Monday, 28 July 2008, 10:30 am – noon US Eastern Time
Renaissance Washington, DC Hotel
Meeting Rooms 12 and 13
Light Refreshments Served
Note: This session immediately follows AACC's Monday plenary session. Proceed from the convention center across Ninth Street NW to the Renaissance Washington, DC Hotel at 999 Ninth Street NW to meeting rooms 12 and 13 located on the meeting room level at the top of the escalators.
I
n conjunction with AACC/ASCLS Annual Meetings and Clinical Lab ExpoJoin CLSI President Gerald A. Hoeltge, MD and experts from the US Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), industry, and the professions to hear the accomplishments, challenges, and strategies for advancing quality performance in medical laboratories. Focus on implementation of laboratory practices, certification of medical laboratories, and regulation of in vitro diagnostic (IVD) tests. Includes updates on the progress of CLSI's documents EP22 and EP23.
Quality
Perspectives on ensuring quality clinical and laboratory performance from CLSI, CMS, and FDA experts.
CLSI Updates: EP22 and EP23
The scope and issues being addressed during the development of new CLSI guidelines EP22 and EP23 focusing on quality control based on risk management. Includes practical values of the guidelines to industry, government regulatory, and medical laboratories.
Accreditation Preparedness
How to avoid the most commonly cited deficiencies during laboratory accreditation inspections.
IVD Regulation
FDA's role in assuring effectiveness and safety of IVD tests.
Featured Speakers
- Gerald A. Hoeltge, MD, President, CLSI
Co-Director, Transfusion Medicine, Cleveland Clinic
- Greg Cooper, CLS, MHA
Manager, Clinical Standards and Practices, Bio-Rad Laboratories, Inc., Quality Systems Division
- James H. Nichols, PhD, DABCC, FACB
Director, Clinical Chemistry, Baystate Medical Center
- Judith A. Yost, MA, MT(ASCP)
Director, Division Laboratory Services, Centers for Medicare & Medicaid Services
- Alberto Gutierrez, PhD
Deputy Director, Premarket Program, Office of In Vitro Diagnostic Device Evaluation and Safety
Visit CLSI at the Clinical Lab Expo booth number 3933 during the AACC and ASCLS Annual Meetings 29-30 July.