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 review of personnel records and confirmed by laboratory personnel identifiers #2 and #4 (refer to the Laboratory Personnel Report) at approximately 2:00 pm on 07/09/2019, the technical consultant failed to evaluate and document the competency of individuals responsible for moderate complexity testing (Hemocue white blood cell [WBC] testing) at least semiannually during the first year the individual tests patient specimens for nine out of 13 new testing personnel (personnel identifiers #6- #8, #10- #12, #14, #15, and #17) trained in 2017-2019. The findings include: 1. Review of personnel records indicated that training was completed for new testing personnel performing Hemocue WBC testing as follows: *11/2017- personnel identifiers #8, #12, #15, and #17 *12/2017- personnel identifiers #6, #7, #10, and #11 *01/2018- personnel identifier #14 *10/2018- personnel identifier #16 *11/2018- personnel identifiers #5 and #9 *01/2019- personnel identifier #13 2. At the time of the survey, the laboratory did not have documentation of semiannual competency evaluation during the first year of patient testing for personnel identifiers #6- #8, #10- #12, #14, #15, and #17. 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 --