Urology Associates, Pc -Gallatin

Summary Statement of Deficiencies 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 observation of the laboratory, a review of patient worksheets, electronic medical record test reports, and staff interviews, the laboratory failed to include the urine sediment microscopic test results on the final patient test report for three of three patients reviewed in 2024 and 2025. The findings include: 1. Observation of the laboratory on 12/10/2025 at 10:40 a.m. revealed a centrifuge and microscope used to perform patient urine sediment testing, and patient flow worksheets used to write urine sediment microscopic results. 2. A review of patient flow worksheets revealed that testing personnel recorded urine sediment microscopic results for the following: 12/27/2024 Patient 823060 (100 WBC/HPF, 100 RBC/HPF, 4+ Bact) 04/29/2025 Patient 2347450 (25-30 WBC/HPF, 0-4 RBC/HPF) 10/29/2025 Patient 67960 (2-4 WBC/HPF, 0-1 RBC/HPF, Rare Epith/HPF) 3. A review of the electronic medical record final patient test reports revealed that the microscopic results were not included for the following: 12/27/2024 Patient 823060 04/29/2025 Patient 2347450 10/29/2025 Patient 67960 4. An interview with the technical consultant on 12/10/2025 at 11:30 a. m. confirmed the survey findings. Word Key: WBC- White Blood Cell RBC- Red Blood Cell Bact- Bacteria Epith- Epithelial Cells HPF- High Power Field 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's procedure manual and staff interview, the laboratory failed to follow its policy for procedure review in 2023. The findings include: 1. A review of the laboratory's policy titled "Addendum to CLIA procedure" revealed the following statements: - "This Policy and Procedure Manual is located on the shared drive (L:) in the Laboratory folder, can be accessed from all computers at Urology Associates, and will be reviewed and signed by the Director(s) annually." - "Below is the signature(s) attesting to the policy review:" There was no signature present in the space provided for 2023. 2. An interview with the Technical Consultant on 06/03/2024 at 10:30 a.m. confirmed the laboratory did not follow their policy for annual procedure review in 2023. 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 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 -- 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)