Laboratory findings - use of reference range values

6 Nov 2019

Please review and respond to attached request for input- as discussed at meeting 29 October 2019

@Cathy Richardson on behalf of @Former user (Deleted)

Please post your final responses in the Country response table below. Discussion comments can be made as comments.

If you require additional time please advise @Cathy Richardson and @Former user (Deleted)

 USA

 06NOV2019

 Looking at the representation of reference range values in other US standards.

NCI Thesaurus (these NCIt concepts are from CDISC):

Parent Concepts:
Report

Child Concepts:

Abnormal Reference Range
Description of Test Result
High Test Reference Range
Low Test Reference Range
No Higher Limit
No Lower Limit
Normal Reference Range
Numeric Test Result
Quantitation Range
Reference Range
Test Reference Text List
Test Result Reference Range Comment
Value Above Reference Range
Value Below Reference Range

These 4 values also balong to the CDISC value set:

CDISC SDTM Reference Range Indicator

Value (qualifiers indented underneath)
Abnormal Reference Range
Normal Reference Range
Value Above Reference Range
Value Below Reference Range

Comments:

• among the children of "report", mix of data elements, types of test ranges and values

• these 4 values are essentially consistent with SNOMED CT's, but SNOMED CT also provides additional values for "near the limit" (upper/lower limit)

• the SNOMED CT concepts 371933006 |Upper limit of reference range (qualifier value)| and 385524004 |Lower limit of reference range (qualifier value)| are ambiguous as to whether they designate

  • a data element for the value for the upper/lower limit

  • a statement that the test result is borderline high/low

• a better description would be: NEAR upper/lower limit – i.e., similar to the other descriptions: start with a proposition)

<Laboratory test> <Reference range interpretation value> (finding)

seems an appropriate pattern

Synonyms could include what is listed under section 3.

Suggestion for additional synonyms:

• "elevated XXX level" for "high XXX level" (found in MedDRA)

• "low-to-normal XXX level" for "XXX at lower limit of reference range" (found in OMIM)

• "normal-to-high" for "XXX at upper limit of reference range" (found in OMIM)

Member countries without a CMAG rep