Meet Our Consultants

Therese "Tracy" Dodd, BA, MBA, RN, CPHQ, FNAHQ

Senior Consultant

Tracy is responsible for assessing, analyzing, and recommending quality and clinical performance improvement processes for the Sarah Cannon Blood Cancer Network and Sarah Cannon Research Institute. She collaborates with the clinical service group to provide division guidance to ensure the cancer service line is in compliance with regulatory and accreditation bodies. She also oversees the performance improvement activities and delivers guidance to the quality coordinators throughout the network. Dodd serves as a senior consultant for the Foundation for the Accreditation of Cellular Therapy (FACT) Consulting Services, a FACT Quality Inspection Auditor, and previously served as the Quality Improvement Committee Chair for the Medical College of Wisconsin BMT Program and as the Blood and Marrow Transplant Manager at Children’s Hospital of Wisconsin. She earned her diploma in nursing at Columbia Hospital School of Nursing and her MBA at the Keller Graduate School of Management.

View Full Profile
Federico Rodriguez, BSMT, SBB (ASCP)

Senior Consultant

Federico has over 25 years of experience in immunohematology and cellular therapy fields and has held numerous different positions during his career: Medical Technologist, Sales Specialist, Laboratory Supervisor, Education Coordinator, Laboratory Manager, Technical Director and recently as a Consultant. He has provided guidance to laboratories and institutions in all aspects of manufacturing, regulatory requirements and compliance, process design, process improvement and quality management systems worldwide, including the United States, Latin America and the Middle East. Federico has been a FACT inspector since 2005 and has performed multiple inspections nationally and internationally. In addition, he was part of a team of inspectors for a pilot program to perform inspections in Spanish. Federico served as Chair of the ISCT Laboratory Practices Committee.

View Full Profile
Peter F. Coccia, MD

Peter F. Coccia, M.D. is the Ittner Professor and Vice-Chairman of the Department of Pediatrics at the University of Nebraska Medical Center (UNMC) College of Medicine in Omaha, NE. He graduated with an A.B. in Chemistry from Hamilton College in 1963. He received his M.D. degree from Upstate Medical Center in Syracuse, New York in 1968 where he also completed a one year pre-doctoral fellowship in Biochemical Pharmacology. His postgraduate training was in clinical pathology and hematopathology at Upstate and in pediatrics and pediatric hematology/oncology at the University of Minnesota. He served in the United States Public Health Service from 1970 - 1972. He was a member of the Pediatric Department faculty at the University of Minnesota Medical School in Minneapolis, MN from 1974 – 1980 and at Case Western Reserve University School of Medicine in Cleveland, OH from 1980 – 1987. At UNMC since 1987, he founded and directed the Division of Pediatric Hematology/Oncology and the Pediatric Stem Cell Transplantation program until 2012. He served as the Chairman of the College of Medicine Promotion and Tenure Committee from 1995 – 2015.

View Full Profile
Nancy Collins, PhD

Dr. Collins has 33 years experience in laboratory operations in hematopoietic stem cell transplantation, cellular therapy, and standards development and compliance. She was Laboratory Director of the stem cell processing laboratory for 26 years at Memorial Sloan-Kettering Bone Marrow Transplantation program under Dr. Richard J. O’Reilly, until her retirement, specializing in T cell depletion in allogeneic related and unrelated donor transplantation. She also directed MSKCC programs for autologous stem cell and cord blood processing, cryopreservation, storage, and release. She co-founded the International Society for Cellular Therapy (ISCT) in 1992 with Dr. Adrian Gee, served as its first president and is currently an emeritus member of North America Legal and Regulatory Affairs. She was co-editor-in–chief for the ISCT journal for 7 years and was first editor of its newsletter, the Telegraft. Dr. Collins was a member of the founding board of FACT, and has served on the FACT standards committees for both cellular therapy and cord blood banking and been an inspector and trainer in both areas, including Category 2 (more than minimal manipulation). Dr. Collins has also served on the AABB Cellular Therapy Standards Committee and been a member or chair of the NMDP Standards Committee (1995-2001), and the Research and Publications Committee, She was also on the BOD of the altruistic kidney donor organization, The Alliance for Paired Donation. She is currently working part-time as a Clinical Assistant Professor of Medicine at the University of Toledo, helping to establish an autologous transplantation laboratory, and programs in mentoring and development of women in science.

View Full Profile
Deborah Griffin, MSc, ASQ, CPGP

Debe has over 20 years of experience in cellular therapy and laboratory science, including both minimally and more-than-minimally manipulated products. Deborah has been a FACT inspector for over a decade and has performed almost 20 external inspections. In addition, she was responsible for the FACT inspections of three independently accredited facilities at UPMC, the adult hematopoietic stem cell lab, the pediatric hematopoietic stem cell lab and a dendritic cell vaccine production facility, and successfully led them through 10 inspections. She is very active in ISCT including Chair of the North America Legal and Regulatory Committee. Deborah was formerly the Director of Quality Management for Cell Therapies of the Cell Therapies Facility at Moffitt Cancer Center in Tampa, FL, USA. Prior to that position, she served as the Manager of Quality Assurance and Regulatory Affairs for Cellular Therapy, and was responsible for three cGMP compliant and FACT accredited cellular therapy facilities at the Hillman Cancer Center, University of Pittsburgh Medical Center, in Pittsburgh, PA, USA.

View Full Profile
Linda Kelley, PhD

Dr. Kelley has provided leadership for cellular therapy facilities for over twenty years at three academic institutions: University of Utah, Dana Farber Cancer Institute at Harvard and H. Lee Moffitt Cancer Center and Research Institute. Her scientific career evolved from a fundamental interest in immunological mechanisms of T lymphocyte function, growth mechanisms of hematopoietic stem and progenitor cells and molecular changes associated with malignant transformation. Knowledge of the hematopoietic system led to an interest in stem cell biology and therapies. As director of the Cell Therapy Facility at the University of Utah from 1994-2011, she devoted approximately equivalent effort to basic and translational research, patient care, teaching and administration. In that capacity she was responsible for developing and expanding a Cell Therapy and Regenerative Medicine Program which included Cord Blood Banking. As director of the Cell Manipulation Core Facility at the Dana Farber Cancer Institute at Harvard from 2011-2012, she devoted efforts to an extensive reorganization of the laboratory including personnel, procedures and infrastructure to effect change consistent with state-of-the-art cell manufacturing and processing. As director of the Cell Therapy Facility at Moffitt Cancer Center, she is responsible for manufacture and compliance of approved cell therapies for stem cell transplantation of malignant and benign disease, as well as, experimental therapies for immune modulation of cancer treatment. In this capacity, she oversees 22 Investigational New Drug applications for on-going clinical trials. In her current and previous positions, Dr. Kelley has served as director of apheresis for stem and mononuclear cell collections. In addition to academics, Dr. Kelley spent two years in industry as Chief Scientific Officer at CryoCell International, a private cord blood bank. Current and past projects involve collaboration with a variety of industry partners to leverage resources and know-how to propel cell therapies to the market place. Dr. Kelley excels at bridging the gap between laboratory-based discoveries and new therapies for patients. Her career has been closely aligned with the implementation of FDA regulations and guidance, as well as the evolution of FACT standards for the industry.

View Full Profile
Robert Rifkin, MD, FACP

Dr. Rifkin has over 20 years of experience in cellular therapy focusing on the clinical aspects of hematopoietic stem cell transplantation. He has been responsible for the creation and accreditation of two hematopoietic stem cell transplant programs. Dr Rifkin remains active in the National Marrow Donor Program in the collection of bone marrows and peripheral blood progenitor cells. Prior to his current position as an attending physician in the Department of Cellular Therapy at Presbyterian/St. Luke’s Medical Center, he was actively involved in FACT since its inception, and was a participant in the writing of the Fourth Edition of the Standards. Dr Rifkin continues to focus on role of hematopoietic stem cell transplantation in the treatment of multiple myeloma. He is also actively involved in the development of biosimilars and their introduction into the United States marketplace.

View Full Profile
Jean Sanders, MD

Dr. Sanders has been active in clinical hematopoietic cell transplantation since 1975. Although retired from clinical service in 2012, Jean remains active with the Fred Hutchinson Cancer Research Center’s Institutional Review Board, with FACT, and as editor of the ASBMT eNews. As a FACT inspector, Jeans has performed 42 FACT inspections, 36 in cellular therapy and 6 cord blood banks. Thus, she is very versed in FACT Standards including quality management, development of SOPs, consent documents and clinical research. As the developer of and director of Pediatric Transplantation until 2011, Dr. Sanders is sensitive to the special needs and requirements for pediatric patients and donors. Jean is expertly qualified to assist a program with meeting FACT Standards for clinical (adult and pediatric) and marrow harvest as well as cord blood banks.

View Full Profile
Ask FACT

FAQ

Ask a Peer

As a Matter of FACT

The FACT accreditation program is a peer-review process.

Accreditation Success Story

The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. The program has been FACT accredited for 10 years, and offers suggestions for large programs considering FACT accreditation. Read more

Knowledge makes all the difference.

  • FACT Consulting Services
  • 6901 Dodge Street, Suite 207
  • Omaha, NE 68132
  • 402-559-1185