Submitted by hswmin on 2023-04-14
| Submitted By: Nedra Y Garrett / CDC | |
|---|---|
| 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. |
| Estimated number of stakeholders capturing, accessing using or exchanging | 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 |
|
| 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; |
| Number of organizations/individuals with which this data element has been electronically exchanged | 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. |
| ONC Evaluation Details Each submitted Data Element has been evaluated based on the following 4 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 |
|
|---|---|
| Maturity – Standards/Technical Specifications | Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification |
| Maturity - Current Use | Level 2 - Used at scale in more than 2 different production environments |
| Maturity - Current Exchange | Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems |
| Breadth of Applicability - # Stakeholders Impacted | Level 2 - Used by a majority of patients, providers or events requiring its use |
| Evaluation Comment | Rationale for Level 2: Maturity - standards / technical spec: Level 2 Maturity - current use: Level 2 Maturity - current exchange: Level 2 Maturity: breadth of applicability & stakeholders impacted: Level 2 |
Submitted by jkegerize on 2023-04-17
ACLA Comment on Laboratory: Result Unit of Measure
The American Clinical Laboratory Association (ACLA) pertains to the Applicable Standard(s): The Unified Code for Units of Measure (UCUM) https://ucum.org/ucum.html \ and the estimate of Overall Burden: Very low burden. This element should already be part of the EHR due to its laboratory regulatory requirement (CLIA). ACLA Comments: These comments pertain to the burden using Unified Code for Units of Measure (UCUM). Using only the UCUM as a standard is problematic and the burden would be very high using this standard. The UCUM cannot be used when it is not supported by the analytic procedure’s documentation for an FDA authorized, cleared, or approved method. Existing interfaces should not be required to update to UCUM. (Note: the FDA approved units must be used for reporting, regardless of the standard used).