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 surveyor review of the submitted Form CMS-209 (Laboratory Personnel Report) and competence evaluations and interview with the Laboratory Manager (Staff A), the laboratory did not establish and follow written policies and procedures to assess seven of seven employees performing general supervisor responsibilities, five of five employees performing technical consultant or technical supervisor responsibilities, and three of three performing clinical consultant responsibilities. Findings include: 1. Review of the Form CMS-209 submitted for the survey showed seven staff members identified as general supervisors (Staff A, B, C, D, E, F, G) and five as technical consultants or supervisors (Staff B, C, D, E, and H), and three clinical consultants (Staff H, I, and J) other than the laboratory director. 2. Review of competence evaluations showed no evidence the laboratory evaluated the competence of staff in performing their assigned general supervisor, technical supervisor, technical consultant, or clinical consultant responsibilities. 3. Interview with Staff A on February 20, 2024, at 4:00 PM confirmed the laboratory had not established procedures to evaluate employee competence in performing the general supervisor, technical supervisor, technical consultant or clinical consultant responsibilities. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of