CLIA Lab Consultant

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Client Summary

CLIA Lab Consultant, seasonal professional in clinical lab management, with over 20 years of expertise in the field. With a deep understanding of CLIA standards and extensive experience in laboratory operations, I have a proven track record in enhancing lab efficiency, compliance, and diagnostic accuracy. As a recognized leader in the industry, I’m a CLIA lab consultant who not only led significant improvements in existing laboratory setups but also excelled in guiding new lab establishments to achieve CLIA certification and operational excellence. My skills are indispensable for labs aiming to maintain the highest standards of clinical accuracy and regulatory compliance.

CLIA Consultant Highlights

• 20+ years in diagnostic medical testing
• Private Corporation experience
• Expert in CLIA / CAP / ISO15189/State Regulations
• Clinical Laboratory expertise: Molecular diagnostics (infectious disease testing), immunology, clinical chemistry, flow cytometry, and mass spectrometry technologies • Business / Lab Management & Planning Experience
• ABMLI Certified; qualified to direct high complexity medical diagnostic laboratories
• New Laboratory Services Rollout experience
• Molecular Diagnostics; Molecular Biology
• Assay Development
• Infectious Diseases

Accomplishments as CLIA Clinical Consultant

  • Established new start-up clinical labs, from the ground up through CLIA, COLA, and CAP accreditation for multiple clients.
  • Optimized, validated, and launched novel Laboratory Developed Tests for multiple clients.
  • Developed quality assessment programs to ensure comprehensive monitoring of pre-, post-,and analytic processes to monitor testing performance and detect issues in a timely manner and develop effective corrective action plans when necessary.
  • Managed the registration activities (management review, auditing, training, resource staffing) for a ISO quality management system for a network of 86 warehouses for food distribution 3PL within 2 years awarding us an additional $8M in business
  • Responsible for overall operation and administration of a CLIA laboratory, ensuring that all duties were properly performed and applicable to CLIA regulations; Hired and maintained qualified personnel; Developed an effective quality system approach to laboratory testing that provided high accuracy and reliable patient test results.
  • Developed and implemented the clinical, technical, fiscal, and quality programs of a diagnostic testing laboratory for corporation in a manner consistent with the needs of clinicians, customer hospitals and labs, and goals of the corporation. Oversaw validation and launch of new Laboratory Developed Tests and ensured that all activities were in full compliance with all regulatory requirements.
  • Acted as subject matter expert for infectious disease testing, focusing on biological threat agents as part of the Federal Select Agent Program (FSAP).
  • Planned and developed policies and procedures to ensure robust North Carolina statewide laboratory biosecurity and biosafety program that encompassed a continuous process of biological hazard recognition, accurate assessment, and comprehensive testing response.

Previous Consultant and Director Roles

    • Consultant
    • CLIA Laboratory Director
    • Director, Laboratory Operation
    • Quality Manager
    • Manager

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