US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1239: Run an ongoing, documented general laboratory systems quality assessment that monitors, assesses and corrects problems in confidentiality, specimen identification, complaints, communications, competency and PT evaluation, reviews the effectiveness of corrective actions, revises procedures to prevent recurrence and discusses the reviews with staff

What does 1239 require?

The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the general laboratory systems requirements of sections 493.1231 to 493.1236. The assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence, and discussion of the quality assessment reviews with appropriate staff, and every assessment activity must be documented.

Maintained by Gerard Blokdyk

Other controls in Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.