Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Through a review of personnel records, lack of documentation, and interviews with staff, it was determined the laboratory director failed to ensure one of three testing personnel received appropriate training prior to testing patient specimens. Survey findings follow: A. The surveyor reviewed personnel records for three laboratory employees (#2, #3, and #5 as listed on the form CMS-209). There was no documentation that laboratory employee #5 had received appropriate training or demonstrated that they could perform all testing operations reliably prior to testing patient specimens. B. The personnel records for laboratory employee #5 included an authorization to test dated 6/10/2019. C. A review of patient test results revealed that employee #5 performed testing 8 days in June 2019, 15 days in July 2019, 16 days in August 2019 and 4 days in September 2019 prior to the competency documentation date 9/10/2019. D. In an interview at 1:15 p.m. on 1/7/2020, laboratory employee #4 confirmed there was no documentation of on-site training for employee #5 prior to testing patients. 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 --