Sanford Luverne Medical Center

Summary Statement of Deficiencies D0000 . The Sanford Luverne Medical Center 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 August 27, 2025. The following standard-level deficiencies were cited: 493.1291 Test report . 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 laboratory personnel, the laboratory failed to ensure one of one qualitative serum hCG (human chorionic gonadotropin) reference intervals were included on a patient test report in 2024 and 2025. Findings are as follows: 1. The laboratory performed qualitative serum hCG testing as indicated on the form CMS-116 provided by the laboratory on the date of survey. 2. Quidel QuickVue hCG combo test kits were observed as present and available for use on patient serum specimens during a tour of the laboratory at 1:05 p. m. on 8/26/25. 3. The qualitative serum hCG reference interval was not listed on a patient test report from 7/2/24 reviewed on the date of survey. 4. The laboratory performed 737 qualitative serum hCG tests in 2024 and 75 qualitative serum hCG tests in 2025. 5. In an interview at 12:41 p.m. on 8/27/25, the Technical Supervisor confirmed the above findings. . 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 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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to successfully participate in pO2 PT under the specialty of General Chemistry in 2023. Finding are as follows: 1. The CMS CASPER Report 0155D and the API 2023 Chemistry - Core 2nd Event Comparative Evaluation and the 2023 API 2023 Chemistry - Core 3rd Event Performance Summary and Comparative Evaluation were reviewed on November 9, 2023. The reports indicated the laboratory failed to achieve satisfactory performance for pO2 in two consecutive testing events in 2023 resulting in unsuccessful performance. See D2096. . 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to achieve satisfactory PT performance for pO2 testing in two consecutive PT events in 2023, constituting unsuccessful performance. Findings include: 1. The CMS CASPER Report 0155D, reviewed on November 9, 2023, indicated the laboratory failed to obtain a successful score of at least 80 percent in two consecutive testing events in 2023 for pO2. 2. The API 2023 Chemistry-Core - 3rd Event Performance Summary confirmed the laboratory failed to obtain a pO2 PT score of at least 80 percent in two consecutive testing events in 2023. -Score of 60% during the 2nd event of 2023 -Score of 60% during the 3rd event of 2023 . -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 document review and interview with laboratory personnel, the laboratory failed to review and evaluate proficiency testing (PT) results from 2 PT events in 2019. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 08/26/21. 2. The laboratory performed PT using the American Proficiency Institute (API) program. 3. The laboratory failed to review and evaluate PT results for the events listed below. API 2019 Chemistry 2nd miscellaneous event API 2019 Hematology 3rd event 4. Review and evaluation of PT results was required as established in the Proficiency Testing Protocol, located in the procedure software PolicyTech. 5. The laboratory was unable to provide documented review and evaluation of the PT results from the above 2019 events upon request. 6. In an interview at 3:30 p.m. on 08/26/21, the GS confirmed the above finding. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 1 of 3 reportable ranges obtained during performance verification activities completed in 2020 on a Hematology analyzer were adopted by the laboratory. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 08/26/21. 2. A Stago STA Compact Max coagulation analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification (PV) activities on the analyzer for D-Dimer were completed in February 2020. The Laboratory Director approved the PV activities on 03/02/20 and testing was implemented on 03/03/20. 4. The upper limit of the reportable range for D-Dimer listed in the D-Dimer - STA Compact Max procedure, located in the procedure software PolicyTech, did not reflect the actual reportable range value obtained by the laboratory during the PV. See below. Analyte PV Procedure D-Dimer 0.21-16.90 0.27-20.0 5. The total number of D-Dimer test results obtained from 03/03 /20 to 08/26/21 was 890. 6. In an interview at 3:55 p.m. on 08/26/21, the GS confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to ensure 5 of 5 testing personnel were evaluated for test procedure competency in all testing areas in 2020. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by General Supervisor during a tour of the laboratory at 8:05 a.m. on 08/26/21. 2. An Opti CCA-TS chemistry analyzer and an Olympus CX31 microscope were observed as present and available for use during the tour. Blood Gas testing was performed on the Opti CCA-TS analyzer and Urine Sediment examinations were performed on the Olympus CX31 microscope as indicated by the GS during the tour. 3. The laboratory's Competency Assessment Procedure, found in the procedure software PolicyTech, indicated TP were evaluated for competency in all testing areas annually. 4. Competency assessments for Blood Gas testing and Urine Sediment examinations were not included in the Annual Competency - Direct Observation of "Objective" Testing forms completed in 2020 for 5 of 5 testing personnel. 5. The laboratory was unable to provide the missing evaluations upon request. 6. In an interview at 10:00 a.m. on 08/26 /21, the GS confirmed the above finding. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate -- 2 of 3 -- results. This STANDARD is not met as evidenced by: missing or incomplete training tp3 . Based on document review and interview with laboratory personnel, the laboratory failed to ensure documented training and initial competency assessments were performed for 1 of 1 new testing personnel (TP) hired in 2020. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 08/26/21. 2. TP3 began employment with the laboratory on 04/12/21 as indicated in laboratory records. The GS confirmed TP3 performed testing independently in the laboratory. 3. The laboratory's Competency Assessment Procedure, found in the procedure software PolicyTech, indicated TP were trained at hire and evaluated for competency in all testing areas. 4. Documentation of TP3's initial training and competency assessment in each of the testing areas was either incomplete or not found during review of laboratory records- see below. The laboratory was unable to provide additional documentation upon request. Incomplete training records Chemistry -Tox/See urine drug screen -Serum hCG Immunology -Amnisure Missing training records Microbiology -GeneXpert analyzer -Vaginal Wet Preparation -Scabies examination Hematology -STA Compact Max analyzer -Manual Differentials -Hematology cell identification -Post vasectomy examination Chemistry -Urine Sediment examination Immunohematology -All analytes 5. In an interview on at 10:00 a.m., the GS confirmed the above finding. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to ensure 1 of 1 new testing personnel (TP) hired in 2020 was evaluated for competency in all testing platforms in use by the laboratory at least semiannually during the first year of patient specimen testing. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 08/26/21. 2. TP3 was hired 04/12/20 as indicated in laboratory records. 3. The laboratory's Competency Assessment Procedure, found in the procedure software PolicyTech, indicated TP were evaluated for competency in all testing areas semi-annually during the first year of patient testing. 4. A semi-annual competency assessment was not found for TP3 during review of laboratory records. The laboratory was unable to provide the semi-annual assessment upon request. 5. In an interview at 10:00 a.m. on 08/26/21, the GS confirmed the above finding. . -- 3 of 3 --