US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1200: Establish and maintain written policies and procedures implementing and monitoring a quality system across the general laboratory, preanalytic, analytic and postanalytic phases, with a quality assessment component that identifies, evaluates and resolves problems and drives continuous improvement, scaled to the specialties, services and clients served

What does 1200 require?

Each laboratory performing nonwaived testing must establish and maintain written policies and procedures that implement and monitor a quality system for all phases of the total testing process (preanalytic, analytic and postanalytic) and for its general laboratory systems. The quality system must include a quality assessment component that ensures continuous improvement of the laboratory's performance and services through ongoing monitoring that identifies, evaluates and resolves problems. Its components must be appropriate to the specialties and subspecialties the laboratory performs, the services it offers and the clients it serves, and are used to meet the specialty condition requirements of sections 493.1201 to 493.1227, each of which points the laboratory to the general, preanalytic, analytic and postanalytic standards and the specialty-specific control standard that applies.