Palm Bay Dermatology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Bay Dermatology on February 10, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: 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, interview, review of the laboratory procedure manual and safety data sheets (SDS), the laboratory failed to ensure protection from chemical hazards used in their Hematoxylin and Eosin (H&E) stain from 12/14/2023 to 02/10 /2026. Findings: 1. During a tour of the laboratory on 02/10/2026 at 9:20 AM, four containers used to store the chemical waste used in their H&E stain and in the Vacuum Infiltration Processor (VIP) was seen on the floor of the laboratory. Review of the procedure title Processor Protocol noted the laboratory used the following chemicals in their VIP:10% Buffered Neutral Formalin, 70% Ethyl Alcohol, 95% Ethyl Alcohol (Reagent Alcohol), 100% Ethyl Alcohol (Reagent Alcohol), Xylene Substitute and Paraffin. Review of the procedure title Hematoxylin and Eosin Stain noted the laboratory used the following chemicals in their H&E stain: Xylene Substitute, 100% Ethyl Alcohol (Reagent Alcohol), 95% Ethyl Alcohol (Reagent Alcohol), Hematoxylin, Focus AQ (aqueous) Clarifier, Bluing reagent, Eosin, and 10% Buffered Neutral Formalin. Review of the SDS's for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific 95% Reagent Alcohol and Mercedes Scientific Xylene Substitute noted, "Store locked up." Review of the SDS for the Cancer Diagnostic Eosin noted "Store locked up." Review of the SDS's for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific 95% Reagent 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 -- Alcohol, and Cancer Diagnostic Eosin showed the each had the symbol for flammable in the SDS. During an interview on 02/10/2026 at 9:25 AM, the Testing Personnel C acknowledged the chemical waste from the H&E stain and the VIP had been stored under the counter on the floor of the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on August 7, 2019. Palm Bay Dermatology was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document training and competency assessment on 1 of 2 Histotechs from April 2018 to August 7, 2019 (A). Findings: Review of the annual competency records showed that the laboratory failed to have documentation of training and competency assessments for Histotech A. During an interview on 8/06/19 at 2:52 PM, Mohs Tech A stated that Histotech A starting working in the laboratory in April 2018. Mohs Tech A also stated that she was unable to find any documentation of training and competency on Histotech A. 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 --