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: Based on review of personnel records, number of patients tests resulted by newly hire testing personnel (TP) the past 30 days (August 24, 2019 to September 23, 2019) and interview with the Technical Supervisor, the laboratory director failed to document initial training for 6 out of 67 testing persons from February 4, 2019 through September 19, 2019. The findings include: 1. Review of personnel records revealed testing persons # 23, 50, 53, 55, 58, 65 listed on the laboratory personnel report did not have documented initial training prior to resulting patients from February 4th, 2019 through September 19th, 2019. 2. Review of the number of patient tests resulted by newly hired testing personnel (TP) for the past 30 days (August 24th, 2019 to September 23rd, 2019) revealed the following: TP #23 resulted 385 patient tests TP #50 resulted 415 patient tests TP #53 resulted 4796 patient tests TP #55 resulted 4535 patient tests TP #58 resulted 910 patient tests TP #65 resulted 1441 patient tests 3. Interview with the Technical Supervisor on September 19, 2019 at 2:30 p.m. confirmed testing persons # 23, 50, 53, 55, 58, 65 listed on the laboratory personnel report did not have documented initial training prior to resulting patients from February 4th, 2019 through September 19th, 2019. 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 --