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 firstname.lastname@example.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.
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).
NBS08 (Proposed Draft)—Newborn Screening for Hemoglobinopathies. This guideline describes the recommended protocols for detecting hemoglobinopathies and thalassemias by population-based newborn screening using dried blood spot specimens. Early, presymptomatic detection to identify newborns with abnormal hemoglobins is critical because it improves treatment effectiveness. This draft document is available to the public for review and comment for 60 days (1 November to 31 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.