Compilation of Rules and Regulations of the State of Georgia › Department 391 - RULES OF GEORGIA DEPARTMENT OF NATURAL RESOURCES › Chapter 391-3 - ENVIRONMENTAL PROTECTION › Subject 391-3-17 - RADIOACTIVE MATERIALS › Rule 391-3-17-.05 - Use of Radionuclides in the Healing Arts

Current through Rules and Regulations filed
				through June 27, 2024
(1)
Purpose and Scope.
This
				Rule, 391-3-17-.05, establishes requirements and provisions for the production,
				preparation, compounding and use of radionuclides in the healing arts and for
				issuance of licenses authorizing these activities. These requirements and
				provisions provide for the radiation safety of workers, the general public,
				patients, and human research subjects. The requirements and provisions of this
				Rule are in addition to, and not in substitution for, others in these
				regulations unless specifically exempted. All numbered and lettered references
				within this Rule refer to parts of this Rule, unless stated
				otherwise.
(2)
Definitions.
(a) "Accredited
				institution," means a teaching facility for nuclear medicine technology or
				radiation therapy technology whose standards are accepted by the United States
				Department of Education.
(b)
				"Address of use," means the building or buildings that are identified on the
				license and where radioactive material may be produced, prepared, received,
				used, or stored.
(c) "Area of use,"
				means a portion of an address of use that has been set aside for the purpose of
				receiving, using, or storing radioactive material.
(d) "Authorized medical physicist," means an
				individual who:
1. Meets the requirements in
				Rules .05(23)(a) and
				.05(27);
				or
2. Is identified as an
				authorized medical physicist on a license or equivalent permit issued by the
				Director, Nuclear Regulatory Commission or Agreement State; or
3. Is identified as an authorized medical
				physicist on a permit issued by the Director, Nuclear Regulatory Commission or
				Agreement State specific license of broad scope that is authorized to permit
				the use of radioactive material.
(e) "Authorized nuclear pharmacist," means a
				pharmacist who:
1. Meets the requirements in
				Rules .05(24)(a) and
				.05(27);
				or
2. Is identified as an
				authorized nuclear pharmacist on a license or equivalent permit issued by the
				Director, Nuclear Regulatory Commission or Agreement State; or
3. Is identified as an authorized nuclear
				pharmacist on a permit issued by the Director, Nuclear Regulatory Commission or
				Agreement State specific license of broad scope that is authorized to permit
				the use of radioactive material.
(f) "Authorized user," means a physician,
				dentist, or podiatrist who:
1. Meets the
				requirements in Rule
				.05(27) and
				.05(43)(a),
				.05(47)(a),
				.05(52)(a),
				.05(53)(a),
				.05(54)(a),
				.05(63)(a),
				.05(66)(a), or
				.05(84)(a);
				or
2. Is identified as an
				authorized user on a license or equivalent permit issued by the Director,
				Nuclear Regulatory Commission or Agreement State; or
3. Is identified as an authorized user on a
				permit issued by the Director, Nuclear Regulatory Commission or Agreement State
				specific license of broad scope that is authorized to permit the use of
				radioactive material.
(g)
				"Brachytherapy," means a method of radiation therapy in which plated, embedded,
				activated, or sealed sources are utilized to deliver a radiation dose at a
				distance of up to a few centimeters, by surface, intracavitary, intraluminal or
				interstitial application.
(h)
				"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.
(i) "Client's address," means the address of
				use or a temporary jobsite for the purpose of providing mobile medical service
				in accordance with Rule
				.05(38).
(j) "Dedicated check source," means a
				radioactive source that is used to assure the consistent response of a
				radiation detection or measurement device over several months or
				years.
(k) "Dentist," means an
				individual licensed to engage in the practice dentistry under the Authority of
				O.C.G.A. 43-11-40.
(l) "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.
(m) "High dose-rate remote afterloader,"
				(HDR) means a device that remotely delivers a dose rate in excess of 12 gray
				(1200 rad) per hour at the treatment site.
(n) "Low dose-rate remote afterloader," (LDR)
				means a device that remotely delivers a dose rate of less than or equal to 2
				gray (200 rad) per hour at the treatment site.
(o) "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.
(p) "Manual
				brachytherapy," means a type of therapy in which brachytherapy sources are
				manually applied or inserted.
(q)
				"Medical institution," means an organization in which several medical
				disciplines are practiced.
(r)
				"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.
(s) "Medium dose-rate remote afterloader,"
				(MDR) means a device that remotely delivers a dose rate of greater than 2 gray
				(200 rad), but less than, or equal to, 12 gray (1200 rad) per hour at the
				treatment site.
(t)
				"Misadministration," means an event that meets the criteria in Rule
				.05(115)(a).
(u) "Mobile medical
				service," means the transportation of radioactive material or its medical use
				at the client's address.
(v)
				"Nuclear medicine technologist," means an individual who meets the requirements
				of Rule .05(25)(a) and, is under the supervision of an authorized user, to
				prepare or administers radioactive drugs to patients or human research
				subjects, or perform
in vivo
or
in vitro
measurements for medical purposes.
(w) "Nuclear medicine technology," means the
				science and art of in vivo and in vitro detection and measurement of
				radioactivity and the administration of radioactive drugs to patients or human
				research subjects for diagnostic and therapeutic purposes.
(x) "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.
(y) "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.
(z) "Pharmacist," means any individual who is
				licensed to practice Pharmacy in this State by the Georgia State Board of
				Pharmacy.
(aa) "Physician," means
				any person who is licensed to engage in the practice of medicine under the
				Authority of O.C.G.A. 43-34-20 or the limited practice of medicine under
				O.C.G.A. 43-35-1.
(bb)
				"Podiatrist," means an individual licensed by the appropriate authority to
				practice podiatry in the state of Georgia.
(cc) "Positron Emission Tomography (PET)
				radionuclide production facility" is defined as a facility operating a
				cyclotron or accelerator for the purpose of producing PET
				radionuclides.
(dd) "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, an Associate Radiation Safety
				Officer or a Radiation Safety Officer.
(ee) "Prescribed dosage," means the specified
				activity or range of activity of radioactive drug as documented:
1. In a written directive; or
2. In accordance with the directions of the
				authorized user for procedures performed pursuant to Rule .05(41), (44) and
				(48).
(ff) "Prescribed
				dose," means:
1. For gamma stereotactic
				radiosurgery, the total dose as documented in the written directive;
2. For teletherapy, the total dose and dose
				per fraction as documented in the written directive;
3. For brachytherapy, either the total source
				strength and exposure time or the total dose, as documented in the written
				directive; or
4. For remote
				brachytherapy afterloaders, the total dose and dose per fraction as documented
				in the written directive.
(gg) "Pulsed dose-rate remote afterloader,"
				(PDR) 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:
1. Is approximately one-tenth of the activity
				of typical high dose-rate remote afterloader sources; and
2. Is used to simulate the radiobiology of a
				low dose rate treatment by inserting the source for a given fraction of each
				hour.
(hh) "Radiation
				Safety Officer," means an individual who:
1.
				Meets the requirements in Rule .05(22)(a) or .05(22)(c)1. And .05(27);
				or
2. Is identified as a Radiation
				Safety Officer on a Nuclear Regulatory Commission or Agreement State license or
				other equivalent permit or license recognized by the Division for similar types
				and uses of radioactive material.
(ii) "Radiation therapist," means an
				individual who meets the requirements of Rule .05(25)(b) and is under the
				supervision of an authorized user to perform procedures and apply radiation
				emitted from sealed radioactive sources to human beings for therapeutic
				purposes.
(jj) "Radiation therapy
				technology," means the science and art of applying radiation emitted from
				sealed radioactive sources to patients or human research subjects for
				therapeutic purposes.
(kk)
				"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.
(ll) "Sealed source,"
				means any radioactive material that is encased in a capsule designed to prevent
				leakage or escape of the radioactive material.
(mm) "Sealed Source and Device Registry,"
				means the national registry that contains the registration certificates
				maintained by the Nuclear Regulatory Commission, that summarize the radiation
				safety information for the sealed sources and devices and describe the
				licensing and use conditions approved for the product.
(nn) "Stereotactic radiosurgery," means the
				use of external radiation in conjunction with a stereotactic guidance device to
				very precisely deliver a dose to a treatment site.
(oo) "Structured educational program," means
				an educational program designed to impart particular knowledge and practical
				education through interrelated studies and supervised training.
(pp) "Teletherapy," as used in this Rule,
				means a method of radiation therapy in which collimated gamma rays are
				delivered at a distance from the patient or human research subject.
(qq) "Temporary jobsite," as used in this
				Rule, means a location where mobile medical services are conducted other than
				the location(s) of use authorized on the license.
(rr) "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.
(ss) "Therapeutic dose,"
				means a radiation dose delivered from a sealed source containing radioactive
				material to a patient or human research subject for palliative or curative
				treatment.
(tt) "Treatment site,"
				means the anatomical description of the tissue intended to receive a radiation
				dose, as described in a written directive.
(uu) "Type of use," means use of radioactive
				material as specified under Rule .05(41), (44), (48), (55), (65), (67) or
				(85).
(vv) "Unit dosage," means a
				dosage that:
1. Is obtained or prepared in
				accordance with the regulations for uses described in Rule .05(41), (44), (48);
				and
2. Is to be administered as a
				single dosage to a patient or human research subject without any further
				manipulation of the dosage after it is initially prepared.
(ww) "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 .05(19).
(xx) "Associate Radiation Safety Officer,"
				means an individual who:
1. Meets the
				requirements in 391-3-17-.05(22) and .05(27); and
2. Is currently identified as an Associate
				Radiation Safety Officer for the types of use of byproduct material for which
				the individual has been assigned duties and tasks by the Radiation Safety
				Officer on:
(i) A specific medical use license
				issued by the Commission or an Agreement State; or
(ii) A medical use permit issued by a
				Commission master material licensee.
(yy) "Ophthalmic physicist," means an
				individual who:
1. Meets the requirements in
				391-3-17-.05(27) and 391-3-17-.05(64)(c)2.; and
2. Is identified as an ophthalmic physicist
				on a:
(i) Specific medical use license issued
				by the Commission or an Agreement State;
(ii) Permit issued by a Commission or
				Agreement State broad scope medical use licensee;
(iii) Medical use permit issued by a
				Commission master material licensee; or
(iv) Permit issued by a Commission master
				material licensee broad scope medical use permittee.