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 observation of the laboratory, review of the Leica Bond III manufacturer users manual, the laboratory's room temperature environmental records and interview with the general supervisor, the laboratory failed to define criteria for environmental conditions in the area where the Leica Bond III stainer was in use that was consistent with manufacturer requirements in 2022 and 2023. The findings include: 1. Observation of the laboratory on 01/11/23 at 9:30 am revealed the Leica Bond III stainer in use for performing H. pylori IHC staining of gastric tissues. 2. Review of the Leica Bond III manufacturer's user manual revealed the following environmental conditions: Minimum Operating Temperature: 5 degrees Celsius, Maximum Operating Temperature 35 degrees Celsius, Temperature Required to meet Staining Performance Requirements: 18-26 degrees Celsius and an Operating Humidity of 30 -80%. 3. Review of the laboratory's room temperature environmental monitoring log in use since September 2022 revealed the following: Temperature range of 15-25 degrees Celsius and a humidity range of 20-70%. Humidity levels that exceeded the manufacturer requirements were recorded 4 of 29 days in October 2022, 17 of 25 days in November 2022, 9 of 19 days in December 2022 and 4 of 7 days in January 2023. 4. Interview with the general supervisor on 01/11/23 at 2 pm confirmed the laboratory failed to define environmental conditions that were consistent with manufacturer 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 -- requirements for the Leica Bond III stainer since beginning testing in September 2022 until the date of the survey on 01/11/23. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Helicobacter pylori (H. pylori) immunohistochemistry (IHC) stain manufacturer package insert, refrigerator temperature logs and interview with the general supervisor, the laboratory failed to ensure