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 the Administrator, the laboratory failed to follow written policies to assess consultant competency for 7 (November 2021 to June 20220 of 7 months the laboratory has been in operation. Findings include: 1. A review of the laboratory's "Competency Assessment" policy revealed a section stating, "Competency assessment will be conducted on all personnel performing patient testing and/or reporting patient results, including but not limited to technical and clinical consultants, technical supervisors, general supervisors and other laboratory staff. Competency shall be based on position responsibilities." 2. The surveyor requested the competency assessment documentation for the Clinical Consultant and the Technical Supervisor on 6/7/22 at 11:22 am and it was not made available. 3. An interview on 6/7/22 at 12:40 pm with the Administrator confirmed the Clinical Consultant and Technical Supervisor competency assessment documentation was not available. 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