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.
Position 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 meetings.Responsible for the regional technical and administrative oversight of Loyola Medicine's Point of Care Testing (POCT). Standardizes POCT processes, documentation, accreditation and compliance, education, and competencies across the region. Works collaboratively with nursing and physician leadership to maintain, recommend, assess and implement POCT instrumentation- based patient care, operational, and financial data. Supervises POC-coordinators across the region. Ensures that POCT across the region produce accurate test results, competency of non-lab staff performing the tests appropriately documented in accordance with accreditation standards and guidelines, and all testing compliance and lab safety standards are adhered to.Receives VOICE reports, investigates and resolves in coordination with involved areas (both inside and outside the Laboratories). Provides feedback appropriately to all care providers as related to performance issues and adverse events. Facilitates the use of the tracer methodology for maintaining regulatory preparedness. Documents that corrective actions are identified, implemented and assessed. Evaluates laboratory data and other information to assess methodologies, logistics and strategies designed to optimize laboratory service and utilization and correct recurring problems. Utilizes the regional EMR (Epic), Laboratory Information Systems (Sunquest, CoPath, Histotrac), and other information systems as needed to answer surveys, troubleshoot problem reports and/or patient events, quality improvement initiatives, and for statistical analysis.Requirements:
Bachelor's degree in Medical Technology, or other laboratory science. Master's degree in Business or Healthcare Administration preferred.6-10 years of previous job-related experienceMust have previous clinical laboratory experience in progressing roles. Experience in laboratory regulatory, compliance, and accreditation preferred.Management experience preferred.Licensure/Certifications:
Certified Medical Technologist, Medical Laboratory Scientist, laboratory discipline specific or specialty certificate (ASCP or AMT)Six Sigma Green BeltAt Gottlieb Memorial Hospital, we know you’re more than your job. We see you and all of your potential. That’s why we invest in our people. Clinical advancement programs, flexible scheduling, tuition reimbursement and day one benefits… at Gottlieb, what’s important to you, is important to us. Join our family.
Benefits from Day OneDaily Pay Career DevelopmentTuition ReimbursementOn Site Fitness Center (Gottlieb Memorial Hospital & LUMC)Educational StipendCertification reimbursement (up to 1 certification)Referral RewardsOur Commitment to Diversity and Inclusion
Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.