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 testing personnel competency verification (CV) documents for 2017 and 2018, confirmed by staff interview, the technical consultant failed to annually evaluate the competency of 4 of 6 testing personnel. Findings: 1. Competency verification documents were reviewed. Forms for testing persons (TP) 1, 2, 3 and 5 (CMS form 209) were signed as follows: For TP 1, form signed 01-31-2017 by TP 2. For TP 2, form signed 01-09-2018 by TP 1. For TP 3, form signed 01-09- 2018 by TP 1. For TP 5, form signed 01-09-2018 by TP 1. 2. Education and training documents were reviewed. It was determined that TP1 and TP 2 did not meet the education and training requirements for technical consultant. 3. In an interview at the site on 01-28-2019, TP 2 stated she had performed the evaluations and signed CV documents for TP 1, 3 and 5, and that TP 1 had signed the CV document for TP 2. She further stated she was unaware regulations precluded delegation of this duty to her or TP 1. 4. Form CMS-209 for the site shows the technical consultant and laboratory director to be one and the same. 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 --