CLIA Regulatory Requirements & Documentation 2 — Questions and Answers
Question 1: Under CLIA, how long must laboratories retain quality control records?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
CLIA requires laboratories to retain quality control records for at least 2 years.
Question 2: Which CLIA certificate is required for laboratories that perform only CLIA-waived tests?
- Certificate of Compliance
- Certificate of Waiver (Correct answer)
- Certificate of Registration
- Certificate of Accreditation
Correct answer: Certificate of Waiver
A Certificate of Waiver is issued to laboratories that perform only tests categorized as waived under CLIA.
Question 3: What is the required frequency for proficiency testing (PT) participation under CLIA for most regulated analytes?
- Monthly
- Quarterly (3 times per year) (Correct answer)
- Semiannually (2 times per year)
- Annually
Correct answer: Quarterly (3 times per year)
CLIA requires laboratories to participate in proficiency testing at least three times per year for each regulated analyte.
Question 4: A laboratory receives a deficiency citation during a CLIA inspection. Within how many days must a plan of correction be submitted?
- 10 days
- 30 days (Correct answer)
- 45 days
- 60 days
Correct answer: 30 days
Laboratories must submit a plan of correction to CMS within 10 days of receiving a deficiency citation, though full correction may be allowed 30 days.
Question 5: Which document type serves as the primary record of a laboratory's personnel qualifications under CLIA?
- Procedure manual
- Personnel file (Correct answer)
- Quality control log
- Proficiency testing records
Correct answer: Personnel file
Personnel files document each employee's education, training, competency assessments, and qualifications as required by CLIA.
Question 6: Under CLIA regulations, which agency has primary enforcement authority?
- FDA
- CDC
- CMS (Correct answer)
- OSHA
Correct answer: CMS
The Centers for Medicare & Medicaid Services (CMS) is the primary agency responsible for CLIA enforcement and regulation.
Question 7: What is the CLIA-mandated minimum retention period for patient test records?
- 1 year
- 2 years (Correct answer)
- 5 years
- 7 years
Correct answer: 2 years
CLIA requires patient test records to be retained for a minimum of 2 years from the date of testing.
CLIA Regulatory Requirements & Documentation 2
Under CLIA, how long must laboratories retain quality control records?