NCCLS and voluntary consensus standards for the clinical laboratory.

We are all aware that in the last two decades there has been an explosive growth in the development and production of analytical instrumentation and reagents for use in the clinical laboratory. It was obvious that much. of this growth was uncontrolled and determined largely by market-place factors and the assessments of individual professionals. Professional societies did take a role in tryingto ensure that diagnostic products and procedures were accurate, reliable, and useful for patient care. Several of the more directly involved organizations-e.g., the American Association of Clinical Chemists, the College of American Pathologists, the Association for the Advancement of Medical Instrumentation, and othershad created committees dedicated to the development of clinical laboratory standards. However, the activities of these groups were narrow in scope and composition, and there were no mechanisms for widespread review and adoption of the output of the committees by either industry or laboratory professionals. Voluntary standards originated by limited groups of professionals did not have the impact required to overcome economic and other important parochial concerns of manufacturers and users. In 1967 a group of professionals representing several laboratory disciplines, met for the purpose of organizing an intersociety organization which could develop voluntary standards on a broad consensus basis. Leaders in this effort included Drs. Howard Bodily, Russell Eilers, E. M. Flipse, Andrew Fodor, James Griffitts, Ralph Thiers, and Mr. J. J. Moran, and they enlisted the support of other interested laboratorians. It was important for this new approach that all of the component contributors to clinical laboratory operation (professional staff, government agencies, and manufacturers) be represented in the decision-making process. In 1968, the National Committee for Clinical Laboratory Standards (NCCLS)