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 on review of the laboratory's personnel competency policy, review of personnel records, and interview with the TC(technical consultant) 1/22/21, the technical consultant failed to evaluate the competency of 1 of 1 TP(testing personnel) for testing performed on the Medonic CBC(complete blood count) analyzer. Findings: The laboratory's Personnel competency policy states under Employee Competency Assessment Plan, "a. Non-waived Testing: The competency of each person to perform each testing platform must be assessed initially, at 6 months, at 12 months, and annually thereafter for non-waived testing by the Technical Consultant or lab Director." Review of personnel records revealed the TP was trained on the Medonic CBC analyzer during the initial installation on 10/22/2018 by Field Service. Review of personnel records revealed there was no semiannual( 6 month)competency evaluation completed for the TP in April 2019 or annual competency evaluation completed for the TP in October 2019 for the Medonic analyzer. During interview at approximately 1pm 1/22/21, the TC confirmed the Medonic CBC analyzer was not added to the TP's assignments in Medialab by the former TC. He confirmed that he evaluated her competency for the Medonic on 10/7/20 during the installation of a new Medonic CBC analyzer. 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 --