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 competency procedure, competencies and interview with technical consultant the laboratory failed to follow competency procedure for two of two testing personnel in 2017. Findings: 1. Review of competency procedure states "Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patient samples. Thereafter, competency assessment must be performed at least annually." 2. Review of 2017 competencies showed testing personnel #1 did not have an annual competency completed and testing personnel #2 did not have a semiannual competency completed in the first year of testing. 3. Interview with the technical consultant on November 20, 2018 at 12:20 PM confirmed the laboratory failed to follow competency procedure. 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 --