CMS SOM App. C, Tag D6120

(b)(7) Identifying training needs and assuring that each individual performing tests

receives regular in-service training and education appropriate for the type and

complexity of the laboratory services performed;

Interpretive Guidelines §493.1451(b)(7)

In some instances, in-service training may be specifically related to an instrument or test,

or may be very general in nature. The laboratory may establish its own format, content,

and schedule or provide training on an as-needed basis. This is acceptable provided the

laboratory does not have deficiencies related to test performance.

(b)(8) Evaluating the competency of all testing personnel and assuring that the staff

maintain their competency to perform test procedures and report test results

promptly, accurately and proficiently.

Interpretive Guidelines §493.1451(b)(8)

The technical supervisor is responsible for assessing the competency of the testing

personnel, and the 6 (six) competency assessment procedures are found under the

technical supervisor responsibilities. Depending on the situation, non-compliance can be

cited at General Laboratory Systems (D5209/§493.1235), laboratory director

(D6103/§493.1445), or technical supervisor (D6120-D6129/§493.1451(b)(8)-

§493.1451(b)(9)).

In order to be able to perform competency assessment, the individual must meet the

regulatory qualifications of a TS, and performance of competency assessment should be

delegated in writing to the individual.

Probes §493.1451(b)(8)

What mechanism is used to ensure that testing personnel are following the laboratory’s

policies and procedures? When approved by the director, these policies and procedures

may include manufacturer’s instructions.