CLSI eNews - 2 June 2008 (Plain Text Version)

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President's Message
Volunteer Focus
Lab Guidelines & Standards
CLSI Catalog Supplement
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Vote and Deadlines
Recently Approved Documents
Call for Nominations
Events and Exhibits
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Call for Nominations

EP9-A2 to A3, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition
Planning for Challenges to Clinical Laboratory Operations During a Disaster

The Area Committee on Evaluation Protocols is inviting subcommittee participation to carry out revisions of the CLSI document described below.

PROJECT REVISION:
EP9-A2 to A3, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

Description:
This document provides both users and manufacturers of clinical laboratory devices with guidance for designing an experiment to evaluate the bias between two methods that measure the same analyte.

Specific Expertise/Work Experience Needed:

Laboratory directors/Laboratory managers,
Manufacturers of in vitro diagnostic (IVD) devices and developers of clinical laboratory measurement methods,
Representatives of industry,
Statisticians,
Clinical chemists,
Laboratory personnel,
Regulatory authorities, and
Medical personnel.

The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 1 July 2008.

Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion.

Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.

The Clinical and Laboratory Standards Institute requests volunteers to serve as subcommittee members for a new voluntary consensus project.

NEW PROJECT:
Planning for Challenges to Clinical Laboratory Operations During a Disaster

Description:
Recent events have emphasized an urgent need to expand laboratory, facility, community, state, and national preparedness to include realistic considerations of the types and magnitudes of emergency incidents heretofore thought impossible. Most North American laboratories are required to have a disaster management plan in place to cover a range of possible eventualities, and although it may not yet be a requirement in other countries, this guideline will serve as starting point for their planning efforts.

This document will provide direction for assessing non-analytic (operational) system components of both clinical and public health testing that may be impaired or at risk of failure in various natural and man-made disasters. Aspects of the guideline will focus upon emergency operational challenges confronting hospital-based laboratories, guidance for POCT, as well as clinical laboratories residing in physicians' offices, medical centers, and reference (independent) laboratories. With the use of this document, institutions will have the necessary guidance to develop a framework to implement a team responsible for reviewing the infrastructures that support both clinical and public health testing and result reporting.

Specific Expertise/Work Experience Needed:

The subcommittee will require representatives as specified below:

Laboratory service providers from private and public health sectors, including hospital/medical center-based laboratories, reference laboratories, physician office laboratories, and ancillary locations at which laboratory services are provided at the point of care.
Individuals who serve or have served on local emergency planning committees.
Individuals familiar with national/regional/local incident management compliance requirements.
Representatives from the Department of Homeland Security (DHS), FEMA, NIMS.

Familiarity with previous or existing standards/guidelines is helpful.

The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 1 July 2008.

Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion.

Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.