Pipestone County Medical Center Laboratory

Summary Statement of Deficiencies D0000 The Pipestone County 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 proficiency testing desk review survey performed on November 13, 2025. 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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in Creatine Kinase (CK) PT under specialty of Routine Chemistry in 2025. Findings are as follows: 1. The CMS CASPER Report 0155D and the API 2025 Chemistry Core - 2nd and 3rd Event Performance Summary and Comparative Evaluations were reviewed on November 13, 2025. 2. The reports indicated the laboratory failed to achieve satisfactory performance for Creatine Kinase in two of three consecutive testing events in 2025, resulting in unsuccessful performance of the analyte. See 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 proficiency testing (PT) reports from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Creatine Kinase (CK) PT testing in two of three consecutive testing events in 2025, constituting unsuccessful performance. Findings are as follows: 1. The API 2025 Chemistry - Core 2nd and 3rd Performance Summary and Comparative Evaluations were reviewed on November 13, 2025. The API reports indicated the laboratory had unsatisfactory performance for CK. See below. 2nd Event 2025 60% 3rd Event 2025 40% . -- 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 proficiency testing (PT) results for four (4) of twenty (20) PT events completed in 2021 and 2022. Findings are as follows: 1. The laboratory performed Microbiology, Diagnostic Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by Technical Consultant 1 (TC1) during a tour of the laboratory at 12:50 p.m. on April 13, 2023. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory failed to review the PT results from API for the following events until April 11, 2023, 2 days prior to the announced on-site CLIA survey: *2021 Hematology/Coagulation 3rd Event *2021 Microbiology 3rd Event *2021 Chemistry-Core 3rd Event 4. There was no evidence of laboratory review for API 2022 Immunology/Immunohematology 1st Event. 5. Investigation and

Summary Statement of Deficiencies 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 observation, record review, and interview with laboratory personnel, the laboratory failed to complete performance verification activities for 1 of 3 new tests implemented by the laboratory between March 2019 and May 2021. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:20 a.m. on 05/27/21. 2. An Abbott i-STAT analyzer was observed as present and available for use during the tour of the laboratory. The i-STAT CHEM8+ cartridge was used as a backup method when the primary Chemistry analyzer was unavailable for use as indicated by the GS during the tour. 3. The laboratory implemented use of the non-waived CHEM8+ cartridge on 03 /11/20 as indicated in laboratory records. Documentation of performance verification (PV) activities for the non-waived CHEM8+ cartridge was not found in laboratory records. The laboratory was unable to provide PV documentation upon request. 4. The laboratory's Abbott i-STAT Patient Result Log indicated 35 patient samples were tested using the i-STAT CHEM8+ cartridges between 03/11/20 and 05/27/21. See below. Month Number tested 2020 March 0 April 0 May 1 June 9 July 0 August 1 September 5 October 1 November 6 December 1 2021 January 3 February 1 March 6 April 0 May 1 5. In an interview at 4:15 p.m. on 05/27/21, the GS confirmed the above finding. 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 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)