Radioactive Materials Common Questions

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.

• List and Descriptions of NRC-Recognized Specialty Board Certifications

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).

Yes, Rule 64E-5.650(3)(a)2g, F.A.C., requires an AU to complete training in the use of generators and reagent kits.

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 Rule 64E-5.655, F.A.C. Rule 64E-5.637(6)(c), F.A.C., also requires an authorized medical physicist listed on the license to be physically present during all gamma stereotactic radiosurgery patient treatments.

The revised regulations Rule 64E-5.648, F.A.C., 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 or an individual that meets the requirements under the alternative pathway.

Rule 64E-5.605, F.A.C., 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.

Nothing in the regulations prohibits a licensee from appointing deputy RSOs; however, as provided in Rule 64E-5.605, F.A.C., 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 Rule 64E-5.609, F.A.C., for up to 60 days each year.

No, as long as the radiation safety officer continues to perform the duties of the RSO as required by the regulations.

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% Rule 64E-5.616, F.A.C.

Yes, under Rule 64E-5.616, F.A.C., 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%.

Receiving a unit-dose preparation and splitting it into two separate doses may only be performed in an ISO Class 5 primary engineering controls (PEC) within a segregated radiopharmaceutical preparation area (SRPA) or an ISO Class 8 or better buffer area, under U.S. pharmacopeia (USP) general chapter <825>, Radiopharmaceuticals: Preparation, Compounding, Dispensing, and Repackaging.

Additionally, the licensee must provide the Department with procedures for multidose vial use including following USP General Chapter <825> radiopharmaceuticals.

The licensee should verify with the radiopharmacy that they comply with any contractual obligations regarding splitting doses.

No. The provisions apply to both diagnostic and therapeutic applications of unsealed byproduct material for medical use.

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.

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.

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.

The Florida Department of Health allows the authorized user 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 Department has established guidelines and licensees must commit to following these guidelines before any authorization by license condition the release of patients with greater than 30 millicuries of sodium Iodide-131.

An authorized medical physicist, as described in Rule 64E-5.6011(1), F.A.C., is required to perform full calibrations and physical decay corrections for teletherapy units, as described in Rule 64E-5.641, F.A.C.

An authorized medical physicist is required to perform full calibrations and physical decay corrections of a remote afterloader, as described in Rule 64E-5.6411(6), F.A.C.

An authorized medical physicist is required to perform full calibrations and physical decay corrections of a gamma stereotactic radiosurgery unit, as described in Rule 64E-5.6412(6), F.A.C.

Emergency response equipment is equipment to respond to a source:

1. Dislodged from the patient
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.

Yes, if the licensee is merely changing its name with the Florida Department of State’s Division of Corporations, then a license amendment is required. The Florida Department of Health checks all name change requests to determine whether a new license is required.

Section 404.061, F.S., 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.

For a simple name change, an amendment request and documentation from the Florida Department of State’s 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.

The licensee must perform the annual records activities annually, or before 365 days have passed since the activity was last performed.

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.

Section 468.302(3)(g), F.S., 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, F.A.C., 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 section 468.302(3)(g), F.S. 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.