CLSI eNews - 11 February 2005 (Plain Text Version)

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News
Executive Vice President's Message
Nationally Recognized Experts to Speak at Equivalent Quality Control Workshop: QC for the Future
Celebrate Our New Name: Clinical and Laboratory Standards Institute
IQLM Landmark Summit to Honor Leaders in Quality
Press Releases
Standards Status
Notice of Vote and Comment Deadline for Consensus Documents
Recently Approved Documents
Recently Distributed ISO Standards
Focus on Global Terminology
Notice of M100-S15 (M7) Table 3A Erratum
Events and Exhibits
Meeting Calendar
Upcoming Events and Exhibits
Membership
Join Us
New and Sustaining Members
Update Your Subscriptions

Nationally Recognized Experts to Speak at Equivalent Quality Control Workshop: QC for the Future

QC for the Future, a special workshop sponsored by AACC, ACLA, AdvaMed, AMT, ASCLS, ASCP, ASM, CAP, CDC, CLMA, COLA, CMS, FDA, JCAHO, and the Clinical and Laboratory Standards Institute (CLSI), takes place 18 March 2005 in Baltimore, MD. An unparalleled group of world-renowned laboratory, industry, and government leaders and luminaries will join forces to share their views on the future of QC, field attendee questions, and encourage dynamic discussion. This in-depth, insightful workshop for technical and management laboratory professionals, IVD industry representatives, and government staff features educational sessions and breakout discussion groups, which provide a multidimensional view of the emerging QC technologies and alternative QC paths for the future.

In this high level educational forum, attendees will learn how fellow healthcare professionals around the world are using QC technologies. They will discuss advances in laboratory technology and hear from industry leaders about the future direction of QC. This workshop provides a hands-on opportunity to meet like-minded professionals, absorb and share knowledge about QC, and discuss practical solutions for QC protocols that ensure equivalent quality testing.

The workshop, moderated by Robert L. Habig, Ph.D., Clinical and Laboratory Standards Institute President-Elect, includes a comprehensive agenda and impressive speaker line-up:

Introductions and Goals for the Meeting
Thomas Hearn, Ph.D., President, CLSI, and Director, Division of Laboratory Systems, CDC will provide an overview of goals, approach, agenda, and CLSI's role in QC consensus document development.

History of QC
D. Joe Boone, Ph.D., Associate Director of Science, Division of Laboratory Systems, CDC will present background and historical perspective of QC.

CLIA QC – Options for the Future
Judy Yost, M.A., Director, Division of Laboratory Services, CMS will outline current CLIA QC regulatory requirements including EQC options. She will describe the potential for nonregulatory alternatives or professional standards under the current regulation, and review the role of government in development, oversight, and enforcement of laboratory QC standards.

Risk Management
Donald Powers, Ph.D., President, Powers Consulting will introduce ISO and U.S. manufacturing concepts of risk management and describe how risk management can interface with QC practices.

Laboratory Issues – POCT/POL Concerns
Valerie Ng, M.D., Ph.D., Professor and Interim Chair, Department of Laboratory Medicine, UCSF will focus on quality issues and concepts in the less sophisticated versus the large central laboratory and will explain the role of the laboratory in QC and test quality.

What is Laboratory Quality?
James Westgard, Ph.D., FACB, President, Westgard QC, Inc, one of the world’s premier QC experts, will discuss what constitutes quality in a laboratory.

Personnel Issues
Elissa Passiment, Ed.M., CLS(NCA), Executive V.P., ASCLS will discuss the current status of testing personnel shortage, training, and personnel competency protocols.

Technology Variations
Fred Lasky, Ph.D., Director, Regulatory Affairs, Genzyme Diagnostics will profile current and future technologies and their innovative concepts for QC and will explain the role of manufacturer in QC and test quality.

Clinical and Laboratory Standards Institute Document Development
Luann Ochs, M.S., Director, Regulatory Submissions, Roche Diagnostic Corporation will address time frames, players, and processes for Clinical and Laboratory Standards Institute (CLSI) consensus standard development. Also, development of a proposed voluntary consensus document will be discussed.

A panel discussion will explain the collaboration of manufacturers, government, and laboratory professionals in the development of QC practices and policies. This discussion will also provide an overview of each constituency’s role in ensuring test quality.

In the afternoon, attendees will breakout into workgroups with the following topics: Consensus Standards/Option 4 Proposal, Future Technology from the Lab Perspective, and Input into Regulations/Guidelines. These groups will provide a unique opportunity to network, meet face-to-face, and freely exchange ideas for alternative options for EQC and the development of a QC plan for the future.

Following the workshop, participants will receive a conference report. The manuscripts from each of the speakers will be published in a laboratory professional journal at a later date.

The QC for the Future workshop is being held in conjunction with the 2005 Clinical and Laboratory Standards Institute Leadership Conference, the must-attend standardization event of the year.

To register or for more information about the Equivalent Quality Control Workshop: QC for the Future or the 2005 Clinical and Laboratory Standards Institute Leadership Conference, visit http://www.clsi.org or contact the Clinical and Laboratory Standards Institute Executive Offices at +610.688.0100.