NCCLS eNews - 8 December 2004 (Print All Articles)Back to Graphical Version | Search back issues Executive Vice President’s Message
During recent discussions about what makes NCCLS/Clinical and Laboratory Standards Institute (CLSI) unique, it occurred to me that many of us commonly use the words “culture” and “values” interchangeably. But these words are actually quite different. The culture of NCCLS will inevitably change when we officially become CLSI, but this can be a positive thing. At his recent retirement party at NCCLS/CLSI, former Executive Vice President, Dr. John V. Bergen, discussed the impact that each of our 17 past volunteer presidents have had on our organization. I was impressed by the impact each one had in changing and evolving the culture of NCCLS/CLSI to make us who we are today. While our culture has changed, our values have remained the same, and they should never change. Values of NCCLS/CLSI, such as integrity, objectivity, and responsiveness and commitment to the consensus process, are the pillars of our past success and define who we are as an organization. If we achieve great reputational and financial success in the future, but we stray from the values that are the foundation of who we are today, we will not consider ourselves successful. During my brief tenure at NCCLS/CLSI, I’ve come to realize that our staff and volunteer leadership are fully committed to carrying on what our values promise to our stakeholders. Sincerely, NCCLS’s Name Will Change, But our Mission and Values Remain the Same
NCCLS is less than a month away from the effective date of our official organizational name change. In recent months, efforts have been coordinated to communicate the new approved name, Clinical and Laboratory Standards Institute, to all of our stakeholders. Why change the name of NCCLS and why now? About a decade ago, our organization started using the initialism “NCCLS” to reflect our brand. There is strong recognition for our organization in the healthcare community; however, brand identity studies showed that many people were confused by the “N” in our name, which used to stand for “national.” Clearly, our identity needs to better reflect our true strengths, scope of work, and global membership base, which have changed over the last 35 years. What were the evolutionary elements of this change? In 2003, an extensive brand identity study was conducted. Based on the results of this extensive market research, our organization found that a name change was imperative and that our name should more accurately represent the organization today and in the future. The Board of Directors asked for feedback on potential new names from our membership base, volunteers, and key stakeholders. From the results of this feedback, the Board presented Clinical and Laboratory Standards Institute as the organization’s new name. The delegate vote to implement our name change to Clinical and Laboratory Standards Institute, by amending the Articles of Incorporation and Bylaws, ended with approval on 19 July 2004. The announcement of delegate approval of the new name was a pivotal moment in the evolution and recognition of Clinical and Laboratory Standards Institute. It was decided that the well-recognized logo would be retained. In addition, the transitional statement, providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards, will be used in communications and documents for an extended period of time in order to retain the established name recognition of NCCLS. As part of the implementation of the new name, all business, financial, operational, and administrative changes have been expedited, integrated, and coordinated. An extensive name change marketing and communication plan is being carried out now and is a major focus for 2005. Amidst the implementation of the name change, our organization has expressed our commitment that two things will not change: 1) our commitment to our mission: to develop and distribute practical and useful consensus standards and guidelines, as well as corresponding educational programs for a variety of healthcare and medical testing services worldwide; and 2) our unwavering commitment to our values: excellence, quality, and creativity; responsiveness and timeliness; participation, openness, and multiple constituency; and fairness, balance, and objectivity. The response from testing and researching our new name has been overwhelmingly positive. More news will be made available as this process unfolds, but we are very confident about the progress we are making and the potential for future growth of our organization. Our key stakeholders and the Executive Office’s staff have enthusiastically embraced our new name, Clinical and Laboratory Standards Institute. It will soon begin appearing everywhere—it reflects our strong history as well as our opportunities for growth now and into the future. Be sure to bookmark our new website, www.clsi.org, which will launch 1 January 2005! Press Releases
James A. Thomas to Serve on NCCLS/Clinical and Laboratory Standards Institute Board of Directors Dr. Thomas L. Hearn, NCCLS President, has appointed James A. Thomas to the NCCLS/Clinical and Laboratory Standards Institute Board of Directors. Mr. Thomas was appointed to fill an unexpired term on the Board which concludes at the 2005 Clinical and Laboratory Standards Institute Leadership Conference. At that time, he will be eligible for nomination to a full three-year term on the Clinical and Laboratory Standards Institute Board of Directors. Read the complete press release.
NCCLS Announces Availability of New Guideline on Continuous Quality Improvement: Integrating Five Key Quality System Components Every clinical service needs ongoing quality improvement. The practicing of continuous quality improvement (CQI) maximizes operational efficiency, effectiveness, and adaptability. These managerial goals are especially important since: national and local governments and peer organizations continue to scrutinize the management of quality in the process of licensing and accrediting clinical services of all sizes; demands of managed health care in a constrained economy compel clinical services to handle more volume with fewer resources; and changing trends in illness, medical practice, and demographics call for clinical services to adapt and meet new customer needs. Consequently, a clinical service should focus on systematic continuous quality improvement as measured by customer satisfaction, including profitability. NCCLS document, Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline—Second Edition (GP22-A2), presents such managerial skills and outlines the importance of the synergistic combination of Quality Planning, Quality Teamwork, Quality Monitoring, Quality Improvement, and Quality Review—all functioning within the whole integrated quality system. This document presents general managerial concepts that apply to any kind of clinical service. Read the complete press release.
NCCLS Announces Availability of New Guideline on Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition “Medical error” has been ascribed to a “failure of process.” Therefore, the clinical laboratory’s best contribution to preventing any medical error for which it could be responsible is to understand the processes in its path of workflow, and improve processes where problems exist. NCCLS document, Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition (GP26-A3), introduces the clinical laboratory’s path of workflow—that is, the processes that transform a request for a clinical laboratory service (i.e., a laboratory that performs screening, diagnostic, or monitoring examinations for patient care) through obtaining and transporting the sample, performing the examination, interpreting the results, and providing the patient’s laboratory examination report. Read the complete press release.
NCCLS Announces Availability of New Guideline on Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition Has the improper handling of blood specimens ever led to an error in your lab? NCCLS has a solution to reduce your risks. This document provides guidelines to prepare an optimal serum or plasma sample to reduce systematic bias that can occur after specimen collection. Implementation of these recommended procedures will assist laboratories in the pursuit of excellent performance, with useful, accurate patient test results as the ultimate goal. NCCLS document, Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition (H18-A3), addresses handling and processing of blood specimens for analytical determinations using serum, plasma, or whole blood in the clinical laboratory. Where applicable, the recommendations should be considered by the following laboratory areas: chemistry, coagulation, hematology, immunology, ligand assay, serology, toxicology/therapeutic drug monitoring, virology, blood bank, and molecular or DNA analysis. Read the complete press release.
NCCLS Announces Availability of New Guideline on A Quality Management System Model for Health Care; Approved Guideline—Second Edition Quality is one of the most challenging issues in healthcare today. The system is ever-increasingly complex. Costs are skyrocketing. Errors are widespread. Better care and assurance of patient safety is demanded. Quality management systems, similar to those being used successfully in the world’s manufacturing and service sectors, can be applied to benefit healthcare organizations and services to improve patient safety. Uniform processes and procedures for implementing the quality policies within the organization reduce medical errors and reduce opportunities for costly discrepancies, conflicts, and competition for limited resources among the organization’s services. NCCLS has developed A Quality Management System Model for Health Care; Approved Guideline—Second Edition (HS1-A2), which provides the necessary background information and infrastructure to develop a quality management system that will meet healthcare quality objectives and be consistent with the quality objectives of each organization or service. Read the complete press release.
Clinical and Laboratory Standards Institute (CLSI), formerly NCCLS, Announces Availability of New Standard for Antimicrobial Susceptibility Testing The supplemental information presented in this document, Performance Standards for Antimicrobial susceptibility Testing; Fifteenth Informational Supplement (M100-S15), is intended for use with the antimicrobial susceptibility testing procedures published in the following Clinical and Laboratory Standards Institute (CLSI), formerly NCCLS, approved standards: Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eighth Edition,(M2-A8), and Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Sixth Edition,(M7-A6). The standards contain information about both disk (M2) and dilution (M7) test procedures for aerobic bacteria. Read the complete press release. View the complete listing of NCCLS press releases.
Read about recently approved document, Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity (I/LA 24-A), as published in the 1 November 2004 issue of Analytical Chemistry.
Daniel W. Tholen, MS, NCCLS volunteer, wrote a letter to the Archives of Pathology, regarding NCCLS document, Evaluation of Linearity in the Clinical Laboratory (EP6-A). Read the published letter, along with a reply from the authors.
Notice of Vote and Comment Deadline for Consensus Document(AST4-A2) Glucose Monitoring NCCLS announces that the following document is submitted for vote as a candidate-for-advancement consensus document. The document and ballot is 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 document. Login to access NCCLS Forums. The deadline for the completed ballot for AST4-A2 to be received in the Executive Offices is 7 February 2005. AST4-A2—Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline–Second 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 DocumentsLimits of Detection and Limits of Quantitation (EP17-A); Continuous Quality Improvement (GP22-A2); Laboratory Quality Management Systems (GP26-A3); Handling and Processing of Blood Specimens (H18-A3); Quality Management System for Health Care (HS1-A2); Maternal Serum Screening (I/LA25-A); Transfer Information Between Clinical Instruments and Computer Systems (LIS2-A2); Nucleic Acid Sequencing (MM9-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. I/LA25-A—Maternal Serum Screening; Approved Standard MM9-A—Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline -Second Notice- EP17-A—Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline 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—Third Edition H18-A3 — Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition HS1-A2—A Quality Management System Model for Health Care; Approved Guideline—Second Edition LIS2-A2—Specification for Transferring Information Between Clinical Instruments and Computer Systems: Approved Standard—Second Edition 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 Published ISO Standards
-Published ISO/TC 76 Standards- (ISO 8536-9:2004) Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-10:2004) Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment (ISO 8536-11:2004) Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment (ISO 13926-1:2004) Pen systems - Part 1: Glass cylinders for pen-injectors for medical use -Second Notice- (ISO 8536-1:2000/Amd 1:2004) Infusion equipment for medical use - Part 1: Infusion glass bottles – Amendment 1 To purchase these recently distributed ISO documents, shop NCCLS. Focus on Global Terminology
This month’s terms:
For complete details on these and other internationally accepted terms, visit our Harmonized Terminology Database. In the database, find standard, internationally preferred terms and definitions, related terms, terms that are not acceptable in the international standards community, and illustrative notes and examples. Seeking Expert Opinions and Volunteer Participation – Call for Nominations
NCCLS is seeking subcommittee membership for the following proposed project: Validate and Implement Secondary Reference Materials This guideline will provide recommendations on tests or procedures that should be performed to characterize secondary reference materials in a patient sample matrix. The document will provide implementation guidelines for established published procedures, and will describe procedures that have not already been established. The document will consist of two parts: The first part will address material characterization such as linearity, parallelism, commutability, matrix effects, and interferences. The second part will address issues related to transfer of values from a secondary reference material to an analytical measurement system. Requested Expertise: Members should have knowledge and expertise in the characterization of blood- and/or urine-based secondary reference materials and/or matrix-based calibrators. Further, knowledge and experience in producing these materials and using them to calibrate clinical testing systems or to assign values to in-house calibrators is needed. This proposed project is undergoing a progressive review process to assess the need and market potential for consensus document development. Review the objective of the proposed project and the requested volunteer expertise, and: Submit a nomination: Give us your expert opinion on the value of the project: Meeting Calendar
6-7 January 2005 8 January 2005 9- 11 January 2005 18-19 January 2005 Check out the complete calendar of meetings. Upcoming Events and Exhibits
What’s New in the 2005 Standards for Antimicrobial Susceptibility Testing? HIMSS 2005 Clinical and Laboratory Standards Institute Leadership Conference Equivalent Quality Control Workshop: QC for the Future 2005 Institute for Quality in Laboratory Medicine Conference 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
New Members Active Associate Active Barnes-Jewish St. Peters, USA Sustaining Members NCCLS acknowledges those partnering organizations that have made a special financial commitment above and beyond their membership dues. Gold Level
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