Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-26 - RADIATION CONTROL › Section 420-3-26-.07 - Use Of Radionuclides In The Healing Arts

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
Purpose and Scope.
This rule
			 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 these rules are in
			 addition to, and not in substitution for, others in these rules. The
			 requirements and provisions of these rules apply to applicants and licensees
			 subject to this rule unless specifically exempted.
(2)
Definitions.
(a) "Address of use" means the building or
			 buildings that are identified on the license and where radioactive material may
			 be prepared, received, used, or stored.
(b) "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.
(c) "As low as is reasonably achievable"
			 (ALARA) means making every reasonable effort to maintain exposures to radiation
			 as far below the dose limits in these rules as is practical, consistent with
			 the purpose for which the licensed or registered activity is undertaken, taking
			 into account the state of technology, the economics of improvements in relation
			 to state of technology, the economics of improvements in relation to benefits
			 to the public health and safety, and other societal and socioeconomic
			 considerations, and in relation to utilization of nuclear energy and licensed
			 or registered sources of radiation in the public interest.
(d) "Associate Radiation Safety Officer"
			 means an individual who:
1. Meets the
			 requirement in
			 420-3-26-.07(26) and
			 (30); and
2. Is currently identified as an Associate
			 Radiation Safety Officer for the types of use of radioactive 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 Agency, the U.S. Nuclear Regulatory Commission, or an Agreement
			 State; or
(ii) A medical use permit
			 issued by a U.S. Nuclear Regulatory Commission master material licensee.
(e)
			 "Authorized medical physicist" means an individual who:
1. Meets the requirements in
			 420-3-26-.07(27)
			 and 420-3-26-.07(30);
			 or
2. Is identified as an
			 authorized medical physicist or teletherapy physicist on:
(i) A U.S. Nuclear Regulatory Commission or
			 Agreement State specific license that authorizes the medical use of radioactive
			 material; or,
(ii) A U.S. Nuclear
			 Regulatory Commission or Agreement State specific license of broad scope that
			 is authorized to permit the medical use of radioactive material; or,
(iii) A permit issued by a U.S. Nuclear
			 Regulatory Commission master material license broad medical use
			 permittee;
3. Is
			 identified as an authorized medical physicist or teletherapy physicist on a
			 specific medical use license issued by the Agency; or,
4. Is identified as an authorized medical
			 physicist or teletherapy physicist on a permit issued by an Agency specific
			 medical use license of broad scope that is authorized to permit the use of
			 radioactive material.
(f)
			 "Authorized nuclear pharmacist" means a pharmacist who:
1. Meets the requirements in
			 420-3-26-.07(28)
			 and 420-3-26-.07(30);
			 or
2. Is identified as an
			 authorized nuclear pharmacist on:
(i) A U.S.
			 Nuclear Regulatory Commission or Agreement State specific license that
			 authorizes medical use or the practice of nuclear pharmacy; or
(ii) A U.S. Nuclear Regulatory Commission or
			 Agreement State specific license of broad scope that is authorized to permit
			 medical use or the practice of nuclear pharmacy; and,
(iii) A permit issued by a U.S. Nuclear
			 Regulatory Commission master materials permittee of broad scope or the
			 authorization from a commercial nuclear pharmacy authorized to list its own
			 authorized nuclear pharmacist; or,
3. Has been approved to practice nuclear
			 pharmacy by the Alabama State Board of Pharmacy; and
4. Is identified as an authorized nuclear
			 pharmacist on a specific license that authorizes medical use, the practice of
			 nuclear pharmacy, commercial nuclear pharmacy or the manufacture and
			 distribution of radiopharmaceuticals issued by the Agency; or
5. Is identified as an authorized nuclear
			 pharmacist on a permit issued by an Agency specific license of broad scope that
			 is authorized to permit the use of radioactive material.
(g) "Authorized user" means a physician,
			 dentist, or podiatrist who:
1. Meets the
			 requirements in
			 420-3-26-.07(30)
			  and
			 420-3-26-.07(47),
			 420-3-26-.07(51),
			 420-3-26-.07(56),
			 420-3-26-.07(57),
			 420-3-26-.07(58),
			 420-3-26-.07(68),
			 420-3-26-.07(69),
			 420-3-26-.07(71),
			 or 420-3-26-.07(89);
			 or
2. Is identified as an
			 authorized user on--
(i) A U.S. Nuclear
			 Regulatory Commission or Agreement State specific license that authorized the
			 medical use of radioactive material; or
(ii) A U.S. Nuclear Regulatory Commission or
			 Agreement State specific license of broad scope, or 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. Is identified as an authorized user on a
			 license issued by the Agency; or
4.
			 Is identified as an authorized user on a permit issued by an Agency specific
			 license of broad scope that is authorized to permit the medical use of
			 radioactive material.
(h)
			 "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.
(i)
			 "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.
(j) "Client's address" means the address of
			 use or a temporary jobsite for the purpose of providing mobile medical service
			 in accordance with
			 420-3-26-.07(42).
(k) "Cyclotron" means a particle accelerator
			 in which the charged particles travel in an outward spiral or circular path. A
			 cyclotron accelerates charged particles at energies usually in excess of 10
			 megaelectron volts and is commonly used for production of short half-life
			 radionuclides for medical use.
(l)
			 "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.
(m) "Dentist"
			 means an individual licensed to practice dentistry by the Alabama Board of
			 Dental Examiners.
(n) "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.
(o) "High dose-rate remote afterloader" (HDR)
			 means a brachytherapy device that remotely delivers a dose rate in excess of 12
			 gray (1200 rads) per hour at the prescribed treatment site.
(p) "Low dose-rate remote afterloader"(LDR)
			 means a brachytherapy device that remotely delivers a dose rate of less than or
			 equal to 2 gray (200 rads) per hour at the prescribed treatment site.
(q) "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.
(r) "Manual
			 brachytherapy" means a type of therapy in which brachytherapy sources are
			 manually placed topically on, or inserted into, either the body cavities that
			 are in close proximity to a treatment site, or directly into the tissue
			 volume.
(s) "Medical institution"
			 means an organization in which more than one medical discipline is
			 practiced.
(t) "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.
(u) "Medium dose-rate remote afterloader"
			 (MDR) means a brachytherapy 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 prescribed treatment site.
(v) "Misadministration" means an event that
			 meets the criteria in
			 420-3-26-.07 (120)(a) or
			 (b).
(w) "Mobile medical service"
			 means the transportation of radioactive material to, and its medical use at,
			 the client's address.
(x)
			 "Ophthalmic Physicist" means an individual who:
1. Meets the requirements in
			 420-3-26-.07 (65.l)(a)2 and (30);
			 and
2. Is identified as an
			 ophthalmic physicist on a:
(i) Specific
			 medical use license issued by the Agency, the U.S. Nuclear Regulatory
			 Commission, or an Agreement State;
(ii) Permit issued by an Agency, the U.S.
			 Nuclear Regulatory Commission, or Agreement State broad scope medical use
			 licensee;
(iii) Medical use permit
			 issued by a U.S. Nuclear Regulatory Commission master material licensee;
			 or
(iv) Permit issued by a U.S.
			 Nuclear Regulatory Commission master material licensee broad scope medical use
			 permittee
(y)
			 "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.
(z) "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.
(aa) "Pharmacist" means an individual
			 licensed by the Alabama Board of Pharmacy.
(bb) "Physician" means a doctor of medicine
			 or doctor of osteopathy licensed by the Alabama State Board of Medical
			 Examiners to prescribe drugs in the practice of medicine.
(cc) "Podiatrist" means an individual
			 licensed by the Alabama State Board of Podiatry.
(dd) "Positron Emission Tomography (PET)
			 radionuclide production facility" is a facility operating a cyclotron or
			 accelerator for the purpose of producing PET radionuclides.
(ee) "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, or an Associate
			 Radiation Safety Officer.
(ff)
			 "Prescribed dosage" means the specified activity or range of activity of a
			 radioactive drug as documented:
1. In a
			 written directive as specified in
			 420-3-26-.07(23);
			 or
2. In accordance with the
			 directions of the authorized user for procedures as specified in
			 420-3-26-.07(45)
			  and
			 420-3-26-.07(48).
(gg) "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 manual 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.
(hh) "Pulsed dose-rate remote afterloader"
			 (PDR) 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:
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.
(ii) "Radiation Safety Officer" means an
			 individual who:
1. Meets the requirements in
			 420-3-26-.07(26)
			  and
			 420-3-26-.07(30),
			 or
2. Is named as a Radiation
			 Safety Officer on a specific medical use license issued by the U.S. Nuclear
			 Regulatory Commission or Agreement State, or a medical use permit issued by a
			 U.S. Nuclear Regulatory Commission master material licensee; or
3. Is named as a Radiation Safety Officer on
			 an Agency license.
(jj)
			 "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.
(kk) "Sealed source"
			 means any radioactive material that is encased in a capsule designed to prevent
			 leakage or escape of the radioactive material.
(ll) "Sealed Source and Device Registry"
			 means the national registry that contains the registration certificates
			 maintained by the U.S. 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.
(mm) "Stereotactic radiosurgery" means the
			 use of external radiation in conjunction with a stereotactic guidance device to
			 very precisely deliver a dose to a tissue volume.
(nn) "Structured educational program" means
			 an educational program designed to impart particular knowledge and practical
			 education through interrelated studies and supervised training.
(oo) "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.
(pp) "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.
(qq) "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.
(rr) "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.
(ss) "Treatment site"
			 means the anatomical description of the tissue intended to receive a radiation
			 dose, as described in a written directive.
(tt) "Type of use" means use of radioactive
			 material as specified under
			 420-3-26-.07(45), (48), (52), (60), (70), (72) or
			 (90).
(uu) "Unit dosage" means a dosage prepared
			 for medical use, 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.
(vv) "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
			 420-3-26-.07(23).