Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted a Aqua Dermatology of Florida, PA on 10/28/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The Standard deficiency cited was as follows: D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that prior to testing patients' specimens, testing personnel received the appropriate training and had demonstrated that they could perform all testing operations reliably to provide and report accurate results at this laboratory for one (TP-B) of two (TP-A and TP-B) for Histopathology testing. Findings included: 1. The CMS-209 Laboratory Personnel Report signed and dated by the Laboratory Director on 09/16/2025, listed two Testing Personnel (TP-A and TP-B). TP-A was the Laboratory Director. The Clinical Laboratory Specialist stated on 10/28/2025 at 12:10 p.m., that TP-B started testing patients on 07/29/2024. 2. The Mohs patient log documented TP-B first performed patient Histopathology testing on 07/29/2024. 3. The laboratory policy and procedure manual last reviewed by the Laboratory Director on 01/03/2025, included a job description of the Laboratory Director which stated, the Laboratory Director would ensure documented training and adequate competency to meet the needs of the laboratory. 4. The Initial Competency for TP-B was signed and dated by the Laboratory Director on 1/20/2025. There was no documentation of training and competency at this laboratory prior to patient testing on 7/29/2024 for TP-B. The Clinical Laboratory Specialist confirmed on 10/28/2025 at 12:10 p.m. that TP-B failed 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 -- to have documentation of training and competency at this laboratory on or prior to 07 /29/2024. -- 2 of 2 --