CLIA CLIA Personnel Requirements & Qualifications 1 — Questions and Answers
Question 1: What is the minimum educational requirement for a laboratory director of a high-complexity testing laboratory under CLIA?
- High school diploma with 10 years experience
- Associate degree in science
- MD, DO, or doctoral degree in a relevant field (Correct answer)
- Bachelor's degree in any science field
Correct answer: MD, DO, or doctoral degree in a relevant field
CLIA requires the laboratory director of a high-complexity lab to hold an MD, DO, or doctoral degree in a chemical, physical, biological, or clinical laboratory science.
Question 2: Under CLIA, who is responsible for the overall operation and administration of the laboratory?
- Technical supervisor
- Laboratory director (Correct answer)
- Clinical consultant
- General supervisor
Correct answer: Laboratory director
The laboratory director bears overall responsibility for the operation and administration of the laboratory, including compliance with CLIA regulations.
Question 3: Which CLIA personnel category is required ONLY in high-complexity testing laboratories?
- Laboratory director
- Testing personnel
- Technical supervisor (Correct answer)
- General supervisor
Correct answer: Technical supervisor
A technical supervisor is a personnel category required specifically for high-complexity testing laboratories but not for moderate-complexity labs.
Question 4: What is the MINIMUM qualification for testing personnel performing moderate-complexity tests under CLIA?
- Doctoral degree in laboratory science
- High school diploma or equivalent (Correct answer)
- Associate degree in a laboratory science
- Bachelor's degree in biology
Correct answer: High school diploma or equivalent
CLIA allows testing personnel in moderate-complexity laboratories to qualify with a high school diploma or equivalent, plus documented training.
Question 5: Under CLIA, what is the role of the clinical consultant?
- Perform bench-level testing
- Provide advice on patient diagnosis and treatment using lab results (Correct answer)
- Maintain laboratory equipment
- Manage proficiency testing enrollment
Correct answer: Provide advice on patient diagnosis and treatment using lab results
The clinical consultant provides consultation regarding the appropriateness of testing and interpretation of test results in relation to patient care.
Question 6: A laboratory director of a CLIA-certified laboratory can direct how many laboratories simultaneously?
- Only one laboratory
- Up to two laboratories
- No limit if the labs are in the same state
- No specific federal limit under CLIA (Correct answer)
Correct answer: No specific federal limit under CLIA
CLIA regulations do not impose a specific federal cap on the number of laboratories a director may oversee, though states and accreditation organizations may impose limits.
CLIA CLIA Personnel Requirements & Qualifications 1
What is the minimum educational requirement for a laboratory director of a high-complexity testing laboratory under CLIA?