Bone Marrow Transplant Quality/Compliance Manager

Job Description

The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance will facilitate implementation of Quality Management principles and tools so that optimal quality of care and research & the highest level of patient safety and outcomes can be achieved. The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance oversees all quality assurance, quality improvement and regulatory compliance activities of the BMT Program, including Perioperative Services bone marrow collection, BMT and Hematology inpatient and ambulatory clinic areas and Cellular therapy. In addition, the Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance may be asked to assist with quality and process improvement activities for other areas such as inpatient units. The Manager, Bone Marrow Quality & Regulatory/Accreditation Compliance will collaborate with leadership, clinical customers, and unit staff on quality projects.

Responsibilities

Quality Manager - 30%

• Serves as the Bone Marrow Transplant resource to establish and maintain systems to review, modify and approve all policies and procedures intended to monitor compliance with the FACT standards and/or performance of the Clinical Program.
• Develop systems for auditing Clinical Program activities to confirm compliance with the written SOPs and policies.
• Oversees the day to day management of the Clinical Program quality management plan.
• Assess the stability, reproducibility and effectiveness of critical processes in order to continually improve the programs efficiency and patient outcomes.
• Communicates trends and opportunities for improvement to key process owners.
• Responsible for the oversight of staff training, development and execution of validation plans, auditing clinical and collection activities for compliance with all accrediting and regulatory facilities, monitoring all equipment maintenance and provide quarterly reports to Bone Marrow Transplant Clinical Program supported by Hoxworth Blood Center collection and processing facilities.
• Chairs BMT Program Quality meeting, prepares agendas and minutes of meetings in a timely manner and ensures completion of meeting action items.
• Prepares an annual quality report meeting all the FACT guidelines.
• Manages archiving and retention of outdated documents.
• Manages Operations Committee.
• Serves as a facilitator for Swarms in assigned areas where appropriate.
• Oversees the Data Management collection, entry and submission of data to CIBMTR.
• Assists with oncology service line quality outcomes.
• Assists with the completion of payer RFIs. Manages projects as assigned.

Accreditation and Regulatory Compliance - 30%

• Responsible for accreditation surveys and readiness.
• Serves as the organizational resource on interpretation of FACT (Foundation for the Accreditation of Cellular Therapy) standards, as well as, the Joint Commission standards, CMS Conditions of Participation and ODH by developing and maintaining expert knowledge.
• Monitors and manages all FACT standards.
• Manages, coordinates and directs operational and patient care services in ongoing survey readiness.
• Coordinates inspections by regulatory and accrediting agencies, prepares response to inspection reports and ensures timely implementation of corrective measures.
• Serves at the organization liaison to UC Health Corporate Compliance department.
• Assists them with the development of auditing priorities, action plans and ongoing audits to ensure compliance.
• Develops regulatory reports to be presented to UC Health Governing Body.
• Provides education and collaboration to hospital departments and managers to assure current knowledge of appropriate standards.
• Designs, organizes and implements systems for tracking, evaluation and reporting efforts and outcomes relative to standards set by accrediting and regulatory agencies.
• Assures continuous readiness thru ongoing evaluation of compliance.
• Provides reports and feedback to Senior Leadership regarding readiness status including timely reports of gaps or potential gaps in readiness.
• Coordinates with GME to get competencies for medical students and residents.

Operational Quality Control and Quality Assurance - 30%

• Collaborates with bone marrow collection facility staff to ensure proper equipment performance testing, preventive maintenance/ calibration, and malfunction documentation and ensures that equipment consistently meets performance requirements.
• Ensures the management of bone marrow collection facility supplier qualification and monitoring processes and environmental control and monitoring systems.
• Plans, prioritizes, delegates and manages the writing and revisions of all SOPs, forms and other documents.
• Responsible for proper document control of all required SOPs.
• Coordinates management of the change control process.
• Responsible for preparation of validation protocols, documentation of results, statistical analyses and generation of reports and ensuring appropriate approval of validation results prior to implementation.
• Collaborates with other departments when revisions to their policies/procedures are required and/or needed for accreditation requirements.
• Manages all deviations, evaluates corrective action taken and communicates relevant information to appropriate stakeholders.
• Evaluates any preventative actions needed to help decrease recurrence of trends, ensures implementation and documentation of any preventative action taken and evaluates effectiveness of such actions.
• Manages process for documentation, investigation and reporting of adverse reactions to cell product collection or infusion and product deviations, collaborates with Hospital Legal Services to report as needed to FDA and other external parties.
• Documents and evaluates all verbal or written complaints that allege communicable disease transmission, impaired function or integrity of cell products, or other potential product deviations and investigates and reports as required in collaboration with Hospital Legal Services.

Education and Communication - 10%

• Provides education and mentoring to managers, staff and physicians to assure attainment of program goals.
• Conducts audits to ensure regulatory compliance.
• Assists in the development of quality education tools.
• Develops and reports effective outcome measures for the regulatory compliance program.
• Coordinates Physician annual education to ensure regulatory compliance. Utilizes diverse communication and education strategies to assure the integration of regulatory compliance practices by all staff, volunteers and physicians utilizes systems thinking to identify causes and solution to errors.
• Utilizes statistical processes and uses dynamic data displays to provide information to front line care givers in a timely manner.

Qualifications

• Minimum Required: Bachelor's Degree In health care required
• Preferred: Master's Degree
• Minimum Required: 3 - 5 Years equivalent experience; 5 years clinical experience preferred with experience in cellular therapy
• Preferred: 3 - 5 Years equivalent experience; Knowledge in field of quality and clinical data analysis experience in hospital/health care setting preferred.
• Formal training or experience in patient safety.