Urology Group Pc, The

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 review of the CMS 209 form, personnel records, and interview conducted on 6/17/2025 it was determined that the competency of the testing personnel was not assessed by the laboratory director on an annual basis. Findings follow: A) Review of Technical Supervisor (TS) personnel files on the CMS 209 form, one of one TS personnel revealed that the annual evaluation of the competency of the TS personnel was not documented annually for 2023, 2024, and 2025. B) Upon request, the laboratory was unable to provide other competency evaluations of the TS personnel on the CMS 209 form, no 2023, 2024 and 2025 competency evaluation for TS. C) In an interview on 6/17/2025 at 10:30 a.m. TS on the CMS 209 form, said, "no other competency evaluations were present and available". D5803 TEST REPORT CFR(s): 493.1291(b) (b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: A review of patient final reports, and interviews with laboratory staff, determined the laboratory failed to indicate the correct address for the test Automated urinalysis test menu. As evidenced by: A. Upon reviewing a randomly selected patient final report 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 -- for the test menu "AutoUA Automated Urinalysis Test", the report stated, "CLIA # 44D2128687 Unless otherwise indicated, all tests are performed at: The Urology Group 6029 Walnut Grove Road Suite 300 Memphis, TN 38120". Record selected: Patient # 265837. B. In an interview on 6/17/2025 at 3:37pm, the testing personnel #2 (as listed on CMS form 209) confirmed the laboratory final report citing the wrong facility where the actual test was performed. C. In an interview on 6/17/2025 at 3: 47pm, the technical supervisor (as listed on CMS form 209) also confirmed the laboratory final report citing the wrong facility where the actual test was performed. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel files for all testing personnel listed on the CMS-209 form, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize two of two testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for all testing personnel (TP), TP- 1 and TP- 2 (as listed on the form CMS-209) failed to have written authorization from the laboratory director, to perform moderate complexity and high complexity testing without direct supervision. B) In an interview on 6/17/2025 at 1:04 pm, the technical supervisor on the CMS 209 form, confirmed the lack of written authorization for two TP on form CMS 209. -- 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 review of proficiency test documentation and interviews with laboratory staff, the laboratory director and testing personnel failed to sign proficiency testing attestation statements for one of one testing events in 2023. Survey findings include: A. A review of proficiency testing documentation from 2022 and 2023 showed the laboratory director and testing personnel failed to sign the attestation statement on the First Testing Event of 2023 (one of three events). B. In an interview, at 11:50 a.m. on 8/31/23, the technical supervisor (as listed on the form CMS-209) confirmed the attestation statement listed above had not been signed by the laboratory director and testing personnel. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems 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 -- identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Through a lack of policy and procedure and interview it was determined that the laboratory did not include written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic systems. Findings follow: A. Upon request, the laboratory could not produce policies and procedures that defined the mechanism to monitor, assess and correct problems identified in the postanalytic systems. B. In an interview on August 31, 2023, at 11:50 a.m. the technical supervisor verified that policies and procedures defining postanalytic quality assessment were not available. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on the lack of laboratory policies and procedures, lack of laboratory records, and interview it was determined that the Laboratory Director failed to ensure quality assessment programs were established in the general laboratory, preanalytic, analytic and postanalytic phases of testing. The Laboratory Director failed to establish and maintain a defined program to identify failures in quality. 1. Upon request, the technical supervisor failed to provide written policies and procedures of an established quality assessment program and failed to identify failures in quality. 2. During an interview on 8/31/23 at 11:58 a.m., the Technical Supervisor confirmed that there was no quality assurance policy available. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon review of personnel records, lack of documentation, and interview it was determined that the laboratory director failed to specify in writing the examinations and procedures that personnel are authorized to perform for one of one testing personnel for which records were presented. Findings follow: A. Upon request, the laboratory was unable to provide a written authorization to perform procedures signed by the laboratory director for the technical supervisor. B. In an interview on 8/31/23 at 11:59 a.m., the technical supervisor confirmed there was no written authorization to perform testing, signed by the laboratory director. -- 2 of 2 --