Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Florida Urology Center on 3/3/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with Testing Person (TP) #1, the laboratory failed to evaluate and document the competency for 7 of 7 testing personnel (TP #2 through #7) reviewed who perform urine sediment examinations. Findings include: A review of the laboratory's personnel records on 3/3/2026 revealed no documentation that competency assessments had been conducted for any of the 7 providers (TP #2 through TP #7) performing urine sediment examinations. In an interview on 3/3/2026 at 1:30 PM, Testing Person #1 confirmed that the laboratory has not performed or documented competency assessments for these seven providers. 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: 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 -- Based on record review and interview with the Testing Person #1, the laboratory failed to verify the accuracy of patient testing at least twice yearly for urine microscopic examination and Adenovirus urine molecular testing. Findings include: 1. A review of the laboratory's 2025 quality records revealed the laboratory performed a peer review (accuracy verification) for the urine microscopic examinations once on 4 /16/2025. The laboratory failed to provide documentation that a second verification of accuracy was performed for urine sediment during the 2025 calendar year. 2. A review of the laboratory ' s 2024 and 2025 Proficiency Testing (PT) records revealed that Adenovirus was not included in PT enrollment or split sample testing. In an interview on 3/3/2026 at 1:30 PM, Testing Person #1 (TP #1) confirmed the peer review dated 4/16/2025 was the only accuracy verification performed for urine microscopic examination in 2025. TP #1 further confirmed that the laboratory had not performed any accuracy verification for Adenovirus urine molecular testing during 2024 or 2025. -- 2 of 2 --