CLSI EP19-Ed2

A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition

Clinical and Laboratory Standards Institute document EP19 - A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures is a reference guide for the use of CLSI documents in method evaluations. It is intended to be especially accessible and useful to those who are new to CLSI documents. To this end, EP19 introduces and explains helpful statistical concepts that are used in CLSI documents, especially as they may be helpful in measurement procedure establishment and implementation. The document also introduces the measurement procedure lifecycle concept to illustrate the utility of all CLSI documents, as well as helpful guidelines from other sources, which are used for method evaluations. EP19 defines all measurement procedure developers as manufacturers, regardless of whether they are commercial entities or noncommercial laboratories that develop their own measurement procedures. It clarifies many terms, including method “establishment” by manufacturers, which includes “development” and “validation,” and “implementation” by end users, which includes “verification.”