For the first time in over three years, the Centers for Medicare & Medicaid Services (CMS) published its list of top 10 most frequently cited Clinical Laboratory Improvement Amendments (CLIA) deficiencies for the previous year. Looking at the list can boost your own compliance efforts as it sheds light on what other labs are doing wrong and what CMS inspectors are focusing on. Key takeaways from the 2021 top 10 list:

• Analytic systems and post-analytic systems accounted for five of the top 10 most cited deficiencies, by far the most of any other part of the CLIA regulations;
• The most cited systems deficiency, which was also number 2 on the list, was failure to ensure proper storage of specimens and reagents, accurate and reliable test system operation, and reporting of test results with 670 or 17.5 percent of labs cited; and
• 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 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