Manager, Laboratory Quality Assurance & Point of Care

Employment type: Full time · Shift: Day shift

About the Role

The Manager of Laboratory Quality Assurance & Point of Care is responsible for planning, leading, and implementing the practices, technologies, statistics and medical testing considerations essential to establishing, assessing, improving, and maintaining standards for laboratory quality assurance, safety, licensure, accreditation, and regulatory compliance, in collaboration with the regional laboratory leadership team. They direct the design, development, coordination, and oversight of activities for performance improvement (PI) and total quality management (TQM) initiatives. They integrate Clinical Laboratory quality, safety and compliance efforts with improvement activities across Loyola Medicine. They direct the region's Point-of-Care Testing (POCT) and provide clinical expertise, guidance, and assure quality results for point-of-care testing services performed by qualified laboratory and non-laboratory employees while maintaining compliance with accreditation and regulatory requirements. This is a regional position covering quality and point of care operations across LUMC, MNH, GMH, Cancer Centers, and ambulatory site labs.

Responsibilities

• Oversees the total quality management (TQM) and performance improvement (PI) systems for the region.
• Serves as project manager for the design, development, coordination, and oversight of the region’s quality activities in leading performance and metrics improvement.
• In close collaboration with the Laboratories’ Medical Directors and laboratory leadership, identifies opportunities to implement quality improvement, Lean, and/or Six Sigma (or equivalent) processes to address and improve individual laboratory efficiencies and methodologies.
• Provides leadership and education for the development of a quality culture through quality management/quality unit teams to address clinical operations and utilize leading edge principles, techniques and tools in quality management, process development and control, patient safety and quality improvement.
• Supervises laboratory staff to complete ongoing quality improvement projects and initiatives.
• In consultation with the Regional Administrative Director, Medical Director, and laboratory leadership, develops and implements a regional quality management program for the regional laboratories, rapid response laboratories, and satellite laboratories, including point of care testing service, in alignment with strategic objectives of the organization and the regulatory/accreditation standards for the hospitals and laboratories.
• Collaborates and works closely with other Loyola Medicine departments in overall organizational quality and process improvement activities.
• Facilitates the development and integration of standardized quality management systems across the region.
• In consultation with the Regional Administrative Director and Medical Director, assesses and ensures the overall preparation of the regional laboratories for inspections by licensing and accrediting agencies (e.g., CAP, TJC, FDA, AABB, FACT, ASHI, State of Illinois, IDPH, City of Chicago).
• Directs compliance for biannual accreditation and interim reviews by CAP, AABB, TJC, FDA and any other regulatory agency, including the registration fees, applications, actual inspections and conferences, and responses to all deficiencies.
• Conducts follow-up consultation with laboratories to correct deficiencies following an inspection.
• Maintains records of all inspection activities for reference as required by regulations.
• In consultation with the Regional Administrative Director and Medical Director, participates directly in establishing, implementing, maintaining, and monitoring quality assurance, performance standards and compliance of the regional laboratories.
• Participates in inter-laboratory surveys, peer review assessments, and other quality improvement initiatives.
• Represents the laboratories (as a region and individually) on Loyola Medicine committees as assigned.
• Participates in Loyola Medicine operational excellence and performance improvement events as needed.
• Communicates Quality Management information regarding performance improvement activities and corrective actions to laboratory leadership and Loyola Medicine departments as necessary.
• Facilitates the regional laboratory quality council