Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at American Institute of Dermatology PA on 06/23/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 Practice Administrator, the laboratory failed to verify the accuracy of the Tzanck testing (virology subspecialty) at least twice a year for 1 (2019) of 2 years reviewed (2019, 2020) for 3 (A, B, C) of 3 (A, B, C) Testing Personnel. Findings Included: Review of quality assurance peer reviews revealed that peer review was not performed for Tzanck testing for 2019 for Testing Personnel A, B, and C. Interview on 06/23/20 at 12:20 PM with the Practice Administrator confirmed that the Tzanck peer review was not performed in 2019 for the 3 Testing Personnel (A, B, and C). He also stated he did not know that the laboratory needed to perform peer reviews for Tzanck testing even when patients were not tested. 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 --