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 observation of Eldon test cards and Ortho-Clinical Diagnostics (TM) Surgiscreen reagents for moderate complexity Rh Typing, review of laboratory Rh Typing test records, the lack of laboratory documents, and interview with laboratory personnel, the Technical Consultant is herein cited for deficient practice in performing personnel competency assessments as followup to initial evaluations. Findings included: 1. Laboratory test records for Rh Typing in 2020 documented testing performed by personnel CL and TL. 2. Laboratory personnel affirmed (6/30/21 at 1PM) records documented training and initial evaluations of Rh Typing performance as follows: Testing person Date of training; Next initial evaluation assessment CL 12 /13/19 11/30/20 TL 2/24/20 none 3. On 7/02/21 at 3:55PM, the laboratory provided for review a record documenting 6-month evaluation of CL that was not performed and documented by the Technical Consultant. 4. The laboratory was unable to provide for review records of the Technical Consultant performing and documenting followup competency assessments of the aforementioned individuals at least semiannually; and thus, due to the failure to comply with the requirement of this regulation, the reliability and quality of Rh Typing results could not be assured. 5. The non-assessed testing personnel performed 83 Rh Typing tests in 2020. 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 --