The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported,

not-for-profit A not-for-profit or non-for-profit organization (NFPO) is a Legal Entity, legal entity that does not distribute surplus funds to its members and is formed to fulfill specific objectives. While not-for-profit organizations and Nonprofit organ ...

standards development organization A standards organization, standards body, standards developing organization (SDO), or standards setting organization (SSO) is an organization whose primary function is developing, coordinating, promulgating, revising, amending, reissuing, interpr ...

. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.

History

In 1968, 31 clinicians and

laboratory A laboratory (; ; colloquially lab) is a facility that provides controlled conditions in which scientific or technological research, experiments, and measurement may be performed. Laboratories are found in a variety of settings such as schools ...

scientists representing 15 organizations convened to establish a formal consensus process for standardization. In 1977, CLSI received accreditation from the American National Standards Institute (

ANSI The American National Standards Institute (ANSI ) is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organiz ...

) as a voluntary consensus standards organization. Around the same time, CLSI became the home of the National Reference System for the Clinical Laboratory (NRSCL), a collection of reference systems intended to enhance the comparability of test results, consistent with medical practice needs. CLSI is a global association with over 1,500 member organizations and individual members, along with more than 2,000 volunteers. Until 2005, CLSI was known as the National Committee for Clinical Laboratory Standards (NCCLS).

Committees

CLSI documents are developed by committees consisting of experts in medical testing or related aspects. Each CLSI committee produces consensus documents related to a specific discipline.

The Consensus Process

CLSI's core focus is the development of globally applicable voluntary consensus

standards Standard may refer to: Symbols * Colours, standards and guidons, kinds of military signs * Standard (emblem), a type of a large symbol or emblem used for identification Norms, conventions or requirements * Standard (metrology), an object t ...

and guidelines for the clinical laboratory. This is achieved through an accredited consensus process.

Volunteers

CLSI relies on more than 2,000 volunteers. Volunteers and mentors also collaborate with CLSI's Global Health Partnerships to help establish laboratory quality management systems in resource-limited countries.

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 The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency under the United S ...

(CDC) and the

National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. NIAID's mis ...

(NIAID), CLSI has been actively involved in improving essential laboratory services. CLSI has provided technical assistance in Côte d'Ivoire, Democratic Republic of the Congo, Dominican Republic, Ethiopia, Georgia, Ghana, Kazakhstan, Kenya, Kyrgyzstan, Malawi, Mali, Mozambique, Namibia, Nigeria, Peru, Rwanda, Tajikistan, Tanzania, Ukraine, Vietnam, and Zambia.

International Organization for Standardization (ISO)

CLSI participates in the development of international standards as the Secretariat of

ISO The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Me ...

Technical Committee (TC) 212, clinical laboratory testing and ''in vitro'' diagnostic test systems. This responsibility was delegated to CLSI by the

American National Standards Institute The American National Standards Institute (ANSI ) is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organiz ...

(ANSI), an

member body. CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.

References

External links

*
CLSI Home page
{{authority control Standards organizations in the United States