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The most-cited CLIA deficiencies, and the record that answers each one
CMS publishes the ten deficiencies its surveyors cite most often. In the 2024 list, the top standard-level findings were storage and operating conditions (42 CFR 493.1252(b)), competency assessment policies (493.1235) and the procedure manual (493.1251). The top condition-level finding was unsuccessful proficiency testing participation (493.803).
Most of these are record problems. The work was often done, and the laboratory could not show it. The tables below give each citation in plain language, what a surveyor typically finds, and the document that puts the evidence on file.
Reviewed 11 Nov 2026 against the sources linked below. General information, not regulatory or legal advice.
- Source
- CMS, Division of Clinical Laboratory Improvement and Quality
- Data year
- 2024
- Counts
- Laboratories cited
- Percent
- "Percent of all labs" as CMS prints it
Top ten standard-level deficiencies
| No. | Tag and citation | What it asks for | Labs cited | Where the evidence goes |
|---|---|---|---|---|
| 1 | D5413 493.1252(b) | Storage and operating conditions Written criteria for the conditions that matter to accurate testing, such as temperature and humidity, and records showing they were monitored. Typical finding: A missing day on a refrigerator log, a range that does not match the package insert, or no action recorded when a reading was out. | 818 5.0% | PM-08 Storage and Operating Conditions Policy PM-09 Temperature and Humidity Log |
| 2 | D5209 493.1235 | Competency assessment policies Written policies and procedures to assess employee and consultant competency, and evidence they are followed. Typical finding: Assessments missing one of the six procedures, a late first-year assessment, or an assessor who does not hold the qualifying role. | 778 4.8% | CA-01 Competency Assessment Policy CA-02 Testing Personnel Assessment Form CA-06 Due-Date Tracker |
| 3 | D5401 493.1251(a) | Procedure manual available and followed A written procedure for every test, available to the people testing and followed by them. Typical finding: A test on the menu with no written procedure, or staff doing something different from what the procedure says. | 635 3.9% | PM-01 Procedure Manual Policy PM-03 Procedure Manual Index and Review Log |
| 4 | D5403 493.1251(b) | Procedure manual content Each procedure covers the items the regulation lists, including specimen requirements, step-by-step performance, calibration, controls, reference intervals, critical values and what to do when the system fails. Typical finding: A package insert used as the procedure with nothing added for the parts it does not cover. | 609 3.7% | PM-02 Test Procedure Template |
| 5 | D5417 493.1252(d) | Expired or deteriorated materials Reagents, controls, kits and supplies are not used past expiration or when they have deteriorated. Typical finding: One expired vial in a drawer, or opened reagents with no open date. | 607 3.7% | PM-08 Storage and Operating Conditions Policy WT-05 Kit and Reagent Lot Log |
| 6 | D5217 493.1236(c)(1) | Twice-yearly accuracy verification For any test not covered by required proficiency testing, the laboratory verifies accuracy at least twice a year. Typical finding: Tests with no proficiency testing program and no record of a split sample or other check. | 548 3.4% | PT-05 Twice-Yearly Accuracy Verification Record |
| 7 | D5421 493.1253(b)(1) | Verification of performance specifications Before reporting patient results from an unmodified FDA-cleared or approved test, the laboratory shows it gets performance comparable to the manufacturer's for accuracy, precision and reportable range, and confirms the reference interval fits its patients. Typical finding: A new analyzer put into use on the installer's printout, with no study the director reviewed and signed. | 451 2.8% | PM-04 Method Verification Plan and Summary PM-05 Verification Data Worksheet |
| 8 | D6016 493.1407(e)(4)(i) | Director and proficiency testing The laboratory director makes sure the laboratory is enrolled in an approved proficiency testing program for the testing it performs, and that samples are tested as required. Typical finding: An analyte added to the menu and never added to the proficiency testing order. | 451 2.8% | PT-01 Proficiency Testing Policy PT-04 Enrollment and Calendar Tracker |
| 9 | D5429 493.1254(a)(1) | Maintenance Maintenance is performed as the manufacturer defines and at least as often as the manufacturer specifies, and it is documented. Typical finding: Monthly or six-monthly maintenance that is done but not written down, or skipped when the service contract lapsed. | 449 2.8% | PM-06 Maintenance and Function Check Log |
| 10 | D5805 493.1291(c) | Test report content Each report carries the required elements: patient name and identification number or a unique identifier, the laboratory's name and address, the report date, the test, the specimen source when appropriate, and the result with units or interpretation. Typical finding: Reports from an interface or an EHR that drop the performing laboratory's address. | 417 2.6% | IR-01 Self-Audit Checklist |
Descriptions are our summaries. A template gives the record its structure. The procedures, the data and the readings in it are yours.
Top ten condition-level deficiencies
| No. | Tag and citation | Condition | Labs cited | Related documents |
|---|---|---|---|---|
| 1 | D2016 493.803 | Successful participation in proficiency testing | 738 4.39% | PT-01 Proficiency Testing Policy PT-03 PT Result Review and Corrective Action |
| 2 | D6000 493.1403 | Laboratory director, moderate complexity | 709 4.22% | IR-03 Personnel File Checklist |
| 3 | D6076 493.1441 | Laboratory director, high complexity | 388 2.31% | IR-03 Personnel File Checklist |
| 4 | D5400 493.1250 | Analytic systems | 340 2.02% | PM-01 Procedure Manual Policy PM-04 Method Verification Plan and Summary PM-06 Maintenance and Function Check Log PM-07 Calibration and Calibration Verification Record |
| 5 | D2000 493.801 | Enrollment and testing of proficiency testing samples | 218 1.30% | PT-01 Proficiency Testing Policy PT-04 Enrollment and Calendar Tracker |
| 6 | D6063 493.1421 | Testing personnel, moderate complexity | 182 1.08% | IR-03 Personnel File Checklist |
| 7 | D6033 493.1409 | Technical consultant, moderate complexity | 189 1.13% | IR-03 Personnel File Checklist CA-03 Role Assessment Forms |
| 8 | D6168 493.1487 | Testing personnel, high complexity | 172 1.02% | IR-03 Personnel File Checklist |
| 9 | D6108 493.1447 | Technical supervisor, high complexity | 110 0.65% | IR-03 Personnel File Checklist CA-03 Role Assessment Forms |
| 10 | D5300 493.1240 | Preanalytic systems | 82 0.49% | QA-01 Quality Assessment Plan |
The order is CMS's. Personnel conditions turn on whether the people in each role hold the qualifications in Subpart M. A checklist helps you gather the proof. It cannot make someone qualified.
What the list tells you
- Logs beat memory. Temperature, maintenance and reagent findings are nearly always gaps in the record.
- Competency is cited for detail. A missing procedure out of the six, or a first-year assessment a month late, is enough.
- Proficiency testing needs an owner. Enrollment slips when the test menu changes, and unreviewed results turn a single miss into a condition-level finding.
- The director's signature matters. Procedures, verification studies and IQCPs all need it before use.
What is the most common CLIA deficiency?
In CMS's 2024 list, the most-cited standard-level deficiency was D5413 under 42 CFR 493.1252(b): criteria for storage and operating conditions, such as temperature, not defined or not monitored. It was cited in 818 laboratories. Competency assessment policies under 493.1235 came second with 778.
What is the difference between a standard-level and a condition-level deficiency?
A standard-level deficiency is a failure to meet one specific requirement. A condition-level deficiency means the laboratory is out of compliance with a whole condition, such as proficiency testing or laboratory director, usually because the problems under it are serious or widespread. Condition-level findings carry heavier consequences and tighter timelines.
Which areas should a small laboratory check first?
The list points to five: temperature and storage records, competency assessments, the procedure manual, expiration dates, and proficiency testing enrollment and follow-up. The readiness check walks through them in about ten minutes.
Check your own laboratory
The free survey readiness check turns this list into yes-or-no questions and shows your gaps. The Inspection Readiness Kit has the full self-audit, a binder index and a plan of correction template.
Sources
- CMS: CLIA top ten deficiencies in the nation, 2024 (PDF)
- 42 CFR Part 493 on eCFR
- ASCLS: Common laboratory deficiencies and ways to avoid them (Feb 2025)
Summaries on this page are ours and are written for convenience. The regulation and the agency documents control.