Are CLSI standards and guidelines mandatory?
CLSI develops and publishes standards and guidelines through a consensus process that involves representatives from government, industry, and the patient-testing professions. Because of the unique credibility our threefold consensus process gives to our documents, regulatory agencies or accrediting bodies often require that a specific CLSI standard or guideline be followed. In these cases, following the standard or guideline becomes mandatory for institutions aiming to meet given regulatory or accreditation requirements.
