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 current, approved standard operating procedures (SOPs), lack of personnel competency evaluation records, as well as interview with the testing person (TP), the Laboratory Director (LD) failed to perform and document clinical consultant (CC) competency evaluations. FINDINGS: 1. There was no documentation of CC competency performance or evaluation. 2. This is contrary to instructions indicated in the current, approved "Laboratory Personnel Policies" SOP. 3. The TP confirmed the findings on March 7, 2024, at 12:30 P.M. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) summary reports and interview with the TP, the laboratory failed to perform and document