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Dana-Farber Cancer Institute has a longstanding commitment to patient safety by ensuring high quality cellular therapy (CT) programs. As part of this commitment, there are several Quality Assurance teams, and each is charged with ensuring program success from a specific perspective: donor related, product related, and clinical treatment related. The combined efforts of these teams ensure quality and ongoing compliance to the highest of standards for cellular therapy programs.
In keeping with those industry standards, our CTQA teams maintain independent reporting structures. This means thaat, because of independent reporting, everything we do is transparent and intended to ensure the very best cellular therapy services, products, and clinical trials for patients.
The Cellular Therapies Quality Assurance teams are a central resource for clinicians, researchers, and other staff — both at Dana-Farber and across all of our Harvard affiliates — for:
Collectively, the CTQA teams provide the services listed below — all with the ultimate aim of ensuring regulatory compliance for the relevant programs we cover, all the while providing the highest standards of quality in the manufacturing and use of cellular products for patients.
Dana-Farber has consistently participated in outcomes reporting. When new legislation came into effect requiring that stem cell transplant centers like ours report their outcomes, we continued to share our data as we always have.
Our program has also played a major role in the development of reporting metrics and standards and the analysis of outcomes data. Capturing quality data ensures that Dana-Farber not only performs in the top tier of cancer centers, but also strives to continually improve our outcomes — ensuring the highest standards of care for our patients. We are a participant in the national Comprehensive Cancer Center Consortium for Quality Improvement (C4QI). Dana-Farber not only meets the benchmarks of other participating institutions, but leads in pushing the envelope in setting higher standards.
In addition to manufacturing cell products used in Dana-Farber's clinical trials for adult and pediatric cancer patients, our Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) also produces the products used in trials for pediatric patients with gene deficiencies at Boston Children's Hospital and other facilities across the country.
The CMCF Quality Assurance group collaborates with investigators at other facilities (Massachusetts General Hospital, UMass Memorial Hospital, Columbia Presbyterian Hospital, and others) to bring novel cell therapies to outside programs.
Dana-Farber Cancer Institute and Brigham and Women's Hospital jointly oversee the Cord Blood Donation Program, providing hope to all patients in need of stem cell transplantation who depend upon unrelated umbilical cord blood as a source of life-saving stem cells for transplant.
Our team members are recognized leaders in the field — at Dana-Farber, throughout the region, and nationwide — with specialized expertise in cellular therapy quality (improvement, assurance, and control). In addition, our team members are experts in regulatory compliance topics unique to this field, including cellular therapy clinical trials, and novel cellular manufacturing regulations.
Olive J. Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA (ASQ)Administrative Director, Cell Manipulation Core Facility (CMCF)
Olive Sturtevant and her team provide leadership and regulatory direction for multiple cellular therapy programs at Dana-Farber, Brigham and Women's Hospital, and Boston Children's Hospital. Olive acts as both a resource and consultant on matters of clinical laboratory compliance; GMP and GTP cell and tissue manufacturing; and overall quality and regulatory topics that range from cellular therapy adverse events and quality improvement processes and metrics to regulatory compliance for early-phase novel cell therapy manufacturing.
Roger Richard, MT (AMT)Senior QA Manager, Cell Therapies
Roger's expertise spans cellular therapy-related regulatory compliance and quality assurance, new product development, workflow processes, data analysis, documentation and training management, and information system qualification and implementation. He and his team are responsible for the clinical administration component of the Hematopoietic Stem Cell Transplantation Program's Foundation for the Accreditation of Cellular Therapy (FACT) continued accreditation. Roger also works closely with clinical program leadership to ensure the successful operations of a robust quality management program in order to ensure compliance with regulatory standards.
Mary Ann Kelley, MT(ASCP)BBQA Manager, Connell and O'Reilly Families Cell Manipulation Core Facility
Mary Ann Kelley provides the Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) with direction and leadership in the development and implementation of quality programs to support regulatory and accreditation requirements. She is responsible for the oversight of quality measures for the Stem Cell Processing Laboratory, Novel Cell Therapy Laboratory, and Quality Control Laboratory. She also oversees policies and procedures for product testing and release; ensures that all processes have been approved and validated; and oversees departmental audits and assessments to ensure regulatory compliance.
Bethany King, CQA (ASQ)Clinical Program Technical Manager
Bethany is responsible for the quality management for cellular therapy donor services and the marrow collection facility. This includes management of FACT accreditation for those areas, National Marrow Donor Program (NMDP) quality assurance, performance metrics and analytics, standard operating procedures, and training and competency for donor services staff and those making donor eligibility and suitability determinations. She oversees the auditing and validation of marrow harvest procedures, and she works closely with the processing lab and apheresis facility to monitor ongoing product quality.
Deborah J. Liney, MBA, CHTCQA Manager, Cell Therapies
Deborah is responsible for quality assurance activities related to continuous process improvement, continued FACT accreditation, and transplant workflow processes. Deborah is also responsible for the annual review of treatment plans and assists by facilitating the creation of new stand-of-care treatment plans. In addition to these responsibilities, Deborah is also responsible for providing QA oversight to the DFCI/BWH Cord Blood Collection Program, a partnership with the Carolinas Cord Blood Bank at Duke University.
Ann Wood (CMCF)Gauravi Prabhu (CMCF)Michelle Lynch (CMCF)Shana Coyne (CMCF)Andrea Wilson (CMCF)Kristie Defalco (CT QA)Jill Tierney (CT QA)QA Regulatory CoordinatorAbby Brehm
Yen HuynhJoceneia Timas
The CTQA Department provides essential support to ensure proper accreditation by all appropriate agencies, including the following:
Care Quality and Patient Safety at Dana-Farber Cancer InstituteConnell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer InstituteDana-Farber Cancer Vaccine CenterDana-Farber Cancer Institute Bone Marrow/Stem Cell Donor ServicesDana-Farber/Brigham and Women's Cancer Center (DF/BWCC) Adult Stem Cell Transplantation ProgramDana-Farber/Boston Children's Cancer and Blood Disorders Center Pediatric Stem Cell Transplantation ProgramDF/BWCC Hematologic Oncology Treatment CenterDF/BWCC Genitourinary Cancer Treatment CenterDF/BWCC Melanoma Treatment Center
Agency for Healthcare Research and QualityCarolinas Cord Blood BankCenter for Human Cell TherapyCenter for International Blood and Marrow Transplant ResearchCenters for Medicaid and Medicaid Services (CMS) Quality Improvement OrganizationsCollege of American PathologistsHarvard Stem Cell InstituteImmune Disease InstituteRadiation Injury Treatment Network (RITN)The Wyss Institute
Clinical Laboratory Improvement Amendments (CLIA)CLIA RegulationsCLIA Test DatabaseNational Institutes of Health Review Process for Human Gene Transfer TrialsU.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) FormsU.S. Food and Drug Administration Approved Donor Tests