Questions for Drs. Applegate, Brent, & Sutlief Q: In your experience, what is the single most important issue in radiation therapy (safety) today? Sutlief: Geometric misses at the time of patient setup during treatment is the most common problem. This can arise because a wrong patient’s plan is used, a wrong version of the correct patient’s plan is used, setup instructions are incorrect or setup instructions are applied incorrectly, among other reasons. Q: Is there a coordination of safety efforts between all the medical societies using x-ray imaging, such as radiologists, cardiologists, pain management, surgeons, etc.? Applegate: While there is no single coordinated safety effort across medical societies for imaging, there are several that bridge multiple societies. In addition to the three I mentioned in the talk, there are payers and credentialing groups that require different metrics for safety: The Joint Commission (TJC), American College of Radiology, and Intersocietal Accreditation Commission are all deemed bodies for imaging. In addition, the National Quality Forum is a nonprofit, multi-stakeholder group that payers and Centers for Medicare and Medicaid Services have asked to develop safety metrics that include radiation safety. I think in the future, TJC will increasingly play a big role. Q: Can you recommend any guidance/websites that compare the balance of the need for diagnostics/ intervention versus risk? Applegate: Certainly. I think from the radiation protection point of view, this is justification (balancing the radiation risk versus the clinical benefit). The International Commission on Radiological Protection, NCRP, and the International Atomic Energy Agency’s Radiation Protection of Patients websites should suffice. For the clinical risk versus benefit discussions about evidence for medical interventions, I would suggest the American College of Radiology Appropriateness Criteria as well as the U.S. 0017-9078/15/0 Copyright © 2014 Health Physics Society DOI: 10.1097/HP.0000000000000244

Preventive Task Force ratings. There is also a National Guidelines Clearing House site for medical guidelines that the Agency for Healthcare Research and Quality hosts (http://www.guideline.gov/search/search.aspx?term=usptf). Q: Could you both address the desire expressed by Dr. Sutlief for less regulation with the concerns expressed by Dr. Applegate on safety culture and lack of knowledge about radiation protection? Sutlief: See my answer to the next question. Applegate: See answer to the next question as well. Q: Combining the concerns Kimberly (Applegate) discussed on safety culture and radiation protection, how do you justify the desire for less regulation? Sutlief: The safety issues encountered in radiology, radiation oncology, and nuclear medicine are inherent in the practice of medicine and not unique to the use of ionizing radiation. The section on "Misadministration Reporting Requirements" was added to 10 CFR Part 35 in 1980. Since that time, many of the concerns for patient safety and patient notification have become a part of standard medical practice such as expressed by The Joint Commission and other entities. While affirming the need for regulatory controls over the transport, storage, and security of radioactive materials for medical use, we recommend that evaluation of correct medical use be handled by only those entities responsible for medical oversight in general. Applegate: I agree with the answer above. The key to creating a strong safety culture is to provide the tools, training, and quality assurance within any system to the people performing the processes. What regulators can and should do is to provide (1) guidance on how to do quality assurance and (2) information about best practices. There is obviously a need for both external oversight and internal professional quality and safety programs. The more that is “owned” by the professionals, the better. Q: Given the spate of recent accidents that have occurred in radiation oncology practices, would radiation oncology benefit from a similar checklist approach as proposed in radiology? Sutlief: Particular care is needed to ensure that the correct plan matches the patient on the treatment table. To ensure a correct match, it is important to use a “time out”



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procedure similar to what is used in surgeries, which is essentially a checklist. The wider use of checklists in radiation therapy has also been endorsed in an American Society for Radiation Oncology white paper (“QA: Quality and Safety Considerations in Intensity Modulated Radiation Therapy,” https://www.astro.org/Clinical-Practice/White-Papers/IMRT. aspx) and by American Association of Physicists in Medicine Task Group No. 230 on checklists, whose report has gone out for pre-publication review.

February 2015, Volume 108, Number 2

Applegate: I am a firm believer in reminders, and checklists are just that. Books that talk about checklists by Malcolm Gladwell and by Atul Gawande may be of interest. At the end of the day, do YOU want the most brilliant pilot to fly your plane or do you want the competent pilot who follows the checklist?


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Radiation protection in medicine (program area committee 4) session Q&A.

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