Cytokine Reference Laboratory

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to evaluate the relationship between test results obtained from 2 identical analyzers and between automated and manual methods at least twice annually in 2020 and 2021. Findings are as follows: 1. The laboratory performed General Immunology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 01/20/22. 2. Two identical ProteinSimple Ella automated test systems were observed as present and available for use during the tour. The first system was implemented in April 2020 and the second in September 2020 as indicated by the LD. Both Ella test systems were used for Cytokine Storm 4Plex and Cytokine Inflammation 4Plex testing. The analytes included in the 4Plex panels were listed on the List of Assays provided by the laboratory. See below. Cytokine Storm 4Plex - implemented April 2020 IL-1b IL-6 IL-8 TNFa Cytokine Inflammation 4Plex - Implemented April 2020 IFNg IL-10 IL-18 IL-2ra 3. Equipment used for manual ELISA testing was also observed during the laboratory tour. The analytes tested using the manual ELISA method were listed on the List of Assays provided by the laboratory. Four of these analytes were also included in the 4Plex panels. See below. Manual ELISA tests IL-1b IL-6 TNFa IFNg 4. A twice annual process for comparison of test results obtained from multiple analyzers and/or multiple testing methods was not established in the laboratory's policies and procedures. 5. Comparison of the 4Plex test results obtained from both Ella test systems or comparison of test results obtained 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 -- from the Ella and manual ELISA methods was not found during review of laboratory records from 2020 and 2021. The laboratory was unable to provide documentation of test comparisons upon request. 6. In an interview at 12:15 p.m. on 01/20/22, the Technical Supervisor confirmed the above findings. . -- 2 of 2 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, record review and interview with laboratory personnel, the laboratory failed to include in procedure or perform equipment function checks as defined by the manufacturer . Findings are as follows: 1. A tour of the laboratory on 01 /16/18 at 9:10 a.m. revealed the presence of the following laboratory equipment: - Laboratory Research Products, Inc. Refrigerator - Hettich Universal 32 R Centrifuge 2. Review of equipment maintenance and function check records did not provide evidence that the verification of accuracy for the refrigerator thermometer, or verification of the accuracy for the centrifuge speed and timer, were performed in 2016 and 2017. 3. The Quality Control Manual: Cytokine Reference Laboratory / Section VII Equipment Maintenance procedure, located in the SOP's manual, did not include functional check criteria for verification of accuracy for the refrigerator thermometer, or for the centrifuge speed and timer settings. 4. The laboratory was unable to provide the missing procedural elements upon request. The laboratory was unable to provide the missing function check records upon request. 5. In an interview on 1/16/18 at 11:30 a.m., Technical Supervisors 1 and 2 confirmed the above 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 --