Davidson Family Medicine/Avance Care

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API (American Proficiency Institute) proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Total Protein on 2 consecutive test events, resulting in unsuccessful participation in proficiency testing. Findings: See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for Total Protein on 2 consecutive testing events, resulting in unsuccessful performance. Findings: Desk review of CMS Casper reports 153D and 155D and 2025 API proficiency testing results revealed the laboratory received a score of: 1. 60% for Total Protein on the 2025 Chemistry-Core 1st Event. 2. 60% for Total Protein on the 2025 Chemistry-Core 2nd Event. 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API proficiency testing results 9/3/25, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2025 API proficiency testing results 9/3/25, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiency cited at D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based upon review of 2022 and 2023 calibration verification documents and interview with an external consultant on 2/8/24, the laboratory failed to perform calibration verification activities that included a minimal value near the lower limit of the reportable range for 1 of 16 analytes performed on the Medica Easy RA instrument. Findings: Review of March 2023 calibration verification documents revealed the following four concentrations of linearity materials were used to assess the reportable 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 -- range of Chloride: 106.5, 142.6, 178.8 and 215 mmol/L. In interview at approximately 12:00 p.m., the external consultant confirmed the laboratory utilizes a reportable range of 50-150 mmol/L for chloride after reviewing the initial verification records of the Medica Easy RA instrument. 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 and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based upon review of the Tosoh AIA-360 (Automated Immunoassay Analyzer) Training Manual, review of 2022 and 2023 laboratory records, and interview with TP#1 (Testing Personnel) on 2/8/24, TP failed to document all instrument maintenance activities performed on the Tosoh AIA-360. Findings: The Tosh AIA- 360 Training Manual lists the following maintenance activities in Tab 6: 1. Daily Maintenance 2. Weekly Maintenance 3. Monthly Maintenance 4. Six-Month Maintenance The review of 2022 and 2023 laboratory records revealed no documentation of the performance of maintenance on the Tosoh AIA-360. In interview at approximately 11:55 a.m., TP#1 stated she does not document maintenance activities performed on the Tosoh AIA-360. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records, review of the manufacturer's IFU(instructions for use), and interview with the COVID nurse 1/27/22, the laboratory failed to follow manufacturer's instructions for the SARS-CoV-2 testing performed to ensure authorized Fact Sheets for patients and providers were included with the SARS-Cov2 test result reports. Findings: Review of laboratory records revealed the laboratory began testing for SARS-CoV-2 using BD Veritor System in September 2020 and Cepheid Gene Xpert in March 2021. 1. The laboratory failed to ensure authorized Fact Sheets for patients and providers were included with SARS CoV-2 test result reports. Review of the IFU for the BD Veritor System for Rapid detection of SARS CoV-2 revealed on page 13 and the IFU for the Cepheid Xpert Xpress SARS CoV-2 test revealed on page 33. "Conditions of Authorization for Laboratories....Authorized laboratories using your product must include with test result reports all authorized fact sheets..." During interview at approximately 11:50 a.m., the COVID nurse confirmed the laboratory does not provide the fact sheets with the test result reports for the BD Veritor or the Cepheid SARS CoV-2 tests. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on the review of laboratory records and absence of documentation 1/27/22, the laboratory failed to retain manufacturer's QC (quality control) assay sheets for chemistry and hematology testing for 2 years. Findings: Random review of 2019, 2020, and 2021 laboratory QC records for the Medica Easy RA analyzer revealed the laboratory failed to retain the Medica Easy QC Chemistry assay sheets with the quality control material acceptable ranges for the following lot numbers: 1. Easy QC Chemistry level A lot # 17270/ level B lot #17271, unknown expiration date; 2. Easy QC Chemistry level B lot# 18276, unknown expiration date; 3. Easy QC Chemistry level A lot#20266/level B lot #20267, expiration date 8/31/23. Random review of 2019, 2020, and 2021 laboratory QC records for the Medonic M series hematology analyzer revealed the laboratory failed to retain assay sheets for the following lot numbers of control material: 1. Boule lot #21811, expiration date 3/28/19; 2. Boule lot #21902, expiration date 6/25/19; 3. Boule lot #22011, expiration date 3/23/21; 4. Boule lot #22101, expiration date 6/16/21. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019, 2020 and 2021 API(American Proficiency Institute) proficiency testing results 5/10/21, the laboratory failed to successfully participate for HDL(high-density lipoprotein) Cholesterol in three of five consecutive testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019, 2020, and 2021 API(American Proficiency Institute) proficiency testing results 5/10/21, the laboratory failed to achieve satisfactory performance for HDL(high-density lipoprotein) cholesterol in three of five consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 samples, resulting in a score of 0% for HDL Cholesterol on the 2019 Chemistry Core 3rd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HDL Cholesterol on the 2020 Chemistry Core 2nd event. 3. Desk review of CMS Casper report 155D and 2021 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for HDL Cholesterol on the 2021 Chemistry Core 1st event. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019, 2020, and 2021 API(American Proficiency Institute) proficiency testing results 5/10/21, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019, 2020, and 2021 API(American Proficiency Institute) proficiency testing results 5/10/21, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency -- 2 of 3 -- testing results revealed the laboratory provided unacceptable responses for 5 of 5 samples, resulting in a score of 0% for HDL Cholesterol on the 2019 Chemistry Core 3rd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HDL Cholesterol on the 2020 Chemistry Core 2nd event. 3. Desk review of CMS Casper report 155D and 2021 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for HDL Cholesterol on the 2021 Chemistry Core 1st event. 4. Desk review of CMS Casper reports 153D and 155D revealed the laboratory failed to achieve satisfactory performance for HDL Cholesterol on three of five consecutive proficiency testing events, resulting in non-initial unsuccessful performance. -- 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 7/21/20, the laboratory failed to successfully participate for HDL (high-density lipoprotein) Cholesterol in two out of three consecutive testing events and Total Calcium in two consecutive testing events, resulting in unsuccessful performance. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 American Proficiency Institute (API) proficiency testing results 7/21/20, the laboratory failed to achieve satisfactory performance for HDL (high-density lipoprotein) Cholesterol in two out of three consecutive testing events and Total Calcium in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. HDL Cholesterol: a. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 samples, resulting in a score of 0% for HDL Cholesterol on the 2019 Chemistry Core 3rd event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HDL Cholesterol on the 2020 Chemistry Core 2nd event. 2. Total Calcium: a. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 samples, resulting in a score of 40% for Total Calcium on the 2020 Chemistry Core 1st event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for Total Calcium on the 2020 Chemistry Core 2nd event. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155 and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 7/21/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on the desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API(American Proficiency Institute) proficiency testing results 7/21/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. HDL (high-density lipoprotein) Cholesterol: a. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 5 of 5 samples, resulting in a score of 0% for HDL Cholesterol on the 2019 Chemistry Core 3rd event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HDL Cholesterol on the 2020 Chemistry Core 2nd event. 2. Total Calcium: a. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 samples, resulting in a score of 40% for Total Calcium on the 2020 Chemistry Core 1st event. b. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for Total Calcium on the 2020 Chemistry Core 2nd event. -- 3 of 3 --