Minimum intervals for CLIA '88 laboratory inspections are ___ years.

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

Answer: (A)

Regular inspections under CLIA '88 occur at least every two years. This biennial schedule is there to ensure laboratories continually meet quality standards for testing, personnel qualifications, proficiency testing, quality control, and record-keeping. Even if a lab is accredited by a CMS-approved accreditation organization, the requirement is still to undergo surveys at least every two years; shorter intervals may happen if issues arise, but the minimum interval remains two years. Intervals of one year, three years, or four years do not satisfy the regulatory requirement.