Urology Group Of Florida Llc

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 10/26/2023 to 10/30/2023. Urology Group of Florida LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Clinical Laboratories. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to perform 1 out of 2 verifications in 2021 and 2 out of 2 verifications in 2022 for twice annual verifications for urinary sediment. Findings Included: Review of Proficiency Test (PT) Policy read, "Analytes for which no PT exists are tested twice per year to verify accuracy using split-sample method missing was step by step process." Review of Urinary Sediment PT revealed no documentation of second PT in 2021 and twice annual PT in 2022 for urinary sediment. On 10/26/2023 at 4:00 PM, the Office Manager and Medical Assistant confirmed accuracy verification was not completed for urinary sediment in 2021 and 2022. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, 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 -- accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review, and interview, the Technical Supervisor failed to perform annual competency assessments for 2 out of 2 Testing Personnel in 2021 and 2022, (Testing Personnel A and B). Findings Included: Review of Quality Assurance Plan revealed no policy documentation for Testing Personnel competency assessment performing fluorescence in situ hybridization (FISH) and urinary sediment. Review of Competency Assessment revealed no documentation of annual competency assessments completed in 2021 and 2022 for Testing Personnel A and B. On 10/26 /2023 at 3:40 PM, the Office Manager confirmed annual competency assessments were not completed for Testing Personnel A and B in 2021 and 2022. . -- 2 of 2 --

Summary Statement of Deficiencies 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 interview with laboratory personnel, there was no documentation to indicate that the laboratory verified the accuracy of urine sediments or fluorescent in situ hybridization (FISH) slide interpretation. Findings include: Review of records for FISH testing on 03/27/2019 revealed that there was alternative proficiency testing results for two of the doctors that read slides 12/16/2018. After the survey, the clinical manager emailed the surveyor a letter that showed that the third physician that read FISH slides had done proficiency testing 08/16/2018. During an intrview with the clinical manager at 11:00 a.m. on 03/27/2019, she confirmed that there were no additional proficiency testing results in the FISH manual, and that she would look into it. Based on review of urine sediment records for the past two years on 03/27/2019, there was no documentation to indicate that any twice a year verification had been performed. During an interview with the clinical manager at 11: 20 a.m. on 03/27/2019, she said that if there was any question with a urine sediment, another doctor would look at it, but that she did not know of any documentation. 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 --