Summary:
Summary Statement of Deficiencies D0000 An on - site announced CLIA recertification survey was conducted at Academic Alliance in Dermatology Inc. on 03/20/2024 - 03/25/2024. The laboratory is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the standard level deficiencies: 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 record review and interview with the Laboratory Manager, the laboratory failed to ensure the accuracy for twice a year testing for parasitology (scabies) testing for Testing Personnel #A for two out of two years reviewed (2022-2023). The findings included: A record review of the laboratory's policy titled "Potassium Hydroxide (KOH) Examination of Skin Hair, or Nails" revealed, "Quality control analysis must be performed every day that patient samples are tested." A record review of the "Proficiency Testing Log Sheet KOH & Scabies Log" revealed that Testing Personnel #A had only verified accuracy for scabies on 7/24/23 for two out of two years reviewed (2022 - 2023). On 03/27/24 at 10:15 AM, the Laboratory Manager confirmed that there was missing semi-annual verification of scabies testing. 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 --