Clinical and Laboratory Standards Institute
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer driven, membership supported, nonprofit, standards organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
In the fall of 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 direct communication links and cooperative programs with many standards-developing organizations around the world.
CLSI's formal education program began with workshops designed to increase the effectiveness of their standards and guidelines, and continues today with teleconferences, videos, and software programs.
Since its start in 1967, CLSI has evolved into a global association of over 2,000 member organizations and more than 2,000 volunteers – all working together to advance quality in health care testing.
Until 2005 CLSI was known under the name 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 committee was 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 area committee is committed to producing consensus documents related to a specific discipline, as described in its mission statement. The committees are:
- Automation and Informatics
- Chemistry and Toxicology
- General Laboratory
- Method Evaluation
- Molecular Methods
- Newborn Screening
- Point-of-Care Testing
- Quality Management Systems
- Veterinary Medicine
The consensus process
CLSI's core business is the development of globally applicable voluntary consensus documents for health care testing. CLSI develops consensus documents through an accredited consensus process. CLSI's voluntary consensus is the substantial agreement by materially affected, competent, and interested parties. It does not always connote unanimous agreement, but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and are willing to accept the resulting agreement.
Membership in the CLSI connects organizations with a large and diverse network of organizations and their representatives. The CLSI consensus process brings together constituencies to address and resolve issues. This process is open to any interested organization that has the opportunity to be involved. It is balanced, to ensure that manufacturers, practitioners, and government meet on an equal basis; and fair.
Participation enables development of consensus documents by openly presenting organizations' needs and perspectives on issues and having this input considered deliberately and fairly within the consensus process. By having an active voice, participants can work to ensure that goals of the standards and guidelines directly affecting them are practical and achievable.
CLSI relies on over 2,000 volunteers to create laboratory standards and guidelines and to improve health care worldwide. People who are interested in creating laboratory standards and guidelines can volunteer to serve as document committee members new projects by responding to a call for volunteers. Volunteers and mentors also work with CLSI's global health partnerships to help establish laboratory quality systems in resource-limited countries.
Standards and guidelines
CLSI documents are published as a standard, guideline, or committee report.
- Standards are developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified.
- Guidelines are developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs.
- Reports are documents that have not been subjected to consensus review and are released by the board of directors.
Global health partnerships
CLSI provides direct assistance in Sub-Saharan Africa to combat HIV/AIDS and other infectious diseases. With grants from the US-based PEPFAR (President's Emergency Plan for AIDS Relief) program administered by a cooperative agreement from the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), CLSI has been directly engaged in essential laboratory services improvement. During the past several years, CLSI mentors, volunteers, and staff have provided technical assistance in: Côte d'Ivoire, Ethiopia, Georgia (country), Ghana, Mali, Malawi, Mozambique, Namibia, Nigeria, Kazakhstan, Peru, Rwanda, Tanzania, Vietnam and Zambia.
International Organization for Standardization (ISO)
The CLSI participates in the development of international standards as the Secretariat of ISO/TC 212, clinical laboratory testing and in vitro diagnostic test systems, a responsibility that was delegated to CLSI by the American National Standards Institute (ANSI), which is an ISO member body.
CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.