Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Harbor Dermatology on 08/20/2025 - 08/21/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to label containers that held tissue ink for the subspecialty of Histopathology. Findings included: 1. The laboratory was toured on 08/20/2025 beginning at 10:05 a.m. 3 small containers of what appeared to be blue tissue ink, green tissue ink, and red tissue ink were observed at the tissue inking/grossing workstation. The containers were not labeled with the identity of the contents or the expiration dates of the contents. The cabinets were searched but no bottles of tissue ink were found. 2. The reagent logs for 2024 and 2025 were reviewed. There were no tissue ink(s) listed on the reagent log. 3. Electronic communication with the Laboratory Director on 08/21/2025 at 9:58 a.m. confirmed the above. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may 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 -- elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to develop a policy or procedure to document they were onsite at least once every 6 months for 2025. Findings included: 1. The laboratory policy and procedure manual failed to contain a policy regarding documenting Laboratory Director onsite visits at leas once every 6 months. 2. Electronic communication from the Laboratory Director on 08/21 /2025 at 9:58 a.m. confirmed the above. -- 2 of 2 --