Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urology Associates of West Broward on 7/15/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 with office manager (OM), the form used to perform annual competency assessment was incomplete. Findings include: Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director on 7/15/2019 revealed that the Clinical Consultant, Technical Supervisor, General Supervisor and the Testing Person was the same person. Review of "Performance Evaluation" form, revealed that: -Failed to evaluate the different roles that are listed in the 209 for the same person, Clinical Consultant, Technical Supervisor, General Supervisor and Testing Person. -Failed to identify the method or methods used by the laboratory director to asses and individual's ability to perform laboratory-associated processes and or testing procedures, as well as the other roles. During an interview on 07/15/2019 at 11:00 AM, with the OM, she confirmed that the "Employee Performance Review" form lacked proper competency assessment 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 --