Brevard Skin And Cancer Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Brevard Skin and Cancer Center on July 10, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on interview, review of personnel records and procedure manual, the laboratory failed to have a written policy and procedure to assess competency for one (B) of two (A, B) High Complexity Testing Personnel who performed the interpretation of the Hematoxylin & Eosin (H&E) stained slides and failed to perform competency assessment on Testing Personnel B from 01/26/2025 to 07/10/2025. Findings: 1. Review of the Laboratory Personnel Report, signed by the Laboratory Director on 07 /03/2025, listed two Testing Personnel (A, B) who performed the interpretation of the H & E stained slides. 2. Review of the laboratory's procedure manual, signed by the Laboratory Director (Testing Personnel A) on 01/07/2025, revealed there was no procedure on competency assessment. 3. Review of the Laboratory Director's job description noted, "Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently." 4. Review of the personnel records revealed there was no competency assessment for Testing Personnel B. 5. During an interview on 07/10/2025 at 11:22 AM, the Laboratory Manager acknowledged there was no procedure on competency 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 -- assessment and no documentation of competency assessments performed on Testing Personnel B. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record the temperature and humidity of the room where testing was performed from 1/23/17 to 1/23/19. Findings: The operations instruction manual for the Leica CM 1510 cryostat read that the operating temperature range was 18 to 40 degrees Celsius, and air humidity less that 60%. A review of the laboratory's logs showed that the laboratory failed to record the temperature and humidity of the room where testing was performed. On 1/123/19 at 10:00 AM, Laboratory Manager acknowledged that they did not record the temperature or humidity of the laboratory. 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 --