NCCLS eNews - 4 February 2004 (Print All Articles)

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NCCLS: Working to Achieve Globalization in Health Care

A global economy is developing at a rapid pace due to expanding access to communication, technology, and transportation. Goods and services are being sold globally, and information is easily exchanged. Global healthcare systems are critical to the global economy, and harmonized healthcare standards are critical to global health care.

For more than 36 years, NCCLS has developed its global presence in the healthcare community. NCCLS membership is open to any organization regardless of geographic location.  Of more than 2000 member organizations, 23% are from outside the United States.  NCCLS promotes mutually beneficial national and international organizational partnerships for standards development and use. NCCLS's effective consensus process is increasingly global. Today, for example, of all standards-developing committees, 50% have representation from outside the United States. In addition, NCCLS documents are purchased and/or used in over 85 countries from around the globe.

In its latest effort to increase access to NCCLS standards and guidelines around the world, NCCLS has formed a Task Group on Resource-Limited Laboratories. The task group has taken the first steps to reach its defined goals which include: simplifying relevant NCCLS documents; developing basic work instruction documents; developing educational programs to accompany the documents; and partnering with organizations and donor agencies.

In addition to its global presence, NCCLS has led the way in championing the cause of global harmonization in medical testing and healthcare standards. The importance of voluntary consensus documents is ever increasing. By developing globally recognized documents, NCCLS addresses the need to reduce regional and national variations in regulatory requirements; promote uniformity of testing practices; reduce trade barriers; facilitate technology transfer; and ultimately, reduce costs. Along with developing globally applicable standards for health care, NCCLS serves as the Secretariat for the International Organization for Standardization Technical Committee 212 (ISO/TC 212). In this role, NCCLS is responsible for harmonizing ISO concepts within healthcare services at the international level. As a service to its members and volunteers, NCCLS is committed to a long-term policy of developing harmonized global consensus standards that define best laboratory practices and quality patient care.

In an effort to reach out to the healthcare community, NCCLS has taken measurable steps towards harmonization by developing educational resources and implementing programs for its volunteers.

The NCCLS Harmonized Terminology Database, developed by the NCCLS Executive Offices’ staff, is a relational database that provides guidance on global terms for the clinical laboratory to NCCLS volunteers. NCCLS is also reaching out to scientific authors and editors of professional journals. In NCCLS’s most recent efforts to promote the understanding and use of the NCCLS Harmonized Terminology Database, the Executive Offices’ staff has secured a place on the conference program at the Council of Science Editors, Sunday, 16 May 2004 in Vancouver, BC. The conference session, presented by Gary L. Myers, PhD, FACB, Centers for Disease Control and Prevention, will explain the harmonization process and promote the use of the NCCLS Harmonized Terminology Database.

It has been a high priority that through the document development process, the language is harmonized. Each subcommittee responsible for an NCCLS project designates a representative to identify harmonization issues during document development.  In addition, a formal harmonization task group comprised of a member from the appropriate area committee, staff, and other interested volunteers review all documents for harmonization issues. “We've made a lot of progress with our existing and new documents.” says Patrice E. Polgar, Assistant Standards Administrator, NCCLS. She adds, “The [NCCLS Harmonized Terminology] database has helped our volunteers understand the importance of harmonization and to identify and address terminology issues.”  

NCCLS is committed to a long-term policy to harmonize its documents, and this policy has become one of its overriding organizational goals. This initiative does not come without challenges, however, which include overcoming differences in regional usage of terms, metrological conventions, and professional practices. NCCLS acknowledges that implementation of this policy will take time as the healthcare community recognizes and understands differences in nomenclature while it takes the necessary steps to achieve worldwide harmonization.

For more information about NCCLS's harmonization program, visit http://www.nccls.org or call the NCCLS Executive Offices +610.688.0100. For more information about the Council of Science Editors conference program, visit http://www.councilscienceeditors.org

 


Press Releases

(GP28-P) Microwave Device Use; (M33-A) Antiviral Susceptibility Testing; and (MM7-A) FISH Methods for Medical Genetics

NCCLS Announces Availability of New NCCLS Document on Microwave Device Use in the Clinical Laboratory; Proposed Guideline

NCCLS document GP28-P — Microwave Device Use in the Clinical Laboratory; Proposed Guideline, provides recommendations for quality assurance and safety procedures for microwave equipment use, and provides a means to understand and troubleshoot conditions that contribute to variability in microwave-accelerated procedures in human clinical, veterinary, and research histopathology laboratories.

Read the complete press release.


NCCLS Announces Availability of New NCCLS Document on Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard

NCCLS document M33-A — Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard, provides a protocol for the performance of the plaque reduction assay for phenotypic antiviral susceptibility testing of herpes simplex virus. 

Read the complete press release.


NCCLS Announces Availability of New NCCLS Document on Fluorescence In Situ Hybridization (FISH) Methods for Medical Genetics; Approved Guideline

NCCLS document MM7-A — Fluorescence In Situ Hybridization (FISH), Methods for Medical Genetics; Approved Guideline, may be used to detect cytogenetic aberrations that are not readily evident by standard cytogenetic banding analyses. 

Read the complete press release.

View the complete listing of NCCLS press releases.


Notice of Vote and Comment Deadline for Consensus Document

(GP28-P) Microwave Device Use

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 GP28-P to be received in the Executive Offices is 4 May 2004.

GP28-PMicrowave Device Use in the Clinical Laboratory; Proposed Guideline
This document provides recommendations for reproducible performance of microwave-accelerated procedures for preparation of biological specimens in the clinical histopathology laboratory.

-Second Notice-

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.


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

(H44-A2) Reticulocyte Counting by Flow Cytometry; (M33-A) Antiviral Susceptibility Testing; and (M36-A) Toxoplasma gondii

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.

H44-A2Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline–Second Edition
This document provides guidance for the performance of reticulocyte counting by flow cytometry.  It includes methods for determining the trueness and precision of the reticu-locyte flow cytometry instrument and a recommended reference procedure.
 
M33-AAntiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard
This document provides a protocol for the performance of the plaque reduction assay for phenotypic antiviral susceptibility testing of herpes simplex virus.
 
M36-AClinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline
This document is intended to serve as a guide to aid in the interpretation of tests for the diagnosis of Toxoplasma infection.

-Second Notice-

H1-A5Tubes 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-A4Collection, 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-AQuality 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.


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, Plastic containers for human blood and ISO 15747, Plastics containers for intravenous injection

-Second Notice-

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)

To purchase these recently published ISO documents, shop NCCLS.


Seeking Input and Volunteer Participation on New Project Committee – Call for Nominations

Use of External RNA Controls for the Quality of Gene Expression Measurements with Microarrays and by Real-Time PCR (RT-PCR)

NCCLS is seeking subcommittee membership for the proposed project, Use of External RNA Controls for the Quality of Gene Expression Measurements with Microarrays and by Real-Time PCR (RT-PCR), which is undergoing a progressive review process to assess the need and market potential for consensus document development.

NCCLS volunteers, experts in the medical-testing community, share and enhance their technical expertise and work together to develop reliable and practical consensus standards and guidelines to improve the efficiency and effectiveness of clinical laboratory practices and medical testing.

Join NCCLS volunteers! For more information on volunteer participation, to see the objective of the proposed project and the requested volunteer expertise for members of the new subcommittee, and to submit a nomination, click here.


Meeting Calendar - February

6 February 2004
W/G on Handling of Blood Specimens – Conference Call

11 February 2004
S/C on Maternal Serum Screening – Conference Call

17 February 2004
A/C Immunology and Ligand Assay – Conference Call

20 February 2004
W/G on Reagent Water – Conference Call

27 February 2004
S/C on Nucleic Acid Sequencing – Conference Call

Check out the complete calendar of meetings.


Upcoming Events and Exhibits

Register now for the 2004 NCCLS Leadership Conference!
18-20 March 2004
Loews L’Enfant Plaza Hotel, Washington, D.C., U.S.A.

For a full list of upcoming events, exhibits, and training, click here.


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.

Maximize your participation in the NCCLS voluntary consensus process. You have the opportunity to influence project development. Members are encouraged to participate as volunteers on project committees. Find out more information about volunteer participation.


New and Sustaining Members

New Members

Active
 
Cepheid, USA

Associate Active
 
Laboratorio Manlab, Argentina


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