The Centers for Medicare & Medicaid Services (CMS) oversee all laboratory testing performed on humans in the United States through the Clinical Laboratory Improvement Amendments (CLIA) program. CLIA establishes quality standards and oversight of clinical laboratories, and ensures the accuracy and reliability of patient laboratory test results.
CMS inspects CLIA laboratories every two years and, occasionally, upon complaints. Inspections can be very valuable for laboratories. The CLIA inspectors review each lab’s policies and procedures to help improve quality and compliance.
Recently, CLIA laboratories owned and operated by Flow Health have been inspected in California, Georgia, Washington and Virginia. We’ve had some excellent inspections with zero deficiencies and others with some condition level deficiencies - this means we continue to operate during the corrective action period. We had deficiencies, such as missing documentation of procedures that were quickly corrected and subsequently approved. Following an inspection with any type of deficiencies, a corrective action process is initiated and implemented under direct supervision of our Lab Directors. Once the issues are resolved, if the initial deficiencies were minor, the inspector will approve and all the lab’s CLIA license to be maintained, which has been the case for our laboratories.
As we scaled to serve the unprecedented demand of COVID testing, we missed some documentation requirements at one of our laboratory locations. Through the inspection process we learned and improved our operation at all of our locations.
As every Laboratory Manager or Medical Director knows, inspections are stressful and difficult. Unannounced inspections are that much more so. We have an incredible team that is devoted to making a difference. We learn from each inspection, even the ones that are perfect, and continue to improve every aspect of our quality and operational performance. All of our laboratories have passed their inspections and are in full compliance of CMS and state regulations. We are investing heavily into scaling these operations as the pandemic continues in 2021 and beyond.
We appreciate all of the partners, public agencies and regulators that we work with on a daily basis. Together, we will successfully persevere through this pandemic.