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Clinical & Laboratory Standards Institute: CLSI Guidelines.

The Clinical and Laboratory Standards Institute (CLSI) creates voluntary consensus standards and guidelines regarding clinical and laboratory testing used within the healthcare and medical testing communities.

The basic format of a CLSI document follows an outline. Each chapter is introduced by a number and a descriptive heading, and is followed by successively numbered chapters and/or subchapters of the main chapters.

Clinical and Laboratory Standards Institute guideline EP26—User Evaluation of Acceptability of a Reagent Lot Change provides recommendations for laboratories on evaluating a new reagent lot, based on a protocol that uses patient samples to detect clinically important changes from the current lot.

CLSI Standards: Guidelines for Health Care Excellence Developed by our members for use by the global laboratory community, CLSI's consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency.

CLSI Standards: Guidelines for Health Care Excellence Developed by our members for use by the global laboratory community, CLSI's consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency.

Clinical and Laboratory Standards Institute document EP26-A—User Evaluation of Between-Reagent Lot Variation; Approved Guideline provides guidance for laboratories on the evaluation of a new reagent lot, including a protocol that uses patient samples to detect significant changes from the current lot.

In 2013, the Clinical and Laboratory Standards Institute (CLSI) published EP26-A, a guideline intended to provide laboratories with a practical protocol for verifying the consistency of the analytical performance of a test between consecutive reagent lot changes [3].