Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Aqua Dermatology of Florida PA on March 13, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(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 record review, and interview, the laboratory failed to document quality of the Hematoxylin and Eosin (H&E) stain in the histopathology laboratory on 01/12 /2024. Findings: 1. Review of the Mohs H&E Stain Policy and Procedure noted, "Daily stain a control slide from the first section of the day. This control slide will be accessed by the Mohs surgeon with the first case of the day. Results will be recorded on the QC sheet for quality of section and stain." 2. Review of the Daily QC Worksheet showed the acceptability of the control slide was not check off by the Mohs Surgeon on 01/12/2024. 3. Review of the Mohs Case Log revealed there were 12 Mohs surgical procedures performed on 01/12/2024, 4. On 03/13/2025 at 2:25 PM, the Histology Supervisor acknowledge the the stain quality was not checked off. 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 --