Oakleaf Clinics- Chippewa

Summary Statement of Deficiencies D2004 ENROLLMENT CFR(s): 493.801(a)(3) (a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; and This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records, federal Certification and Survey Provider Enhanced Reports (CASPER), and interview with the laboratory supervisor (Staff A), the laboratory changed PT providers for 21 of 23 analytes in the chemistry specialty (subspecialties: routine chemistry and endocrinology) after two out of three PT events in 2025 and did not participate in a single approved PT program for the 21 analytes in 2025. Findings include: 1. Review of PT records and reports for 21 analytes in the chemistry specialty in 2025 showed the laboratory participated in the Wisconsin State Laboratory of Hygiene (WSLH) PT program for events one and two in 2025. Records for event three in 2025 showed the laboratory participated in the American Proficiency Institute (API) PT program. 2. Review of the CASPER 155D Individual Laboratory Profile report showed the laboratory received results for 23 analytes in the chemistry specialty. Further review showed for 21 analytes in the chemistry specialty, the laboratory received results from the WSLH PT program for the first and second event in 2025 and received results from the API PT program for the third event in 2025. 3. Interview with Staff A on April 16, 2026, at 12: 25 PM confirmed the laboratory changed PT providers from WSLH to API after the second event in 2025. The laboratory submitted results to WSLH for the first and second event in 2025. For event three, the laboratory submitted results to API and did not submit results to WSLH to complete the 2025 year with the WSLH PT provider for 21 analytes in the chemistry specialty. D2006 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory proficiency testing (PT) records from the Wisconsin State Laboratory of Hygiene (WSLH) PT program, and interview with the laboratory supervisor (Staff A), the laboratory did not examine or test the PT samples in the same manner as its patient specimens for hematology cell identification for one of three events in 2025. Findings include: 1. Review of the 'Proficiency Review - Chippewa Falls' form for hematology PT event one in 2025 revealed Staff D and Staff F performed the testing. The form also had a sticky note addressed to Staff D and F asking, "Did the slides get divided between techs when reporting them?" The response was, "No. We both did them independently and compared results all in agreement." 2. During an interview with Staff A on April 16, 2026, at 1:50 PM, Staff A confirmed both testing personnel identified all images for the event and compared results. The interview further confirmed testing personnel independently evaluate and report the cell identification as part of the manual differential test on patient specimens and therefore the laboratory did not examine or test PT samples in the same manner as it tests patient specimens for one of three hematology PT events in 2025. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of procedures, Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), competency assessment records, and interview with the technical consultant (Staff B), the laboratory did not follow their competency assessment procedures while performing direct observation (DO) of testing personnel for three of four competency assessment records reviewed. Findings include: 1. Review of the laboratory's procedure, '6 Step Competency Testing' stated in step 5.0, in part, "The following six procedures will be directly observed by the technical consultant. 1. Direct Observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing." 2. Review of Form CMS-209 showed Staff B was the sole staff member holding the technical consultant position. 3. Review of the laboratory's 2025 'Competence Assessment Record' forms for the Vitros 350 test system for Staff D and E and the Triage Biosite D dimer test system for Staff E showed Staff C performed the direct observation portion of the assessment. 4. Interview with Staff B on April 16, 2026, at 9:45 AM confirmed that Staff C performed competency assessments of -- 2 of 5 -- testing personnel and confirmed the laboratory did not follow their procedure which required the technical consultant to perform the direct observation as part of the competency assessment. 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 surveyor review of laboratory proficiency testing (PT) records from the Wisconsin State Laboratory of Hygiene (WSLH) PT program and interview with the laboratory supervisor (Staff A), the laboratory did not identify that the laboratory's results were out of range and did not verify the accuracy of four out of five thyroid stimulating hormone (TSH) results when the PT program did not obtain the agreement required for scoring in the chemistry/endocrinology PT event one in 2025. Findings include: 1. Review of the WSLH PT Evaluation report for the chemistry /endocrinology PT event one in 2025 showed four out of the five samples for TSH were not scored and indicated, "Non-consensus - Self-assessment Needed". The report showed, in part, the four non-consensus results for TSH: Sample | Result | Mean | Range CET-1 | 4.15 | 3.27 | 2.62 - 3.92 CET-2 | 1.31 | 1.01 | 0.81 - 1.21 CET-3 | 8.61 | 7.08 | 5.66 - 8.50 CET-5 | 2.67 | 2.13 | 1.70 - 2.56 2. Review of the 'Proficiency Test

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 surveyor review of laboratory records and interview with the Laboratory Supervisor (Staff A), the laboratory did not evaluate two of the four required performance characteristics (precision and reference intervals) and did not evaluate the remaining performance characteristics (accuracy and reportable range) prior to reporting patient test results with the Diesse MINI-CUBE ESR (Erythrocyte Sedimentation Rate) analyzer used for patient testing starting on October 12, 2022. Findings include: 1. Review of the verification documentation for the MINI-CUBE ESR analyzer showed the laboratory performed comparison studies that the laboratory director approved on November 10, 2022. The documentation showed no evidence the laboratory evaluated precision or the reference intervals (normal values) of the analyzer. 2. Interview with Staff A on March 5, 2024, at 1:00 PM confirmed the verification studies did not show evaluation of precision or reference ranges. Email communication with Staff A on March 8, 2024, at 10:58 AM confirmed the laboratory reported patient test results with the MINI-CUBE ESR analyzer starting on October 12, 2022. 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 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 surveyor review of laboratory information system (LIS) patient reports, Clinical Labortory Improvement Amendments (CLIA) Application for Certification Form CMS-116 and interview with the laboratory supervisor, staff A, the test report did not include the correct testing address. Findings include: 1. Review of LIS test report for patient 1 showed the address of the laboratory as 855 Lakeland Drive, Eau Claire, WI 54701. 2. Review of the CLIA Form CMS-116 showed the address of the laboratory as 855 Lakeland Drive, Chippewa Falls, WI 54729. 3. Interview with staff A on March 16, 2022 at 9:40 AM confirmed the laboratory's address is 855 Lakeland Drive, Chippewa Falls, WI 54729 and the LIS test report did not include the correct testing address. Further interview confirmed LIS test reports were distributed to providers and patients when necessary. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument 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 -- and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of the troponin procedure, Individualized Quality Control Plan (IQCP), quality control (QC) logs and interview with the laboratory supervisor, staff A, testing personnel did not perform and document quality control for the troponin test every thirty days according to the procedure from February 24 through November 15, 2021. Findings include: 1. Review of the I-Stat troponin procedure and IQCP showed testing personnel must test two levels of QC every thirty days. 2. Review of the troponin quality control logs showed: a. QC was performed February 24, 2021 and April 21, 2021 with no additional QC performed between those dates. QC was due to be performed March 26, 2021. b. QC was performed April 21, 2021 and June 11, 2021 with no additional QC performed between those dates. QC was due to be performed May 21, 2021. c. QC was performed June 11, 2021 and July 20, 2021 with no additional QC performed between those dates. QC was due to be performed July 11, 2021. d. QC was performed July 20, 2021 and September 23, 2021 with no additional QC performed between those dates. QC was due to be performed August 19, 2021. e. QC was performed September 23, 2021 and November 15, 2021 with no additional QC performed between those dates. QC was due to be performed October 23, 2021. 3. Interview with staff A on March 16, 2022 at 11:08 AM confirmed testing personnel did not perform and document quality control for the troponin test every thirty days according to the procedure from February 24 through November 15, 2021. -- 2 of 2 --