I represent a payer or healthcare quality/transparency organization
Please consider making some or all of the following three points to the NRC in addition to answering any or all of the NRC’s specific Public Comment questions.
Please use your own words; the NRC will ignore repetitive, verbatim comments.
Point 1 – NRC should protect patients
- Payers count on NRC policies to protect our members when radiation is being used medically.
- Healthcare quality and transparency organizations want patient safety to be at the forefront of the NRC and want access to information that shows healthcare quality.
- In the August 3, 2020 Federal Register (65 FR 47654) the NRC explains their current Medical Use Policy Statement. The NRC “has a role assuring accurate delivery of radiation doses and dosages to patients and has rejected the notion that NRC should not regulate patient radiation safety.”
- Extravasations are, by definition, the inaccurate delivery of radiation doses. Significant extravasations can harm patients.
- Extravasations are currently exempted from reporting as medical events because of the NRC 1980 policy, which we now know is incorrect. Therefore, extravasations should not be treated any differently than other medical events.
- The NRC is not meeting their own Medical Use Policy Statement—they need to make extravasations reportable events.
Point 2 – Patients and their doctors need to know
- Members may undergo unnecessary additional or wrong procedures due to extravasation-compromised diagnostic procedures.
- Members may not benefit from radio-therapy if the radio-therapy is misadministered.
- Many nuclear medicine patients are predisposed to an increased radiosensitivity at lower radiations doses due to factors like obesity, diabetes, and prescribed chemotherapy and other drugs.
- Patients and their doctors should be informed – this information is important to patients and their care.
Point 3 – NRC needs to follow the evidence
- Clinical evidence shows that extravasations are a frequent occurrence, that they harm patients, and that they can be improved. NRC should be aware of these facts and eliminate the exemption policy accordingly.
The following section details the NRC’s specific Public Comments questions and provides points for you to consider in your response.
Feel free to answer as many questions as you wish, but please use your own words; the NRC will ignore repetitive, verbatim comments.
NRC Topic: Injection Quality Monitoring
Q1: How frequently does radiopharmaceutical extravasation occur?
Centers who extravasate and have not published their findings will not be likely to admit it in a public forum. However, if you review the 2008 and 2009 ACMUI transcripts or if you review the 9 peer-reviewed studies from 13 centers over the last 10 years, you will find that extravasations occur approximately 15.2% of the time.
Centers that are not monitoring extravasations cannot know their frequency. Centers retrospectively reviewing images will underestimate the frequency since most nuclear medicine images do not include the injection site.
It is hard to know how often they happen in centers we work with since most centers do not track this metric, but if they do happen, our members and I would want to know. There are patient care and financial implications.
Q2: Do you know of any extravasations that have resulted in harm to patients? If so and without including information that could lead to the identification of the individual, describe the circumstances, type of effect harm, and the impacts.
A review of the NRC website indicates that medical event reporting does not necessarily indicate patient harm. Your website says “Medical event reporting may indicate potential problems in a medical facility’s use of radioactive materials. It does not necessarily result in harm to the patient.”
The petition and other communications with the NRC cite references to medical literature and cases that show patient harm. Additionally, the FDA has had adverse events reports associated with extravasations.
It is well understood that harm from radiation to tissue may not show up for months or years and the literature suggests that the nuclear medicine community does not routinely perform dosimetry or follow extravasated patients. Therefore, clinicians cannot know when their patients have been harmed.
If nuclear medicine procedures must be repeated due to extravasation, then surely the additional radiation exposure could be considered a type of harm. Additionally, payors and patients are harmed by the wasted cost of such procedures.
Q3: For medical use licensees, does your facility currently monitor for radiopharmaceutical extravasation? If so, why and how do you monitor? If not, why not?
Q4: Do you expect that monitoring for extravasation and reviewing the results would improve radiopharmaceutical administration techniques at medical use licensee facilities? If so, how? If not, why not?
Monitoring a process is the first step in understanding and improving the process.
Use of quality improvement processes has already been proven to reduce the frequency of extravasation in chemotherapy and contrast CT injections/infusions.
In 2019, the world’s largest nuclear medicine injection quality improvement project was published. It demonstrated that nuclear medicine centers who follow a quality improvement process significantly improved their extravasation rates.
The Mammography Quality Standards Act (MQSA) that Congress passed in the 1990’s ensured monitoring and improved mammography quality. The extravasation issue is no different.
Q5: Do you believe an NRC regulatory action requiring monitoring and review of extravasation would improve patient radiological health and safety? If so, how? If not, why not?
Regulatory action and public reporting will drive quality improvement efforts that will lead to reduced frequency.
50 peer-reviewed publications indicate how extravasation can negatively affect patient images and ensuing care. Reducing extravasations will reduce these negative effects.
The nuclear medicine community has stated that irradiating patient tissue with 1.0 Sv dose equivalent leads to adverse tissue reactions. Reducing extravasations will reduce the number of patients suffering from adverse tissue reactions.
NRC Topic: Medical Event Classification and Reporting Criteria
Q1: Are there any benefits, not related to medical techniques, to monitoring and reporting certain extravasations as medical events? What would be the burden associated with monitoring for and reporting certain extravasations as medical events?
Public awareness of which nuclear medicine centers are performing high quality injections will lead to more patients choosing these facilities and their higher quality care.
Preventing extravasation in the future would reduce overall health care spending. Neither payers nor members should have to pay for procedures that were not performed properly or for expensive improper treatments that are based on compromised imaging or for the incomplete delivery of radiotherapies.
Q2: If the NRC were to require that licensees report certain extravasations as medical events (recorded in NMED), what reporting criteria should be used to provide the NRC data that can be used to identify problems, monitor trends, and ensure that the licensee takes corrective action(s)?
The NRC should collect similar data to that collected for other medical events. Extravasations that exceed 0.5 Sv to tissue should be reported.
The ratio of significant extravasations to administrations would provide important information for understanding how a facility administers radioactive material. Centers that are not improving their reportable extravasation ratio should warrant closer scrutiny by the NRC.
Q3: If the NRC requires reporting of extravasations that meet medical event reporting criteria, should a distinction be made between reporting extravasations of diagnostic and therapeutic radiopharmaceuticals? If so, why? If not, why not?
It does not matter to a patient whether the high dose from an extravasation results from a diagnostic or therapeutic radiopharmaceutical.
The petition cites many cases of diagnostic extravasation which exceeded 0.5 Sv to tissue and references many therapeutic extravasations that must have exceeded the reporting limit. Both should be reported.