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Provides oversight and leadership of all quality management activities carried out in all areas of transfusion medicine for two medical center facilities. Provides guidance to the department in regards to meeting the requirements of regulatory and accrediting agencies for patient testing and blood product manufacturing. Demonstrates a level of working knowledge of the following agencies (as appropriate): Food and Drug Administration (FDA); California Department of Public Health (CDPH); Center for Medicare and Medicaid Services (CMS); Joint Commission (JC); AABB (formerly American Association of Blood Banks); and College of American Pathologists (CAP).
Responsibilities: Plans, coordinates, and leads all areas of the Division of Transfusion Medicine in activities related to quality, and compliance/regulatory affairs. Communicates quality activities to management. Coordinates the design, collection, and monitoring of quality measures/metrics for reporting to sectional/departmental management for quality assurance providing objective, unbiased observations to ensure compliance with current manufacturing practice as defined by FDA. Acts as liaison to departmental quality committees and managers. Works with the Pathology quality management team to ensure the Blood Bank is in compliance with all departmental and institutional standards and regulations. Manages the transfusion medicine service quality plan, which consists of policy and process documents that direct quality functions of all Blood Bank operations.
Coordinates sectional preparation for all regulatory reviews. Provides reports to external regulatory/accrediting agencies as required. Serves as a transfusion medicine primary contact and liaison with all external regulatory and accrediting agencies. Performs internal assessments and audits, to assess the effectiveness of process improvement initiatives, and to report to the transfusion committee regarding the status of current good manufacturing practices. Assists areas with the development of validation plans and documents appropriate for the process/equipment being validated, and provides assistance with data analysis, as needed. Ensures that adequate validation procedures are performed.
Facilitates appropriate change management activities within the division in response to new and/or revised regulatory or accrediting agency requirements. Integrates new quality management directions into Blood Bank operations. Participates in writing, approval and implementation the Blood Bank documents and implements new versions of policies and procedures. Monitors and assesses compliance training and maintenance of current good manufacturing practices program. Participates in occurrence management. Prepares and reviews error documentation to assure that corrective action is taken when required. Reviews and summarizes/refers periodic quality reports. Coordinates with the nursing services on issues related to quality of services.
Provides educational instruction to the pathology residency and clinical lab science program on the development and management of a quality systems program. Acts as an informational sciences resource to section. Designs, collects, formats, and interprets statistics as required by regulatory agencies, using various information systems as sources of data to compile monthly reports, performance measures, quality assurance reports, and transfusion committee reports, among others. Performs CGMP training for all Blood Bank employees and ensures that production personnel follow CGMP. Collaborates with transfusion medicine information systems staff on the evaluation, proper use of, and development of transfusion medicine information systems.Monitors the proper integration of transfusion medicine information systems with laboratory and hospital information systems. Performs other duties as required or assigned.
Clinical Laboratory Scientist (CLS).
Must have at least five (5) years experience of applicable clinical laboratory experience.
A Bachelor's Degree.
Blood Bank compliance.
Transfusion medicine liaison.
Experience with designing, collecting, formatting, and interpreting statistics as required by regulatory agencies.
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