CLIA/CAP Laboratory Compliance Consultant

Request Expert / Similar Expert

Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs

Client Summary

I am an experienced molecular biologist and Clinical Services Director with over 20 years in cancer biology research, molecular biology, next-generation sequencing services, and clinical genetic testing. My experience includes four years of building and directing a molecular testing laboratory, developing new tests such as cystic fibrosis, True Sight cancer, custom cancer panels, pharmacogenomics panels, urine tract infection tests, and Covid-19 testing and sequencing. I am a well-versed clinical laboratory consultant in CLIA, CAP, and NY state regulations, laboratory operations and management, assay development and validation, and have a strong background in Quality Assurance program development and practice. Additionally, I have over four years of experience in clinical genetic testing lab operations, encompassing costing, labor forecasting, hiring, staffing, workflow planning, and developing business plans for laboratory rollouts.

Laboratory Consultant Highlights

• 20+ years in molecular biology assays
• Private Corporation experience
• Expert in CLIA / CAP / NY State Regulations and Certification
• Laboratory Compliance Consultant
• Clinical Laboratory expertise: Molecular diagnostics (infectious disease testing), next-generation sequencing, and genetic testing technologies
• Business / Lab Management & Planning Experience
• Qualified to direct high-complexity medical diagnostic laboratories in Pennsylvania
• New Laboratory Services Rollout experience
• Molecular Diagnostics; Molecular Biology
• Assay Development
• Infectious Diseases

Accomplishments as Laboratory Consultant

• As a laboratory compliance consultant established a new genetic testing lab, from the ground up through CLIA and CAP accreditation.
• Optimized, validated, and launched novel Laboratory Developed Tests.
• Developed quality assessment programs to ensure comprehensive testing performance detect issues in a timely manner and develop effective corrective action plans when necessary.
• Responsible for the 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 and quality programs of a diagnostic testing laboratory for a corporation in a manner consistent with the needs of clinicians 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 next-generation sequencing and high throughput real-time PCR testing, focusing on cancer germline mutation detection and pharmacogenomics clinical testing.

Previous Clinical Director and Lab Consultant Roles

• • GLP study director
  • CLIA/CAP Laboratory NGS Director
  • GCLP study director
  • Genomic Scientist of Molecular Pathology

Education/Certifications

• • Ph.D. in Biomedical Science
  • Post-doctoral training, Institute for Cancer Genetics

Request Expert / Similar Expert

Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs