Regulatory Requirements & Documentation Flashcards
7 cards from real CLIA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Requirements & Documentation flashcards as text
Which of the following laboratories is exempt from most CLIA requirements?
Answer: Forensic laboratory
Forensic laboratories are exempt from CLIA because they do not perform testing for the diagnosis, prevention, or treatment of disease in humans.
Under CLIA, the technical supervisor for high-complexity testing must have at minimum which qualification?
Answer: Bachelor's degree in a chemical, physical, or biological science plus laboratory experience
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.
A CLIA laboratory must perform and document competency assessment for testing personnel at which intervals?
Answer: Semiannually for the first year, then annually
CLIA requires competency assessment semiannually during the first year of employment, then annually thereafter.
Under CLIA, which of the following is a required component of a laboratory's written quality assurance (QA) program?
Answer: Process to evaluate and document patient test management
CLIA requires the QA program to include processes for evaluating patient test management, including specimen handling, result reporting, and corrective actions.
Which CLIA requirement applies specifically to laboratories performing provider-performed microscopy (PPM)?
Answer: Testing must be performed by the practitioner during the patient's visit
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.
When a laboratory identifies an error in a previously reported patient result under CLIA, what is required?
Answer: Issue a corrected report and notify the authorized person who ordered the test
CLIA requires laboratories to issue a corrected report and notify the authorized person (ordering clinician) when an error in a previously reported result is identified.
Under CLIA, the general supervisor for high-complexity testing must be on-site or available during which hours?
Answer: All hours testing is performed
CLIA requires the general supervisor to be on-site or available (by phone or electronic means) at all times that testing is being performed.
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Sources & references
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- cms.gov — Eligibility, renewal, score validity, fees · verified Oct 2026