Summary:
Summary Statement of Deficiencies D0000 The Choice Cancer Care Lewisville clinical laboratory is not in compliance with the 42 CFR Part 493, Requirements for Laboratories. Biennial certification survey was conducted 07/18/19. Standard level deficiencies were cited as follows: 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 API (American Proficiency Institute) proficiency testing results and interview with the Technical Consultant the laboratory failed to score at least 80% for Red Cell Count for 1 (1st testing event in 2017) out of 7 testing events (1st testing event 2019, 1st, 2nd, 3rd testing event 2018, and 1st, 2nd, 3rd testing event 2017) reviewed. Findings Included: Review of API proficiency testing 1st testing event in 2017 revealed a score of 40% for Red Cell Count. Interview on 07/18/19 at 4:00 PM the Technical Consultant confirmed the failure of Red Cell Count proficiency in the 1st testing event 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 --