Quality & Regulatory Manager - Blood and Marrow Transplant and Cellular Therapy
Fairview Health Services
Location: Minneapolis, Minnesota
Internal Number: 2021-80693
The Quality and Regulatory Manager for Blood and Marrow Transplant & Cellular Therapy Program (BMT & CT) is responsible for operational oversight and facilitation of the BMT & CT Programs initiatives to improve the quality of care, patient safety, and patient experience provided to adult and pediatric BMT & CT patients. This role will work with the director, operational team, quality improvement consultant and physician leadership and other roles to develop and implement best practice guidelines & protocols, to ensure the electronic medical record supports the quality and best practice initiatives, to implement metrics to help the BMT & CT Program to measure and improve clinical and financial performance as well as to drive process improvement projects that improve performance and results. This role will have the oversight for audits for regulatory compliance, policies and procedures, compliance plan, corrective action plans, Quality steering committee, and collaboration with the Quality Improvement Consultant on the QAPI or Quality Management plan.
The Quality and Regulatory Manager will coordinate the development implementation and monitoring of improvement efforts to assure that clinical, safety or other quality metrics are meeting national best practice metrics and accreditation standards. The Manager will lead project teams, create accountability for progress and ensure project completion.
This role will work with the director of BMT & CT, BMT & CT operations Manager, Quality Improvement Consultant and physician leadership to develop and implement best practice guidelines, SOPs, & protocols, to ensure the electronic medical record supports the quality and best practice initiatives, to implement metrics to help the BMT Program to measure and improve clinical and financial performance as well as to drive process improvement projects that improve performance and results.
Responsible for the submission and achievement of the FACT accreditation initiatives/ standards, management of SOPs and protocols for FACT, CMS, TJC, and Department of Health, FDA accreditation and mandatory submissions for cellular therapies in collaboration the quality improvement consultant. Assures that systems and processes are in place to achieve accreditation requirements.
The Clinical Program Quality Manager must have an active role in preparing, reviewing, approving, or implementing QM policies and SOPs and must confirm that the SOPs are in compliance with FACT-JACIE Standards and all Applicable Law before implementation. (i.e. CMS, TJC, FACT, FDA CAR T products).
Responsible for reviewing and understanding new/old FDA approved cell therapy products along with clinical trials on cellular therapies to ensure that we are compliant with FACT and FDA regulations and provide guidance on developing order sets, SOP updates, education and training changes needed to meet the requirements; working in collaboration with the Quality Improvement Consultant.
Work in collaboration with the Quality Improvement Consultant to co-lead Quality Improvement efforts and develop the BMT & CT quality management plan.
Responsible for development of transplant MD, APP, Learners, nurse coordinator staff education and clinical competency needs for FACT, Cellular Therapy, and other requirements.
Leads all Regulatory responses required of the BMT & CT collaborating with the BMT Director, Operations Manager, Quality Improvement Consultant. Responsible for the adverse event reporting, and corrective action plans.
A key role of the Quality Manager is to develop systems for auditing Clinical Program activities to confirm compliance with the written policies and SOPs.
The position requires proficiency in reviewing and understanding regulatory and compliance requirements, identifying gaps, and facilitating solutions to meet standards as specified by but not limited to FACT, FDA, CMS, JC, and the Minnesota Department of Health. Maintains knowledge of current and developing accreditation standards through accessing and/or participating in BMT professional societies, reporting agencies, and accrediting bodies.
Collaborates with operations/clinical colleagues on clinical and regulatory indicators for BMT & CT population and diseases working with the BMT data analyst and the Quality Improvement Consultant.
In addition to these responsibilities, the Quality and Regulatory Manager plays a lead coordinating role in the achievement of accreditation initiatives/standards, management of standard operating procedures, and payer/other site visits. The Manager works with the with the BMT & CT team to support completion of payer RFP responses.
Ensures that structures and processes are in place to drive a focus on improving quality and developing best practice protocols. Ensures the protocol development is integrated with clinical research priorities.
Coordinates the identification, assessment, and prioritization of opportunities for clinical protocol development and quality improvement efforts.
Works in collaboration with the Quality Improvement Consultant to provide direction for the planning, design, and implementation of quality and patient safety improvement efforts.
Identifies best practice and benchmark targets and implements systems to measure program clinical performance.
Determines the most appropriate improvement methodologies and allocation of resources to implement improvement initiatives.
Drives and develops a process to develop and maintain clinical guidelines, protocols, and standard order sets to drive standardization to evidence based best practice.
Connects to the organizational quality structure through attending meetings, reporting status of quality initiatives, and leading/supporting root cause analyses.
Leads identification and assessment of process improvement opportunities working with performance improvement teams and by providing benchmarking analysis to promote understanding of how BMT compares with top performers.
Promotes Patient Safety: Monitors, reports and influences patient safety in the inpatient units and outpatient clinics. Reviews patient incident report trends and assists clinical operational leaders with quality monitoring, and process improvements to improve patient safety. Reports metrics to Operations and Leadership teams. Works with the operational team in identification and assessment of root causes and recommendations to minimize patient safety issues.
Bachelor's degree in healthcare management or related healthcare field, or
Bachelor's in nursing
10+ years experience in a clinical setting including clinical experience
Significant experience with process improvement related to clinical quality and safety.
Working knowledge of accreditation requirements and other healthcare regulations that impact quality and safety initiatives.
Strong written and verbal communication skills.
Ability to facilitate groups and work in a collaborative manner.
Demonstrated success in working with physicians and other clinicians.
Education and experience in measurement and benchmarking.
Advanced degree in a relevant area related to healthcare clinical quality and patient safety.
Experience and knowledge of blood and marrow transplant, transplant standards (FACT, AABB) and experience with accreditation process.
Formal training and certification in one or more aspects of QM is encouraged, but not required.
Formal training may include practical work experience in a facility, fellowship, or certification
Together with the University of Minnesota and University of Minnesota Physicians we have created M Health Fairview. M Health Fairview is the newly expanded collaboration among the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine — expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.
Fairview Health Services (fairview.org) is an award-winning, nonprofit health system providing exceptional care across the full spectrum of health care services. Fairview is one of the most comprehensive and geographically accessible systems in the state, with 10 hospitals—including an academic medical center and long-term care hospital—serving the greater Twin Cities metro area.
Its broad continuum also includes 60 primary care clinics, specialty clinics, senior living communities, retail and specialty pharmacies, pharmacy benefit management services, rehabilitation centers, counseling and home health care services, medical transportation, an integrated provider network and health insurer PreferredOne. In partnership ...with the University of Minnesota, Fairview’s 32,000 employees and 2,400 affiliated providers embrace innovation to drive a healthier future through healing, discovery and education.