64E-5.1603. Training and Education

(1) Qualification of Authorized User.

(a) The registrant shall require the authorized user to be a physician who:

1. Is licensed by the department as a medical doctor or doctor of osteopathy;

2. Has completed a manufacturer’s device-specific training as specified in subsection 64E-5.1603(5), F.AC.; and

3. Is certified in:

a. Radiation oncology or therapeutic radiology by the American Board of Radiology;

b. Radiation oncology by the American Osteopathic Board of Radiology;

c. Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or

d. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons.

(b) A physician shall not act as an authorized user for any electronic brachytherapy device until such time as said physician’s training has been reviewed and approved by the department.

(2) Qualification of Authorized Medical Physicist.

(a) The registrant shall require the authorized medical physicist to be a person who:

1. Is currently licensed pursuant to Section 483.901, F.S., as a therapeutic radiological physicist; and

2. Has completed a manufacturer’s device-specific training as specified in subsection 64E-5.1603(5), F.A.C.

(b) A medical physicist shall not act as an authorized medical physicist for any electronic brachytherapy device until such time as said physicist’s training has been reviewed and approved by the department.

(3) Qualification of Authorized Operator. A person, other than an authorized user, who operates an electronic brachytherapy device to apply ionizing radiation to a human, shall be:

(a) Certified in accordance with the Chapter 468, Part IV, F.S., as a radiation therapy technologist; and

(b) Have completed a manufacturer’s device-specific training as specified in subsection 64E-5.1603(5), F.A.C.

(4) Qualification of Radiation Safety Officer. The registrant shall require the radiation safety officer to be a person who has completed a manufacturer’s device specific training as specified in subsection 64E-5.1603(5), F.A.C., and be:

(a) An authorized user or authorized medical physicist; or

(b) A person certified by:

1. The American Board of Radiology in Radiology, Diagnostic Radiology, Therapeutic Radiology, or Radiation Oncology;

2. The American Board of Health Physics in Comprehensive Health Physics;

3. The American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics;

4. The American Board of Nuclear Medicine;

5. The American Board of Science in Nuclear Medicine; or

6. The American Board of Medical Physicists; or

(c) A person who has completed classroom and laboratory training consisting of the following:

1. One hundred hours of radiation physics and instrumentation;

2. Thirty hours of radiation protection;

3. Twenty hours of mathematics pertaining to the use and measurement of radiation;

4. Twenty hours of radiation biology;

5. Thirty hours of medical therapy training; and

6. One year of full time experience in radiation safety at a medical institution under the supervision of the individual identified as the radiation safety officer.

(5) Manufacturer’s Training. The registrant shall require training in electronic brachytherapy device operation, safety procedures, and US Food & Drug Administration approved clinical uses. All training taken to satisfy this requirement must have been completed within the 7 years preceding the date of application. This training requirement must be approved by the department and must be satisfied by:

(a) Completion of a training program provided by the manufacturer; or

(b) Completion of a training program which is provided by an institution approved by the manufacturer; or

(c) Receiving training that is substantially equivalent to the manufacturer’s training program from an authorized user or authorized medical physicist who is authorized to use the device on a department registration.

(6) Annual Training.

(a) The registrant shall provide radiation safety training, initially and at least annually, to all personnel providing patient care and treatment planning to patients.

(b) The training should include device operation, safety procedures and clinical use updates.

(7) Training Records. The registrant shall retain for three years a record of each individual receiving initial manufacturer’s training and annual training.

Rulemaking Authority 404.051(4), 404.22 FS. Law Implemented 404.051, 404.081(1), 404.22 FS. History–New 3-12-09.