Medical Director, Clinical Laboratory Improvement Amendments (CLIA)

The Medical Director, Clinical Laboratory Improvement Amendments (CLIA), provides physician leadership and medical oversight for clinical laboratory testing performed under the organisation's CLIA certificates.

This role partners with laboratory, quality, compliance, and operational leaders to establish standards, evaluate performance, address risk, and advance safe, effective patient care.

Essential Functions

• Ensure lab is in compliance with CAP accreditation requirements
• Serve as the laboratory director or medical director for assigned CLIA-certified laboratories
• Provide medical, scientific, and clinical oversight to ensure laboratory testing is accurate, reliable, timely, and appropriate for patient care
• Ensure adequate qualified personnel, supervision, policies, procedures, equipment, facilities, safety practices, and quality systems are in place
• Approve and periodically review the laboratory's test menu, methodologies, reference ranges, validation or verification studies, procedures, and significant changes before implementation
• Ensure quality control, quality assessment, proficiency testing, calibration, maintenance, competency assessment, and corrective action processes meet applicable requirements
• Review laboratory performance data, proficiency testing results, quality indicators, complaints, incidents, patient safety events, and audit findings
• Direct timely investigation and corrective action when needed
• Ensure testing personnel meet applicable education, training, experience, licensure, and competency requirements
• Provide consultation to clinicians regarding test selection, specimen requirements, result interpretation, limitations, critical values, and appropriate use of laboratory services
• Establish or approve processes for reporting critical, abnormal, corrected, and potentially erroneous results
• Partner with laboratory operations, compliance, quality, infection prevention, information technology, and clinical leaders to maintain regulatory and accreditation readiness
• Participate in inspections and surveys, review cited deficiencies, approve corrective action plans, and verify sustained remediation
• Evaluate emerging technologies, testing platforms, and clinical practices and provide medical guidance on implementation, utilisation, and patient impact
• Chair or participate in laboratory governance and quality committees and communicate material risks, trends, and recommendations to executive and clinical leadership
• Remain accessible to the laboratory as required and arrange qualified coverage when unavailable
• Reference lab oversight

Minimum Qualifications

• MD or DO with ABMS or equivalent AOA Board Certification in a relevant specialty
• Active Medical Licensure
• Minimum three years of clinical experience in relevant specialty and experience in leading successful quality improvement projects within the clinical setting
• Effective verbal, written, and interpersonal communications skills

Preferred Qualifications

• 3 plus years of experience as a Medical Director of a CAP accredited laboratory

Physical Requirements

• Interact with others requiring employee to verbally communicate as well as hear and understand spoken information
• Operate computers, telephones, office equipment, and manipulate paper requiring the ability to move fingers and hands
• See and read computer monitors and documents