Gundersen St Elizabeth's Hospital And Clinics

Summary Statement of Deficiencies D0000 . The Gundersen St. Elizabeth's Hospital and Clinics 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 completed on February 20, 2025. The following standard-level deficiencies were cited: 493.1254 Maintenance and function checks 493.1291 Test report . D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure function checks for one of four Chemistry analyzers were performed and documented as required in 2023 and 2024. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 11:07 AM on 2/19/2025. 2. An Abbott iSTAT analyzer was observed as present and available for use during the tour. The laboratory used the iSTAT analyzer for Blood Gas testing. The iSTAT was also used as a back-up analyzer for Basic Metabolic Panel and Troponin testing. 3. Twice- annual verification of the iSTAT thermal probe was required by the manufacturer as indicated in the Abbott iSTAT System Manual and as established in the laboratory's Blood Gas (CG8+) iSTAT, Lab-0910 procedure provided by the laboratory on the date of survey. 4. Evidence of thermal probe verification was not found in laboratory maintenance records for 2023 and 2024. The laboratory was unable to provide this 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 -- documentation upon request. 5. In an interview at 1:20 PM on 2/20/2025, the TC confirmed the twice-annual thermal probe verifications were not performed with routine maintenance of the iSTAT analyzer. . D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with the laboratory personnel, the laboratory failed to ensure two Chemistry reference intervals were consistent between the procedure and a patient test report in 2023 and 2024. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 11:07 AM on 2/19/2025. 2. The following Chemistry analyzers were observed as present and available for use during the tour of the laboratory: Roche C501 - the laboratory performed Ammonia (AMM) testing using this analyzer Roche E411 - the laboratory performed Free Thyroxine (FT4) testing using this analyzer 3. AMM reference intervals listed in the Ammonia (NH3) - Roche/Hitachi Cobas C Systems, Lab 4225 procedure provided by the laboratory were not consistent with those included on a patient test report from 6 /30/2023. FT4 reference intervals listed in the Free Thyroxine (FT4 IV) - Cobas E411, Lab 1594 procedure provided by the laboratory were not consistent with those included on a patient test report from 12/2/2024. See below. Analyte Procedure Test Report AMM (umol/L) 11-51 13-56 FT4 (ng/dL) 0.90-1.70 0.92-1.68 4. In an interview at 11:15 AM on 2/20/2025, the TC confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of five 2020 non-graded proficiency testing (PT) results for a non-regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 04/23/21. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One Chemistry result from the second 2020 Chemistry PT event was not graded by API due to lack of participants. See below. Sample ID Analyte CH-01 through CH-05 Vancomycin 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test results. The data summaries for the above samples were not present in laboratory records. Evaluation of the non-graded results was not found in laboratory records. 5. Evaluation of non-graded PT results was required as established in the Proficiency Testing Policy. The laboratory was unable to provide an evaluation of the non-graded results upon request. 6. In an interview at 11:50 a.m. on 04/23/21, the GS confirmed the above finding. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure the reportable ranges obtained during performance verification activities for 2 Chemistry analyzers were adopted by the laboratory. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 04/23 /21. 2. A Roche Cobas c501 chemistry analyzer and a Roche e411 chemistry analyzer were observed as present and available for use during the tour of the laboratory. 3. Performance verification (PV) activities were completed on 02/24/21 and the laboratory began testing patient specimens using theses analyzers on 03/01/21 as indicated by the GS. Sodium (Na), Potassium (K), and Chloride (Cl) testing was performed on the c501 and Thyroid Stimulating Hormone (TSH) testing was performed on the e411. 4. The adopted upper and lower limit of the reportable ranges found in the Sodium, Potassium, Chloride (ISE)-Cobas c501 procedure and the TSH - Cobas e411 procedure for 4 of 4 analytes reviewed on date of survey did not reflect the actual reportable range values obtained by the laboratory during the PV. See below. Analyte PV Adopted Na 84.0-171.7 80-180 K 1.8-9.613 1.5-10 Cl 70.53- 135.17 60-140 TSH 0.10-99.0 0.02-100 5. In interviews at 2:40 p.m. and 4:00 p.m. on 04/02/21, the GS confirmed the above findings and indicated the laboratory adopted the manufacturers analytical measurement ranges as their reportable ranges for the analytes. . -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)