Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at American Institute of Dermatology PA on 07/07/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; This STANDARD is not met as evidenced by: Based on observation and interview, the Lab Director failed to establish a means of ensuring a safe environment to protect employees form chemical hazards for two of two years 07/2024 to 07/2026. Findings included: 1. Observations were conducted during a tour of the laboratory beginning at 10:55 a.m. In the Biopsy/Tissue Processing room, two large autostainers were present for processing tissue and staining them with hematoxylin & eosin. No cross ventilation system was present nor system to ventilate the air out of the room. 2. The Safety Data Sheet for UltraClear Xylene Substitute, with a revision date of 10/05/2016, was reviewed. Safety and precautions included: use only in well-ventilated area, avoid breathing vapors, if inhaled to move the person to fresh air, and if insufficient ventilations to wear respiratory protection. 3. An interview was conducted with the Lab Director and Chief Operations Officer on 07/07/2026 at approximately 12:30 p.m. They confirmed staff work in the room approximately 3 times per week and the lab does not have a system to monitor exposure to the Xylene Substitute. 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 --