Kittson Memorial Hospital Association

Summary Statement of Deficiencies D0000 . The Kittson Memorial Hospital Association 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 performed on May 22, 2025. The following standard-level deficiencies were cited: 493.1451 Technical supervisor responsibilities . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 Supervisor failed to ensure comprehensive initial, semi-annual, and annual competency assessments were performed on five of five testing personnel in 2023, four of four testing personnel in 2024, and one of one new testing personnel in 2025. Findings are as follows: 1. The laboratory performed Urinalysis and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:20 a.m. on 05/22/25. 2. A Nikon Eclipse e200 microscope was observed as present and available for use during the tour. Urine sediment microscopic examinations (USed) were performed using the microscope. Compatibility Testing (Crossmatch) was performed by the laboratory as part of Immunohematology services provided as confirmed by the GS during the tour. 3. Personnel competency evaluations encompassing all duties performed were required as established in the Competency Assessment and Training procedure found in the Lab Services Manual. 4. The USed and Crossmatch tests were not included on 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 -- competency assessment forms completed in 2023 through May 2025. Testing personnel (TP) were not assessed for competency on these tests. See below. 2023 - 2 of 2 new TP were not assessed initially or semi-annually 2023 - 3 of 3 tenured TP were not assessed annually 2024 - 2 of 2 new TP were not assessed initially or semi- annually 2024 - 2 of 2 tenured TP were not assessed annually 2025 - 1 of 1 new TP was not assessed initially Semi-annual and annual competency assessments for 2025 are in progress but have not yet been completed. 5. The laboratory was unable to provide documentation of USed and Crossmatch competency assessments completed in 2023, 2024, and 2025 upon request. 6. In an interview at 11:55 a.m. on 05/22/25, the GS confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 Supervisor failed to ensure comprehensive initial training for one of one new testing personnel (TP) was performed and documented in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as confirmed by the General Supervisor during a tour of the laboratory at 8:10 a.m. on 03 /30/23. 2. The following tests were performed by the laboratory in 2021 as indicated by GS during the tour: Manual differential (Diff) KOH microscopic examination (KOH) Vaginal wet preparation examination (VWP) Post vasectomy semen analysis (PV) Albumin/Creatinine ratio on the DCA Vantage (A/C) 3. Training during employee orientation was required as established in the Competency Assessment and Training procedure found in the Lab Services Manual. 4. Initial training was completed for TP5 in July and August 2021 as indicated on competency forms found in the Competence of Current KMHC Laboratory Employees manual. Documentation of TP5's initial training for the Diff, KOH, VWP, PV, A/C tests was not found. 5. The laboratory was unable to provide the missing training records upon request. 6. In an interview at 10:10 a.m. on 03/30/23, Technical Consultant 1 (TC1) confirmed the above finding. At 11:20 a.m., TC1 confirmed TP5 performed the above tests on patient specimens between August 2021 and May 2022, the month of TP5's subsequent complete and acceptable competency assessment. . 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director or designee and Testing Personnel failed to attest to the integration of proficiency testing samples into the routine patient workload on two occasions in 2018. Findings are as follows: 1. The laboratory Chemistry and Immunohematology testing as confirmed by the General Supervisor during a tour of the laboratory on 03 /13/19 at 8:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) PT provider. 3. The Laboratory Director and Testing Personnel were required to sign the attestation statements as established in the Quality Plan Proficiency Testing procedure located in the Quality Assurance manual. 4. The Laboratory Director or designee and Testing Personnel failed to attest to the integration of PT samples into the routine patient workload for 2 of 23 API PT events reviewed in the June 2017 through March 2019 timeframe. See below. Event Specialty missing attestation 2018-2 Chemistry Miscellaneous (document absent) 2018-3 Immunohematology (document blank) 5. In an interview on 03/13/19 at 11:05 a.m., Technical Consultant 1 confirmed the above finding. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate unacceptable Hematology (Coagulation) proficiency testing (PT) results for 2 analytes in 2018. Findings are as follows: 1. The laboratory performed proficiency testing (PT) through the American Proficiency Institute (API) program. 2. The laboratory received unacceptable PT result in the API 2018 Hematology /Coagulation 3rd event for the analytes listed below. Sample Test Lab result API range COA-11 APTT* 59 42-58 COA-12 PT* 14.3 10.4-14.1 3. Investigation of unacceptable results was required within 30 days of receipt as established in the Quality Plan Proficiency Testing procedure located in the Quality Assurance manual. 4. An investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation completed within 30 days of receiving the unacceptable results upon request. 5. In an interview on 03/13/19 at 10:55 a.m., Technical Consultant 2 confirmed a documented investigation of the unacceptable results was not performed. * Note APTT - Activated Partial Thromboplastin Time PT - Prothrombin Time D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-regulated Hematology analyte at least twice annually in 2017 and 2018. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 02/07/19 at 8:20 a.m. 2. The Semen Analysis microscopic examination was included on the Kittson Healthcare Annual Average Assay Count 2018 document provided by the laboratory. 3. Twice annual verification of accuracy documents for Semen Analysis were not found during review of laboratory records from 2017 and 2018. The laboratory was unable to provide the documents upon request. 4. In an interview on 03/13/19 at 9:45 a.m., Technical Consultant 2 confirmed the accuracy of the Semen Analysis microscopic examination had not been verified twice annually in 2017 and 2018. 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)