Tag: regulatory support

25 Feb 2022
CT radiation medical event

What are Radiation Medical Events and How to Prevent Them

The use of radiation in medicine via radiology, nuclear medicine, and radiotherapy helps detect and treat a variety of medical conditions in humans. It is a commonly used practice, with over 10 million procedures performed in the United States each year and thousands of lives saved as a result.

When radiation is administered improperly it is classified as a radiation medical event. A radiation medical event can occur when certain forms of radioactive sources are applied differently from what was intended or prescribed.

Although a radiation medical event does not necessarily result in harm to the patient, it does indicate that there is a potential problem in the medical facility’s use of radioactive sources (materials or equipment). An investigation into the event is required as soon as a medical event is suspected, typically by a clinical health physicist, as well as a written report documenting their findings.

What is a Radiation Medical Event?

The NRC defines an incident as a radiation medical event when (10 CFR 35.3045) the administration of byproduct material or radiation from byproduct material for, except permanent implant brachytherapy, results in—

  1. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
    1. The total dose delivered differs from the prescribed dose by 20 percent or more; or
    1. The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or
    1. The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more.
  2. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following—
    1. An administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure;
    1. An administration of a radioactive drug containing byproduct material by the wrong route of administration;
    1.  An administration of a dose or dosage to the wrong individual or human research subject;
    1. An administration of a dose or dosage delivered by the wrong mode of treatment; or
    1. A leaking sealed source.
  3. A dose to the skin or an organ or tissue other than the treatment site that exceeds by:
    1. 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and
    1. 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.
  4. For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in—
    1. The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;
    1. The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or
    1. An administration that includes any of the following:
      1. The wrong radionuclide;
      1. The wrong individual or human research subject;
      1. Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or
      1. A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.
  5. Intervention of a patient or human research subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

Radiation Medical Event Reports

Any of these medical events must be reported by telephone to the appropriate regulatory agency (i.e., Nuclear Regulatory Commission or Agreement State agency) no later than the next calendar day after discovery. A detailed written report, as described in 10 CFR 35.3045, must be submitted within 15 days after the discovery of the event. Such reports do not include information that could identify the affected patient as these reports are made available to the public.

medical event report

While medical events are accidental, it should be noted that a radiation medical event and a radiation accident are not the same things. Radiation accidents are defined as an event that “has led to significant consequences to people, the environment, or the facility,” such as a nuclear reactor core melt.

The purpose of medical event reporting is to initiate a process that will: (i) determine the root cause(s) and contributing cause(s); (ii) implement immediate corrective actions as may be necessary; (iii) identify preventative actions necessary to prevent a reoccurrence, and (iv) ensure appropriate notification of the patient and referring physician has occurred.  Additionally, the event may trigger the regulatory agency to alert other licensees to a potential problem that should be addressed.   

A medical event may indicate that there are problems within a facility that needs to be addressed. Communication problems, improper labeling, lack of training, and basic human error are all possible explanations.

An investigation into the technical aspects of the procedure, overall quality assurance practices (i.e., audits), and treatment delivery are required. A physician may also need to provide a separate analysis of potential injury or inadequate treatment to determine if any harm came to the patient because of the medical event.

Other medical event reports include:

  1. Report and notification of a dose to an embryo/fetus or a nursing child (10 CFR 35.3047) This includes an unintended dose to an embryo/fetus or a nursing child greater than 5 rem resulting from administration of a byproduct material to the mother/breast feeding individual. No report is required if the dose to the embryo/fetus was approved by the authorized user; or
  2. Report of a leaking sealed source (10 CFR 35.3067). The written report should include the model number, serial number, the radionuclide and its estimated activity, the date and results of the leak test, and the action taken.

How Are Patients Notified of a Medical Event?

NRC regulations state that it is the licensee’s responsibility to notify the exposed individual and their referring physician of the medical event within 24 hours of its discovery. If the notice is made verbally, the patient can request a written notification as well as access to the full report.

Severe events are rare, and harm is unlikely to befall a patient involved with a radiation medical event. However, it is important that the individual receive the appropriate medical care as soon as possible if needed.

Radiation Medical Events Can Be Prevented

With proper continuing education training, regular machine and technology upkeep, a working standard operating procedure, and efficient reporting systems, radiation medical events can be prevented.

It also helps to have a third-party consultant who can identify potential problems in your radiation safety program.

The team at Versant Physics is trained and equipped to help radiology departments and medical facilities prevent radiation medical events. Our board-certified medical and health physicists can help by performing acceptance testing of radiation-producing machines, conducting regulatory compliance audits, performing shielding evaluation and design calculations, and leading training opportunities.

Contact our regulatory team to discuss your radiation safety program needs.

Further Reading:

28 Jan 2021
Five Reasons Your Facility Needs a Radiation Safety Officer

Five Reasons Your Facility Needs a Radiation Safety Officer

A radiation safety officer is an individual responsible for radiation safety in a Nuclear Regulatory Commission (NRC) or Agreement State licensed program. They ensure that any activity involving radiation and radioactive materials is conducted safely to prohibit unnecessary exposure and that all licensed activities are conducted in compliance with both license and regulation requirements. Their responsibilities are varied and extensive, however, an RSO can generally expect to conduct reviews of occupational exposures, surveys and program audits, and lead radiation safety training sessions for authorized users, workers, and ancillary personnel. They are also in charge of spill response and contamination protocols, radioactive material transportation, storage, and disposal, and enforcing the ALARA (As Low as Reasonably Achievable) principle.

RSOs are frequently found in medical facilities that intentionally administer radioactive materials to patients in the form of X-ray and fluoroscopy procedures, radiopharmaceuticals (bone scan, stress test, PET/CT, etc), and radiation therapy. To perform these procedures, medical facilities are required to obtain a permit or license, either issued by the NRC or Agreement State, which an RSO must be listed on.

Medical x-ray machines.

But is an RSO needed for non-medical facilities as well?

In short, yes. Having an RSO on your team is not only beneficial for the overall safety of your clients and staff but is also a requirement of any licensed radiation safety program. We have outlined five reasons that will help you determine if your facility needs an RSO.

1. Your facility houses or utilizes radioactive materials, radiation-producing machines, and/or non-ionizing radiation sources such as lasers.


Specific regulations vary from state to state, however, if your facility utilizes any kind of ionizing or non-ionizing radiation source, you need a radiation safety program, and someone specifically trained to manage it.

In addition to overseeing the radiation safety program and all that entails, the RSO will keep an inventory of all material and machines located in your organization, ensure proper labeling, maintain current machine registrations, and ensure appropriate calibration and testing are performed regularly.

2. You need a highly trained individual who is well-versed in the U.S. NRC or state specific regulations that govern radiation safety and medical use of radioactive materials.


An RSO is properly trained on principles and practices of radiation protection, radiation measurement and monitoring, the biological effects of radiation, and more.

As part of their training, they are also familiar with the extensive regulations laid out by the U.S. Nuclear Regulatory Commission (NRC) or Agreement States. It is their duty to navigate these regulations for your organization to ensure compliance, and to keep on top of any updates that may impact your organization or its employees.

NRC Agreement States

3. You need someone to enforce radiation policies and procedures.


An RSO is granted the authority by management to enforce policies and procedures regarding radiation safety and regulatory compliance established in an organization’s radiation protection program or license. With all that is required of a safe, successful radiation protection program, you can rely on the RSO to make sure everything is in order and the rules are being followed by all participants.

4. You want to identify problems and implement corrective actions quickly.


Of course, accidents happen. Whether due to human error or technical malfunction, they are unavoidable. While we are all familiar with the devastating effects of radiation-related accidents, including those which occurred in the wake of nuclear accidents at Three Mile Island and Fukushima, these types of accidents are not likely to occur in your organization’s day-to-day activities. However, issues such as missing signs, incorrect labels, faulty shielding, or improperly calibrated instruments can not only cost your organization big fines but can pose direct health risks to you and your staff if left unchecked.

A designated RSO not only takes charge and initiates corrective actions during an emergency, but they are also responsible for investigating incidents and finding solutions to ensure such issues do not occur again. They are often the link between management and operations, alerting them to any problems that exist, and continually update and revise the policies laid out in their radiation safety program. They also perform regular safety training and program audits which are excellent ways to identify problem areas and terminate unsafe operations before they become a problem.

5. You want to protect your personnel from occupational radiation exposure risks.


Medical personnel are not the only ones at risk of occupational radiation exposure. Anyone who regularly uses or operates radiation-producing machinery, including researchers, manufacturers, and salespeople, can be exposed. If not properly controlled and monitored, these exposures can cause damage to the cells and genetic material and lead to serious health problems such as cataracts, temporary or permanent sterility, and cancer.

professionals at risk of occupational radiation exposure
Medical personnel are not the only ones at risk of occupational radiation exposure.

Although direct supervision of individuals using ionizing radiation is not typically a role of the RSO, the RSO is responsible for ensuring all authorized users and ancillary workers are properly trained in basic radiation safety and enforce control measures, such as shielding and personal protective equipment (PPE).

An RSO will also likely suggest a personnel monitoring program that assigns dosimeters to your staff and monitors their received radiation dose as well. In addition to advising on who and when individuals should be monitored, they will regularly monitor doses, manage declared pregnancies, and provide compliance reports.

See our post about using Odyssey to manage your personnel dosimetry program.

Next Steps


A properly trained individual, whether they are a licensed medical professional or not, can be added to a license as the RSO if they have successfully completed all the education and experience requirements of the current regulations and agree to be responsible for implementing the radiation safety program. Depending on their other professional responsibilities, they can serve as full or part-time. An RSO should also have excellent management and record-keeping skills and be comfortable with interacting with regulatory agencies.

Due to the extensive training and knowledge required for this role, many organizations choose to outsource this work. Versant Physics offers RSO and Regulatory support for traditional medical facilities such as hospitals and clinics, universities, small businesses, medical equipment manufacturers, and more. Whether you are looking for a consultant to assist on minor aspects of your program, on-site personnel to perform a program audit or survey, or you need help managing your personnel dosimetry program, our experienced, knowledgeable medical and health physicists, qualified experts, and support specialists can help.

Visit our regulatory page for a complete list of regulatory service offerings or contact sales@versantphysics.com to speak to a physicist about your unique program needs. 


References:

  1. Versant Medical Physics and Radiation Safety. Virtual MRSO Course. January 22, 2021. https://www.versantphysics.com/online-mrso-training
  2. 35.50 Training for Radiation Safety Officer and Associate Radiation Safety Officer. January 16, 2019. https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0050.html
  3. “RSO Responsibilities” https://www.apnga.com/rso-responsibilities/
  4. AAPM Report No. 160. “Radiation Safety Officer Qualifications for Medical Facilities.” November 2010.
  5. https://www.osha.gov/ionizing-radiation

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Forum Article "Radiopharmaceutical Extravasation: Pragmatic Radiation Protection" published ahead of print

An article written by Versant team members Dr. Darrell R. Fisher, Ph.D. and Misty Liverett, M.S., CNMT was recently published ahead of print in Health Physics. The article provides an unbiased, scientific assessment of pragmatic and reasonable health physics actions that should be taken in response to inadvertent extravasation events. Click the link below to view the article.

Permits

THE PERMISSION SYSTEM FOR INVENTORY TRACKING, MACHINE MANAGEMENT & EQUIPMENT CATALOG MODULES

Permit Profile

Each permit has a dedicated profile of information that includes authorized personnel, radioactive material, machines, and devices. Permit conditions, completed audits, and forms are also found on this profile.

Authorized Condition Database

Create and view authorized conditions included on permits. Previously created authorized conditions are listed with their code, category, and description.

Permit Enforcement

Information specified on a permit not only serves as a record of that permit, but also controls what can be added to other modules. The location, owner and type of radioactive materials, machines, and equipment can be enforced by permits.

Permit Audits

Perform permit audits, mail the results to relevant personnel, and track responses to non-compliances.