SYNCOR INTERNATIONAL

Description of Event or Problem

NINE (9) PEDIATRIC PTS REC'D A GREATER DOSE OF GALLIUM 67 THAN WAS ORDERED. THIS WAS DISCOVERED IN OR ABOUT 1/1/98. CAUSES INCLUDE: 1. DEFAULT PROCESS OF EQUIPMENT (SOFTWARE). 2. LACK OF UNDERSTANDING BY STAFF OF THE DEFAULT PROCESS. NOTE: FACILITY DOES NOT ANTICIPATE ANY INJURY TO THE PTS, HOWEVER, FELT IF WAS IMPORTANT TO REPORT. FOLLOW UP WHEN THE PROBLEM WAS DISCOVERED INCLUDED: 1. THE INCIDENT WAS REPORTED TO THE STATE DEPT OF NUCLEAR SAFETY. 2. THE PT'S PARENTS AND ATTENDING PHYSICIANS WERE NOTIFIED. 3. SYNCOR INT'L, THE MFR, WAS NOTIFIED AND CONSULTED. NOTE: SYNCOR HAS NOT PROVIDED AN UNDATED OPERATOR'S MANUAL DESPITE IMPLEMENTATION OF SOFTWARE UPDATES AND A REQUEST FOR SAME SUBSEQUENT TO DISCOVERY OF THIS INCIDENT. 4. CORRECTIVE ACTION TAKEN INCLUDED: A) THE DEFAULT PROGRAMMING WAS OVERRIDEN. B) INSERVICE EDUCATION WAS CONDUCTED FOR STAFF. C) A PRACTICUM EXAM WAS DESIGNED TO ENSURE OPERATOR PROFICIENCY. D) THE PROCEDURE WAS MODIFIED TO REQUIRE THAT A PHYSICIAN SIGN FOR APPROVAL OF PEDIATRIC DOSES. 5. EXPERT OPINION WAS REQUESTED AND REC'D FROM A UNIV MED CTR.