Michael F. Breard MS, MT(ASCP)SBB, CQA(ASQ), PMP(PMI)
Division Director, Consulting Services
Michael is currently Division Director for AABB Consulting Services. Michael obtained his BS in Medical Technology from the University of North Carolina, Chapel Hill, received his Medical Technology Training at Duke University and his MS in Medical Technology from California State University. He has over 40 years experience in Blood Banking including transfusion service, donor center, commercial manufacturing (reagent, kit, instrument, software), project management and consulting. Experience includes assisting companies/clients with ISO certification, AABB Accreditation, FDA Inspection preparation, FDA 483 and Warning Letter Response/Compliance, cGMP and cGTP Training and Compliance, and Document Development/Training (SOPs, Processes, Policies, Quality Manuals, etc.). He is an active member of the AABB, ISBT, Project Management Institute, a Board Member and Director of Scholarships for the Suzanne Ledin Memorial Foundation and a Senior Member of the American Society for Quality, ISO 15189 Trained, Past Secretary of the TOPS/ASQ Section, Past VP of Communications for the Tucson PMI Chapter, VP of Finance for the Tucson PMI Chapter and Co-Chair of the ISBT Traceability Task Force.
Mary Kay Belota
Mary Kay Belota, Consultant, brings over 25 years experience in cellular therapy, blood center operations, and transfusion medicine to AABB's Consulting Services Division. With such diverse experience, she is well-versed in accreditation and licensure requirements, to include FDA's cGMP and cGTP. Building organizational capacity, Mary Kay integrates standards and regulations with workplace protocols to achieve patient-centered, quality-driven operations. Prior to joining AABB, Mary Kay was the technical supervisor with the St. Louis Cord Blood Bank in St. Louis, MO, serving as the manufacturing subject matter expert during their successful application for FDA licensure. As the laboratory director of the GMP Facility at Washington University in St. Louis, Mary Kay focused on the development of quality systems for this translational research program. She gained Director-level experience in blood center operations with the American Red Cross Missouri-Illinois Region, responsible for collections, manufacturing, donor testing and blood product inventory management. Mary Kay managed the transfusion service at St. Louis University Hospital, a tertiary care teaching facility. Mary Kay received her Bachelor of Science degree in Medical Technology from West Virginia University and is certified as a Specialist in Blood Banking by the American Society for Clinical Pathology. She graduated from Washington University in St. Louis with a Master of Arts in Human Resources Management.
Kenra Ford, MBA, MT(ASCP)
Kenra Ford, Consultant, AABB Consulting Services Division, has more than 20 years experience in the field of blood center operations, transfusion medicine and cell therapy. Prior to joining AABB Consulting Services Division, Kenra was a consultant working with the AABB International Division providing technical assistance to African countries receiving PEPFAR funding for the development and strengthening of national volunteer blood donation programs. From 1988 to 2004, Kenra held several technical positions at the Oklahoma Blood Institute, with the most recent position of Vice-President of Operations. Major responsibilities included technical and administrative oversight for the collections, manufacturing and testing operations as well as blood inventory management. During this time Kenra supported the implementation of nucleic acid testing, system wide red blood cell and platelet apheresis leukoreduction, and bacterial detection testing of apheresis platelets. Kenra holds a Masters of Business Administration degree, as well as a Bachelor of Science degree in Medical Technology.
June A. Fried, CLS, MT(ASCP)BB
June Fried, AABB Consultant, has well over 20 years of experience in all areas of transfusion medicine and cellular therapies. She earned her BS in Medical Technology at the Medical University of South Carolina. She received her Medical Technology training at the MUSC Medical Center, located in Charleston, SC, and her BB(ASCP) certification after years of on-the-job training in facilities around the country. Having held both technical and management positions, June possesses a broad range of knowledge and skills essential to the successful operation of hospital based Transfusion Services, Blood & Marrow Transplant Programs, and university based Translational Research Facilities. In her most recent position as Director, Regulatory Affairs & Quality Assurance for MUSC's Center for Cellular Therapy, June acquired in-depth knowledge and experience in novel cell processing techniques such as those used in Pancreatic Islet isolations, umbilical cord & bone marrow derived Mesenchymal Stem Cell products, chemically modified Dendritic Cell cancer vaccines, and genetically modified autologous T-Cell products. Additional skills include validation of research/clinical protocols, application of quality principles to all aspects of translational research, implementation of quality plans specific to the needs of research facilities, preparation and submission of IND's, and coordination of FDA approved clinical trials. June's unique level of expertise has made her particularly successful in acquiring initial CT Facility accreditation, as well as implementing and maintaining regulatory compliance.
Jane Norris, MT(ASCP)SBB, CQA(ASQ)
Jane Marshall Norris joined AABB as a consultant in 2005. She is certified as a Specialist in Blood Banking by the American Society for Clinical Pathology and as a Quality Auditor by the American Society for Quality. A graduate of Baylor University in Waco, Texas, she received her Medical Technology training at Baylor University Medical Center in Dallas and her Specialist in Blood Banking training at the San Diego Blood Bank in San Diego, California. Before joining AABB, Ms. Norris served as CEO of the Blood Center of the St. Johns in St. Augustine, Florida; Executive Director of Suncoast Communities Blood Bank in Sarasota, Florida; and Chief Operating Officer of Florida Georgia Blood Alliance in Jacksonville, Florida. In addition to executive management positions, she has been a Technical Director and a Reference Laboratory Supervisor. She has also taught classes in immunohematology at the college level and has a wide range of experience at various other levels of blood bank and hospital operations. She is a past President of the Florida Association of Blood Banks, served on the Administrative Section Coordinating Committee of AABB, and was Chair of the Benchmarking Committee for America's Blood Centers. Ms. Norris has presented at numerous professional meetings and conferences and has published a number of both technical and quality-focused articles. She was the lead author of "Change Management" in a recent issue of Transfusion. Since joining AABB, Ms. Norris has worked with blood banks, plasma centers, and transfusion services throughout the United States and in seven foreign countries. She has developed procedures that integrate quality principles into daily operations and conducted training for both staff and management. She regards her most vital work as assisting facilities in preparing their responses to regulatory and accrediting organizations and designing strategies to implement the necessary corrective actions.