Explore CLSI’s New Implementation Guides

Created to help your lab staff properly implement the procedures in our Evaluation Protocol (EP) standards, CLSI’s new implementation guides can help your laboratory verify test precision, accuracy, and other important performance characteristics. The guides are intended to be used by the laboratory scientists who perform verification testing. They describe the procedures necessary for a medical laboratory to verify a manufacturer’s or a laboratory-developed test’s performance claims.

Simplified protocols are provided with instructions for the entire testing process, including gathering the appropriate samples, testing the samples, and analyzing the data. Each Implementation Guide is accompanied by an Excel workbook, for use when calculations need to be performed. Users can simply enter the requested information and enter the data to obtain verification results.

These implementation guides and workbooks are not meant to replace the respective CLSI EP documents with which they correspond, but are intended to be used alongside the EP documents as an aid for the verification testing procedure.

Our most recently published implementation guide EPIG-26 was developed to be used with the new second edition of EP26—User Evaluation of Acceptability of a Reagent Lot Change, 2nd Edition and describes the minimum procedures necessary for a medical laboratory to verify that new reagent lots, when received and implemented by the laboratory, will produce results consistent with previous reagent lots.

In addition, on Thursday, May 26, 2022 at 1:00 pm (EST), CLSI will be hosting a webinar, EP26: User Evaluation of Acceptability of a Reagent Lot Change. Following this presentation attendees will be able to:

• Discuss the importance of verifying reagent lot changes.
• Outline how to design an effective reagent lot change study.
• List the steps in conducting a reagent lot change study.

Webinar attendees will earn 1.0 PACE^® CE Credit.

Find all Implementation Guides here.