Summary:
Summary Statement of 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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually since begining testing on October 11, 2022. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Histotechnologist (HTL) during a tour of the laboratory at 10:10 a.m. on February 7, 2023. 2. The Tareen Dermatology Mohs Procedure Manual contained a Proficiency Testing (PT) Procedure that directed the laboratory to perform biannual comparison in July and December with a Dermatopatholgist to meet the PT requirement. 3. Documentation of the December 2022 PT performance could not be found durring review of laboratory records and could not be produced when requested. 4. The laboratory performed approximately 50 Mohs micrographic surgery procedures scince begining patient testing in October 2022, as indicated in laboratory testing records. 5. In an interview at 10:55 a.m. on February 7, 2023, the HTL confirmed the above finding. . 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 --