Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was completed on 12/9/20 at Dermatology of Gainesville Llc, a clinical laboratory in Newberry, FL. The facility was NOT in compliance with the 42 CFR Part 493, Requirements for Laboratories. 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 staff interview, the laboratory failed to send Histopathology patient slides for peer review for one of two years reviewed. (2019 - 2020) The findings include: The record review of documented peer review for 2019 and 2020 showed that patient slides were only sent once (August 2020) since the laboratory opened in May of 2019 to a pathologist to verify accuracy of results. The interview with the Office Manager person on 12/9/20 at 10:15am confirmed that slides were not sent for verification of accuracy in 2019. 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 --