Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Florida Institute of Dermatology LLC on January 15, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on interview, and record review, the laboratory failed to document quality control information including lot numbers, expiration dates, and open dates for all the reagents used in their Hematoxylin and Eosin (H&E) stain from 09/15/2025 to 01/15 /2026. Findings: 1. Review of the procedure titled Procedure: H&E Staining showed, the laboratory used the following reagent: 100% Alcohol, Hematoxylin, Bluing Reagent, Eosin, and XS-3 (Xylene Substrate) used in the H&E Stain. 2. Review of the Laboratory Reagent Log for September 2025 to December 2025 showed the log failed to include the lot numbers, expiration dates, and open dates for the Hematoxylin stain and Eosin stain used in the H&E Stain. 3. During an interview on 01/15/2026 at 9:45 AM, the Risk Management and CLIA Compliance Supervisor acknowledged the Hematoxylin and Eosin were not listed. 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 --