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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 standard@clsi.org or by fax to 610.688.0700.

Documents for Review and Comment

EP34 (Proposed Draft)—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking

Voting Deadline: 15 May 2017

It is often medically necessary to provide results for specimens with concentrations above the analytical measuring interval of an in vitro diagnostic measurement procedure. This guideline helps manufacturers and laboratory scientists with establishing, validating, or verifying a dilution scheme that will provide an extended measuring interval for such specimens.

This draft document is available to the public for review and comment for 60 days (March 17 to May 15).

EP07 (Proposed Draft)—Interference Testing in Clinical Chemistry

Voting Deadline: 19 June 2017

This guideline provides background information, guidance, and experimental procedures for investigating, identifying, and characterizing the effects of interfering substances on clinical chemistry test results.

EP07 (Proposed Draft) includes EP37 (Proposed Draft)—Supplemental Tables for Interference Testing in Clinical Chemistry as a reference document. This document includes recommended testing concentrations for analytes and endogenous substances that may interfere in clinical chemistry measurement procedures and is intended for use with the evaluation procedures in CLSI guideline EP07.

This draft document is available to the public for review and comment for 60 days (April 19 to June 19).


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.

 

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

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