Laboratory

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.

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')

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".

Support for further specifying which type of LOINC is used

APHL supports the comment by Dr. Abhyankar to further specify use of LOINC from the laboratory class (type 1).

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.

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.

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.