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Radionuclides in the Healing Arts FAQs
These FAQs and answers come directly from the regulations or regulatory guidance documentation available from the Radioactive Materials program. If your question does not appear in the list, please email it to us using the link below. As more questions are asked, more answers will be posted on this web page.
However, please be aware that under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing (F.S. 668.6076). Email Radiation Answers
Authorized User (AU) Questions
Radiation Safety Officer (RSO) Questions
Dose Limit Questions
Therapy Equipment Calibration Questions
Licensing Activities Questions
General QuestionsWhat is the effective date of the current rules?
On March 21, 2016, several changes regarding the use of radionuclides in the healing arts took effect in Chapter 64E-5, Florida Administrative Code (FAC).
In what parts of Chapter 64E-5, FAC were the changes made?
Changes can be found in Part V, Part VIII, and Part XVI of 64E-5 FAC.
Authorized User (AU) Questions
I'm American Board of Radiology certified in Diagnostic Radiology and I've been an AU on a medical license for several years. I wanted to expand my practice to another location under a different medical use license. What do I need to do?
For any specific authorization on the license you may transfer the authorization to another license through reciprocity. If you wish to perform different procedures or therapies at the new location you will be required to document your training and education through board certification and attestation of training and education or the alternative pathway for new activities. All boards were evaluated by the Nuclear Regulatory Commission and certification acceptance is dependent on the date the board was approved. For physicians and medical physicists who completed certification prior to that date, they will need to make application under the alternative pathway. The list and descriptions of the NRC recognized Specialty Board Certifications may be found at: Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35.
What is the meaning of "physically present" for authorized users (AUs) and authorized medical physicists (AMPs) and can an electronic communication device such as a radio transmitter (walkie-talkie) be used?
No. Use of communication devices, including "walkie-talkies," would enable the identified individuals to be at a distance from the location of therapeutic medical use, and thus not "physically present" (i.e., "within hearing distance of normal voice").
Is training for the use of Generators and Reagent Kits still a requirement to be an authorized user for Diagnostic Radiopharmaceuticals?
Yes, 64E-5.650(3)(a)2.g. requires an Authorized User to complete training in the use of generators and reagent kits.
Do neurosurgeons performing gamma stereotactic radiosurgery (Gamma Knife, Perfexion, Icon) qualify as authorized users (AUs) with regard to the 64E-5.637(6), FAC, requirement for an AU to be physically present throughout the entire patient treatment involving the unit?
No. A neurosurgeon is not named on the license for gamma stereotactic radiosurgery (gamma knife) and does not qualify as an authorized user and cannot fulfill the physical presence requirement of an AU unless the neurosurgeon is named as the AU for gamma knife on the license. To be named on the license the neurosurgeon would need to meet the training requirements of an AU specified in 64E-5.655. Note that 64E-5.637(6)(c), FAC, also requires an authorized medical physicist listed on the license to be physically present during all gamma stereotactic radiosurgery patient treatments.
Radiation Safety Officer (RSO) Questions
What are the requirements to be a RSO on a license?
The revised regulations 64E-5.648, FAC, describe the minimum training and experience required to be a RSO. The RSO may be a current authorized user, or an individual who is certified by a specialty board recognized by the U.S. Nuclear Regulatory Commission (NRC) or an individual that meets the requirements under the alternative pathway.
What are the duties of the RSO?
64E-5.605, FAC, describes the administrative requirements and duties of the RSO. The licensee must appoint a RSO who accepts the responsibility in writing. The RSO has specific requirements in the regulations, such as assuring the daily operations and radiation safety activities are performed using approved procedures and regulatory requirements. The RSO must sign and date occupational radiation exposure records at least every 3 months.
Can a licensee, if appropriate to its operations, appoint RSOs for particular medical uses?
Nothing in the regulations prohibits a licensee from appointing deputy RSOs; however, as provided in 64E-5.605, FAC, at any given time, only one RSO can be designated by a licensee, and that individual must be identified on the license. A licensee can, through its appointed RSO (who has responsibility for implementing the licensee's radiation protection program), assign or delegate radiation safety program tasks and duties, but not responsibilities associated with particular medical use, as approved under its license, to individuals that can be designated in any way the licensee chooses, including as deputy RSOs. These individuals can, but need not be authorized users in the particular medical uses. However, the single RSO identified on the license retains overall responsibility for daily operations and for implementing the total radiation protection program. Additionally, as necessary, the licensee may appoint a visiting RSO as described in 64E-5.609, FAC, for up to 60 days each year.
If the radiation safety officer continues an association with the licensee after their retirement, is state notification required?
No, as long as the radiation safety officer continues to perform the duties of the RSO as required by the regulations.
How do we maintain compliance with the determinations of dosage for radiopharmaceutical administrations?
Unless directed by the authorized user, a licensee may not use a dose if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed quantity by more than 20% 64E-5.616, FAC.
Does the requirement of a range of +/- 20% for dose apply to both therapeutic and diagnostic dose?
Yes, under 64E-5.616, FAC, the dosage range applies to all unsealed byproduct material for medical use. An AU may prescribe a dosage or a dosage range. The permitted variation for an administered dose when an AU has not prescribed a dosage is a dosage range +/- 20%.
Can a licensee split a unit dose and if that is permissible what are the conditions that allow a unit dose to be manipulated?
When a unit dosage is manipulated in any way, it stops being considered a unit dosage. If the change in dose modifies the volume of a unit dosage under the direction of an Authorized User and it meets the requirements of 64E-5.616, FAC, it is acceptable. The licensee will need to assay and make corrections to the administered dose as approved by the AU. If the dosage is split between patients, the licensee must provide the Department with procedures for Multidose Vial use.
Does the determination of dosages provisions of 64E-5.616, FAC, apply only to dosages to be used for therapeutic purposes?
No. The provisions of 64E-5.616, FAC apply to both diagnostic and therapeutic applications of unsealed byproduct material for medical use.
Dose Limit Questions
Does 64E-5.312(5), FAC, allow a visitor to receive 500 millirem each time he or she visits a hospitalized therapy patient?
No. The pre-authorized elevated limit of 500 millirem applies to the total dose accumulated by the visitor through all visits to a particular individual who cannot be released. The 500 millirem is the annual dose limit, with pre-authorization, for an individual member of the public from the licensed operations of a single medical use licensee.
Does the 500 millirem apply per patient visited or 500 millirem per individual who visits the patient?
The pre-authorized elevated limit of 500 millirem applies to the total dose accumulated by a visitor through all visits to a particular individual who cannot be released. Multiple visitors to the individual could receive up to 500 millirem each through visits (one or more) to the individual.
Does 64E-5.312, FAC, allow a visitor who is a minor to receive up to 500 millirem when visiting a hospitalized therapy patient?
Yes. Any person, including a minor, who is permitted by the medical facility/licensee to visit the therapy patient, can be allowed by the licensee to receive up to 500 millirem through such visitation, as long as the authorized user has determined before the visit that a dose not exceeding 500 millirem is appropriate.
Why does the Bureau of Radiation Control not require hospitalization of patients receiving therapeutic doses of radioactive Iodine-131?
The Bureau allows the authorized user (AU) to determine what is best for the patient and the public. Some patients meet the patient release criteria and may be safely sent home to recover from the therapeutic procedures. Others because of their mental or physical health or living arrangements would remain hospitalized until the radiation levels are reduced to a specified level for unrestrictive activities. The Bureau has established guidelines and licensees must commit to following these guidelines before the Bureau will authorize by license condition the release of patients with greater than 30 millicuries of Sodium Iodide-131.
Therapy Equipment Calibration Questions
Who must perform calibrations on therapy units?
An authorized medical physicist, as described in 64E-5.6011(1), FAC, is required to perform full calibrations and physical decay corrections for teletherapy units as described in 64E-5.641, FAC.
An authorized medical physicist is required to perform full calibrations and physical decay corrections of a remote afterloader as described in 64E-5.6411(6), FAC.
An authorized medical physicist is required to perform full calibrations and physical decay corrections of a gamma stereotactic radiosurgery unit as described in 64E-5.6412(6), FAC.
What is the definition of "emergency response equipment" under 64E-5.625(9), FAC?
Emergency response equipment is equipment to respond to a source (1) dislodged from the patient or (2) lodged within the patient following removal of the source applicators and should include shielded storage containers, remote handling tools and, as appropriate, supplies necessary to remove applicators or sources from the patient. Responders should also have ready access to an appropriate survey instrument, which is often needed for locating dislodged sources and/or for assessing doses to people from dislodged sources.
Licensing Activities Questions
Is a license amendment required for a change in the company name?
Yes, if the licensee is merely changing its name with the Florida Department of State, Division of Corporations, then a license amendment is required. The Bureau checks all name change requests to determine whether a new license is required. S. 404.061, FS, requires a new application when the majority of the ownership or controlling interest in a license has been assigned or transferred. Each license is only valid for the person to whom it was issued and is not subject to sale, assignment or other transfer. "It is rare for a name change to occur without a change in controlling interest." A new license application and fee would be required along with a request to terminate the old license. Every attempt will be made to assure a transition that does not hinder the day-to-day operations if the both the current and new owner makes an effort to timely respond to licensing issues. For licensees that possess radioactive material in quantities greater than IAEA Class 1 and 2, all security requirements must be met before legal transfer of the licensed materials.
What about the change of name for a licensee who possesses Category 1 or 2 sources?
For a simple name change, an amendment request and documentation from the Florida Department of State, Division of Corporations indicating the change is all that is necessary. If a New license is needed, due to a change of ownership or controlling interest, then additional security requirements and inspection will need to be completed before the new license is issued.
What is the policy on performance of annual records activities? For example, when is an action late (+/- 24%, calendar year)
The Bureau expects the licensee to perform the annual records activities annually or before 365 days have passed since the activity was last performed.
Can an individual initial a record? Or does it have to be a full signature?
Most records require the full signature of the person performing or reviewing the activity that generates the record. For each record, please review Regulatory Guide 1.30, Revision 5, 2014 which provides guidance on records for medical use programs.
What are the requirements for a Certified Nuclear Medicine Technologist to perform PET/CT?
S. 468.302(3)(g), FS, allows certified nuclear medicine technologists to perform the following:
- Conduct in vivo and in vitro measurements of radioactivity and administer radiopharmaceuticals to human beings for diagnostic and therapeutic purposes; and
- Administer X-radiation from a combination nuclear medicine-computed tomography device if that radiation is administered as an integral part of a nuclear medicine procedure that uses an automated computed tomography protocol for the purposes of attenuation correction and anatomical localization and the person has received device-specific training on the combination device.
Certified nuclear medicine technologists are prohibited from performing:
- Radioimmunoassay and other clinical laboratory testing regulated pursuant to Chapter 483, F.S.;
- Creating or modifying automated computed tomography protocols; and
- Any other operation of a computed tomography device, especially for the purposes of stand-alone diagnostic imaging, which must be performed by a general radiographer certified under this part.
Device specific training is defined in rule 64E-3.033, FAC as a means of training supplied by or taught by a PET-CT device manufacturer, or a course approved by the department as continuing education for radiologic technologists. The course must be at least 16 hours in duration and cover the following subjects concerning PET and CT:
- PET-CT theory and physics;
- Radiation safety;
- Equipment operation;
- Image formation, reconstruction and evaluation; and
- Quality control and assurance.
A Nuclear Medicine Technologist who has completed device-specific training shall maintain proof of completion of training at their place of practice and provide it to the department upon request. Such proof shall, at a minimum, consist of a course completion certificate containing the following information: date of course completion, the title of the course, the technologist's full name, the name of the company providing the training, and the instructor's full name.
If a Nuclear Medicine Technologist is certified in Computed Tomography by the American Registry of Radiologic Technologists, the technologist has met the requirement for device-specific training needed to perform the CT portion of a PET-CT examination described under s. 468.302(3)(g), FS. The American Registry of Radiologic Technologist's wallet card bearing the technologist's name and the credential of the Computed Tomography certification will be accepted as proof of completion.
If an individual is Florida-certified as both a Nuclear Medicine Technologist and a General Radiographer, the person may perform PET/CT, full diagnostic CT, and nuclear medicine examinations.
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