Description of Event or Problem · 1
MFR WAS NOTIFIED BY ONE CLIENT THAT THE MFR'S BLOOD BANK SOFTWARE FAILED TO GENERATE AN EXPECTED WARNING MESSAGE AT THE TIME A DONOR UNIT WAS BEING REVIEWED FOR FINAL LABELING. THE MALFUNCTION MANIFESTED ITSELF ONLY UNDER CERTAIN CIRCUMSTANCES RELATED TO PAGING UP AND DOWN THROUGH COMPUTER SCREENS WHICH DISPLAYED THE RESULTS OF DONOR UNIT TESTING. IN ALL CASES, THE SOFTWARE DISPLAYS ONLY ONE UNIT AT A TIME ON THE SCREEN FOR REVIEW. RESULTS ARE DISPLAYED AND THE SYSTEM FLAGS ANY "UNACCEPTABLE" RESULT (E.G., HEPATITIS POSITIVE). IF THE USER WERE TO ATTEMPT TO ACCEPT THE UNAVAILABLE UNIT INTO ACTIVE INVENTORY, THE SYSTEM WOULD, UNDER NORMAL CONDITIONS, GENERATE A WARNING MESSAGE WHICH REQUIRES THE USER TO ENTER A PASSWORD TO OVERRIDE. SECURITY LEVELS FOR PASSWORD OVERRIDE ARE UNDER CLIENT CONTROL AND SYSTEM ADMINSTRATORS ARE ADVISED TO CAREFULLY EVALUATE WHICH EMPLOYEES ARE ASSIGNED OVERRIDE CAPABILITY. IN THE CASE OF THIS MALFUNCTION, THE FLAG AND WARNING MESSAGE WERE NOT GENERATED. HOWEVER, THE USER WAS AWARE OF THE SYSTEM MALFUNCTION IN THAT AN ERROR MESSAGE WAS DISPLAYED (PROGRAM: BB8F2; MESSAGE: INDEFINED VARIABLE). THERE WERE ADD'L SAFEGUARDS IN PLACE TO PREVENT DONOR UNITS UNACCEPTABLE TESTING RESULTS FROM REACHING INVENTORY. THAT IS, AS THE TEST RESULT IS ENTERED INTO THE SYSTEM, USER-DEFINABLE MAINTENANCE WOULD ALLOW FOR AUTOMATICALLY PLACING THE UNIT IN QUARANTINE STATUS. ONCE IN QUARANTINE, A UNIT MUST BE DEALT WITH VIA ANOTHER PASSWORD PROTECTED FUNCTION TO DETERMINE ITS FINAL DISPOSITION (E.G.,DISCARD). NO INJURIES OR DEATH OCCURRED AS A RESULT OF THE PROBLEM. ONE PROGRAM WAS MODIFIED TO CORRECT THE DEFECT. MFR NOTIFIED ALL AFFECTED CLIENTS. SOFTWARE CORRECTION WAS DESIGNED, DEVELOPED, TESTED AND DISTRIBUTED PER MFR'S STANDARD OPERATING PROCEDURES AND DISTRIBUTED TO CLIENTS IN A TEST ENVIRONMENT. CLIENTS WERE PROVIDED WITH TESTING GUIDELINES AND REQUIRED TO VALIDATE THE SYSTEM PRIOR TO INSTALLATION OF THE SOFTWARE IN THE LIVE ENVIRONMENT.