BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version (2015)
Chapter: Appendix B: Study Activities
The committee held three information-gathering meetings in Washington, DC, and heard from federal, state, and local officials, medical and laboratory professionals, and academic and private-sector researchers. The committee also heard from presenters in data-gathering sessions that were not open to the public under Subsection 15(b)(3) of the Federal Advisory Committee Act, 5 U.S.C. App. The National Academy of Sciences determined that to open these sessions to the public would have disclosed information protected under the Freedom of Information Act, 5 U.S.C. § 552(b).
The first meeting, held March 13-14, 2014, in Washington, DC, included speakers from the Department of Homeland Security—the sponsor of the study—as well as experts on PCR standards development and evaluation. The meeting objectives were to hear from the study sponsor regarding the statement of task given to the committee, receive an overview of the BioWatch program and its current processes, obtain information about the Stakeholder Panel on Agent Detection Assays (SPADA) PCR standards development process, learn from the Centers for Disease Control and Prevention about their involvement in the BioWatch program and in relevant standards development and evaluation activities, obtain background information on the PCR-based detection system used by the U.S. Postal Service, and hear from public health laboratories on the use of BioWatch assays and from public health leaders in emergency preparedness and response to better understand their issues and needs.
During the second meeting, held June 12-13, 2014, in Washington, DC, the committee learned about the history of federal biosurveillance standards efforts and about relevant activities within the Department of Defense. The committee heard from additional experts involved in developing and validating PCR assays and in the design and development of PCR performance standards. The discussion considered performance characteristics and validation strategies, approaches in the design of PCR performance standards, issues that may affect assay performance and validation, and conceptual and practical tradeoffs between different types of approaches.
At the third meeting, held September 3-4, 2014, in Washington, DC, the committee spoke with additional public health laboratory professionals and public health decision makers within BioWatch jurisdictions on their views and needs with regard to the PCR detection assays and on issues encountered in understanding and interpreting assay results.
The committee also gathered input via several questions online and expresses its appreciation to those who shared their views.
INVITED SPEAKERS
The following individuals were invited speakers at meetings and data-gathering sessions of the committee:
Linda Beck, Ph.D.
Department of Homeland Security
Andrew Cannons, Ph.D.
Florida Department of Public Health
Patrick Cusick, R.S., M.S.P.H.
Cleveland Department of Public Health
Matthew Davenport, Ph.D.
Johns Hopkins University Applied Physics Laboratory
Jeffrey S. Duchin, M.D.
Public Health–Seattle and King County, Washington
Peter Emanuel, Ph.D.
U.S. Army Edgewood Chemical Biological Center
Stella Fogleman, R.N., M.S.N./M.P.H., C.N.S.
Los Angeles County Department of Public Health
Alexander Garza, M.D., M.P.H.
Saint Louis University College for Public Health and Social Justice
Bruce Goodwin
Critical Reagents Program, JPEO-CBD
J. Peyton Hobson, Ph.D.
Food and Drug Administration
Scott Hughes, Ph.D.
New York City Public Health Laboratory
Anne Hultgren, Ph.D.
Department of Homeland Security
Molly Isbell, Ph.D.
Signature Science, LLC
Paul Keim, Ph.D.
Northern Arizona University
Moon Kim, M.D., M.P.H., F.A.A.P.
Los Angeles County Department of Public Health
Luther Lindler, Ph.D.
Armed Forces Health Surveillance Center
Beth Maldin Morgenthau, M.P.H.
New York City Department of Health and Mental Hygiene
Laurene Mascola, M.D., M.P.H.
Los Angeles County Department of Public Health
Suzet M. McKinney, Dr.P.H., M.P.H.
Chicago Department of Public Health
Toby Merlin, M.D.
Centers for Disease Control and Prevention
Jane B. Morrow, Ph.D.
National Institute of Standards and Technology
Stephen A. Morse, Ph.D.
Centers for Disease Control and Prevention
Pejman Naraghi-Arani, Ph.D.
Lawrence Livermore National Laboratory
David Norwood, Ph.D.
U.S. Army Medical Research Institute of Infectious Diseases
Kristin Omberg, Ph.D.
Los Alamos National Laboratory
William O’Neill
U.S. Postal Service
Sally Phillips, R.N., Ph.D.
Department of Homeland Security
Segaran Pillai, Ph.D.
Department of Homeland Security
Benjamin Schwartz, M.D.
Los Angeles County Department of Public Health
Sanjiv Shah, Ph.D.
National Homeland Security Research Center
Colin Stimmler, M.A.
New York City Department of Health and Mental Hygiene
Maureen Sullivan, M.P.H.
Minnesota Department of Health
Robert K. Tran, Ph.D.
Los Angeles County Public Health Laboratory
Michael Walter, Ph.D.
Department of Homeland Security
