Amarillo Urology Associates

Summary Statement of Deficiencies D0000 The Amarillo Urology Associates laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey 10/29/2025 and recertification is recommended. Standard level deficiency was cited. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports, interview, and pre-survey paperwork, the laboratory failed to ensure the name and address of the facility where the grossing was performed was on the test report for histopathology prostate specimens for two of eight reports reviewed. Findings follow. A. Review of 8 test reports showed 2 were missing the name and address of the facility where the grossing occurred: Date of Service Accession: 1. 04/17/2025 AUA-25-00296 2. 04/29/2025 AUA-25-00326 B. Interview with the Laboratory Manager/General Supervisor (as listed on the CMS Form 209) on October 29, 2025 at 1050 hours confirmed the test reports did not have the name and address of the facility for the grossing performed. C. Review of the CMS Form 116 showed an annual test volume of approximately 11,000 blocks per year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of laboratory records and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for gross analysis of tissue specimens (high complexity) performed by testing personnel. Findings included: 1. A review of the laboratory's records from 2020 and 2021 found the laboratory had no documentation for performing twice annual accuracy assessment of gross analysis of tissue specimens available for review. 2. Interview of the General Supervisor conducted November 17, 2021 at 10:57 AM confirmed that there was no documentation available for review of semi-annual accuracy assessment of gross analysis of tissue specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, quality control logs, patient test logs, and interview, the laboratory failed to follow the laboratory's established quality control (QC) criteria for acceptable QC results and reported patient testing when QC failed. Findings follow. Review of the laboratory's Quality Assurance policy and procedure stated under "Quality Control Program" on page 4, "When a control is found to be outside of the specified range or expected result, the control will be re-ran. If the control is still outside of the specified range or expected result, further investigation will be initiated including contacting technical support for assistance if needed. Patient samples will not be tested until it has been resolved and the controls are within the specified range." Random review of quality control logs for Free PSA (Prostate Specific Antigen) performed on the Beckman Access 2 chemistry analyzer from 8/1/2020-9/01/2020 showed Biorad Level 1, Lot 40980, established QC range was 0.12-0.18, and was out of range 4 out of 21 days on the following dates of testing: 1. 08/14/2020 Biorad Level 1 result was 0.11 (out of range) 2. 8/17/2020 Biorad Level 1 result was 0.11 (out of range) 3. 8/18/2020 Biorad Level 1 result was 0.11 (out of range) 4. 08/20/2020 Biorad Level 1 result was 0.11 (out of range). Review of patient test logs from 8/15/2020-8/20/2020 showed 3 patients were reported on 8/14/2020 (patient IDs: 161636, 174035, and 117573), 4 patients were reported on 8/18/2020 (patient IDs: 139703, 137440, 95752, and 106871), and 5 patients were reported on 8 /20/2020 (patient IDs: 135151, 174539, 170570, 142258, and 170306). Interview with testing personnel #16 on the CMS form 209 on 10/21/2020 at 1600 hours acknowledged when QC was out of range, he would compare to the control assay 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 -- sheet (3 standard deviation range), peer data, or the new lot he was running in parallel to determine its acceptability. D5781