Join us in celebrating our 50th Anniversary!
Join us in celebrating our 50th Anniversary!

CLSI Standards Documents for Public Review

Comment on New and Revised Standards Drafts

Help shape the standards that affect 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 draft documents before they are approved for publication. Opening the dialogue to CLSI members and nonmembers alike, we encourage your involvement in shaping our documents to ensure all interested parties are given a voice.

General Information

Requests for documents should be submitted via e-mail to vote@clsi.org or by fax to +1.610.688.0700. 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 below.

CLSI Standards Documents for Public Review and Comment

GP33 (Proposed Draft)—Accuracy in Patient and Specimen Identification. This standard specifies the processes required to ensure accurate patient and specimen identification in manual and electronic systems across the health care enterprise. Processes include system design considerations, differences in requirements for patients with or without identification bands, and provisions for patients with communication barriers. This draft document is available to the public for review and comment for 60 days (30 August to 29 October 2018).

AUTO16 (Proposed Draft)—Next-Generation In Vitro Diagnostic Instrument Interface. This standard applies to the exchange of analytical testing data between in vitro diagnostic instruments and health care informatics systems. This draft document is available to the public for review and comment for 60 days (11 October to 10 December 2018).

EP06 (Proposed Draft)—Evaluation of Linearity of Quantitative Measurement Procedures. This guideline provides information for characterizing the linearity interval of a measurement procedure, for validating (establishing) a linearity interval claim, and for verifying an established linearity interval claim by the end user. This draft document is available to the public for review and comment for 60 days (11 October to 10 December 2018).



The review and comment period provides an opportunity for the public to offer input on CLSI draft consensus documents. At the end of the 60-day review and comment period, the committee that developed the document is required to review and provide responses to all comments received and revise the draft document as appropriate.

Please note CLSI draft 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 be considered either final or published and may not be quoted or referenced.