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.
Cellular Therapy Quality Assurance Services
- Planning for and coordinating FDA, Joint Commission, and
Foundation for the Accreditation of Cellular Therapy (FACT) inspections
- Conducting and participating in interdisciplinary quarterly quality review meetings across the DF/BWH/BCH institutions
- Conducting audits of critical processes and initiating quality improvement projects
- Managing document control system
- Managing the Adult Transplant program standardized treatment plans and consent forms
- Ensuring that all documents are current with practice and regulations by managing the annual review process
- Actively managing the Deviation reporting and investigation process as well as CAPAs (Corrective Action and Preventative Action) process for relevant programs
- Tracking and trending event to initiate corrective action and planning subsequent audits to demonstrate desired outcome
- Reporting events both internally and externally as required
- Gathering, analyzing and reporting outcomes data
- Reviewing technical issues on a regular basis and facilitate the change control and improvement process
- Performing various regulatory functions:
- IND-CMC development
- Maintaining regulatory binders for PI-initiated CT studies
- Submitting events and amendments to regulatory bodies as needed
Quality Management Services
- Detecting and correcting any deficiencies that may adversely affect the quality of patient care
- Leading efforts to obtain, report, and analyze data to improve the outcomes and care management of stem cell/bone marrow donors and patients undergoing stem cell transplantation Environmental Monitoring Services
- Monitoring environmental conditions in the stem cell processing laboratory
- Establishing the best environment to create and apply new discoveries and therapies
- Conducting studies to improve patient safety by identifying trends to initiate improvement process
Validation and Qualification Services
- Performing validation and qualification studies of critical materials, processes and services
- Vetting and auditing suppliers
- Managing customer agreements and product recalls for cellular therapy programs
- Evaluating vendors and contracts with the Dana-Farber Office of General Counsel
Regulatory Requirement, Proficiency, and Documentation Services
- Ensuring that Dana-Farber investigators, outside sponsors of trials and contracted services meet all regulatory requirements, pass proficiency tests, and complete documentation in their cell therapy studies
Disaster Planning and Emergency Management Services
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.
Cord Blood Donation Program
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.