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 laboratory policy, testing personnel competency assessment records, and interview with facility personnel the laboratory failed to follow established procedures for the competency assessment of 3 of 6 personnel performing non-waived testing. The findings included: 1. Based on review of the laboratory's policy "Personnel Training and Competency", approved by the Laboratory Director on 6/3/2016, the procedures states: "*Each employee will be given an evaluation for competency after training, at six months from initial competency and annually thereafter. * Employees should not have performed unsupervised laboratory testing without documentation of competency. *The Laboratory Director or Technical Consultant will assess the competency of each individual to fulfill the duties and responsibilities of their position using the Laboratory Competency Assessment form and supporting documentation. * Competency evaluations will have included the pre- analytical, analytical, and post-analytical phases of testing. the evaluation procedures for moderately complex testing must include: Direct observation of patient testing performance, including patient preparation and specimen handling, processing, and testing. Monitoring the recording and reporting of test results. Review of worksheets, quality control records, proficiency testing results, and preventative maintenance sheets. Direct observation of performance of instrument maintenance and function checks. Evaluating test performance by offering previously analyzed specimens, proficiency testing samples or internal blind testing. Evaluation of problem solving skills." 2. Based on the review of personnel competency assessments: The competency documentation for Testing Person 6 indicated evaluations were Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- performed on 8/21/2015, 2/23/2016, 8/23/2016, 8/23/2017, and 8/24/2018. The competency assessments include the Assessment of test performance (PT/blind samples) for 8/21/2015, 6/27/2016, and 8/30/2016. The competency assessment documentation does not include: Direct observation of patient testing performance, including patient preparation and specimen handling, processing, and testing. Monitoring the recording and reporting of test results. Review of worksheets, quality control records, proficiency testing results, and preventative maintenance sheets. Direct observation of performance of instrument maintenance and function checks; or Evaluation of problem solving skills. The competency documentation for Testing Person 5 indicated evaluations were performed on 5/1/2015, 1/25/2016, 5/3/2016, 8/23 /2017, and 8/24/2018. The competency assessments include the Assessment of test performance (PT/blind samples) for 5/1/2015, and 8/30/2016. The competency assessment documentation does not include: Direct observation of patient testing performance, including patient preparation and specimen handling, processing, and testing. Monitoring the recording and reporting of test results. Review of worksheets, quality control records, proficiency testing results, and preventative maintenance sheets. Direct observation of performance of instrument maintenance and function checks; or Evaluation of problem solving skills. The competency documentation for Testing Person 3 indicated evaluations were performed on 3/27/2017, 10/06/2017, and 3/26/2018. The competency assessments include the Assessment of test performance (PT/blind samples) for 3/27/2017, 11/27/2017, and 7/11/2018. The competency assessment documentation does not include: Direct observation of patient testing performance, including patient preparation and specimen handling, processing, and testing. Monitoring the recording and reporting of test results. Review of worksheets, quality control records, proficiency testing results, and preventative maintenance sheets. Direct observation of performance of instrument maintenance and function checks; or Evaluation of problem solving skills. 3. In an interview at 09:32 hours on 11 /07/2018, the Technical Consultant stated the individuals performing moderate complex microscopic procedures rotated through proficiency testing but no other documentation of competency had been completed. -- 2 of 2 --