Florida Bladder Institute

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at FLORIDA BLADDER INSTITUTE from 05/07/2026 to 05/18/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: 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: Based on record review and staff interview, the laboratory failed to verify the accuracy of testing method at least twice annually for 21 out of 82 tests performed by the laboratory for detection of Urinary Tract Infection (UTI) or Vaginal Infection since 01/01/2025. Findings included: 1-Review of the test menu provided with the form CMS-116 Clinical Laboratory Improvement Amendment (CLIA) Application for Certification signed by the Laboratory Director on 04/06/2026 listed the detection of Vaginal microorganism and gene resistance markers using a Reverse Transcription- Polymerase Chain Reaction (RT-PCR) laboratory developed test (LDT) that included: Acinetobacter baumanii, Atopium vaginae, Bacterial Vaginosis-Associated Bacterium 2 (BVAB2), Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Chlamydia trachomatis, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, HSV I, HSV II, Klebsiella oxytoca, Klebsiella pneumoniae, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii, Megasphaera I, Megasphaera II, Mobiluncus curtisii, Mobiluncus Mulieris, Morganella morganii, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhea, Prevotella bivia, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens, Staph. Saprophyticus, Staphylococcus 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 -- aureus, Strep. Agalactiae (Group B), Treponema pallidum, Trichomonas vaginalis, Ureaplasma parvum, Ureaplasma urealyticum, ampC, ant2, Antla, aph2, aph3, CTX- M Group1, CTX-M Group2, DfrA, DfrA1, DfrA5, ErmA, ErmB, femA, fosA, GyrA, KPC, mecA, mefA, NDM, OXA-48, ParC, PVL, QNrA, QnrB, SHV, Sul1, Sul2, TEM, TetB, TetM, TetO, Van1/2vanB, VI /IMP7. 2- Review of American Proficiency Institute (API) Proficiency Testing (PT) worksheet for 2026 first event of Microbiology Vaginal and Urinary Tract Infection (UTI) panels, revealed that the following microorganisms and resistance markers were not listed: Candida auris, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii, Megasphaera I, Megasphaera II, Mobiluncus curtisii, Mobiluncus Mulieris, Morganella morganii, ant2, Antla, aph2, aph3, DfrA, DfrA1, DfrA5, fosA, GyrA, ParC, TetO, 3-The laboratory did not have any records of a twice a year accuracy verification for: Candida auris, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii, Megasphaera I, Megasphaera II, Mobiluncus curtisii, Mobiluncus Mulieris, Morganella morganii, ant2, Antla, aph2, aph3, DfrA, DfrA1, DfrA5, fosA, GyrA, ParC, TetO. 4-The laboratory tested 935 patients from 01/01/2025 to 05/07/2026. 5-During an interview on 05/07/2026 at 02: 00 PM, the Laboratory Director confirmed that the laboratory failed to do twice a year verification for Candida auris, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii, Megasphaera I, Megasphaera II, Mobiluncus curtisii, Mobiluncus Mulieris, Morganella morganii, ant2, Antla, aph2, aph3, DfrA, DfrA1, DfrA5, fosA, GyrA, ParC, TetO during the period of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on November 14, 2024. Florida Bladder Institute 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, procedure manual review and interview with Testing Person (TP) the laboratory failed to have a uni-directional workflow while performing PCR (Polymerase Chain Reaction) Urinary Tract Infection (UTI) Panel since 07/18/2024. Findings included: 1-During the laboratory tour on 11/14/2024 at 9:00 AM the surveyor observed that the laboratory had one room, with 4 work areas: accession, extraction, PCR mix preparation and amplification. The laboratory had one mini centrifuge located in the PCR mix preparation area. 2-Review of the sample preparation procedure effective on 07/15/2024 revealed that the steps for the direct extraction of urinary samples require to transfer 1 ml of the sample to a microfuge tube and centrifuge at 5000 rpm for 10 minutes, remove supernatant and prepare the cel lysis. Review of BPX Duo Direct Detection Kit read, "set up lysis at -55 Celsius (C) -8mins, 95(C) spin down the sample and prepare PCR reaction mix. Where possible a unidirectional workflow is preferable, where this is not possible the separation of pre and post amplification areas is key to preventing contamination." 3- The laboratory is using the same centrifuge for urine sample preparation for direct extraction and for the step of the sample preparation mix for PCR reaction. During an interview on 11/14/2024 at 9:30 AM, the TP confirmed that the PCR test for UTI was not set up for uni-directional workflow. 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 --