Clinical and Laboratory Standards Institute (CLSI)
Standards and guidelines regarding clinical and laboratory testing for use within the healthcare and medical testing communities.
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
- Coagulation (Hemostasis)
- Cytology and Histology
- Flow Cytometry
- General Laboratory
- Laboratory Information Systems (LIS)
- Method Evaluation
- Molecular Methods
- Newborn Screening
- Point-of-care Testing
- Quality Assurance (Quality Control and Proficiency Testing)
- Quality Management Systems
- Specimen Collection and Handling
- Veterinary Microbiology