Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based upon review of competency documents and interview with the TC (Technical Consultant) on 11/3/23, the TC failed to assess the competency of 1 of 13 TP (Testing Personnel) performing non waived testing in the years of 2020, 2021, 2022 and 2023. Findings: Review of competency documents revealed the absence of a competency assessment of TP #10 in the years of 2020, 2021, 2022 and 2023 for use of the Medonic Hematology instrument. No competency assessments have been performed on TP #10 since August 2019. During interview with the TC at approximately 10:25 a. m., the TC confirmed that TP #10 utilizes the Medonic Hematology analyzer to perform patient testing. Also, the TC confirmed the absence of competency assessments for TP #10 and stated the oversight was due to the laboratory's document management software not generating alerts for TP #10. 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 --