Description of Event or Problem · 1
ON 06/22/2016 TOSOH BIOSCIENCE, INC. RECEIVED INFORMATION THAT ON (B)(6) 2016 A PATIENT SPECIMEN WAS DRAWN IN A RED TOP TUBE, SPUN DOWN, POURED OFF INTO ANOTHER TUBE, AND THEN FROZEN. THE FROZEN SPECIMEN WAS THAWED ON (B)(6) 2016 AND TESTED FOR PSA. TWO QCS WERE TESTED WITH THE PATIENT SPECIMEN RUN IMMEDIATELY AFTER THE TWO QCS. THE RESULTS WERE: QC 1 = 0.35 NG/ML (TARGET RANGE 0.25 NG/ML - 0.47 NG/ML). QC 2 = 17.00 NG/ML (TARGET RANGE 13.24 NG/ML - 24.00 NG/ML). PATIENT = 1.86 NG/ML. BOTH QCS WERE WITHIN THE TARGET RANGE AND THERE WERE NO FLAGS OR ERROR CODES ON THE ANALYZER. THE TECHNOLOGIST NOTED THAT THERE WAS NOT ANY PSA IMPRECISION NOTED IN THE DAILY QC AS MONITORED. THE PATIENT WAS SENT TO A SECOND LAB FOR ADDITIONAL TESTING ON THE SAME DAY (B)(6) 2016. THE PATIENT WAS REDRAWN AT THE REFERENCE LAB AND TESTED FOR PSA. THE REFERENCE LAB PSA RESULT WAS 7.36 NG/ML. THE INITIAL RESULT WAS QUESTIONED AND TOSOH BIOSCIENCE, INC. WAS CALLED TO QUESTION WHY THE RESULTS DID NOT CORRELATE. THE TECHNOLOGIST WAS ADVISED THAT FURTHER TROUBLESHOOTING SHOULD BE COMPLETED BY: RUNNING PRECISION USING BOTH LEVELS OF THE QC MATERIAL TO CONFIRM ANALYZER PRECISION. REDRAWING THE PATIENT, SPLITTING THE SPECIMEN AND RUNNING THE SPECIMEN PRIOR TO FREEZING THEN SUBMITTING THE SPLIT SPECIMEN FOR TESTING AT THE REFERENCE LAB TO ELIMINATE ISSUES WITH FREEZING/THAWING THE SPECIMEN. THE TECHNOLOGIST STATED THAT THEY RECEIVE MANY SPECIMENS WITH FIBRIN. THE CURRENT PROCEDURE IS TO ALLOW THE SPECIMEN TO CLOT THEN CENTRIFUGE FOR 10 MINUTES. THEY PREVIOUSLY HAD AN ISSUE AND HAD INCREASED THE CENTRIFUGATION TIME TO 15 MINUTES BUT HAVE RETURNED TO THE 10 MINUTE CENTRIFUGATION FOR AN UNKNOWN REASON. TOSOH BIOSCIENCE, INC. ATTEMPTED TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION BUT ADDITIONAL TROUBLESHOOTING INFORMATION WAS NOT RECEIVED FROM THE CUSTOMER. ROOT CAUSE: SPECIMEN INTEGRITY, FIBRIN INTERFERENCE.