What's New and Important in College of American Pathologists Inspection for the Clinical Microbiology Laboratory

Abstract

Proficiency testing and laboratory accreditation have been focuses of the College of American Pathologists since its inception in 1946. At the outset, the programs were voluntary and designed as educational self-improvement exercises. However, the passage of two major bills in 1967 and 1988 transformed the process into a mandatory and regulatory one — first for hospital laboratories, and then for all laboratories that test human specimens. The college has “deemed” status from the federal government to accredit laboratories, using criteria that meet or exceed federal standards. In 2004, a high-profile laboratory failure concentrated media and congressional attention on oversight of the laboratory industry. As a result, numerous changes have been made by both the government and accrediting organizations. This article provides a summary of what has changed and what has remained the same, with particular attention to microbiology laboratories. Suggested strategies for adapting to the changes are provided.