Description of Event or Problem · 1
WHILE REVIEWING A LYMPHOCYTE SUBSET TEST RESULT, A LAB TECHNOLOGIST FOUND THAT THE CD3% RESULT HAD BEEN FALSELY REPORTED AS 93%. THE RESULT WAS GENERATED BY FDA-APPROVED SOFTWARE DESIGNED FOR USE WITH THE BD MULTITEST LYMPHOCYTE SUBSET REAGENT, WITH DATA ACQUIRED ON A FACSCANTO FLOW CYTOMETER FROM BECTON DICKINSON. AFTER ADJUSTING THE MARKERS ON THE PLOTS, THE CORRECT CD3% RESULT IS 0.66%. WHILE FURTHER REVIEWING PRIOR RESULTS FROM THIS PATIENT, THE LAB TECHNOLOGIST FOUND THAT THE CD3% RESULT ON AN EARLIER SAMPLE SHOWED THE SAME CD3 ERROR AS THE FIRST RESULT, AND HAD BEEN ANALYZED USING THE SAME SOFTWARE. UNFORTUNATELY, THE TECH WHO HAD VERIFIED THE RESULTS DID NOT CATCH THE SOFTWARE ERROR AND REPORTED THE FALSE HIGH CD3%.AFTER THE CLINICAL TEAM GOT THE WRONG RESULT, THEY BELIEVED THE PATIENT HAD UNWANTED CIRCULATING T CELLS, RAISING CONCERN FOR GRAFT-VS-HOST DISEASE (GVHD), AND GAVE HIM FOUR DOSES OF METHYLPREDNISOLONE OVER THE NEXT FOUR DAYS. THIS MEDICATION WAS INTENDED TO MINIMIZE THE RISK OF GRAFT REJECTION.THE LAB NOTIFIED A MEMBER OF THE CLINICAL TEAM THAT THE CD3% TEST RESULT WAS WRONG, AND REPORTED THE CORRECT RESULT OF 0.66%. THE PATIENT'S ATTENDING PHYSICIAN WAS ASKED IF THERE HAD BEEN ANY SERIOUS PATIENT INJURY. IT WAS CONFIRMED THE METHYLPREDNISOLONE TREATMENT THAT COULD HAVE BEEN AVOIDED, AND REPLIED THAT THERE HAD NOT BEEN ANY EVIDENCE OF SERIOUS PATIENT INJURY DUE TO THIS ERROR.