Clinical and Laboratory Standards Institute
Encyclopedia
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.
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 heath care testing.
Until 2005 CLSI was known under the name National Committee for Clinical Laboratory Standards (NCCLS).
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.
Participation enables development of consensus documents by openly presenting organization's 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.
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
, Mozambique
, Namibia
, Nigeria
, Kazakhstan
, Peru
, Rwanda
, Tanzania
, Vietnam
, and Zambia
.
(ANSI), which is an ISO
member body.
CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.
Standards organization
A standards organization, standards body, standards developing organization , or standards setting organization is any organization whose primary activities are developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise producing technical standards that are...
. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
History
In the fall of 1967, 31 clinicians and laboratoryLaboratory
A laboratory is a facility that provides controlled conditions in which scientific research, experiments, and measurement may be performed. The title of laboratory is also used for certain other facilities where the processes or equipment used are similar to those in scientific laboratories...
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
Ansi
Ansi is a village in Kaarma Parish, Saare County, on the island of Saaremaa, Estonia....
) 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 heath care testing.
Until 2005 CLSI was known under the name National Committee for Clinical Laboratory Standards (NCCLS).
Committees
Clinical and Laboratory Standards Institute (CLSI) documents are developed by document development committees composed of experts in medical testing activities, or ancillary aspects of these activities, around which the document development committee was formed. The primary responsibility of the document delevopment 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.- Automation and Informatics
- Clinical Chemistry and Toxicology
- Evaluation Protocols
- Hematology
- Immunology and Ligand Assay
- Microbiology
- Molecular Methods
- Point-of-Care Testing
- Quality Systems and Laboratory Practices
The Consensus Process
Clinical and Laboratory Standards Institute's (CLSI) core business is the development of globally applicable voluntary consensus documents for health care testing. It is why members and volunteers actively support and participate in CLSI.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
Membership in the Clinical and Laboratory Standards Institute (CLSI) connects organizations with a large and diverse network of organizations and their representatives concerned with quality in the medical testing and health care fields. The CLSI consensus process brings together multiple constituencies to address and mutually resolve issues. This process is open to any interested organization that has the opportunity to be involved; balanced, to ensure that manufacturers, practitioners, and government meet on an equal basis; and fair.Participation enables development of consensus documents by openly presenting organization's 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.
Volunteers
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 committe members new projects by responding to a Call for Volunteers. Volunteers and mentors also work with global health programs to help establish laboratory quality systems in resource-limited countries.Standards and guidelines
Clinical and Laboratory Standards Institute (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 is providing 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
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
(CDC) and the National Institute of Allergy and Infectious Diseases
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases is one of the 27 institutes and centers that make up the National Institutes of Health , an agency of the United States Department of Health and Human Services...
(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
Côte d'Ivoire
The Republic of Côte d'Ivoire or Ivory Coast is a country in West Africa. It has an area of , and borders the countries Liberia, Guinea, Mali, Burkina Faso and Ghana; its southern boundary is along the Gulf of Guinea. The country's population was 15,366,672 in 1998 and was estimated to be...
, Ethiopia
Ethiopia
Ethiopia , officially known as the Federal Democratic Republic of Ethiopia, is a country located in the Horn of Africa. It is the second-most populous nation in Africa, with over 82 million inhabitants, and the tenth-largest by area, occupying 1,100,000 km2...
, Georgia (country)
Georgia (country)
Georgia is a sovereign state in the Caucasus region of Eurasia. Located at the crossroads of Western Asia and Eastern Europe, it is bounded to the west by the Black Sea, to the north by Russia, to the southwest by Turkey, to the south by Armenia, and to the southeast by Azerbaijan. The capital of...
, Ghana
Ghana
Ghana , officially the Republic of Ghana, is a country located in West Africa. It is bordered by Côte d'Ivoire to the west, Burkina Faso to the north, Togo to the east, and the Gulf of Guinea to the south...
, Mali
Mali
Mali , officially the Republic of Mali , is a landlocked country in Western Africa. Mali borders Algeria on the north, Niger on the east, Burkina Faso and the Côte d'Ivoire on the south, Guinea on the south-west, and Senegal and Mauritania on the west. Its size is just over 1,240,000 km² with...
, Mozambique
Mozambique
Mozambique, officially the Republic of Mozambique , is a country in southeastern Africa bordered by the Indian Ocean to the east, Tanzania to the north, Malawi and Zambia to the northwest, Zimbabwe to the west and Swaziland and South Africa to the southwest...
, Namibia
Namibia
Namibia, officially the Republic of Namibia , is a country in southern Africa whose western border is the Atlantic Ocean. It shares land borders with Angola and Zambia to the north, Botswana to the east and South Africa to the south and east. It gained independence from South Africa on 21 March...
, Nigeria
Nigeria
Nigeria , officially the Federal Republic of Nigeria, is a federal constitutional republic comprising 36 states and its Federal Capital Territory, Abuja. The country is located in West Africa and shares land borders with the Republic of Benin in the west, Chad and Cameroon in the east, and Niger in...
, Kazakhstan
Kazakhstan
Kazakhstan , officially the Republic of Kazakhstan, is a transcontinental country in Central Asia and Eastern Europe. Ranked as the ninth largest country in the world, it is also the world's largest landlocked country; its territory of is greater than Western Europe...
, Peru
Peru
Peru , officially the Republic of Peru , is a country in western South America. It is bordered on the north by Ecuador and Colombia, on the east by Brazil, on the southeast by Bolivia, on the south by Chile, and on the west by the Pacific Ocean....
, Rwanda
Rwanda
Rwanda or , officially the Republic of Rwanda , is a country in central and eastern Africa with a population of approximately 11.4 million . Rwanda is located a few degrees south of the Equator, and is bordered by Uganda, Tanzania, Burundi and the Democratic Republic of the Congo...
, Tanzania
Tanzania
The United Republic of Tanzania is a country in East Africa bordered by Kenya and Uganda to the north, Rwanda, Burundi, and the Democratic Republic of the Congo to the west, and Zambia, Malawi, and Mozambique to the south. The country's eastern borders lie on the Indian Ocean.Tanzania is a state...
, Vietnam
Vietnam
Vietnam – sometimes spelled Viet Nam , officially the Socialist Republic of Vietnam – is the easternmost country on the Indochina Peninsula in Southeast Asia. It is bordered by China to the north, Laos to the northwest, Cambodia to the southwest, and the South China Sea –...
, and Zambia
Zambia
Zambia , officially the Republic of Zambia, is a landlocked country in Southern Africa. The neighbouring countries are the Democratic Republic of the Congo to the north, Tanzania to the north-east, Malawi to the east, Mozambique, Zimbabwe, Botswana and Namibia to the south, and Angola to the west....
.
International Organization for Standardization (ISO)
The Clinical and Laboratory Standards Institute (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 InstituteAmerican National Standards Institute
The American National Standards Institute is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international...
(ANSI), which is an ISO
International Organization for Standardization
The International Organization for Standardization , widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates worldwide proprietary, industrial and commercial...
member body.
CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.