Medical Director, Clinical Laboratory Improvement Amend (CLIA)

Essential Functions

• Ensure lab is in compliance with CAP accreditation requirements
• Serve as the laboratory director or medical director for assigned CLIA-certified laboratories, as designated, and fulfill all responsibilities applicable to the laboratory’s testing complexity, specialties, and subspecialties.
• 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 for the scope and volume of testing performed.
• 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 and that delegated duties are assigned to qualified individuals.
• 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 and for communicating information that may affect patient care.
• 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, utilization, 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. Select and continuously monitor reference laboratories for service quality, analytical performance, and licensure.

Skills

• Leadership
• Interpersonal Communication
• Relationship Building
• Strategic Planning
• People Management
• Continual Improvement Process
• Workforce Planning
• Health Administration
• Medical Staff Training
• Health Care