|Submitted By: Nedra Y Garrett / CDC|
|Data Element Information|
|Use Case Description(s)|
|Use Case Description||Physicians, nurses, epidemiologists, and anyone who is using laboratory reports for patient care, including patients, will depend on the reference range for the correct interpretation of the provided laboratory results. It must be available to the authorized person who ordered the test and, if applicable, the individual responsible for using the test results.|
|Estimate the breadth of applicability of the use case(s) for this data element||Level 2 - Element pertain to most or all patients, providers or requestors.|
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||The Unified Code for Units of Measure (UCUM)
|Current Use||Extensively used in production environments|
Reference Range 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 when the reference range is expressed in numerical units. In some cases, the reference range is complicated and may not be simply expressed in just upper and lower limits.
US Core Observation Clinical Test Result FHIR Profile has included Reference Range as an optional element. See link #1 below.
In the US Core Implementation Guide JSON representation example in link #2, this element is also expressed in UCUM.
For Laboratory Results Interface (LRI), the applicable data type is String.
|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.|
“Reference Range” is a CLIA requirement under 42 CFR 493.1291(d).
Because it is a regulatory requirement, all numerical test results include this data element. Hence it is used extensively in the production environment.
|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|