CMS SOM App. C, Tag D6064

Each individual performing moderate complexity testing must--

(a) Possess a current license issued by the State in which the laboratory is located, if

such licensing is required; and

Interpretive Guidelines §493.1423

NOTE: See §493.2 for the definition of laboratory training or experience.

The laboratory director is responsible for ensuring the testing personnel have the

appropriate education and experience and receive the appropriate training for the type and

complexity of testing performed. The experience required is clinical in nature. This

means examination of and test performance on human specimens for purposes of

obtaining information for the diagnosis, treatment, and monitoring of patients, or for

providing information to others who will do the diagnosing and treating of the patient’s

condition. (Use D6029).

Each individual must have documentation of training applicable to the types and

complexity of testing performed. This training should be such that the individual can

demonstrate that he/she has the skills required for proper performance of preanalytic,

analytic, and postanalytic phases of testing. For example, if the individual performs a

rapid Strep test, he/she should be able to demonstrate the skills for:

• Proper specimen handling prior to testing, e.g., ensuring the specimen is properly

labeled and received and tested within appropriate timeframes, the swab is

received at the proper temperature, and the ampule on the swab containing

transport media is broken;

• Proper test performance according to the laboratory’s policies and manufacturer’s

instructions, e.g., using reagents that are not outdated, are at the proper

temperature, and of the same lot number, accurate timing of all steps in the

procedure, proper performance of quality control procedures; and

• Proper reporting of patient test results in accordance with the laboratory’s

policies, e.g., notifying the person authorized to receive test results of a positive

result, not reporting the test result if quality control fails.