Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Florida Cancer Specialists & Research Institute on 01/28/2020. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are 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 record review of American Proficiency Institute (API) proficiency testing for the specialty of Hematology and interview with the Laboratory Quality Assurance Supervisor, the laboratory failed to score at least 80% for White Blood Cell Differential in 1 (1st testing event of 2019) out of 6 testing events (1st, 2nd, and 3rd testing events in 2018 and 2019) reviewed. Findings Included: Review of API proficiency testing revealed that the laboratory scored a 72% (60% for lymphocytes and 0% for neutrophils) for White Blood Cell Differential in the 1st testing event of 2019. Interview on 01/28/20 at 11:15 AM with the Laboratory Quality Assurance Supervisor confirmed the proficiency testing failure. 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 --