Tenn. Comp. R. & Regs. 0400-20-07-.05 - DEFINITIONS

When used in this Chapter, the following terms have the meanings given below unless otherwise specified:

(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.

(2) "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.

(3) "Authorized medical physicist" means an individual who:

(a) Meets the requirements in paragraph (1) of Rule 0400-20-07-.24 and Rule 0400-20-07-.27; or

(b) Is identified as an authorized medical physicist or teletherapy physicist on:

1. A specific medical use license or permit issued by the Division, U.S. Nuclear Regulatory Commission, or Agreement State;

2. A medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee;

3. A permit issued by a Division, U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use licensee; or

4. A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee.

(4) "Authorized nuclear pharmacist" means a pharmacist who:

(a) Meets the requirements in paragraph (1) of Rule 0400-20-07-.25 and Rule 0400-20-07-.27; or

(b) Is identified as an authorized nuclear pharmacist on:

1. A specific license or equivalent permit issued by the Division, U.S. Nuclear Regulatory Commission, or Agreement State that authorizes medical use or the practice of nuclear pharmacy;

2. A permit issued by a U.S. Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

3. A permit issued by a Division, U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

4. A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(c) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(d) Is designated as an authorized nuclear pharmacist in accordance with part (10)(b)4 of Rule 0400-20-10-.13.

(5) "Authorized user" means a physician, dentist, or podiatrist who:

(a) Meets the requirements in Rule 0400-20-07-.27 and subparagraph (1)(a) of Rule 0400-20-07-.39, subparagraph (1)(a) of Rule 0400-20-07-.43, subparagraph (1)(a) of Rule 0400-20-07-.47, subparagraph (1)(a) of Rule 0400-20-07-.48, subparagraph (1)(a) of Rule 0400-20-07-.49, subparagraph (1)(a) of Rule 0400-20-07-.59, Rule 0400-20-07-.60, subparagraph (1)(a) of Rule 0400-20-07-.62, or subparagraph (1)(a) of Rule 0400-20-07-.80; or

(b) Is identified as an authorized user on:

1. A Division, U.S. Nuclear Regulatory Commission, or Agreement State license that authorizes the medical use of radioactive material;

2. A permit issued by a U.S. Nuclear Regulatory Commission master material licensee that is authorized to permit the medical use of radioactive material;

3. A permit issued by a Division, U.S. Nuclear Regulatory Commission, or Agreement State specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

4. A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee that is authorized to permit the medical use of radioactive material. .

(6) "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.

(7) "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.

(8) "Client's address" means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with Rule 0400-20-07-.36.

(9) "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.

(10) "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.

(11) "Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration, or in the case of sealed sources for diagnosis, the procedure.

(12) "Division" means the Division of Radiological Health.

(13) "High dose-rate remote afterloader" means a device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the treatment site.

(14) "Low dose-rate remote afterloader" means a device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the treatment site.

(15) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or that person's delegate or delegates.

(16) "Manual brachytherapy" means a type of therapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed or inserted.

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

(18) "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.

(19) "Medium dose-rate remote afterloader" means a device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

(20) "Misadministration" means an event that meets the criteria in Rule 0400-20-05-.145.

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

(22) "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 a specified set of exposure conditions. .

(23) "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.

(24) "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.

(25) "Physician" means a doctor of medicine or doctor of osteopathy licensed by the 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.

(26) "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.

(27) "Positron Emission Tomography (PET) radionuclide production facility" is defined as a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(28) "Preceptor" means an individual who provides, directs, or verifies 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.

(29) "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

(a) In a written directive as specified in Rule 0400-20-07-.20; or

(b) In accordance with the directions of the authorized user for procedures performed under Rules 0400-20-07-.38 and 0400-20-07-.40.

(30) "Prescribed dose" means:

(a) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(b) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(c) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(d) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(31) "Pulsed dose-rate remote afterloader" means a special type of remote afterloading device that uses a single source capable of delivering dose rates in the "high dose-rate" range, but:

(a) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

(b) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(32) "Radiation safety officer" means an individual who meets the requirements in paragraph (1) or subparagraph (3)(a) of Rule 0400-20-07-.23 and Rule 0400-20-07-.27 or is named as a Radiation Safety Officer on a specific medical use license or equivalent permit issued by the Division, U.S. Nuclear Regulatory Commission or Agreement State or a medical use permit issued by a Commission master material licensee.

(33) "Radioactive drug" means any chemical compound containing radioactive material that may be used on or administered to patients or human research subjects as an aid in the diagnosis, treatment, or prevention of disease or other abnormal condition.

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

(35) "Sealed Source and Device Registry" means the national registry that contains all the registration certificates, generated by both the U.S. Nuclear Regulatory Commission 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.

(36) "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.

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

(38) "Teletherapy," for the purpose of this Chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

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

(40) "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.

(41) "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.

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

(43) "Type of use" means use of radioactive material under Rule 0400-20-07-.38, 0400-20-07-.40, 0400-20-07-.44, 0400-20-07-.51, 0400-20-07-.61, 0400-20-07-.63 or 0400-20-07-.81.

(44) "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.

(45) "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 Rule 0400-20-07-.20.

Notes

Tenn. Comp. R. & Regs. 0400-20-07-.05

Original rule filed February 22, 2012; effective May 22, 2012.

Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.