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 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

QMS05 (Proposed Draft)Qualifying, Selecting, and Evaluating a Referral Laboratory. This guideline provides recommended criteria and easily implemented processes to qualify, select, and evaluate a referral laboratory. This draft document is available to the public for review and comment for 60 days (15 October to 13 December 2019).

MM13 (Proposed Draft)Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods. This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type. This draft document is available to the public for review and comment for 60 days (18 September to 18 November 2019).

H62 (Proposed Draft)Validation of Assays Performed by Flow Cytometry. This guideline includes validation strategies for cell-based assays. This guideline also includes recommendations for instrument qualification and standardization, assay optimization, and examination phase and postexamination phase best practices. This draft document is available to the public for review and comment for 60 days (18 September 2019 to 18 November 2019).


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.