AB 1774 Summary: Clinical Laboratories: Licensure

• Repeals existing state licensure requirements for clinical laboratories, allowing them to either seek federal CLIA certification through approved accrediting organizations or be regulated by the State Department of Public Health.

• Shifts the Department of Public Health's role from routine licensing and inspection to monitoring, inspecting, and investigating only non-accredited laboratories and handling complaints and violations.

• Authorizes the Department to assess inspection fees on non-accredited laboratories only after the Clinical Laboratory Improvement Fund balance drops below $1,000,000, capped at $1,050 per inspection.

• Makes conforming changes to provisions governing clinical laboratory personnel licensing, proficiency testing requirements, quality assurance standards, and penalties for violations.

• Maintains existing fraud prevention provisions related to patient referrals and billing transparency, and strengthens record retention and reporting requirements for laboratories that cease operations.