Alfredo D Fernandez Md Pa D/B/A

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Alfredo D Fernandez MD PA d/b/a ADF Dermatology and Skin Surgical Center on 01/17/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 record review and interview, the laboratory failed to document the reactions of the control slide for hematoxylin and eosin (H&E) stained tissue when patient slides were ran/interpreted for 6 (06/24/2024, 06/17/2024, 06/12/2024, 06/05/2024, 06 /04/2024, and 06/03/2024) of 20 days reviewed (5 days in July 2023, 8 days in June 2024, and 7 days in December 2024). Findings include: 1. The laboratory policy and procedure manual, signed by the Lab Director 01/09/2023, 01/08/2024 and 01/06 /2025 was reviewed. The policy titled Stain Maintenance showed, "A QC [quality control] worksheet is documented daily on the stains quality..." 2. The Daily QC Worksheet included a section to document the quality of the QC slide as acceptable or not acceptable on days patient slides were stained with H&E. The forms were signed by the MOHS surgeon/Lab Director to verify the quality of the slides; however, the control slide acceptability section was not documented on 06/24/2024, 06/17/2024, 06 /12/2024, 06/05/2024, 06/04/2024, and 06/03/2024. 3. Interview with the Compliance Personnel/MOHS Technician on 01/17/2025 at 11:55 AM confirmed the quality of the QC was not documented as acceptable for 6 of the 8 days in June 2024. 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 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the Histology Technician, the laboratory failed to dispose of Eosin Y, GILL III Hematoxylin, Histo-Clear, and 100% Reagent Alcohol for 2 out of 2 (2016-2018) years reviewed. Findings Included: Observation of reagents in the flammable cabinet on 7/10/2018 at 9:45 AM revealed the labels on the Eosin Y, GILL III Hematoxylin, Histo-Clear, and 100% Reagent Alcohol stated the contents/container be disposed at an approved waste disposal plant. (Photographic evidence obtained). On 07/10/18 at 9:45 AM, the Histology Technician stated that all reagent waste was disposed of down the drain of the sink with copious amounts of water. 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 --