Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Brandon Dermatology at Apollo Beach on 02/06/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review of the Lab Director's job description, the Quality Assessment (QA) Plan and interview with the Histology Tech, the laboratory failed to ensure the quality assessment program was established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur for two of two years (2023-2024). Findings include; The Laboratory Director job description signed and approved on 11/3/2022 showed a key responsibility to ensure the "quality assessment programs are established and maintained to identify failures in quality as they occur." The Quality Assessment Plan approved and signed by the Laboratory Director on 11/03/2022 showed "Monitoring and evaluation is a planned, systematic, and ongoing process..The records of our quality assessment monitoring are filed in the QA Monitoring Section of this manual..All records to be dated and initialed by the staff performing the review, and by the laboratory director." No QA records for 2023- 2024 were present in the manual or provided for review when requested. The Histology Tech on 2/06/2025 at 11:00 AM confirmed there were no QA records for 2023-2024 available for review. 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 --