Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 06/07/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's test menu, twice annual test accuracy verification records, policies/procedures, patient test records and staff interview, the laboratory failed to document test accuracy verification for 1 of 2 tests performed by the laboratory in 2023 and 2024, the KOH (Potassium Hydroxide) test. Findings included: 1. Review of laboratory's test menu revealed the laboratory performed KOH testing on site. 2. Review of laboratory's twice annual test accuracy verification records for 2023 and 2024 revealed there was no test accuracy verification documented for the KOH test. 3. Review of laboratory's policies/procedures revealed the laboratory did not have protocols in place for twice annual test accuracy verification for the KOH test. 4. Review of laboratory's patient test records revealed the laboratory performed 13 KOH tests in 2023. 5. In an interview on 06/07/2024 at 1330 hours in the laboratory, the facility's Manager (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. 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 --