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
Under CLIA, how long must laboratories retain quality control records?
Answer: 2 years
CLIA requires laboratories to retain quality control records for at least 2 years.
Which CLIA certificate is required for laboratories that perform only CLIA-waived tests?
Answer: Certificate of Waiver
A Certificate of Waiver is issued to laboratories that perform only tests categorized as waived under CLIA.
What is the required frequency for proficiency testing (PT) participation under CLIA for most regulated analytes?
Answer: Quarterly (3 times per year)
CLIA requires laboratories to participate in proficiency testing at least three times per year for each regulated analyte.
A laboratory receives a deficiency citation during a CLIA inspection. Within how many days must a plan of correction be submitted?
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.
Which document type serves as the primary record of a laboratory's personnel qualifications under CLIA?
Answer: Personnel file
Personnel files document each employee's education, training, competency assessments, and qualifications as required by CLIA.
Under CLIA regulations, which agency has primary enforcement authority?
Answer: CMS
The Centers for Medicare & Medicaid Services (CMS) is the primary agency responsible for CLIA enforcement and regulation.
What is the CLIA-mandated minimum retention period for patient test records?
Answer: 2 years
CLIA requires patient test records to be retained for a minimum of 2 years from the date of testing.