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 an interview, the laboratory failed to establish written policies and procedures to assess employee competency as specified in the personnel requirements in subpart M. Findings Include: 1. Review of the laboratory's "Personnel Competency Assessment Policy"' on 12/10/18 at 1:01 pm, found the following: "All testing personnel must have a competency assessment semi-annually for the first year and annually thereafter. This assessment must include the six necessary points for evaluation. These six points are: 1. Direct observation of routine patient testing 2. Monitoring of reporting patient results 3. Review of immediate test records 4. Direct observation of instrument maintenance 5. Evaluation of problem-solving skills" 2. The laboratory's competency assessment policy and procedure failed to include the following requirements as specified in subpart M: Under CFR 493.1451 (b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 3. An interview with the Clinical Consultant,on 12/10/18 at 2:52 pm, confirmed that the competency assessment policy and procedure did not contain evaluation of proficiency testing results as specified in the personnel requirements in subpart M. 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 --