Gundersen Lutheran Medical Center

Summary Statement of Deficiencies D0000 The Gundersen Winona Campus 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 proficiency testing desk review survey performed on April 13, 2026. The following condition-level deficiencies were cited: 493.803 Successful Participation The following standard-level deficiencies were cited: 493.841 Routine chemistry . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and API (American 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 -- Proficiency Institute) records from 2025 and 2026, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte Chloride. Refer to D2096. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Proficiency Institute (API) records, the laboratory failed to successfully participate in proficiency testing (PT) for the analyte Chloride under the subspecialty Routine Chemistry in two out of three consecutive testing events in 2025 and 2026, constituting unsuccessful performance. Findings include: 1. The CASPER Report 0155D and the API 2026 Chemistry - Core 1st Event and API 2025 Chemistry - Core 3rd Event Performance Summary and Comparative Evaluations were reviewed on April 13, 2026. 2. The laboratory received unsatisfactory performance for Chloride in two out of three consecutive events in 2025 and 2026, leading to unsuccessful participation as indicated in the above reports. See below. Unsatisfactory Chloride PT events -Score of 40% during the 3rd event of 2025 -Score of 40% during the 1st event of 2026 . -- 2 of 2 --

Summary Statement of Deficiencies D0000 . The Gundersen Winona Campus 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 November 20, 2025. The following standard-level deficiencies were cited: 493.1251 Procedure manual 493.1253 Establishment and verificaiton of performance specifications 493.1291 Test report . 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 Gunderson Lutheran Medical Center Winona Campus 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 initial survey performed on July 11, 2024. The following condition-level deficiency was cited: 493.1421 Laboratories performing moderate complexity testing: testing personnel The following standard-level deficiency was cited: 493.1423 Testing personnel qualifications . D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on personnel record review and interview and email communication with laboratory personnel, the laboratory failed to ensure staff performing moderate complexity testing met the qualification requirements of 493.1423 to perform the functions specified in 493.1425 for the complexity of testing performed. Findings are as follows: Documentation was not provided for one of fourteen testing personnel showing educational requirements for moderate complexity testing were met. See D6065. . D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in 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 2 -- chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on document review and interview and email communication with laboratory personnel, the laboratory failed to ensure one of fourteen testing personnel had the required educational credentials to perform moderate complexity testing in 2023 and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology, Chemistry, and Hematology testing and Microscopic Examinations for bacteria, parasites, fungus, urine sediment, and rupture of fetal membranes as confirmed the Technical Supervisor (TS) during a tour of the laboratory at 8:35 a.m. on 07/11/24. The laboratory performed approximately 119,583 moderate complexity tests annually. 2. Documentation of a high school education was not found for Testing Personnel 6 (TP6) during review of laboratory documents. A Phlebotomy Certificate for TP6 was provided. 3. Survey document Form CMS-209, signed by the Laboratory Director on 07/09/24, listed TP6 as qualified to perform moderate complexity testing. 4. In an interview at 9:25 a.m. on 07/11/24, the TS confirmed documentation of a high school education was not present for TP6. The laboratory was given an opportunity to provide the credentials within five days of the survey. 5. In an email received at 8:43 a. m. on 07/16/24, the TS provided an incomplete high school transcript and indicated official documentation of a high school equivalency diploma had not been received for TP6. -- 2 of 2 --