Dana-Farber Cancer Institute has a longstanding commitment to patient safety by ensuring high quality cellular therapy (CT) programs. As part of this commitment, we have established a dedicated Department of Cellular Therapies Quality Assurance (CTQA) to ensure the quality and ongoing compliance to the highest of standards for cellular therapy programs.
Our CTQA Department is one of the only programs of its kind to follow an independent reporting structure. This means that, because we report independently to Dana-Farber's Vice President of Quality Improvement and Patient Safety, everything we do is transparent — and intended to ensure the very best cellular therapy services, products, and clinical trials for patients.
The Department of Cellular Therapies Quality Assurance (CTQA) is a central resource for clinicians, researchers, and other staff — both at Dana-Farber and across all of our Harvard affiliates — for:
The CTQA Department provides 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)Director of Quality Assurance for Cell Therapies
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.
Theona ArsenaultQA Manager, Hematopoietic Stem Cell Transplantation Program
Theona Arsenault's expertise spans regulatory compliance and quality assurance, transplant coordination, transplant workflow processes, data analysis, case management software application implementation, and documentation management. She has helped lead the Hematopoietic Stem Cell Transplantation Program's Foundation for the Accreditation of Cellular Therapy (FACT) re-accreditation process since 2004. Theona also works closely with clinical program leadership to ensure the successful operations of a robust quality management program and compliance with rigorous regulatory standards.
Mary Ann Kelley, MT(ASCP)BBQA Manager, Connell and O'Reilly Families Cell Manipulation Core Facility
Mary Ann Kelley directs the Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) 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 CMCF's Stem Cell Processing Laboratory, Novel Cell Therapy Laboratory, and Quality Control Laboratory. In addition, she oversees policies and procedures for product testing and release and ensures that all processes have been approved and validated.
Deborah J. Liney, MBA, CHTCAssociate Director of QA, Stem Cell/Bone Marrow Donor Services
Deborah Liney is responsible for quality assurance, improvement, FACT accreditation, and training documentation for the stem cell/bone marrow collection program. She creates the annual competency assessment and validates the procedures and materials used for bone marrow collection. Deborah is also responsible for the annual review of treatment plans and facilitating the creation of new standard-of-care treatment plans. In addition to these responsibilities, Deborah is the Director of the DFCI/BWH Cord Blood Collection Program.
Kristie DefalcoAndrew PatmosJill TierneyMary UrbinaMichele Vasquez
Danielle EliopoulosYen HuynhLaura MelanconJoceneia 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
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