Native American Community Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a December 9, 2025 desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company's evaluations. The Native American Community Clinic laboratory was found to be out of compliance with the Conditions of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493). The following condition-level deficiency was cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) . 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 records from the Center for Medicare 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 Medicaid Services (CMS) Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing 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. 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 review of proficiency testing (PT) reports from CMS and WSLH, the laboratory failed to achieve successful PT performance (80% or better) for Hematocrit (HCT) testing under the specialty of Hematology in two of three consecutive PT events in 2025. Findings include: 1. Review of the CMS CASPER 0155D report revealed the following results: Hematology 2025 2nd Event: The laboratory received an unsatisfactory score of 40% for HCT. Hematology 2025 3rd Event: The laboratory received an unsatisfactory score of 40% for HCT. 2. Review of WSLH 2025 PT records (WSLH PT 2025-HemeReg2 and WSLH PT 2025-HemeReg3 Proficiency Testing Evaluations) confirmed the laboratory received the above results. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 . The Native American Community 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 July 25, 2025. The following standard-level deficiencies were cited: 493.1251 Procedure manual 493.1253 Establishment and verification of performance specifications 493.1254 Maintenance and function checks 493.1289 Analytic Systems Quality Assessment 493.1407 Laboratory director responsibilities . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with laboratory personnel, the laboratory failed to report SARS-CoV-2 positive test results for 16 of 16 days of testing in January 2023 through April 2023. Findings are as follows: 1. The laboratory performed SARS-CoV-2 testing using the BinaxNOW COVID-19 Antigen Card as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:20 a.m. on 04/21/23. 2. During the tour, TP1 indicated positive SARS-CoV-2 results had not been reported to the appropriate health authorities since test implementation. At 10:35 a.m. on 04/21/23, the Laboratory Director (LD) confirmed positive SARS-CoV-2 test results had not been reported since BinaxNOW COVID-19 Antigen Card test implementation in January 2023. 3. Manual patient testing logs were not completed for the testing. Results were available in the laboratory's electronic medical records (EMR) system. A BinaxNOW COVID-19 Antigen Card positive result report from the EMR was provided by the LD on date of survey. 4. The laboratory performed 19 positive SARS-CoV-2 tests between 01/18/23 through 04/05/23 as indicated on the EMR report. 19 of 19 SARS-CoV-2 positive test results were not reported as required. Number of days of non-reporting are indicated below. 2023 Days not reported January 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 -- 2 February 7 March 6 April 1 5. In an interview at 12:30 p.m. on 04/21/23, the LD confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to retain Hematology calibration verification records for at least 2 years. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:20 a. m. on 04/21/23. 2. A Horiba ABX Micros 60 hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Hematology analyzer calibration verification was required every six months as established in the Laboratory Calendar found in the Laboratory Policies and Procedures Manual. 4. Calibration verification was performed by the Horiba service technician in August 2022 as indicated in the service report. Calibration verification documentation from August 2022 was not found in laboratory records. 5. Laboratory record retention was required for two years as established in the Quality Assurance section of the Laboratory Policies and Procedures Manual. 6. In an interview at 2:00 p.m. on 04/21/23, TP1 confirmed the above finding. . D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on proficiency testing, procedure, test report, calibration verification, and quality assurance record review and interview with laboratory personnel, the laboratory failed to meet requirements for the specialty of Hematology as specified in 493.1236, 493.1251, 493.1255, and 493.1289. Findings are as follows: 1. The laboratory failed to investigate one unacceptable Hematology proficiency testing (PT) result out of fifteen challenges completed in 2022. See D5211 2. The laboratory failed to include accurate Hematology reference ranges in the procedure manual for five of five analytes reviewed for Complete Blood Count testing since April 2021. See D5403 3. The laboratory failed to perform and document calibration verification on a Hematology analyzer at least once every 6 months in 2021. See D5439 4. The laboratory failed to follow established quality assurance procedures in 2021 and 2022. See D5791 . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing -- 2 of 5 -- 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 Hematology proficiency testing (PT) result out of fifteen challenges completed in 2022. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:20 a.m. on 04/21/23. 2. The laboratory performed PT using the American Academy of Family Physicians (AAFP) provider. 3. The laboratory received one unacceptable PT result of fifteen Granulocyte testing challenges completed in 2022 as indicated in AAFP reports. See below. 2022 - C event Test: Granulocytes Sample: HD-15 Laboratory Result: 24.7 AAFP expected range: 89.2-93.4 4. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing Policy located in the Laboratory Policies and Procedures Manual. 5. Investigation documentation for the unsuccessful score was not found in laboratory records. The laboratory was unable to provide evidence of PT result investigation and

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with laboratory personnel, the laboratory failed to report SARS-CoV-2 positive test results for 16 of 16 days of testing in January 2023 through April 2023. Findings are as follows: 1. The laboratory performed SARS-CoV-2 testing using the BinaxNOW COVID-19 Antigen Card as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:20 a.m. on 04/21/23. 2. During the tour, TP1 indicated positive SARS-CoV-2 results had not been reported to the appropriate health authorities since test implementation. At 10:35 a.m. on 04/21/23, the Laboratory Director (LD) confirmed positive SARS-CoV-2 test results had not been reported since BinaxNOW COVID-19 Antigen Card test implementation in January 2023. 3. Manual patient testing logs were not completed for the testing. Results were available in the laboratory's electronic medical records (EMR) system. A BinaxNOW COVID-19 Antigen Card positive result report from the EMR was provided by the LD on date of survey. 4. The laboratory performed 19 positive SARS-CoV-2 tests between 01/18/23 through 04/05/23 as indicated on the EMR report. 19 of 19 SARS-CoV-2 positive test results were not reported as required. Number of days of non-reporting are indicated below. 2023 Days not reported January 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 -- 2 February 7 March 6 April 1 5. In an interview at 12:30 p.m. on 04/21/23, the LD confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to retain Hematology calibration verification records for at least 2 years. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:20 a. m. on 04/21/23. 2. A Horiba ABX Micros 60 hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Hematology analyzer calibration verification was required every six months as established in the Laboratory Calendar found in the Laboratory Policies and Procedures Manual. 4. Calibration verification was performed by the Horiba service technician in August 2022 as indicated in the service report. Calibration verification documentation from August 2022 was not found in laboratory records. 5. Laboratory record retention was required for two years as established in the Quality Assurance section of the Laboratory Policies and Procedures Manual. 6. In an interview at 2:00 p.m. on 04/21/23, TP1 confirmed the above finding. . D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on proficiency testing, procedure, test report, calibration verification, and quality assurance record review and interview with laboratory personnel, the laboratory failed to meet requirements for the specialty of Hematology as specified in 493.1236, 493.1251, 493.1255, and 493.1289. Findings are as follows: 1. The laboratory failed to investigate one unacceptable Hematology proficiency testing (PT) result out of fifteen challenges completed in 2022. See D5211 2. The laboratory failed to include accurate Hematology reference ranges in the procedure manual for five of five analytes reviewed for Complete Blood Count testing since April 2021. See D5403 3. The laboratory failed to perform and document calibration verification on a Hematology analyzer at least once every 6 months in 2021. See D5439 4. The laboratory failed to follow established quality assurance procedures in 2021 and 2022. See D5791 . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing -- 2 of 5 -- 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 Hematology proficiency testing (PT) result out of fifteen challenges completed in 2022. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:20 a.m. on 04/21/23. 2. The laboratory performed PT using the American Academy of Family Physicians (AAFP) provider. 3. The laboratory received one unacceptable PT result of fifteen Granulocyte testing challenges completed in 2022 as indicated in AAFP reports. See below. 2022 - C event Test: Granulocytes Sample: HD-15 Laboratory Result: 24.7 AAFP expected range: 89.2-93.4 4. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing Policy located in the Laboratory Policies and Procedures Manual. 5. Investigation documentation for the unsuccessful score was not found in laboratory records. The laboratory was unable to provide evidence of PT result investigation and

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, 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 failed ensure 2 of 5 personnel who routinely performed Hematology testing on patient samples participated in Hematology proficiency testing (PT) in 2018. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed the Laboratory Manager (LM) during a tour of the laboratory on 04/12/19 at 10:10 a.m. 2. The laboratory performed PT using the American Academy of Family Physicians (AAFP) proficiency provider. 3. Testing Personnel 1 (TP1) and Testing Personnel 2 (TP2) did not participate in 3 of 3 AAFP Hematology PT events completed by the laboratory in 2018. 4. In an interview on 04/12/19 at 12:40 p.m., the LM stated TP1 and TP2 routinely performed Hematology testing on patient samples and confirmed neither participated in PT as indicated above. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure hematology proficiency testing samples were tested 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 -- consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory manager (LM) during a tour of the laboratory on 04/12 /19 at 10:10 a.m. An ABX Micros 60 hematology analyzer was observed as present and available for use during the tour. 2. The laboratory performed proficiency testing (PT) for Hematology using the American Academy of Family Physicians (AAFP) proficiency provider. 3. Hematology PT sample HD10 from the AAFP 2018-B event and sample HD15 from the AAFP 2018-C event were tested three times each as indicated on test result documents generated by the ABX Micros 60 hematology analyzer. See below for dates and time of day testing was performed. Sample Tested on 06/26/18 HD10 4:19 4:21 4:28 Sample Tested on 10/23/18 HD15 6:20 6:24 6:34 4. In an interview on 04/12/19 at 12:45 p.m., the LM confirmed the PT samples had been tested three times and patient specimens were routinely tested twice. 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 a 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 Laboratory manager (LM) during a tour of the laboratory on 04/12/19 at 10:10 a.m. 2. The Fern test microscopic examination was included in the test menu provided by the laboratory. 3. Verification of accuracy for Fern testing was performed once annually in 2017 and 2018 through the American Academy of Family Physicians (AAFP) proficiency provider. The laboratory was unable to provide documentation of additional verifications upon request. 4. In an interview on 04/12/19 at 1:45 p.m., the LM confirmed the accuracy of the Fern test microscopic examination had not been verified twice annually in 2017 and 2018. 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 in 2018. Findings are as follows: 1. The laboratory manually entered test results from non-interfaced test systems into the Centricity Electronic Medical Record (EMR). 2. The Laboratory Audit Procedure located in the Quality Assurance manual indicated the accuracy of -- 2 of 3 -- manually entered test results was verified quarterly via chart audits. 3. Documentation of the quarterly verification of manually entered test results was found through September 2017. The laboratory was unable to provide documentation of chart audits performed between 10/01/17 and 04/12/19 upon request. 4. In an interview on 04/12 /19, at 1:50 p.m. the LM stated quarterly verification of manually entered test results was not performed after September 2017. -- 3 of 3 --