NCCLS eNews - 7 July 2004 (Print All Articles)Back to Graphical Version | Search back issues Tenth Meeting of ISO/TC 212 in Utrecht was a Success
The tenth meeting of The International Organization for Standardization Technical Committee (ISO/TC) 212, Clinical laboratory testing and in vitro diagnostic test systems, was held 7-9 June in Utrecht, The Netherlands. The meeting was hosted by NEN (Nederlands Normalisatie-Instituut) and RIVM (Dutch National Institute for Public Health and the Environment), with supporting funds from Digene Corp, USA; Roche Diagnostics, Germany; Bio-Rad Laboratories France; CCKL, Dutch Foundation for accreditation of medical laboratories; Sysmex Corp., Japan; PerkinElmer/Wallac Finland; Becton Dickinson, Belgium; Biomerieux France; and Medtronic, USA. ISO/TC 212 was established in 1995, based on a proposal by NCCLS. ISO granted the Secretariat to the American National Standards Institute (ANSI), who in turn delegated the Secretariat responsibility to NCCLS. As manager of ISO’s standards-development process in this field, NCCLS’s role is a global one carried out on behalf of the patient-testing community throughout the world. Currently, the membership of ISO/TC 212 is comprised of 33 participating member countries and 15 observer countries. As part of the organizational structure, ISO/TC 212 project development responsibilities are assigned to four working groups: Working Group 1, Quality management in the clinical laboratory; Working Group 2, Reference systems; Working Group 3, In vitro diagnostic products; and Working Group 4, Antimicrobial Susceptibility Testing. The ISO/TC 212 meetings in Utrecht were very productive and addressed major items including: the review of work, target dates and working group structure, future work items, and harmonization of definitions. Along with the Technical Committee, Working Group 1 (WG1) and Working Group 3 (WG3) also met in Utrecht. ISO/TC 212 manages the development of its family of standards according to ISO’s established time line. Accordingly, at the meetings in Utrecht, the Committee reviewed the current documents being developed by all working groups. WG1 and WG3 presented reports directly and met over a two-day period to continue their work; written reports were received from the other working groups. WG1 recommended a title change, revised scope, and CD vote for a new proposal on risk management. Approved in May 2004, the proposal is being developed as a Technical Report, Medical laboratories – Reduction of error through risk management and continual improvement. ISO/TC 212 agreed with the recommendation and approved advancement of the document. In addition, the document, known as ISO/TR 22869, was approved for distribution and vote. At the meeting of the ISO/TC 212/WG1 in Atlanta on 15 December 2003, Keith Shinton, ISO/TC212/WG1 Convener, announced his intention to resign at the close of the plenary meeting on 9 June 2004. In Utrecht, ISO/TC 212 unanimously approved the appointment of Des Kenny (Ireland) as the new convener. At the meeting of ISO/TC 212/WG3, significant progress was made in the development of a new work item, ISO 18112: Clinical laboratory testing and in vitro diagnostic test systems – In vitro diagnostic medical devices – Information supplied by the manufacturer. ISO/TC 212 approved the development of ISO 18112 in five parts which include: Part 1- General requirements; Part 2- Reagents for professional use; Part 3 – Instruments for professional use; Part 4 – Reagents for self-testing; and Part 5 – Instruments for self-testing. In addition, ISO/TC 212 approved ISO 17953, Clinical laboratory testing and in vitro diagnostic test systems — Requirements for in vitro monitoring systems for self-testing of oral anticoagulation therapy, for distribution and vote as a DIS with the inclusion of an informational annex. ISO/TC 210/JWG1 and ISO/TC 212/WG3 held a meeting to address comments and complete ISO/CD 14971, Annex H – Guidance on risk analysis for in vitro diagnostic medical devices. The working groups have worked diligently to meet established timelines. Once approved, the annex will become part of ISO 14971, and further revision will be the responsibility of TC 210/JWG1, with participation and concurrence by representatives of TC 212/WG3. U.S.A. to Host 2005 Meeting ISO/TC 212 accepted the formal invitation extended by the U.S.A. to hold its next meeting in the Washington, D.C. area in May 2005. The meeting will be co-sponsored by NIST and AdvaMed. The Technical Committee also accepted the invitation of Germany to hold its subsequent meeting in Berlin in 2006. Press Releases
NCCLS Announces Availability of New NCCLS Document on Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition NCCLS standard M22-A3 is a revision of the approved standard, M22-A2, published in December 1996. The media included in M22-A3 are from three surveys conducted by the College of American Pathologists. Read the complete press release. NCCLS Announces Availability of a New Informational Supplement on Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals NCCLS document M31-S1 provides updated tables for the NCCLS antimicrobial susceptibility testing standard M31-A2, Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard-Second Edition. Read the complete press release. NCCLS Announces Availability of New NCCLS Guideline on Antifungal Disk Diffusion Susceptibility Testing of Yeasts The method described in this document, M44-A, is intended for testing Candida species. Read the complete press release. NCCLS Announces Availability of New NCCLS Guideline on Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine This guideline, MM9-P, will provide recommendations for all aspects of the sequencing process including specimen collection and handling, isolation of nucleic acid, amplification and sequencing of nucleic acids, and general interpretation and reporting of genotyping results. Read the complete press release. View the complete listing of NCCLS press releases. Notice of Vote and Comment Deadlines 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. -Second Notice- 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 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 DocumentsContent of Data for Specimen ID (AUTO7-A); Capillary Blood Specimens (H4-A5); and Media QC (M22-A3) 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. AUTO7-A — Laboratory Automation: Data Content for Specimen Identification; Approved Standard H4-A5 — Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Fifth Edition M22-A3 — Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition -Second Notice- 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 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. 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. -Second Notice- 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
26 July 2004 AC on Clinical Chemistry & Toxicology SC on Limits of Detection US TAG for ISO/TC 212 27 July 2004 AC on Evaluation Protocols 28 July 2004 AC on Automation & Informatics AC on Point-of-Care Testing Check out the complete calendar of meetings. Upcoming Events and Exhibits
2004 AVMA Annual Convention AACC 2004 Annual Meeting Monday, July 26, 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 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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