A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
|Publication Date:||1 June 2015|
EP19 is organized around the measurement procedure lifecycle paradigm (see Tables 1 and 2), which follows the concept that all measurement procedures undergo an initial establishment phase performed by manufacturers, followed by implementation in laboratories. The document follows the measurement procedure lifecycle and is logically organized in a step-by-step manner. The steps describe the considerations and requirements for measurement procedure evaluations including planning and the selection of appropriate CLSI documents and other related documents for validation, verification, and other evaluations. EP19 is designed to organize the evaluation process for the use of CLSI documents.
EP19 defines and explains the many kinds of evaluations that may be performed during the development of a measurement procedure, its initial trial for acceptable suitability by end users, and ongoing demonstration of acceptable performance. EP19 assembles the existing CLSI resources, especially evaluation protocol (EP) documents, and presents them in a logical manner. It is written to facilitate users' identification of the specific kinds of evaluations they may wish to perform. To aid in the understanding of CLSI standards and guidelines used for measurement procedure evaluations, this report includes definitions of several relevant statistical terms and descriptions of specific statistical tools.
Because CLSI documents are updated regularly, they are considered an authoritative source for how evaluations should be performed. EP19 is only intended to provide general guidance on which specific CLSI documents may be used for evaluations and considerations for how users might most effectively use them, depending upon their needs. Users of EP19 will need to refer to the relevant CLSI documents for sufficient details to perform the evaluations correctly. Some measurement procedures, eg, those that produce an index result (ie, discreet categories, eg, positive, negative, specific mutation result) will involve special evaluations for which, currently, there are no CLSI documents.
EP19 is intended for use by clinical laboratory professionals, manufacturers, and governmental agencies. The term "manufacturers" includes both commercial manufacturers and clinical and... View More
EP19 is intended for use by clinical laboratory professionals, manufacturers, and governmental agencies. The term "manufacturers" includes both commercial manufacturers and clinical and other laboratories that conduct research and measurement procedure development. Clinical laboratories that modify commercial measurement procedures, eg, by changing the reagent, sample volumes, or sample types; adding analytespecific reagents (ASRs); changing to sample types that are not mentioned in the product labeling; as well as many other potential modifications, are essentially creating a new measurement procedure. In this case, the laboratory needs to establish acceptable performance through analytical validation and clinical validation, and then reverify performance as part of implementation.
It is important to clarify the need for laboratories to assume the responsibility for establishment of performance, regardless of whether they have a recognized research and development facility, or are clinical laboratories that incorporate presumably minor modifications to a measurement procedure or measuring system. According to EP19, both laboratories that create new measurement procedures and those that make relatively minor changes to commercial measurement procedures are considered manufacturers.
EP19 was written to be especially useful for laboratorians who are just beginning to use CLSI documents, including those who work in laboratories that may have been modifying commercial measurement procedures without performing any subsequent evaluations. These laboratories may have been using CLSI documents to a limited extent or not at all. The EP19 high-level roadmap is expected to be a helpful resource in these settings.View Less