Public Policy Initiatives
Lucerno Dynamics encourages patients and their family members, patient advocates, patient safety organizations, clinicians, physicists, medical physicists, radiation safety officers, hospital administrators, accreditation organizations, payers, benefit advisers, regulators, and risk managers to become familiar with Lucerno’s public policy efforts to improve patient safety and the quality of nuclear medicine procedures. These efforts, which we pursue with our Washington, D.C. partners CRD Associates, are focused on ensuring that nuclear medicine injection infiltrations, that exceed medical event reporting criteria, are shared with the patient, their physician, and the Nuclear Regulatory Commission.
Lucerno Nuclear Regulatory Commission and Congressional Engagement Timeline
To access actual communications click on the text in blue font
April 1, 2020: Lucerno requests NRC reject the ACMUI Patient Intervention recommendation because it completely conflicts with the clinical evidence.
March 30, 2020: The Advisory Committee on the Medical Use of Isotopes (ACMUI) subcommittee on Patient Intervention presented recommendations to the ACMUI at the Spring Meeting. In essence, the subcommittee suggested that NRC should consider infiltrations as patient intervention that would not have to be reported to NRC as a medical event. This recommendation suggests the patient is to blame for infiltrations and is NOT supported by any evidence. Additionally, the recommendation is in direct conflict with comments from previous ACMUI members.
March 17, 2020: NRC reports back to Congress on the topic – Updates to Injection Quality Monitoring, Classification, and Reporting Requirements for Extravasations.
NRC’s report provided Congress with background on extravasations, the position of the Advisory Committee on the Medical Use of Isotopes Assessment of Extravasations, and NRC’s planned next steps. Lucerno has developed follow-up questions that we intend to share with NRC.
March 16, 2020: Lucerno provides two pieces of additional evidence to the NRC for their independent evaluation of the extravasation topic. The first piece of evidence is a recent paper that summarizes a 2018 IAEA technical meeting of global radiation experts, including NRC’s Lisa Dimmick. The topic of the meeting was the prevention of unintended exposures and accidents in nuclear medicine, and the focus was extravasations. Also, Lucerno provides three more cases of dosimetry that show patients are receiving high doses of radiation to their tissue when they are infiltrated.
March 4, 2020: Lucerno provides additional evidence to the NRC from Australia and the Organization of Agreement States.
February 12, 2020: Lucerno provides three pieces of additional evidence to the NRC to help the NRC staff conduct an independent evaluation of the infiltration issue. The first piece of evidence was a paper that published ahead of print in the American Society of Clinical Oncology JCO Oncology Practice journal on 2/11/2020. Next, was evidence that nuclear medicine centers will not have to go beyond their current standard of practice if they have to report infiltrations, since many guidelines suggest that centers image injections sites if they suspect an infiltration. Finally, Lucerno provided three more cases of dosimetry that show patients are receiving high doses of radiation to their tissue when they are infiltrated.
January 28, 2020: NRC publicly announces they are conducting an independent evaluation of the infiltration/extravasation issue. Additionally, NRC states they are working on their report on the extravasation issue that is due to Congress by March 20.
Here is an excerpt from the meeting transcript of the NRC staff discussing the topic of infiltrations or extravasations.
“The last activity that I wanted to highlight is related to extravasations involving radiopharmaceuticals. Generally, an extravasation is the inadvertent injection of a medical fluid into tissue surrounding the vein or in artery. An Advisory Committee on the Medical Use of Isotopes (ACMUI) subcommittee concluded that extravasation is a practice of medicine issue and not an item that needs to be regulated by the NRC. And that extravasation should not be considered a medical event unless there is an unattended permanent functional damage. Considering ACMUI’s recommendation and the interest from external stakeholders, the NRC Staff has begun an independent evaluation of whether extravasation of a radiopharmaceutical should be considered a medical event. Additionally, the further consolidated appropriations act will require the Staff to provide a separate report to congress on this matter, this spring.” Here is the slide that was presented to the Commissioners.
January 28, 2020: Lucerno sends a copy of a Royal Free London presentation, “Extravasation of radionuclides: recognizing the danger and managing the consequences” by Tamar Willson to the NRC that Lucerno discovered during our ongoing research on the dangers of infiltrations or extravasations. The presentation highlights that patients can receive high radiation doses that result in harmful patient side effects from interventional radiology procedures and then showed how the same effects can happen if a nuclear medicine dose is “tissued” or infiltrated/extravasated. The presentation highlights the fact that “tissuing” happens and the associated risk factors. The presentation also highlights a patient case and shows the harm that is caused to the patient from a therapeutic radiopharmaceutical infiltration. The images are graphic. Finally, the author suggests that tissuing of the diagnostic radiopharmaceuticals can also cause patient harm.
In this same communication with the NRC, Lucerno provided an update from the SNMMI Mid-Winter meeting. Nuclear medicine centers confirmed that infiltrations certainly occur in their centers at the published rate of 15% or higher. Nuclear medicine leaders were surprised to hear that diagnostic radiopharmaceuticals could lead to high equivalent doses to tissue, were concerned that they may have to report many infiltrations to the NRC, but also were confident that using quality improvement methods, their centers could dramatically reduce their rate of infiltrations. None of the nuclear medicine professionals we spoke with believed infiltrations were caused by patients; they all recognized that their teams contribute to causing infiltrations.
January 22, 2020: Lucerno provides additional evidence to the NRC on the extravasation topic. Lucerno shares a recently published paper from the University of Tennessee Knoxville describing their very low infiltration rate. This paper clearly shows that the NRC 1980 policy that exempts infiltrations because “infiltrations are nearly impossible to avoid” is incorrect. Lucerno also shares a 2017 article that shows the side effects of high radiation doses to patient tissue, and the difficulty for patients to necessarily connect these delayed side effects to their previous radiation exposure. Finally, Lucerno provided three additional cases that demonstrate that extravasations can possibly exceed the NRC reporting limit.
January 10, 2020: Lucerno responds to an NRC request for evidence that the nuclear medicine community or physics community accepts the dosimetric method that Lucerno employee, Josh Knowland, is using to calculate tissue dose. Lucerno provides NRC with the abstract, a copy of the American College of Nuclear Medicine acceptance letter, and in advance of the meeting – the actual poster that was to be presented at the Society of Nuclear Medicine and Molecular Imaging and American College of Nuclear Medicine Mid-Winter Meeting on January 24, 2020.
December 20, 2019: President Trump signs the omnibus spending bill that includes language highlighting evidence about occurrence of extravasation and the risks they pose to patients, and directs NRC, VA, and CMS report back to Congress within 90 days on the topic of infiltrations.
The report accompanying the Energy & Water appropriations bill includes the following provision, a version of which was contained in both the House and Senate versions:
Re-Evaluation of Nuclear Medicine Event Reporting. – The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medicine procedures within and across health care providers. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. The Committee supports the work of the Commission and the Advisory Committee on medical Use of Isotopes to consider new evidence in evaluating whether all radiotracer extravasations should be reportable as medical events under 10 C.F.R. Part 35. Not later than 90 days after the enactment of this Act, the Commission shall provide to the Committees on Appropriations of both Houses of Congress a report on updates to injection quality monitoring, classification, and reporting requirements regarding extravasations.
The Centers for Medicare & Medicaid Services (CMS) maintains conditions of participation (CoPs), which providers must meet in order to begin and continue participating in the Medicare and Medicaid programs, including for nuclear medicine services. The report accompanying the Labor, Health & Human Services, Education Appropriations bill includes the following provision, a version of which was contained in both the House and Senate versions:
Extravasations.—The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medicine procedures. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. The Committee encourages CMS to consider adding required monitoring of injection quality and submission of reportable extravasations to the Nuclear Regulatory Commission to its conditions of participation for nuclear medicine services. The Committee requests an update on this issue in the fiscal year 2021 Congressional Budget Justification.
The Veterans Health Administration is the largest integrated health care system in the United States, providing care at 170 VA Medical Centers. The report accompanying the Military Construction-VA Appropriations bill includes the following provision:
Nuclear Medicine Quality Improvements.—The Committee is aware of evidence demonstrating the prevalence of extravasations in nuclear medical procedures. Extravasations of diagnostic radiopharmaceuticals negatively affect the sensitivity and quantification of nuclear medicine scans. Extravasations can affect disease staging and treatment assessment, result in unnecessary invasive procedures and additional radiation exposure, and lead to higher costs for patients and payers. As America’s largest integrated healthcare system, the VAMC should lead by example in acting to reduce medical errors and medical waste. The Committee encourages VAMCs to monitor injection quality and develop a physician/patient reporting system to disclose when extravasations occur. No later than 90 days after the enactment of this Act, VHA shall provide to the Committees on Appropriations of both Houses of Congress a report on efforts to monitor injection quality and reduce the incidence of extravasations.
December 20, 2019: Lucerno provides additional infiltration cases for NRC review and additional support for the dosimetric method used to calculate radiation dose.
November 18, 2019: Lucerno provides the NRC an additional case that demonstrates how patients are being exposed to very high arm tissue doses that exceed NRC reporting limits. Lucerno also suggests that the NRC consider the impact of these infiltrations on patient safety with regard to a publication on their own website.
November 12, 2019: Lucerno responds to an NRC request for a detailed explanation of the method used to calculate dosimetry of tissue radiation exposure.
October 2019: Representative David Price visits Lucerno Dynamics for a briefing on infiltrations.
October 9, 2019: Lucerno submits a detailed request asking NRC to reject the ACMUI recommendation. Lucerno highlights the inaccuracies inherent in the ACMUI recommendation. Lucerno submits detailed evidence demonstrating that patients who experience moderate to significant infiltrations are unintentionally exposed to high radiation doses to their tissue. Doses range from 1,000 mSv to 31,300 mSv compared to NRC reporting limits (500 mSv).
September 13, 2019: Senator Thom Tillis visits Lucerno Dynamics for a briefing on infiltrations.
September 10, 2019: ACMUI and their subcommittee recommend that the NRC retain the infiltration reporting exemption and the NRC consider infiltrations to be the result of patient intervention.
April – August 2019: Lucerno provides additional information (peer-reviewed published evidence that infiltrations can be reduced, patient letters of support, physician and healthcare quality organization letters of support, case studies) to NRC and ACMUI to support removing the infiltration reporting exemption. Lucerno and CRD educate members of Congress, their staff, and members of the Appropriations Committee on the infiltration issue and request Appropriations report language for NRC, VA, and CMS agencies.
April 3, 2019: Lucerno presents evidence to the ACMUI that the incidence of nuclear medicine infiltrations can be significantly improved. ACMUI Chairman establishes a subcommittee to review the NRC internal 1980 policy that exempts infiltrations from being reported as a medical event – even when the infiltration unintentionally exposes patient tissue to radiation doses that exceed medical event reporting criteria.
April 2, 2019: Lucerno submits written evidence to the NRC and ACMUI asking that they reevaluate their 1980 internal policy that exempts infiltrations from being reported as medical events.
February 2019: NRC invites Lucerno to present evidence to the NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI) at the ACMUI Spring 2019 meeting.
December 2018: Lucerno presents information to the Nuclear Regulatory Commission (NRC) on the frequency of nuclear medicine infiltrations and provides evidence that counters the NRC belief that infiltrations cannot be avoided in nuclear medicine injections.