI) and has a risk of becoming outdated, if not properly maintained
  • c) use cases based on what type of testing is performed - may be hard to request for manual tests, that are not IVD generated (some cultures, microscopy, anatomic pathology would fall into that category)
  • d) DI can be published in LIVD, looked up in the GUDID database (https://accessgudid.nlm.nih.gov/) or read on the package insert

#4 - LDTs are out of scope for SHIELD, so we didn’t explicitly consider it, but overall that area needs to be examined for impacts

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.