Urology Center Of Florida Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted from 07/09/2024 to 07/12/2024 found the UROLOGY CENTER OF FLORIDA PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain daily maintenance records for Histology area for one out of two years reviewed. Findings included: Review of Daily Maintenance log for Miles Scientific Vacuum Infiltration Processor (VIP) E300, Tissue Tek dispensing console, Microtome, water bath, room and humidity log, daily maintenance for Hematoxylin and Eosin for 2023 and 2024 revealed that records for 2023 were missing, The annual testing volume for the laboratory based on the Form CMS -116 (03/240 was 80 patients. During an interview on 07/09/2024 at 11:30 AM, the Histology technician confirmed those records were missing and explained that in 2023 there was another person managing the Histology Section and they failed to give them the records for 2023. 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 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/30/2022 found the UROLOGY CENTER OF FLORIDA PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have attestation signed by the Testing Person for two out of five events reviewed for the specialty of Microbiology (2021-2022). Findings include: -Review of Proficiency American Institute (API) proficiency testing (PT) records revealed that for second and third event of 2021 the testing person failed to sign the attestation for the Urine Colony Count test During an interview on 08/30/2022 at 2:45 PM, the Office Manager confirmed that the laboratory failed to have a signed attestation for the events of reference. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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, accurately and proficiently. 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 personnel records review and interview with Office Manager (OM) revealed that the technical consultant failed to perform six months competency evaluation for testing person (TP) D during 2022. Findings include: Review of personnel records revealed that TP D had an initial evaluation on 10/27/2021, no records found for the six months evaluation. During an interview on 08/30/2022 at 3:00 PM with OM, he confirmed that there was no record of six months competency evaluation for TP D in 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/05/2020 -10/12/2020, found that Urology Center of Florida PA clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. Immediate Jeopardy (IJ) was identified during the survey. The laboratory failed to complete the validation on a moderate complexity Frend System instrument for prostate-specific antigen (PSA) and Testosterone before it began patient testing on 11/19/19 and through out 10/9/2020. (see 5421) The laboratory failed to document the performance of daily quality control (QC) Cartridges and Monthly External QC CLINIQA level 1 and 2 runs on the unvalidated Frend System instrument for PSA and Testosterone for the period of time mentioned above.(see 5441) The laboratory failed to follow and document analytic quality assessments(QA) which resulted in failure to review quality controls and ensure the validation of the Frend system instrument from Nov 19, 2019 to Oct 9, 2020.(see 5791) (see 5400) The following are IJ Conditions: 5400- Analytic Systems The following Conditions were not met: 5200- General Laboratory Systems 6063- Laboratory Testing Personnel 6076- Laboratory Director The laboratory was notified of IJ level deficiencies on 10/09/2020 at 4:52 pm. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interviews, the laboratory failed to have a CLIA Certificate of Compliance that included the subspecialty of Endocrinology for Testosterone from January 1, 2019 to October 9, 2020. Findings Included: Review of the CMS-116 report revealed the subspecialty of Endocrinology was not added. Review of Patient Report logs revealed patient testing for Testosterone from 1/1/2019 to 10/09/2020. During an interview on 10/12/2020 at 10:05 am, the office manager Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- confirmed the lab was testing for Testosterone without the subspecialty of Endocrinology in CLIA Certificate of Compliance from January 1, 2019 to October 9, 2020. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: This a repeated deficiency from 8/21/2018. Based on record review and interview, the laboratory failed to follow their competency assessment plan and failed to perform annual competency assessments for 1(TP#E) out of 5 testing personnel (TP) in 2019 and 2020. (See 5209) Based on record review and interview, the laboratory failed to perform endocrinology proficiency testing (PT) for Testosterone twice annually to verify to accuracy of testing in 2019 and 2020. (see 5217) This is a repeated deficiency from 8/21/2018. Based on record review and interview, the laboratory failed to follow their quality assessment (QA) procedure and perform a QA checklist monthly from June 2019 to September 2020. (see 5291) 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: This a repeated deficiency from 8/21/2018. Based on record review and interview, the laboratory failed to follow their competency assessment plan and perform annual competency assessments for 1(TP#E) out of 5 testing personnel (TP) in 2019 and 2020. Findings Included: Review of the Laboratory Training Procedure stated "there will be an annual employee evaluation of laboratory personnel." Review of CMS-209 Laboratory Personnel Form indicated TP#E is a testing person. Review of Personnel Competency Assessment folder lacked documentation of annual competency assessments done for TP#E in 2019 and 2020. During an interview on 10/12/2020at 10:05am, the office manager confirmed annual competency assessments were not done for TP#E in 2019 and 2020. 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. -- 2 of 7 -- This STANDARD is not met as evidenced by: This is a repeated deficiency from 8/21/18. Based on record review and interview, the laboratory failed to perform endocrinology proficiency testing (PT) for Testosterone twice annually to verify the accuracy of testing in 2019 and 2020. Findings Included: Review of Patient Report Logs revealed that Testosterone testing had been performed on patients since 2019. Review of American Proficiency Institute folder revealed PT was not performed twice annually in 2019 and 2020 for Testosterone. There was no documentation of Testosterone enrollment for the year of 2019 and 2020. During an interview on 10/12/2020 at 10:15am, the office manager confirmed PT was not performed twice annually for Testosterone in 2019 and 2020. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory was enrolled in American Proficiency Institute (API) proficiency testing (PT) and failed to have documentation for the 0% received in 1st event of 2019 and 2nd event of 2020 for prostate-specific antigen (PSA). Findings Included: Review of API proficiency folder revealed there was no documentation of

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain quality control records. Findings: 1. Review of the quality control documentation in the bacteriology, routine chemistry and urinalysis laboratory showed that the laboratory failed to retain the, "Certificate of Analysis" from the Uricult CLED/EMB urine culture paddles from 8/21/16 to 8/21/18. During an interview on 8/21/18 at 3:27 PM, Manager stated that they did not keep the certificates. 2. Review of the histopathology laboratory's quality control records showed that the records for all quality control and maintenance for 2017 were missing. During an interview on 8/23/18 at 11:24 AM, Manager stated the previous histology technician took the 2017 records to make a copy and had not returned them. 3. Review of the histopathology laboratory's quality control records showed that there were no records documenting the stain quality of the H&E stain from 8/21/16 to 8/23/18. During an interview on 8/23/18 at 11:30 AM, Manager stated that the clinical consultant might have the records. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to monitor, evaluate and correct problems in the general laboratory systems. The bacteriology, routine chemistry and urinalysis laboratory failed to establish and follow a written policy to assess employees (D5209), verify the accuracy of test performed in urine colony counts, prostate specific antigen (PSA), pathology and cytology at least twice a year. (D5217), document proficiency testing evaluation and verification activities (D5221), and establish and follow a written quality assessment policy (D5291). 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, the bacteriology, routine chemistry and urinalysis laboratory failed to establish and follow a written policy to assess employees. Findings: Review of the bacteriology, routine chemistry and urinalysis laboratory's procedure manual showed that the laboratory failed to have a procedure on training and competency assessments for employees working in the bacteriology, routine chemistry and hematology laboratory. The laboratory also failed to document training and competency assessment on Testing Personnel B. During an interview on 8 /21/18 at 3:50 PM, Manager stated that they did not have a procedure on competency and they did not perform and document annual competency assessments on Testing Personnel B. 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, the laboratory failed to verify the accuracy of test performed in urine colony counts, prostate specific antigen (PSA), pathology and cytology at least twice a year. Findings: 1. Record review of the the American Proficiency Institute (API) event test result showed the following failing score: 2016 Chemistry - Miscellaneous 3rd Event PSA 50% 2017 Chemistry - Miscellaneous 2nd Event PSA 33% 2017 Microbiology 1st Event Urine Colony Count 0% 2017 Microbiology 3rd Event Urine Colony Count 50% There were 3 events per year for Chemistry - Miscellaneous in 2016, Microbiology and 2 events per year for Chemistry - Miscellaneous in 2017.