Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Suncoast Skin Solutions Inc on 09/29/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. A Standard deficiency was cited 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, record review, and staff interview the laboratory failed to store chemicals to ensure protection from chemical hazards. Findings included: 1. During a tour of the laboratory on 09/29/2025 which began at 9:50 a.m., 2 gallon jugs of sodium hypochlorite (bleach), 5 gallon jugs of 100% Reagent Alcohol, and 1 gallon of Vintage Bluing reagent were observed stored under the sink. 2. The Laboratory Manager confirmed the above during the tour. 3. The safety data sheets (SDS), provided by the laboratory, were reviewed for each reagent. A. The SDS for bleach, with a revision date of 06/12/2015, indicated the chemical was a strong oxidizer with a pH of approximately 12 (strong base). B. The SDS for 100% Reagent Alcohol, with a revision date of 11/06/2015, indicated it reacted with strong oxidants causing fire and explosion hazards. C. The SDS for Vintage Bluing, with a revision date of 06/04 /2014, indicated it was incompatible with strong bases and strong oxidizers. 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 --