CLSI eNews - 1 August 2007 (Print All Articles)Back to Graphical Version | Search back issues Executive Vice President's MessageStaying True to Our Mission… CLSI was founded on a tax exempt charitable charter. While our mission statement has been fine tuned throughout our 40-year history, it has not fundamentally changed. We have remained steadfast in our commitment to advancing quality in healthcare testing. In our mission, we promise: “To develop best practices in clinical and laboratory testing and promote their use throughout the world, using a consensus-driven process that balances the viewpoints of industry, government, and the healthcare professions.” How we go about fulfilling our mission will continue to evolve. We will always seek opportunities to refine our voluntary consensus process and expand the breadth and depth of our standards, guidelines, and other products. We will look for new partnerships and ways to expand our global reach. We will introduce new technologies to remove barriers for volunteers, enabling them to focus on standards development. We will make these changes and others, but our focus on fulfilling our mission will not waver. CLSI enjoys a strong reputation based on our standards and guidelines. In fact, our reputation is CLSI’s most important asset. It’s what attracts talented staff and volunteers. It’s why world class leaders in their fields commit time, which we recognize is a precious commodity, to volunteer their services. It speaks volumes that the founders of CLSI (then NCCLS) had the foresight to create a mission that continues to endure the test of time through myriad scientific and technological changes. Your support for that mission is always appreciated and your comments always welcome. Glen CLSI President-Elect to Meet With JCCLS in TokyoHoeltge to give presentation on the value of standards, meet with Japanese government representatives From 23 – 26 August 2007, Clinical and Laboratory Standards Institute President-Elect Gerald Hoeltge, MD, will be in Tokyo for the Japanese Committee for Clinical Laboratory Standards (JCCLS) Summer Seminar. At the scientific session, Hoeltge will speak on The Importance of Laboratory Standards to a Culture of Safety. Using CLSI’s portfolio product The Key to Quality as the example, the presentation will show how standards and guidelines contribute directly to patient care. While in Tokyo, Hoeltge will also meet with representatives of the Japanese government on the subject of clinical laboratory standards. Formed in 1985, JCCLS is a Japanese standards-development organization based upon the model of CLSI—with representation from the three sectors, industry, government, and the healthcare professions. On the formation of the now 22-year-old organization, Hoeltge says, “They liked our model, and respected the quality of our documents and the integrity and talent of the volunteers who put them together.” Over the past two decades, JCCLS membership has grown to over 100 member organizations. A total of 12 area committees have been organized and have developed or certified more than 30 documents. Hoeltge says the organizations share an ongoing tradition of attending one another’s annual meetings. In 2007, JCCLS Vice President Naotaka Hamasaki, MD, PhD, became a member of the CLSI Board of Directors and attended the CLSI Leadership Conference in Baltimore, Maryland, USA. Dr. Hoeltge has practiced clinical pathology for 30 years at the Cleveland Clinic. His professional interests center on health-system quality, transfusion medicine, and cytogenetics. CLSI's The Key to QualityThe Fundamentals for Implementing a Quality Management System in the Clinical Laboratory Indicators show that quality is high on health care organizations’ priority lists for 2007 and beyond. Strategies to operate with well-defined, documented policies, processes, and procedures have risen to the top of the clinical-laboratory agenda. With recent emphasis on education and communication in the regulatory and accreditation process, laboratories are challenged to boost their efforts to meet requirements and provide the highest level of patient care. Since numerous challenges remain, many health care organizations are still trying to create the right quality-management-systems strategy, and are striving to get organizational commitment, communication, and alignment. After years of experience with the quality-management systems approach, the Clinical and Laboratory Standards Institute (CLSI) released a proven model, The Key to Quality, designed to assist clinical laboratories with creating, implementing, and refining a quality-management system. A recent CLSI market-research evaluation survey included a prototype for review and comment by laboratory professionals. Results from the survey on its practical application show that laboratory professionals believe The Key to Quality would be useful and would ease many of the difficulties in guiding management and staff in implementing a quality-management system in the laboratory. Read the full article as originally published in LABMEDICINE, June 2007. Lois Schmidt, DA Appointed CLSI’s Vice President of StandardsWe are pleased to announce that Lois Schmidt, DA, has been appointed CLSI’s Vice President of Standards. Dr. Schmidt has been with CLSI for almost six years, most recently serving as the Director of Standards and Development. She has been the staff liaison to the Area Committees on Evaluation Protocols; Molecular Methods; Immunology and Ligand Assay; Automation and Informatics; and Microbiology, as well as Secretary for the US Technical Advisory Group to ISO/TC 212. Dr. Schmidt has a strong history of success in the clinical laboratory in technical and administrative capacities; education—principally as the director of undergraduate and graduate Medical Technology Programs at the Catholic University of America in Washington, DC; and sales and marketing with E.I. DuPont (Diagnostic and Bioresearch Products), Gen-Probe, Oncor, Gen Trak, and Vysis companies. Dr. Schmidt holds BS and MS degrees; MT(ASCP) certification; and a Doctor of Arts degree from the Catholic University of America, majoring in Physiological Chemistry with a minor concentration in Education. “Lois’s excellent experience and her commitment to CLSI provide a strong background for her senior staff leadership role in shaping CLSI’s growth and achieving our short- and long-range goals,” said Glen Fine, Executive Vice President at CLSI. Dr. Schmidt will be responsible for the creation, delivery, and oversight of the consensus standards and guidelines development process, as well as the management of the standards staff. She will also direct all key aspects of volunteer relations, including the recruitment and retention of volunteers. James Nichols, PhD, DABCC, FACB To Serve as CLSI’s Editorial Review Board Representative for Lab Tests OnlineJames Nichols, PhD, DABCC, FACB, will be the new Clinical and Laboratory Standards Institute representative to participate on the Editorial Review Board of the Lab Tests Online® website at http://www.labtestsonline.org/. This website is the product of a unique collaboration among professional societies representing the clinical laboratory community. Organized by the American Association for Clinical Chemistry (AACC), each participant in this collaboration has supported the development of content on the site through countless voluntary hours writing, editing, and reviewing the material. AACC produced the site as part of its ongoing commitment to educating the public about laboratory testing. CLSI is a collaborating partner with Lab Tests Online. We are dedicated to service in the area of healthcare testing and related healthcare services, and value this opportunity to support the much-needed effort for consumer education in the area of medical laboratory testing. “Jim is a talented CLSI volunteer and we are proud that he is our representative at Lab Tests Online,” said Glen Fine, Executive Vice President at CLSI. Lab Tests Online has been designed to help patients and family caregivers better understand the many clinical laboratory tests that are part of routine care, as well as diagnosis and treatment of a broad range of conditions and diseases. It is also a quick reference tool and resource for medical professionals to keep up with advances in laboratory science. Lab Tests Online helps users learn about their tests and discuss them more clearly with their doctors.
Honoring the Life and Accomplishments of Richard R. Miller, Jr.
Richard R. Miller Jr.'s two daughters, Patricia and Katrina, accept an award on his behalf from the Industry Division of AACC at the 2007 Annual Meeting & Clinical Lab Expo in San Diego, California. It is with sadness and respect that we honor the life and accomplishments of Richard R. Miller, Jr. Rick passed away on 7 July 2007 at age 63, and his loss will be felt by everyone in the clinical laboratory community. We all extend our deepest sympathy to his wife, Debra, and their three children, Christopher, Patricia, and Katrina. Rick received a BS degree in Physiological Chemistry from the Ohio State University in 1966. He began his career as a clinical chemist in a four-hospital complex. He then moved to the in vitro diagnostics (IVD) industry where he held several positions with Technicon (transitioning to Revlon and then Bayer), including Manager of Quality Systems, Manager for the Evaluation and Reference Laboratory, Principle Scientist for Calibration Systems, Manufacturing Manager, and Manager of Customer Complaints Investigation. He ended his career with Dade Behring where he was Quality Manager for the Stratus Product Line and Staff Scientist responsible for Metrology and Calibration Traceability in Production Systems. Rick was an outstanding contributor to laboratory medicine and served the profession in many capacities over his career. He volunteered generously to the Clinical and Laboratory Standards Institute (CLSI), American Association for Clinical Chemistry (AACC), International Organization for Standardization (ISO), and Joint Committee for Traceability in Laboratory Medicine (JCTLM) to promote standardization and traceability of laboratory testing. He was a member of the CLSI, then NCCLS, Council for the National Reference System for the Clinical Laboratory; Area Committee for Clinical Chemistry and Toxicology; and chaired or participated in development of standards for quality control, electrolytes, traceability, uncertainty of measurement, and other aspects of laboratory practice. He was the AACC representative to JCTLM, a past-chair of the AACC Industry Division, and received the Industry Division’s Service Award for contributions to the profession this year. He was a member of the US Technical Advisory Group for ISO Technical Committee 212, Clinical laboratory testing and in vitro diagnostic test systems. Recently, Rick was instrumental in organizing and presenting several CLSI, AACC, and CLMA workshops to inform clinical laboratorians about industry’s approach to risk management for enhanced patient safety. I have had the pleasure of working with Rick for many years on a number of standardization activities. I have come to respect his breadth of knowledge, balanced approach to consensus development, and emphasis on quality and practicality. Rick clearly articulated and championed the important role of the IVD industry in the practice of laboratory medicine. Rick truly went above and beyond in his dedication to clinical chemistry and could always be counted on to have a good idea or to bring helpful clarity to a complex discussion. I knew him as a colleague and a friend, and speak for the entire clinical laboratory profession in recognizing his contributions and our sadness at losing his wit and wisdom. Respectfully submitted, Greg Miller Recent Changes to CLSI Membership CategoriesBased on input from members CLSI recently simplified its Corresponding/Associate Active member options. Now hospital-affiliated or hospital-based laboratories, physician office laboratories (POLs), and clinics can self-select one of four membership levels based on their requirements and budget. To reflect this new, simpler approach to membership, we are calling these types of organizations Associate Active members. In the past, independent/commercial laboratories qualified for Corresponding/Associate Active Membership. In April, the CLSI Quality and Ethics Committee proposed a bylaws change, which was approved by the Board of Directors and member organizations, to incorporate independent/commercial laboratories into the Active Member category. The change became effective 1 July 2007. With this change, independent/commercial laboratories will be migrated to an annual January billing cycle. Independent/commercial laboratories are defined as non-hospital-based and/or affiliated independent laboratories. Other types of Active members include IVD manufacturers and suppliers, pharmaceutical companies, biotechnology firms, and LIS/HIS providers. CLSI is contacting independent/commercial laboratories that are scheduled for dues renewal well in advance to advise them of the membership change and enhanced benefits. As Active members they will receive the following:
If you have questions about membership, contact Colleen Sweeney, Membership Manager, at +610.688.0100 x 134 or csweeney@clsi.org. Press ReleasesNewborn Screening Specimen Collection (LA4-A5); Verification and Validation of Multiplex Nucleic Acid Assays (MM17-P) CLSI Publishes Standard for Newborn Screening Specimen Collection
New CLSI Guideline Provides Protocols for Verification and Validation of Multiplex Nucleic Acid Assays
Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Verification and Validation of Multiplex Nucleic Acid Assays; Proposed Guideline (MM17-P), which provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials.
Vote and DeadlinesAnalytical Procedures for the Determination of Lead in Blood and Urine (C40-A); Laboratory Instrument Implementation, Verification, and Maintenance (GP31-P); Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture (H3-A6); Protocol for the Evaluation, Validation, and Implementation of Coagulometers (H57-P); Platelet Function Testing by Aggregometry (H58-P); Verification and Validation of Multiplex Nucleic Acid Assays (MM17-P) CLSI submits the following for vote as a candidate-for-advancement consensus documents. The documents and ballots are available to delegates and alternates of Active and Associate Active member organizations through CLSI Forums. MM17-P—Verification and Validation of Multiplex Nucleic Acid Assays
Second Notice C40-A—Analytical Procedures for the Determination of Lead in Blood and Urine; Approved Guideline
GP31-P—Laboratory Instrument Implementation, Verification, and Maintenance; Proposed Guideline
H3-A6—Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition
H57-P—Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Proposed Guideline
H58-P—Platelet Function Testing by Aggregometry; Proposed Guideline
Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to 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 a CLSI document. Please send your completed ballot to the CLSI offices by the above deadline. In the 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. Find out more about Active and Associate Active membership. Recently Approved DocumentsBlood Collection on Filter Paper for Newborn Screening Programs (LA4-A5)
LA4-A5—Blood Collection on Filter Paper for Newborn Screening Programs; Approved Guideline—Fifth Edition
Our 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 that participates in the consensus process by carefully reviewing and commenting on the standard or guideline.
You may automatically receive or select approved-level documents as a member benefit. Find out more about joining CLSI: view membership options and benefits. Recently Distributed ISO StandardISO20776-2:2007 Second Notice Published ISO/TC 212 Standard ISO 20776-2:2007 - Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices
Call for NominationsHow to Construct an Error Grid for Diagnostic Assays; Evaluating Between Reagent Lot Variation; Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP6-A); Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (EP21-A) The Clinical and Laboratory Standards Institute requests volunteers to serve as subcommittee members for a new voluntary consensus project. The project description and specific qualifications needed are provided below: NEW PROJECT:
Description: Although there are many evaluation protocols, one can always ask the question, is the estimated performance “good enough”. This is a difficult question to answer and previous attempts from CLSI and ISO/TC212 to establish analytical performance goals for assays have failed to be completed. The proposed project will provide a new approach by leveraging the longstanding, existing glucose error grids. The project will explain how to construct error grids for any diagnostic assay, with focus on * The region that should include most (95%) of the data – the acceptable result region
Moreover, these grids will be illustrated for different diseases and uses (e.g., screening vs. monitoring). This can lead to different error grids for the same assay. These grids will be graphed in a spreadsheet, so that existing CLSI Evaluation Protocols documents can have data displayed in the error grid. It is intended to provide guidance on how to quantify the amount of data and the corresponding confidence interval in each error grid region. In addition, the document is geared towards manufacturers with respect to construction of error grids. However, it is also applicable to clinical laboratories, since data from protocols such as CLSI document EP15-A2—User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition can be displayed in an error grid. Whereas this project provides a means to construct error grids, it is important to note that it will not attempt to provide a list of completed error grids for assays, which is another way of saying that it will not attempt to provide goals for assays, but rather the format for how goals can be produced. Guideline Content: 1. Forward
Specific Expertise/Work Experience Needed:
The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 September 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087. The Clinical and Laboratory Standards Institute requests volunteers to serve as subcommittee members for a new voluntary consensus project. The project description and specific qualifications needed are provided below: NEW PROJECT:
Description: Prior to the 1992 enactment of CLIA 88, reagent lot validation practices were highly variable. General guidelines for measuring and responding to lot-related shifts in control and patient data were not widely applied and very few laboratories validated new reagent lots by re-analyzing retained patient specimens. Section 493.1255 of the CLIA 88 Standard specifies that whenever a complete change of reagents occurs, “the laboratory . . . demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes”. Soon after the enactment of CLIA 88, the requirement for lot validation was promulgated in the accreditation checklists of various professional organizations including that of the College of American Pathologists (CAP). The rigor in fulfilling lot validation depends on the knowledge, confidence and prior practices of the laboratory directors and the supervisory technologists. While some CLSI guidelines are being developed for demonstrating equivalence in analyzers operated within a health care system, the evaluation of between lot variation has not been yet addressed by CLSI. This guideline will address the following quality control issues:
Guideline Content:
Specific Expertise/Work Experience Needed:
The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 September 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087. Clinical and Laboratory Standards Institute’s Area Committee on Evaluation Protocols has requested nominations to serve as subcommittee members to revise the CLSI guideline described below: PROJECT REVISION:
Description: EP6-A, which was published in 2003 provides an economical and user-friendly method of establishing or verifying the linear range for use by both manufacturers and users of quantitative analytical methods. This guideline also can be used to demonstrate the extent to which a quantitative analytical method meets clinical requirements or manufacturer's linear range claims. In revising EP6 the following updates/revisions will be considered:
Specific Expertise/Work Experience Needed:
The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 September 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087. Clinical and Laboratory Standards Institute’s Area Committee on Evaluation Protocols has requested nominations to serve as working group members to revise the CLSI guideline described below: PROJECT REVISION:
Description: EP21-A, which was published in 2003 provides manufacturers and end users a means to estimate total analytical error for an assay. The procedure includes a data collection protocol and analysis method, which is largely graphical. The result is compared to a total analytical error goal. Specific Expertise/Work Experience Needed:
The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 September 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.
Upcoming Events47th Annual Interscience Conference on Antimicrobial
Upcoming PresentationsSymposium for Clinical Laboratories: An Interactive Experience in Quality Systems
Join speaker Glen Fine, MBA, MS, Executive Vice President, CLSI
The majority of errors caused in any organization are due to system and process errors. Your laboratory undoubtedly has areas for improvement and the chances are that others have had the same ones ….so why not learn from them? Standardization is a combination of vision and action. Mr. Fine will make the case of why standards not only matter, but how they are essential for quality patient care. Using examples from CLSI, a nonprofit, voluntary consensus standards-developing organization in the clinical laboratory field, Mr. Fine will discuss the essentials of following best practice standards and guidelines.
CLSI Meetings Calendar21-22 August 2007
Browse CLSI's complete calendar of meetings for event details and registration information. VolunteerMaximize your voice in the global medical community. Take part in developing the very standards that affect the work you do each day. Join your colleagues in the governmental, industrial, and professional sectors of
Don't just follow the gold standard. Set it. New and Sustaining MembersCLSI Welcomes New Associate Active Members New Associate Active Members AK Molecular Diagnostic Laboratory (USA)
Sustaining Members CLSI acknowledges those partnering organizations that have made a special financial commitment above and beyond their membership dues: Gold Level
Silver Level
View our complete list of members. Update Your SubscriptionIf you would like to edit your CLSI eNews or press release subscriptions, or to opt out of receiving printed versions of all promotions, login here. For more information or to contact us directly, please visit clsi.org | © CLSI, 2003 – All rights reserved |