Uw Health-Sun Prairie

Summary Statement of Deficiencies D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor review of documented humidity readings in the laboratory and interview with a Technical Consultant (Staff A), the Laboratory Director did not ensure the humidity in the laboratory was appropriate for the testing performed on the Sysmex XS-1000i analyzer in January and February 2025, two of two winter months reviewed. Findings include: 1. Review of the "UWMF Satellite Temperature and Decontamination Log" records from January and February 2025 showed the laboratory documented relative humidity readings in the laboratory each day of testing. Testing personnel documented readings that were less than 30% every day of testing in January and February 2025. 2. Interview with Staff A on August 27, 2025, at 10:50 AM revealed the manufacturer's acceptable relative humidity range for the Sysmex XS-1000i was 30 - 80%. Further interview confirmed the laboratory humidity was not within the defined range during January and February 2025 and confirmed the director did not ensure the laboratory could maintain the appropriate humidity levels as defined by the analyzer manufacturer during winter months. 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 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 surveyor review of laboratory records and interview with the laboratory director, the laboratory had not evaluated and defined the relationship between test systems for hematology differential testing on a twice a year basis for 2022. Findings include: 1. Review of laboratory records showed evaluation of test systems between the Sysmex XS1000i automated differential and manual differential testing in June 2022. Further review showed no additional evaluation in 2022. 2. Interview with the laboratory director on June 19, 2023, at 2:30 PM confirmed the laboratory had not evaluated and defined the relationship between the test systems for hematology differential testing on a twice a year basis for 2022. 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 --