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 and interview with the compliance manager, the laboratory failed to have a written procedure to assess the competency for 1 of 1 technical consultant, 1 of 1 technical supervisor and 1 of 1 general supervisor since 10/08/2021. The laboratory performs approximately 1,000 tests annually. Findings include: 1. Record review of the laboratory procedures on 5/2/2023 at approximately 3:00 PM, revealed the laboratory failed to have a policy or procedure to assess the competency of the position of technical consultant, technical supervisor and general supervisor since 10/08/2021. 2. An interview with the compliance manager on 5/2/2023 at approximately 3:00 PM, confirmed the laboratory failed to have a policy or procedure to assess the competency for the position of technical consultant, technical supervisor and general supervisor. 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 --