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Clinical and Medical
Laboratory Consultants LLC
Ever thought about starting a CLIA Clinical Laboratory? Want to reduce laboratory costs? Need help on how to validate a LDT, modify a FDA Cleared/Approved test? You have a Lab but things aren't going well? You failed an inspection or in trouble with the regulatory agencies? Staff struggling understanding the CLIA regulations? You want to develop at Home collection kit test/novel test? Or perhaps you just want to pass an inspection.
Read along my services.
Regulatory
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Complete FDA, CLIA, California, New York state application process; including Medical Lab Director Placement* Including applications for Accreditation Agencies such as CAP, Joint Commission, COLA
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Regulatory lab preparedness, inspection, including audits. Full access to expert advice
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CLSI Quality Management System build, including Training and Competency Assessment
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New equipment Validation, FDA Cleared, Approved, Modified or LDT
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CLSI Document Control build
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Ongoing technical and regulatory support
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510k/PMA Application/process-FDA
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At-Home collection test design/LDT Test
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Consulting
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Identify and support quality monitoring and improvement projects/data analytics
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Advance statistical QC system build including Six Sigma/Lean QC
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Six Sigma workflow optimization
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Weekly/Monthly QA review
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Full support for onsite testing personnel
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General Lab Operation Advice including P&L review/optimization
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How to save on lab costs
General Laboratory Services
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Develop and review policies and procedures for pre-analytical, analytical, post-analytical, and general laboratory functions
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Evaluate laboratory workflows
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Clinical Laboratory design
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Verify clinical laboratory personnel qualifications and licenses.
A la Carte
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Advise on general clinical laboratory Operations, budget, equipment and etc
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Proficiency Testing Enrollment and workflow design
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Train personnel on how to operate new instruments, document the training and how to maintain the regulatory and accreditation standard
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Training and Competency Assessment documentation and Tracking
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Provide strategic input on LDT development and launch
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Complete CLIA and State Applications only
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PreInspection audit
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P&L review and modification
About
Fourd Hamoud
My experience with CLIA, CAP, COLA, CA-LFS, TJC, NY State, Penn State, and the FDA compliance requirements has been gained through years of working in clinical and medical laboratories, as a licensed CA-Clinical Laboratory Scientist (ASCP)CM in all specialties (e.g., hematology, chemistry, immunohematology, microbiology, toxicology, immunology, etc.); with emphasis in Molecular/Biotech and Toxicology (LC-MS/MS systems).
Upon completion of the CLS program at San Jose State university, in San Jose CA, USA, as Generalist CA-CLS (ASCP)CM, I worked as bench testing personnel for Marin General Hospital, Natera, Sutter Health and Kaiser Permanente.
Consultation work has included but not limited to Planned Parenthood of Northern California, DC3 Therapeutics, California Cardiovascular Consultants and Medical Associates.
