Advanced Heart & Vein Surgery, Llc

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on September 16, 2026, deficiencies were cited for Advanced Heart and Vein Surgery, LLC laboratory loacated in Thornton, Colorado. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 a surveyor review of Avoximeter 1000E procedure manual, a surveyor review of Avoximeter 1000E maintenance documents, and an interview with the technical consultant (TC) during the survey, the laboratory failed to perform and document calibration verification procedures at least once every 6 months. The laboratory performs approximately 1000 routine chemistry tests annually. Findings 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 -- include: 1. A surveyor review of Avoximeter 1000E procedure manual revealed the laboratory must run calibration verification controls twice annually. 2. A surveyor review of Avoximeter 1000E maintenance documents revealed the laboratory has not performed calibration verification since the beginning of operation in 2024. 3. An interview with TC on September 16, 2026, at 12:30 PM confirmed that the laboratory has not performed calibration verification since the beginning of operation in 2024. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on the surveyor review of the laboratory quality control documents and an interview with the technical consultant (TC), the laboratory failed to perform Quality Control (QC) at least once each day patient specimens are tested with Avoximeter 1000E. The laboratory performed approximately 1000 tests annually since the start of the test in 2024. Findings include. 1. A surveyor review of the laboratory quality control documents for Avoximeter 1000E instrument revealed that the laboratory performs three levels of liquid quality control weekly. 2. An interview with the TC, on September 16, 2026, at 12:18 PM confirmed the laboratory performs three levels of liquid quality control weekly for Avoximeter 1000E instrument. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory ' s competency records and policies and procedures, and an interview with the laboratory ' s technical consultant (TC), the laboratory failed to establish and follow written policies or procedures to, and evaluate consultant competency for one out of one TC listed on the CMS-209 form, since the laboratory ' s last survey on 03/08/2022. The laboratory performs approximately 800 tests annually. Findings include: 1. A review of the laboratory ' s policies and procedures revealed that there was no written policy or procedure to evaluate TC competency. 2. A review of the laboratory ' s competency records showed that there were no documented evaluations of TC competency. An interview with the laboratory ' s TC on 06/07/2024 at approximately 11 A.M. confirmed that the laboratory did not have a policy or procedure to evaluate TC competency and had not been doing so since the last survey on 03/08/2022. 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 a review of the laboratory ' s records and an interview with the laboratory ' s 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 -- technical consultant (TC), the laboratory failed to twice annually verify the accuracy of it ' s Activated Clotting Time (ACT) and Blood Oximetry (Blood OX) tests, since the last survey on 03/08/2022. The laboratory performs approximately 800 ACT and Blood OX tests per year. Findings include: 1. A review of the laboratory ' s records failed to find any evidence of twice annual accuracy verification for ACT and Blood OX tests. 2. An interview with the laboratory ' s TC on 06/07/2024 at approximately 11 A.M. confirmed that the laboratory did not have any policy or procedure to verify the accuracy of the ACT and Blood OX tests, and had not been doing so since the last survey on 03/08/2022. -- 2 of 2 --