Quality and Accreditation Manager (Program Manager, Oncology Services)

Department Overview

The Quality and Accreditation Manager oversees quality assurance and regulatory compliance activities of the BMT and Cellular Therapy Program, including bone marrow collection, the Apheresis Unit, and inpatient and ambulatory clinical programs.

Under the joint direction of the Northwest Marrow Transplant Program Director, the Medical Director of the Adult Blood and Marrow Stem Cell Transplant and Cellular Therapy Program, and the Quality Medical Director of the Division of Hematology and Medical Oncology, the Quality and Accreditation Manager is responsible for planning, implementing, performing, maintaining, and evaluating all quality assurance and improvement activities under the scope of the position to ensure provision of the highest quality care to patients. The Quality and Accreditation Manager is responsible for regulatory and accreditation compliance including but not limited to DNV-GL, FACT, and FDA through the development, review and implementation of Standard Operating Procedures (SOPs), the development of Quality Management Plans, and other systems/processes to ensure compliance with the above organization’s standards. The incumbent will interpret regulatory regulation requirements in a way that efficiently supports and improves clinical care. The position requires meeting timely regulatory reporting requirements, ensuring adequate staff education, training and competency related to those standards, and maintaining up-to-date knowledge of all relevant standards, rules, and regulations.

Accreditation by FACT (Foundation for the Accreditation of Cellular Therapy) is a requirement of national, regional, and local insurance companies for inclusion in their transplant networks.

Function/Duties of Position

Quality Program Management:

• Establishes and maintains systems and procedures to monitor the quality of the areas under the scope of the position.
• Performs scheduled and unscheduled quality audits of processes, analyzes outcome, and process indicators for the clinical program and Apheresis Unit. Generates reports, reviews with leadership, management and other appropriate stakeholders, and makes recommendations based on results.
• Responsible for accreditation surveys and readiness.
• Ensures compliance with all applicable regulatory and accrediting agency requirements.
• Coordinates inspections by regulatory and accrediting agencies, prepares response to inspection reports, and ensures timely implementation of corrective measures.
• Communicates trends and opportunities for improvement to key process owners.
• Participates in the BMT Program Cross Functional Quality Committee and other Hematology Oncology and Apheresis Unit quality committees and workgroups as needed. Assists in preparation of agendas and minutes of meetings and ensures completion of meeting action items at the discretion of the Committee chairperson.
• Regularly compiles reports for presentations to quality committees.
• Performs a comprehensive quality audit annually of the BMT Program and Cellular Therapy Program, Apheresis Unit, and marrow collection services, and reports to program leadership on the overall performance of the  quality program.
• Prepares the NWMTP annual quality management plan reports for the BMT Program Cross Functional Quality Committee.
• Serves as liaison for the areas under the scope of this position to relevant quality committees.
• Collaborates with Clinical and Hospital Quality Management staff for completion and review of relevant Hospital Event Reports.
• Participates in projects as assigned.

Operational Quality Control and Quality Assurance:

• Plans and facilitates the writing and revision of SOPs, forms, and other critical documents.
• Responsible for the document control process of all required SOPs, forms, and other critical documents needed for accreditation requirements. 
• 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.
• Coordinates reporting of all Clinical Program and Apheresis Unit 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.
• Coordinates with the Apheresis Unit to ensure documentation, investigation, and reporting of adverse reactions to cell product collection and p