Summary:
Summary Statement of Deficiencies 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 the third quarter (Q3-2017) of the American Association of Bioanalysts (AAB) proficiency testing records, random patient samplings test results and interview with the technical consultant, it was determined that; the laboratory failed to attain a score of at least 80 percent of acceptable responses for Erythrocytes (RBC) and Hematocrit (HCT) analytes. The findings included: a. Q3-2017, AAB reported an unsatisfactory proficiency testing scores of 40% for RBC, and 60% for HCT analytes. b. For two (2) out of eight (8) random patient sampling test results reviewed covering period from 11/20/2017 to 2/14/2019, two (2) patients test results cannot be assured. c. The technical consultant confirmed (8/16/2019, 1400) that the laboratory received the above unsatisfactory proficiency testing scores. 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 --