CLIA Regulatory Requirements & Documentation 4

Question 1

Which of the following laboratories is exempt from most CLIA requirements?

Accepted Answer

Forensic laboratory

Answer

Forensic laboratories are exempt from CLIA because they do not perform testing for the diagnosis, prevention, or treatment of disease in humans.

Question 2

Under CLIA, the technical supervisor for high-complexity testing must have at minimum which qualification?

Accepted Answer

Bachelor's degree in a chemical, physical, or biological science plus laboratory experience

Answer

CLIA requires the technical supervisor for high-complexity testing to hold at minimum a bachelor's degree in a chemical, physical, biological, or clinical laboratory science with appropriate laboratory experience.

Question 3

A CLIA laboratory must perform and document competency assessment for testing personnel at which intervals?

Accepted Answer

Semiannually for the first year, then annually

Answer

CLIA requires competency assessment semiannually during the first year of employment, then annually thereafter.

Question 4

Under CLIA, which of the following is a required component of a laboratory's written quality assurance (QA) program?

Accepted Answer

Process to evaluate and document patient test management

Answer

CLIA requires the QA program to include processes for evaluating patient test management, including specimen handling, result reporting, and corrective actions.

Question 5

Which CLIA requirement applies specifically to laboratories performing provider-performed microscopy (PPM)?

Accepted Answer

Testing must be performed by the practitioner during the patient's visit

Answer

PPM requires that microscopic examination be performed by the ordering practitioner during the patient's visit using a direct wet mount or similar immediate procedure.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Regulatory Requirements & Documentation 4