Summary:
Summary Statement of Deficiencies D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on observation, document review and interview with laboratory personnel, the technical consultant failed to ensure comprehensive competency assessments for 2 of 8 testing personnel were performed annually. Findings are as follows: 1. A Hemocue WBC hematology analyzer was observed as being available for use during a tour of the laboratory on 02/21/20, at 10:05 a.m.. 2. Competency assessment of testing personnel was established in the Procedures for Laboratory Personnel Training and Evaluation, found in the Laboratory Quality Work Plan manual. 3. Competency assessment review did not provide evidence that TP1 and TP2 was evaluated for competency in 2019 for the above test method. 4. The laboratory was unable to provide the missing competency assessments upon request. 5. In an interview on 02/21 /20 at 11:00 a.m., the Technical Consultant confirmed the above finding. 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 --