CLIA CLIA Personnel Requirements & Qualifications 2 — Questions and Answers
Question 1: Under CLIA, who may serve as general supervisor for a high-complexity testing laboratory?
- Any employee with 2 years of lab experience
- A person with an associate degree and 2 years of high-complexity testing experience (Correct answer)
- Only an MD or DO
- A high school graduate with 5 years experience
Correct 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.
Question 2: Which personnel role in a CLIA-regulated lab is responsible for day-to-day supervision of testing personnel?
- Clinical consultant
- Laboratory director
- General supervisor (Correct answer)
- Technical supervisor
Correct answer: General supervisor
The general supervisor is responsible for the day-to-day supervision of testing personnel and reporting test results.
Question 3: What must a laboratory maintain for each testing personnel member under CLIA?
- Annual performance bonus records
- Documentation of qualifications, training, and competency assessment (Correct answer)
- Records of every patient sample handled
- Union membership status
Correct 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.
Question 4: How often must a CLIA laboratory assess the competency of testing personnel?
- Only at initial hire
- Every 5 years
- At least twice in the first year, then annually thereafter (Correct answer)
- Monthly for the first year only
Correct 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.
Question 5: Under CLIA, which of the following is NOT a required element of a personnel competency assessment?
- Direct observation of routine patient test performance
- Monitoring the reporting and recording of test results
- Review of the employee's personal health records (Correct answer)
- Evaluation of problem-solving skills
Correct 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.
Question 6: If a laboratory director of a CLIA-certified lab leaves, what must the laboratory do?
- Continue operating indefinitely until a replacement is found
- Immediately cease all testing
- Appoint a qualified replacement director promptly to maintain compliance (Correct answer)
- Notify CMS only if testing volume is high
Correct 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.
CLIA CLIA Personnel Requirements & Qualifications 2
Under CLIA, who may serve as general supervisor for a high-complexity testing laboratory?