Summary:
Summary Statement of Deficiencies 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 review of the laboratory's policies and procedures, review of personnel records, and interview with TS (technical supervisor) #1 on 1/14/25, the laboratory failed to follow written policies for evaluating the competency of personnel. Findings: Review of the laboratory's "General Policies and Procedures" revealed "SECTION 1 - PERSONNEL ... 1.2 Competency Assessment... Documented competency assessments will be performed on all persons that perform patient testing and/or report patient test results. At a minimum, this includes technical and clinical consultants, technical supervisors, general supervisors and testing personnel. The Technical Supervisor/Laboratory Director is responsible for performing and documenting competency assessments. ..." Review of personnel records for TS #1 revealed there were no 2023 technical supervisor, general supervisor, and testing personnel competency evaluations available for review. During interview at approximately 1:15 p.m., TS #1 stated they were unable to locate the 2023 competency evaluations. 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 --