Burnsville Family Physicians

Summary Statement of Deficiencies D0000 . The Burnsville Family Physicians 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 10, 2025. The following standard-level deficiencies were cited: 493.1251 Procedure manual 493.1291 Test report . 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 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 a Chemistry procedure (performance verification) was approved, signed, and dated by the laboratory director prior to use. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 06/17/21, at 9:05 a.m. 2. An Alfa Wassermann ACE Alera chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification activities were completed and the laboratory began testing patient specimens using the analyzer on 04 /29/19, as confirmed by TP1. 4. The laboratory Director did not approve, sign, or date the Precision, Reportable Range, Accuracy and Expected Range performance verification documents prior to use of the analyzer. 5. In an interview on 06/17/21, at 12:30 p.m., TP1 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) (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. 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 -- This STANDARD is not met as evidenced by: . Based on direct observation, document review and interview with laboratory personnel, the laboratory failed to verify the reference ranges for a chemistry analyzer prior to reporting patient test results. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 06/17/21, at 9:05 a.m. 2. An Alfa Wassermann ACE Alera chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. In an interview on 06/17/21, at 12:30 p.m., TP1 indicated the laboratory began testing patient specimens using the analyzer on 04/29/19. 4. By review of laboratory records, the laboratory failed to verify the reference ranges of the following chemistry analytes prior to testing patient samples: Cholesterol Triglycerides High Density Lipoprotein Low Density Lipoprotein Carbon Dioxide Creatinine Glucose Sodium Potassium Chloride Total Protein Albumin Alkaline Phosphatase Alanine Aminotransferase Aspartate Aminotransferase Total Bilirubin Direct Bilirubin Calcium 5. In an interview on 06/17/21, at 12:30 p.m., TP1 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 reference intervals were consistent between a Chemistry procedure and a patient test report. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 06/17/21, at 9:05 a.m. 2. An Alfa Wassermann ACE Alera chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification activities were completed and the laboratory began testing patient specimens using the analyzer on 04/29/19, as confirmed by TP1. 4. Reference intervals listed in the "Chemistry Analyzer - Alfa Wassermann ACE Alera" procedure, found in the Laboratory Policy & Procedure Manual, were not consistent with that included on a patient test report reviewed on date of survey as indicated below. Date of Service: 07/10/20 Patient: Female, 58 years Analyte Procedure Report Carbon dioxide 23.0 - 30.0 20 - 32 Creatinine 0.6-1.30 0.7 - 1.18 Glucose 70 - 99 60 - 99 Sodium 136.0 - 146.0 135 - 146 Blood Urea Nitrogen6 - 25 7 - 25 Calcium 8.5 - 10.4 8.6 - 10.3 5. In an interview on 06/17/21, at 12:30 p.m., TP1 confirmed the above finding. . -- 2 of 2 --

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 reports and American Academy of Family Physicians proficiency testing reports, the laboratory failed to successfully participate in proficiency testing for Albumin testing under the specialty of Chemistry. Findings are as follows: D2087 - the laboratory failed to attain satisfactory Albumin PT scores D2096 - the laboratory failed to achieve successful Albumin PT performance . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- 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 a review of Center for Medicare and Medicaid Services reports and American Academy of Family Physicians (AAFP) proficiency testing (PT) reports, the laboratory failed to attain satisfactory PT scores for Albumin testing. Findings are as follows: 1. The laboratory failed to attain PT scores for Albumin testing of at least 80 percent in two testing events. Scores less than 80 percent resulted in unsatisfactory performance for the analyte. 2. AAFP PT reports listed the following unsatisfactory Albumin scores. - 2019 2nd event (AAFP PT 2019-B): 20% - 2019 3rd event (AAFP PT 2019-C): 40% . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on a review of Center for Medicare and Medicaid Services reports and American Academy of Family Physicians (AAFP) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance for Albumin testing. Findings are as follows: 1. The laboratory failed to attain satisfactory Albumin PT scores in two consecutive PT events. Two consecutive unsatisfactory PT scores for the same analyte constituted unsuccessful performance. 2. AAFP PT reports listed the following unsatisfactory Albumin scores. - 2019 2nd event (AAFP PT 2019-B): 20% - 2019 3rd event (AAFP PT 2019-C): 40% . -- 2 of 2 --

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 1 of 3 personnel who routinely performed Microbiology, Chemistry and Hematology testing on patient samples was included in testing proficiency testing (PT) samples in 2017 and 2018. Findings are as follows: 1. The laboratory performed non-waived Microbiology, Chemistry, and Hematology testing as indicated by Testing Personnel 1 (TP1) during a tour of the laboratory on 03/20/19 at 12:35 p.m. 2. The laboratory performed PT using the American Association of Family Physicians (AAFP) proficiency provider. 3. Testing Personnel 3 (TP3) did not participate in 6 of 6 AAFP PT events completed by the laboratory in 2017 and 2018. 4. In an interview on 03/20/19 at 2:05 p.m., TP1 stated TP3 routinely performed non-waived testing on patient samples but did not participate in the 2017 or 2018 PT for this testing. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical 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 -- consultant failed to ensure 3 of 3 testing personnel were assessed through testing Microbiology, Chemistry,and Hematology previously analyzed specimens, blind samples, or proficiency testing samples at least annually in 2017 and 2018. Findings are as follows: 1. The laboratory performed KOH*, Wet Preparations and Urine Sediment Microscopic Examinations (ME), Throat Cultures (TC), and Complete Blood Count (CBC) testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 03/20/19 at 12:35 p.m. 2. Proficiency testing (PT) results for were being used to evaluate testing personnel competency. Evaluation of PT for each of the above non-waived tests was not included on the 2017 and 2018 Laboratory Competency Assessment form for 3 of 3 testing personnel. 3. Laboratory records indicated all testing personnel did not perform PT for each non-waived test in 2017 and 2018. The laboratory was unable to provide additional documented evaluations of blind sample testing upon request. See below where "x" indicates proficiency testing was not performed. 2017 Testing Personnel 1 2 3 ME x TC x x CBC x x 2018 Testing Personnel 1 2 3 ME x x TC x CBC x x 4. In an interview on 03/20/19 at 2:05 p.m., TP1 verified all testing personnel routinely performed the above non-waived testing and confirmed PT for this testing was not completed by all staff in 2017 and 2018. *Note KOH - Potassium Hydroxide -- 2 of 2 --