shop now
clinical laboratory standards institute logo


About CLSI


Share Your Comments on New and Revised Standard Documents

Help shape the standards that impact your day-to-day work.

To preserve the integrity of standards developed through the CLSI consensus process, we seek input from the public on our in-process drafts before they are approved for publication. Opening the dialogue to CLSI members and non-members alike, we encourage your involvement in the final shaping of our documents to ensure that all interested parties are given a voice.

General Information

Comments related to CLSI draft documents shall be made in writing using the comment table form and shall be submitted no later than the comment deadline indicated above. Comments, as well as requests for a copy of the document, should be submitted via e-mail to or by fax to 610.688.0700.

Documents for Review and Comment

EP21 (Proposed Draft)Evaluation of Total Analytical Error for Quantitative Clinical Laboratory Measurement Procedures. This guideline provides manufacturers and end users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and data analysis method are provided to estimate TAE based upon a comparison of methods experiment with patient samples, and to assess it relative to a pre-established goal for clinical acceptability. This draft document is available to the public for review and comment for 60 days (May 8 to July 6).

M23 (Proposed Draft)Development of In Vitro  Susceptibility Testing Criteria and Quality Control Parameters. This guideline addresses the required and recommended data needed for the selection of appropriate interpretive criteria and quality control ranges for antimicrobial agents. This draft document is available to the public for review and comment for 60 days (May 6 to July 6).

GP41 (Proposed Draft)Collection of Diagnostic Venous Blood Specimens. This standard provides procedures for the collection of diagnostic specimens by venipuncture, including line collections, blood culture collection, and venipuncture in children. This draft document is available to the public for review and comment for 60 days (June 10 to August 10).

GP48  (Proposed Draft)Essential Elements of a Phlebotomy Training Program. This guideline is a resource for health care professionals and educators for development and implementation of curricula for phlebotomy training programs and courses.  This draft document is available to the public for review and comment for 60 days (June 10 to August 10).

The review and comment period helps ensure that consensus is achieved so that approved consensus documents can be distributed for use in the health care community. At the end of the 60-day review and comment period, the committee that developed the document is obligated to review all comments, respond in writing to all substantive comments, and revise the draft document as appropriate. CLSI greatly appreciates your valuable feedback.

Please note draft CLSI documents are available only for the purposes of review and comment, and are not to be reproduced or circulated for any other reason. Draft documents have not completed the consensus review process, and therefore, shall not be used for any clinical purposes or to satisfy regulatory or accreditation requirements. They should not to be considered either final or published and may not be quoted or referenced.


Did You Know?

CLSI distributes more than
75,000 standards and guidelines per year, worldwide.


Register | Lost your password?