CMS SOM App. C, Tag D5217

(c)(1) Any test or procedure it performs that is not included in subpart I of this part.

Interpretive Guidelines §493.1236(c)(1)

Refer to subpart I, Proficiency Testing Programs for Nonwaived Testing. Subpart I

includes those specialties, subspecialties, analytes and tests that are considered regulated

tests. For those tests not listed in subpart I (not regulated), the laboratory must verify the

accuracy of the test or procedure twice annually, including the accuracy of calculated

results, if applicable.

For those tests not listed under Subpart I, the laboratory may enroll in a PT program to

verify the accuracy of their test or procedure. However, under no circumstances may

these PT samples be referred (or results communicated) to another laboratory for any

reason prior to the PT testing event cut-off date. The PT referral consequences (loss of

certificate and bar on owner/operator) apply equally to all PT testing samples and results.

(See D2013).

If the laboratory is using multiple test platforms to test an analyte, it must choose one

primary method per analyte and use that method to test for all samples in a Proficiency

Testing (PT) challenge.

For a PPM laboratory performing testing not included in subpart I, the laboratory must

verify accuracy at least twice annually.