Summary:
Summary Statement of Deficiencies D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2017 and staff interview, the laboratory failed to successfully attain a score of at least 80 percent in two consecutive testing events for the analyte Lymphocytes (%) using the Abbott Cell-Dyn Emerald analyzer. Findings: 1. The API Performance Summary for hematology covering 2017 (3 events) was reviewed. Scores for Lymphocytes showed the following unsatisfactory results: Event Analyte Score 2017 2nd Lymphocytes % 60 % 2017 3rd Lymphocytes % 60 % 2. Two consecutive unsatisfactory scores in the same analyte resulted in a long-term unsuccessful grade in the analyte. 3. In an interview at the site on 01-25-2019, the laboratory director acknowledged the scores and stated that the analyzer was removed from service in January 2018. 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 --