University Of Miami Hospital & Clinics

Summary Statement of Deficiencies D0000 A recertification survey was conducted from November 19, 2024 to November 22, 2024. UNIVERSITY OF MIAMI HOSPITAL & CLINICS-CRB clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5805 TEST REPORT CFR(s): 493.1291(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 patient reports review and staff interview, the laboratory failed to include the location the laboratory that performed the cytology interpretation test on 3 out of 3 (Patients #1, #2, and #3) reports reviewed. Findings included: 1- Review of random patient final report pulled 06/01/20023 (#1), 01/08/2024 (#2), and 05/09/2024 (#3) revealed that all three reports failed to list the laboratory that performed the Cytology Professional Component. 2- During phone interview on 11/22/2024 at 1:30 PM the director of Quality Assurance confirmed that the laboratory that performed the Professional component for Cytology was not recorded on the final reports. 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 An initial certification survey conducted at UNIVERSITY OF MIAMI HOSPITAL & CLINICS on 04/24/2023 found the clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor (TS) failed to evaluate the Initial for seven Testing Personnel (TP) and semiannual competency for one TP. Findings included: -Review of policy "EMPLOYEE COMPETENCY EVALUATION POLICY # GEN-03" revealed that on page 2 on topic 7 it stated: "Competency evaluation will be done by the Direct Supervisor/Manager/Director who is licensed as a State of Florida." -Review of the FORM CMS-209 signed by the Laboratory Director (LD) on 04/24/2023 revealed that the LD was also the Clinical Consultant (CC), TS and General Supervisor (GS). Listed also that the laboratory had eight TP (TP#1, TP#2, TP#3, TP#4, TP#5, TP#6, TP#7 and TP#8). -Review of personnel records revealed that TP# 2 had an initial evaluation on 10/26/2022 and a semiannual competency on 04/06/2023. Competency records for TP#3, TP#3, TP#5, TP#6, TP# 7 and TP#8 revealed that they had the initial competency done on 04/06 /2023. Review of all competencies revealed that they were performed by a pathologist that was not listed in the FORM CMS209. During an interview on 04/24/2023 at 11: 30 AM with the quality manager, she confirmed that the TS failed to perform the competencies listed above. 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 --