Avera Weskota Memorial Medical Center

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 the CASPER proficiency testing (PT) reports 153D and 155D and 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's American Proficiency Institute (API) 2025 and 2026 PT reports, the laboratory failed to achieve successful participation in the subspecialty of routine chemistry for the total creatine kinase (CK) analyte. Unsatisfactory results for total CK had been received in three of five PT testing events (API 2025 Chemistry-Core first and third events; 2026 second event) resulting in unsuccessful PT participation. 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 review of the CASPER proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute's (API) 2025 and 2026 PT reports, and interview with technical consultant A, the laboratory failed to achieve a satisfactory score of 80% or above in the subspecialty of routine chemistry for the total creatine kinase (CK) analyte for three of five testing events (API 2025 Chemistry-Core first and third events; 2026 second event). Findings include: 1. Review of the 7/20/26 CASPER Unsuccessful PT report 153D revealed the laboratory had received unsatisfactory scores (less than 80%) for the total CK analyte in each of the three testing events listed above. Review of the 7/20/26 CASPER Individual Laboratory Profile PT report 155D report revealed the laboratory had received unsatisfactory scores of 60% in the 2025 first event, 0 % in the 2025 third event and 60% in the 2026 second event for the total CK analyte. Review on 7/20/26 of the individual event total CK analyte scores for the three API PT events revealed: a. 2025 Chemistry-Core first event total CK results were: (i) CH-01 result was 112. The range of acceptable results was 121-182 units/liter (U/L). (ii) CH-03 result was 267. The range of acceptable results was 274-412 U/L. b. 2025 Chemistry-Core second event total CK results were: (i) CH-11 result was 54. The range of acceptable results was 70-106 U/L. (ii) CH-12 result was 145. The range of acceptable results was 163-246 U/L. (iii) CH-13 result was 29. The range of acceptable results was 32-50 U/L. (iv) CH-14 result was 67. The range of acceptable results was 86-131 U/L. (v) CH-15 result was 89. The range of acceptable results was 108-162 U/L. c. 2026 Chemistry-Core second event total CK results were: (i) CH-06 result was 248. The range of acceptable results was 254-383 U /L. (ii) CH-08 results was 36. The range of acceptable results was 38-58 U/L. Interview on 8/5/26 via email with technical consultant A revealed there was a potential issue with the running of the PT samples after the stated 14 day specimen stability. a. The survey samples were received on 5/20/26 and were processed on 6/5 /26, 16 days after the survey samples were received. b. The survey samples were thawed and repeated as part of the investigation. CH-06 and CH-08 repeated as 200 and 33 U/L, respectively. Both results were below the acceptable limits. c. API was notified and replacement PT samples were requested. The replacement PT samples were tested immediately upon receipt and the results were within the acceptable ranges. d. The initial PT samples were processed on total CK reagent lot # 2688 with an expiration date of 1/27. The new PT samples were run on total CK reagent lot # 2692 with an expiration date of 7/1/27. e. Quality control (QC) results during the affected time period were reviewed and found to be acceptable. Review of the peer -- 2 of 3 -- QC data from May and June indicated the laboratory's means and standard deviations were within acceptable ranges. f. Patient specimen testing was ceased during the investigation. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of CASPER 153D and 155D reports and American Proficiency Institute 2025 and 2026 PT reports, the laboratory director failed to ensure

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 proficiency testing (PT) record review and interview with technical consultant A, the laboratory failed to achieve successful participation for the creatine kinase (CK) test method. Unsatisfactory results had been received in two of three PT testing events (American Proficiency Institute [API] 2025 Chemistry-Core first and third events) resulting in unsuccessful PT participation. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (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 review of the Federal proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute's (API) PT reports and interview with technical consultant A, the laboratory failed to achieve a satisfactory score of 80% or above for the creatine kinase (CK) test method for two of three testing events (API 2025 Chemistry-Core first and third testing events). Findings include: 1. Review of the 10/30/2025 CASPER Unsuccessful PT report 153D revealed the laboratory had received unsatisfactory scores (less than 80%) for the CK test method in each of the two testing events listed above. Review of the 10/30/25 CASPER Individual Laboratory Profile PT report 155D report revealed the laboratory had received unsatisfactory scores of 60% in the first event and 0 % in the third event for the CK test method. Review on 10/1/25 of the individual event CK test method scores for the two API PT events revealed: a. 2025 Chemistry-Core first event CK results were: (i) CH-01 result was 112. The range of acceptable results was 121-182 units/liter (U/L). (ii) CH-03 result was 267. The range of acceptable results was 274-412 U/L. b. 2025 Chemistry-Core second event CK results were: (i) CH-11 result was 54. The range of acceptable results was 70-106 U/L. (ii) CH-12 result was 145. The range of acceptable results was 163-246 U/L. (iii) CH-13 result was 29. The range of acceptable results was 32-50 U/L. (iv) CH-14 result was 67. The range of acceptable results was 86-131 U/L. (v) CH-15 result was 89. The range of acceptable results was 108-162 U/L. Interview on 10/29/25 via email with technical consultant A revealed there was a potential issue with the PT samples. a. The original PT samples were thawed and repeated. The results were similar to the laboratory's reported results. b. Quality control results during the affected time period were reviewed and found to be acceptable. c. Linearity studies were performed on 9/29/25. The results were all within the acceptable ranges. d. API was notified and replacement PT samples were requested. The replacement PT samples were tested and the results were within the acceptable ranges. f. Patient specimen testing was ceased during the investigation. Previously processed and reported patient specimens from the time period were reviewed and where possible repeated. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/25/2019. The Avera Weskota Memorial Medical Center laboratory was found not in compliance with the following requirement: D5447. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the D-dimer (nonwaived test method) quality control (QC) record, and interview with the lead laboratory person, the laboratory failed to perform two levels of controls or establish an equivalent quality control method to verify the accuracy of D-Dimer test results for three of four dates (2/12/19, 1/16/19, and 1/14 /19) of patient testing reviewed. Findings include: 1. Review of the 2019 D-dimer QC records revealed QC results had not been documented on the three days identified above. Patient test results had been reported to the provider on those days. Interview on 4/25/19 at 10:40 am with the lead laboratory person revealed current laboratory practice was to perform QC on a monthly basis and whenever a new test kit was put into use. She was not aware QC was required each day patient testing was performed unless an equivalent control method had been established. 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 --