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 on review of 11 of 11 testing personnel competency documents for performing Complete Blood Counts (CBC) and upon interview with the lead quality manager, determined the technical consultants failed to ensure documented/signed annual competency evaluations including problem solving of testing personnel for 2017- 2018. The findings include: 1. There were no competency evaluations with problem solving documented/signed for 11 of 11 testing personnel in 2017-2018 for performance of CBC testing. 2. Upon interview with the lead quality manager at approximately 9:30am. on March 5, 2019, confirmed the Technical Consultants failed to document/sign competency assessments including problem solving for 11 of 11 testing persons in 2017-2018 for CBC testing. 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 --