Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Romagosa Barron Dermatology on August 13, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document daily maintenance and function checks for three days (1/29/26, 3/12/26, 6/24/26) on the maintenance logs reviewed from 1/7/26 to 8/13/26. Findings included: 1. Review of the procedure titled Quality Control Procedures (signed and dated by the Laboratory Director on 6/9/26) noted, "All information regarding daily temperatures, room temperature and humidity, cleaning, oiling or maintenance must be logged and kept in Mohs Maintenance Log which can be found in the Laboratory." 2. Review of the PSL Temperature, Medium and Mounting Medium Log revealed there was nothing documented for 3/12/26. 3. Review of the Maintenance Record - Cryostat revealed, the maintenance for 3/12/26 and 6/24/26 were not documented. 4. Review of the PSL Reagent Maintenance Log revealed, the maintenance for 3/12/26 was not documented. 5. Review of the Maintenance Record - Microscope revealed the maintenance for 1/29 /26 and 3/12/26 were not documented. 6. Review of the Mohs Log Book revealed, there were seven Mohs procedures on 1/29/26, six on 3/12/26, and six on 6/24/26. 7. 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 -- During an interview on 8/13/26 at 12:05 PM, the Laboratory Manager acknowledged the maintenance was not documented. Word Key PSL - Port St Lucie -- 2 of 2 --