Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of the Palm Beaches LLC on 02/14/23. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 review of manufacturer's instructions, lack of documentation, and interview with the Laboratory Director, the laboratory failed to document the room temperature where fungal cultures were incubated for two out of two years (2021 - 2023). Findings included: Review of the manufacturer's instructions for the Dermatophyte test medium (for fungal cultures) revealed "Incubation at room temperature, 20 [degrees] C [Celsius]- 30 [degrees] C (68 [degrees] F [Fahrenheit] - 86 [degrees] F) is satisfactory for growth..." No documentation of room temperature from January 29, 2021 to February 14, 2023 could be provided. On 02/14/23 at 1:50 p.m., during an interview, the Laboratory Director stated he did not know that he should be documenting room temperature for the fungal cultures. . 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 --