Centracare - Becker Clinic

Summary Statement of Deficiencies D0000 The Centracare Becker 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 December 10, 2025. The following condition-level deficiencies were cited: 493.803 Condition: Successful participation 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of 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 -- American Pathologists (CAP) records, 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 specialty of Hematology for the analyte Hematocrit (HCT). Refer to D2130. . D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 CASPER 0155 report and College of American Pathologists (CAP) 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events in the specialty of Hematology for the analyte Hematocrit (HCT). Findings are as follows: 1. Review of the CASPER 0155 report revealed the following results: Hematology/Coagulation 2025 2nd Event: The laboratory received an unsatisfactory score of 60% Hematology/Coagulation 2025 3rd Event: The laboratory received an unsatisfactory score of 60% 2. A review of the College of American Pathologists (CAP) 2025 proficiency testing records (F16-B and F16-C 2025 Hematology Auto Differentials) confirmed the laboratory received the above results. . 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 0155 report and College of American Pathologists (CAP) records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on a proficiency testing desk review of CASPER 0155 report and College of American Pathologists (CAP) records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centracare Becker 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 recertification survey performed on January 2, 2025. The following standard-level deficiencies were cited: 493.1291 Test Report 493.1413 Technical consultant responsibilities . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 test reports reviewed on date of survey were accurately entered in the patient electronic medical record (EMR) in 2024. Findings are as follows: 2. The laboratory performed chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:34 a.m. on 01/02/25. 3. An Abbott iSTAT chemistry device was observed as present and available for use during the tour of the laboratory. The laboratory performed 9,731 chemistry tests in 2024 as indicated on the Form CMS-116 provided by the laboratory on date of survey. 4. Patient #026 received Basic Metabolic Panel (BMP) chemistry testing on 10/2/24 as indicated on the iSTAT Patient Log. 5. The Anion Gap result included in the BMP was misreported in the patient's EMR. See below: iSTAT Patient Log result: Anion 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 -- Gap 14.5 mmol/L EMR Test Report result: Anion Gap 16 mmol/L 6. In an interview on 01/02/25, the LD confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES 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 observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure two of two tenured testing personnel were evaluated for test procedure competency in all testing areas in 2023 and 2024. Findings are as follows: 1. The laboratory performed Bacteriology, Mycology, Parasitology, Chemistry, and Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:34 a.m. on 01/02/2025. 2. The following instruments, equipment, and devices were observed as present and available for use during the tour: Abbott iSTAT chemistry device Triage Meter chemistry device Beckman Coulter DXH520 hematology analyzer Alcor Mini iSED hematology analyzer Olympus CH30 microscope 3. The Personnel Assessment Procedure in the Quality Assurance Manual provided by the laboratory indicated testing personnel were evaluated for competency in all testing areas during initial training, after six months, after one year and annually thereafter. 4. Competency assessments for two of two testing personnel were not found for 2023. 5. Competency assessments for two of two testing personnel included one of six required elements for 2024. Blind sample evaluations were completed for both testing personnel. 6. The laboratory was unable to provide the missing competency assessments upon request. 7. In an interview at 11: 32 a.m. on 01/02/2025, the LD confirmed the above finding. . -- 2 of 2 --

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, document review, and interview with laboratory personnel, the laboratory failed to ensure three of five reportable ranges obtained during the single Hematology performance verification (PV) activity completed in 2021 were adopted by the laboratory. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 12/12/22. 2. A Beckman Coulter DxH520 hematology analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began performing Complete Blood Counts (CBC's) with Automated Differential testing on this analyzer in May 2021. 3. PV activities on the DxH520 analyzer were completed in May 2021 as indicated in laboratory records found in the Performance Verification Data Manual DxH520. Five analytes were reviewed for reportable range accuracy as indicated below. WBC - White Blood Cells RBC - Red Blood Cells HGB - Hemoglobin PLT - Platelets HCT - Hematocrit 4. The upper reportable range limits adopted by the laboratory for HGB, PLT, and HCT did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents and the Performing Complete Blood Count with Differential on the DxH 520 Analyzer procedure located in the Laboratory Procedure Manual. See below. Analyte PV Procedure HGB 0-21.06 0.2-25.0 PLT 0.1-1967.8 7.0- 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 -- 2000.0 HCT 0.0-76.2 0.0-85.0 5. The laboratory performed approximately 10,374 Hematology tests annually as indicated on the Clinical Laboratory Improvement Amendments Application for Certification provided by the laboratory on 12/12/22. 6. In an interview at 1:15 p.m. on 12/12/22, the LD confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. 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-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 12/06 /18 at 10:00 a.m. 2. The laboratory performed PT using the College of American Pathologists (CAP) PT provider. 3. The laboratory received non-graded results from CAP due to no consensus in Chemistry and Hematology for the events and tests listed below. The Data Summaries from CAP with the expected results for these tests were not included in the laboratory's records. Event Sample ID Test 2017 SEM-A UA-03 Semen Analysis 2018 CM-B USP-04 Urine Sediment 4. An evaluation of the non- graded PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 12/06/18 at 12: 10 p.m., the LD confirmed an evaluation of the non-graded PT results was not performed. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of all tests performed at least twice annually. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 12/06 /18 at 10:00 a.m. 2. A Polymedco Sedimat 15 Plus automated sedrate analyzer was observed as present and available for use during the tour. The laboratory performed Erythrocyte Sedimentation Rate (ESR) testing using this analyzer. 3 The laboratory performed PT using the College of American Pathologists (CAP) as the Proficiency Testing (PT) provider. One completed CAP ESR PT event was found in 2017 laboratory records. The laboratory was unable to provide documentation of additional 2017 ESR verification of accuracy upon request. 4 In an interview on 12/06/18 at 11; 45 a.m., the LD confirmed the above findings. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 manually entered test results. Findings are as follows: 1. The laboratory manually entered test results from non-interfaced test systems into the Epic/Beaker laboratory information system. 2. The Centracare Clinic-Becker Laboratory Quality Assurance Plan located in the Quality Assurance Manual indicated the accuracy of manually entered test results was verified quarterly. 3. Documentation of the quarterly verification of manually entered test results was not found during review of laboratory records. The laboratory was unable to provide this documentation upon request. 4. In an interview on 12/06/18, at 1:10 p.m. the LD stated quarterly verification of manually entered test results was not routinely performed. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES 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 (TC) failed to evaluate required Hematology and Chemistry competency assessment elements for all testing personnel (TP) in 2017. Required elements include; 1) Direct observation of test performance, 2) Monitoring the recording and -- 2 of 3 -- reporting of test results, 3) Review of intermediate test results or worksheets and records, 4) Direct observation of instrument maintenance, 5) Assessment of test performance with previously analyzed specimens, and 6) Assessment of problem solving skills. Findings are as follows: The laboratory performed Hematology and Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 12/06/18 at 10:00 a.m. A. Microbiology 1. The laboratory performed Vaginal Wet Preparations, KOH microscopic examinations under the Microbiology specialty. 2. The 2017 Annual Competency records for 2 of 3 tenured TP reviewed on date of survey were incomplete. See below. Vaginal Wet Preparations TP Missing elements TP1 1, 2, 3, 5, 6 TP2 1, 2, 3, 5, 6 KOH Microscopic examinations TP Missing elements TP2 1, 2, 3, 5, 6 3. In an interview on 12/06/18 at 11:10 a.m., the LD confirmed the 2017 Microbiology competency assessments were incomplete for the TP1 and TP2. B. Hematology 1. The laboratory performed Complete Blood Count (CBC) using the Beckman Coulter AcT 5diff CP hematology analyzer under the Hematology specialty. In addition, the laboratory performed Erythrocyte Sedimentation Rate (ESR) testing on the Polymedco Sedimat 15 analyzer and Post- Vasectomy microscopic examinations. 2. 2017 hematology competency assessment records for 3 of 3 tenured TP reviewed on date of survey were incomplete. See below. Beckman Coulter AcT 5diff CP TP Missing elements TP2 1, 2, 4, 6 TP3 1, 2, 4, 5, 6 Polymedco Sedimat 15 TP Missing elements TP1 1, 2, 3, 5, 6 TP2 1, 2 TP3 1, 2, 3, 5, 6 Post-Vasectomy TP Missing elements TP1 1, 2, 3, 4, 5, 6 TP2 1, 2, 3, 4, 6 TP3 1, 2, 3, 4, 5, 6 3. In an interview on 12/06/18 at 11:10 a.m., the LD confirmed the 2017 Hematology competency assessments were incomplete for TP1, TP2 and TP3. C. Chemistry 1. The laboratory performed Troponin and B-type Natriuretic Peptide testing using the Alere Triage Meter Plus and Urine Sediment microscopic examinations under the Chemistry specialty. 2. 2017 Chemistry competency assessment records for 3 of 3 tenured TP reviewed on date of survey were incomplete. See below. Alere Triage Meter Plus TP Missing elements TP1 1, 2, 4, 6 TP2 1, 2, 4, 6 TP3 1, 2, 4, 5, 6 Urine Sediment TP Missing elements TP2 1, 2, 3, 4, 5, 6 TP3 1, 2, 3, 4, 5, 6 3. In an interview on 12/06/18 at 11:10 a.m., the LD confirmed the 2017 Chemistry competency assessments were incomplete for TP1, TP2 and TP3. -- 3 of 3 --