Laboratory Technical Consultant

Service Description

Laboratory Consulting Services Supporting Excellence in Lab Compliance, Quality, and Operations I offer comprehensive consulting services for clinical laboratories that need expert oversight, technical support, and guidance to meet regulatory requirements and streamline operations. Whether you're running a high-complexity lab or starting up a moderate/waived lab, my services are designed to ensure accuracy, efficiency, and compliance at every stage. What I Offer ✅ Personnel & Documentation • Personnel record reviews & file organization • Licensing support and guidance for hiring qualified staff • Continuing ed recommendations tailored to your lab’s testing complexity ✅ Regulatory Compliance & Readiness • Proficiency testing (PT) enrollment & ongoing compliance • Preparation for CLIA or COLA inspections • Mock surveys to identify gaps before real inspections • Corrective action plans for unsuccessful surveys • Plans of Required Improvement for COLA • Full pre-inspection walkthroughs and documentation review ✅ Quality Systems & Technical Oversight • Quality Control (QC) program design and structuring • Quality Assurance (QA) planning and ongoing support • Development of Maintenance Programs • Technical consulting for complex testing questions or regulatory requirements • Equipment validation and documentation ✅ Policy & Procedure Development • Creation of fully customized Procedure & Policy Manuals • Implementation support and updates aligned with current regulations ✅ Lab Startup & Growth Support • New lab set up consulting, from application to operational readiness • Waived and moderate complexity lab guidance • Vendor and supply recommendations • Instrument selection and validation assistance • Workflow design for efficient operations Why Work With Me? I bring hands-on lab experience and deep knowledge of CLIA and COLA regulations. My role is to make compliance simple, help you avoid costly errors, and ensure your lab provides accurate, reliable patient testing. With a monthly oversight model, I provide: • Unlimited phone/video consultation during business hours • One on-site visit each month • Emergency visits as needed, at my discretion Ready to Elevate Your Lab? Let’s make sure your lab meets every standard with confidence. Whether you're correcting a failed inspection, improving your quality systems, or preparing for your next survey—I’m here to help. 📩 Contact me today to schedule a consultation and discuss a plan tailored to your lab.