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 competency records and interview with the General Supervisor (GS)/Technical Supervisor (TS) the laboratory failed to perform annual competency for the GS/TS. Findings include: 1. The laboratory had one individual identified as the GS and the TS. 2. Review of competency records for 2021 and 2022 revealed there were no competency assessment performed for the GS and the TS. 3. Interview with the GS/TS on 12/14/2022 @ 10:20 AM confirmed these findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) results and interview with the Technical Supervisor (TS) the laboratory failed to follow the PT