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, policy review, and interview with an office staff member, the Laboratory Director (LD) failed to review and evaluate the competency for Testing Personnel #2 (TP2) for 2 of 2 years. Findings include: 1. Record review for the "Quality Assurance Statement and Information" policy stated, "the Laboratory Director will hold bi-yearly staff evaluations for tests performed to assure employee competence." The laboratory had no documentation to show the bi-yearly competency evaluation was completed for TP2 in 2017 and 2018. 2. Interview with an office staff member on 4/16/19 at 11:30 am, the office staff acknowledged bi-yearly competency evaluations for 2017 and 2018 were not available for TP2. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --