Advanced Urology Associates Of Florida, Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Urology Associates of Florida PA on December 3, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, interview and record of the procedure manual, the laboratory failed to use non-expired reagents in their Papanicolaou Stain for staining patient's cytology slides form 11/19/2023 to 01/07/2024 and 04/03/2025 to 12/02/2025. Findings: 1. During a tour of the laboratory on 10/08/2025 at 11:00 AM, one bottle of hydrochloric acid lot #1322 with an expiration date of 11/18/2023 was found in the flammable cabinet. 2. Review of the procedure titled Equipment, reagents, materials, supplies noted, "All expired reagents, solutions, control materials and other supplies will be discarded and not used past expiration date." 3. Review of the procedure titled Routine Cytology Papanicolaou Stain Procedure revealed hydrochloric acid was used in the making of the 25% Acidic Alcohol used in the Papanicolaou stain. 4. On 12/03 /2025 at 11:00AM, Testing Personnel E acknowledged the the hydrochloric acid was expired and that she had used the expired reagent. 5. On 12/03/2025 at 4:00AM, Testing Personnel E stated the Previous Pathologist's last day of work was 01/07/2024 and no cytology slides were stained from 1/8/2024 to 4/2/2025. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- (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 interview, review of the histopathology and cytology reports, the laboratory failed to report where the histopathology professional component was performed from 12/10/2024 to 12/3/2025 and for cytology reports from 4/3/2025 to 12/03/2025, Finding: 1. Review of the histopathology and cytology reports revealed the reports failed to include the name and address of where the professional component was performed. 2. On 12/03/2025 at 2:58 PM, Testing Personnel E stated histopathology and cytology slides were sent to a different location to be interpreted. and the name and address of the laboratory where the slides were interpreted was not on the reports. 3. On 12/03/2025 at 4:00AM, Testing Personnel E stated the Previous Pathologist's last day of work was 01/07/2024 and no histopathology slides were interpreted from 01/08/2024 to 12/09/2024 and no cytology slide were interpreted from 1/8/2024 to 4/2 /2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted from July 11, 2023 to July 12, 2023. Advanced Urology Associates of Florida clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation, record of the procedure manual, and interview, the laboratory failed to ensure uni-directional sample preparation, reagent prep and amplification for PCR (Polymerase Chain Reaction) Urinary Tract Microbiata detection from 05/11 /2021 to 07/12/2023. Findings: The laboratory had two rooms, the sample processing room and the clean room, that were used for the processing and running of PCR Urinary Tract Microbiata detection. A tour of the sample processing room (dirty room) and the PCR room (clean room) on 07/12/2023 at 3:24 PM, revealed the centrifuge was in the clean room. Review of the procedure titled Isolation of DNA for Urinary Tract Microbiata Profiling Experiments using the MagMAX MVP Ultra Kit on the KingFisher Duo Purification System, noted 100 mL (microliters) of the patient's sample was added to the appropriate wells in row A of the processing plate, the wells were covered with a clear adhesive and centrifuged at 2250 x g (gravity) for 15 minutes. After centrifugation, the supernatant is removed, PBS (Phosphate Buffered Saline) and Enzyme Mix is added to each sample, and the processing plate is then brought to the clean room. On 7/12/23 at 3:24 PM, Testing Personnel C stated the samples were added to the processing plate, sealed, brought to the clean room to be centrifuged for 15 minutes, and brought back to the dirty room where PBS and Enzyme Mix were added to each sample. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of quality control documents and the i-Stat Chem8+ instructions, and interviews, the laboratory failed to provide documentation of the performance of the calibration on the Abbott i-Stat instrument at least once every 6 months for 184 patients from 9/1/2021 to 07/12/2023 (See 5439), and the laboratory failed to perform two levels of quality controls at least daily on days when patient specimens were tested on the Abbott i-Stat instrument for 184 patients from 9/1/2021 to 07/12/2023 (See D5447). D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of quality control documents and the i-Stat Chem8+ instructions, and interview, the laboratory failed to provide documentation of the performance of the calibration on the Abbott i-Stat instrument at least once every 6 months for 184 patients from 9/1/2021 to 07/12/2023. Findings: Review of a letter to i-Stat customers dated September 2021 noted the "i-Stat Chem8+ (blue) cartridge is now also U.S. FDA 510 (k) cleared for use with venous and arterial whole blood samples collected in non-anticoagulated syringes and blood collection tubes in non-waived settings." Review of the laboratory's quality control documents showed the laboratory did not -- 2 of 3 -- have documentation of the calibration of the Abbott i-Stat instrument. The i-Stat Chem 8+ Intended for Use instructions noted that calibration verification "may be required by regulatory or accreditation bodies." The Chem 8+ i-Stat cartridges included the following chemistry analytes: sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide. On 07/12/2023 at 2:15 PM, Testing Personnel C stated she thought the test was a waived test and that calibrations on the i-Stat were not performed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control documents and interview, the laboratory failed to perform two levels of quality controls at least daily on days when patient specimens were tested on the Abbott i-Stat instrument for 184 patients from 9/1/2021 to 07/12 /2023. Findings: Review of a letter to i-Stat customers dated September 2021 noted the "i-Stat Chem8+ (blue) cartridge is now also U.S. FDA 510 (k) cleared for use with venous and arterial whole blood samples collected in non-anticoagulated syringes and blood collection tubes in non-waived settings." Review of the laboratory's quality control records for the Abbott i-Stat instrument showed the laboratory performed the electronic simulator check each day of patient testing and two levels of controls when new shipment of cartridges arrived. The Chem 8+ i-Stat cartridges included the following chemistry analytes: sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide. On 07/12/2023 at 2:21 PM, Testing Personnel C stated she thought the test was a waived test and two levels of controls were run only when the laboratory received a new shipment. Testing Personnel C also stated the lab did not have an Individualized Quality Control Plan. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 11, 2021. Advanced Urology Associates of Florida clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record the temperatures and humidity of the rooms where testing was performed from 05/11/2019 to 05/11 /2021. Findings: 1. Review of quality control documents showed there were no logs recording the temperature and humidity of the room where testing was performed in the laboratory. Review of the Architect System Operations Manual for the chemistry instrument noted the room temp should be 15 to 30 degrees Celsius (C) (59 to 86 degrees Fahrenheit (F)) and the humidity of the room should be 10% to 85% (percent). Review of the Tissue Tek Vacuum Infiltration Processor Operations Manual for the histology instrument Operations Manual noted the room temperature should be 10 to 35 degrees C (50 - 95 degrees F). 2. Review of the Daily Temperature Chart for the PCR (Polymerase Chain Reaction) room showed the humidity of the room was not recorded. Review of the Applied Biosystems QuantStudio 12K Flex Real-Time PCR System user guide noted the humidity of the room should be 20% to 80%. Review of the King Fisher Duo Prone Brief Users Manual noted the humidity of 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 -- the room should be "maximum relative humidity of 80%. for temperatures up to 31 degrees C decreasing linearly to 50% relative humidity at 40 degrees C." 3. Review of quality control documents showed there were no logs recording the temperature of the room in the embedding/draw station room. Review of the Leica EG1160 Paraffin Embedding Center Operations Manual for the histology instrument noted the room temperature should be 18 to 35 degrees C. On 04/07/21 at 1:40 PM, the General Supervisor stated they did not record the temperature and humidity in the main lab, the humidity in the PCR room and the temperature in the embedding/draw station room. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to receive an overall testing score of at least 80% in 2 (2nd events for 2017 & 2018) out of 6 (1st, 2nd & 3rd events for 2017 and 2018) testing events reviewed. Findings: Review of American Proficiency Institute (API) proficiency testing results showed that the laboratory received an overall score of 58% in bacteriology for the 2nd testing event in 2017, and an overall score of 73% in bacteriology for the 2nd testing event in 2018. During an interview on 4/4/19 at 11:10 AM, the General Supervisor B acknowledged the failure. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview and record review, the laboratory failed to perform a sterility check on the Uricult urine culture paddles, and failed to check and document each 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 -- batch of urine culture paddles for its ability to support growth and select or inhibit specific organisms, or have an Individualized Quality Control Plan (IQCP) from April 4, 2017 to April 4, 2019. Findings: Review of the quality control records revealed no documentation showing that the laboratory performed a sterility check or that the laboratory had checked the Uricult urine culture paddles for its ability to support growth and select or inhibit specific organisms. Review of the laboratory's procedure manual showed that the laboratory failed to have an IQCP. During an interview on 4 /04/19 at 2:19 PM, the General Supervisor B stated that they didn't perform sterility check on the Uricult urine culture paddles, and they did not have an IQCP. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document and maintain records number of hours spent examining cytology slides during each 24 hour period. Findings: Review of the laboratory's cytology logs showed that the laboratory failed to have records showing the amount to time spent examining cytology slides during each 24 hour period from 4/04/17 through 4/04/19. During an interview on 4/04/19 at 3:20 PM, the General Supervisor B acknowledged that the pathologist did not record the amount to time spent examining cytology slides. -- 2 of 2 --