Froedtert Community Hospital - Mequon

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 surveyor review of humidity level records and interviews with the hospital administrator (Staff A) and the laboratory director (Staff B), the laboratory failed to define criteria that were consistent with the manufacturer's instructions for the Sysmex XN-300 hematology analyzer for two of two months reviewed. Findings include: 1. Review of the Primex OneVue reports for the laboratory from December 2025 and April 2026 showed the low humidity limit was set at 0%. 2. Interview with Staff A on April 22, 2026, at 1:10 PM confirmed the Primex system was programmed with a low acceptable humidity level of 0% for the laboratory. Interview with Staff B on April 22, 2026, at 1:15 PM confirmed the manufacturer identified 20% as the low limit of the humidity environmental specification for the Sysmex XN-300 and confirmed the limits defined in the Primex system were not consistent with the manufacturer's instructions. 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 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory director, the laboratory did not retain accurate expiration dates for quality control (QC) performed on the Sysmex XN-330 hematology analyzer from May through August 2022 and did not document changes in lot numbers and expiration date during the month of use. Findings include: 1. Review of the "Sysmex Maintenance Log" showed the following QC lot numbers and expiration dates: Month/Lot/Expiration date recorded May/2070/June 21, 2022 June/2070/June 7, 2022 July/2154/July 11, 2022 August/2154/August 15, 2022 Further review showed no documentation of when new lots were opened and in use. 2. Interview with the laboratory director on November 9, 2022, at 12:15 PM confirmed the laboratory did not retain accurate expiration dates for quality control (QC) performed on the Sysmex XN-330 hematology analyzer from May through August 2022 and did not document changes in lot numbers and expiration date during the month of use. 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 --