Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Delta Pathology, LLC Slidell Memorial East, CLIA ID 19D2284152, on February 3, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 the laboratory's policies, temperature logs, and interview with personnel, the laboratory failed to define the acceptable range for the room temperature. Findings: 1. Review of the laboratory's "Temperature & Environmental Monitoring" policy revealed "Acceptable ranges are to be clearly stated on each log sheet and results checked daily to ascertain if the reading is in range." 2. Review of the laboratory's "Frozen Section Room/Area Environmental Logs" revealed the laboratory had two (2) differing acceptable ranges for the room temperature. 3. Further review of the laboratory's "Frozen Section Room/Area Environmental Logs" revealed the following differing acceptable room temperature ranges: a) 20-25 degrees Celsius was the acceptable range for June 2024, October 2024, and November 2024 b) 18-35 degrees Celsius, was the acceptable range for July 2024, August 2024, September 2024, December 2024, and January 2025 4. In interview on February 3, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 2025 at 11:13 am, Compliance Personnel 1 confirmed the laboratory did not define the acceptable range for the room temperature. The Compliance Personnel 1 stated she was unsure why the room temperature's acceptable range varied. D5785