Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based upon review of competency documentation and interviews with the TC (Technical Consultant) on 11/2/23 and 11/8/23, the TC failed to assess the competency of 1 of 8 TP (Testing Personnel) performing non waived testing in the laboratory. Findings: Review of competency documents revealed the absence of any competency assessment of TP #8 for use of the BD Affirm analyzer. Competency assessments completed for TP #8 included only waived test systems. In interview at approximately 9:45 a.m. on 11/2/23, the TC confirmed the absence of any documentation to assess the competency of TP #8 utilizing the BD Affirm analyzer. The TC also stated that TP #8 only performs waived testing. In email on 11/8/23 at approximately 2:02 p.m., the TC confirmed that TP #8 has been performing patient testing utilizing the BD Affirm analyzer at this facility. 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 --