Validation and Verification

The Vexing World of Test Method Validation and Verification

Location: Lawrence Memorial Hospital, Conference Room A (Lower Level)

Parking: Free visitor parking is available in the parking lot directly west of the hospital on Arkansas St. Attendees should enter LMH via the first floor Arkansas Street entrance. The workshop will be held in Conference Room A on the lower level. Signage will be posted to direct attendees.

Speaker: Mike Loeffelholz, PhD, D(ABMM)

Sponsors: Lawrence Memorial Hospital and Cepheid

SWACM Coordinators: Rachael Liesman - rliesman@kumc.edu and Mary Ann Henthorne - mary.henthorne@lmh.org

***Non-member registration includes a 2019 membership.***

HALF DAY AM WORKSHOP

7:30 - 8:00 Registration & continental breakfast

8:00 - 9:00 Overview and key concepts; regulations

9:00 - 10:15 Review of verification and validation processes

10:15 - 10:30 Break & refreshments

10:30 - 12:15 Verification and validation case studies, Q&A

ABOUT THIS WORKSHOP

Regulations require that diagnostic microbiology laboratories verify or validate the performance characteristics of tests prior to reporting patient results. Regulations and guidance documents provide information to help laboratories navigate this process, but this still remains one of the least clear responsibilities of the laboratory. Questions such as “Do I validate or verify?” “Does this change require validation?”, and “How do I verify this new test?” are common. This workshop will focus on the regulatory requirements for the verification and validation of tests performed in the diagnostic microbiology laboratory. The differences between verification and validation will be reviewed. A number of validation/verification cases will be presented and discussed.

COURSE OBJECTIVES

After attendance, participants will be able to:

1. Define verification and validation.

2. Describe components of the verification and validation processes.

3. Recognize the verification requirements for unmodified FDA-cleared tests.

4. Identify the verification requirements for modified (off-label) commercial tests and laboratory-developed tests.

P.A.C.E. ®

SWACM is approved as a Provider of Continuing Education Programs in Clinical Laboratory Sciences by the ASCLS P.A.C.E.® Program. Completion of this program will provide 4.0 contact hours of continuing education. SWACM programs are approved for California-licensed clinical laboratory scientists and personnel. The instructional level of this program is intermediate.

ABOUT THE SPEAKER

Michael Loeffelholz, Ph.D D(ABMM) Dr. Loeffelholz earned a Ph.D. in microbiology from Ohio University in 1987 and completed a post-doctoral fellowship in medical and public health microbiology at the University of Rochester in 1990, under the mentorship of Marilyn Menegus. Dr. Loeffelholz is currently Senior Director of Medical Affairs at Cepheid. Prior to that he was at the University of Texas Medical Branch at Galveston for over a decade, as Professor in the Department of Pathology, Director of the Clinical Microbiology Laboratory, and Director of the Medical Microbiology Fellowship program. Prior to his tenure at UTMB, Dr. Loeffelholz held positions in public health and private reference laboratories. Dr. Loeffelholz has over 80 peer-reviewed publications and book chapters. He is Editor-in-Chief of the Clinical Virology Manual, 5th Edition, and an editor of the Journal of Clinical Microbiology. He currently serves as the Secretary/Treasurer of the Pan American Society for Clinical Virology. Dr. Loeffelholz has served on a number of committees at the national level, including the ASM Committee on Professional Affairs, CDC Board of Scientific Counselors/Office of Infectious Diseases, and the Association of Public Health Laboratories board of directors. He is a diplomate of the American Board of Medical Microbiology (ABMM).