CLIA Regulatory Requirements & Documentation 4 — Questions and Answers
Question 1: Which of the following laboratories is exempt from most CLIA requirements?
- Hospital reference laboratory
- Physician office laboratory performing only waived tests
- Forensic laboratory (Correct answer)
- Veterans Affairs hospital laboratory
Correct 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.
Question 2: Under CLIA, the technical supervisor for high-complexity testing must have at minimum which qualification?
- Associate degree in a health-related field
- Bachelor's degree with 1 year of laboratory training
- Bachelor's degree in a chemical, physical, or biological science plus laboratory experience (Correct answer)
- Medical degree
Correct 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.
Question 3: A CLIA laboratory must perform and document competency assessment for testing personnel at which intervals?
- Once, at hire only
- Semiannually for the first year, then annually (Correct answer)
- Annually at all times
- Only when a new test is introduced
Correct answer: Semiannually for the first year, then annually
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?
- Marketing strategy for new tests
- Process to evaluate and document patient test management (Correct answer)
- Plan for expanding laboratory test menu
- Billing and coding compliance policy
Correct 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.
Question 5: Which CLIA requirement applies specifically to laboratories performing provider-performed microscopy (PPM)?
- Must have a full-time laboratory director on site
- Testing must be performed by the practitioner during the patient's visit (Correct answer)
- Must use automated microscopy equipment only
- Requires full high-complexity personnel qualifications
Correct 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.
Question 6: When a laboratory identifies an error in a previously reported patient result under CLIA, what is required?
- Discard the original report and issue a new one without notation
- Issue a corrected report and notify the authorized person who ordered the test (Correct answer)
- Report the error only to the laboratory director with no further action
- Document the error in the QC log without notifying clinicians
Correct 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.
Question 7: Under CLIA, the general supervisor for high-complexity testing must be on-site or available during which hours?
- Day shift only
- Day and evening shifts
- All hours testing is performed (Correct answer)
- Only during CAP or accreditation inspections
Correct 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.
CLIA Regulatory Requirements & Documentation 4
Which of the following laboratories is exempt from most CLIA requirements?