CMS SOM App. C, Tag D6066

(b)(6)(ii) Have documentation of laboratory training appropriate for the testing

performed prior to analyzing patient specimens. Such training must ensure that the

individual has-

(b)(6)(ii)(A) The skills required for proper specimen collection, including patient

preparation, if applicable, labeling, handling, preservation or fixation, processing or

preparation, transportation, and storage of specimens;

(b)(6)(ii)(B) The skills required for implementing all standard laboratory

procedures;

(b)(6)(ii)(C) The skills required for performing each test method and for proper

instrument use;

(b)(6)(ii)(D) The skills required for performing preventive maintenance,

troubleshooting, and calibration procedures related to each test performed;

(b)(6)(ii)(E) A working knowledge of reagent stability and storage;

(b)(6)(ii)(F) The skills required to implement the quality control policies and

procedures of the laboratory;

(b)(6)(ii)(G) An awareness of the factors that influence test results; and

(b)(6)(ii)(H) The skills required to assess and verify the validity of patient test

results through the evaluation of quality control sample values prior to reporting

patient test results.

Interpretive Guidelines §493.1423(b)(6)

Personnel qualifying under this requirement must have a high school diploma or GED.

There is no standardized approach to home schooling across the country. Should a

surveyor be presented with home high school diploma, in general, they would accept the

home high school diploma at face value and focus on the employee’s training and

competency. At this time, CMS is not aware that Primary Source Verification (PSV)

companies verify home school programs.

Probes §1493.1423(b)(6)

How does the laboratory ensure that personnel receiving orientation and training have the

necessary skills for properly performing assigned responsibilities?