Aurora Health Center-Waukesha

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with a technical consultant, Staff A, the laboratory director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for five of thirty-four events in 2019 and 2020. Findings include: 1. Review of WSLH PT records from 2019 and 2020 showed the laboratory director or designee did not sign the attestation form for the following events: a. 2019-HemeReg1 b. 2020-HemeReg1 c. 2020- HemeReg2 d. 2020-Chem/Endo/Tx2 e. 2020-Cardiac2 2. Interview with Staff A on May 27, 2021 at 10:25 AM confirmed the laboratory director or designee did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for five of thirty-four events in 2019 and 2020. 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 D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control records and interview with the technical consultant, the laboratory did not test quality control material before testing patient samples with a new lot of troponin reagents on the i-STAT analyzer. Findings include: 1. Review of the "WAUK i-STAT cTnl Quality Control Log" showed troponin cartridge lot number M1812713 was first tested with control material on July 8, 2018. The log showed July 1, 2018 as the 'date in use' for this cartridge lot. 2. Interview with the technical consultant, staff A, on December 17, 2018 at 10:30 AM confirmed troponin patient testing was performed prior to testing control materials on the i- STAT analyzer after a change to a new reagent lot number. 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 --