Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency assessment policy and interview with the technical consultant (TC), the laboratory failed to follow the approved competency evaluation policy for new testing personnel (TP). FINDINGS: 1. It was noted that the laboratory's competency evaluation policy included the required components for competency assessment including training, six-month evaluation and assessment for the first year of testing, as well as annually thereafter. a. Training, evaluation, and approval were performed and documented for the TP hired April 10, 2022. However, there was no documentation of the required six-month evaluation due February 10, 2023. 2. The TC confirmed on October 5, 2023, at approximately 1:30 P.M. that the laboratory director (LD) failed to perform, document, and approve the required six- month evaluation for the new TP. Refer to D6053. 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 the competency evaluation records and confirmed by interview Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- with the TC, the LD failed to perform, document, and approve the required six-month competency evaluation for the new TP. Refer to D5209. -- 2 of 2 --