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 a review of laboratory competency procedures and an interview with the laboratory testing person, the laboratory failed to follow their written policies and procedures to assess the competency of the laboratory testing personnel semi-annual and annual for the first year of patient testing. Findings Include: It was confirmed by the laboratory testing person on August 14, 2018, at approximately 11:45 am, that the director acting as the technical consultant failed to have documentation of semi- annual and annual competency for the testing person since testing began for toxicology in December 2016. 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