NCCLS eNews - 13 October 2004 (Plain Text Version)

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News
Glen A. Fine Named New Executive Vice President of NCCLS/Clinical and Laboratory Standards Institute
Press Releases
Standards Status
Notice of Vote and Comment Deadline for Consensus Documents
Recently Approved Documents
Recently Distributed ISO Standards
Focus on Global Terminology
Seeking Volunteer Participation on Area Committees – Call for Nominations
Seeking Expert Opinions and Volunteer Participation – Call for Nominations
Events and Exhibits
Meeting Calendar
Upcoming Events and Exhibits
Membership
Join Us
New and Sustaining Members
Update Your Subscriptions

Seeking Expert Opinions and Volunteer Participation – Call for Nominations

Optimizing Detection of HLA-Specific Alloantibody by Flow Cytometry for Solid Organ and Stem Cell Transplantation; Verification of Comparability of Patient Results Within One Healthcare System; Implementation Guide of POCT1 for Healthcare Providers; and Implementation Guide of POCT1 for Manufacturers

NCCLS is seeking subcommittee membership for the following proposed projects:

Optimizing Detection of HLA-Specific Alloantibody by Flow Cytometry for Solid Organ and Stem Cell Transplantation

This proposed guideline will describe criteria for optimizing the detection of HLA alloantibody by cytometric methods. The methodologies addressed include the flow cytometric crossmatch, as well as microparticle detection of HLA alloantibody in conventional and multiplexed platforms. Specific areas include the use of standardized instrument setup and staining procedures, reporting formats, interpretation, and multicenter quality assurance.

Required Expertise:
Laboratory directors, clinicians involved with organ transplantation, technologists who routinely perform such testing, administrators with regulatory oversight in this area

Verification of Comparability of Patient Results Within One Healthcare System

The scope of this project would include: (1) laboratory validation of acceptable comparability of patient results before a change in reagent or calibrator lot; and (2) laboratory validation of acceptable comparability of results assayed by two or more methodologies or instruments within one healthcare system. The protocol should be applicable to the full spectrum of laboratory testing from the physician’s office laboratory to the esoteric reference laboratory.

Intended users are primarily clinical laboratories.

Requested Expertise:
Practicing pathologists, statistician(s), manufacturers, CMS representative, CDC representative

Implementation Guide of POCT1 for Healthcare Providers

This guideline will provide the healthcare provider or end user with clear and concise information on what features to expect in a connectivity-compliant device and practical advice on how to optimally apply these features to their daily operation/practice. It will also address possible pitfalls encountered during implementation. Where necessary or useful, it will define and explain, in nontechnical language, terms used in POCT1-A.

Requested Expertise:
Laboratory directors, chemists, pathologists, and/or managers and POCT coordinators, IVD manufacturers, and individuals familiar with laboratory and hospital information systems

Implementation Guide of POCT1 for Manufacturers

This guideline will provide the framework for IVD manufacturers to implement POCT1-A into their device software. It is intended to be used by the project manager or engineer new to the POCT1-A standard to better understand the components of a POCT1-A interface and how to break down the interface writing project into manageable tasks. This guideline is intended to be used as a companion to POCT1-A and is not intended to be used in place of or obviate the need for the standard.

Requested Expertise:
IVD manufacturers, software engineers, laboratory directors, POCT coordinators, and individuals familiar with laboratory and hospital information systems

These proposed projects are undergoing a progressive review process to assess the need and market potential for consensus document development.

Review the objective of the proposed projects, and the requested volunteer expertise, and:

Submit a nomination:
The deadline to submit the nomination form, including a curriculum vitae and disclosure of interests form, to the NCCLS Executive Offices is 12 November 2004.

Give us your expert opinion on the value of the projects:
To provide input on the need for, and utility of, each of these proposed new projects, click here.