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 of policies and procedures, record review and an interview with the Laboratory Manager (LM), the laboratory failed to follow written policies and procedures to assess the competency of Testing Personnel (TP) based on the responsibilities of their positions. Findings Include: 1. Review of the laboratory's policies and procedures, titled "Laboratory Services-KHN EMPLOYEE REQUIREMENTS" signed and dated by the Lab Director on 5/31/2017, found the following statement: "Competency is assessed after 6 months of employment, annually thereafter, and as needed." 2. Review of initial and 6-month competency assessment documentation revealed no 6-month documentation for TP #4 and TP #8. 3. The LM confirmed the laboratory did not follow the competency assessment policy and procedures and did not assess TP #4 and TP #8 based on the responsibilities of each of the positions and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 11/27/2018 at 2:55 PM. 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 --