Uf Health Oncology-Baymeadows

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, UF Health Oncology Baymeadows was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and staff interview, the laboratory had 1 out of 3 testing events in 2018 that had an analyte that received less than 80% in the specialty of Hematology. The findings include: Review of API proficiency testing results found the 2nd testing event in 2018 had a 60% for White Blood Cell Differential. During an interview on 8/30/19 at 10: 20am, the Technical Consultant confirmed the proficiency testing failure stating it was caused by the instrument being in the wrong mode during 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 --

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 record review and staff interview, the laboratory failed to test hematology proficiency testing samples the same number of times that it tests patient samples for one proficiency testing event in 2017. The findings include: A record review of 2018 American Proficiency Institute (API) proficiency testing was done on June 6, 2018. The documentation showed testing of the five proficiency samples was performed twice on March 27th, 2017. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Red cell distribution width (RDW), Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils. CTR-01: 3/27/17 at 10:19 and 10:20 CTR-02: 3/27/17 at 10:22 and 10:23 CTR-03: 3/27/17 at 10:24 and 10:26 CTR-04: 3/27/17 at 10:28 and 10:29 CTR-05: 3/27/17 at 10:30 and 10:33 Interview with the technical consultant on 6 /6/18 at 9:27am confirmed hematology proficiency testing had been performed in duplicate against laboratory policy. 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 --