Program Manager, Lab Quality & Regulatory

The Program Manager, Lab Quality & Regulatory is responsible for providing laboratory quality and performance improvement expertise, coordinating regulatory acitivites, to enhance safe, cost-effective, efficient, timely, equitable patient care. This position will help facilitate achievement of organizational quality priorities and Departmental goals through monitoring, assessment, analyzing, reporting, and facilitating improvement activities of laboratory processes and outcomes. The incumbent partners with department director, lab management, lab faculty, and Quality Management by providing consultation, data analyses, reporting, auditing, occurrence report tracking and response, and assistance in the development and implementation of annual departmental quality plans. Additionally, this position will function as safety coordinator.

Function/Duties of Position

Quality & Regulatory

• Maintains Quality Assessment & Improvement (QA/QI) program for laboratory, including developing and preparing annual Departmental Quality Plan, coordinating quarterly QA/QI Committee meeting and all associated activities. In conjunction with appropriate lab leadership, review and determine relevant key performance indicators to track on laboratory indicator dashboard.

• Performs data analysis for indicators

• Maintains departmental list of performance improvement initiatives

• Facilitates quality improvement initiatives, supporting section leads

• Subject matter expert on regulations for accreditation, compliance and quality requirements

• Prepare & submit bi-annual accreditation application to The College of American Pathologists (CAP)

• Maintain test activity menus

• Maintain CAP competency program for dept.

• Maintain proficiency testing (PT) program (ordering materials, communication of shipment dates)

• Manages communications and responses to regulatory agencies (DNV, CAP, FDA)

• Maintains Lab Services OPEx plan.

• Manages CLIA certificate renewals and maintains spreadsheet of CLIA labs within OHSU

• Support staff with, performing QC audits continuous CAP compliance, and tracking of competency testing in each lab section in adherence to departmental policies and procedures

Analysis and Reporting

• Conduct on-going and focused analyses with available quality data to help indentify priorities, improvement opportunities, trends, and improved performance in all lab sections

• Develop dashboards and reports for laboratory

• Present monitoring and performance data as requested

• Perform and oversee departmental audits on various systems and topics, including but not limited to competency testing, Point of Care Testing, proficiency testing, QC performance and review, compliance with CAP and NIAHO standards, and annual QSE audits

Facilitation

• Participate in project management, change management, and performance improvement methodology in laboratory

• Serve as the facilitator with projects and priority areas assigned by Administrative Department Director.

• Lead Kaizen Events, Root Cause Analyses and/or Failure Mode Effects and Criticality Analyses

• Facilitate quarterly QA/QI meetings for the Department of Pathology

• Provide education and training on performance improvement and change management methods, tools, and activities to faculty and staff

• Provide education on indicator development and data analyses to faculty and staff

Compliance Management

• Provide and maintain records for ongoing compliance education and training

• Coordinate corrective and preventive action for areas of noncompliance as identified in periodic audits and through online reporting systems

• Perform follow-up reviews for potential noncompliant areas

Safety Management

• Conduct safety portion of interim CAP self-inspection, including documentation of deficiencies and corrective actions. Maintain continual CAP readiness in areas of checklists pertaining to safety

• Coordinate and co-chairs safety committee

• Review, revise, and maintain laboratory safety policies and procedures

• Consult with Infection Prevention and Occupational Health departments as needed

• Reviews PSI events as needed, including the identification of trends in the laboratory related to patient safety

Other Duties

• Perform other projects as requested by manager.

• Attend meetings, conferences, workshops, or training programs as requested by manager.

• Perform requirements for Staff Members as outlined in Compliance Roles and Responsibilities in OHSU Hospitals and Clinics and understands and complies with the Code of Conduct, OHSU and departmental policies and procedures, and other applicable procedures, rules and regulations.

• Communicate and works effectively as part of a team, and interacts with a variety of clients including doctors, nurses, laboratory staff and patients, maintaining a customer service focus at all times.

• Carry out job responsibilities ethically, professionally, and with personal integrity, and functions as part of the team exhibiting excellent communication, teamwork and customer service skills.

Required Qualifications

• Bachelor's Degree in Medical Technology, chemical, physical, or biological science.

• Master's Degree or evidence of progression toward an advanced degree.

• Four years of experience in a clinical laboratory with increasing responsibilities and involvement in complex projects

• Experience that demonstrates expertise in quality, performance improvement & and regulatory standards.

• MT (ASCP) or MLS (ASCP) or equivalent

• Must be able to perform the essential functions of the position with or without accommodation

Preferred Qualifications

• Master's or advanced degree in medical technology, business or healthcare related field

• Previous lead or supervisory experience

• Knowledge, experience in Lean, Six Sigma, Project Management and other performance improvement tools

• Experience with statistical flow diagram applications

• Certification in healthcare quality