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.
Requests for documents should be submitted via e-mail to email@example.com 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.
QMS27 (Proposed Draft)—Decontamination of Laboratory Instrumentation. This guideline describes a recommended approach to decontaminating laboratory instruments. It explains the purposes of decontamination, details the circumstances in which decontamination is necessary, describes appropriate decontamination methods, and specifies the parties responsible for each part of the process. This draft document is available to the public for review and comment for 60 days (19 January 2021 to 19 March 2021).
QMS15 (Proposed Draft)—Laboratory Internal Audit Program. This guideline provides recommendations for establishing a laboratory internal audit program to enhance the quality of laboratory services through continual improvement. An audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, and the audit process describes the details of conducting individual laboratory internal audits. This draft document is available to the public for review and comment for 60 days (16 February 2021 to 16 April 2021).
MM09 (Proposed Draft)—Human Genetic and Genomic Testing Using Traditional and High-Throughput Nucleic Acid Sequencing Methods. This guideline in conjunction with instructional worksheets and educational examples provides step-by-step recommendations for designing, testing, validating, reporting, and continual quality management of clinical tests based on next-generation sequencing and Sanger sequencing. This draft document is available to the public for review and comment for 60 days (23 February 2021 to 23 April 2021).
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.