Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 18, 2022. Aesthetic Dermatology PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to retain quality control documents for 2021 and 2022. Findings: Review of the online "H&E Staining Quality Control Log" (Hematoxylin and Eosin) for 2021 and 2022 showed the dates when Mohs, frozen sections, and biopsy specimens were processed in the laboratory. Review of the online "Yearly Quality Control and Maintenance" log for the Avantik QS11 cryostat and the "Yearly Quality Control and Maintenance" log for the Shandon Linistat H&E stainer for 2021 and 2022 revealed the data recorded did not match with the dates from the "H&E Staining Quality Control Log" for 2021 and 2022. Review of the online "Yearly Quality Control and Maintenance" log for the Olympus microscope for 2021 and 2022 revealed only the yearly service was recorded. On 10/18/2022 at 11: 03 AM, the Mohs Technician stated it appeared the 2020 logs for the cryostat and H&E stainer were saved on top of the files for 2021 and 2022. On 10/18/2022 at 11: 30 AM, the Mohs Technician stated she did not know what happened to the microscope maintenance logs. 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 --