Analytic Systems Account for 5 of Top 10 Most Cited CLIA Deficiencies

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

Rank	Regulatory Subpart	Regulatory Cite	Deficiency	# of labs with deficiency	% of labs with deficiency
1	Personnel Competency Assessment (D5209) STANDARD	493.1235	Subpart M personnel rules require lab to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency.	726	18.96%
2	Analytic Systems (D5413) STANDARD	493.1252(b)	Lab must define criteria for conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. Criteria must be consistent with manufacturer's instructions, if provided. Conditions must be monitored and documented.	670	17.50%
3	General Lab Systems (D5217) STANDARD	493.1236(c)(1)	At least twice a year, lab must verify the accuracy of any test or procedure it performs that isn’t included in subpart I or this part.	623	16.27%
4	Verification of Performance Specifications (D5421) STANDARD	493.1253(b)(1)	Each lab that introduces an unmodified, FDA-cleared, or approved test system must demonstrate that it can obtain performance specifications comparable to those established by the manufacturer.	610	15.93%
5	Analytic Systems (D5403) STANDARD	493.1251(b)	Procedure manual must include requirements for specimen acceptability, microscopic examination, step-by-step performance of the procedure, preparation of materials for testing, etc.	560	14.63%
6	Procedure Manual (D5401) STANDARD	493.1251(a)	Written procedure manual for all tests, assays, and examinations performed by the lab must be available to, and followed by, lab personnel.	558	14.57%
7	Analytic Systems (D5429) STANDARD	493.1254(a)(1)	Maintenance required as defined by and with at least the frequency specified by the manufacturer.	498	13.01%
8	Analytic Systems (D5417) STANDARD	493.1252(d)	Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they exceed their expiration date, have deteriorated, or are of substandard quality.	494	12.90%
9	Post Analytic Systems (D5805) STANDARD	493.1291(c)	Test report must indicate the following: for positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number, the name and address of the lab location where the test was performed, and other requirements specified in 493.1291(c).	447	11.67%
10	Laboratory Director's Responsibility (D6016)	493.1407(e) (4)(i)	Ensure that the lab is enrolled in an HHS approved proficiency testing program for the testing performed and that — (i) The proficiency testing samples are tested as required under subpart H of this part.	392	10.24%

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