NCCLS eNews - 9 January 2004 (Print All Articles)

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Welcome to NCCLS eNews

In an effort to keep our members, volunteers, and customers involved and informed in our organization, NCCLS has combined the Update/Standards Status Newsletter and Announcement List into a new, easy-to-use, electronic newsletter, NCCLS eNews.

Each monthly edition of NCCLS eNews will include:

  • News articles and press releases
     
  • Standards Status, with vote and comment deadlines for consensus documents, a listing of published NCCLS and ISO standards, and requests for volunteer participation on committees
     
  • Membership news
     
  • Updated calendars of meetings, events, and exhibits
      
  • And much more

You are receiving this message because you were a subscriber of Update/Standards Status Newsletter or the NCCLS Announcement List.

TECH TIPS:

With this first edition of NCCLS eNews, we thought some tech tips might help you familiarize yourself with the new format.

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Enjoy this first edition. Stay in touch with important news and events with future monthly editions of NCCLS eNews!


2004 NCCLS Leadership Conference

The most important consensus learning event of the year!

NCCLS members and volunteers will gather at the 2004 NCCLS Leadership Conference in Washington, D.C., 18-20 March, to explore the latest trends in consensus process implementation. The leadership conference is dedicated to helping volunteers and members understand, participate effectively in, and implement NCCLS’s most important initiatives affecting the organization and standards development. The conference will also provide practical solutions for delivery of consistent, high quality, cost-effective services through the establishment of a quality infrastructure. 

Every member and volunteer will build vital knowledge about standards, guidelines, and best practices during this in-depth educational experience. The conference program is composed of interactive sessions focusing on:

  • global harmonization of standards emphasizing quality and competence in the medical laboratory,
  • consensus mediation,
  • demystification of the consensus process,
  • volunteer mentoring, and
  • metrological traceability.

From intimate sessions to forward-thinking workshops, the NCCLS Leadership Conference addresses the issues that will expand your reach within NCCLS and refine your competitive edge in your field. The general session, a case study on harmonization, will offer in-depth discussion of ISO 15189, Medical laboratories—Particular requirements for quality and competence, to provide insight on globally focused requirements for healthcare quality. Additional discussion centered on HS1-A, A Quality System for Model for Health Care, and GP26-A2, Application of a Quality System Model for Laboratory Services, will shed light on practical solutions for implementing ISO 15189; attaining regulatory/accreditation compliance, foundations of a quality management system; and providing a platform for continuous improvement.

In addition, an integrated schedule of meetings will be held, including the Board of Directors, NCCLS’s area committees and selected subcommittees, the NCCLS annual business meeting, the U.S. TAG for ISO/TC 212, educational workshops, the member/volunteer appreciation luncheon, and the President’s reception.

Special highlights and networking events at the conference include the second annual joint area committee session, where fellow committee members will share success stories. This session provides a unique opportunity to discuss common challenges, lessons learned, and practical solutions in consensus mediation. On Saturday, 20 March, the member/volunteer appreciation luncheon provides an opportunity to recognize the outstanding and important contributions of NCCLS members and volunteers who have dedicated their time and energy to ensuring the effectiveness of the NCCLS process.

Washington D.C. is where you want to be for three days in March. Join your fellow NCCLS colleagues and peers at the most important consensus standards learning event of the year. Register now, or for more information about attending the conference, click here or contact the NCCLS Executive Offices at +610.688.0100.


Press Releases: M100-S14, M11-A6, M40-A, AUTO7-P and EP21-A

NCCLS Announces Availability of New NCCLS Document on Performance Standards for Antimicrobial Susceptibility Testing; Fourteenth Informational Supplement

NCCLS document M100-S14 is an informational supplement for global application developed through the NCCLS consensus process.

Read the complete press release. To purchase this document, shop NCCLS.


NCCLS Announces Availability of New NCCLS Document on Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Sixth Edition

This standard (M11-A6) provides reference methods for the determination of minimal inhibitory concentrations (MICs) of anaerobic bacteria by agar dilution and broth microdilution.

Read the complete press release. To purchase this document, shop NCCLS.


NCCLS Announces Availability of New NCCLS Document on Quality Control of Microbiological Transport Systems; Approved Standard

NCCLS document M40-A provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.

Read the complete press release. To purchase this document, shop NCCLS.


NCCLS Announces Availability of New NCCLS Document on Laboratory Automation: Data Content for Specimen Identification

NCCLS document AUTO7-P, Laboratory Automation: Data Content for Specimen Identification; Proposed Standard provides specifications for the content of linear bar codes on specimen container tubes in the clinical laboratory and for use on laboratory automation systems.

Read the complete press release. To purchase this document, shop NCCLS.


NCCLS Announces Availability of New NCCLS Standards Application based on the EP21-A Guideline

NCCLS EP21-A-C, Total Error Estimator, is an Excel Add-in which provides users with a means to estimate total analytical error for an assay and can aid in judging the clinical laboratory acceptability of new methods by using patient specimens, or in monitoring an assay’s total analytical error by using quality control samples.

Read the complete press release. To purchase this product, shop NCCLS.

View the complete listing of NCCLS press releases.


Notice of Vote and Comment Deadlines for Consensus Documents: H4-A5, HS6-P, and HS10-P

NCCLS announces that the following documents are submitted for vote as candidate-for-advancement consensus documents.

The documents and ballots are posted on NCCLS Forums to delegates of Active and Associate Active member organizations. If you are a voting delegate or alternate, we request that you access NCCLS Forums to obtain the candidate-for-advancement documents. Login to access NCCLS Forums.

The deadline for the completed ballot for H4-A5 to be received in the Executive Offices is 9 March 2004.

H4-A5Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Fifth Edition
This document provides a technique for the collection of diagnostic capillary blood specimens, including recommendations for collection sites and specimen handling and identification. Specifications for disposable devices used to collect, process, and transfer diagnostic capillary blood specimens are also included.

The deadline for the completed ballots for HS6-P and HS10-P to be received in the Executive Offices is 8 April 2004.

HS6-PStudies to Evaluate Patient Outcomes; Proposed Guideline
This guideline describes the essential issues in planning outcomes research including resources needed, formulating a research question, validity and sources of error, feasibility, and ethical issues; addresses the design and implementation of a patient outcomes research plan including study design, study subjects, measurements, interventions, and analysis; summarizes recommendations for reporting patient outcomes research; and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.

HS10-PApplication of a Quality System for Inpatient Medication Use; Proposed Guideline
This document provides a model for providers of pharmacy services that will assist with implementation and maintenance of an effective quality system.

-Second Notice-

The deadline for the completed ballots for GP17-A2 and GP21-A2 to be received in the Executive Offices is 26 January 2004.

GP17-A2Clinical Laboratory Safety; Approved Guideline—Second Edition
This document contains general recommendations for implementing a high-quality laboratory safety program, which are provided in a framework that is adaptable within any laboratory.

GP21-A2Training and Competence Assessment; Approved Guideline—Second Edition
This document provides background information and recommended processes for the development of training and competence assessment programs that meet quality/regulatory objectives.

The deadline for the completed ballots for AUTO7-P and I/LA24-P to be received in the Executive Offices is 24 February 2004.

AUTO7-PLaboratory Automation: Data Content for Specimen Identification; Proposed Standard
This document provides specifications for the content of linear bar codes on specimen container tubes in the clinical laboratory and for use on laboratory automation systems.

I/LA24-PFluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Proposed Guideline
This guideline describes the basic principles, the reference materials, and the laboratory procedures upon which quantitative fluorescence calibration is based. 


Under our Administrative Procedures, an NCCLS document approved by the area committee at the first level of the consensus process is submitted to the NCCLS delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.

As a delegate, your vote is to affirm (or reject) the document for advancement as an NCCLS document. Please send your completed ballot to the Executive Offices by the above deadline.

In the NCCLS consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement. For more information on Active and Associate Active membership, click here.


Recently Approved Documents: H1-A5, H21-A4, M40-A and MM7-A

NCCLS is pleased to announce that the following documents have been approved by the Board of Directors for publication.  See the text following this list for information on options for member and nonmember organizations to obtain copies.

H1-A5 — Tubes and Additives for Venous Blood Specimen Collection; Approved Standard—Fifth Edition
This document contains requirements for venous blood collection tubes and additives, including technical descriptions of ethylenediaminetetraacetic acid (EDTA), sodium citrate, and heparin compounds used in blood collection devices.

H21-A4 — Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fourth Edition
This document provides procedures for collecting, transporting, and storing blood; processing blood specimens; storage of plasma for coagulation testing; and general recommendations for performing the tests.

M40-A — Quality Control of Microbiological Transport Systems; Approved Standard
This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.

MM7-AFluorescence In Situ Hybridization (FISH) Methods for Medical Genetics; Approved Guideline
This document addresses FISH methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification.  Recommendations for probe and assay development, manufacture, qualification, verification, and validation; instrument requirements; quality assurance; and evaluation of results are also included.

-Second Notice-

H3-A5Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Fifth Edition
This document provides procedures for the collection of diagnostic specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children.

M11-A6Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Sixth Edition
This standard provides reference methods for the determination of minimal inhibitory concentrations (MICs) of anaerobic bacteria by agar dilution and broth microdilution.

M100-S14Performance Standards for Antimicrobial Susceptibility Testing; Fourteenth Informational Supplement
This document provides updated tables for the NCCLS antimicrobial susceptibility testing standards M2-A8 and M7-A6.


The NCCLS procedures have been designed to assure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community which participates in the consensus process by carefully reviewing and commenting on the standard or guideline.

The listed approved consensus documents are available for purchase. You may automatically receive or select approved-level documents as a member benefit. For information on joining NCCLS, and viewing membership options and benefits, click here.

 


Recently Published ISO Standards: ISO 3826-1 and ISO 15747

ISO 3826-1 Plastic collapsible containers for human blood and blood components – Part 1: Conventional containers (2003)

ISO 15747 Plastics containers for intravenous injection (2003)

-Second Notice-

ISO 15190 Medical laboratories – Requirements for safety (2003)

To purchase these recently published ISO documents, shop NCCLS.


Notice of Document No Longer Under Review: GP14-A

By action of the Chairholders Council and Board of Directors, the following NCCLS document is no longer being reviewed in the NCCLS consensus process. However, because of its usefulness to a limited segment of the patient-testing community, NCCLS is continuing to make the document available for its informational content.

-Second Notice-

GP14-ALabeling of Home-Use In Vitro Testing Products; Approved Guideline


Notice of Cancelled Documents: EP11-P, EP20-P, I/LA13-A and NRSCL8-A

By action of the Chairholders Council and Board of Directors, the following projects have been cancelled and NCCLS has discontinued distribution of the related documents.

-Second Notice-

EP11-PUniform of Claims for In Vitro Diagnostic Tests; Proposed Guideline

EP20-PQuality Goals for Performance Threshold Criteria for Outliers; Proposed Guideline

I/LA13-AHuman Immunodeficiency Virus Type 1, Reference Material Specifications; Approved Guideline

NRSCL8-ATerminology and Definitions for Use in NCCLS Documents; Approved Standard


New Projects Authorized

NCCLS announces the authorization of four new projects by the Chairholders Council and approved by the Executive Committee.

-Second Notice-

The newly authorized projects are:

  • Diagnostic Microbiology for Limited-Resource Laboratories
  • Laboratory Diagnosis of Mycobacterial Infections
  • Mass Spectrometry in the Clinical Laboratory: Implementation, Operation, and Quality Assurance
  • Principles and Procedures for Blood Cultures


Meeting Calendar

January 2004

8-9 January 2004 
SC on Veterinary AST Meeting

10 January 2004
SC on Antifungal Susceptibility Tests

11-13 January 2004
SC on Antimicrobial Susceptibility Testing

11 January 2004
WG on Fastidious Organisms

21 January 2004
SC on Quality Assessment of Molecular Methods, Conference Call

29-30 January 2004
SC on Principles and Procedures for Blood Cultures  

Click here to register for these meetings, and to view the complete calendar of meetings.


Upcoming Events and Exhibits

January 2004

What’s New in the 2004 NCCLS Standards for Antimicrobial Susceptibility Testing?Teleconference
21 January 2004, 12:30 – 2:00 PM (EST) or 22 January 2004, 3:00 – 4:30 PM (EST)

Click here to download the program brochure for this teleconference, and to check out the full list of upcoming events, exhibits, and training.


Join Us

Membership is the most effective way for your organization to participate in the standards-development process and to influence the consensus process. By having an active voice, participants can work to ensure that goals of the standards and guidelines directly affecting them are practical and achievable.  

To find out more information about NCCLS membership options and benefits, and to download a membership brochure and application, click here.


Sustaining Members

NCCLS acknowledges those partnering organizations that have made a special financial commitment above and beyond their membership dues.

Gold Level

  • Ortho-Clinical Diagnostics, Inc.

Silver Level

  • Abbott Laboratories
  • American Association for Clinical Chemistry
  • Bayer Corporation
  • BD
  • Beckman Coulter, Inc.
  • bioMérieux, Inc.
  • CLMA
  • College of American Pathologists
  • GlaxoSmithKline 
  • Pfizer Inc
  • Roche Diagnostics, Inc.

View NCCLS's complete membership list.


For more information or to contact us directly, please visit nccls.org | © NCCLS, 2003 – All rights reserved