ABSTRACT
Laboratories engaged essentially in small operations and/or those involved in diversified programs, on first consideration, may conclude that a formal quality assurance program is virtually impossible. A high-level research effort approaches the craftsman-artisan situation but will be benefited by some aspects of a formal quality assurance program. The adoption and enunciation of a quality assurance policy by management is a prerequisite for an effective quality assurance program. The development of a quality assurance program should involve all levels of laboratory personnel. The process of development of a quality assurance program need not be complicated. The developers should identify the goals to be accomplished and the motivation behind its development. The quality assurance manual may be viewed as an instruction kit that the laboratory itself has developed to guide its laboratory operations in the production of quality data. The Clinical Laboratories Improvement Act of 1967 contains requirements for quality assurance as part of the general licensing requirements for such laboratories.
