Regulatory & Quality Management Specialist - Cellular Therapy
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.
Works under the direction of the HCT Quality/Regulatory Manager. Maintains current knowledge of FACT (Foundations for the Accreditation of Cellular Therapy), AABB (American Association of Blood Banks), and NMDP (National Marrow Donor Program) Accreditation standards including Federal and State Regulatory reporting and licensing requirements for cellular therapy programs. Also acts as a change agent to lead, facilitate and support the improvement of clinical and service quality for the City of Hope Hematopoietic Cell Transplantation Program. Scope of responsibility crosses multiple Departments, in support of the City of Hope Hematology/HCT Department's joint pediatric-adult Oncology Hematopoietic Cell Transplant Program. Includes consultation for program leaders and staff, development of performance measures, education, root cause analysis, statistical process control and use of quality improvement tools. Acts as facilitator for achievement of key Quality Initiatives and objectives which are integral to the success of the Hematopoietic Cell Transplantation Program.
Key Responsibilities include:
Compliance and regulatory affairs
- Assumes responsibility to assure cross-organizational compliance with Foundation for the Accreditation of Cellular Therapy (FACT) accreditation standards and preparation for re-accreditation surveys and other regulatory requirements.
- Reviews, interprets, and assesses the application of all new, and revised regulations, standards, guidelines, etc. from regulatory and accrediting agencies for the Hematopoietic Cell Program including Blood and Marrow Transplant and Cellular Therapies.
- Facilitates preparation, review, approval, and implementation of HCT Quality Management program policy and procedures ensuring they are in compliance with FACT Standards and all applicable state and government laws and regulations.
- Completes error/accident/event investigations, tracking, reporting, and follow-up as applicable.
- Completes procedural validation audits and review of all equipment, process, and system validation activities applicable to hematopoietic cellular therapy.
- Attends ongoing education and training related to the field of cellular therapy and quality management in accordance with FACT standards and regulatory or certification requirements.
Licensing and Accreditation of the Hematopoietic Cell Program
- Serve as the primary contact and liaison with all applicable external regulatory and accrediting agencies. Prepare for, coordinate, host, and follow-up on all inspections and provide reports and requested information.
- Develop, maintain, and administer the HCT Quality Management Plan /Program with the HCT Program Director, associate directors and /or designees
- Assists the HCT Regulatory Quality Manager and Chair of the COH HCT Quality Management Council and sub-committees, provides agenda and meeting support. Documents HCT Quality Management Council activities and provides reports to institutional quality committees and ad hoc committees.
- Coordinates the development, monitoring and reporting of quality improvement processes and quality controls for the HCT program as required by accrediting agencies and in concert with the goals of the program.
- Performs quality audits and other ongoing assessments; develop annual quality initiatives and coordinates activities to achieve program goals.
- Identifies opportunities for the HCT Program and the department's quality improvement work to be recognized nationally.
- Consults with stakeholders in the development of HCT performance measures for specific Standard Operating Procedures or overall program measures
- Assists in the oversight of HCT Policy and procedure development, review and revision documentation processes and compliance to key operating procedures.
- Acts as a resource for hospital and medical staff performance improvement. Consults with identified hospital or medical staff to understand the HCT Quality Management Program requirements, QI process, their relationship to FACT Accreditation requirements, and in general to improve care and services.
- Analyzes and stratifies data, identifies trends and uses quality improvement theory for interpreting statistical variation and control, acting on findings and formulating plans for continued evaluation/improvement. Provides reports to the HCT Program Director and associate directors as well as administrative leadership of HCT services at COH, regarding deviations from standard operating procedure, including impact on quality, resources, and/or cost of care, and recommendations for correction
- Takes action on issues that need improvement, while identifying any current systems that are barriers to improvement. Facilitates the development of HCT-related clinical pathways to standardize care and resource utilization.
- Assists with HCT Program education activities for department and medical staff and assists the director in developing educational plans for the department around performance improvement.
- Provides just-in-time and formal education related to improving quality. Serves as an internal resource for PDSA, FMEA and other improvement methodologies. Works closely with HCT services QI team and members of the multi-disciplinary HCT Quality management program to monitor quality and develop improvement strategies.
- Uses available technology to enhance documentation, track outcomes and communicate with other care providers.
Basic education, experience and skills required for consideration:
- BSN or BS/BA in related/complementary field required. A background in a related field such as medical technology, blood banking, or quality management with appropriate experience may substitute for the education requirement with VP approval.
- Content expert in quality improvement concepts plus minimum of 5-7 years of nursing and/or health care leadership experience.
- One to two years of quality improvement experience, to include consultation or direct work in process improvement or rapid cycle improvement, systems thinking concepts, team facilitation, performance measurement and/or stratification of data.
- An ideal candidate will have experience in Clinical Hematology/Hematopoietic Cellular Therapy Transfusion medicine services or solid organ transplant program.
- Content expert in quality improvement concepts, ongoing education and training related to the field of cellular therapy and quality management (FACT standard and CIBMTR requirements).
- Requires strong interpersonal and facilitation skills to work effectively with HCT program members from multiple organizations, to include leading meetings, coordinating program activities such as Standard Operating Procedure (SOP) development, and negotiating differences of opinion regarding program direction.
- Requires proficiency in data analysis required by both internal and external reporting (e.g. accreditation and payer networks).
- Independent judgment, analytical ability to problem solve, make decisions, formulate reports, perform statistical analysis and interpret data, create and monitor work plans (e.g. in preparation for accreditation surveys), prioritize workload, and meet deadlines.
- Strong writing skills to support accreditation, SOP development, and other quality-related responsibilities.
- Ability to take action on quality issues while challenging the existing systems.
- Knowledgeable of federal, state, local and other accreditation/regulatory requirements.
- Microsoft Office, Excel QI Macro, Visio and other organizational software as appropriate to duties.
Preferred education experience and skills:
- Master's Degree in Nursing or in related/complementary field.
- Experience inan accredited Hematopoietic Cellular Therapy/TransplantProgram or solid organ transplant program.
- Database development or experience
- Quality Management related courses.
- CPHQ (Certified Professional in Heath care Quality), CPHM (Certified Professional in Healthcare Management), Medical technologist ASCP or equivalent as applicable.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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