Radionuclides in the Healing Arts FAQs
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Email Radiation Answers General Questions
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 February 11, 2010, 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?
Most of the changes can be found in Part VI of 64E-5 FAC, but there are also changes throughout the regulations in Part I, Part II, Part III, and Part XIII,that may impact licensees activities. There is also a new application form DH 1322, 12/09.
Some licensees authorized under 64E-5.626, 64E-5.627, 64E-5.628, 64E-5.629, 64E-5.630, 64E-5.631, 64E-5.632, and 64E-5.634, FAC, have previously committed to using procedures from Regulatory Guide 1.30, dated October 1992. Are such licensees required to comply with those procedures after February 11, 2010, the effective date of the new rule?
No. Licensees are not required to comply with procedures in Regulatory Guide 1.30, dated 1992, when the procedures differ from a regulatory requirement in the revised regulations. The Bureau will be updating current licenses with new information as the licenses are amended or renewed. Inspections will be conducted on licensee's activity and will be based on compliance with the new regulations.
If a license condition requires a licensee to use syringe shields, what happens under the revised regulations?
Licensees are not required to comply with procedures in the Regulatory Guide 1.30, dated 1992, when the procedures differ from a regulatory requirement in the revised regulations. The Bureau will be updating current licenses with new information as the licenses are amended or renewed. Inspections will be conducted on licensee's activity and will be based on compliance with the new regulations.
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.
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").
Do neurosurgeons performing gamma stereotactic radiosurgery (gamma knife) 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 meet the physical presence requirement of an AU unless the neurosurgeon is named as the AU on the license. To be named on the license the neurosurgeon would need to meet the definition of an AU. 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 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 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 new determinations of dosage for radiopharmaceutical administrations?
The AU may prescribe a dosage or a dosage range as described in 64E-5.616, FAC. When an AU does not describe a range, the range allowed to be administered must be +/- 20% of the prescribed dose.
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.
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 safe 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?
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 license.
What about the change of name for a licensee who possesses Category 1 or 2 sources?
Additional security requirements and inspection will need to be completed before a change in the license occurs.
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 the Regulatory Guide 1.30, Revision 3, February 2010, which provides guidance on the preparation of applications 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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