Urology Group Of Florida Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urology Group of Florida LLC on 01/17/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing and interview with General Supervisor, the laboratory failed to evaluate ungraded results in microbiology proficiency testing for one (1st testing event in 2021) out of seven ( 3rd testing event 2020 , 1st, 2nd, and 3rd testing event in 2021, and 1st, 2nd, and 3rd testing event 2022) testing events for urine culture susceptibility interpretation for sulfisoxazole and trimethoprim. Findings Included: Review of API proficiency testing results for the 1st testing event for 2021 found two ( sulfisoxazole and trimethoprim) out of 10 ( ampicillin, cefazolin, ciprofloxacin, levofloxacin, nitroflurantoin, oxacillin, sulfisoxazole, tetracycline, and trimethoprin) urine susceptibility testing scores were ungraded (not graded due to no appropriate peer group) by API and the laboratory had not performed a self evaluation. On 01/17/2023 at 02:30 PM, General Supervisor stated she did not know that the laboratory was to perform a self evaluation of ungraded results and did not know how to perform self evaluation for ungraded scores. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) 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 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) proficiency testing, laboratory's policies and procedure, and interview with the General Supervisor, the laboratory failed to ensure

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted at Urology Group of Florida on 10 /15/20. The laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 technical supervisor evaluated the performance of the one non-physician high complexity testing person over the past two years. The findings included: Review of personnel competency records for the past two years on 10/15/20 revealed that there were no documented competency evaluations for the medical technologist. During an interview with this testing person at 10:05 a.m. on 10 /15/20, she said that there were no evaluations of her over the past two years. 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 --