Clinical and Laboratory Standards Institute (CLSI)

The Clinical and Laboratory Standards Institute (CLSI) promotes the development of voluntary consensus standards and guidelines regarding clinical and laboratory testing for use within the healthcare and medical testing communities.

Wayne, Pa.-based CLSI is accredited by the American National Standards Institute (ANSI), and its standards are used in professional practice guidelines and are referenced in government (including FDA) regulations and international standards. The FDA, for example, recognizes CLSI standards for use by industry in product submissions for regulatory approval of medical devices.

CLSI documents are developed by experts working on document-development committees, subcommittees or working groups under the direction and supervision of a consensus committee.

CLSI standards and guidelines focus on:

• Antifungal Susceptibility Testing
• Antimicrobial Susceptibility Testing
• Automation
• Chemistry
• Coagulation (Hemostasis)
• Cytology and Histology
• Flow Cytometry
• General Laboratory
• Hematology
• Immunology
• Laboratory Information Systems (LIS)
• Method Evaluation
• Microbiology
• Molecular Methods
• Newborn Screening
• Point-of-care Testing
• Quality Assurance (Quality Control and Proficiency Testing)
• Quality Management Systems
• Specimen Collection and Handling
• Toxicology
• Veterinary Microbiology

CLSI Standards Collection

The IHS CLSI Documents Collection includes approximately 130 Active standards. Each CLSI consensus committee produces consensus documents related to a specific discipline, as described in its mission statement (see below). The CLSI committees include:

• Automation and Informatics
• Clinical Chemistry and Toxicology
• Evaluation Protocols
• Hematology
• Immunology and Liquid Assay
• Microbiology
• Molecular Methods
• Point-of Care Testing
• Quality Systems and Laboratory Practices

Laboratories use CLSI standards to:

• Ensure compliance with applicable regulatory requirements
• Achieve accurate laboratory test results
• Establish cost-effective laboratory operations
• Implement uniform procedures that meet international standards
• Reduce time for approval and adoption of new technologies
• Create sustainable laboratory capacity.

The use of CLSI standards by industry scientists helps speed up product development, ensures standardization across the field, and helps customers compare performance of products.