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Summary
This Clinical Laboratory Operations Expert is a highly experienced Chief Operating Officer (COO)/CLIA Director/Clinical Laboratory Consultant/Professor specializing in laboratory operations and regulatory compliance. He has a proven track record of success in leading complex clinical laboratory settings. Currently, He is leading strategic business units at the Chicago Internal Medical Practice and Research (CIMPAR). He has been instrumental in establishing and growing the Clinical Laboratory and Mobile Diagnostic Imaging Business Units within CIMPAR. His expertise lies in operational excellence and clinical laboratory regulatory compliance. He has extensive expertise with CLIA regulations and all clinical laboratory accrediting agencies’ standards (CAP, TJC, COLA, AABB, et cetera). He is a fellow of the Association of Clinical Scientists, demonstrating his commitment and expertise in laboratory methods for elucidating, diagnosing, and treating human diseases. He has informed clinical laboratory quality standards in formal and peer-reviewed mediums and has presented clinical laboratory scientific and regulatory issues in various symposia. He has a robust understanding of laboratory operations and quality assurance gleaned from directing clinical laboratories across prominent healthcare institutions with nuanced insights into the complexities of diagnostic testing result communication. In addition to executive responsibilities, he has served as a self-employed Clinical Laboratory Consultant, offering specialized expertise in toxicology and hematology malpractice cases. Notably, he has leveraged his knowledge and experience to act as an expert witness, providing critical insights and testimony to support legal proceedings.
Highlights
- 20+ years in diagnostic medical testing
- Expert in CLIA / CAP / TJC / COLA/ ISO15189/State Regulations
- Clinical Laboratory expertise: Regulatory compliance, Molecular diagnostics (infectious disease testing), immunology, clinical chemistry, hematology, toxicology, and transfusion medicine
- Business / Lab Management & Planning Experience
- Regulatory Response Expertise
- Clinical Laboratory Litigation Experience
- Assay Development
Relevant Accomplishments
- Established new start-up clinical labs from the ground up through CLIA, COLA, TCJ, 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, which monitored testing performance, detected issues in a timely manner, and developed 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, fiscal, and quality programs of a diagnostic testing laboratory consistent with the needs of clinicians, customer facilities, and the company’s goals.
- Oversaw validation and launch of new LDTs and ensured that all activities were in full compliance with all regulatory requirements.
- Acted as a subject matter expert for CLIA and accrediting agencies compliance.
- CITI certification in GMP and GCP
Roles
- COO, CIMPAR
- Clinical Laboratory Consultant
- Program Director
- CLIA Laboratory Director
- Director, Laboratory Operation
- Laboratory Manager
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