Lab Quality Compliance Coordinator

Job Summary

The Laboratory Quality and Compliance Coordinator is responsible for laboratory quality, compliance, and process improvement activities of the clinical laboratory areas. This position coordinates accreditation activities for laboratory services across the organization (Laboratory and Point of Care) assists other members of the Organizational Improvement office with other hospital or ambulatory process improvement and regulatory review and compliance.

Job Responsibilities

• Provide technical and scientific oversight of clinical laboratory operations and ensure compliance with accreditation and regulatory requirements including CAP, CLIA, AABB, and COLA
• Oversee departmental policies and procedures and participate in the review and implementation of new and revised technical procedures
• Lead change management and process improvement initiatives to align operations with strategic objectives and quality improvement goals
• Provide education and resources related to quality and regulatory compliance to support staff development
• Evaluate workflow and productivity to improve operational efficiency and establish quality metrics that enhance laboratory and other hospital services
• Oversee the laboratory quality control program to ensure accurate high quality diagnostic testing and compliance with organizational and regulatory standards
• Ensure enrollment and active participation in proficiency testing programs for all laboratory testing performed
• Collaborate with vendors to evaluate products and technologies that support high quality point of care testing services
• Work with IT teams to ensure compliance and optimize system performance for LIS, BBIS, and HIS platforms
• Foster a culture of empowerment by encouraging team members to identify opportunities to improve patient care.
• Manage and provide oversight related to CLIA certification and ACHC certification requirements
• Support the Emergency Room/Urgent Care locations by overseeing point of care testing and assisting with CLIA, COLA, ACHC and IDOH inspections
• Review and validate new processes and methodologies to ensure compliance with standards
• Coordinate competency assessments for staff in order to meet regulatory requirements.
• Other duties as assigned.

Education Requirements

• Minimum: Bachelor's degree in medical technology, or chemical, physical, or biological science from an accredited institution.
• Preferred: Master's degree in clinical laboratory science, Medical Technology, and five (5) years of laboratory training or experience, or both, in high complexity testing.

Experience Requirements

• Minimum: Three (3) years' experience with Laboratory testing (general lab), quality reporting, laboratory accreditation, phlebotomy, point of care, and management. Prior experience working in a position of oversight of an analytical or quality function of the laboratory with a strong understanding of regulation and compliance is required.

License/Certification Requirements

• Minimum: MT (ASCP) registered or MLS certified. Must meet requirements for Technical Supervisor and Technical Consultant under CLIA 1988.