One good way to avoid being cited for Clinical Laboratory Improvement Amendments (CLIA) deficiencies is to be aware of what other labs are doing wrong. And that’s where the Centers for Medicare & Medicaid Services (CMS) top 10 list comes in handy. The agency used to publish a list of the 10 most common issues for which labs were cited during a calendar year. Unfortunately, CMS hadn’t published such a list since October 2018. Until now, that is. In January, the agency posted the list of top 10 most cited CLIA deficiencies in 2021. Requirements under the analytic systems and post-Analytic systems parts of the regulation proved to be the most troublesome for labs to comply with, accounting for five of the top 10 deficiencies, including number two on the list for failure to ensure proper storage of specimens and reagents, accurate and reliable test system operation, and reporting of test results (670 or 17.5 percent of labs were found to have the deficiency). The most frequently cited deficiency was related to personnel management, specifically, failure to establish and follow written policies and procedures for assessing the competency of lab employees and consultants (nearly 19 percent of labs were cited for the deficiency). Here’s the entire top 10 list, which you should share with your lab directors and managers for determining parts of your own operations you might want to target for a CLIA compliance audit.

Top 10 CLIA Deficiencies in the Nation in 2021, CMS Surveys

Source: Division of Clinical Laboratory Improvement and Quality, Centers for Medicare and Medicaid Services