Laboratory Compliance Manager presso Wilmington Health

Title: Laboratory Compliance Manager Department: Lab

FLSA Status: Exempt Reports to: Director of Ancillary Services

Job Number: Approved/Revised Date: 10/1/2024

About Wilmington Health

Since 1971, Wilmington Health has been committed to the care and health of our community in Wilmington as well as all of Southeastern North Carolina. Wilmington Health is a multi-specialty physician-owned medical practice with integrated primary care. In this way, Wilmington Health is able to provide a comprehensive and coordinated approach to the care of all our patients. Wilmington Health is committed to using collaborative, evidence-based medicine in providing the highest quality of care to the patients we serve.

Purpose:

Provides managerial-level services and oversight of all laboratory compliance efforts within the organization.

Essential Duties/Responsibilities:

· Reports directly to the Director of Ancillary Services for the overall functions of laboratory compliance.

· Serves as the Technical Supervisor and Technical Consultant for Wilmington Health’s laboratories.

· Works with the Physician Lab Director and Director of Ancillary Services to plan, develop, and implement a Quality Assurance Plan.

· Manages, monitors, and evaluates practices and procedures in accordance with CLIA regulations at all laboratory locations.

· Prepares reports and key performance indicators for regular evaluation of compliance performance.

· Reviews and approves laboratory reports for quality assurance and quality control for accuracy and completeness.

· Coordinates and develops SOPs for laboratory operations.

· Develops and oversees a competency assessment program for laboratory staff.

· Coordinates and performs QA Plan audits.

· Monitors and maintains a QA database that contains QC reviews, instruments calibrations, etc.

· Evaluates and makes recommendations on new analytical methods and instrumentation for use, the purchase of prepared reagents, and the outsourcing of laboratory analyses.

· Provides technical expertise and troubleshooting assistance.

· Performs other related work as required or assigned (and/or delegated by the Laboratory Director).

· Serves as a Lab Tech when needed for benchwork to maintain competency and/or in conjunction with Technical Supervisor duties.

Other Duties:

· As assigned by Physician Lab Director, Director of Ancillary Services, and/or administration of Wilmington Health

QUALIFICATIONS

Required:

· Must meet the CLIA requirements for Technical Supervisor.

· Minimum education of a BS degree in Medical Technology or one of the physical or biological sciences, and professional certification by a recognized certification agency (ASCP, AMT, etc.); minimum experience of four years, generalist.

· Minimum of two years of laboratory leadership experience

· Ability to work independently

ADA Physical Demands:

Rarely (Less than .5 hrs/day) Occasionally (0.6 – 2.5 hrs/day) Frequently (2.6 – 5.5 hrs/day) Continuously (5.6 – 8.0 hrs/day)

Physical Demand Required? Frequency

Standing Occasionally

Sitting Continuously

Walking Frequently

Kneeling/Crouching Occasionally

Lifting Occasionally

Reaching Occasionally