Teaching Responsible Conduct of Research (RCR): A Resource Guide for Professional Science Master’s Degree Programs Case Studies from Medical Physics Case: CT Scanner Patient Overdose Incident Discipline: Medical Physics Title: CT Scanner Patient Overdose Incident Author: Steven Goetsch, Ph.D. Edited by: Usha Sinha, Ph.D. A major highly respected California medical center begins to receive complaints from patients scanned in their radiology department of unexpected hair loss. Investigation reveals that all patients received a CT scan for suspected stroke. The hospital physicist reproduces the scan conditions and discovers that the patients were exposed to eight times the dose considered acceptable, and enough to cause epilation. Within days a newspaper publishes a story about it and soon 260 patients were confirmed to have been over-exposed. The hospital had wanted to avoid a press release and keep everything “low key” but now the story is out. Administration and hospital attorneys drafted a carefully worded letter to be sent to patients suggesting there might be a problem and they should contact their referring physician “who would know best.”. The referring physicians, mostly neurologists, have no expert knowledge about CT scans and are enraged to be blamed for the situation and being asked by the hospital to deal with scared, angry patients. The medical physicist also determines that these incidents occurred after a new protocol was introduced. The specific protocol was requested by a new radiologist with the vendor technical support engineer and the CT technologist involved in actual implementation. The medical physicist knew of the introduction of the new protocol and quickly skimmed through the settings, but at the time did not perform any tests to make sure that dose was in acceptable range. Mr. T was then a new intern physicist from a local academic institution training in CT. Mr T was zealous about his new position and took the responsibility of the physicist seriously. He noticed that no physicist check was performed and enquired of the lead medical physicist. Mr. T’s suggestions were swept aside: the chief physicist claimed that the vendor support engineer was experienced, knew how to set protocols, and that the new radiologist was very particular about having the protocol set that way. Page 1 Teaching Responsible Conduct of Research (RCR): A Resource Guide for Professional Science Master’s Degree Programs Mr. T was intimidated by the chief physicist and does not pursue it any further even when he notices that very thin slices are being acquired, which would mean high doses. Other hospitals in other parts of the country later report scattered similar instances and more than one CT scanner manufacturer is involved. Plaintiff lawyers soon appear and sign up clients for a class action lawsuit against the very wealthy hospital. The State of California Radiologic Health Branch begins an investigation with local experts from major academic medical centers to find the cause, but cannot cite any violation of state laws or even guidelines. Within months a major new piece of radiation regulation is passed by the California legislature and signed into law by the governor. Teaching Questions: 1. What went wrong? Was the manufacturer to blame? Should the radiation technologist have “known better”? 2. Was the hospital medical physicist to blame? Should he or she have done QA measurements that would have revealed this situation? 3. As the intern, did Mr. T have any other option after the chief medical physicist brushed away his suggestions? Could he have conducted the QA tests himself without the medical physicists explicit permission? 4. Should Mr. T have been more alert to the ‘thin slice’ situation and performed the dose calculations to confirm if they met regulations or not? Or alerted someone in the organization? 5. Who should the intern have approached after he got nowhere with the chief medical physicist? What is the chain of command in a hospital setting that the intern has recourse to: e,g, the Chief Technologist, the radiologist who was using the protocol, the Radiation Safety Officer? 6. Should the intern have consulted with the faculty at his/her academic institution? 7. How should the hospital have handled this situation? Is “stonewalling” a good idea? Is it best to “contain” the situation or be bluntly honest? Page 2 Teaching Responsible Conduct of Research (RCR): A Resource Guide for Professional Science Master’s Degree Programs 8. Should the manufacturer have explicitly warned the hospital that their CT scanner was powerful enough to deliver a dose comparable to a cancer therapy dose just from a diagnostic study? Were the radiation technologists to blame for not knowing the consequences of such prolonged scans? Were the radiologists to blame for forgetting their radiation biology training and demanding many consecutive high dose scans? 9. Why is there never enough time to do it right but always enough time to do it over? Page 3