When working on these rules, I found that:
- about 10% of them is just damned wrong
- another about 10% is ununderstandable, even for people with a lot of experience in SDTM and define.xml
As we all know, there are so many tests for which there are no units for the results, just to name a few:
- pH is dimensionless
- all qualitative tests have no units. For example: presence of 24356-8)
The rule FDAC084 sounds: "Standard Units (--STRESU) must be consistent for all records with same Short Name of Measurement, Test or Examination (--TESTCD), Category (--CAT), Specimen Type (--SPEC) and Method of Test or Examination (--METHOD)"
A quick search trough the LOINC database shows that this rule is just damned wrong.
Just take the following combination:
LBTESTCD=GLUC (glucose), LBCAT=URINANALYSIS, LBSPEC=URIN, LBMETHOD=TEST STRIP
One quickly finds following tests for this combination: