NCCLS eNews - 7 June 2004 (Print All Articles)Back to Graphical Version | Search back issues Gary L. Myers, Ph.D., FACB Presents NCCLS Harmonized Terminology Database Session at CSE
Gary L. Myers, Ph.D., FACB, Chairholder, NCCLS Global Programs Committee, Board of Directors, presented a session, International Standards: Research Guidelines and Harmonized Terminology, 16 May 2004 at the Council of Science Editors (CSE)Conference in Vancouver, BC. The in-depth conference for hundreds of editors, representing international biomedical and scientific journals, government, universities, healthcare institutions, medical and scientific societies, and research centers featured presentations and educational sessions by influential leaders in the scientific and healthcare publications community. The program, themed "Access Now and Into the Future," examined the various means of access to the scientific literature, databases, standards, and resources, and ways in which these issues are evolving for the future. During the NCCLS educational session, over 30 attendees learned about NCCLS’s Harmonized Terminology Database, a relational database that provides guidance on global terms for the clinical laboratory. The discussion highlighted the important role the scientific editorial community plays in the use of global terminology. This session outlined how harmonized healthcare standards are critical to the global economy; provided examples of international terms and definitions included in the database; explained NCCLS’s current harmonization efforts; emphasized the importance of harmonized terms; and described how to access and use NCCLS’s database. One participant congratulated NCCLS for its efforts, and said, “As a journal editor trying to communicate best practices as clearly as possible, the ability to find the terminology all in one place is a distinct advantage.” In addition to the sessions, attendees explored the CSE exhibit floor, 15 May – 17 May, where they could network and test-drive products, solutions, and resources discussed in the conference program. The development of harmonized healthcare standards is a key organizational goal for NCCLS. By reaching out to scientific authors, and editors of professional journals about the public on-line terminology resource, NCCLS strengthens its commitment to educate the healthcare community on the use of harmonized terms to improve consistency of language for global uniformity. For more information about NCCLS’s Harmonized Terminology Database, visit http://www.nccls.org or call the NCCLS Executive Offices +610.688.0100 (127). NCCLS Mails Ballots for Delegate Vote on Organizational Name Change
On 20 May 2004, NCCLS mailed ballots to Active-Member delegates to vote on amending the Articles of Incorporation to implement an NCCLS organizational name change effective January 2005. Over the past two years, NCCLS has conducted extensive branding research and came to the decision that a name change is necessary. In the most recent efforts to determine a name that most effectively reflects our global organization’s brand, represents the diversity of our members, and reflects the scope of the products and services we provide, NCCLS has reviewed comments from members and volunteers, conducted focus groups, provided educational sessions, and invited name options. At the 2004 NCCLS Annual Leadership Conference in March, the Board of Directors voted in favor of an organizational name change to Clinical and Laboratory Standards Institute, and is confident that the chosen name is the best reflection of our organization’s mission and goals today and into the future. If approved, the new name will be formally adopted in January 2005. In anticipation of the change, NCCLS is currently developing an extensive plan to facilitate a smooth transition to the new name. As a top priority to emphasize the brand connection to NCCLS’s world renowned status, the logo will be retained, and a transitional statement, providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards, will be used in communications and documents for several years. The Board of Directors believes that this progressive step will bring new, exciting growth and future opportunities for the organization, and for its committed members and volunteers. Watch for future articles and updates about the NCCLS organizational name change. Press Releases
NCCLS Announces Availability of New NCCLS Document: NCCLS Announces Availability of New NCCLS Document Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline Assessing the quality of immunoassay systems is challenging but essential for improving the quality and performance of Immunoassays. To aid in meeting this challenge, the newly published NCCLS document, I/LA23-A, is a valuable resource for manufacturers of assay reagents and kits, regulatory and accrediting bodies, and scientists and healthcare professionals that develop and apply immunoassays for a variety of analytical purposes. The range of applications for immunoassays is extensive. The degree of variations in configurations is large and may involve a hierarchy of antibodies used with different specificities for capture, separation, measurement, and dose amplifications. Several commonly used dose-response indicator categories, (e.g., radioisotopes, enzymes, fluorescence, luminescence, reagents, and experimental components criteria) are commonly used to characterize an immunoassay. Read the complete press release.
NCCLS Presidential Briefing at AACC (Monday, 26 July, 10:30-12:00) Including a Case Study in Evaluation Protocols NCCLS will present a “special session” on Monday, 26 July from 10:30 a.m.-12 noon at the AACC 2004 Annual Meeting in Los Angeles, CA. At the session, attendees will learn about NCCLS and its global role in developing consensus standards, guidelines, and best practices. Read the complete press release. View the complete listing of NCCLS press releases. Notice of Vote and Comment Deadline for Consensus Documents(GP22-A2) CQI; (GP26-A3) Quality System for Laboratory Services; (HS1-A2) Quality System for Health Care; (LIS2-A2) Transferring Information Between Clinical Instruments and Computer Systems; and (MM9-P) Nucleic Acid Sequencing 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 ballots for GP22-A2, GP26-A3, HS1-A2, and LIS2-A2 to be received in the Executive Offices is 6 August 2004. GP22-A2 — Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline—Second Edition GP26-A3 — Application of a Quality Management System Model for Laboratory Services; Approved Guideline HS1-A2 — A Quality Management System Model for Health Care; Approved Guideline—Second Edition LIS2-A2 — Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition The deadline for the completed ballot for MM9-P to be received in the Executive Offices is 7 September 2004. MM9-P — Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Proposed Guideline -Second Notice- The deadline for the completed ballot for H18-A3 to be received in the Executive Offices is 6 July 2004. H18-A3 — Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition 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(I/LA23-A) Immunoassay Systems; (M31-S1) Veterinary Antimicrobial Susceptibility Testing Supplement 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. I/LA23-A — Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline M31-S1 — Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Informational Supplement -Second Notice- M44-A — Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline The NCCLS procedures have been designed to ensure 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 Distributed Draft ISO Standard(ISO/ PDTR 18112) In Vitro Diagnostic Medical Devices for Professional Use -Second Notice- (ISO/ PDTR 18112) ISO Technical Report: In Vitro Diagnostic Medical Devices for Professional Use – Summary of Regulatory Requirements for Information Supplied by the Manufacturer To purchase these recently distributed ISO documents, shop NCCLS. Notice of Category B Documents(DI2-A2) Immunoprecipitin Analyses; (DI3-A) Agglutination Analyses; and (LA1-A2) Radioimmunoassay Systems By action of the Chairholders Council and Board of Directors, the following NCCLS documents are no longer being reviewed in the NCCLS consensus process. However, because of the documents’ usefulness to a limited segment of the patient-testing community, NCCLS is continuing to make the documents available for informational content. DI2-A2 — Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline DI3-A — Agglutination Analyses: Antibody Characteristics, Methodology, Limitations, and Clinical Validation; Approved Guideline LA1-A2 — Assessing the Quality of Radioimmunoassay Systems—Second Edition; Approved Guideline Meeting Calendar
11-12 June 2004 13-15 June 2004 21-22 June 2004 Check out the complete calendar of meetings. Upcoming Events and Exhibits
2004 AVMA Annual Convention AACC 2004 Annual Meeting Monday, 26 July 2004 • 10:30 a.m. – 12 noon Plan to attend, NCCLS-Consensus Standards for Medical Testing - An Invitation to Participate, providing an opportunity to learn about NCCLS and its global role in developing consensus standards and guidelines. As an example of a consensus document in development, it will focus on Protocols for Determination of Limits of Detection and Limits of Quantitation; Proposed Guideline (EP17-P) and describe specifics on how this guideline can be used by clinical laboratories and manufacturers of in vitro diagnostic tests to determine limits of detection and limits of quantitation. Presented by: Thomas L. Hearn, Ph.D., President, NCCLS; and Daniel W. Tholen, M.S., Chairholder, NCCLS Subcommittee on Limits of Detection AACC/ASCLS Clinical Lab Exposition Visit NCCLS booth #1972 in the Clin Lab Expo to see a hands-on demonstration of new electronic product, Total Error Estimator (based on Estimation of Total Analytical Error for Clinical Laboratory Methods, EP21). 2004 ASCLS Annual Meeting View 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. 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
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