Summary:
Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of laboratory employee competency records and an interview with Technical Consultant 1 (TC1), the laboratory failed to evaluate and document the competency of testing personnel at least semiannually during the first year the individual tests patient specimens. Findings: 1. A review of employee competency files for TP4, identified an initial training on 8/15/17. A 6 month employee competency was documented on 2/14/18. The first year of patient testing for TP4 was from the completion of initial training (8/15/17) thru 08/18. No documentation of an annual competency for August of 2018 could be located. The next competency documented as performed on TP4 is an annual competency dated 1/2/19. 2. An interview with TC1, on 10/2/19 at approximately 9:43 AM, confirmed that during the first year of TP4 testing patient specimens only a 6 month competency was performed and documented. 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 --