Summary:
Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures and confirmation by the director of operations on 03/16/2022 at 11:30 AM, it was determined that the laboratory director failed to specify in writing, the responsibilities and duties of each consultant as well as each person engaged in the performance of the preanalytic, analytic, and post analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether director review is required prior to reporting patient test results. The findings include: 1. The laboratory Form CMS-209 lists six clinical consultants/testing personnel and one histotech 2. The director of operations stated that the laboratory director and six clinical consultants each rotated through the laboratory based on their individual schedules 3. The laboratory performed 10 histopathology/cytology procedures in 2021 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 --