Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the laboratory's records, and staff interview, it was revealed the laboratory failed to have documentation of two accuracy assessments for KOH (potassium hydroxide preparations) in 2022. The findings include: 1. A review of the laboratory's records from 2022 revealed the laboratory performed one assessment of accuracy for KOH in 2022. It was performed on November 1, 2022. 2. The laboratory was asked to provide documentation of a second accuracy assessment for 2022. No documentation was provided. 3. An interview with the MOHs tech on 01/30/2023 at 1000 hours in the laboratory confirmed only 1 assessment had been performed in 2023. 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 --