Submitted by kelly.clarke@j… on 2023-09-20
Submitted By: Nedra Y Garrett / CDC | |
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Data Element Information | |
Use Case Description(s) | |
Use Case Description | Physicians, nurses, epidemiologists, and anyone using laboratory reports for patient care, including patients, will depend on the correct representation of units of measure of laboratory results. |
Estimate the breadth of applicability of the use case(s) for this data element | Level 2 – elements pertain to most or all patients, providers or requestors. About 1,000,000 practicing physicians, 120,000 physician assistants, 290,000 licensed nurse practitioners, and almost all of the population of the USA who will get a laboratory result with a numerical value will be involved in the capture, asses, use, or exchange of Laboratory Results Units of Measure. |
Healthcare Aims |
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Maturity of Use and Technical Specifications for Data Element | |
Applicable Standard(s) | The Unified Code for Units of Measure (UCUM). https://ucum.org/ucum.html |
Additional Specifications | http://hl7.org/fhir/R4/datatypes-definitions.html#Quantity.unit |
Current Use | Extensively used in production environments |
Supporting Artifacts |
Level 2 This data element is exchanged extensively in the current production environment in all electronic exchanges of laboratory test results as it is part of CLIA regulations. It is mapped to UCUM as a standard in most of these exchanges. US Core Observation Clinical Test Result FHIR Profile has included Units of Measure as a mandatory and must support element and must be coded in UCUM. See link #1 below. In the US Core Implementation Guide JSON representation example in link #2, this element is also used in UCUM. For Laboratory Results Interface (LRI), the applicable standard provided in the IG is UCUM. https://hl7.org/fhir/us/core/StructureDefinition-us-core-observation-clinical-test.html; https://hl7.org/fhir/us/core/Observation-blood-glucose.json.html; |
Extent of exchange | 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
Supporting Artifacts |
Level 2 “Units of measure” is a CLIA requirement under 42 CFR 493.1291(c)(6). See the link below in 1: Because it is a regulatory requirement, all numerical test results include this data element. Hence it is used extensively in the production environment. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR9482366886d579f/section-493.1291#p-493.1291(c)(6); |
Potential Challenges | |
Restrictions on Standardization (e.g. proprietary code) | No restriction. |
Restrictions on Use (e.g. licensing, user fees) | No restriction. |
Privacy and Security Concerns | No concerns. |
Estimate of Overall Burden | Very low burden. This element should already be part of the EHR due to its laboratory regulatory requirement (CLIA) |
Other Implementation Challenges | None. |
Submitted by jkegerize on 2023-09-20
ACLA Comment on the Result Unit of Measure for USCDI v5
The American Clinical Laboratory Association (ACLA) comments pertain to the burden of using the Unified Code for Units of Measure (UCUM). ACLA believes the vocabulary standard, UCUM, should be recommended, but not required. Laboratories should be allowed to use units of measure other than UCUM. The unit of measure provided by the instrument manufacturers, including FDA authorized, cleared, or approved method, is the standard that laboratories need to adhere to for result reporting. We recommend conversations and adoption from instrument manufacturers is incumbent for the adoption of UCUM to be viable. We would also recommend the ONC solicit feedback from CAP and CLIA on their stance on the need for conversion to UCUM. The UCUM can be a preferred standard, but it should not be required for all tests. Currently, there is a large base of units of measure that are in use across trading partners. To convert these units to UCUM would be problematic, difficult to achieve and time consuming. While ACLA acknowledges UCUM as an option for standardized vocabulary for units of measure it is crucial to recognize and understand the limitations of the UCUM coding system and the impact of key issues identified by ACLA prior to universal adoption.