[ RadSafe ] Medical incident (Bill Lipton)

[KARAM, PHILIP]

With regards to reporting incidents - I don't believe anyone suggested simply missing a regulatory requirement. My understanding of what Matt said was to make sure you have a reportable incident before making a report. As you pointed out, the regs call for notifying the regulator *within a day*. Matt said not to call *immediately*. These statements are completely consistent - and they do not suggest that MSKCC is trying to get away with anything.

I am also an advocate of not calling the instant I hear bad news. I want to find out what happened, confirm the initial reports, check regulatory requirements, check in with my boss (and maybe with the chair of the RSC), and see what more I can learn about the circumstances. After all of that - IF there is something that really does need reporting - I can contact the regulators. Not only have I made sure that the report is really necessary, but I can also give a much more complete report than if I were to just call up the moment I hear of something without knowing anything about what happened.

So I agree completely with what Matt said - there is no reason, regulatory or otherwise, to call immediately. But of course you have to call within the period required by regs if you meet the criteria for doing so.

Andy
 

________________________________
 From: Peter Crane <kinderhook46 at yahoo.com>
To: radsafe at health.phys.iit.edu 
Sent: Friday, 6 September 2013, 1:15
Subject: [ RadSafe ] Medical incident (Bill Lipton)
  

This thread began with an incident in Oregon in which, depending on how you look at it, a patient got the wrong pharmaceutical or the right pharmaceutical went to the wrong patient. This was first described by NRC as a reportable event, but a day later, it was classified as non-reportable. I checked with the NRC today and ascertained that the reason that this was determined to be non-reportable was the low dose to the patient from what was a diagnostic procedure. (Kent Lambert surmised rightly that this was the case.) Still, it is a sign of a failure of QA, as Bill Lipton points out, and as such, raises a red flag. A licensee that is sloppy about low-dose diagnostic procedures may be equally sloppy about high-dose therapeutic procedures.

The statement of Matt Williamson of Memorial Sloan-Kettering Cancer Center that he counsels people "NEVER to call the regulator ASAP" sent me to the NRC's regulations. 10 CFR 35.3045 says that such errors as administering the wrong radioactive drug to a patient, or administering a dose to the wrong patient, must be reported to the NRC by the next calendar day. I hope that doesn't mean that Matt has been telling people at MSKCC to disregard the NRC requirement of next-day reporting.  

The point of requiring such prompt reporting is that you get to the regulators and the referring physician quickly and tell them of the event, with the explicit understanding that this is preliminary and that the details will have to be sorted out later. Sometimes this may call for immediate regulatory action, sometimes not. In this case, the fact that the event report was retracted a day later is not a sign that the system failed, but on the contrary, that it worked.    

MSKCC is a world-class facility, probably the place where I would tell any loved one in New York to go for cancer care, but that doesn't mean that it is exempt from the regulations that apply to every other licensee.  

-- Peter Crane, NRC Counsel for Special Projects (retired)    




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