Mille Lacs Health System

Summary Statement of Deficiencies D0000 The Mille Lacs Health System 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 June 13, 2024. The following condition-level deficiency was cited: 493.1250 Analytic Systems, D5400 The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance, D5211 493.1251 Procedure manual, D5401 493.1253 Establishment and verification of performance specifications, D5421 493.1256 Control Procedures, D5445 and D5473 493.1407 Laboratory Director responsibilities, D6013 and D6030 493.1413 Technical Consultant responsibilities, D6046 . 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 one unacceptable Chemistry proficiency testing (PT) result out of fifteen challenges completed in 2022 and one unacceptable Hematology PT result out of fifteen challenges completed in 2023. 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 06/13/24. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The laboratory received one unacceptable PT result of fifteen Calcium testing challenges completed in 2022 as indicated in API reports. See below. 2022 - 3rd Chemistry core event Test: Calcium Sample: CH-13 Laboratory Result: 1.8 API expected result: 8.9-11.0 4. The laboratory received one unacceptable PT result of fifteen Blood Cell Identification testing challenges completed in 2023 as indicated in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- API reports. See below. 2023 - 1st Hematology event Test: Blood Cell Identification Sample: BCI-04 Laboratory Result: Plasma cell API expected result: Lymphocyte, normal 5. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing procedure located in the MLHS Shared Drive electronic procedures folder. 6. Investigation documentation for the unsuccessful Calcium and Blood Cell Identification scores was not found in laboratory records. The laboratory was unable to provide evidence of PT result investigation and

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 two performance verifications completed in 2021 was approved, signed, and dated by the laboratory director prior to implementation. 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 09/08/22. 2. A Werfen GEM Premier 5000 blood gas testing system was observed as present and available for use during the tour of the laboratory. The laboratory performed the following tests on this analyzer: pH - Potential of Hydrogen pCO2 - Partial pressure of Carbon Dioxide Na - Sodium K - Potassium Ca - Calcium Cl - Chloride Glu - Glucose Lac - Lactate tHb - Total Hemoglobin pO2 - Partial pressure of Oxygen 3. A performance verification (PV) for the GEM 5000 analyzer, found in the GEM 5000 manual, was completed in June 2021 as indicated in laboratory records. 4. The laboratory director's approval signature and date were not found in the PV documents. 5. In an interview at 1:15 p.m. on 09/08/22, 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) 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 -- (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, document review, and interview with laboratory personnel, the laboratory failed to ensure ten of ten reportable ranges obtained during one of two performance verification (PV) activities completed in 2021 were adopted by the laboratory. 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 09/08/22. 2. A Werfen GEM Premier 5000 blood gas testing system was observed as present and available for use during the tour of the laboratory. The laboratory performed the following tests on this analyzer: pH - Potential of Hydrogen pCO2 - Partial pressure of Carbon Dioxide Na - Sodium K - Potassium Ca - Calcium Cl - Chloride Glu - Glucose Lac - Lactate tHb - Total Hemoglobin pO2 - Partial pressure of Oxygen 3. PV activities on the GEM 5000 were completed in June 2021 as indicated in laboratory records found in the GEM 5000 manual. 4. The upper and/or lower reportable range limits adopted by the laboratory did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV EP Evaluator documents and the GEM 5000 Operating Procedure found in the laboratory's electronic chemistry procedure folder . See below. Analyte PV Adopted pH 6.93-7.71 7.0-7.92 pCO2 13-135 6-125 Na 107-171 100-190 K 1.2-10.1 1.0-19.0 Ca 1.0-13.1 0.4-17 Cl 71-155 40-158 Glu 16-672 4-685 Lac 0.4- 16.1 0.3-17 tHb 6.8-20.6 3.0-23.0 pO2 31-510 6-690 5. In an interview at 1:30 p.m. on 09/08/22, the GS confirmed the above finding. D5807 TEST REPORT CFR(s): 493.1291(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 four of six reference intervals were consistent between a procedure and a patient test report. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/08/22. 2. A Werfen GEM Premier 5000 blood gas testing system was observed as present and available for use during the tour of the laboratory. The laboratory included the following analytes in the arterial blood gas test performed on this analyzer: pCO2 - Partial pressure of Carbon Dioxide pO2 - Partial pressure of Oxygen HCO3 - Bicarbonate BE - Base Excess sO2 - Oxygen Saturation pH - Potential of Hydrogen 3. Reference intervals listed in the GEM 5000 Operating Procedure, located in the laboratory's electronic chemistry procedures folder, were not consistent with those included on a patient test report from 07/30/21 reviewed on date of survey as indicated below. Analyte Report Procedure pCO2 35- 45 32-35 pO2 80-100 83-108 HCO3 22-26 21-28 sO2 - Oxygen Saturation 85-100 94- 98 4. In an interview at 3:20 p.m. on 09/08/22, the GS confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- 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 failed to ensure nine of nine testing personnel were evaluated for test procedure competency in all testing areas in 2021. Findings are as follows: 1. The laboratory performed the following microscopic examinations as confirmed by General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/08/22: Post Vasectomy Preparation (PV) KOH Preparation (KOH) Vaginal Wet Preparation (VWP) 2. The laboratory's Competency Assessment procedure, found in the electronic procedure folder, indicated testing personnel were evaluated for competency in all testing areas during training, after 6 months of work, and annually thereafter. 3. Competency assessments for PV, KOH, and VWP testing were not included in the Testing Personnel Competency Assessment forms completed for nine of nine testing personnel in 2021. 4. The laboratory was unable to provide the missing evaluations upon request. 5. In an interview at 9:55 a.m. on 09/08/22, the GS confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control (QC) activities as established in the a Immunology Individualized Quality Control Plan (IQCP) in 3 of 14 months reviewed . Findings are as follows: 1. The laboratory performed Immunology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:05 a. m. on 11/12/20. 2. AmnioSure fetal Rupture of membrances (fROM) test kits were observed as present and available for use during the tour. 3. fROM QC performance was required monthly or on the day of patient testing, whichever is greater, as established in the laboratory's IQCP for the test. 4. Documentation on the QC Log for the fROM test indicated the time interval between fROM QC performance exceeded that established in the IQCP on 1 occasion in the timeframe reviewed, potentially affecting 1 patient test result. See below. QC date: 1/14/2019 Reagent Lot #: 557012573 Expiration Date: 2/4/2020 Patient: Female, aged 35 years Date tested: 4/2 /2019 QC date: 4/25/2019 Reagent Lot #: 560012275 Expiration Date: 7/21/2021 QC interval: 3 months, 1.5 weeks 5. In an interview at 9:30 a.m. on 11/13/20, 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 2 -- D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to evaluate the relationship between test results obtained from the Hematology analyzer and a manual testing method at least twice annually. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:05 a.m. on 11/12/20. 2. A Sysmex XN-1000 hematology analyzer was observed as present and available for use during the tour. The GS indicated the laboratory performed and reported automated and manual White Blood Cell differential testing. 3. The Sysmex XN-1000 procedure located in the Hematology folder of the on-line Laboratory Manual did not include a requirement to compare automated and manual differential testing twice annually. Twice annual comparisons of these test methods was not found in laboratory records. The laboratory was unable to provide comparison records upon request. 4. In an interview on 11/12/20 at 1:15 p.m., the GS confirmed the above findings. . -- 2 of 2 --

Summary Statement of Deficiencies 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 failed to verify the accuracy of Microbiology, Chemistry, Hematology, and Immunohematology proficiency testing scores when the proficiency testing (PT) program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 08/09/18 at 8:25 a.m. 2. The laboratory performed PT using the American Proficiency Institute PT provider. 3. Ten PT results from 2016, 2017, and 2018 were not graded due to lack of consensus. See below for sample identifications (ID) and analytes. 2016 Sample ID Analyte UDS-05 Benzodiazepine 2017 Sample ID Analyte UA-02 Urobilinogen UR-06 Susceptibility Testing UA-03 Urobilinogen DAT-04 Direct Antiglobulin Test BCH-04 Body Fluid Amylase 2018 Sample ID Analyte CYS-02 Body Fluid Crystals BCI-01 Blood Cell Identification DAT-01 Direct Antiglobulin Test UDS-02 Opiates 4. The API expected results data summaries were not present in laboratory records. Evaluations for accuracy of the non- graded results was not found during review of laboratory documents. The laboratory was unable to provide evaluations of non-graded results upon request. 5. In an interview on 08/09/18 at 1:25 p.m., the GS confirmed the non-graded results had not been evaluated for accuracy. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure a blood collection vacutainer used for Hematology tests was not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Hematology (Coagulation) testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 08/09/18 at 8:25 a.m. 2. BD Sodium Citrate Vacutainer Venous Blood Collection Tubes with lot number 7256765 and expiration date 06/30/2018 were observed as present in the tube rack located in the blood draw area and available for use during the tour. The intended use of these blood collection tubes was for Coagulation testing per the GS and manufacturer's online instructions. 3. In an interview on 08/09/18 at 8:26 a.m., the GS confirmed expired blood collection tubes had been available for use in the blood draw area tube rack. -- 2 of 2 --