The challenges of verifying, validating, and monitoring assay performance, improving efficiency and effectiveness, and, ultimately, enhancing quality procedures and practices in the clinical laboratory have made evaluation protocols a top priority of manufacturers, regulatory agencies, and laboratory professionals. The 2007 Clinical and Laboratory Standards Institute Leadership Conference and Workshop, taking place 18-20 April in Baltimore, Maryland, is designed to delve into strategies and tactics to help organizations keep pace and maintain compliance.

CLSI Strategic Progress and Future Plans Discussed at 2007 CLSI Leadership Conference

The 2007 Leadership Conference will focus on the efforts of CLSI to anticipate and meet the needs of customers, continually improve the effectiveness of the consensus process, and define and provide updates about the organization’s priorities and goals. The comprehensive and insightful lineup of meetings includes: CLSI Board of Directors, Board of Directors’ Committees, and CLSI area committees and subcommittees. CLSI area committees, made up of leading experts from professions, government, and industry, will meet 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 scans. In addition, subcommittee sessions will be held to collaborate, interact, and complete work on existing projects in development.

The President’s Reception on Wednesday, 18 April, hosted by Robert L. Habig, PhD, CLSI President, will offer unlimited networking opportunities, including one-on-one discussions with CLSI members and volunteers.

On Thursday, 19 April, a special Member/Volunteer Appreciation Luncheon will provide an opportunity to acknowledge the outstanding and important contributions of CLSI members and volunteers, install new directors, and recognize 2007 award recipients.

The 2007 CLSI awards program recognizes the exceptional contributions of volunteers who support the development of CLSI documents and products. Highlights of this year’s program include: Service Recognition, John V. Bergen Award, Honor Awards, and the Russell J. Eilers Memorial Award. Service Recognition awards are given to CLSI volunteers who have completed terms of office or project leadership. The annual John V. Bergen Award recognizes the volunteer or group who advances CLSI organizational directives and objectives through unique and significant contributions. Based on the results of a nomination and review process with a selection of categories including Excellence in Standards Development, Consensus Management, Global Leadership, Mentoring, and Member Organization Leadership, Honor Awards will be bestowed at the conference. In addition, the prestigious Russell J. Eilers Memorial Award will be presented to an individual who has made an outstanding contribution to voluntary consensus.

Reinvigorate Evaluation Protocols Strategy and Thinking by Attending Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop

This year’s high-value, one-day Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop, taking place Friday, 20 April, will cover a spectrum of useful information about evaluation protocols for clinical and laboratory professionals, manufacturers involved in verifying, validating, troubleshooting, and supporting laboratory test systems, representatives from regulatory and accrediting organizations, and students in clinical laboratory sciences.

Among the many things participants will learn at the workshop are how to maintain compliance and meet requirements for accreditation; how to establish device performance for FDA submission and approval; and practical approaches for using CLSI evaluation protocols documents and global applications, including ISO 15189 and ISO 17025.

“Improving quality procedures and practices in the clinical laboratory depends upon continually expanding information and educational resources,” explains Jennifer McGeary, MT(ASCP), MSHA, CLSI Director, Standards and Quality. McGeary adds, “The CLSI Leadership Conference and Workshop brings manufacturers, government, and clinical and laboratory professionals together in a forum that covers this year’s priorities, but also helps the healthcare community learn and plan for the future.”

The core of the program includes:

* Overview of the CLSI Evaluation Protocols Documents and How They Fit Together Into a Quality System 
- Daniel W. Tholen, MS, American Association for Laboratory Accreditation

* FDA View of CLSI Evaluation Protocols
- Steven I. Gutman, MD, MBA, FDA Ctr. for Devices/Rad. Health

* Documents Relevant to Industry
- George P. Brotea, PhD, Ortho-Clinical Diagnostics, Inc.

* CLIA View on Use of CLSI Evaluation Protocols
- Judith A. Yost, MA, MT(ASCP), Centers for Medicare & Medicaid Services

* Evaluation Protocols Relevant to the Laboratory 
- R. Neill Carey, PhD, Peninsula Regional Medical Center

* Equivalent Quality Control Update 
- Greg Cooper, CLS, MHA, Bio-Rad Laboratories, Inc., QSD Division 
- James H. Nichols, PhD, DABCC, FACB, Baystate Medical Center

* Panel Q&A Discussion

Breakout Sessions
Concurrent afternoon breakout sessions will allow participants to hear case studies and get targeted training for their specific areas of interest. Participants will choose two afternoon training sessions from the following topics:

* Breakout Sessions for Laboratory Professionals
    - R. Neill Carey, PhD, Peninsula Regional Medical Center
    - James H. Nichols, PhD, DABCC, FACB, Baystate Medical Center
    - Judith A. Yost, MA, MT(ASCP), Centers for Medicare & Medicaid Services

    Topics include:

• How to check the performance of a new test before placing it into service
• How to verify/validate the analytical measurement range (AMR)
  - if calibration materials do not span the full AMR
  - if laboratory’s AMR extends beyond manufacturer’s stated AMR
• How to determine if the same results are obtained from multiple instruments used for testing a given analyte
• How to check a new reagent lot before it is placed into service
• How to check for interferences for analytes measured

* Breakout Session on Statistical Considerations for Manufacturers
    - Marina Kondratovich, PhD, FDA Ctr. for Devices/Rad. Health
    - Jan S. Krouwer, PhD, Krouwer Consulting
    - Kristen L. Meier, PhD, FDA Ctr. for Devices/Rad. Health
   
    Topics include:

• Statistical methods from some of the more rigorous CLSI evaluation protocols
  documents, including: linearity (EP9); limit of detection (EP17); and more

McGeary explains, “This program allows attendees to meet face-to-face and get in touch with the experience and insights of the experts shaping the industry at the highest level.” She adds, “Implementing evaluation protocols requires organization-wide momentum, collaboration, and a strong commitment from all staff involved in the process. This forum offers case studies, implementation techniques, and up-to-date information that participants can take back to their workplace and use in daily practice.”

CLSI looks forward to the support for this year’s workshop from leading professional associations and key IVD manufacturers in the healthcare industry.

Continuing education credits in the form of ACCENT© and PACE® contact hours will be made available to conference attendees. For more information regarding continuing education, visit www.clsi.org.

For more information about the CLSI 2007 Leadership Conference and Workshop and to register now, visit www.clsi.org, call +610.688.0100 or toll free 877.447.1888. [ return to top ]