Bois Forte Medical Clinic

Summary Statement of Deficiencies D0000 The Bois Forte Medical 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 September 14, 2023. The following standard-level deficiencies were cited: 493.1105 Retention requirements 493.1236 Evaluation of proficiency testing performance . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain microscopic examination verification of accuracy records for at least two years in 2022. Findings are as follows: 1. The laboratory performed Potassium Hydroxide (KOH) microscopic examinations as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 09/14/23. 2. The Laboratory performed proficiency testing using the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing provider in 2022. KOH testing was evaluated using the WSLH MiscQA_POC package. 3. The attestation statement and testing records for the WSLH 2022 MiscQA_POC2 event were not found in laboratory records. The laboratory was unable to provide the missing documents upon request. 4. The laboratory performed approximately 1 KOH examination annually as indicated on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 12: 05 p.m. on 09/14/23, TP1 confirmed the above finding. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 -- 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 review proficiency testing (PT) results for one of two Microbiology PT events completed in 2022. Findings are as follows: 1. The laboratory performed Potassium Hydroxide (KOH) microscopic examinations as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 09/14/23. 2. The Laboratory performed proficiency testing using the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing provider in 2022. KOH testing was evaluated using the WSLH MiscQA_POC package. 3. The results from the WSLH 2022 MiscQA_POC2 PT event were not found in laboratory records. The laboratory was unable to provide evidence of PT result review for this event upon request. 4. The laboratory performed approximately 1 KOH examination annually as indicated on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 12: 05 p.m. on 09/14/23, TP1 confirmed the above finding. . 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 perform and document activities used to verify the accuracy of one of two microscopic examinations and two of two chemistry tests performed in the laboratory at least twice annually in 2022. Findings are as follows: 1. The laboratory performed Urine Sediment microscopic examinations and Microalbumin and Creatinine chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 09/14/23. 2. The Laboratory performed proficiency testing using the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing provider in 2022. 3. Twice annual Urine Sediment, Microalbumin, and Creatinine accuracy verification documentation was not found for 2022 during review of WSLH documents and laboratory records. The laboratory was unable to provide the missing accuracy verification documentation upon request. 4. The laboratory performed approximately 67 Urine Sediment examinations and Microalbumin/Creatinine ratio tests annually as indicated on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 12:15 p.m. on 09/14/23, TP1 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 complete a performance verification (PV) for one non-waived test implemented by the laboratory in 2021. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 10/21/21. 2. A Seimens DCA Vantage analyzer was observed as present and available for use during the tour of the laboratory. Microalbumin to Creatinine Ratio (ACR) was performed on this analyzer. 3. PV documentation for ACR on the DCA Vantage was not found during review of laboratory records. The laboratory was unable to provide a PV upon request. 4. A PV procedure was not found during review of laboratory procedure manuals. 5. The ACR Patient Result Sheet indicated 39 patients had received ACR testing since implementation on 04/12/21 through date of survey, 10/21/21 6. In an interview at 2: 15 p.m. on 10/21/21, TP1 confirmed the above finding. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on document review, interview with laboratory personnel, and review of the FDA test classification database, the laboratory failed to ensure quality control testing (QC) was performed each day of non-waived Chemistry testing in 2021. Findings are as follows: The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 10/21/21. An Abaxis Piccolo Xpress analyzer and a Seimens DCA Vantage analyzer were observed as present and available for use. Complete Metabolic Panels, Basic Metabolic Panels, and Lipid Panels were performed on the Piccolo Xpress analyzer and Microalbumin to Creatinine Ratio (ACR) was performed on the DCA Vantage. A. Abaxis Piccolo Xpress 1. In an interview at 11:50 a.m. on 10/21/21, TP1 indicated approximately three serum specimens had been tested on the Piccolo Xpress analyzer since 07/26/21. The use of a serum specimen changed the classification of the test from waived to moderate complexity. 2. Piccolo Xpress QC performance was required every 30 days as established in the Use and Maintenance of the Chemistry Analyzer Piccolo Xpress procedure found in the Piccolo Waived Compliance Binder manual. 3. Laboratory records confirmed QC had been performed with new lots and every 30 days in the timeframe reviewed, July 2021 - October 2021. 4. An Individualized Quality Control Plan (IQCP) to reduce the frequency of QC was not found in laboratory records. The laboratory was unable to provide an IQCP upon request. 5. In an interview at 11:50 a. m. on 10/21/21, TP1 confirmed the above finding and indicated QC was not performed each day of serum specimen testing. TP1 was unable to determine the exact number of serum specimens tested on the Piccolo Xpress as this information had not been documented. B. Seimens DCA Vantage 1. ACR on the DCA Vantage was classified by the FDA as moderate complexity testing. 2. ACR QC performance was required with new lots and at regular intervals as established in the DCA Systems Microalbumin/Creatinine Reagent Kit procedure found in the DCA Vantage A1C manual. 3. Laboratory records confirmed QC had been performed with new lots and monthly in the timeframe reviewed, April 2021 - October 2021. 4. An Individualized Quality Control Plan (IQCP) to reduce the frequency of QC was not found in laboratory records. The laboratory was unable to provide an IQCP upon request. 5. The ACR Patient Result Sheet indicated 39 patients had received ACR testing since implementation on 04/12/21 through date of survey, 10/21/21 6. In an interview at 1: 30 p.m. on 10/21/21, TP1 confirmed the above finding. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to ensure competency was assessed at least semi-annually during the first year of patient specimen testing for one of one testing personnel hired in 2019. -- 2 of 3 -- Findings are as follows: 1. The laboratory performed Hematology testing and Urine Sediment and KOH microscopic examinations as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 10/21/21. 2. A Cell-Dyn Emerald 22 hematology analyzer and a McKesson Lumion microscope were observed as present and available for use during the tour of the laboratory. 3. Testing Personnel 4 (TP4) received initial competency assessment in October 2019 as indicated in personnel records. 4. The Laboratory Personnel - Quality Assurance procedure, found in the CLIA Manual book, indicated new employees were assessed for competency twice in the first year of testing. 5. A semi-annual competency assessment for TP4 was not found during review of laboratory records. The laboratory was unable to provide the missing assessment upon request. 6. In an interview at 1:35 p.m. on 10/21 /21, TP1 confirmed the above finding. . -- 3 of 3 --

Summary Statement of Deficiencies 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 review of Center for Medicare and Medicaid Services (CMS) reports and Medical Laboratory Evaluation (MLE) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2020 and 2021 for Cell ID / White Blood Cell Differential, under the specialty of Hematology. Findings include: 1. The CMS CASPER Report 0155D and MLE PT Performance Summary, reviewed on August 16, 2021, indicated the the laboratory failed to successfully participate in Cell ID / White Blood Cell Differential testing in two testing events in 2020 and 2021. Unsatisfactory PT performance in White Blood Cell Differential was obtained in the following events: -2020 3rd event 60% -2021 2nd event 40% 2. 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 -- CMS CASPER Report 0155D and MLE PT Performance Summary indicated the laboratory failed to obtain successful Cell ID / White Blood Cell Differential scores of at least 80 percent in two out of three consecutive testing events in 2020 and 2021. See D2121 and D2130. . D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from Center for Medicare and Medicaid Services (CMS) and Medical Laboratory Evaluation (MLE), the laboratory failed to obtain a PT score for Cell ID / White Blood Cell Differential of at least 80 percent which resulted in unsatisfactory performance for the analyte. Findings include: 1. The CMS CASPER Report 0155D and MLE PT Performance Summary, reviewed on August 16, 2021, indicated the the laboratory failed to obtain Cell ID / White Blood Cell Differential successful scores of at least 80 percent in two testing events in 2020 and 2021. 2. The MLE Performance Summary confirmed the laboratory failed to obtain a Cell ID / White Blood Cell Differential PT score of at least 80 percent in two testing events in 2020 and 2021. -2020 3rd event 60% -2021 2nd event 40% . D2130 HEMATOLOGY CFR(s): 493.851(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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the Medical Laboratory Evaluation (MLE), the laboratory failed to achieve successful PT performance for Cell ID / White Blood Cell Differential testing in two of three consecutive PT events in 2020 and 2021. Findings include: 1. The CMS CASPER Report 0153D, reviewed on August 16, 2021, indicated the laboratory failed to obtain Cell ID / White Blood Cell Differential PT successful scores of at least 80 percent in two out of three consecutive testing events in 2020 and 2021. 2. The MLE Performance Summary confirmed the laboratory failed to obtain a Cell ID / White Blood Cell Differential PT score of at least 80 percent in two testing events in 2020 and 2021. -2020 3rd event 60% -2021 2nd event 40% . -- 2 of 2 --