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 observation of the laboratory, review of personnel records and interview with testing personnel number one, the laboratory director failed to ensure training documentation for testing personnel number one , prior to patient testing, in 2017. The findings include: 1) Observation of the laboratory on January 25, 2018 at 10:15 a.m. revealed the high complexity testing BioTek ELX-800 instrument in use for enzyme- linked immunosorbent assay (ELISA) anti-nuclear antibody test (ANA) and cyclic citrullinated peptide (anti-CCP)patient testing. 2) Review of the personnel records revealed testing personnel number one hire date 11-2-17 with no training documentation. 3) Interview on January 25, 2018 at 11:15 a.m. with testing personnel number one confirmed there is no training documentation available for review with continued performance of patient testing since November 2017. 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 --