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. 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 committee produces consensus documents related to a specific discipline.
Nine expert panels manage the development of documents and related products in their respective subject areas. They ensure that each document meets CLSI’s requirements for consensus, technical accuracy, relevancy, and excellence.
The consensus committees are:
- Automation and Informatics
- Clinical Chemistry and Toxicology
- Evaluation Protocols
- Hematology and Immunology and Ligand Assay
- Molecular Methods
- Point-of-Care Testing
- Quality Systems and Laboratory Practices
Document development committees are charged by the expert panels with developing new documents and revising existing ones. A document development committee is led by a chairholder who is responsible for meeting committee objectives as well as planning, budgeting, and scheduling. Members are considered to be authors and subject matter experts. They collaborate to develop the table of contents; identify primary references; and draft, review, revise, and vote on the document. They also resolve voting comments at all stages of the CLSI consensus process.
Working groups are formed as subunits of subcommittees. They are appointed to complete specific assignments.
CLSI's Consensus Council is responsible for evaluating document proposals across specialty areas and focuses resources on those that meet the greatest need. At the end of document development and before publication, the Consensus Council is also responsible for ensuring that CLSI's consensus process was followed.
The consensus process
CLSI's core business is the development of globally applicable voluntary consensus standards and guidelines for the clinical laboratory. 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 suggest 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.
CLSI membership connects organizations and individuals with a large and diverse network of organizations and their representatives or “delegates.” The CLSI consensus process brings together constituencies to address and resolve issues. This process is open to any interested organization or individual that has the interest in being involved. It is balanced, to ensure government, industry, and health care professionals meet on an equal and fair basis.
Participation enables development of consensus documents by openly presenting organizations' needs and perspectives on issues, which allows this input to be 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 more than 2,000 volunteers to create laboratory standards and guidelines that help improve health care worldwide. People who are interested in creating laboratory standards and guidelines can volunteer to serve as document development or expert panel members on 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 management systems in resource-limited countries.
Standards and guidelines
CLSI publishes voluntary consensus standards and guidelines, reports, and a number of companion products.
- Standards are documents developed through the consensus process that clearly identify specific, essential requirements for materials, methods, or practices for use in an unmodified form. Standards may, in addition, contain discretionary elements, which are clearly identified.
- Guidelines are documents developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. Guidelines 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 appropriate consensus committee.
- Companion products include any item provided or sold that is intended to be used in conjunction with a CLSI standard or guideline. Examples include, but are not limited to, Quick Guides, Wall Charts, software, and templates. Companion products typically contain or refer to technical content taken directly from standards or guidelines.
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, 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 Technical Committee (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.