Summary:
Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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 and interview with the compliance specialist (CS), the laboratory director failed to ensure that testing personnel number 4 (TP#4) had a foreign credential equivalency evaluation to ensure they met CLIA personnel requirements for TP performing high-complexity testing. Findings: 1. The Laboratory Personnel Report (form CMS-209) listed four TP. 2. Credential records for TP#4 were from foreign educational institutions. 3. There was no evaluation of the foreign credentials to determine the equivalency of their education to an education obtained in the United States in order to determine qualification for high-complexity testing. 4. During the survey on 01/22/2024 at 3:15 PM, the CS confirmed that the laboratory did not have a foreign credential equivalency evaluation for TP#4. 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 --