Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on November 6, 2024. Advanced Dermatology and Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on interview and review of quality control and patient logs, the laboratory failed to document quality control and function checks in the histopathology laboratory from 08/24/2022 to 11/06/2024. Findings: Review of the Daily Quality Control Slide log showed the acceptability of the stain quality was not recorded for 09 /07/2024. Review of the Mohs Log showed there were seven Mohs surgical procedures performed on 09/07/2024. Review of the Laboratory Temperature /Humidity Log showed the room temperature and humidity of the laboratory was not recorded on 03/29/23, 10/04/2024, and 07/16/2024. Review of the Mohs Log showed there were five Mohs surgical procedures performed on 03/29/23, eleven Mohs surgical procedures performed 10/04/2024, and five Mohs surgical procedures performed 07/16/2024. On 11/06/2024 at 2:15 PM, the Laboratory Assistant acknowledge the missing documentation on the stain quality and room temperature and humidity. 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 --