Under the CLIA '88 framework, inspections must occur at least every ___ years.

• A. 1 year
• B. 3 years
• C. 4 years
• D. 2 years

Answer: (D)

Under CLIA '88, laboratories are reviewed on a biennial basis. The standard cadence is every two years, which ensures ongoing verification of quality practices, personnel qualifications, proficiency testing, and proper recordkeeping without imposing excessive disruption. This interval provides regular oversight to maintain patient safety and test validity. Shorter annual inspections aren’t the default requirement, and longer gaps would reduce timely monitoring.