Summary:
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 review of Accuderm test results log and interview with the lead medical assistant (MA), the laboratory failed to follow the manufacturer's package inserts for the Accuderm Dermatophyte Test Medium (DTM) culture media for reading test results. Findings include: 1. Review of the Accuderm test results log from July 2021 to September 19, 2023 revealed 26 Accuderm DTM cultures were resulted beyond the 14 days of incubation. 2. The manufacturer's package inserts states " Incubate at room temperature 25-30 degrees centigrade for 14 days. Do not incubate more than 14 days as it may yield false positive results". 3. The laboratory performed 91 Accuderm DTM cultures from 01/01/2021 to 12/31/2021. 4. Interview with the lead MA on 09/19/2023 at 11:30 AM concur with findings. 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 --