Saint Francis Lab-Ba Kenosha

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/03/2025 through 12/04/2025. The laboratory was found in compliance with standard-level deficiencies cited. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/25/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and incoming technical consultant at the conclusion of the survey. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 a review of records and interview with the laboratory director, the laboratory failed to ensure the performance specification data had been evaluated prior to implementing one of two new test methods introduced into the laboratory. Findings include: (1) On 01/25/2024 at 10:00 am, the laboratory director stated the laboratory began using the Beckman Coulter DxH 520 analyzer to perform CBC (Complete Blood Count) testing on 05/15/2023; (2) A review of the performance specification records for the new test system identified no evidence the data had been signed and dated as approved by the laboratory prior to putting into use for patient testing; (3) Interview with the laboratory director on 01/25/2024 at 02:30 pm confirmed there was no documentation to prove the performance specification data had been reviewed and approved by the laboratory prior to putting into use. D5441 CONTROL PROCEDURES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for three of seven months reviewed for testing performed using the Beckman Coulter DxH 520 Hematology analyzer. Findings include: (1) On 01/25/2024 at 10:00 am, the laboratory director stated the following: (a) The laboratory began using the Beckman Coulter DxH 520 analyzer to perform CBC (Complete Blood Count) testing on 05/15/2023; (b) Three levels of QC (quality control) materials were performed each day of patient testing. (2) A review of records from June 2023 through December 2023 identified no evidence, such as Levey- Jennings graphs and cumulative statistical data, to prove that QC results had been monitored for variances (i.e.,biases, shifts, trends) for three of seven months (October, November, and December 2023); (3) Interview with the laboratory director on 01/25 /2024 at 03:35 pm confirmed that QC data to include Levey-Jennings graphs and cumulative statistical data had not been printed and reviewed from October through December 2023. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to perform a negative and positive control material ten of 19 days of patient SARS-CoV-2, Influenza A, Influenza B, and RSV (Respiratory Syncytial Virus) testing reviewed from October through December 2023. Findings include: (1) On 01 /25/2024 at 10:10 am, the laboratory director stated the following: (a) The laboratory began performing SARS-CoV-2, Influenza A, Influenza B, and RSV testing using the Cepheid Gene Xpert DX analyzer on 10/23/2023; (b) An IQCP (Individualized Quality Control Program) had not been developed for the test system (the laboratory was in the process of developing an IQCP). (2) A review of the test volume list completed for the survey identified the laboratory performed approximately 24 of each of the tests annually; (3) A review of QC (Quality Control) and patient testing -- 2 of 3 -- records for testing performed from October through December 2023 identified negative and positive QC materials had not been documented as performed each day of patient testing for ten of 19 days. The specific days of patient testing were 10/27 /2023; 11/14,17,20,27,30/2023; and 12/13,20,21,26/2023; (4) The records were reviewed with the laboratory director who stated on 01/25/2024 at 04:15 pm, negative and positive QC materials had not been documented as performed as stated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/04/2021. The findings were reviewed with the laboratory director and technical consultant #2 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with technical consultant #2, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for 1 of 4 Hematology events reviewed. Findings include: (1) On 10/04/2021, the surveyor reviewed proficiency testing records for the first, second, and thirds events in 2020; and the first event in 2021. The following was identified for 1 of 4 Hematology events: (a) First 2020 Event for Blood Cell ID (Educational) - 1 of 5 results had not been graded by the proficiency testing program: (i) For 1 of 5 results (ECI-01), the following was identified: (aa) ECI-01 - Under "Expected Results" it stated, "See Commentary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (2) The surveyor reviewed the records with technical consultant #2 who stated on 10/04/2021 at 12:26 pm, the laboratory had not evaluated the result that was not graded by the proficiency testing program and

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/11/19. The findings were reviewed with the laboratory director/technical consultant #1 and technical consultant #2 during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records, manufacturer's instructions, and interview with technical consultant #2, the laboratory failed to retain quality control records for at least 2 years. Findings include: (1) At the beginning of the survey, technical consultant #2 stated to the surveyor CBC (Complete Blood Count) testing was performed using the Cell-Dyn Emerald; (2) Later during the survey, the surveyor reviewed quality control records between April 2019 through August 2019 with the following identified: (a) May 2019 records were not available (b) June 2019 records were not available (c) July 2019 records were not available (3) The surveyor ask technical consultant #2 if the quality control records for May 2019, June 2019, and July 2019 could be located; (4) Technical consultant #2 stated the May 2019, June 2019, and July 2019 quality control records for CBC testing could not be located. The surveyor could not determine if the quality control records for the above months had been monitored and evaluated. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 a review of records and interview with technical consultant #2, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following: (a) Third 2018 Hematology Event - The proficiency testing program did not evaluate 1 of 5 results for Platelets. In addition, the reported result did not agree with the expected result provided on the evaluation form: (i) Platelet (HEM-02) - The reported result was 86. The expected result was a range between 49- 83. (2) The surveyor further reviewed the records. There was no evidence the laboratory identified the results had not been evaluated by the proficiency testing program; and there was no evidence the laboratory investigated the discrepancy between the submitted and expected results as indicated above; (3) The records were reviewed with technical consultant #2, who stated the laboratory had not investigated the discrepancy as indicated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 a review of records, procedure manual, and interview with technical consultant #2, the laboratory failed to demonstrate the performance specifications for new test methods; Findings include: (1) At the beginning of the survey, technical consultant #2 stated the laboratory began using the Abbott iSTAT analyzer (serial# 400580) to perform PT/INR (Prothrombin Time/International Normalized Ratio) testing for patient testing beginning 06/25/18; (2) The surveyor reviewed the validation records for the analyzer but could not locate any records to prove the laboratory had verified the manufacturer's reportable range; (3) The surveyor asked technical consultant #2 if any additional testing had been performed to verify the reportable range prior to reporting patient results. Technical consultant #2 stated the reportable range had not been verified. D5783

Summary Statement of Deficiencies D0000 The findings were reviewed with the laboratory director and technical consultant #1 at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and technical consultant #1, the laboratory failed to follow the manufacturer's instructions for waived testing. Findings include: (1) At the beginning of the survey, the laboratory director stated the laboratory used the Siemens CLINITEK Status Analyzer to perform macroscopic urinalysis testing; (2) Surveyor #2 reviewed the manufacturer's instructions for the analyzer which required a relative humidity of 18-80%; (3) Surveyor #2 reviewed the humidity records between the following: (a) January 01, 2016 through April 20, 2016 (b) December 06, 2016 through January 30, 2017 (c) December 21, 2017 through January 09, 2018 (4) Humidity - for 29 of 159 days the documented humidity was less than 18% (a) January 2016 - Days 10,11,17,18 (b) February 2016 - Days 9,10,13,14 (c) December 2016 - Days 10,15,18,19,20,21,30 (d) January 2017 - Days 5,6,7,8,9,28 (e) December 2017 - Days 27,28,31 (f) January 2018 - Days 1,2,3,4,6 (5) The surveyors reviewed the findings with the laboratory director and technical consultant #1 who stated the laboratory failed to follow manufacturer's storage instructions for Siemens CLINITEK Status Analyzer. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and technical consultant #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following was identified: (a) 2016 Hematology - 3rd Event (i) Platelet Count - The laboratory received a score of 80% (failed 1 of 5 results). There was no evidence that