Clinical Laboratory Services

At Gaston & Barnes Consulting, we understand the challenges involved in implementing, managing, and sustaining quality clinical laboratory services. Whether you're a seasoned laboratorian or a new lab owner or manager, we are here to alleviate the strain and provide expert assistance. With over 40 years of experience, knowledge, and expertise in compliance and legal regulations, we ensure your clinical laboratory operates in accordance with the guidelines of Health and Human Services (HHS), the Clinical Laboratory Improvement Amendments (CLIA), and the Office of the Inspector General (OIG).

Our comprehensive range of services is designed to help you operate a sustainable clinical laboratory that exceeds the standards and guidelines established by HHS, CLIA, and the OIG. Here's what we offer:

• Completion, Submission, and Maintenance of Paperwork for Laboratory Licensing: We handle all aspects of paperwork, ensuring your laboratory remains in compliance with licensing requirements.
• Development and Maintenance of a Laboratory Compliance Plan: We create and maintain a robust compliance plan that aligns with the guidelines set by the OIG and HHS. This plan ensures adherence to standards of conduct, medical necessity, billing practices, reliance on standing orders, compliance with applicable HHS OIG fraud alerts, marketing guidelines, prices charged to physicians for profiles, retention of records, and compliance as an element of a performance plan.
• Compliance Audits: We conduct thorough compliance audits to prepare your laboratory for CLIA, COLA, CAP, and JCO surveys. Our audits ensure your operations meet the stringent standards set by the OIG and HHS, positioning you for success.
• Maintenance and Oversight of Lab Operations: We provide ongoing maintenance and oversight of your lab operations to ensure audit readiness, enabling you to meet OIG and HHS standards consistently.
• Assistance with Personnel Selection and Training: We offer support in personnel selection and provide training documentation for your staff, ensuring they are well-equipped and knowledgeable.
• Feasibility, Cost Analysis, and ROI Analysis: We perform in-depth feasibility studies, cost analyses, and ROI evaluations to help you make informed decisions about the implementation of new testing services. Our goal is to maximize the efficiency and profitability of your laboratory.

At Gaston & Barnes Consulting, we pride ourselves on delivering professional and reliable services. Trust us to be your partner in navigating the complex landscape of clinical laboratory operations. Let us help you build and maintain a high-quality laboratory that consistently surpasses industry standards while complying with all regulatory requirements.