Laboratory Compliance is an ongoing effort. CLIA 88 requires continuous quality assessment of all clinical labs with focus on patient test management, quality control, proficiency testing, Test comparisons , relating results to clinical data, personnel, communications, complaints, staff review and records. These compliance standards encompass a range of activities and efforts that make it possible for labs to achieve high test accuracy and reliability despite enormous challenges.
Many Clinical Laboratories issued a CLIA certificate are also required to go through inspections to assess the laboratory’s regulation compliance. These inspections may occur any time during the laboratory’s hours of operation and may include review of Waived and Physician Performed Microscopy testing. Subsequent inspections may be conducted by CMS or its representatives on a biennial basis or as deemed necessary to ensure compliance. With our team of experienced regulatory inspectors, Bagrove Health will do a comprehensive review of your laboratory to ensure continuous inspection readiness. This includes a review of all checklists as applicable and tailored guidance on how to meet them. We will also provide after inspection guidance and assist in citation responses. Our team has inspected hundreds of laboratories throughout the United States and internationally as volunteer College of American Pathologist Inspectors.
Let the Bagrove Health team of experts take this huge responsibility from you as you focus on more pertinent patient care issues.