Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UNIVERSITY OF MIAMI HOSPITALS & CLINICS 02/24/2025 to 02/26/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 laboratory records review and staff interview, the laboratory procedure manual failed to define how will perform and frequency of the competency for: Technical Supervisor (TS), Clinical Consultant (CC), General Supervisor (GS) and Technical Consultant (TC). Findings included: -Review of FORM CMS 209 signed by the Laboratory Director (LD) on 02/24/2025 revealed that the LD was CC#1, CC#2 was TS for Hematology specialty, one TC for Chemistry specialty, one GS for Hematology and two Testing Person (TP) (TP#1, and TP#2). -Review of Policy "GEN-07", effective 02/2025 "Policy Area SOP (Fort Lauderdale)", revealed that the policy did not include competency evaluation for CC, TS, TC and GS. -The laboratory provided via email on 02/26/2025 a second Policy with number CP.QA.0015 with Initial Date of 09/27/2022 with Title " Delegation of competency assessment" review of this policy revealed that the policy failed to show evidence that belongs to this laboratory. The Checklist for the TS, CC, TS, TC and GS, listed the position of the policy of reference as "Pathology laboratory" what does not match with the laboratory of reference. The copy provided failed to have signature and date of the LD for this laboratory. During an interview on 02/24/2024 at 1:30 PM, with Laboratory Manager she confirmed that the laboratory procedure manual failed to have a personnel policy 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 -- for competencies for CC, TC, TS and GS. The Laboratory Manager requested time to deliver the missing policy, the policy received via email did not meet the requirements. -- 2 of 2 --