Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing and interview with testing personnel on 6/27 /2019 at 11:35 AM the laboratory failed to test proficiency testing samples the same number of times it routinely tested patient samples. Findings are: 1. Review of proficiency testing for 2018 and 2019 revealed the laboratory tested samples in duplicate for the all three events in 2018 and the first event 2019 for all the hematology analytes. 2. Interview with testing personnel confirmed the hematology proficiency testing samples had been run in duplicate and patients were routinely run only one time. Staff indicated patient tests are only run in duplicate if there are flags indicating a rerun is needed. 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 --