Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on observation of the I-Stat test system used for Blood Gas analyses, review of laboratory documents for personnel [Laboratory Personnel Report (CLIA), 8/06/18], patients test records, and 2017 proficiency testing records; and interview with laboratory personnel, it was determined that the laboratory failed to test samples by personnel routinely testing patient specimen. Findings include: a. Ten out of 13 personnel tested samples in 2017 CAP proficiency testing events. b. For 4 out of 5 patients test records from February to November 2017, the Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) were routinely performed by two personnel who failed to test any proficiency samples in 2017. c. Laboratory personnel affirmed (8/13/18) the aforementioned; and thus, the laboratory had failed to test proficiency samples by personnel routinely testing patients specimen. d. The reliability and quality of Blood Gas results reported by 2 out of 13 testing personnel could not be assured. Based on the stated annual test volume, the laboratory reported 72 Blood Gas results for pediatric patients in 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 --