Highlight 2007 CLSI Leadership Conference and Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop

Presenting at the podium is Robert Habig, PhD, CLSI President, and seated on the dais are Wayne Brinster, BD Diagnostics – TriPath Imaging , a CLSI Board member as well as W. Gregory Miller, PhD, Virginia Commonwealth University, also a CLSI Board member.

More than 380 clinical and laboratory professionals, manufacturers, regulatory and accrediting organization representatives, and students from around the world gathered for the CLSI Leadership Conference and Workshop 18-20 April in Baltimore, Maryland USA.

“The 2007 CLSI Leadership Conference and Workshop exceeded our expectations,” said Glen Fine, Executive Vice President, CLSI. “It had buzz and optimism that attracted CLSI members, volunteers, and participants from around the globe, including representatives from Columbia, Canada, France, Germany, Japan, Sweden, Tanzania, Trinidad, and Turkey. We look forward to building on this momentum next year.” 

The 2007 CLSI Leadership Conference, dedicated to helping volunteers and members understand, participate effectively in, and implement CLSI standards-development initiatives, offered a variety of opportunities for attendees to network and help define future strategies for the organization.

CLSI area committees, made up of leading experts from professions, government, and industry, met to review the status of current projects, establish priorities for 2007-2008, resolve any outstanding issues related to advancing priority projects through the consensus process, and conduct environmental analyses. In addition, subcommittee sessions collaborated, interacted, and completed work on existing projects in development.

The US Technical Advisory Group Meeting for ISO/TC 212, headed by Chairholder William F. Koch, PhD, was of particular interest to attendees. Reports from the four working groups were reviewed and discussion also focused on the US strategy to take for members attending the upcoming meeting in Beijing, China.

Judith A. Yost, MA, MT(ASCP), Director, Division Laboratory Services, Centers for Medicare and Medicaid Services, explains, “The US TAG for ISO/TC212 meeting in Baltimore provided an opportunity for me to participate in formulating and understanding the strategy that we will be delivering at the upcoming 21 – 23 May Beijing meeting.”

As evidenced by the Centers for Disease Control and Prevention (CDC) Cooperative Agreement, CLSI's vision of global growth and its mission to place its products where they will be of the most benefit to the most people is a key strategic priority for the organization. The Leadership Conference provided a forum to discuss the progress of the CDC cooperative agreement initiatives. Christina W. Mwangi, MBCHB, MMED, Lead Laboratory Support Team, CDC – Tanzania, Comforce, notes, “There are really two values that I associate with attending the Leadership Conference. First are the issues involving standards, which I find very interesting professionally as a laboratory medicine specialist and useful for application in Tanzania. Secondly, I had the opportunity to meet one-on-one with CLSI to discuss the CDC Cooperative Agreement and bring new insight and alignment.”

Special Events Provided an Ideal Forum to Network and Honor CLSI Leaders

From left to right: Professor Naotaka Hamasaki, MD, PhD, Nagasaki International University; Michael Mwasekaga, Coordinator, Laboratory Quality Systems, United Republic of Tanzania, Ministry of Health and Social Welfare (MOHSW); and Zhimin Cao, MD, PhD Assistant director of Endocrinology, New York State Department of Health, network at the President’s Reception.

The President’s Reception on Wednesday, 18 April, hosted by Robert L. Habig, PhD, CLSI President, offered an opportunity for members and volunteers to mingle and celebrate their participation in CLSI.

As in the past, CLSI installed newly elected officers and directors at the Member/Volunteer Appreciation Luncheon on Thursday, 19 April. The luncheon provided an opportunity to acknowledge the outstanding and important contributions of CLSI members and volunteers and served as an appropriate place to recognize the newly elected members of the Board of Directors, as well as the 2007 award recipients.

Yost, who was given the John V. Bergen Award at the luncheon, declared, “I was delighted, pleased, and honored to be recognized at the CLSI Member/Volunteer Appreciation luncheon and to receive the John V. Bergen Award.” The award is given annually to an outstanding volunteer or group in recognition of advances in CLSI organizational directives and objectives, through unique and significant contributions.

Newly installed board directors included:

• Janet K. A. Nicholson, PhD, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention
• Professor Naotaka Hamasaki, MD, PhD, Nagasaki International University

Some members of the Board of Directors gather for a photo, from left to right: Timothy O’Leary, MD, PhD, Biomedical Laboratory Research and Development; Wayne Brinster – BD Diagnostics – TriPath Imaging; W. Gregory Miller, PhD, Virginia Commonwealth University; Janet K. A. Nicholson, PhD, Centers for Disease Control and Prevention; Naotaka Hamasaki, MD, PhD, Nagasaki International University; and Dr. Klaus Stinshoff.

Award recipients included:

Service Recognition
Jeannie Miller, RN, MPH – Board of Directors

Gary L. Myers, PhD – Board of Directors

Kiyoaki Watanabe, MD – Board of Directors

Judy Dye, MA – Area Committee on Health Care Services

Lucia M. Berte, MA, MT(ASCP), SBB – Working Group on Technical Procedure Manuals (GP2)

Donald R. Callihan, PhD – Subcommittee on Culture Media (M6)

Lorraine M. Clarke, PhD –Subcommittee on Viral Culture (M41)

Randy R. Davis – Subcommittee on Remote Access to Clinical Laboratory Diagnostic Devices via the Internet (AUTO9)

Stephen P. Day, PhD – Subcommittee on Genotyping for Infectious Diseases (MM10)

Wayne W. Grody, MD, PhD – Working Group on Molecular Genetics (MM1)

John P. Hawke, PhD – Working Group on Aquaculture (M42 and M49) 

David W. Hecht, MD – Subcommittee on Antimicrobial Susceptibility Testing (Anaerobe AST) (M11)

Janet F. Hindler, MCLS, MT(ASCP) – Working Group on Susceptibility Testing of Infrequently Encountered or Fastidious Bacteria (M45)

Ellis Jacobs, PhD, DABCC, FACB – Subcommittee on Point-of-Care IVD Testing (POCT4)

James H. Jorgensen, PhD – Working Group on Susceptibility Testing of Infrequently Encountered or Fastidious Bacteria (M45)

Andrzej J. Knafel, PhD – Subcommittee on IT Security of IVD Instruments and Software Systems (AUTO11)

John A. Koepke, MD – Reference Procedure for ESR (H20)

Jan S. Krouwer, PhD – Working Group on Method Comparison and Bias Estimation (EP10)

Marilyn M. Lightfoote, MD, PhD – Working Group on Quality Assurance for IF-ANA (I/LA2)

W. Gregory Miller, PhD – Working Group on Reagent Water (C3)

Karen K. Mortland, AIA, MT(ASCP) – Working Group on Laboratory Design (GP18)

William Neeley, MD, FACP, DABCC – Subcommittee on Automated Verification of Clinical Laboratory Test Results (AUTO10)

Frederick S. Nolte, PhD – (MM3)

Sandy Pearson, MT(ASCP) – Subcommittee on Protocols to Validate Laboratory Information Systems (AUTO8)

Renate Reimschuessel, VMD, PhD – Working Group on Aquaculture (M42 and M49)

Robert P. Rennie, PhD – Subcommittee on Culture Media (M6)

Carolyn Sue Richards, PhD, FACMG – Working Group on Molecular Genetics (MM1)

Marc L. Salit, PhD – Working Group on Metrological Traceability (X5)

Thomas R. Shryock, PhD – Subcommittee on Veterinary Antimicrobial Susceptibility Testing 

Diane I. Szamosi, MA, MT(ASCP)SH – Subcommittee on Body Fluid Analysis for Cellular Composition (H56)

Daniel W. Tholen, MS – Subcommittee on Quality Improvement (GP27)

Judith Tuerck, RN, MS – Subcommittee on Newborn Screening Follow-up (I/LA27)

Janet A. Warrington, PhD – Subcommittee on External RNA Controls (MM16)

James O. Westgard, PhD – Working Group on Statistical Quality Control (C24)

John V. Bergen Award

Judith A. Yost, MA, MT(ASCP)
Director, Division of Laboratory Services,
US Department of Health and Human Services, Centers for Medicare and Medicaid Services

Honor Awards

Excellence in Standards Development - Ms. Janet Hindler, Dr. Albert Rabinovitch, and Dr. Barth Reller
Excellence in Consensus Management - W. Gregory Miller, PhD
Excellence in Global Leadership - Mary F. Burritt, PhD
Excellence in Mentoring - Bruce H. Davis, MD
Excellence in Member Organization Leadership - Ortho-Clinical Diagnostics, Inc.

Russell J. Eilers Memorial Award

William F. Koch, PhD
Deputy Director, Chemical Science and Technology Laboratory,
National Institute of Standards and Technology

Robert Habig, President of CLSI, presents the 2007 Russell J. Eilers Memorial Award to William F. Koch, PhD, Deputy Director, Clinical Science and Technology Laboratory, National Institute of Standards and Technology, in recognition of his outstanding contribution to voluntary consensus. The Eilers is the highest award that CLSI confers.

Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop Offered Detailed Information and Practical Solutions

Anders Kallner, MD, PhD presents a session titled, “The European IVD Directive 98/79 – What Does it Mean to Me?” to a packed conference room of workshop attendees.

The Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop featured visionaries and expert speakers, representing more than 100 years of collective CLSI experience, who discussed evaluation protocols (EP) strategies and tactics to help organizations keep pace and maintain compliance.

The general feeling was an appreciation of the unique opportunity to network, meet face-to-face with colleagues, and hear challenges faced by other organizations.

“Our goal was to help workshop attendees find value in using CLSI Evaluation Protocols (EP) documents to assist with compliance in their laboratories. They had an opportunity to learn how to use these standards and recognize their value with specific examples presented by people in labs using them and applying them successfully. It provided a wonderful opportunity to have an exchange with individuals on a one-to-one basis to get assistance,” explained Yost, workshop presenter of the “CLIA QC and CLSI Evaluation Protocol (EP) Documents” session and panelist at the “Streamlining Laboratory Compliance Using CLSI Evaluation Protocols (EP) Documents” session.
 
Attendees enjoyed the comprehensive coverage, open discussion, and targeted breakout groups focused entirely on evaluating analytical performance and describing how CLSI documents are helpful in meeting regulatory and accreditation requirements. Clinical laboratory professionals and manufacturers agreed that they received practical knowledge and solutions to apply in their workplaces.

Barbara Barnes, Quality Improvement Manager, Clinical Labs of Hawaii, explains, “This was my first CLSI Leadership Conference.  In fact, I came solely to participate in the workshop – all the way from Hawaii. I was just hired in a new position as the quality improvement manager for a very large chain of labs. This lab system was created by acquiring existing facilities that each had its own operating guidelines. I am responsible for establishing a uniform standard, including bringing in new instrumentation, validating all of the testing—you name it.  I was interested in attending this CLSI workshop so that I could hear it and ‘get information direct from the source’ and take back what I have learned to help facilitate our standardization process.”

Catherine Carman, Staff Applications Scientist, Beckman Coulter, Inc., says, “The main reason that I attended the workshop was because I work for a manufacturer and we use several of the CLSI documents as references when we do submissions.  Attending the Leadership Conference sessions gave me a better sense of what is on the horizon and an understanding of the consensus process.”

 “Attending the CLSI Leadership Conference gave me an opportunity to become more familiar with the CLSI Evaluation Protocols documents and how they can fit into the scheme of our quality management system. We have been using CLSI standards and guidelines to help in building our quality management systems within Caribbean laboratories, and this has given me a good perspective of what is available for guidance in the area of validation and verification,” comments Valerie Wilson, MSc., MBA, Project Manager, Caribbean Epidemiology Centre (CAREC). CAREC is a public health information, service and consulting organization, focused on improving health and preventing disease in the Caribbean. 

Did You Miss the Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop?

Stay tuned.  Based on positive feedback from workshop attendees, we are preparing to rebroadcast the presentations as a series of three one-hour segments that will be available for continuing education credits.

Mark your calendar now for the CLSI 2008 Leadership Conference taking place 2-4 April 2008 at the Renaissance Harborplace Hotel, Baltimore, MD USA. Watch for future editions of CLSI eNews for more details. [ return to top ]