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 record review of personnel competency documentation and interview with the general supervisor (GS), the laboratory failed to establish and follow written policies and procedures to assess competency testing for one of one technical supervisors (TS) and one of one general supervisors (GS), since the laboratory began testing patient samples in 2022. Findings: 1. Review of 2022, 2023, and 2024 personnel competency documentation revealed the laboratory failed establish and follow written policies and procedures to assess competency for the positions of TS and GS for 2022, 2023, and 2024. 2. Interview with the GS on February 15, 2024, at 10:25 AM confirmed the laboratory failed to document competency for one of one TS and one of one GS for 2022, 2023, and 2024. 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 --