University Of Minnesota Genomics Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of one non-regulated analyte at least twice annually in 2021 and 2022. Findings are as follows: 1. The laboratory performed Virology testing as confirmed by General Supervisor (GS) during a tour of the Oakdale facility laboratory at 9:05 a.m. on 11/23/22. 2. A ThermoFisher quantstudio 5 PCR system was observed as present and available for use during the tour. 3. The laboratory performed COVID-19 PCR testing on this analyzer beginning in November 2020. 4. A Proficiency Testing procedure requiring enrollment in Proficiency Testing (PT) for COVID-19 PCR testing by the laboratory was not found in the Laboratory SOP Binder. 5. Verification of accuracy documents for COVID-19 PCR testing were not found during review of Quality Assurance records from 2021 and 2022. The laboratory was unable to provide COVID-19 PCR verification records upon request. 6. COVID-19 PCR testing was performed on approximately 250,000 patient specimens in each of 2021 and 2022, as indicated on the CMS-116 provided by the GS on 11/22/22. 7. In an interview at 10:15 a.m. on 11/23/22, the GS confirmed the above finding. . 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 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to establish a function check procedure and maintain function check records for all laboratory equipment. Findings are as follows: The laboratory performed Molecular Diagnostics testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/8/18 at 9:35 a.m. A. Refrigerator and Freezer 1. A Fridgedaire refrigerator (S/N = FFRU17B2qw) and a Fridgedaire freezer (S/N = FFFh20F2qW) were observed as present and available for use during a tour of the laboratory. 2. Fisher Brand In-outdoor digital electronic temperature monitors were observed as attached to each of the refrigerator and freezer to display internal temperatures. A monitor unit serial number and manufacturer calibration expiration date label was not affixed to either unit. 3. The laboratory was unable to provide a function check procedure or calibration records for the above equipment upon request. 4. In an interview on 10/8/18 at 10:50 a.m., GS confirmed that the above findings B. Timers 1. The following digital timers were observed as present and available for use during a tour of the laboratory.: Fisher Scientific Color = Black Unit serial number = Illegible Manufacturer Calibration Expiration Date = 10/19/11 Fisher Scientific Traceable Color = White Unit serial number = 160570811 Manufacturer Calibration 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 -- Expiration Date = 7/16/15 3. The laboratory was unable to provide a function check procedure or calibration records for the above equipment upon request. 4. In an interview on 10/8/18, at 10:50 a.m., GS confirmed that the above findings -- 2 of 2 --