Summary:
Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1, the Technical Consultant failed to assure personnel performing urine sediment and post vasectomy microscopic examinations maintained their competency with the performance of direct observation of testing for 1 (Testing Personnel #18) of 18 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's competency assessments revealed Testing Personnel #18 did not have documented competency assessments including direct observation of testing for 2019 and 2020. 2. A review of the laboratory's "PPM Competency" policy revealed a section stating, "during each assessment period, unless an element is not applicable to the test system. Elements of competency assessment include but are not limited to: 1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing (Peer-to-peer direct observation)." 3. An interview on 1/5/21 at 12:20 pm with Technical Consultant #1 confirmed the competency assessments for Testing Personnel #18 did not include direct observation. 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 --