Summary:
Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 the laboratory's policies and procedures, and interviews with the Practice Manager and Testing Personnel (TP), (as listed on the Laboratory Personnel Report (CLIA) Form CMS-209 signed by the Laboratory Director on 01/08/2018), the Technical Supervisor (TS) failed to evaluate the competency of testing personnel to ensure the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. Findings Include: 1. Review of the laboratory's policy and procedure manual titled "Dermatopathology Laboratory Manual for Mercy Health, 4700 E. Galbraith Road Suite 201, Cincinnati OH 45236, Mohs", approved by the Laboratory Director, on 01/2017 found no mention of competency assessments for Testing Personnel. 2. Review of the laboratory's Form CMS-209 revealed Testing Personnel (TP) certified by the Laboratory Director to perform highly complex laboratory testing. 3. The Practice Manager and TP#1 confirmed no competency assessment for TP#1 was conducted in 2017 as required by a qualified TS. The interviews occurred on 01/11/2018 at 1:38 PM. 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 --