Health Center At Auraria

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on January 22, 2026, deficiencies were cited for Health Center at Auraria in Denver, Colorado. 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 a review of the laboratory Cepheid GeneXpert CT/NG control documents, an interview with the testing personnel 7 during the survey, and a review of the laboratory IQCP documents, the laboratory failed to perform control procedures for Cepheid GeneXpert CT/NG every day of testing and failed to develop a complete written IQCP. Findings include: 1. A review of the laboratory control logs on January 22, 2026, revealed that the laboratory performs control procedures for Cepheid GeneXpert CT/NG on every new lot received. 2. An interview with the testing personnel 7 on January 22, 2026, at approximately 11:30 AM confirmed that the laboratory performed control procedures on every new lot of cartridges received. 3. A review of the Cepheid verification documents on January 22, 2026, revealed that the laboratory failed to develop a complete written IQCP for the Cepheid GeneXpert CT 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 -- /NG test system. The laboratory did not have a written Risk Assessment, Quality Assessment, or a Quality Control Plan associated with the IQCP. Additionally, the IQCP did not have approval from the laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a record review and an interview with the Laboratory Director, the laboratory failed to document the handling and each step in the testing and reporting of microscopic urinalysis results for The American Academy of Family Physicians (AAFP) proficiency testing in all events of 2021 and 2022. Findings include: 1. Record review of proficiency testing documentation from AAFP revealed the laboratory failed to document who performed the testing and reporting, as well as the date of test performance for all events in 2021 and 2022. 2. An interview with the laboratory director on March 6, 2023, at 2:00 p.m. confirmed the lab failed to document who performed the proficiency testing, reporting and the date testing was performed for microscopic urinalysis in all events in 2021 and 2022. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of 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 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require