CLIA Personnel Requirements & Qualifications Flashcards

Under CLIA, who may serve as general supervisor for a high-complexity testing laboratory?

Answer: A person with an associate degree and 2 years of high-complexity testing experience

A general supervisor in a high-complexity lab must have at least an associate degree in a laboratory or science field and at least 2 years of laboratory training or experience in high-complexity testing.

Which personnel role in a CLIA-regulated lab is responsible for day-to-day supervision of testing personnel?

Answer: General supervisor

The general supervisor is responsible for the day-to-day supervision of testing personnel and reporting test results.

What must a laboratory maintain for each testing personnel member under CLIA?

Answer: Documentation of qualifications, training, and competency assessment

CLIA requires laboratories to maintain records documenting each testing person's qualifications, training, and ongoing competency assessments.

How often must a CLIA laboratory assess the competency of testing personnel?

Answer: At least twice in the first year, then annually thereafter

CLIA requires competency assessment at least twice during the first year of employment and at least annually after the first year.

Under CLIA, which of the following is NOT a required element of a personnel competency assessment?

Answer: Review of the employee's personal health records

CLIA competency assessments focus on work performance elements such as testing technique, result recording, and problem-solving—not personal health information.

If a laboratory director of a CLIA-certified lab leaves, what must the laboratory do?

Answer: Appoint a qualified replacement director promptly to maintain compliance

The laboratory must promptly appoint a qualified replacement director and notify CMS, as operating without a director violates CLIA compliance requirements.