Aurora Health Care Metro Inc - Kenosha South

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview the technical consultant, the laboratory did not perform calibration verification every six months for three of five chemistry analytes on the Siemens Xpand chemistry analyzer. Findings include: 1. Review of Siemens Xpand calibration verification records showed calibration verification was performed on calcium and AST on July 6, 2023, January 12, 2024, and July 11, 2024, while the sodium, potassium and chloride were performed on July 6, 2023, January 12, 2024 and August 13, 2024, one month after the due date of July 12, 2024. 2. Interview with the technical consultant on February 19, 2025, at 10:30 AM confirmed the laboratory did not perform 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 -- verification every six months for sodium, potassium and chloride on the Siemens Xpand chemistry analyzer. -- 2 of 2 --

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 proficiency testing (PT) records from 2022 and interview with the technical supervisor, the laboratory director or designee did not attest to the routine integration of the PT samples into the patient workload. The director did not sign the attestation statements for two of three hematology, three of three chemistry, and two of two miscellaneous point of care (POC) events. Findings include: 1. Review of PT records from 2022 showed no evidence the director or designee attested to the routine integration of the samples into the patient workload using the laboratory's routine methods for seven of eight events. Review of the attestation statement forms showed the director or designee did not sign the forms for the following events: Hematology 2022, Events two and three Chemistry 2022, Events one, two and three Miscellaneous POC 2022, Events one and two 2. Interview with the technical supervisor on April 25, 2023 at 10:30 AM confirmed director or designee signatures were missing from the attestation statements for seven of eight events during 2022 and confirmed the director or designee did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually 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 -- after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on surveyor review of competence evaluation records and interview with the technical consultant, the technical supervisor did not evaluate and document the performance of one of three testing personnel at this laboratory in 2021 or 2022. Findings include: 1. Review of competence evaluation records for the three testing personnel showed staff A had no documented competence evaluation at this laboratory in 2021 or 2022. 2. Interview with the technical consultant on April 25, 2023 at 12:45 PM confirmed the laboratory did not have records available to show the technical supervisor had evaluated competence of testing personnel staff A in 2021 or 2022 at this laboratory. -- 2 of 2 --