South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS
Subpart A - GENERAL INFORMATION
Section 61-63.IV.A.RHA 4.2 - Definitions

4.2.1 "Address of use" means the building or buildings that are identified on the license and where radioactive material may be received, prepared, used, or stored.

4.2.2 "Agreement State" means any State with which the Nuclear Regulatory Commission (hereafter referred to as NRC) or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.

4.2.3 "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing radioactive material.

4.2.4 "Associate Radiation Safety Officer" means an individual who-

4.2.5 "Authorized medical physicist" means an individual who-

4.2.6 "Authorized nuclear pharmacist" means a pharmacist who-

4.2.7 "Authorized user" means a physician, dentist, or podiatrist who-

4.2.8 "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

4.2.9 "Brachytherapy source" means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

4.2.10 "Client's address" means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with RHA 4.33.

4.2.11 "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility.

4.2.12 "Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

4.2.13 "Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

4.2.14 "High dose-rate remote afterloader," as used in this part, means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

4.2.15 "Low dose-rate remote afterloader," as used in this part, means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

4.2.16 "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

4.2.17 "Manual brachytherapy," as used in this part, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

4.2.18 "Medical event" means an event that meets the criteria in RHA 4.117.1.

4.2.19 "Medical institution" means an organization in which more than one medical discipline is practiced.

4.2.20 "Medical use" means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

4.2.21 "Medium dose-rate remote afterloader," as used in this part, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

4.2.22 "Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

4.2.23 "Ophthalmic physicist" means an individual who-

4.2.24 "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for specified set of exposure conditions.

4.2.25 "Patient intervention" means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

4.2.26 "Pharmacist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.

4.2.27 "Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.

4.2.28 "Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

4.2.29 "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

4.2.30 "Preceptor" means an individual who provides, directs or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer.

4.2.31 "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented-

4.2.32 "Prescribed dose" means-

4.2.33 "Pulsed dose-rate remote afterloader," as used in this part, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate" range, but-

4.2.34 "Radiation Safety Officer" means an individual who-

4.2.35 "Sealed source" means any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.

4.2.36 "Sealed Source and Device Registry" means the national registry that contains all the registration certificates, generated by both NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

4.2.37 "Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

4.2.38 "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

4.2.39 "Teletherapy," as used in this part, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

4.2.40 "Temporary job" means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

4.2.41 "Therapeutic dosage" means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

4.2.42 "Therapeutic dose" means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

4.2.43 "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

4.2.44 "Type of use" means use of radioactive material under RHA 4.35, 4.37, 4.40, 4.46, 4.56 4.58 or 4.88.

4.2.45 "Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

4.2.46 "Written directive" means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in RHA 4.17.