Website Yale New Haven Health
Yale New Haven Health
Company : Yale New Haven Health
To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values – integrity, patient-centered, respect, accountability, and compassion – must guide what we do, as individuals and professionals, every day.
This position reports to the Cellular Therapy Program Manager. There is also an indirect reporting relationship to the Smilow Director of Quality and Safety. This position has responsibility and accountability for coordinating, planning, and maintaining overall quality management for the Adult and Pediatric Cell Therapy Programs at Yale New Haven Hospital, as well as for improving key processes, policies and procedures as they relate to regulatory compliance with all applicable agencies (e.g., FACT, FDA, NMDP, AABB, TJC, CMS, etc.). The incumbent is responsible for coordinating all quality activities for the Adult and Pediatric Cell Therapy Program, including CIBMTR, NMDP, requests for QA and patient data from insurance companies and all hospital and program related internal quality initiatives. The position is responsible for the analysis of quality and performance improvement including responsibilities for coordination and collection of data, analysis, and trending of required regulatory indicators (internal and external), process measures and clinical outcomes measures. This position interacts closely with Apheresis and Cell Therapy Laboratories to assure compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards and other quality measures identified by program leadership. This position also serves to educate staff and providers throughout the hospital on regulatory/accrediting requirements to promote readiness and ongoing compliance. This position is also responsible for integrating new cellular therapy products into current program policies and SOPs. In this capacity, the Cellular Therapy Quality Manager is expected to develop and maintain professional affiliations to keep abreast of the regulatory requirements for Cellular Therapy in both the outpatient and inpatient hospital settings.
1. Develops, revises, and maintains a quality management plan for the Adult and Pediatric Cell Therapy Program, integrating and aligning the clinical program with the quality management plans for collection and processing activities.
2. Serves as a resource and consultant for quality activities to all members of the Program, including but not limited to, medical staff, nursing, cell therapy coordinators, data registry and others, such as apheresis, cell therapy processing laboratory, and blood bank.
3. Facilitates the coordination of multidisciplinary efforts regarding regulatory readiness (e.g., self-assessment, measurement of success data, corrective action plans). Provides leadership in meeting goals and objectives.
4. Communicates among the clinical, collection and processing services to ensure that the entire program functions cohesively.
5. Ensures that the Program is prepared for regulatory site visits and coordinates site visit logistics (hosts, escorts, scribes, etc.). Maintains associated applications, checklists, and other documents related to regulatory/ accreditation compliance.
6. As necessary, leads, facilitates, and coordinates projects to improve clinical and non-clinical areas with regard to the Program. Interacts with managers, staff, department heads, clinical service coordinators, vice presidents, and chiefs of respective departments in relation to projects.
7. Conducts audits to ensure the quality management system is operating effectively; analyzes collected data, and coordinates multidisciplinary corrective action plans and quality improvement activities within the Program.
8. Prepares periodic reports regarding quality activities, and presents to the Program’s executive management at least quarterly on the status of the quality management system. Compiles and prepares the Program’s Annual Report in conjunction with quality personnel from key support services.
9. Coordinates Program’s quality meetings including agendas, minutes and attendance logs.
10. Facilitates educational activities related to the field of Cellular Therapy, Safety, and Quality to ensure that all areas receive continuing education.
11. Other projects, assignments and responsibilities as indicated.
Master’s degree required (nursing or other healthcare specialty related to Cellular Therapy. RN, CLS, or MT(ASCP) licensure/board certification required.
Three (3) to five (5) years of progressive clinical or technical experience required with at least one (1) year in a management/leadership role. Required three (3) to five (5) years of experience in healthcare with demonstrated teaching experience, and process improvement with healthcare/ laboratory operations and experience with high level analytical tools. Experience and knowledge of FACT/AABB standards and survey accreditation process preferred.
Will vary depending on clinical specialty
Proven analytical/problem-solving skills. Outstanding communication, presentation, and facilitation skills. Strong computer skills (e.g., Microsoft PP and Excel) and demonstrated ability to successfully lead process change are needed. Strong management skills and communication skills and very strong planning skills are required.
Working knowledge of SOP writing, management of SOPs. BMT/Cell Therapy experience.Quality and managerial experience preferred.