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 personnel records, personnel policy, and staff interview, the laboratory personnel policy did not include assessing technical consultant (TC) competency, as required. The findings include: 1. Review of the laboratory personnel records revealed the following: Delegation of technical consultant (TC) duties by the lab director to one TC. There were no records for documentation of technical consultant competency by the director of the lab for 2021, 2022, and 2023. 2. Review of the laboratory personnel competency policy revealed no requirement for assessment of technical consultant competency. 3. Phone interview with the laboratory lead on 04/25/23 at 8:15 am confirmed the laboratory personnel competency policy did not include a requirement for technical consultant competency be performed by the laboratory director. 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 --