CMS SOM App. C, Tag D5215

(b)(2) Any analyte, specialty or subspecialty assigned a proficiency testing score that

does not reflect laboratory test performance (that is, when the proficiency testing

program does not obtain the agreement required for scoring as specified in subpart

I of this part, or the laboratory receives a zero score for nonparticipation, or late

return or results).

Interpretive Guidelines §493.1236(b)(2)

The laboratory must have a process for, and documentation of, routine review of its

proficiency testing results that are evaluated by its PT providers. This includes a review

of its reported PT results against the PT provider’s participant summary results for the

particular PT event and when any of the following occur:

• The PT program assigned an artificial score of 100% (e.g., results not evaluated or

scored);

• A zero score for nonparticipation; if the laboratory did not test the specimen, it

must document what other means were used to assess the accuracy of the test for

the PT event that was missed; or

• The PT provider notifies the laboratory that its results were not evaluated (given a

score of “0”) due to missing the return deadline.

NOTE: Refer to §493.1239(a)-(d)

Probes §493.1236(b)(2)

Has the laboratory reviewed its test menu to determine if it tests any analyte(s) that are

not listed in subpart I?

§493.1236(c) At least twice annually, the laboratory must verify the accuracy of the

following: