Clinical and Laboratory Standards Institute

The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community. The organization’s mission is to develop clinical and laboratory practices and promote their use worldwide.

In 1968, 31 clinicians and laboratory scientists representing 15 organizations met to discuss ways of "improving what we are doing for patients" and to develop a formal consensus process for standardization. In 1977, CLSI was accredited by the American National Standards Institute (ANSI) as a voluntary consensus standards organization. At about the same time, CLSI became the home of the National Reference System for the Clinical Laboratory (NRSCL), a collection of broadly understood reference systems intended to improve the comparability of test results, consistent with the needs of medical practice.

CLSI actively promotes global harmonization of standards through its own initiatives and through communication and cooperation with many standards-developing organizations around the world.

CLSI's formal education program began with workshops designed to increase the effectiveness of its standards and guidelines, and continues today with online workshops, webinars, and certificate programs.

Since its start in 1968, CLSI has evolved into a global association of 1,500+ member organizations and individual members, as well as more than 2,000 volunteers—all working together to advance quality in health care testing. Until 2005, CLSI was called the National Committee for Clinical Laboratory Standards (NCCLS).

CLSI documents are developed by committees composed of experts in medical testing, or ancillary aspects of these activities, around which the committees were formed. The primary responsibility of the committees is drafting consensus documents and evaluating and addressing comments received during each phase of the consensus process. Development of CLSI standards is a dynamic process. Each CLSI consensus committee is committed to producing consensus documents related to a specific discipline, as described in its mission statement.

Nine consensus committees manage the development of documents and related products in their respective subject areas. As the consensus body, they ensure that each document meets CLSI’s requirements for consensus, technical accuracy, relevancy, and excellence (in essence, they are the document development quality control team). The consensus committee is responsible for final review and approval, and deems documents ready for publication as approved standards or guidelines.

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