Hennepin Healthcare - Emergency Ambulance Service

Summary Statement of Deficiencies D0000 . The Hennepin Healthcare - Emergency Ambulance Service laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on August 20, 2025. The following standard-level deficiency was cited: 493.1281 Comparison of test results . 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. 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 one of one Hematology test results obtained from identical testing devices at least twice annually 2023 and 2024. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant 1 (TC1) during a tour of the laboratory office at 10:10 a.m. on 08/20/25. 2. Four Abbott i-STAT devices were observed as present and available for use during the tour. The fourth device, 440427, was implemented in March 2024. The laboratory used the i-STAT PT/INR cartridge for PT/INR testing on these devices. 3. Comparison of test results obtained from duplicate instruments was required twice annually as established in the Quality Control Plan - Point of Care procedure found in the MediaLab document management system. 4. Comparison of PT /INR test results obtained from the three i-STAT devices in use in 2023 was completed on 05/04/23 as indicated on the i-STAT Instrument to Instrument Comparison spreadsheet. A second 2023 comparison was not found in laboratory 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 -- records. Comparison of PT/INR test results obtained from the four i-STAT devices in use in 2024 were completed as indicated on the i-STAT Instrument to Instrument Comparison spreadsheet as follows: i-STAT's compared Date of comparison 334879 and 374827 6/26/24 374839 and 440427 12/13/24 The laboratory was unable to provide the missing test comparisons from 2023 and 2024 upon request. 5. In an interview at 1:20 p.m. on 08/20/25, TC1 confirmed the above finding. 6. In an email received at 8:42 a.m. on 08/21/25, TC1 indicated 226 PT/INR tests were performed between 08/21/23 and 12/31/23 and 681 PT/INR tests were performed in 2024. . -- 2 of 2 --

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 and interview with laboratory personnel, the laboratory failed to perform and document function checks (calibration) for 1 of 1 digital thermister unit from 02/18/20 to 08/25/120. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by Technical Consultant 3 (TC3) during the entrance interview on 06/18/21, at 9:05 a.m. 2. A VersaTrak digital themister unit with serial number (S/N) 17985 was observed as in use in the laboratory refrigerator during a tour of the storage area. Control materials and testing cartridges were observed in the refrigerator. 3. The manufacturer's original calibration date (08/25/20) and expiration date (8/25/22) was indicated on the Certificate of Accuracy for the currently installed unit. A review of the installed thermister unit records revealed that the previously installed unit (S/N 11721) had a manufacturer's original calibration date (02/18/18) and expiration date (2/18/20.) 4. During an interview on 06/18/21, at 12:05 p.m., and in a subsequent email received 6/21/21, TC3 confirmed that the installed VersaTrak digital themister units had a 6 month, 1 week gap in certified accuracy calibration, and indicated the facility maintenance department had not replaced the themister unit on time. . 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed ensure 2 of 4 personnel who routinely performed Chemistry and Hematology testing on patient samples participated in proficiency testing (PT) in 2017 and 2018. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by Technical Consultant 3 (TC3) during the entrance interview on 03/27/19 at 1:05 p.m. 2. The laboratory performed PT using the American Proficiency Testing Institute (API) proficiency provider. 3. Testing Personnel 1 (TP1) did not participate in 6 of 6 API PT events completed by the laboratory in 2017. Testing Personnel 3 (TP3) did not participate in 6 of 6 API PT events completed by the laboratory in 2018. 4. In an interview on 03/27/19 at 1:45 p.m., TC3 indicated TP1 and TP3 routinely performed testing on patient samples and confirmed neither participated in PT as indicated above. 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. 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 -- (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, document review, and interview with laboratory personnel, the laboratory failed to document storage temperatures for Chemistry and Hematology test cartridges and quality control material from 08/10/17 to date of survey, 03/27/19. Findings are as follows:: 1. The laboratory performed Chemistry and Hematology testing as confirmed by Technical Consultant 3 (TC3) during the entrance interview on 03/27/19 at 1:05 p.m. 2. Control materials and testing cartridges were observed in the refrigerator during a tour of the storage area. A Fischer Scientific Min/Max digital thermometer with serial number 101848968 and calibration expiration date 08/20/17 was observed as in use - See D5435. 3. Storage temperature documentation was not found in laboratory records for the timeframe reviewed, 08/10/17 through 03/27/19. The laboratory was unable to provide the missing records upon request. 4. During an interview on 03/27/19 at 1:17 p.m., TC3 confirmed the storage temperatures had not been documented. 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 and interview with laboratory personnel, the laboratory failed to perform and document function checks (calibration) for 1 of 1 Min/Max digital thermometers from 08/20/17 to date of survey, 03/27/19. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by Technical Consultant 3 (TC3) during the entrance interview on 03/27/19 at 1:05 p.m. 2. A Fischer Scientific Min/Max digital thermometer with serial number 101848968 was observed as in use in the laboratory refrigerator during a tour of the storage area. Control materials and testing cartridges were observed in the refrigerator. 3. The manufacturer's calibration due date, 08/20/17, was indicated on the back of the Min /Max digital thermometer. The laboratory was unable to provide calibration records for the thermometer from the timeframe reviewed, 08/10/17 through 03/27/19, upon request. 4. During an interview on 03/27/19 at 3:05 p.m., TC3 confirmed the Min/Max digital thermometer calibration was overdue and indicated the facility maintenance department had not performed calibrations on this piece of equipment. -- 2 of 2 --