Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Melbourne - Iconic Dermatology on March 17, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are 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 interview, observation, 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 2/28/2024 to 03/17 /2026. Findings Included: 1. During a tour of the laboratory on 03/17/2026 at 12:31 PM, one large container used to store chemical waste used in their H&E stain was seen on the floor of the laboratory. 2. Review of the procedure titled, H&E Staining signed and dated by the Laboratory Director on 1/2026 noted the laboratory used the following chemicals in their H&E stain: 100% Reagent Alcohol, Hematoxylin, Eosin, Xylene Substitute, and Scott's Tap Water. 3. Review of the SDS for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific Eosin Y Solution, 1% w/v in Alcohol and Mercedes Scientific Xylene Substitute noted, "Store locked up." 4. Review of the SDS for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific Eosin Y Solution, 1% w/v in Alcohol noted, "Store in an approved Flammable Liquids storage area." 5. Review of the SDS for the Mercedes Scientific 100% Reagent Alcohol, and Mercedes Scientific Eosin Y Solution, 1% w/v in Alcohol showed each had the symbol for flammable in the SDS. 6. During an interview on 03/17/2026 at 12:31 PM, the Laboratory Supervisor acknowledged the chemical waste from the H&E stain had been stored on the floor of the laboratory. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to use non-expired reagent in their Hematoxylin and Eosin stain for staining patients' histopathology slides on 04/01/2024. Findings: 1. Review of the Daily Mohs Laboratory Log indicated the hematoxylin stain lot number 157027 with an expiration date of 03/31 /24 was used on 04/01/2024. 2. Review of the patient accession logs showed there were eight patients who had Mohs surgical procedures on 04/01/2024. 3. During an interview on 03/17/2026 at 11:05 AM, the Laboratory Supervisor acknowledged the hematoxylin used on 04/01/2024 was expired. -- 2 of 2 --