Weigh the Risks & Benefits: FDA & CMS Look to Your Hospital to Manage Radiation Dosages

When your entire way of doing something changes, adjusting takes time – especially when that “something” is 41 pages of detailed changes to the already unwieldy hospital Conditions of Participation (CoPs). These extra changes to radiology and nuclear medicine have many hospitals confused, particularly when added on to the U.S. Food and Drug Administration (FDA) crackdown on appropriate radiation usage. If your hospital is one of those confused, you’re not alone, and you’ll need to know how to comply with the changes.

With more than 30 years of hospital compliance experience, Sue Dill Calloway has several tips and tricks for you to navigate the FDA regulations and new CoPs. In her presentation, “CMS Hospital Conditions of Participation for Radiology and Nuclear Medicine,” Calloway gives you the tools and knowledge to implement updated required safety precautions. Equipped with this information, your hospital will confidently demonstrate compliance whenever the surveyors show up.

3 Radiation Procedures Under Scrutiny

Pay Attention: Radiation and nuclear science are two areas under special scrutiny from the Centers for Medicare & Medicaid Services (CMS) and the FDA because of the significant associated health risks. The three main procedures in focus are:


Problems: With each of these procedures, patients face repeated or extended exposure to the radiation. For example, a CT scan of the head equals roughly only 2.4 days of radiation you’re exposed to naturally, but a scan of the abdomen equals roughly 2.7 years of natural background radiation, according to a recent report by Medical News Today. This amount of radiation can lead to higher health complications for the patients.

That’s why, although these procedures made up only around 26 percent of the imaging procedures using radiation in the United States in 2009, that same year they also contributed 89 percent of the total radiation exposure from medical imaging, according to a 2009 study published in Health Physics. The stricter rules implemented since then are aimed at protecting patients’ health, although they do mean more rules for you to follow.

In Sum:  CMS and the FDA recognize that these procedures are of great medical benefit, which is why they haven’t banned the practices altogether. Instead, the government bodies believe that more oversight and stricter guidelines will ensure these procedures will only be performed when the benefits clearly outweigh the risks.

CDS Software Implementation Delayed

The FDA’s crackdown on unnecessary radiation exposure from medical imaging began in 2010, when the FDA’s Center for Devices and Radiological Health (CDRH) launched its radiation exposure initiative, which has the following as its two main goals:

  • Justification: Providers should perform imaging procedures only to answer medical questions, treat diseases, or guide procedures, and only when the benefits outweigh the risks to the patient. Clinicians should consider the patient’s dose history and clinical indication before ordering imaging examinations.
  • Dose optimization: The dose used should be “As Low as Reasonably Achievable,” meaning that it should be not too high or too low, but just enough to provide the image required. The dose should take into consideration the patient’s size, the areas scanned, and the clinical indication.


Get Ready: With that in mind, what’s new for 2018? Essentially, you’ll have to prepare for the clinical decision support (CDS) software documentation initiative. Originally scheduled to take effect in January 2018, the deadline is now pushed to Jan. 1, 2020. This software, which must be approved by CMS, is required for physicians ordering CAT scans, medical resonance imaging (MRIs), and nuclear imaging scans. CMS will automatically deny any orders without appropriate use criteria (AUC) software consultation.

Don’t Delay: Although a year and a half may seem like plenty of time to comply, that actually is the perfect amount of time to pick a system and begin implementing it so you can have all the kinks worked out by the final deadline. Your patients’ health depends on responsible radiation usage, so the faster you take action, the better for everyone.

Implement Patient Protection Measures

CMS and the FDA have always been serious about patient safety, but when it comes to radiology and nuclear medicine they’ve taken several swift measures for you to remain compliant, says Calloway. One way to do so is through training: adopting new information is difficult, especially when there’s so much of it. Training your staff on AUC software and imaging technology quickly will better ensure patient’s long-term safety in terms of radiation exposure.

To join the conference or see a replay, order a DVD or transcript, or read more

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

error: Content is protected !!