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 Testing Personnel (TP) # A, the laboratory failed to perform the annual competency assessment on 2 out of 2 testing personnel since at least 2017. Findings include: Review of employee documentation found no competency evaluations on testing person #A and #B for the years 2017 to 2018. During an interview on 10/31/2018 at 10:30 AM, with the TP#A, she confirmed that there were no competencies performed on the employees listed above for the years of reference. 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