Laboratory quality management: a roadmap.

Laboratories in the United States are subject to so many national, state, and local requirements that it is very complicated to track compliance with every individual organization's listed requirements. What is needed is a roadmap for quality that ensures that each laboratory makes its best contribution to patient care and safety while continually meeting all requirements. This article presents such a roadmap for laboratory quality management that is based on the many and various published laboratory regulations, standards, and accreditation requirements. This model also clearly illustrates the important relationship between quality activities that should be designed and supported by laboratory management and the technical activities that produce laboratory results for patient care.