Shakopee Dakota Clinic

Summary Statement of Deficiencies D0000 The Shakopee Dakota Clinic 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 Sodium. 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 Sodium 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 Sodium in two out of three consecutive events in 2025 and 2026, leading to unsuccessful participation as indicated in the above reports. See below. Unsatisfactory Sodium PT events -Score of 20% during the 3rd event of 2025 -Score of 20% during the 1st event of 2026 . -- 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 investigate an unacceptable Hematology proficiency testing (PT) result for 1 analyte in 2018. Findings are as follows: 1. The laboratory performed proficiency testing (PT) through the American Proficiency Institute (API) program. 2. The laboratory received an unacceptable PT result in the 2018 Hematology / Coagulation 3rd Event for Mean Platelet Volume (MPV) on sample HEM-15. 3. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 4. In an interview on 03/13/19 at 3:30 p.m., Testing Personnel 7 (TP7) confirmed the above finding. . 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 document review and interview with laboratory personnel, the laboratory 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 -- failed to verify the accuracy of Hematology proficiency testing (PT) scores when the PT program returned evaluations of 4 analytes as Not Graded in 2017. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 3/13/19 at 9:5 a.m. 2. The laboratory performed proficiency testing (PT) through the American Proficiency Institute (API) program. 3. The following PT results from 2017 were not graded by the PT provider. Survey: Hematology / Coagulation 3rd Event Sample ID: HEM-15 Tests: White Blood Cell Count Granulocytes Lymphocytes Monocytes 5. The API expected results data summaries were not present in laboratory records. Evaluations for accuracy of the non-graded results were not found during review of laboratory documents. The laboratory was unable to provide evaluations of non-graded results upon request. 6. In an interview on 03/13/19 at 3:30 p.m., Testing Personnel 7 (TP7) confirmed the above finding. . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements. Findings are as follows: 1. The Laboratory Procedures Manual did not include a Proficiency Testing (PT) procedure by which to monitor, assess, and, when indicated, correct problems identified in the PT process. 2. The laboratory was unable to provide the above document upon request. 3. In an interview on 3/13/19 at 10:00 a.m., the General Supervisor confirmed the above findings. . 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)