Congress: Protect patients and enact the Nuclear Medicine Clarification Act

If a preventable error that might cause harm occurs during medical care, should there be transparency, or should the incident be swept under the rug? A rule proposed by the U.S. Nuclear Regulatory Commission (NRC) leans toward the latter.

We believe that transparency is best: patients need it so they know what happens to them during their care; clinicians need it so they can mitigate harm and prevent future errors. But some federal regulators, and those exerting influence on them, seem to prioritize protecting providers from embarrassment and liability.

At issue is a proposed rule by the NRC regarding when clinicians need to report cases of patients who are unintentionally exposed to high levels of radiation due to misadministered radioactive drugs, which are often used to help detect and treat diseases. These faulty injections, called extravasations, deposit radioactivity at the injection site rather than into the bloodstream as intended. Extravasations can harm healthy tissue and can compromise the imaging used to guide care.

Currently, all extravasations — no matter how serious — are exempt from NRC’s medical event reporting requirements. This loophole means that not only is the NRC never told about these errors, but they can also be kept from the patient. The commission’s proposed rule to address this loophole is extraordinarily weak. Rather than a simple, objective reporting criterion based on the severity of the episode, it requires patients to prove they were injured by an extravasation before reporting could occur. This subjective standard would place enormous burden on patients, who may not recognize the symptoms of an extravasation and chalk them up to something else, rather than on clinicians, who should have the tools and training to perform these procedures properly.

This rule is the product of a bureaucracy captured by the industry it regulates and is designed to preserve the status quo. That’s not just our opinion. The NRC’s own Office of the Inspector General said in a recent report that the NRC “failed to follow” standards of ethical conduct on preventing conflicts of interest, allowing advisers with conflicts of interest to help shape the proposed rule. The main impact of the proposed rule — which mirrors the recommendations of the conflicted advisors — would be to minimize extravasation reporting rather than to reduce extravasations.

One of us (P.K.) has experienced an extravasation at least once during treatment for metastatic breast cancer. The other (B.K.) is the chief of molecular imaging at a medical center that has all but eliminated extravasations. We are pleased that lawmakers in Congress are proposing responsible legislation to correct this unjustifiable situation, and strongly support enactment of the Nuclear Medicine Clarification Act of 2023 (H.R. 6815), which was introduced by Reps. Morgan Griffith (R-Va.), Don Davis (D-N.C.), and Ben Cline (R-Va.). This legislation is simple. It closes the outdated and incorrect loophole in NRC reporting rules by providing transparency for patients and encouraging clinicians to address and fix problems surrounding injection of radioactive medicines.

The Nuclear Medicine Clarification Act does not second-guess the radiation level that NRC has determined could indicate potential problems in handling nuclear materials. It does not interfere with the doctor-patient relationship. It simply directs the NRC to update its internal rules to treat nuclear medicine extravasations just as any other unintended irradiation is treated. If a patient is accidentally irradiated above NRC’s dose-based threshold, that incident should be reported, regardless of how it happened.

To guard against any burden of administering this act, the legislation also establishes an 18-month grace period before implementation. If clinicians take basic steps now to ensure high-quality nuclear medicine injection processes, they will not have anything to report later.

Entrenched interests such as the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the American College of Radiology (ACR), which oppose more transparent reporting and aim to preserve the status quo, falsely claim that patients “need not be concerned” (SNMMI) if they are unintentionally irradiated, and “must not be burdened” (ACR) with this basic information about their care. Such condescending statements indicate that the true goal of these organizations is to protect the practice of bad medicine from the accountability that comes from disclosure, whereas the proposed legislation will protect the patient.

Congress has a history of stepping in to protect patients when evidence suggests that a clinical quality problem has not been adequately addressed. In 1992, Congress enacted the Mammography Quality Standards Act in response to the federal government uncovering numerous quality problems in the field of mammography. According to the American College of Radiology, that act improved care through regulatory standards that resulted in strict accreditation, certification, and inspection requirements.

The same should occur today with diagnostic and therapeutic nuclear medicine services. Patients needing these lifesaving technologies deserve the same quality assurance that Congress provided for breast cancer patients more than 30 years ago.

Pam Kohl has been living with stage 4 metastatic breast cancer since January 2017. She is a volunteer advocate with Patients for Safer Nuclear Medicine, a coalition of patient advocacy organizations that has called on NRC to change its extravasation rule and alleged conflicts of interest among NRC’s advisory committee. Bill Kiser, M.D., is a board-certified radiologist in Roanoke, Va., with special competency in nuclear medicine.