Manager, Laboratory Quality Assurance & Compliance

Manager, Laboratory Quality Assurance & Compliance

Responsible for the overall management of two functional areas, quality assurance in the laboratories and point of care testing in the clinical areas. This individual will develop and manage programs for monitoring quality and advancing improvement for these entities; will collaborate with the laboratory management team to implement and maintain quality standards of operations and will assure departmental compliance with applicable regulatory requirements and with Kaiser Permanentes Principles of Responsibility. He/she will be responsible for developing and maintaining up to date policy and procedure catalogs for both functional areas; be accountable for the development, analysis and presentation of quality assurance reports to the laboratory and Senior Leadership teams as required and ensure that competency obligations for both groups of staff are fulfilled.

Essential Responsibilities:

• Quality Assurance Responsibilities: Develops the quality management strategy for the Laboratory, including QA/QI programs. Develops, implements and ensures compliance with the Laboratory Quality Assurance Plan. Assures that all laboratories are compliant with applicable policies, laws, regulations and standards. Maintains current information/knowledge of all applicable policies, local/state/federal laws & regulations, and accreditation standards. Analyzes current state, identifies gaps for specific requirements of laboratory licensing/accreditation agencies and facilitates development of action plan to address gaps. Directs lab management team in the design of policies, procedures and programs to ensure compliance w/regulatory agencies, quality of care, patient & employee safety. Uses and promotes use of PI tools throughout the Laboratory such as RIM. Develops and manages the implementation of the competency assessment program for laboratory and point of care testing. Responsible for oversight of the Laboratory Document Control system. Monitors & tracks QA/QI activities, facilitates development of action plan to address any issues. Ensures that training activities incorporate all applicable policies, laws, regulations and standards. Responsible for interviewing, selecting, training, motivating, evaluating assigned staff in compliance with the personnel policies of the organization. Manages and directs the work of the Point of Care Coordinator(s) and/or Point of Care Specialist(s) to ensure compliance with POCT regulatory requirements. Demonstrates leadership in quality activities providing technical, educational, & consultative support. Serves as a Laboratory liaison with other departments, i.e. Risk management, Compliance, as related to quality, patient safety & compliance. Performs other duties as assigned.
• Administrative Responsibilities: Direct and manage all quality assurance, compliance and point of care activities. Responsible for management, development and overall performance of direct report staff. Provide timely response to requests for reports from leadership and other sources such as SQRMC or from the laboratory seeking new procedures, for instance. Participate in departmental, regional and national meetings as required.
• Interactions & Relationships: Demonstrate and foster an atmosphere of openness and cooperation when interfacing with individuals in the laboratory and other areas. Stay abreast of all QA Compliance activities and ensure issue-resolution and information dissemination occur satisfactorily in accordance with the need to know policies of the organization. Keep the Director of Laboratory Services up to date on all matters affecting high level decisions relating to quality, compliance, budgetary and other aspects relevant to laboratory and POCT. Provide Director of Laboratory Services with pertinent data required for the upper management forums and assist with the preparation and delivery of said reports. Ensure good working relationships are maintained. Promote beneficial interactions between the laboratory and the Provider group through ongoing physician surveys or other useful means. Accountable for consistently demonstrating service behaviors and principles defined by the Kaiser Permanente Service Quality Credo, the KP Mission as well as specific departmental/organizational initiatives. Accountable for consistently demonstrating the knowledge, skills, abilities, & behaviors necessary to provide superior & culturally sensitive service to each other, to our members, & to purchasers, contracted providers and vendors.

Basic Qualifications:

• Experience: Minimum five (5) years medical technology experience post certification.
• Experience: Minimum three (3) years laboratory supervisory experience with technical training in a clinical setting.
• Experience: Minimum two (2) years in Quality Assurance and/or Compliance.
• Education: Bachelors Degree in Medical Technology or Allied Health Sciences required.
• License, Certification, Registration: GA Dept HR CLIA MT MLT Grnfthr OR American Medical Technologist Medical Technologist Certificate OR Medical Technologist Certificate

Additional Requirements:

• Good working knowledge of laboratory instrumentation, systems and processes.
• Understanding of statistical processes to monitor Quality Assurance functions.
• Working knowledge of Laboratory Information System.
• Knowledgeable in State and Federal laboratory and point of care regulationsWorking Knowledge of Microsoft Office and Excel.Ability to analyze data and interpret statistics to assist in forecasting and problem solving.
• Experience with statistical processes to monitor Quality Assurance functions.
• Proficiency in Microsoft Office and particularly Excel.
• Ability to create and manage databases.
• Strong interpersonal, written & verbal communication skills.

Preferred Qualifications:

• Minimum five (5) years supervisory experience.
• Minimum two (2) years conducting technical training in a clinical setting.
• Master of Science degree.