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

Data Element
Test Kit Unique Device Identifier
Description
Uniquely identifies the type of test (at minimum by using test name and manufacturer (similar to the make and model of a car)) that was used to obtain the Test Result Value. It is a device identifier and should be referenced using Device Identifiers (DI), when available. The DI is contained within the unique device identifier (UDI), created by manufacturer (Manufacturer requests UDI issuance, then provides DI, or can be pulled from GUDID database (https://accessgudid.nlm.nih.gov/)
Submitted By: Riki Merrick / Association of Public Health Laboratories
Data Element Information
Data Element Description Uniquely identifies the type of test (at minimum by using test name and manufacturer (similar to the make and model of a car)) that was used to obtain the Test Result Value. It is a device identifier and should be referenced using Device Identifiers (DI), when available. The DI is contained within the unique device identifier (UDI), created by manufacturer (Manufacturer requests UDI issuance, then provides DI, or can be pulled from GUDID database (https://accessgudid.nlm.nih.gov/)
Rationale for Separate Consideration This qualifies the Performed Test (currently called Tests) - in order to fully understand, if lab results in a patient's record (or across different patient records for a research study) can be safely intermingled in the flow sheet or the analysis it is important to know, what specific test was done (and if the test was harmonized against an international standard) - this is a patient safety issue.
Use Case Description(s)
Use Case Description For COVID-19 pandemic HHS released the following guidance about how t report COVID-19 test results and what elements need to be included - this is representing #7 Device Identifier on the list.
Reporting requirement under What to report: https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html
Implementation guidance: https://www.hhs.gov/sites/default/files/hhs-guidance-implementation.pdf
Estimate the breadth of applicability of the use case(s) for this data element For the COVID-19 use case it would be ANY lab that provides testing under HHS guidance.
Link to use case project page https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html
Use Case Description Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) = In 2016, the FDA sponsored the creation of the Systematized Harmonization and Interoperability for Laboratory Data (SHIELD) project as a public-private partnership to address the critical area of laboratory data availability and interoperability for IVD devices - the simple title: "Name the same test the same way across the healthcare ecosystem."
The URL link is to the highest level of the current work to draft the strategic plan - see the following pages for a bit more detail:
https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/991264904/Use+Case+Names
https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/994639889/Standards+Links
Estimate the breadth of applicability of the use case(s) for this data element This is a 70-organization joint operation, involving federal agencies, in vitro diagnostics (IVD) organizations, standards development orgnanizations, EHR and LIS vendors, medical associations, and other professional laboratory organizations.
Link to use case project page https://aphlinformatics.atlassian.net/wiki/spaces/SC/overview?homepageId=986579060
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) N/A
Additional Specifications AS part of the response HL7 created this guidance page for implementation of HHS elements: https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-DeviceIdentification; See specifcially this section for the Device Identification: https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-DeviceIdentification
This guidance has been written up as the LAB_HHS_ELR_Guidance_Component for LOI and LRI for pre-adoption with ANY HL7 v2 order or reslt message (in ballot Sept 2021), so not currenlty linkable publically
Current Use In limited use in production environments
Supporting Artifacts Since this is a NEW requirement (effective Aug 1, 2020) most every system: LIS, EHR-s and Public Health Surveillance System had to create a place for this element - most of the test kits for COVID-19 (under EUA) and instruments do NOT yet have a UDI assigned to them, so accommodations for a syntax of __ was created (https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-DeviceIdentification) - it is being exchanged in some ELR messages currently
Extent of exchange 4
Supporting Artifacts I picked 4, even though I assume it has probably been sent to more than 4 PHAs nationwide, BUT the last statement, that is is widely in production certainly does not apply to it at this time (outside of the COVID-19 reporting to PH use case)
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) none, though it requires a request for assignment of the device ID by the FDA, so has a process step needed to get to the desired format for this data element.
Restrictions on Use (e.g. licensing, user fees) none
Privacy and Security Concerns none
Estimate of Overall Burden Need to add new fields to each system in the healthcare ecosystem that uses the lab results and ensure the integrity of all related elements.
The manufacturer needs to request assignment of a DI from FDA, so that it can be accessible via the GUUID, which may take some time.
The systems need to suport two possible formats for this device ID, as not every test kit may have a device ID (it is more likely to be able to have device IDs for all instruments).
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 0 - Data element is not represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 1 - Use cases apply to several care settings or specialties.
Evaluation Comment This data element is a subset of the broader Unique Device Identifier concept, and has demonstrated very little if any use in production electronic health records or laboratory information systems.

Comment

Submitted by aphillips@imoh… on

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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