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

Data Element
Tests
Description

The name of the analysis of specimens derived from humans which provide information for the diagnosis, prevention, treatment of disease, or assessment of health.

Applicable Vocabulary Standard(s)

Applicable Standards (*Please confirm or update this field for the new USCDI version*)
  • Logical Observation Identifiers Names and Codes (LOINC®) version 2.67

View guidance on Applicable Vocabulary Standards and versioning.

Comment

Submitted by Brianmaugo on

Coding completeness of the Tests element in practice

I support APHL's and CSTE's recommendation to clarify this element as the coded representation of the performed test, and Regenstrief's recommendation to specify LOINC laboratory (Type 1) terms. Those recommendations assume a LOINC code is present. In practice, lab entries frequently arrive without one, and a record can conform to USCDI while its lab data is largely unusable for downstream purposes. I recommend that for this element USCDI distinguish between the element being exchangeable and its LOINC code being populated, and encourage implementers to report LOINC coding completeness alongside conformance.

Submitted by BLampkins_CSTE on

Test - CSTE Comment

CSTE concurs with APHL's comment and is supportive of the suggested changes for the name of this element to be updated to Laboratory Performed Test Code in order to clarify that this element is the coded representation of the performed test. Consequently the definition should be updated to: The coded representation of the analysis of specimens derived from humans, which provide information for the diagnosis, prevention, treatment of disease, or assessment of health.

Submitted by BLampkins_CSTE on

CSTE Comment - v5

CSTE concurs with APHL's comment and is supportive of the suggested changes for the name of this element to be updated to Laboratory Performed Test Code in order to clarify that this element is the coded representation of the performed test.

Consequently the definition should be updated to: The coded representation of the analysis of specimens derived from humans, which provide information for the diagnosis, prevention, treatment of disease, or assessment of health.

Submitted by Riki Merrick on

Rename to Performed Test Code

As in prior years APHL suggests to make the name of this data element more precise. APHL requests the name of this element to be updated to Laboratory Performed Test Code. in order to clarify that this element is the coded representation of the performed test.

Consequently the definition should be updated to: The coded representation of the analysis of specimens derived from humans, which provide information for the diagnosis, prevention, treatment of disease, or assessment of health.
It corresponds to the coded representation of CLIA element in §493.1291(c)(4) in CLIA 42 CFR 493.1291 - Test Report (http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_11291)

As previously requested by Regenstrief and supported by APHL to Vocabulary should be more constrained than just LOINC - suggest LOINC from Lab class, 'obs only' or 'both')

Submitted by Riki Merrick on

APHL suggest making this data element name more specific

As previously described in https://www.healthit.gov/isa/comment/6991 and also pointed out by Nedra Garrett in https://www.healthit.gov/isa/comment/13084 this data element should be renamed to "performed test".

Submitted by CDC_DSMH_WG on

CDC's Consolidated Comment for USCDI v4

  • This element, by itself or with a combination of other elements, does not allow the test submitter or the performing laboratory to differentiate between the ordered or performed test. An ordered test may be a test panel leading to the reporting of multiple results. Another example would be additional tests performed due to reflex testing that would be done based on the results of the initially ordered test and clinical information. We recommend creating two data elements to differentiate between the two:
  1. Ordered Laboratory Test,
  2. Reported Laboratory Test.
  • Comments from NACCHO: NACCHO recommends inclusion of this data element - Tests.
  • Please Note- This is already an element in USCDI v3.

Submitted by Riki Merrick APHL on

APHL comment to update and clarify the definition of Test Name

The current definiton does not differentiate if this is the test that was ordered (in v2 tracked in OBR-4), or the test that was performed (in v2 reported in OBX-3, in C-CDA and FHIR in observation.code).

From a result re-use perspective the test of interest to track is the performed test - this is a subtype of the proposed element Observation Code (https://www.healthit.gov/isa/taxonomy/term/1406/level-2), so if that is added clarification between when to use which would be needed.

This is a CLIA required element.

The vocabulary binding should indicate that the most recent version of LOINC should be used (currently 2.71) and that the version listed is merely applicable version at the time of publication.

 

Submitted by sabhyankar on

Specifying LOINC lab terms

The Regenstrief LOINC team recommends adding “Type 1 (Laboratory) terms” to the Applicable Standard(s) text for the Tests row. LOINC contains 4 different types of terms, and type 1 encompasses the laboratory domain.

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