Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Florida Institute of Dermatology on January 15, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document all maintenance and quality control activities for three days of maintenance and quality control records reviewed from 11/01/2023 to 12/31/2025. Findings: A1. Review of the daily Mohs Laboratory Quality Control Worksheet showed the log was used for recording the Hematoxylin and Eosin (H&E) stain control slide number and quality, microscope verification and maintenance, the cryostat maintenance, the cryostat temperature, the room temperature, the room humidity, the technician's initials, and the doctor's initials. A2. Review of the daily Mohs Laboratory Quality Control Worksheet showed there was nothing documented for 09/30/2025. A3. Review of the Mohs Accession Log showed there were eight Mohs surgical procedures on 9/30/25. A4. During an interview on 01/15/2026 at 12:07 PM, the Risk Management and CLIA Compliance Supervisor acknowledged the logs were not completely filled out. B1. Review of the Hematoxylin and Eosin Staining Maintenance Log showed the log was used for documenting if the reagents in the H&E stain were changed, rotated, filtered, added to, or if the reagents were okay. B2. Review of the Hematoxylin and Eosin Staining Maintenance Log showed there was nothing documented for 08/23/24, 08/27 /24, and 09/30/2025. B3. Review of the Mohs Accession Log showed there were three Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Mohs surgical procedures on 08/23/2024, ten Mohs surgical procedures on 08/27 /2024, and eight Mohs surgical procedures on 9/30/25. B4. During an interview on 01 /15/2026 at 12:07 PM, the Risk Management and Compliance Supervisor acknowledged the logs were not completely filled out. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of the procedure manual, record review, and interview, the laboratory failed to document the acceptability of the Hematoxylin and Eosin (H&E) control slide for three day (3/31/25, 9/9/25, 9/30/25) of the quality control (QC) worksheets reviewed from 11/1/2023 to 12/31/2025. Findings: 1. Review of the policy titled, Quality Evaluation of Histology Sections noted, "A Quality Evaluation Sheet will be submitted to the Doctor reading the first case of the day basis to rate slides with regards to adequacy for histologic sections, including thinness, nuclear detail, general clarity and staining. The doctor will initial on the sheet and write comments if necessary." 2. Review of Daily QC Worksheet forms showed the Mohs surgeon failed to document the acceptability of the H&E stain by initialing the forms on 3/31/25, 9/9 /25, and 9/30/25. 3. Review of the Mohs Log showed there were seven Mohs surgical procedure on 3/31/25, nine Mohs surgical procedure on 9/9/25, and eight Mohs surgical procedure on 9/30/25. 4. During an interview on 01/15/2026 at 12:05 PM, the Risk Management and Compliance Supervisor acknowledged the Laboratory Director had not initialed the forms accepting the quality of the stain. -- 2 of 2 --