Augusta Urology Associates Llc

Summary Statement of Deficiencies D0000 A recertification survey was performed on , July 11, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Associates of Bioanalysts (AAB) Proficiency Testing (PT) provider and staff interview, the Laboratory failed to provide a copy of the Attestation Statement for the Specialty Chemistry- Subspecialties Testosterone (TEST), Prostate Specific Antigen (PSA), and Prostate Specific Antigen Free (PSAF), for the year 2023, all three events. Findings: 1. Review of the AAB, PT documents for 2023, failed to provide a copy of the attestation statements, for all three events. 2. Interview with the General Supervisor, on 07/11/2024 at approximately 12:16 in the staff breakroom, confirmed the above statement. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of 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 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 -- identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 24, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the review of the Standard Operating Procedure(SOP) and staff interview, the laboratory failed to establish a safety procedure for an Eyewash. The Findings include: 1. SOP document review revealed that the laboratory failed to establish a safety procedure for an Eyewash for the laboratory. 2. During an interview with the Office Manager on August 24, 2022 in a back office, confirmed that the laboratory failed to establish a safety procedure for an Eyewash. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. 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 -- This STANDARD is not met as evidenced by: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing The findings include: 1. The SOP did not include a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, or how to obtain additional assistance) for staff to follow when sending specimens to reference laboratory (Quest Diagnostics, LabCorp, and PathGroup). 2. During an interview on August 24, 2022 at: 11:00 AM with the Office Manager in a back office, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to reference laboratories. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the review of the Standard Operating Procedure(SOP) and staff interview, the laboratory failed to have procedures approved, signed, and dated by the current laboratory director(LD) before use. The Findings include: 1. SOP document review revealed the laboratory failed to have procedures approved, signed, and dated by the laboratory director (LD). 2. During an interview with the Office Manager in a back office, confirmed that the laboratory failed to have procedures approved, signed, and dated by the LD before use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 On December 22,2020, an off site followup review was completed. The report revealed that