Avante Medical Center

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing (PT) from 2025 and 2026, the laboratory failed to meet the following conditions, resulting in an initial unsuccessful PT participation. D2016- 493.803 Condition: Successful participation [proficiency testing]. D6000- 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Proficiency Institute (API) proficiency testing records, the laboratory failed to 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 -- 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 test of total calcium, total cholesterol, and total protein resulting in initial unsuccessful participation. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 proficiency testing (PT) desk review from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analytes (total calcium, total cholesterol, and total protein) in two (2) of three (3) consecutive testing events in the specialty of Routine Chemistry. Findings included: 1. Review of the CASPER 0155 report revealed the following results: General Chemistry 2025-3rd Event the laboratory received an unsatisfactory score of 60% for total calcium. General Chemistry 2026-1st Event the laboratory received an unsatisfactory score of 60% for total calcium. General Chemistry 2025-3rd Event the laboratory received an unsatisfactory score of 0% for total cholesterol. General Chemistry 2026-1st Event the laboratory received an unsatisfactory score of 60% for total cholesterol. General Chemistry 2025-3rd Event the laboratory received an unsatisfactory score of 20% for total protein. General Chemistry 2026-1st Event the laboratory received an unsatisfactory score of 60% for total protein. 2. A review of the American Proficiency Institute (API) proficiency testing records 2025 Chemistry- Core- 3rd Event and 2026 Chemistry- Core- 1st Event confirmed the laboratory received the above results. 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 a proficiency testing desk review of CASPER 0155 report and American Proficiency Institute 2025 and 2026 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

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 on record review and interview with the laboratory director, the laboratory did not verify the reportable range of the chemistry tests in those instances where the calibration verification material did not extend to the entire analytical measurement range of the Alfa Wasserman Ace Axcel chemistry analyzer. Findings include: 1. The calibration verifications using Audit MicroControls did not extend to the full analytical measurement range for alkaline phosphatase, calcium, cholesterol, sodium, 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 -- total protein, and triglyceride. 2. In an interview on 12/7/22 at 12:30 PM the laboratory director confirmed the laboratory's reportable ranges were not adjusted to the limits determined by the calibration verification. 3. The laboratory reported 20,900 chemistry tests annually on the CMS-116 dated 12/7/2022. -- 2 of 2 --