Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the laboratory's competency records, proficiency testing (PT) records, and an interview with a laboratory testing personnel (TP23), the laboratory failed to rotate the testing of Chlamydia trachomatis and Neisseria gonorrhoeae (CT /NG) PT samples between the nine TPs competent to and regularly performing CT /NG assays during all PT events from 2022 through 2024. The laboratory performs approximately 700 CT/NG tests annually. Findings include: 1. A review of the laboratory's competency records showed that of the 23 TPs listed on form CMS-209, nine were competent to and regularly performed CT/NG testing in the laboratory. 2. A review of the laboratory's PT attestations and records from 2022 through 2024 revealed that only one of nine TPs competent to and regularly performing CT/NG testing in the laboratory had participated in CT/NG PT events from 2022 through 2024. 3. An interview with TP23 on 06/12/2024 at approximately 11 A.M. confirmed that only one of the nine TPs competent to and regularly performing CT/NG testing in the laboratory had handled CT/NG PT samples from 2022 through 2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --