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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), testing personnel records, patient test report, and staff interview, the laboratory directory failed to ensure testing person number two had the appropriate documentation of education prior to performing moderately complex patient testing in 2021 (1 of 2 testing personnel reviewed). The findings include: 1. Review of the Form CMS-209 revealed moderately complex testing perform by testing personnel number two. 2. Review of testing personnel records revealed no evidence of highest level of education for testing personnel number two. 3. Review of patient accession number 11-052-079 revealed testing personnel number two performed moderate complex patient testing for Complete Blood Count on 03.10.21. 4. Interview on 9.3.21 at approximately 11:30 am, the laboratory director confirmed there was no evidence of highest level of education for testing personnel number two prior to performing moderate complex patient testing. The laboratory director failed to ensure testing personnel number two had the appropriate documentation of education prior to performing moderately complex patient testing. 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 --