Current through Register Vol. 42, No. 5, February 29, 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).
(3) Maintenance of Records.
Each record required by this rule must be legible throughout
the retention period specified by each Agency regulation. The record may be the
original, a reproduced copy, or a microform provided that the copy or microform
is authenticated by authorized personnel and the microform is capable of
producing a clear copy throughout the required retention period. The record may
also be stored in electronic media with the capability for producing legible,
accurate, and complete records during the required retention period. Records
such as letters, drawings, and specifications, must include all pertinent
information such as stamps, initials, and signatures. The licensee shall
maintain adequate safeguards against tampering with and loss of records.
(4)
Provisions for Research
Involving Human Subjects.
A licensee may conduct research involving human subjects using
radioactive material provided:
(a) That
the research is conducted, funded, supported, or regulated by a federal agency
which has implemented the Federal Policy for the Protection of Human Subjects.
Otherwise, a licensee shall apply for and receive approval of a specific
amendment to its Agency license before conducting such research. Both types of
licensees shall, at a minimum, obtain prior informed consent from the human
subjects and obtain prior review and approval of the research activities by an
"Institutional Review Board" in accordance with the meaning of these terms as
defined and described in the Federal Policy for the Protection of Human
Subjects;
(b) The research
involving human subjects authorized in 420-3-26-.07(4)(a) shall be conducted
using radioactive material authorized for medical use in the license;
and
(c) Nothing in 420-3-26-.07(4)
relieves licensees from complying with the other requirements in this rule.
(5)
U.S. Food and
Drug Administration, Federal, and State Requirements. Nothing in this
rule relieves the licensee from complying with applicable U.S. Food and Drug
Administration, other Federal, and State requirements governing radioactive
drugs or devices.
(6)
Implementation.
(a) When a
requirement in this Rule differs from the requirement in an existing license
condition, the requirement in this Rule shall govern.
(b) Any existing license condition that is
not affected by a requirement in this Rule remains in effect until there is a
license amendment or license renewal.
(c) If a license condition exempted a
licensee from a provision of this Rule on its effective date, it will continue
to exempt a licensee from the corresponding provision in this rule.
(d) If a license condition cites provisions
in this rule that were deleted on the effective date of this rule, then the
license condition remains in effect until there is a license amendment or
license renewal that modifies or removes this condition.
(e) Licensees shall continue to comply with
any license condition that requires it to implement procedures required by
420-3-26-.07(75), 420-3-26-.07(81), 420-3-26-.07(82) and 420-3-26-.07(83) until
there is a license amendment or renewal that modifies the license condition.
(7)
License
Required.
(a) A person shall only
manufacture, produce, prepare, acquire, receive, possess, use, or transfer
radioactive material for medical use in accordance with a specific license
issued by the Agency, or as allowed in 420-3-26-.07(7)(b) or
420-3-26-.07(7)(c).
(b) An
individual may receive, possess, use, or transfer radioactive material in
accordance with the regulations in this rule under the supervision of an
authorized user as provided in 420-3-26-.07(22), unless prohibited by license
condition.
(c) An individual may
prepare unsealed radioactive material for medical use in accordance with the
regulations in this rule under the supervision of an authorized nuclear
pharmacist or authorized user as provided in 420-3-26-.07(22), unless
prohibited by license condition.
(8)
Application for License, Amendment,
or Renewal.
(a) An application must be
signed by the applicant's or licensee's management.
(b) An application for a license for medical
use of radioactive material as described in 420-3-26-.07(45), (48), (52), (60),
(70), (72) or (90) must be made by:
1. Filing
an original of Agency Form RM that includes the facility diagram, equipment,
and training and experience qualifications of the Radiation Safety Officer,
Associate Radiation Safety Officer(s), authorized user(s), authorized medical
physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s);
and
2. Submitting procedures
required by sections 420-3-26-.07(75), 420-3-26-.07(81), 420-3-26-.07(82) and
420-3-26-.07(83), as applicable.
(c) A request for a license amendment or
renewal must be made by:
1. Submitting an
original request in letter format.
2. Submitting procedures required by sections
420-3-26-.07(75), 420-3-26-.07(81), 420-3-26-.07(82) and 420-3-26-.07(83), as
applicable.
(d) In
addition to the requirements in 420-3-26-.07(8)(b) and 420-3-26-.07(8)(c), an
application for a license or amendment for medical use of radioactive material
as described in 420-3-26-.07(90) of this rule must also include information
regarding any radiation safety aspects of the medical use of the material that
is not addressed in 420-3-26-.07(1) through 420-3-26-.07(44), identification of
and commitment to follow applicable radiation safety program requirements in
420-3-26-.07(45) though 420-3-26-.07(90); as well as any specific information
on:
1. Radiation safety precautions and
instructions;
2. Training and
experience of proposed users;
3.
Methodology for measurement of dosages or doses to be administered to patients
or human research subjects; and
4.
Calibration, maintenance, and repair of instruments and equipment necessary for
radiation safety.
(e) The
applicant or licensee shall also provide any other information requested by the
Agency in its review of the application.
(f) An applicant that satisfies the
requirements specified in
420-3-26-.02(10)(e)
may apply for a Type A specific license of broad scope.
(9)
Mobile Medical Service
Administrative Requirements.
(a) The
Agency shall license mobile medical services or clients of such services. The
mobile medical service shall be licensed if the service receives, uses or
possesses radioactive material. The client of the mobile medical service shall
be licensed if the client receives or possesses radioactive material to be used
by a mobile medical service.
(b)
Mobile medical service licensees shall obtain a letter signed by the management
of each location where services are rendered that authorizes use of radioactive
material at the client's address of use. This letter shall clearly delineate
the authority and responsibility of both the client and the mobile medical
service. If the client is licensed, the letter shall document procedures for
notification, receipt, storage and documentation of transfer of radioactive
material delivered to the client's address for use by the mobile medical
service.
(c) A mobile medical
service shall not have radioactive material delivered directly from the
manufacturer or the distributor to the client, unless the client has a license
allowing possession of the radioactive material. Radioactive material delivered
to the client shall be received and handled in conformance with the client's
license.
(d) A mobile medical
service shall inform the client's management who is on site at each client's
address of use at the time that radioactive material is being
administered.
(e) A licensee
providing mobile medical services shall retain the letter required in (9)(b) in
accordance with 420-3-26-.07 (102).
(f) A mobile medical service licensee shall,
at a minimum, maintain the following documents on each mobile unit:
1. The current operating and emergency
procedures;
2. A copy of the
license;
3. Copies of the letter
required by (9)(b);
4. Current
calibration records for each survey instrument and diagnostic equipment or dose
delivery device in use; and
5.
Survey records covering uses associated with the mobile unit during, at a
minimum, the preceding 30 calendar days.
(g) A mobile medical service licensee shall
maintain all records required by rules
420-3-26-.03
and 420-3-26-.07 of these regulations at a location within the Agency's
jurisdiction that is:
1. A single address of
use:
(i) Identified as the records retention
location; and
(ii) Staffed at all
reasonable hours by individual(s) authorized to provide the Agency with access
for purposes of inspection; or
2. When no address of use is identified on
the license for records retention, the mobile unit:
(i) Identified in the license; and
(ii) Whose current client's address schedule
and location schedule is reported to the Agency at a frequency specified by the
Agency.
(10)
License Amendments. A
licensee shall apply for and must receive a license amendment:
(a) Before it receives, prepares or uses
radioactive material for a type of use that is permitted under this rule, but
that is not authorized on the licensee's current license issued pursuant to
this rule;
(b) Before it permits
anyone, except a visiting authorized user described in 420-3-26-.07(12), a
visiting authorized medical physicist as described in 420-3-26-.07(13), or a
visiting authorized nuclear pharmacist as described in 420-3-26-.07(14) to work
as an authorized user, authorized nuclear pharmacist, authorized ophthalmic
physicist, or authorized medical physicist under the license.
(c) Before it changes Radiation Safety
Officers, except as provided in 420-3-26-.07(19)(c);
(d) Before it permits anyone to work as an
Associate Radiation Safety Officer, or before the Radiation Safety Officer
assigns duties and tasks to an Associate Radiation Safety Officer that differ
from those for which this individual is authorized on the license;
(e) Before it receives radioactive material
in excess of the amount, or in a different physical or chemical form than is
authorized on the license;
(f)
Before it adds to or changes the areas of use identified in the application or
on the license; Before it permits anyone to work as an Associate Radiation
Safety Officer, or before the Radiation Safety Officer assigns duties and tasks
to an Associate Radiation Safety Officer that differ from those for which this
individual is authorized on the license;
(g) Before it changes the address(es) of use
identified in the application or on the license;
(h) Before it changes statements,
representations, and procedures which are incorporated into the license:
and
(i) Before it receives a sealed
source from a different manufacturer or of a different model number than
authorized by its license unless the sealed source is used for manual
brachytherapy, is listed in the Sealed Source and Device Registry, and is in a
quantity and for an isotope authorized by the license.
(11)
Notifications. A licensee
shall notify the Agency by letter no later than 30 days after:
(a) A Radiation Safety Officer, authorized
user, authorized medical physicist or authorized nuclear pharmacist permanently
discontinues performance of duties under the license, or has a name
change;
(b) The licensee's mailing
address changes;
(c) The licensee's
name changes, but the name change does not constitute a transfer of control of
the license as described in
420-3-26-.02(12)(b);
or
(d) The licensee has added to or
changed the areas where radioactive material is used in accordance with
420-3-26-.07(45), or 420-3-26-.07(48), if the change does not include addition
or relocation of either an area where PET radionuclides are produced or a PET
radioactive drug delivery line from the PET radionuclide/PET radioactive drug
production area; or
(e) The
licensee obtains sealed source for use in manual brachytherapy from a different
manufacturer or with a different model number than authorized by its license
for which it did not require a license amendment as provided in
420-3-26-.07(88). The notification must include the manufacturer and model
number of the sealed source, the isotope, and the quantity per sealed
source.
(12)
Visiting Authorized User.
(a) A
licensee may permit a physician to act as a visiting authorized user and use
licensed material for medical use under the terms and conditions of the
licensee's license for 60 days each calendar year if:
1. The visiting authorized user has the prior
written permission of the licensee's management, and the Radiation Safety
Committee if one is required;
2.
The licensee has a copy of:
(i) An Agency
license that identifies the visiting authorized user, by name, as an authorized
user for medical use; or
(ii) A
permit issued by an Agency specific license of broad scope that identifies the
visiting authorized user, by name, as an authorized user for medical use;
and,
3. The visiting
authorized user performs only those procedures:
(i) For which they are specifically
authorized to perform on an Agency license; and,
(ii) Which are specifically approved on the
licensee's license.
(b) A licensee need not apply for a license
amendment in order to permit a visiting authorized user to use licensed
material as described in 420-3-26-.07(12)(a).
(c) A licensee shall retain copies of the
records specified in 420-3-26-.07(12)(a) for three years from the date of the
last visit.
(13)
Visiting Authorized Medical Physicist.
(a) A licensee may permit a medical physicist
to act as a visiting authorized medical physicist and perform the duties of a
medical physicist under the terms and conditions of the licensee's license for
60 days each calendar year if:
1. The
visiting authorized medical physicist has the prior written permission of the
licensee's management, and the Radiation Safety Committee if one is required;
and,
2. The licensee has a copy of:
(i) An Agency license that identifies the
visiting authorized medical physicist, by name, as an authorized medical
physicist; or
(ii) A permit issued
by an Agency specific license of broad scope that identifies the visiting
authorized medical physicist, by name, as an authorized medical
physicist.
(b)
A licensee need not apply for a license amendment in order to permit a visiting
authorized medical physicist to perform licensed duties as described in
420-3-26-.07(13)(a).
(c) A licensee
shall retain copies of the records specified in 420-3-26-.07(13)(a) for three
years from the date of the last visit.
(14)
Visiting Authorized Nuclear
Pharmacist.
(a) A licensee may permit
a nuclear pharmacist to act as a visiting authorized nuclear pharmacist and
perform the duties of a nuclear pharmacist under the terms and conditions of
the licensee's license for 60 days each calendar year if:
1. The visiting authorized nuclear pharmacist
has the prior written permission of the licensee's management, and the
Radiation Safety Committee if one is required;
2. The licensee has a copy of:
(i) An Agency license that identifies the
visiting authorized nuclear pharmacist, by name, as an authorized nuclear
pharmacist; or
(ii) A permit issued
by an Agency specific license of broad scope that identifies the nuclear
pharmacist, by name, as an authorized nuclear
pharmacist.
(b)
A licensee need not apply for a license amendment in order to permit a visiting
authorized nuclear pharmacist to perform licensed duties as described in
420-3-26-.07(14)(a).
(c) A licensee
shall retain copies of the records specified in 420-3-26-.07(14)(a) for 3 years
from the date of the last visit.
(15)
Exemptions Regarding Type A
Specific Licenses of Broad Scope. A licensee possessing a Type A
specific license of broad scope for medical use is exempt from:
(a) The provisions of 420-3-26-.07(8)(d),
regarding the need to file an amendment to the license for medical uses of
radioactive material, as described in 420-3-26-.07(90);
(b) The provisions of
420-3-26-.07(10)(b);
(c) The
provisions of 420-3-26-.07(10)(e) regarding additions to or changes in the
areas of use at the addresses specified in the license;
(d) The provisions of 420-3-26-.07(11)(a)
regarding notification to the Agency for authorized users, authorized medical
physicists, authorized nuclear pharmacists, and ophthalmic
physicists;
(e) The provisions of
420-3-26-.07(11)(c) and (d); and
(f) The provisions of
420-3-26-.07(25)(a).
(16)
License Issuance.
(a) The Agency
shall issue a license for the medical use of radioactive material if:
1. The applicant has filed an Agency Form RM
in accordance with the instructions in 420-3-26-.07(8);
2. The applicant has paid any applicable
fee;
3. The applicant meets the
requirements of
420-3-26-.02 of these
regulations; and
4. The Agency
finds the applicant equipped and committed to observe the safety standards
established by the Agency in these regulations for the protection of the public
health and safety.
(b)
The Agency shall issue a license for mobile services if the applicant:
1. Meets the requirements in
420-3-26-.07(16)(a); and
2. Assures
that individuals to whom radioactive drugs or radiation from implants
containing radioactive material will be administered, may be released following
treatment in accordance with 420-3-26-.07(41).
(17)
Specific Exemptions. The
Agency may, upon application of any interested person or upon its own
initiative, grant such exemptions from the regulations in this rule as it
determines are authorized by law and will not endanger life or property or the
common defense and security and are otherwise in the public interest.
(18)
ALARA Program.
(a) Each licensee shall develop and implement
a written program to maintain radiation doses and releases of radioactive
material in effluents to unrestricted areas as low as reasonably achievable in
accordance with
420-3-26-.03(5)(b)
of these rules.
(b) To satisfy the
requirement of 420-3-26-.07(18)(a):
1. The
management, Radiation Safety Officer and all authorized users shall participate
in the establishment, implementation, and operation of the program as required
by these regulations or required by the Radiation Safety Committee.
2. For licensees that are not medical
institutions, management and all authorized users shall participate in the
program as requested by the Radiation Safety Officer.
(c) The ALARA program shall include an annual
review, by the Radiation Safety Committee for licensees that are medical
institutions, or management and the Radiation Safety Officer for licensees that
are not medical institutions, of summaries of the types and amounts of
radioactive material used, occupational dose reports, and continuing education
and training for all personnel who work with or in the vicinity of radioactive
material.
(d) The purpose of the
review is to ensure that individuals make every reasonable effort to maintain
occupational doses, doses to the general public, and releases of radioactive
material as low as reasonably achievable, taking into account the state of
technology, and the cost of improvements in relation to benefits.
(e) The licensee shall retain a current
written description of the ALARA program for the duration of the license.
The written description must include:
1. A commitment by management to keep
occupational doses as low as reasonably achievable;
2. A requirement that the Radiation Safety
Officer brief management once each year on the radiation safety
program;
3. Personnel exposure
action levels that, when exceeded, will initiate an investigation by the
Radiation Safety Officer of the cause of the exposure; and
4. Personnel exposure investigational levels
that, when exceeded, will initiate a prompt investigation by the Radiation
Safety Officer of the cause of the exposure and a consideration of actions that
might be taken to reduce the probability of recurrence.
(19)
Authority and
Responsibilities for the Radiation Protection Program.
(a) In addition to the radiation protection
program requirements of
420-3-26-.03(5)
of these regulations, a licensee's management must approve in writing:
1. Requests for license application, renewal,
or amendments before submittal to the Agency;
2. Radiation protection program changes that
do not require a license amendment and are permitted under 420-3-26-.07(20);
and
3. Any individual before
allowing that individual to act as a visiting authorized user, visiting
authorized medical physicist or a visiting authorized nuclear
pharmacist.
(b) A
licensee's management shall appoint a Radiation Safety Officer, who agrees in
writing to be responsible for implementing the radiation protection program.
The licensee, through the Radiation Safety Officer, shall ensure that radiation
safety activities are being performed in accordance with licensee-approved
procedures and regulatory requirements. A licensee s management may appoint, in
writing, one or more Associate Radiation Safety Officers to support the
Radiation Safety Officer. The Radiation Safety Officer, with written agreement
of the licensee's management, must assign the specific duties and tasks to each
Associate Radiation Safety Officer. These duties and tasks are restricted to
the types of use for which the Associate Radiation Safety Officer is listed on
a license. The Radiation Safety Officer may delegate duties and tasks to the
Associate Radiation Safety Officer but shall not delegate the authority or
responsibilities for implementing the radiation protection program.
(c) For up to 60 days each year, a licensee
may permit an authorized user or an individual qualified to be a Radiation
Safety Officer to function as a temporary Radiation Safety Officer and to
perform the functions of a Radiation Safety Officer, as provided in
420-3-26-.07(19)(e), provided the licensee takes the actions required in
420-3-26-.07(19)(b),(d), (e) and (h). A licensee may simultaneously appoint
more than one temporary Radiation Safety Officer, if needed, to ensure that the
licensee has a temporary Radiation Safety Officer that satisfies the
requirements to be a Radiation Safety Officer for each of the different uses of
radioactive material permitted by the license.
(d) A licensee shall establish in writing the
authority, duties, and responsibilities of the Radiation Safety
Officer.
(e) A licensee shall
provide the Radiation Safety Officer sufficient authority, organizational
freedom, time, resources, and management prerogative, to:
1. Identify radiation safety
problems;
2. Initiate, recommend,
or provide corrective actions;
3.
Stop unsafe operations; and,
4.
Verify implementation of corrective actions.
(f) Licensees that are authorized for two or
more different types of radioactive material use under 420-3-26-.07(52),
420-3-26-.07(60), 420-3-26-.07(72) and 420-3-26-.07(90), or two or more types
of units under 420-3-26-.07(72) shall establish a Radiation Safety Committee to
oversee all uses of radioactive material permitted by the license. The
committee must include an authorized user of each type of use permitted by the
license, the Radiation Safety Officer, a representative of the nursing service,
and a representative of management who is neither an authorized user nor a
Radiation Safety Officer, and may include other members as the licensee deems
appropriate.
(g) A licensee shall
provide the Radiation Safety Officer sufficient authority, organizational
freedom, time, resources, and management prerogative, to:
1. Identify radiation safety
problems;
2. Initiate, recommend,
or provide corrective actions;
3.
Stop unsafe operations; and
4.
Verify implementation of corrective actions.
(h) For record requirements, see
420-3-26-.07(91).
(20)
Radiation Protection Program Changes.
(a) A licensee may revise its radiation
protection program without Agency approval if:
1. The revision does not require an amendment
under 420-3-26-.07(10);
2. The
revision is in compliance with the regulations and the license;
3. The revision has been reviewed and
approved by the Radiation Safety Officer, licensee management and licensee's
Radiation Safety Committee (if applicable); and
4. The affected individuals are instructed on
the revised program before the changes are implemented.
(b) A licensee shall retain a record of each
change in accordance with 420-3-26-.07(92).
(21)
Duties of Authorized Users and
Authorized Medical Physicists.
(a) A
licensee shall assure that only authorized users for the type of radioactive
material used:
1. Select the patients to
receive radiopharmaceuticals or radiation from radioactive materials;
2. Prescribe the radiopharmaceutical dosage
and/or dose to be administered, in writing, through the issuance of a written
directive as described in 420-3-26-.07(23) or by written reference to the
diagnostic clinical procedures manual;
3. Direct, as specified in 420-3-26-.07(22)
and 420-3-26-.07(23), or in license conditions, the administration of
radiopharmaceuticals or radioactive material for medical use to patients or
human research subjects;
4. Prepare
and administer, or supervise the preparation and administration of
radiopharmaceuticals or radioactive material for medical use, in accordance
with 420-3-26-.07(7)(b), 420-3-26-.07(7) (c) and 420-3-26-.07(22);
and
5. Perform the final
interpretation of the results of tests, studies, or treatments.
(b) A licensee shall assure that
only authorized medical physicists perform, as applicable:
1. Full calibration measurements as described
in 420-3-26-.07(78), 420-3-26-.07(79) and 420-3-26-.07(80);
2. Periodic spot checks as described in
420-3-26-.07(81), 420-3-26-.07(82) and 420-3-26-.07(83); and
3. Radiation surveys as described in
420-3-26-.07(85).
(22)
Supervision.
(a) A licensee that permits the receipt,
possession, use, or transfer of radioactive material by an individual under the
supervision of an authorized user or as allowed by 420-3-26-.07(7)(b) shall:
1. In addition to the requirements in
420-3-26-.10(3)
of these regulations, instruct the supervised individual in the licensee's
written radiation protection procedures, written directive procedures,
regulations of this rule, and license conditions with respect to the use of
radioactive material; and
2.
Require the supervised individual to follow the instructions of the supervising
authorized user for medical uses of radioactive material, written radiation
protection procedures, written directive procedures, regulations of this rule,
and license conditions with respect to the medical use of radioactive
material.
(b) A licensee
that permits the preparation of radioactive material for medical use by an
individual under the supervision of an authorized nuclear pharmacist or
physician who is an authorized user, as allowed by 420-3-26-.07(7)(c)., shall:
1. Instruct the supervised individual in the
preparation of radioactive material for medical use, as appropriate to that
individual's involvement with radioactive material; and
2. Require the supervised individual to
follow the instructions of the supervising authorized user or authorized
nuclear pharmacist regarding the preparation of radioactive material for
medical use, the written radiation protection procedures, the regulations of
this rule, and license conditions.
(c) Unless physical presence as described in
other sections of this rule is required, a licensee who permits supervised
activities under 420-3-26-.07(22)(a) and 420-3-26-.07(22)(b) shall require an
authorized user to be immediately available (by telephone within ten minutes)
to communicate with the supervised individual, and able to be physically
present within one hour of notification; and
(d) A licensee that permits supervised
activities under 420-3-26-.07(22)(a) and 420-3-26-.07(22)(b) is responsible for
the acts and omissions of the supervised individual.
(23)
Written Directives.
(a) A written directive must be dated and
signed by an authorized user prior to administration of I-131 sodium iodide
greater than 1.11 megabecquerel (30 microcuries), any therapeutic dosage of
radioactive material or any therapeutic dose of radiation from radioactive
material.
1. If, because of the emergent
nature of the patient's condition, a delay in order to provide a written
directive would jeopardize the patient's health, an oral directive will be
acceptable, provided that the information contained in the oral directive is
documented as soon as possible in writing in the patient's record and a written
directive is prepared within 48 hours of the oral directive.
(b) The written directive must
contain the patient or human research subject's name and the following:
1. For an administration of quantities
greater than 1.11 megabecquerel (30 microcuries) of sodium iodide I-131, the
dosage;
2. For any administration
of therapeutic dosage of unsealed radioactive material other than sodium iodide
I-131, the radioactive drug, dosage, and route of administration;
3. For gamma stereotactic radiosurgery, the
total dose, treatment site, and values for the target coordinate settings per
treatment for each anatomically distinct treatment site;
4. For teletherapy, the total dose, dose per
fraction, number of fractions, and treatment site;
5. For high dose rate remote afterloading
brachytherapy, the radionuclide, treatment site, dose per fraction, number of
fractions, and total dose;
6. For
permanent implant brachytherapy;
(i) Prior to
implantation, the treatment site, the radionuclide, and the total source
strength; and
(ii) After
implantation but before the patient leaves the post-treatment recovery area the
treatment site, the number of sources implanted, the total source strength
implanted, and the date; or
7. For all other brachytherapy including LDR,
MDR, and PDR:
(i) Prior to implantation:
treatment site, the radionuclide, and dose; and
(ii) After implantation but prior to
completion of the procedure: the radioisotope, treatment site, number of
sources, and total source strength and exposure time (or, the total dose), and
date.
(c) For
all other medical uses of radioactive material that do not require a specific
written directive, an authorized user shall prescribe the radiopharmaceutical
dosage and/or dose from radioactive material to be administered in writing, or
by written reference to the diagnostic clinical procedures manual.
(d)
1. A
written revision to an existing written directive or written prescription may
be made provided that the revision is dated and signed by an authorized user
prior to the administration of the dosage of radioactive drug containing
radioactive material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose, or the next fractional dose.
2. If, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
or written prescription would jeopardize the patient's health, an oral revision
to an existing written directive will be acceptable, provided that the oral
revision is documented as soon as possible in the patient's record and a
revised written directive is signed by the authorized user within 48 hours of
the oral revision.
(e)
The licensee shall retain the written directive in accordance with
420-3-26-.07(93).
(24)
Procedures for Administrations Requiring a Written Directive.
(a) For any administration requiring a
written directive, the licensee shall develop, implement, and maintain written
procedures to provide high confidence that:
1.
The patient's or human research subject's identity is verified before each
administration; and
2. Each
administration is in accordance with the written directive.
(b) The procedures required by
420-3-26-.07(24)(a) must, at a minimum, address the following items that are
applicable for the licensee's use of radioactive material:
1. Verifying the identity of the patient or
human research subject;
2.
Verifying that the specific details of the administration are in accordance
with the treatment plan, if applicable, and the written directive;
3. Checking both manual and
computer-generated dose calculations;
4. Verifying that any computer-generated dose
calculations are correctly transferred into the consoles of therapeutic medical
units authorized by 420-3-26-.07(72) and (90);
5. Determining if a misadministration as
defined in 420-3-26-.07 (120) has occurred; and
6. Determining for permanent implant
brachytherapy, within 60 calendar days from the date the implant was performed,
the total source strength administered outside of the treatment site compared
to the total source strength documented in the post-implantation portion of the
written directive, unless a written justification of patient unavailability is
documented.
(25)
Suppliers for Sealed Sources or
Devices for Medical Use. For medical use, a licensee may only use:
(a) Sealed sources or devices initially
manufactured, labeled, packaged, and distributed in accordance with a license
issued pursuant to
420-3-26-.02 of these
regulations or the equivalent requirements of the U.S. Nuclear Regulatory
Commission or an Agreement State;
(b) Sealed sources or devices noncommercially
transferred from an Agency, U.S. Nuclear Regulatory Commission or Agreement
State licensee: or
(c) Teletherapy
sources manufactured and distributed in accordance with a license issued
pursuant to
420-3-26-.02 of these
regulations or the equivalent requirements of the U.S. Nuclear Regulatory
Commission or an Agreement State.
(26)
Training for Radiation Safety
Officer and Associate Radiation Safety Officer. Except as provided in
420-3-26-.07(29), the licensee shall require an individual fulfilling the
responsibilities of the Radiation Safety Officer (RSO) or an individual
assigned duties and tasks as an Associate Radiation Safety Officer as provided
in 420-3-26-.07(19)(b) to be an individual who:
(a) Is certified by a specialty board whose
certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State and who meets the requirements of
paragraphs (d) of this section. The names of board certifications that have
been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an
Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.
To have its certification process recognized, a specialty board shall require
all candidates for certification to:
1.
(i) Hold a bachelor's or graduate degree from
an accredited college or university in physical science or engineering or
biological science with a minimum of 20 college credits in physical
science;
(ii) Have 5 or more years
of professional experience in health physics (graduate training may be
substituted for no more than 2 years of the required experience), including at
least 3 years in applied health physics; and
(iii) Pass an examination administered by
diplomates of the specialty board, which evaluates knowledge and competence in
radiation physics and instrumentation, radiation protection, mathematics
pertaining to the use and measurement of radioactivity, radiation biology, and
radiation dosimetry; or
2.
(i) Hold
a master's or doctor's degree in physics, medical physics, other physical
science, engineering, or applied mathematics from an accredited college or
university;
(ii) Have 2 years of
full-time practical training and/or supervised experience in medical physics:
(I) Under the supervision of a medical
physicist who is certified in medical physics by a specialty board recognized
by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State;
or
(II) In clinical nuclear
medicine facilities providing diagnostic and/or therapeutic services under the
direction of physicians who meet the requirements for authorized users in
420-3-26-.07(29), 420-3-26-.07(51) or 420-3-26-.07(56); and
(iii) Pass an examination,
administered by diplomats of the specialty board, that assesses knowledge and
competence in clinical diagnostic radiological or nuclear medicine physics and
in radiation safety; or
(b)
1. Has
completed a structured educational program consisting of both:
(i) 200 hours of classroom and laboratory
training in the following areas:
(I) Radiation
physics and instrumentation;
(II)
Radiation protection;
(III)
Mathematics pertaining to the use and measurement of radioactivity;
(IV) Radiation biology; and
(V) Radiation dosimetry; and
(ii) One year of full-time
radiation safety experience under the supervision of the individual identified
as the Radiation Safety Officer on an Agency, U.S. Nuclear Regulatory
Commission, Agreement State license, or permit issued by a U. S. Nuclear
Regulatory Commission master material licensee that authorizes similar type(s)
of use(s) of radioactive material. An Associate Radiation Safety Officer may
provide supervision for those areas for which the Associate Radiation Safety
Officer is authorized by an Agency, the U.S Nuclear Regulatory Commission, or
an Agreement State license, or a permit issued by a U.S. Nuclear Regulatory
Commission master material licensee. The full-time radiation safety experience
must involve the following:
(I) Shipping,
receiving, and performing related radiation surveys;
(II) Using and performing checks for proper
operation of instruments used to determine the activity of dosages, survey
meters, and instruments used to measure radionuclides;
(III) Securing and controlling radioactive
material;
(IV) Using administrative
controls to avoid mistakes in the administration of radioactive
material;
(V) Using procedures to
prevent or minimize radioactive contamination and using proper decontamination
procedures;
(VI) Using emergency
procedures to control radioactive material; and
(VII) Disposing of radioactive material;
and
2. This
individual must obtain a written attestation, signed by a preceptor Radiation
Safety Officer or Associate Radiation Safety Officer who has experience with
the radiation safety aspects of similar types of use of radioactive mate1ial
for which the individual is seeking approval as a Radiation Safety Officer or
an Associate Radiation Safety Officer. The written attestation must state that
the individual has satisfactorily completed the requirements in paragraphs (b)1
and (d) of this section, and is able to independently fulfill the radiation
safety related duties as a Radiation Safety Officer or as an Associate
Radiation Safety Officer for a medical use license; or
(c)
1. Is a
medical physicist who has been certified by a specialty board whose
certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State under 420-3-26-.07(27)(a) and has
experience in radiation safety for similar types of use of radioactive material
for which the licensee is seeking the approval of the individual as Radiation
Safety Officer or Associate Radiation Safety Officer, and who meets the
requirements in paragraphs 420-3-26-.07(26)(d) and (e); or
2. Is an authorized user, authorized medical
physicist, or authorized nuclear pharmacist identified by an Agency, U.S.
Nuclear Regulatory Commission, or an Agreement State license, a permit issued
by a U. S. Nuclear Regulatory Commission master material licensee, a permit
issued by an Agency, U.S. Nuclear Regulatory Commission, or an Agreement State
licensee of broad scope, or a permit issued by a U. S. Nuclear Regulatory
Commission master material broad scope permittee, has experience with the
radiation safety aspects of similar types of use of radioactive material for
which the licensee seeks the approval of the individual as the Radiation Safety
Officer or Associate Radiation Safety Officer, and meets the requirements of
paragraph 420-3-26-.07(26)(d); and
3. Has experience with the radiation safety
aspects of the types of use of radioactive material for which the individual is
seeking simultaneous approval both as the Radiation Safety Officer and the
authorized user on the same medical use license issued by the Agency. The
individual must meet the requirements in paragraph
420-3-26-.07(26)(d).
(d)
Has training in the radiation safety, regulatory issues, and emergency
procedures for the types of use for which a licensee seeks approval. This
training requirement may be satisfied by completing training that is supervised
by a Radiation Safety Officer, an Associate Radiation Safety Officer,
authorized medical physicist, authorized nuclear pharmacist, or authorized
user, as appropriate, who is authorized for the type(s) of use for which the
licensee is seeking approval.
(27)
Training for Authorized Medical
Physicist. Except as provided in 420-3-26-.07(29), the licensee shall
require the authorized medical physicist to be an individual who:
(a) Is certified by a specialty board whose
certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State and who meets the requirements in
paragraphs 420-3-26-.07(27)(c). The names of board certifications that have
been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an
Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.
To have its certification process recognized, a specialty board shall require
all candidates for certification to:
1. Hold a
master's or doctor's degree in physics, medical physics, other physical
science, engineering, or applied mathematics from an accredited college or
university;
2. Have 2 years of
full-time practical training and/or supervised experience in medical physics:
(i) Under the supervision of a medical
physicist who is certified in medical physics by a specialty board whose
certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission, or an Agreement State; or
(ii) In clinical radiation facilities
providing high-energy, external beam therapy (photons and electrons with
energies greater than or equal to 1 million electron volts) and brachytherapy
services under the direction of physicians who meet the requirements for
authorized users in 420-3-26-.07(29), 420-3-26-.07(68) or 420-3-26-.07(89); and
3. Pass an examination, administered by diplomates of the specialty board, that
assesses knowledge and competence in clinical radiation therapy, radiation
safety, calibration, quality assurance, and treatment planning for external
beam therapy, brachytherapy, and stereotactic radiosurgery; or
(b)
1. Holds a master's or doctor's degree in
physics, medical physics, other physical science, engineering, or applied
mathematics from an accredited college or university; and has completed 1 year
of full-time training in medical physics and an additional year of full-time
work experience under the supervision of an individual who meets the
requirements for an authorized medical physicist for the type(s) of use for
which the individual is seeking authorization. This training and work
experience must be conducted in clinical radiation facilities that provide
high-energy, external beam therapy (photons and electrons with energies greater
than or equal to 1 million electron volts) and brachytherapy services and must
include:
(i) Performing sealed source leak
tests and inventories;
(ii)
Performing decay corrections;
(iii)
Performing full calibration and periodic spot checks of external beam treatment
units, stereotactic radiosurgery units, and remote afterloading units as
applicable; and
(iv) Conducting
radiation surveys around external beam treatment units, stereotactic
radiosurgery units, and remote afterloading units as applicable; and
2. Has obtained written
attestation that the individual has satisfactorily completed the requirements
in paragraphs 420-3-26-.07(27)(b) l. and (c), and is able to independently
fulfill the radiation safety-related duties as an authorized medical physicist
for each type of therapeutic medical unit for which the individual is
requesting authorized medical physicist status. The written attestation must be
signed by a preceptor authorized medical physicist who meets the requirements
in 420-3-26-.07(27), 420-3-26-.07(29) or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements for an authorized medical physicist
for each type of therapeutic medical unit for which the individual is
requesting authorized medical physicist status; and
(c) Has training for the type(s) of use for
which authorization is sought that includes hands-on device operation, safety
procedures, clinical use, and the operation of a treatment planning system.
This training requirement may be satisfied by satisfactorily completing either
a training program provided by the vendor or by training supervised by an
authorized medical physicist authorized for the type(s) of use for which the
individual is seeking authorization.
(28)
Training for an Authorized Nuclear
Pharmacist. Except as provided in 420-3-26-.07(29), the licensee shall
require the authorized nuclear pharmacist to be a pharmacist who:
(a) Is certified by a specialty board whose
certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State. The names of board certifications
that have been recognized by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State are posted on the NRC s Medical Uses Licensee
Toolkit Web page. To have its certification process recognized, a specialty
board shall require all candidates for certification to:
1. Have graduated from a pharmacy program
accredited by the American Council on Pharmaceutical Education (ACPE) or have
passed the Foreign Pharmacy Graduate Examination Committee (FPGEC)
examination;
2. Hold a current,
active license to practice pharmacy;
3. Provide evidence of having acquired at
least 4000 hours of training/experience in nuclear pharmacy practice. Academic
training may be substituted for no more than 2000 hours of the required
training and experience; and
4.
Pass an examination in nuclear pharmacy administered by diplomates of the
specialty board, that assesses knowledge and competency in procurement,
compounding, quality assurance, dispensing, distribution, health and safety,
radiation safety, provision of information and consultation, monitoring patient
outcomes, research and development; or
(b)
1. Has
completed 700 hours in a structured educational program consisting of both:
(i) 200 hours of classroom and laboratory
training in the following areas
(I) Radiation
physics and instrumentation;
(II)
Radiation protection;
(III)
Mathematics pertaining to the use and measurement of radioactivity;
(IV) Chemistry of radioactive material for
medical use; and
(V) Radiation
biology; and
(ii)
Supervised practical experience in a nuclear pharmacy involving
(I) Shipping, receiving, and performing
related radiation surveys;
(II)
Using and performing checks for proper operation of instruments used to
determine the activity of dosages, survey meters, and, if appropriate,
instruments used to measure alpha-or beta-emitting radionuclides;
(III) Calculating, assaying, and safely
preparing dosages for patients or human research subjects;
(IV) Using administrative controls to avoid
medical events in the administration of radioactive material; and
(V) Using procedures to prevent or minimize
radioactive contamination and using proper decontamination procedures;
and
2. Has
obtained written attestation, signed by a preceptor authorized nuclear
pharmacist, that the individual has satisfactorily completed the requirements
in 420-3-26-.07(28)(b)1. and is able to independently fulfill the radiation
safety-related duties as an authorized nuclear pharmacist.
(29)
Provisions for
Experienced Radiation Safety Officer, Medical Physicist, Authorized User, and
Nuclear Pharmacist.
(a)
1. An individual identified on an Agency, a
U.S. Nuclear Regulatory Commission or an Agreement State license, or a permit
issued by an Agency, a U.S. Nuclear Regulatory Commission or an Agreement State
broad scope license, or master material license permit, or by a master material
license permittee of broad scope as a Radiation Safety Officer, a teletherapy
or medical physicist, or an authorized medical physicist, a nuclear pharmacist
or an authorized nuclear pharmacist on or before November 14, 2021 need not
comply with training requirements of 420-3-26-.07(26), 420-3-26-.07(27) or
420-3-26-.07(28), respectively, except the Radiation Safety Officers and
authorized medical physicists identified in this paragraph must meet the
training requirements in 420-3-26-.07(26)(d) or 420-3-26-.07(28)(c), as
appropriate for any material or uses for which they were not authorized prior
to this date.
2. Any individual
certified by the American Board of Health Physics in Comprehensive Health
Physics; American Board of Radiology· American Board of Nuclear
Medicine; American Board of Science in Nuclear Medicine; Board of
Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical
Physics in radiation oncology physics; Royal College of Physicians and Surgeons
of Canada in nuclear medicine; American Osteopathic Board of Radiology; or
American Osteopathic Board of Nuclear Medicine on or before October 24, 2005,
need not comply with the training requirements of 420-3-26-.07(26) to be
identified as a Radiation Safety Officer or as an Associate Radiation Safety
Officer on an Agency, a U.S. Nuclear Regulatory Commission, or an Agreement
State license or U.S. Nuclear Regulatory Commission master material license
permit for those materials and uses that these individuals performed on or
before October 24, 2005.
3. Any
individual certified by the American Board of Radiology in therapeutic
radiological physics, Roentgen ray and gamma ray physics, x-ray and radium
physics, or radiological physics or certified by the American Board of Medical
Physics in radiation oncology physics, on or before October 24, 2005, need not
comply with the training requirements for an authorized medical physicist
described in 420-3-26-.07(27), for those materials and uses that these
individuals performed on or before October 24, 2005.
(b)
1.
Physicians, dentists, or podiatrists identified as authorized users for the
medical use of radioactive material on a license issued by the Agency, an
Agreement State or U.S. Nuclear Regulatory Commission, a permit issued by an
Agency, Agreement State or U.S. Nuclear Regulatory Commission broad scope
licensee, or a permit issued by a U.S. Nuclear Regulatory Commission master
material license broad scope permittee before January 14, 2019, who perform
only those medical uses for which they were authorized on that date need not
comply with the training requirements of this rule.
2. Physicians, dentists, or podiatrists
identified as authorized users for the medical use of radioactive material on a
license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an
Agreement State, a permit issued by a U.S. Nuclear Regulatory Commission master
material licensee, a permit issued by an Agency, a U.S. Nuclear Regulatory
Commission, or an Agreement State broad scope licensee, or a permit issued by a
U.S. Nuclear Regulatory Commission master material license of broad scope on or
before October 24, 2005, need not comply with the training requirements of the
rule for those materials and uses that these individuals performed on or before
October 24, 2005, as follows:
(i) For uses
authorized under 420-3-26-.07(45) or 420-3-26-.07(48), or oral administration
of sodium iodide I-131 requiring a written directive for imaging and
localization purposes, a physician who was certified on or before October 24,
2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic
radiology by the American Board of Radiology; diagnostic radiology or radiology
by the American Osteopathic Board of Radiology; nuclear medicine by the Royal
College of Physicians and Surgeons of Canada; or American Osteopathic Board of
Nuclear Medicine in nuclear medicine;
(ii) For uses authorized under
420-3-26-.07(52), a physician who was certified on or before October 24, 2005,
by the American Board of Nuclear Medicine; the American Board of Radiology in
radiology, therapeutic radiology, or radiation oncology; nuclear medicine by
the Royal College of Physicians and Surgeons of Canada; or the American
Osteopathic Board of Radiology after 1984;
(iii) For uses authorized under
420-3-26-.07(60) or 420-3-26-.07(72), a physician who was certified on or
before October 24, 2005, in radiology, therapeutic radiology, or radiation
oncology by the American Board of Radiology, radiation oncology by the American
Osteopathic Board of Radiology; radiology, with specialization in radiotherapy,
as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal
College of Radiology"; or therapeutic radiology by the Canadian Royal College
of Physicians and Surgeons; and
(iv) For uses authorized under
420-3-26-.07(70), a physician who was certified on or before October 24, 2005,
in radiology, therapeutic radiology, or radiation oncology by the American
Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine;
diagnostic radiology or radiology by the American Osteopathic Board of
Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons
of Canada.
(c)
Individuals who meet the provisions for experienced Radiation Safety Officer,
Authorized Medical Physicist, Authorized User or Authorized Nuclear Pharmacist
may serve as a preceptor for, and supervisors of, applicants seeking
authorization on Agency licenses for the same uses for which the preceptoring
individual is authorized.
(30)
Recentness of Training. The
training and experience specified in this rule must have been obtained
within the seven (7) years preceding the date of application or the individual
must have had related continuing education and experience since the required
training and experience was completed.
(31)
Quality Control of Diagnostic
Equipment. Each licensee shall establish written quality control
procedures for all diagnostic equipment used for radionuclide studies. As a
minimum, quality control procedures and frequencies shall be those recommended,
in writing, by equipment manufacturers or procedures which have been approved
by the Agency. The licensee shall conduct quality control procedures in
accordance with written procedures.
(32)
Possession, Use, and Testing of
Instruments to Measure the Activity of Unsealed Radioactive Materials.
(a) For direct measurements performed in
accordance with 420-3-26-.07(34), a licensee shall possess and use
instrumentation to measure the activity of unsealed radioactive materials prior
to administration to each patient or human research subject.
(b) A licensee shall:
1. Check each dose calibrator for constancy
with a dedicated check source at the beginning of each day of use. To satisfy
the requirement of this section, the check must be done on a frequently used
setting with a sealed source of not less than 3700 kilobecquerel (100
microcuries) for any photon-emitting radionuclide with a half-life greater than
90 days;
2. Test each dose
calibrator for accuracy upon installation and at intervals not to exceed 12
months thereafter by assaying at least 2 sealed sources containing different
radionuclides, the activity of which the manufacturer has determined within 5
percent of the stated activity, with minimum activity of 3700 kilobecquerel
(100 microcuries) for any photon-emitting radionuclide, and at least one of
which has a principal photon energy between 100 keV and 500 keV;
3. Test each dose calibrator for linearity
upon installation and at intervals not to exceed three months thereafter over
the range of use between 1.1 Megabecquerel (30 µCi) and the highest
dosage that will be administered; and
4. Test each dose calibrator for geometry
dependence upon installation over the range of volumes and volume
configurations for which it will be used. The licensee shall keep a record of
this test for the duration of the use of the dose calibrator.
(c) A licensee shall
mathematically correct dosage readings for any geometry or linearity error that
exceeds 10 percent if the dosage is greater than 1.1 Megabecquerel (30
µCi) and shall repair or replace the dose calibrator if the accuracy or
constancy error exceeds 10 percent.
(d) A licensee shall also perform checks and
tests required by 420-3-26-.07(32) following adjustment or repair of the dose
calibrator.
(e) A licensee shall
retain a record of each instrument test required by 420-3-26-.07(32) in
accordance with 420-3-26-.07(96).
(33)
Calibration of Survey
Instruments.
(a) A licensee shall
ensure that the survey instruments used to show compliance with 420-3-26-.07
and
420-3-26-.03
of these regulations have been calibrated before first use, annually, and
following any repair that will affect the calibration.
(b) To satisfy the requirements of
420-3-26-.07(33)(a), the licensee shall:
1.
Calibrate all required scale readings up to 10 millisieverts (1000 millirem)
per hour with a radiation source;
2. Have each radiation survey instrument
calibrated:
(i) At energies appropriate for
use and at intervals not to exceed 12 months or after instrument servicing,
except for battery changes;
(ii)
For linear scale instruments, at two points located approximately one-third and
two-thirds of full-scale on each scale; for logarithmic scale instruments, at
mid-range of each decade, and at two points of at least one decade; and for
digital instruments, at 3 points between 0.02 and 10 millisieverts (2 and 1000
millirem) per hour; and
(iii) For
dose rate instruments, so that an accuracy within plus or minus 20 percent of
the true radiation dose rate can be demonstrated at each point
checked.
3. Conspicuously
note on the instrument the date of calibration.
(c) The licensee shall not use survey
instruments if the difference between the indicated exposure rate and the
calculated exposure rate is greater than 20 percent.
(d) A licensee shall check each survey
instrument for consistent response with a dedicated check source before each
use. The licensee is not required to keep records of these checks.
(e) The licensee shall retain a record of
each survey instrument calibration in accordance with
420-3-26-.07(97).
(34)
Determination of Dosages of Radioactive Material for Medical Use.
(a) A licensee shall determine and record the
activity of each dosage prior to medical use. For photon-emitting radioactive
material, this determination shall be within 30 minutes prior to medical use.
For all other radioactive material, this determination shall be within the
period before medical use that is no greater than 10 percent of the physical
half-life of the radioactive material.
(b) This determination must be made by direct
measurement of radioactivity or by a combination of measurements of
radioactivity and mathematical calculations or combination of volumetric
measurements and mathematical calculations, based on the measurement made by a
manufacturer or preparer licensed pursuant to
420-3-26-.02 of these
regulations, or equivalent provisions of the U.S. Nuclear Regulatory Commission
or an Agreement State.
(c) Unless
otherwise directed by the authorized user, a licensee shall not use a dosage if
the dosage differs from the prescribed dosage by more than 20
percent.
(d) A licensee shall
retain a record of the dosage determination required by this rule in accordance
with 420-3-26-.07(98).
(35)
Authorization for Calibration,
Transmission and Reference Sources.
(a)
Any person authorized by 420-3-26-.07(7) for medical use of radioactive
material may receive, possess, and use the following radioactive material for
check, calibration, transmission, and reference use:
1. Sealed sources manufactured and
distributed by persons specifically licensed pursuant to
420-3-26-.02 or
equivalent provisions of the U.S. Nuclear Regulatory Commission or an Agreement
State and that do not exceed 1.11 gigabecquerels (30 millicurie)
each;
2. Sealed sources, not
exceeding 1.11 gigabecquerels (30 millicuries) each, redistributed by a license
authorized to redistribute the sealed sources manufactured and distributed by a
person licensed pursuant to
420-3-26-.02 or
equivalent provisions of the U.S. Nuclear Regulatory Commission or an Agreement
State providing the redistributed sealed sources are in t11e original packaging
and shielding and are accompanied by the manufacturer's approved
instructions.
3. Any radioactive
material with a half-life of 120 days or less in individual amounts not to
exceed 555 megabecquerels (15 millicurie);
4. Any radioactive material with a half-life
greater than 120 days in individual amounts not to exceed the smaller of:
(i) 7.4 megabecquerels (200 µCi);
or
(ii) 1000 times the quantities
in Appendix B of
420-3-26-.02;
or
5. Technetium-99m in
amounts as needed.
(b)
Radioactive material in sealed sources authorized by this provision shall not
be:
1. Used for medical use as defined in
420-3-26-.07(2) except in accordance with the requirements in 420-3-26-.07(70);
or
2. Combined (i.e. bundled or
aggregated) to create an activity greater than the maximum activity of any
single sealed source authorized under this section.
(c) A license using calibration,
transmission, and reference sources in accordance with the requirements in
420-3-26-.07(35)(a) or (b) need not list these sources on specific medical use
license.
(36)
Requirements for Possession of Sealed Sources and Brachytherapy
Sources.
(a) A licensee in possession
of any sealed source or brachytherapy source shall follow the radiation safety
and handling instructions supplied by the manufacturer or equivalent
instructions approved by the Agency.
(b) A licensee in possession of a sealed
source shall:
1. Test the source for leakage
in accordance with
420-3-26-.03.
2. Test the source for leakage at intervals
not to exceed 6 months or at other intervals approved by the Agency, an
Agreement State or the U.S. Nuclear Regulatory Commission in the Sealed Source
and Device Registry.
(c)
If the leak test reveals the presence of 185 becquerels (0.005 µCi) or
more of removable contamination, the licensee shall:
1. Immediately withdraw the sealed source
from use and store, dispose, or cause it to be repaired in accordance with the
requirements of
420-3-26-.02 and
420-3-26-.03;
2. File a report with the Agency within 5
days of receiving the leak tests results in accordance with 420-3-26-.07
(122).
(d) A licensee in
possession of a sealed source or brachytherapy source, except for gamma
stereotactic radiosurgery sources, shall conduct a semi-annual physical
inventory of all such sources. The licensee shall retain each inventory record
in accordance with 420-3-26-.07(99).
(37)
Syringe Shields.
(a) A licensee shall keep syringes that
contain radioactive material to be administered in a radiation
shield.
(b) A licensee shall
require each individual who prepares or administers radiopharmaceuticals to use
a syringe radiation shield unless the use of the shield is contraindicated for
that patient.
(38)
Vial Shields. A licensee shall require each individual preparing
or handling a vial that contains a radioactive drug to keep the vial in a vial
radiation shield.
(39)
Labels. Each syringe and vial that contains a radioactive drug
shall be labeled to identify the radioactive drug. Each syringe shield and vial
shield shall also be labeled unless the label on the syringe or vial is visible
when shielded.
(40)
Surveys
for Ambient Radiation Dose Rate and Contamination.
(a) Except as provided in 420-3-26-.07(40)(b)
of this section, a licensee shall survey with a radiation detection survey
instrument at the end of each day of use all areas where radioactive drugs were
prepared for use or administered.
(b) A licensee shall survey with a radiation
detection survey instrument once each week, or at other intervals authorized by
the Agency, all areas where radioactive drugs, sealed sources or radioactive
wastes are stored.
(c) A licensee
shall conduct the surveys required by 420-3-26-.07(40)(a) and (b) so as to able
to measure dose rates as low as 1 microsievert (0.1 millirem) per
hour.
(d) A licensee shall
establish dose rate action levels for the surveys required by
420-3-26-.07(40)(a) and (b) and shall require that the individual performing
the survey immediately notify the Radiation Safety Officer if a dose rate
exceeds an action level.
(e) A
licensee shall survey for removable contamination at the end of each day of
use, or at other intervals authorized by the Agency, all areas where
radioactive drugs were prepared for use or administered. The licensee shall
also survey for removable contamination each week all areas where radioactive
materials are stored.
(f) A
licensee shall conduct the surveys required by 420-3-26-.07(40)(e) so as to be
able to detect contamination on each wipe sample of 33.3 becquerels (2000
dpm).
(g) A licensee shall
establish removable contamination action levels for the surveys required by
420-3-26-.07(40)(e) and shall require that the individual performing the survey
immediately notify the Radiation Safety Officer if contamination exceeds action
levels.
(h) A licensee does not
need to perform the surveys required by 420-3-26-.07(40)(a) in area(s) where
patients or human research subjects are confined when they cannot be released
pursuant to 420-3-26.07(41).
(i) A
licensee shall retain a record of each survey in accordance with 420-3-26-.07
(100).
(41)
Release
of Individuals Containing Radioactive Drugs or Implants.
(a) A licensee may authorize the release from
its control of any individual who has been administered radioactive drugs or
implants containing radioactive material if the total effective dose equivalent
to any other individual from exposure to the released individual is not likely
to exceed 5 millisieverts (0.5 rem).
(b) A licensee shall provide the released
individual, or the individual's parent or guardian, with oral and written
instructions on actions recommended to maintain doses to other individuals as
low as is reasonably achievable. If a breast-feeding infant or child could
receive a radiation dose as a result of the release of the patient, the
instructions shall also include:
1. Guidance
on the interruption or discontinuation of breast-feeding; and
2. Information on the potential consequences,
if any, of failure to follow the guidance.
(c) Release of the patient must be approved
by an individual listed as an authorized user on the Agency license, and who is
approved for the type of radioactive material use for which the patient being
released has received.
(d) The
licensee shall maintain a record of the basis for authorizing the release of an
individual in accordance with 420-3-26-.07 (101).
(e) The licensee shall maintain a record of
instructions provided to breast-feeding women in accordance with 420-3-26-.07
(101).
(f) Notwithstanding
420-3-26-.07(41)(a), the licensee may be held responsible for the proper
disposal of any individual's radioactive waste discovered in a solid waste
stream that can be traced to the licensee.
(g) The licensee shall immediately notify the
Agency in accordance with 420-3-26-.07 (123) if a patient departs prior to an
authorized release.
(h) The
licensee shall notify the Agency in accordance with 420-3-26-.07 (124):
1. When they are aware that a patient
containing radioactive material and who has been released in accordance with
420-3-26-.07(41) dies; and,
2. If
it is possible that any individual could receive exposures in excess of 5
millisieverts (500 millirem) as a result of the deceased's body.
(42)
Mobile
Medical Service Technical Requirements. A licensee providing mobile
medical service shall:
(a) Transport to each
client's address only syringes or vials containing prepared drugs or
radioactive materials that are intended for reconstitution of radioactive drug
kits;
(b) Bring into each client's
address all radioactive material to be used and, before leaving, remove all
unused radioactive material and associated radioactive waste;
(c) Secure or keep under constant
surveillance and immediate control all radioactive material when in transit or
at a client's address;
(d) Check
instruments used to measure the activity of unsealed radioactive material for
proper function before medical use at each client's address or on each day of
use, whichever is more frequent. At a minimum, the check for proper function
shall include a constancy check.
(e) Check survey instruments for consistent
response with a dedicated check source before use at each client's
address;
(f) Prior to leaving a
client's address, perform area surveys and survey for removable contamination
in all areas of use, to ensure compliance with
420-3-26-.03;
(g) Use radioactive gases only in areas of
use and under conditions which have been evaluated and approved by the Agency
for compliance with airborne release standards; and,
(h) Retain a record of each survey required
by 420-3-26-.07(42)(f) in accordance with 420-3-26-.07 (102).
(43)
Storage of Volatiles
and Gases.
(a) A licensee shall store
volatile radioactive materials and radioactive gases in a radiation shield and
container.
(b) A licensee shall
store and use a multi-dose container in a properly functioning fume
hood.
(c) A licensee who
administers radioactive aerosols or gases shall do so with a system that will
keep airborne concentrations within the limits prescribed in
420-3-26-.03.
(d) The system shall either be directly
vented to the atmosphere through an air exhaust or provide for collection and
decay or disposal of the aerosol or gas in a shielded container.
(e) A licensee shall only administer
radioactive gases in rooms that are at negative pressure with respect to
surrounding rooms.
(f) Before
receiving, using, or storing a radioactive gas, the licensee shall calculate
the amount of time needed after a release to reduce the concentration in the
area of use to the occupational limit listed in Appendix B of
420-3-26-.03.
The calculation shall be based on the highest activity of gas handled in a
single container and the measured available air exhaust rate.
(g) A licensee shall post the time calculated
in 420-3-26-.07(43)(f) at the area of use and require that, in case of a gas
spill, individuals evacuate the room until the posted time has
elapsed.
(h) A licensee shall check
the operation of collection systems monthly and measure the ventilation rates
in areas of use at intervals not to exceed 6 months. Records of these checks
and measurements shall be maintained for 3 years.
(i) A copy of the calculations required in
420-3-26-.07(43)(f) shall be recorded and retained for the duration of the
license.
(44)
Decay-in-Storage.
(a) A licensee
may hold radioactive material with a physical half-life of less than or equal
to 120 days for decay-in-storage before disposal without regard to its
radioactivity if the licensee:
1. Monitors
radioactive material at the container surface before disposal and determines
that its radioactivity cannot be distinguished from the background radiation
level with an appropriate radiation detection survey instrument set on its most
sensitive scale and with no interposed shielding;
2. Removes or obliterates all radiation
labels, except for material that will be handled as biomedical waste after
release; and
3. Separates and
monitors each generator column individually with all radiation shielding
removed to ensure that its contents have decayed to background radiation level
before disposal.
(b) For
radioactive material disposed in accordance with 420-3-26-.07(44)(a), the
licensee shall retain a record of each disposal in accordance with 420-3-26-.07
(103).
Specific Requirements for the Use of Radioactive Material
for Uptake, Dilution, or Excretion Studies
(45)
Use of Unsealed Radioactive
Material for Uptake, Dilution, or Excretion Studies for Which a Written
Directive is Not Required. A licensee may use any unsealed radioactive
material, in quantities that do not require a written directive, for a
diagnostic use involving measurements of uptake, dilution, or excretion that
is:
(a) Obtained from a manufacturer or
preparer licensed pursuant to
420-3-26-.02 or
equivalent regulations of another Agreement State or the U.S. Nuclear
Regulatory Commission; or
(b)
Prepared by an authorized nuclear pharmacist, a physician who is an authorized
user and who meets the requirements specified in 420-3-26-.07(51) or
420-3-26-.07(56), and 420-3-26-.07(51)(c) l(ii)(VII), or an individual under
the supervision of either as specified in 420-3-26-.07(22); or
(c) Obtained from and prepared by an Agency,
U.S. Nuclear Regulatory Commission or an Agreement State licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
protocol or an Investigational New Drug (IND) protocol accepted by the U.S.
Food and Drug Administration; or
(d) Prepared by the licensee in accordance
with a Radioactive Drug Research Committee-approved application or an
Investigational New Drug (IND) protocol accepted by the U.S. Food and Drug
Administration for use in research.
(46)
Possession of Survey Instrument. A
licensee authorized to use radioactive material for uptake, dilution,
and excretion studies shall possess a portable radiation detection survey
instrument capable of detecting dose rates over the range 1 microsievert (0.1
millirem) per hour to 500 microsieverts (50 millirem) per hour. The instrument
shall be operable and calibrated in accordance with 420-3-26-.07(33).
(47)
Training for Uptake, Dilution, and
Excretion Studies. Except as provided in 420-3-26-.07(29), the licensee
shall require an authorized user of unsealed radioactive material for the uses
authorized under 420-3-26-.07(45) to be a physician who:
(a) Is certified by a medical specialty board
whose certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State. The names of board certifications
that have been recognized by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State are posted on the NRC's Medical Uses Licensee
Toolkit Web page. To have its certification process recognized, a specialty
board shall require all candidates for certification to:
1. Complete 60 hours of training and
experience in basic radionuclide handling techniques and radiation safety
applicable to the medical use of unsealed radioactive material for uptake,
dilution, and excretion studies that includes the topics listed in paragraphs
420-3-26-.07(47)(c)(1)(i) and (c)(1)(ii); and
2. Pass an examination, administered by
diplomates of the specialty board, that assesses knowledge and competence in
radiation safety, radionuclide handling, and quality control; or
(b) Is an authorized user under
420-3-26-.07(51) or (56), or equivalent U.S. Nuclear Regulatory Commission or
Agreement State requirements; or
(c)
1. Has
completed 60 hours of training and experience, including a minimum of 8 hours
of classroom and laboratory training, in basic radionuclide handling techniques
applicable to the medical use of unsealed radioactive material for uptake,
dilution, and excretion studies. The training and experience must include:
(i) Classroom and laboratory training in the
following areas:
(I) Radiation physics and
instrumentation;
(II) Radiation
protection;
(III) Mathematics
pertaining to the use and measurement of radioactivity;
(IV) Chemistry of radioactive material for
medical use; and
(V) Radiation
biology; and
(ii) Work
experience, under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(47), 420-3-26-.07(51),
420-3-26-.07(56) or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements, involving
(I) Ordering,
receiving, and unpacking radioactive materials safely and performing the
related radiation surveys;
(II)
Performing quality control procedures on instruments used to determine the
activity of dosages and performing checks for proper operation of survey
meters;
(III) Calculating,
measuring, and safely preparing patient or human research subject
dosages;
(IV) Using administrative
controls to prevent a misadministration involving the use of unsealed
radioactive material;
(V) Using
procedures to contain spilled radioactive material safely and using proper
decontamination procedures; and
(VI) Administering dosages of radioactive
drugs to patients or human research subjects; and
2. Has obtained written
attestation that the individual has satisfactorily completed the requirements
in paragraph 420-3-26-.07(47)(c)(1) and is able to fulfill the radiation safety
related duties as an authorized user for the medical uses authorized under
420-3-26-.07(45). The attestation must be obtained from either:
(i) A preceptor authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(47) or 420-3-26-.07(51), or
420-3-26-.07(56), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements; or
(ii) A
residency program director who affirms in writing that the attestation
represents the consensus of the residency program faculty where at least one
faculty member is an authorized user who meets the requirements in
420-3-26-.07(29), 420-3-26-.07(47), 420-3-26-.07(51), or 420-3-26-.07(56), or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements,
and concurs with the attestation provided by the residency program director.
The residency training program must be approved by the Residency Review
Committee of the Accreditation Council for Graduate Medical Education or the
Royal College of Physicians and Surgeons of Canada or the Council on
Postdoctoral Training of the American Osteopathic Association and must include
training and experience specified in 420-3-26-.07(41)(c) l.
Specific Requirements for the Use of Radioactive Material
for Imaging and Localization Studies
(48)
Use of
Unsealed Radioactive Material for Imaging and Localization Studies for Which a
Written Directive is Not Required. A licensee may use, for imaging and
localization studies, any radioactive material prepared for medical use, in
quantities that do not require a written directive as described in
420-3-26-.07(23) that is:
(a) Obtained from a
manufacturer or preparer licensed pursuant to
420-3-26-.02 or
equivalent regulations of another Agreement State or the U.S. Nuclear
Regulatory Commission; or
(b)
Prepared by an authorized nuclear pharmacist, a physician who is an authorized
user and who meets the requirements specified in 420-3-26-.07(51), or
420-3-26-.07(56) and 420-3-26-.07(51)(c)(ii)(VII), or an individual under the
supervision of either as specified in 420-3-26-.07(22); or
(c) Obtained from and prepared by an Agency,
U.S. Nuclear Regulatory Commission or an Agreement State licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
protocol or an Investigational New Drug (IND) protocol accepted by the Food and
Drug Administration; or
(d)
Provided the conditions of 420-3-26-.07(43) are met, a licensee shall use
radioactive aerosols or gases only if specific application is made to and
approved by the Agency.
(49)
Radionuclide Contaminants.
(a) A licensee shall not administer to humans
a radioactive drug containing:
1. More than
0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15
µCi of molybdenum-99 per millicurie of technetium-99m);
2. More than 0.02 kilobecquerel of
strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02
µCi of strontium-82 per millicurie of rubidium-82 chloride);
3. More than 0.2 kilobecquerel of
strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi
of strontium-85 per millicurie of rubidium-82);
(b) To demonstrate compliance with
420-3-26-.07(49)(a), the licensee preparing radioactive drugs from radionuclide
generators shall:
1. Measure the concentration
of radionuclide contaminant in the first eluate after receipt of a
molybdenum-99/technetium-99m generator;
2. Measure the concentration of radionuclide
contaminant in each eluate or extract, as appropriate for other generator
systems.
(c) To
demonstrate compliance with 420-3-26-.07(49)(a), the licensee that uses a
strontium-82/rubidium-82 generator for preparing a rubiclium-82
radiopharmaceutical shall, before the first patient use of the day, measure the
concentration of radionuclides strontium-82 and strontium-85.
(d) If a licensee is required to measure the
molybdenum-99 concentration or strontium-82 and strontium-85 concentrations the
licensee shall retain a record of each measurement in accordance with
420-3-26-.07 (104).
(e) A licensee
shall report immediately to the Agency each occurrence of radionuclide
contaminant concentration exceeding the limits specified in
420-3-26-.07(49)(a).
(50)
Possession of Survey Instruments. A licensee authorized to use
radioactive material for imaging and localization studies shall possess a
portable radiation detection survey instrument capable of detecting dose rates
over the range of 1 microsievert (0.1 millirem) per hour to 500 microsieverts
(50 millirems) per hour, and a portable radiation measurement survey instrument
capable of measuring dose rates over the range 10 microsieverts (1 millirem)
per hour to 10 millisieverts (1000 millirems) per hour. The instruments shall
be operable and calibrated in accordance with 420-3-26-.07(33).
(51)
Training for Imaging and
Localization Studies. Except as provided in 420-3-26-.07(29), the
licensee shall require an authorized user of unsealed radioactive material for
the uses authorized under 420-3-26-.07(48) to be a physician who:
(a) Is certified by a medical specialty board
whose certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State. The names of board certifications
that have been recognized by the Agency the U.S. Nuclear Regulatory Commission,
or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web
page. To have its certification process recognized, a specialty board shall
require all candidates for certification to:
1. Complete 700 hours of training and
experience in basic radionuclide handling techniques and radiation safety
applicable to the medical use of unsealed radioactive material for imaging and
localization studies as described in 420-3-26-.07(51)(c)1(i) and (ii);
and
2. Pass an examination,
administered by diplomates of the specialty board, which assesses knowledge and
competence in radiation safety, radionuclide handling, and quality control;
or
(b) Is an authorized
user under 420-3-26-.07(56) and meets the requirements in
420-3-26-.07(51)(c)1(ii)(VII), or equivalent U.S. Nuclear Regulatory Commission
or Agreement State requirements; or
(c)
1. Has
completed 700 hours of training and experience, including a minimum of 80 hours
of classroom and laboratory training, in basic radionuclide handling techniques
applicable to the medical use of unsealed radioactive material for imaging and
localization studies. The training and experience must include, at a minimum
(i) Classroom and laboratory training in the
following areas:
(I) Radiation physics and
instrumentation;
(II) Radiation
protection;
(III) Mathematics
pertaining to the use and measurement of radioactivity;
(IV) Chemistry of radioactive material for
medical use;
(V) Radiation biology;
and
(ii) Work experience,
under the supervision of an authorized user, who meets the requirements in
420-3-26-.07(29), 420-3-26-.07(51), or 420-3-26-.07(51)(c) l(ii)(VII) and
420-3-26-.07(56), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements. An authorized nuclear pharmacist who meets the requirements
in 420-3-26-.07(28) or 420-3-26-.07(29) may provide the supervised work
experience under 420-3-26-.07(51)(c) l(ii)(VII). Work experience must involve:
(I) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(II) Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
(III) Calculating, measuring, and safely
preparing patient or human research subject dosages;
(IV) Using administrative controls to prevent
a misadministration involving the use of unsealed radioactive
material;
(V) Using procedures to
safely contain spilled radioactive material and using proper decontamination
procedures;
(VI) Administering
dosages of radioactive drugs to patients or human research subjects;
and
(VII) Eluting generator systems
appropriate for preparation of radioactive drugs for imaging and localization
studies, measuring and testing the eluate for radionuclide purity, and
processing the eluate with reagent kits to prepare labeled radioactive drugs;
and
2. Has
obtained written attestation that the individual has satisfactorily completed
the requirements in 420-3-26-.07(51)(c) l and is able to independently fulfill
the radiation safety- related duties as an authorized user for the medical uses
authorized under 420-3-26-.07(45) and (48). The attestation must be obtained
from either:
(i) A preceptor authorized user
who meets the requirements in 420-3-26-.07(29), 420-3-26-.07(51) or
420-3-26-.07(56), and 420-3-26-.07(51)(c)1(ii)(VII), or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements
(ii) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements of 420-3-26-.07(29), 420-3-26-.07(51) or
420-3-26-.07(56), and 420-3-26-.07(5l)(c) l(ii)(VII), or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements, and concurs with
the attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada of the Council on Postdoctoral Training of
the American Osteopathic Association and must include experience specified in
420-3-26-.07(5l)(c) l.
Radioactive Material - Written Directive
Required
(52)
Use of Unsealed Radioactive
Material for Which a Written Directive is Required. A licensee may use
any unsealed radioactive material identified in 420-3-26-.07(56)(b) l(ii)(VII)
prepared for medical use for which a written directive is required that is:
Obtained from:
1. a
manufacturer or preparer licensed in accordance with
420-3-26-.02 or
equivalent regulations of another Agreement State or the U.S. Nuclear
Regulatory Commission; or
2. A PET
radioactive drug producer licensed under
420-3-26-.02(10)(a)5
or equivalent regulations of another Agreement State or the U.S. Nuclear
Regulatory Commission; or
(b) Excluding
production of PET radionuclides, prepared by an authorized nuclear pharmacist,
a physician who is an authorized user and who meets the requirements specified
in 420-3-26-.07(51) or 420-3-26-.07(56), or an individual under the supervision
of either as specified in 420-3-26-.07(22); or
(c) Obtained from and prepared by an Agency,
U.S. Nuclear Regulatory Commission or an Agreement State licensee in accordance
with a Radioactive Drug Research Committee-approved protocol or an
Investigational New Drug (IND) protocol accepted by the U.S. Food and Drug
Administration for use in research; or
(d) Prepared by the licensee in accordance
with a Radioactive Drug Research Committee-approved application or an IND
protocol accepted by U.S. Food and Drug Administration for use in
research.
(53)
Safety Instruction. In addition to the requirements of
420-3-26-.10(3):
(a) A licensee shall provide radiation safety
instruction to personnel caring for patients or human research subjects that
have received therapy with a radioactive drug, and cannot be released in
accordance with 420-3-26-.07(41). The training must be provided initially and
at least annually. The instruction must be appropriate to the personnel's
assigned duties and include the following:
1.
Patient or human research subject control;
2. Visitor control to include the following:
(i) Routine visitation to hospitalized
individuals in accordance with
420-3-26-.03;
(ii) Contamination control;
(iii) Waste control; and
(iv) Notification of the RSO, or his or her
designee, and the authorized user if the patient or the human research subject
dies or has a medical emergency.
(b) A licensee shall retain a record of
individuals receiving instruction in accordance with 420-3-26-.07
(105).
(54)
Safety
Precautions.
(a) For each patient or
human research subject receiving radiopharmaceutical therapy and hospitalized
for compliance with 420-3-26-.07(41), a licensee shall:
1. Quarter the patient or the human research
subject either in:
(i) A private room with a
private sanitary facility; or
(ii)
A room, with a private sanitary facility, with another individual who also has
received radiopharmaceutical therapy and who cannot be released in accordance
with 420-3-26-.07(41); and,
2. Visibly post the patient's or the human
research subject's room with a "Radioactive Materials" sign and note on the
door or in the patient's or human research subject's chart where and how long
visitors may stay in the patient's or the human research subject's room;
and
3. Either monitor material and
items removed from the patient's or the human research subject's room to
determine that their radioactivity cannot be distinguished from the natural
background radiation level with a radiation detection survey instrument set on
its most sensitive scale and with no interposed shielding, or handle such
material and items as radioactive waste.
(b) The Radiation Safety Officer, or his or
her designee, and the authorized user shall be notified immediately if the
hospitalized patient dies or has a medical emergency. The licensee shall also
notify the Agency in accordance with 420-3-26-.07 (124) if it is possible that
any individual could receive exposures in excess of
420-3-26-.03(14)
as a result of the deceased's body.
(55)
Possession of Survey
Instruments. A licensee authorized to use radioactive material for which
a written directive is required shall possess a portable radiation detection
survey instrument capable of detecting dose rates over the range of 1
microsievert (0.1 millirem) per hour to 500 microsieverts (50 millirems) per
hour, and a portable radiation measurement survey instrument capable of
measuring dose rates over the range 10 microsieverts (1 millirem) per hour to
10 millisieverts (1000 millirems) per hour. The instruments shall be operable
and calibrated in accordance with 420-3-26-.07(33).
(56)
Training for Use of Unsealed
Radioactive Material for Which a Written Directive is Required. Except
as provided in 420-3-26-.07(29), the licensee shall require an authorized user
of unsealed radioactive material for the uses authorized under 420-3-26-.07(52)
to be a physician who:
(a) Is certified by a
medical specialty board whose certification process has been recognized by the
Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and who
meets the requirements in paragraphs 420-3-26-.07(56)(b) l.(ii)(VII). The names
of board certifications that have been recognized by the Agency, the U.S.
Nuclear Regulatory Commission, or an Agreement State are posted on the NRC's
Medical Uses Licensee Toolkit Web page. To be recognized, a specialty board
shall require all candidates for certification to:
1. Successfully complete residency training
in a radiation therapy or nuclear medicine training program or a program in a
related medical specialty. These residency training programs must include 700
hours of training and experience as described in paragraphs
420-3-26-.07(56)(b)1.(i) through (b)1.(ii)(V). Eligible training programs must
be approved by the Residency Review Committee of the Accreditation Council for
Graduate Medical Education, the Royal College of Physicians and Surgeons of
Canada, or the Council on Postdoctoral Training of the American Osteopathic
Association; and
2. Pass an
examination, administered by diplomates of the specialty board, which tests
knowledge and competence in radiation safety, radionuclide handling, quality
assurance, and clinical use of unsealed radioactive material for which a
written directive is required; or
(b)
1. Has
completed 700 hours of training and experience, including a minimum of 200
hours of classroom and laboratory training, in basic radionuclide handling
techniques applicable to the medical use of unsealed radioactive material
requiring a written directive. The training and experience must include:
(i) Classroom and laboratory training in the
following areas
(I) Radiation physics and
instrumentation;
(II) Radiation
protection;
(III) Mathematics
pertaining to the use and measurement of radioactivity;
(IV) Chemistry of radioactive material for
medical use; and
(V) Radiation
biology; and
(ii) Work
experience, under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(56), or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements. A supervising authorized
user, who meets the requirements in 420-3-26-.07(56)(b) must also have
experience in administering dosages in the same dosage category or categories
(i.e., 420-3-26-.07(56)(b)1.(ii)(VII)) as the individual requesting authorized
user status. The work experience must involve:
(I) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(II) Performing quality
control procedures on instruments used to determine the activity of dosages,
and performing checks for proper operation of survey meters;
(III) Calculating, measuring, and safely
preparing patient or human research subject dosages;
(IV) Using administrative controls to prevent
a misadministration involving the use of unsealed radioactive
material;
(V) Using procedures to
contain spilled radioactive material safely and using proper decontamination
procedures;
(VI)
[Reserved]
(VII) Administering
dosages of radioactive drugs to patients or human research subjects from the
three categories in this paragraph. Radioactive drugs containing radionuclides
in categories not included in this paragraph are regulated under
420-3-26-.07(90). This work experience must involve a minimum of three cases in
each of the following categories for which the individual is requesting
authorized user status;
(A) Oral
administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of
sodium iodide I-131, for which a written directive is required;
(B) Oral administration of greater than 1.22
gigabecquerels (33 millicuries) of sodium iodide
I-13124;
(C) Parenteral administration of any
radioactive drug that contains a radionuclide that is primarily used for its
electron emission, beta radiation characteristics, alpha radiation
characteristics, or photon energy of less than 150 keV, for which a written
directive is required; and
2. Has obtained written attestation that the
individual has satisfactorily completed the requirements in 420-3-26-.07(56)(b)
and is able to independently fulfill the radiation safety- related duties as an
authorized user for the medical uses authorized under 420-3-26-.07(52) for
which the individual is requesting authorized user status. The attestation must
be obtained from either:
(i) A preceptor
authorized user who meets the requirements in 420-3-26-.07(29),
420-3-26-.07(56), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements and has experience in administering dosages in the same
dosage category or categories as the individual user status; or
(ii) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in 420-3-26-.07(29), 420-3-26-.07(56), or equivalent
U.S. Nuclear Regulatory Commission or Agreement State requirements, has
experience in administering dosages in the same dosage category or categories
as the individual requesting authorized user status, and concurs the
attestation provided by the residency program director. The residency training
program must be approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Council on Postdoctoral Training of the American
Osteopathic Association and must include training and experience specified in
420-3-26-.07(56)(b) l.
(57)
Training for the Oral
Administration of Sodium Iodide I-131 in Quantities Less than or Equal to 1.22
Gigabecquerels (33 millicuries) for which a Written Directive is
Required. Except as provided in 420-3-26-.07(29), the licensee shall
require an authorized user for the oral administration of sodium iodide I-131
requiring a written directive in quantities less than or equal to 1.22
gigabecquerels (33 millicuries), to be a physician who:
(a) Is certified by a medical specialty board
whose certification process includes all of the requirements in paragraphs
420-3-26-.07(57)(c) l. and (c)2. and whose certification process has been
recognized by the Agency, the U.S. Nuclear Regulatory Commission or an
Agreement State. The names of board certifications that have been recognized by
the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State are
posted on the NRC's Medical Uses Licensee Toolkit Web page; or
(b) Is an authorized user under
420-3-26-.07(56)(a), 420-3-26-.07(56)(b) for uses listed in
420-3-26-.07(56)(b)1(ii) (VII)(A) or (B), 420-3-26-.07(58) or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements; or
(c)
1. Has
successfully completed 80 hours of classroom and laboratory training,
applicable to the medical use of sodium iodide I-131 for procedures requiring a
written directive. The training must include:
(i) Radiation physics and
instrumentation;
(ii) Radiation
protection;
(iii) Mathematics
pertaining to the use and measurement of radioactivity;
(iv) Chemistry of radioactive material for
medical use; and
(v) Radiation
biology; and
2. Has work
experience, under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(56), 420-3-26-.07(57),
420-3-26-.07(58) or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements. A supervising authorized user who meets the requirements in
420-3-26-.07(56)(b), must also have experience in administering dosages as
specified in 420-3-26-.07(56)(b)1.(ii) (VII)(A) or (B). The work experience
must involve:
(i) Ordering, receiving, and
unpacking radioactive materials safely and performing the related radiation
surveys;
(ii) Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
(iii) Calculating, measuring, and safely
preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent
a misadministration involving the use of radioactive material;
(v) Using procedures to contain spilled
radioactive material safely and using proper decontamination procedures;
and
(vi) Administering dosages to
patients or human research subjects, that includes at least 3 cases involving
the oral administration of less than or equal to 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131; and
3 Has obtained written attestation that the
individual has satisfactorily completed the requirements in paragraphs
420-3-26-.07(57)(c) l. and (c)2., and is able to independently fulfill the
radiation safety-related duties as an authorized user for oral administration
of less than or equal to 1.22 gigabecquerels (33 millicuries) or sodium iodide
I-131 for medical uses authorized under 420-3-26-.07(52). The written
attestation must be obtained from either.
(i)
A preceptor authorized user who meets the requirements in 420-3-26-.07(29),
420-3-26-.07(56), 420-3-26-.07(57), 420-3-26-.07(58), or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements and has
experience in administering dosages in the same dosage category or categories
as the individual user status; or
(ii) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in 420-3-26-.07(29), 420-3-26-.07(56), 420-3-26-.07(57),
420-3-26-.07(58), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements, has experience in administering dosages in
420-3-26-.07(56)(b) l(ii)(VII)(A) or (B), and concurs with the attestation
provided by the residency program director. The residency training program must
be approved by the Residency Review Committee of the Accreditation Council for
Graduate Medical Education or the Royal College of Physicians and Surgeons of
Canada or the Council on Postdoctoral Training of the American Osteopathic
Association and must include training and experience specified in paragraphs
(c)1 and (c)2 of this section.
(58)
Training for the Oral
Administration of Sodium Iodide I-131 in Quantities Greater than 1.22
Gigabecquerels (33 millicuries) for which a Written Directive is
Required. Except as provided in 420-3-26-.07(29), the licensee shall
require an authorized user for the oral administration of sodium iodide I-131
in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a
physician who:
(a) Is certified by a medical
specialty board whose certification process includes all of the requirements in
paragraphs 420-3-26-.07(58)(c) l. and (c)2., and whose certification has been
recognized by the Agency, the U.S. Nuclear Regulatory Commission or an
Agreement State. The names of board certifications that have been recognized by
the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State are
posted on the NRC's Medical Uses Licensee Toolkit Web page; or
(b) Is an authorized user under
420-3-26-.07(56)(a), 420-3-26-.07(56)(b) for uses listed in
420-3-26-.07(56)(b)1. (ii)(VII)(B), or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements; or
(c)
1. Has
successfully completed 80 hours of classroom and laboratory training,
applicable to the medical use of sodium iodide I-131 for procedures requiring a
written directive. The training must include:
(i) Radiation physics and
instrumentation;
(ii) Radiation
protection;
(iii) Mathematics
pertaining to the use and measurement of radioactivity;
(iv) Chemistry of radioactive material for
medical use; and
(v) Radiation
biology; and
2. Has work
experience, under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(56), 420-3-26-.07(58), or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.
A supervising authorized user, who meets the requirements in
420-3-26-.07(56)(b), must also have experience in administering dosages as
specified in 420-3-26-.07(56)(b)1(ii)(VII)(B). The work experience must
involve:
(i) Ordering, receiving, and
unpacking radioactive materials safely and performing the related radiation
surveys;
(ii) Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
(iii) Calculating, measuring, and safely
preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent
a misadministration involving the use of radioactive material;
(v) Using procedures to contain spilled
radioactive material safely and using proper decontamination procedures;
and
(vi) Administering dosages to
patients or human research subjects, that includes at least 3 cases involving
the oral administration of less than or equal to 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131; and
3. Has obtained written attestation that the
individual has satisfactorily completed the requirements in paragraphs
420-3-26-.07(57)(c) l. and (c)2., and is able to independently fulfill the
radiation safety-related duties as an authorized user for oral administration
of less than or equal to 1.22 gigabecquerels (33 millicuries) or sodium iodide
I-131 for medical uses authorized under 420-3-26-.07(52). The written
attestation must be obtained from either:
(i)
A preceptor authorized user who meets the requirements in 420-3-26-.07(29),
420-3-26-.07(56), 420-3-26-.07(57), 420-3-26-.07(58), or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements and has
experience in administering dosages in the same dosage category or categories
as the individual user status; or
(ii) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in 420-3-26-.07(29), 420-3-26-.07(56), 420-3-26-.07(57),
420-3-26-.07(58), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements, has experience in administering dosages in
420-3-26-.07(56)(b) l(ii)(VII)(A) or (B), and concurs with the attestation
provided by the residency program director. The residency training program must
be approved by the Residency Review Committee of the Accreditation Council for
Graduate Medical Education or the Royal College of Physicians and Surgeons of
Canada or the Council on Postdoctoral Training of the American Osteopathic
Association and must include training and experience specified in paragraphs
(c)1 and (c)2 of this section
(59)
Training for the Parenteral
Administration of Unsealed Radioactive Material Requiring a Written
Directive. Except as provided in 420-3-26-.07(29), the licensee shall
require an authorized user for the parenteral administration requiring a
written directive, to be a physician who:
(a)
Is an authorized user under 420-3-26-.07(56) for uses listed in
420-3-26-.07(56)(b)1.(ii)(VII)(C), or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements; or
(b) Is an authorized user under
420-3-26-.07(68) or 420-3-26-.07(89), or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements and who meets the requirements in
paragraph 420-3-26-.07(59)(d) of this section; or
(c) Is certified by a medical specialty board
whose certification process has been recognized by the Commission or an
Agreement State under 420-3-26-.07(68) or 420-3-26-.07(89) and who meets the
requirements in paragraph 420-3-26-.07(59)(d) of this section.
(d)
1. Has
successfully completed 80 hours of classroom and laboratory training,
applicable to parenteral administrations listed in 420-3-26-.07(56)(b)
l(ii)(VII)(C). The training must include:
(i)
Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and
measurement of radioactivity;
(iv)
Chemistry of radioactive material for medical use; and
(v) Radiation biology;
and
2. Has work
experience under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(56), 420-3-26-.07(59), or
equivalent U.S Nuclear Regulatory Commission or Agreement State requirements,
in the parenteral administrations listed in 420-3-26-.07(56)(b) l(ii)(VII)(C).
A supervising authorized user who meets the requirements in 420-3-26-.07(56),
420-3-26-.07(59), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements, must have experience in administering dosages in the same
category or categories as the individual requesting authorized user status. The
work experience must involve:
(i) Ordering,
receiving, and unpacking radioactive materials safely, and performing the
related radiation surveys;
(ii)
Performing quality control procedures on instruments used to determine the
activity of dosages, and performing checks for proper operation of survey
meters;
(iii) Calculating,
measuring, and safely preparing patient or human research subject
dosages;
(iv) Using administrative
controls to prevent a misadministration involving the use of unsealed
radioactive material;
(v) Using
procedures to contain spilled radioactive material safely, and using proper
decontamination procedures; and
(vi) Administering dosages to patients or
human research subjects, that include at least 3 cases involving the parenteral
administration as specified in 420-3-26-.07(56)(b) l(ii)(VII)(C); and
3 Has obtained written attestation
that the individual has satisfactorily completed the requirements in paragraphs
420-3-26-.07(59)(d) l and (d)2 of this section, and is able to independently
fulfill the radiation safety related duties as an authorized user for the
parenteral administration of unsealed radioactive material requiring a written
directive. The written attestation must be obtained from a preceptor authorized
user who meets the requirements in 420-3-26-.07(29), 420-3-26-.07(56),
420-3-26-.07(59), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements. A preceptor authorized user, who meets the requirements in
420-3-26-.07(56) must have experience in administering dosages in the same
category or categories as the individual requesting authorized user status; or.
(i) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in 420-3-26-.07(29), 420-3-26-.07(56), 420-3-26-.07(59),
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements, has experience in administering dosages in same dosage category
or categories as the individual requesting authorized user status, and concurs
with the attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Council on Postdoctoral Training of
the American Osteopathic Association and must include training and experience
specified in paragraph (d)(l) and (2) of this section.
Manual Brachytherapy
(60)
Use of Sealed
Sources for Manual Brachytherapy. A licensee shall use only
brachytherapy sources:
(a) As approved in the
Sealed Source and Device Registry for manual brachytherapy medical use. The
manual brachytherapy sources may be used for manual brachytherapy uses that are
not explicitly listed in the Sealed Source and Device Registry, but must be
used in accordance with the radiation safety conditions and limitations
described in the Sealed Source and Device Registry; or
(b) In research to deliver therapeutic doses
for medical use in accordance with an active Investigational Device Exemption
(IDE) application accepted by the U.S. Food and Drug Administration provided
the requirements of 420-3-26-.07(25)(a) are met.
(61)
Surveys After Source Implant and
Removal.
(a) Immediately after
implanting sources in a patient or a human research subject, the licensee shall
perform a survey to locate and account for all sources that have not been
implanted.
(b) Immediately after
removing the last temporary implant source from a patient or a human research
subject, the licensee shall make a survey of the patient or the human research
subject with a radiation detection survey instrument to confirm that all
sources have been removed.
(c) A
licensee shall retain a record of the surveys in accordance with 420-3-26-.07
(106).
(62)
Brachytherapy Sources Inventory.
(a) A licensee shall maintain accountability
at all times for all brachytherapy sources in storage or use.
(b) As soon as possible after removing
sources from a patient or a human research subject, a licensee shall return
brachytherapy sources to a secure storage area.
(c) A licensee shall maintain a record of the
brachytherapy source accountability in accordance with 420-3-26-.07
(107).
(63)
Safety
Instruction. In addition to the requirements of
420-3-26-.10(3):
(a) The licensee shall provide radiation
safety instruction, initially and at least annually, to personnel caring for
patients or human research subjects that are undergoing implant therapy and
cannot be released in accordance with 420-3-26-.07(41). Instruction must be
commensurate with the duties of the personnel and shall include the following:
1. Size and appearance of the brachytherapy
sources;
2. Safe handling and
shielding instructions;
3. Patient
or human research subject control;
4. Visitor control, including both:
(i) Routine visitation of hospitalized
individuals in accordance with
420-3-26-.03(14)(a)1.;
and
(ii) Visitation authorized in
accordance with
420-3-26-.03(14)(b);
and
5. Notification of
the Radiation Safety Officer, or his or her designee, and an authorized user if
the patient or the human research subject dies or has a medical emergency. The
licensee shall also notify the Agency in accordance with 420-3-26-.07 (124) if
it is possible that any individual could receive exposures in excess of
420-3-26-.03(14)
as a result of the deceased's body.
(b) A licensee shall retain a record of
individuals receiving instruction in accordance with 420-3-26-.07
(105).
(64)
Safety
Precautions for Patients or Human Research Subjects Receiving
Brachytherapy.
(a) For each patient or
human research subject that is receiving brachytherapy and cannot be released
in accordance with 420-3-26-.07(41), a licensee shall:
1. Not place the patient or human research
subject in the same room as an individual who is not receiving
brachytherapy;
2. Visibly post the
patient's or human research subject's room with a "Radioactive Materials" sign
and note on the door or in the patient's or human research subject's chart
where and how long visitors may stay in the patient's or human research
subject's room.
(b) A
licensee shall have emergency response equipment available near each treatment
room to respond to a source that inadvertently becomes:
1. Dislodged from the patient; or
2. Lodged within the patient following
removal of the source applicators.
(c) The Radiation Safety Officer, or his or
her designee, and the authorized user shall be notified immediately if the
hospitalized patient or human research subject dies or has a medical
emergency.
(65)
Calibration Measurements of Brachytherapy Sealed Sources.
(a) Prior to the first medical use of a
brachytherapy sealed source on or after June 23, 2006, a licensee shall perform
the following:
1. Determine the source output
or activity using a dosimetry system that meets the requirements of
420-3-26-.07(77);
2. Determine
source positioning accuracy within applicators; and
3. Use published protocols accepted by
nationally recognized bodies to meet the requirements of 420-3-26-.07(65)(a)1.
and (a)2.
(b) A licensee
may use measurements provided by the source manufacturer or by a calibration
laboratory accredited by the American Association of Physicists in Medicine
that are made in accordance with 420-3-26-.07(65)(a).
(c) A licensee shall mathematically correct
the outputs or activities determined in 420-3-26-.07(65)(a) of this section for
physical decay at intervals consistent with 1.0 percent physical
decay.
(d) An authorized medical
physicist shall perform or review the calculation measurements made pursuant to
420-3-26-.07(65)(a), (b) and (c).
(e) Only an authorized medical physicist
shall calculate the activity of each strontium-90 source that is used to
determine the treatment times for ophthalmic treatments. The decay must be
based on the activity determined in accordance with paragraphs
420-3-26-.07(65)(a), (b) and (c).
(f) A licensee shall retain a record of each
calibration in accordance with 420-3-26-.07 (108).
(g) A licensee shall retain a record of decay
calculations required by 420-3-26-.07(65)(e) in accordance with 420-3-26-.07
(109).
(65.1)
Strontium-90 Sources for Ophthalmic Treatments.
(a) Licensees who use strontium-90 for
ophthalmic treatments must ensure that certain activities as specified in
paragraph (b) of this section are performed by either:
1. An authorized medical physicist;
or
2. An individual who:
(i) Is identified as an ophthalmic physicist
on a specific medical use license issued by the Agency, the U.S. Nuclear
Regulatory Commission, or an Agreement State; permit issued by an Agency, a
U.S. Nuclear Regulatory Commission, or Agreement State broad scope medical use
licensee; medical use permit issued by a U.S. Nuclear Regulatory Commission
master material licensee; or permit issued by a U.S. Nuclear Regulatory
Commission master material licensee broad scope medical use permittee;
and
(ii) Holds a master's or
doctor's degree in physics, medical physics, other physical sciences,
engineering, or applied mathematics from an accredited college or university;
and
(iii) Has successfully
completed 1 year of full-time training in medical physics and an additional
year of full-time work experience under the supervision of a medical physicist;
and
(iv) Has documented training
in:
(I) The creation, modification, and
completion of written directives;
(II) Procedures for administrations requiring
a written directive; and
(III)
Performing the calibration measurements of brachytherapy sources as detailed in
420-3-26-.07(65).
(b) The individuals who are identified in
paragraph (a) of this section must:
1.
Calculate the activity of each strontium-90 source that is used to determine
the treatment times for ophthalmic treatments. The decay must be based on the
activity determined under 420-3-26-.07(65); and
2. Assist the licensee in developing,
implementing, and maintaining written procedures to provide high confidence
that the administration is in accordance with the written directive. These
procedures must include the frequencies that the individual meeting the
requirements in paragraph (a) of this section will observe treatments, review
the treatment methodology, calculate treatment time for the prescribed dose,
and review records to verify that the administrations were in accordance with
the written directives.
3.
Licensees must retain a record of the activity of each strontium-90 in
accordance with 420-3-26-.07 (109).
(66)
Therapy-related Computer
Systems. The licensee shall perform acceptance testing on the treatment
planning system in accordance with published protocols accepted by nationally
recognized bodies. At a minimum, the acceptance testing must include, as
applicable, verification of:
(a) The
source-specific input parameters required by the dose calculation
algorithm;
(b) The accuracy of
dose, dwell time, and treatment time calculations at representative
points;
(c) The accuracy of isodose
plots and graphic displays; and
(d)
The accuracy of the software used to determine radioactive source positions
from radiographic images.
(67)
Possession of Survey
Instruments. A licensee authorized to use manual brachytherapy sources
shall possess a portable radiation detection survey instrument capable of
detecting dose rates over the range of 1 microsievert (0.1 millirem) per hour
to 500 microsieverts (50 millirems) per hour, and a portable radiation
measurement survey instrument capable of measuring dose rates over the range of
10 microsieverts (1 millirem) per hour to 10 millisieverts (1000 millirems) per
hour. The instruments shall be operable and calibrated in accordance with
420-3-26-.07(33).
(68)
Training for Use of Manual Brachytherapy Sources. Except as
provided in 420-3-26-.07(29), the licensee shall require an authorized user of
a manual brachytherapy source for the uses authorized under 420-3-26-.07(60) to
be a physician who:
(a) Is certified by a
medical specialty board whose certification process has been recognized by the
Agency, the U.S. Nuclear Regulatory Commission or an Agreement State. The names
of board certifications that have been recognized by the Agency, the U.S.
Nuclear Regulatory Commission, or an Agreement State are posted on the NRC's
Medical Uses Licensee Toolkit Web page. To have its certification process
recognized, a specialty board shall require all candidates for certification
to:
1. Successfully complete a minimum of 3
years of residency training in a radiation oncology program approved by the
Residency Review Committee of the Accreditation Council for Graduate Medical
Education or the Royal College of Physicians and Surgeons of Canada or the
Council on Postdoctoral Training of the American Osteopathic Association;
and
2. Pass an examination,
administered by diplomates of the specialty board, that tests knowledge and
competence in radiation safety, radionuclide handling, treatment planning,
quality assurance, and clinical use of manual brachytherapy; or
(b)
1. Has completed a structured educational
program in basic radionuclide handling techniques applicable to the use of
manual brachytherapy sources that includes:
(i) 200 hours of classroom and laboratory
training in the following areas:
(I) Radiation
physics and instrumentation;
(II)
Radiation protection;
(III)
Mathematics pertaining to the use and measurement of radioactivity;
and
(IV) Radiation biology;
and
(ii) 500 hours of
work experience, under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(68), or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements at a medical institution
authorized to use radioactive material under 420-3-26-.07(60), involving
(I) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(II) Checking survey
meters for proper operation;
(III)
Preparing, implanting, and removing brachytherapy sources;
(IV) Maintaining running inventories of
radioactive material on hand;
(V)
Using administrative controls to prevent a medical event involving the use of
radioactive material;
(VI) Using
emergency procedures to control radioactive material; and
2. Has completed 3 years of
supervised clinical experience in radiation oncology, under an authorized user
who meets the requirements in 420-3-26-.07(29), 420-3-26-.07(68), or equivalent
U.S. Nuclear Regulatory Commission or Agreement State requirements, as part of
a formal training program approved by the Residency Review Committee for
Radiation Oncology of the Accreditation Council for Graduate Medical Education
or the Royal College of Physicians and Surgeons of Canada or the Council on
Postdoctoral Training of the American Osteopathic Association. This experience
may be obtained concurrently with the supervised work experience required by
paragraph 420-3-26-.07(68)(b)1.(ii); and
3. Has obtained written attestation that the
individual has satisfactorily completed the requirements in paragraphs
420-3-26-.07(68)(b) l and (b)2 of this section and is able to independently
fulfill the radiation safety-related duties as an authorized user of manual
brachytherapy sources for the medical uses authorized under 420-3-26-.07(60).
The attestation must be obtained from either:
(i) A preceptor authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(68), or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements; or
(ii) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in 420-3-26-.07(29), 420-3-26-.07(68), or equivalent
U.S. Nuclear Regulatory Commission or Agreement State requirements, and concurs
with the attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Council on Postdoctoral Training of
the American Osteopathic Association and must include training and experience
specified in paragraph (b)1 and (b)2 of this section.
(69)
Training for
Ophthalmic Use of Strontium-90. Except as provided in 420-3-26-.07(29),
the licensee shall require an authorized user of a strontium-90 source for
ophthalmic uses authorized under 420-3-26-.07(60) to be a physician who:
(a) Is an authorized user under
420-3-26-.07(68), or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements; or
(b)
1. Has completed 24 hours of classroom and
laboratory training applicable to the medical use of strontium-90 for
ophthalmic radiotherapy. The training must include:
(i) Radiation physics and
instrumentation;
(ii) Radiation
protection;
(iii) Mathematics
pertaining to the use and measurement of radioactivity; and
(iv) Radiation biology; and
2. Supervised clinical training in
ophthalmic radiotherapy under the supervision of an authorized user at a
medical institution, clinic, or private practice that includes the use of
strontium-90 for the ophthalmic treatment of five individuals. This supervised
clinical training must involve:
(i)
Examination of each individual to be treated;
(ii) Calculation of the dose to be
administered;
(iii) Administration
of the dose; and
(iv) Follow up and
review of each individual's case history; and
3. Has obtained written attestation, signed
by a preceptor authorized user who meets the requirements in 420-3-26-.07(29),
420-3-26-.07(68) or 420-3-26-.07(69), or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements, that the individual has
satisfactorily completed the requirements in paragraphs (b)1 and 2 of this
section, and is able to independently fulfill the radiation safety-related
duties as an authorized user of strontium-90 for ophthalmic use.
Sealed Sources For Diagnosis
(70)
Use of Sealed
Sources and Medical Devices for Diagnosis.
(a) A licensee must use only sealed sources
that are not in medical devices for diagnostic medical uses if the sealed
sources are approved in the Sealed Source and Device Registry for diagnostic
medicine. The sealed sources may be used for diagnostic medical uses that are
not explicitly listed in the Sealed Source and Device Registry but must be used
in accordance with the radiation safety conditions and limitations described in
the Sealed Source and Device Registry.
(b) A licensee must only use medical devices
containing sealed sources for diagnostic medical uses if both the sealed
sources and medical devices are approved in the Sealed Source and Device
Registry for diagnostic medical uses. The diagnostic medical devices may be
used for diagnostic medical uses that are not explicitly listed in the Sealed
Source and Device Registry but must be used in accordance with the radiation
safety conditions and limitations described in the Sealed Source and Device
Registry.
(c) Sealed sources and
devices for diagnostic medical uses may be used in research in accordance with
an active Investigational Device Exemption (IDE) application accepted by the
U.S. Food and Drug Administration provided the requirements of
420-3-26-.07(25)(a) are met.
(71)
Training for Use of Sealed Sources
and Medical Devices for Diagnosis. Except as provided in
420-3-26-.07(29), the licensee shall require the authorized user of a
diagnostic sealed source for use in a device authorized under 420-3-26-.07(70)
to be a physician, dentist, or podiatrist who:
(a) Is certified by a specialty board whose
certification process includes all of the requirements in 420-3-26-.07(71)(c)
and (d) and whose certification has been recognized by an Agreement State or
the U.S. Nuclear Regulatory Commission. The names of board certifications that
have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or
an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web
page; or
(b) Is an authorized user
for uses in 420-3-26-.07(48) or equivalent U.S. Nuclear Regulatory Commission
or Agreement State requirements; or
(c) Has completed 8 hours of classroom and
laboratory training in basic radionuclide handling techniques specifically
applicable to the use of the device. The training must include:
1. Radiation physics and
instrumentation;
2. Radiation
protection;
3. Mathematics
pertaining to the use and measurement of radioactivity;
4. Radiation biology; and
(c) Has completed training in the
use of the device for the uses requested.
Photon Emitting Remote Afterloader Units, Teletherapy
Units, and Gamma Stereotactic Radiosurgery Units
(72)
Use of Sealed
Sources in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic
Radiosurgery Unit.
(a) A licensee shall
use sealed sources:
1. As approved in the
Sealed Source and Device Registry in photon-emitting remote afterloader units,
teletherapy units, or gamma stereotactic radiosurgery units to deliver
therapeutic doses for medical uses; or
2. In research involving photon-emitting
remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
units in accordance with an active Investigational Device Exemption (IDE)
application accepted by the U.S. Food and Drug Administration provided the
requirements of 420-3-26-.07(25)(a) are met.
(b) A licensee must use photon-emitting
remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
units:
1. Approved in the Sealed Source and
Device Registry to deliver a therapeutic dose for medical use. These devices
may be used for therapeutic medical treatments that are not explicitly provided
for in the Sealed Source and Device Registry, but must be used in accordance
with radiation safety conditions and limitations described in the Sealed Source
and Device Registry; or
2. In
research in accordance with an active Investigational Device Exemption (IDE)
application accepted by the FDA provided the requirements of
420-3-26-.07(25)(a) are met.
(73)
Surveys of Patients and Human
Research Subjects Treated with a Remote Afterloader Unit.
(a) Before releasing a patient or a human
research subject from licensee control, a licensee shall make a survey of the
patient or the human research subject and the remote afterloader unit with a
portable radiation detection survey instrument to confirm that the source(s)
has been removed from the patient or human research subject and returned to the
safe, shielded position.
(b) A
licensee shall retain a record of the surveys in accordance with 420-3-26-.07
(106).
(74)
Installation, Maintenance, Adjustment, and Repair.
(a) Only a person specifically licensed by
the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State shall
install, maintain, adjust, or repair a remote afterloader unit, teletherapy
unit, or gamma stereotactic radiosurgery unit that involves work on the
source(s) shielding, the source(s) driving unit, or other electronic or
mechanical component that could expose the source(s), reduce the shielding
around the source(s), or compromise the radiation safety of the unit or the
source(s).
(b) Except for low
dose-rate remote afterloader units, only a person specifically licensed by the
Agency, an Agreement State or the U.S. Nuclear Regulatory Commission shall
install, replace, relocate, or remove a sealed source or source contained in
other remote afterloader units, teletherapy units, or gamma stereotactic
radiosurgery units.
(c) For a low
dose-rate remote afterloader unit, only a person specifically licensed by the
Agency, an Agreement State or the U.S. Nuclear Regulatory Commission, or an
authorized medical physicist shall install, replace, relocate, or remove a
sealed source(s) contained in the unit.
(d) A licensee shall retain a record of the
installation, maintenance, adjustment and repair done on remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units in
accordance with 420-3-26-.07 (110).
(75)
Safety Procedures and Instructions
for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units.
(a) A licensee
shall:
1. Secure the unit, the console, the
console keys, and the treatment room when not in use or unattended;
2. Permit only individuals approved by the
authorized user, Radiation Safety Officer, or authorized medical physicist to
be present in the treatment room during treatment with the source(s);
3. Prevent dual operation of more than one
radiation producing device in a treatment room, if applicable; and
4. Develop, implement, and maintain written
procedures for responding to an abnormal situation when the operator is unable
to place the source(s) in the shielded position, or remove the patient or human
research subject from the radiation field with controls from outside the
treatment room. This procedure must include:
(i) Instructions for responding to equipment
failures and the names of the individuals responsible for implementing
corrective actions;
(ii) The
process for restricting access to and posting of the treatment area to minimize
the risk of inadvertent exposure; and
(iii) The names and telephone numbers of the
authorized users, the authorized medical physicist, and the Radiation Safety
Officer to be contacted if the unit or console operates abnormally.
(b) A copy of the
procedures required by 420-3-26-.07(75)(a)4. must be physically located at the
unit console.
(c) A licensee shall
post instructions at the unit console to inform the operator of:
1. The location of the procedures required by
420-3-26-.07(75)(a)4.; and
2. The
names and telephone numbers of the authorized users, the authorized medical
physicist, and the Radiation Safety Officer to be contacted if the unit or
console operates abnormally.
(d)
1.
Prior to the first use of patient treatment of a new unit or an existing unit
with a manufacturer upgrade that affects the operation and safety of the unit,
a licensee shall ensure that the vendor operational and safety training must be
provided by the device manufacturer or by an individual certified by the device
manufacturer to provide the operational and safety training.
2. A licensee shall provide operational and
safety instructions, initially and at least annually, to all individuals who
operate the unit, as appropriate to the individual's assigned duties, in:
(i) The procedures identified in
420-3-26-.07(75)(a)4. of this section; and
(ii) The operating procedures for the
unit.
(e) A
licensee shall ensure that operators, authorized medical physicists, and
authorized users participate in drills of the emergency procedures, initially
and at least annually.
(f) A
licensee shall retain a record of individuals receiving instruction required by
420-3-26-.07(75)(d), in accordance with 420-3-26-.07 (105).
(g) A licensee shall retain a copy of the
procedures required by 420-3-26-.07(75)(a)4. and (d)2. In accordance with
420-3-26-.07 (111).
(76)
Safety Precautions for Remote Afterloader Units, Teletherapy Units, and
Gamma Stereotactic Radiosurgery Units.
(a) A licensee shall control access to the
treatment room by a door at each entrance.
(b) A licensee shall equip each entrance to
the treatment room with an electrical interlock system that will:
1. Prevent the operator from initiating the
treatment cycle unless each treatment room entrance door is closed;
2. Cause the source(s) to be shielded
promptly when an entrance door is opened; and
3. Prevent the source(s) from being exposed
following an interlock interruption until all treatment room entrance doors are
closed and the source(s) on-off control is reset at the console.
(c) A licensee shall require any
individual entering the treatment room to assure, through the use of
appropriate radiation monitors, that radiation levels have returned to ambient
levels.
(d) Except for low-dose
remote afterloader units, a licensee shall construct or equip each treatment
room with viewing and intercom systems to permit continuous observation of the
patient or the human research subject from the treatment console during
irradiation.
(e) For licensed
activities where sources are placed within the patient's or human research
subject's body, a licensee shall only conduct treatments which allow for
expeditious removal of a decoupled or jammed source.
(f) In addition to the requirements specified
in 420-3-26-.07(76)(a) through (e), a licensee shall:
1. For low dose-rate, medium dose-rate, and
pulsed dose-rate remote afterloader units, require:
(i) An authorized medical physicist and
either an authorized user or a physician, under the supervision of an
authorized user, who has been trained in the operation and emergency response
for the unit to be physically present during the initiation of all patient
treatments involving the unit; and
(ii) An authorized medical physicist and
either an authorized user or an individual, under the supervision of an
authorized user, who has been trained to remove the source applicator(s) in the
event of an emergency involving the unit, to be immediately available during
continuation of all patient treatments involving the unit.
2. For high dose-rate remote afterloader
unit, require:
(i) An authorized user and an
authorized medical physicist to be physically present during the initiation of
all patient treatments involving the unit; and
(ii) An authorized medical physicist and
either an authorized user or a physician, under the supervision of an
authorized user, who has been trained in the operation and emergency response
for the unit, to be physically present during continuation of all patient
treatments involving the unit.
3. For gamma stereotactic radiosurgery units,
require an authorized user and an authorized medical physicist to be physically
present throughout all patient treatments involving the unit.
4. Notify the Radiation Safety Officer, or
his or her designee, and an authorized user as soon as possible, if the patient
or human research subject has a medical emergency and, immediately, if the
patient dies.
(g) A
licensee shall have emergency response equipment available near each treatment
room, to respond to a source that inadvertently:
1. Remains in the unshielded position;
or
2. Lodges within the patient
following completion of the treatment.
(77)
Dosimetry Equipment.
(a) Except for low dose-rate remote
afterloader sources where the source output or activity is determined by the
manufacturer, a licensee shall have a calibrated dosimetry system available for
use. To satisfy this requirement, one of the following two conditions must be
met.
1. The system must have been calibrated
using a system or source traceable to the National Institute of Standards and
Technology (NIST) and published protocols accepted by nationally recognized
bodies; or by a calibration laboratory accredited by the American Association
of Physicists in Medicine (AAPM). The calibration must have been performed
within the previous 2 years and after any servicing that may have affected
system calibration; or
2. The
system must have been calibrated within the previous 4 years; 18 to 30 months
after that calibration, the system must have been intercompared with another
dosimetry system that was calibrated within the past 24 months by NIST or by a
calibration laboratory accredited by the AAPM. The results of the
intercomparison must have indicated that the calibration factor of the
licensee's system had not changed by more than 2 percent. The licensee may not
use the intercomparison result to change the calibration factor. When
intercomparing dosimetry systems to be used for calibrating sealed sources for
therapeutic units, the licensee shall use a comparable unit with beam
attenuators or collimators, as applicable, and sources of the same radionuclide
as the source used at the licensee's facility.
(b) The licensee shall have available for use
a dosimetry system for spot-check output measurements, if applicable. To
satisfy this requirement, the system may be compared with a system that has
been calibrated in accordance with 420-3-26-.07(77)(a). This comparison must
have been performed within the previous year and after each servicing that may
have affected system calibration. The spot-check system may be the same system
used to meet the requirement in 420-3-26-.07(77)(a).
(c) The licensee shall retain a record of
each calibration, intercomparison, and comparison in accordance with
420-3-26-.07 (112).
(78)
Full Calibration Measurements on Teletherapy Units.
(a) A licensee authorized to use a
teletherapy unit for medical use shall perform full calibration measurements on
each teletherapy unit:
1. Before the first
medical use of the unit; and
2.
Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate
that the output differs by more than 5 percent from the output obtained at the
last full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the source or
following reinstallation of the teletherapy unit in a new location;
(iii) Following any repair of the teletherapy
unit that includes removal of the source or major repair of the components
associated with the source exposure assembly; and
3. At intervals not exceeding one
year.
(b) To satisfy the
requirement of 420-3-26-.07(78)(a), full calibration measurements must include
determination of:
1. The output within +/-3
percent for the range of field sizes and for the distance or range of distances
used for medical use;
2. The
coincidence of the radiation field and the field indicated by the light beam
localizing device;
3. The
uniformity of the radiation field and its dependence on the orientation of the
useful beam;
4. Timer accuracy and
linearity over the range of use;
5.
On-off error; and
6. The accuracy
of all distance measuring and localization devices in medical use.
(c) A licensee shall use the
dosimetry system described in 420-3-26-.07(77)(a) to measure the output for one
set of exposure conditions. The remaining radiation measurements required in
420-3-26-.07(78)(b)1 may be made using a dosimetry system that indicates
relative dose rates.
(d) A licensee
shall make full calibration measurements required by 420-3-26-.07(78)(a) in
accordance with published protocols accepted by nationally recognized
bodies.
(e) A licensee shall
mathematically correct the outputs determined in 420-3-26-.07(78)(b)1. for
physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for
cesium-137, or at intervals consistent with 1 percent decay for all other
nuclides.
(f) Full calibration
measurements required by 420-3-26-.07(78)(a) and physical decay corrections
required by 420-3-26-.07(78)(e) must be performed by the authorized medical
physicist.
(g) A licensee shall
retain a record of each calibration in accordance with 420-3-26-.07
(113).
(79)
Full
Calibration Measurements on Remote Afterloader Units.
(a) A licensee authorized to use a remote
afterloader unit for medical use shall perform full calibration measurements on
each unit:
1. Before the first medical use of
the unit;
2. Before medical use
under the following conditions:
(i) Following
replacement of the source or following reinstallation of the unit in a new
location outside the facility; and
(ii) Following any repair of the unit that
includes removal of the source or major repair of the components associated
with the source exposure assembly; and
3. At intervals not exceeding 1 quarter for
high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units
with sources whose half-life exceeds 75 days; and
4. At intervals not exceeding 1 year for low
dose-rate remote afterloader units.
(b) To satisfy the requirement of
420-3-26-.07(79)(a), full calibration measurements must include, as applicable,
determination of:
1. The output within +/- 5
percent;
2. Source positioning
accuracy to within +/- 1 millimeter;
3. Source retraction with backup battery upon
power failure; and
4. Length of the
source transfer tubes;
5. Timer
accuracy and linearity over the typical range of use;
6 Length of the applicators; and
7. Function of the source transfer tubes,
applicators, and transfer tube-applicator interfaces.
(c) A licensee shall use the dosimetry system
described in 420-3-26-.07(77)(a) to measure the output.
(d) A licensee shall make full calibration
measurements required by 420-3-26-.07(79)(a) in accordance with published
protocols accepted by nationally recognized bodies.
(e) In addition to the requirements for full
calibrations for low dose-rate remote afterloader units in 420-3-26-.07(79)(b),
a licensee shall perform an autoradiograph of the source(s) to verify inventory
and source(s) arrangement at intervals not exceeding one quarter.
(f) For low dose-rate remote afterloader
units, a licensee may use measurements provided by the source manufacturer that
are made in accordance with 420-3-26-.07(79)(a) through (e).
(g) A licensee shall mathematically correct
the outputs determined in 420-3-26-.07(79)(b)1. for physical decay at intervals
consistent with 1 percent physical decay.
(h) Full calibration measurements required by
420-3-26-.07(79)(a) and physical decay corrections required by
420-3-26-.07(79)(VII) must be performed by the authorized medical
physicist.
(i) A licensee shall
retain a record of each calibration in accordance with 420-3-26-.07 (113).(80)
(80)
Full
Calibration Measurements on Gamma Stereotactic Radiosurgery Units.
(a) A licensee authorized to use a gamma
stereotactic radiosurgery unit for medical use shall perform full calibration
measurements on each unit:
1. Before the first
medical use of the unit;
2. Before
medical use under the following conditions:
(i) Whenever spot-check measurements indicate
that the output differs by more than 5 percent from the output obtained at the
last full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the sources or
following reinstallation of the gamma stereotactic radiosurgery unit in a new
location; and
(iii) Following any
repair of the gamma stereotactic radiosurgery unit that includes removal of the
sources or major repair of the components associated with the source assembly;
and 3. At intervals not exceeding 1 year, with the exception that relative
helmet factors need only be determined before the first medical use of a helmet
and following any damage to a helmet.
(b) To satisfy the requirement of
420-3-26-.07(80)(a), full calibration measurements must include determination
of:
1. The output within +/-3
percent;
2. Relative helmet
factors;
3. Isocenter
coincidence;
4. Timer accuracy and
linearity over the range of use;
5.
On-off error;
6. Trunnion
centricity;
7. Treatment table
retraction mechanism, using backup battery power or hydraulic backups with the
unit off;
8. Helmet
microswitches;
9. Emergency timing
circuits; and 10. Stereotactic frames and localizing devices
(trunnions).
(c) A
licensee shall use the dosimetry system described in 420-3-26-.07(77)(a) to
measure the output for one set of exposure conditions. The remaining radiation
measurements required in 420-3-26-.07(80)(b)1. may be made using a dosimetry
system that indicates relative dose rates.
(d) A licensee shall make full calibration
measurements required by 420-3-26-.07(80)(a) in accordance with published
protocols accepted by nationally recognized bodies.
(e) A licensee shall mathematically correct
the outputs determined in 420-3-26-.07(80)(b)1. at intervals not exceeding 1
month for cobalt-60 and at intervals consistent with 1 percent physical decay
for all other radionuclides.
(f)
Full calibration measurements required by 420-3-26-.07(80)(a) and physical
decay corrections required by 420-3-26-.07(80)(e) must be performed by the
authorized medical physicist.
(g) A
licensee shall retain a record of each calibration in accordance with
420-3-26-.07 (113).
(81)
Periodic Spot-Checks for Teletherapy Units.
(a) A licensee authorized to use teletherapy
units for medical use shall perform output spot-checks on each teletherapy unit
once in each calendar month that include determination of:
1. Timer accuracy, and timer linearity over
the range of use;
2. On-off
error;
3. The coincidence of the
radiation field and the field indicated by the light beam localizing
device;
4. The accuracy of all
distance measuring and localization devices used for medical use;
5. The output for one typical set of
operating conditions measured with the dosimetry system described in
420-3-26-.07(77)(b); and 6. The difference between the measurement made in
420-3-26-.07(81)(a)5. and the anticipated output, expressed as a percentage of
the anticipated output (i.e., the value obtained at last full calibration
corrected mathematically for physical decay).
(b) A licensee shall perform measurements
required by 420-3-26-.07(81)(a) in accordance with procedures established by
the authorized medical physicist. That individual need not actually perform the
spot check measurements.
(c) A
licensee shall have the authorized medical physicist review the results of each
spot-check within 15 days. The authorized medical physicist shall promptly
notify the licensee in writing of the results of each spot-check.
(d) A licensee authorized to use a
teletherapy unit for medical use shall perform safety spot-checks of each
teletherapy facility once in each calendar month and after each source
installation to assure proper operation of:
1.
Electrical interlocks at each teletherapy room entrance;
2. Electrical or mechanical stops installed
for the purpose of limiting use of the primary beam of radiation (restriction
of source housing angulation or elevation, carriage or stand travel and
operation of the beam on-off mechanism);
3. Source exposure indicator lights on the
teletherapy unit, on the control console, and in the facility;
4. Viewing and intercom systems;
5. Treatment room doors from inside and
outside the treatment room; and
6.
Electrically assisted treatment room doors with the teletherapy unit electrical
power turned off.
(e) If
the results of the checks required in 420-3-26-.07(81)(d) indicate the
malfunction of any system, a licensee shall lock the control console in the off
position and not use the unit except as may be necessary to repair, replace, or
check the malfunctioning system.
(f) A licensee shall retain a record of each
spot-check required by 420-3-26-.07(81)(a) and (d), in accordance with
420-3-26-.07 (114).
(82)
Periodic Spot-Checks for Remote Afterloader Units.
(a) A licensee authorized to use remote
afterloader units for medical use shall perform spot-checks of each remote
afterloader facility and on each unit:
1. At
the beginning of each day of use of a high dose-rate, medium dose-rate or
pulsed dose-rate remote afterloader unit;
2. Prior to each patient treatment with a low
dose-rate remote afterloader unit; and
3. After each source installation.
(b) The licensee shall have the
authorized medical physicist establish written procedures for performing the
spot-checks required in 420-3-26-.07(82)(a). The authorized medical physicist
need not actually perform the spot-check measurements.
(c) A licensee shall have the authorized
medical physicist review the results of each spot-check within 15 days. The
authorized medical physicist shall notify the licensee as soon as possible in
writing of the results of each spot check.
(d) To satisfy the requirements of
420-3-26-.07(82)(a), spot-checks must, at a minimum, assure proper operation
of:
1. Electrical interlocks at each remote
afterloader unit room entrance;
2.
Source exposure indicator lights on the remote afterloader unit, on the control
console, and in the facility;
3.
Viewing and intercom systems in each high dose-rate, medium dose-rate and
pulsed dose-rate remote afterloader facility;
4. Emergency response equipment;
5. Radiation monitors used to indicate the
source position;
6. Timer
accuracy;
7. Clock (date and time)
in the unit's computer; and
8.
Decayed source(s) activity in the unit's computer.
(e) If the results of the checks required in
420-3-26-.07(82)(d) indicate the malfunction of any system, a licensee shall
lock the control console in the off position and not use the unit except as may
be necessary to repair, replace, or check the malfunctioning system.
(f) A licensee shall retain a record of each
check required by 420-3-26-.07(82)(d) in accordance with 420-3-26-.07
(115).
(83)
Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units.
(a) A licensee authorized to use a gamma
stereotactic radiosurgery unit for medical use shall perform spot-checks of
each gamma stereotactic radiosurgery facility and on each unit:
1. Monthly;
2. At the beginning of each day of use;
and
3. After each source
installation.
(b) The
licensee shall have the authorized medical physicist:
1. Establish written procedures for
performing the spot-checks required in 420-3-26-.07(83)(a); and
2. Review the results of each spot-check
required by 420-3-26-.07(83)(a) within 15 days of the check. The authorized
medical physicist need not actually perform the spot-check measurements. The
authorized medical physicist shall notify the licensee as soon as possible, in
writing, of the results of the spotcheck.
(c) To satisfy the requirements of
420-3-26-.07(83)(a) 1., spot-checks must, at a minimum:
1. Assure proper operation of:
(i) Treatment table retraction mechanism,
using backup battery power or hydraulic backups with the unit off;
(ii) Helmet microswitches;
(iii) Emergency timing circuits;
and
(iv) Stereotactic frames and
localizing devices (trunnions).
2. Determine:
(i) The output for one typical set of
operating conditions measured with the dosimetry system described in
420-3-26-.07(77)(b);
(ii) The
difference between the measurement made in 420-3-26-.07(83)(c)2.(i) and the
anticipated output, expressed as a percentage of the anticipated output (i.e.,
the value obtained at last full calibration corrected mathematically for
physical decay);
(iii) Source
output against computer calculation;
(iv) Timer accuracy and linearity over the
range of use;
(v) On-off error;
and
(vi) Trunnion
centricity.
(d)
To satisfy the requirements of 420-3-26-.07(83)(a)2. and 3., spot-checks must
assure proper operation of:
1. Electrical
interlocks at each gamma stereotactic radiosurgery room entrance;
2. Source exposure indicator lights on the
gamma stereotactic radiosurgery unit, on the control console, and in the
facility;
3. Viewing and intercom
systems;
4. Timer
termination;
5. Radiation monitors
used to indicate room exposures; and 6. Emergency off buttons.
(e) A licensee shall arrange for
prompt repair of any system identified in 420-3-26-.07(83)(c) that is not
operating properly.
(f) If the
results of the checks required in 420-3-26-.07(83)(d) indicate the malfunction
of any system, a licensee shall lock the control console in the off position
and not use the unit except as may be necessary to repair, replace, or check
the malfunctioning system.
(g) A
licensee shall retain a record of each check required by 420-3-26-.07(83)(c)
and (d) in accordance with 420-3-26-.07 (116).
(84)
Additional Technical Requirements
for Mobile Remote Afterloader Units.
(a) A licensee providing mobile remote
afterloader service shall:
1. Check survey
instruments before medical use at each address of use or on each day of use,
which ever is more frequent; and
2.
Account for all sources before departure from a client's address of
use.
(b) In addition to
the periodic spot-checks required by 420-3-26-.07(82), a licensee authorized to
use mobile afterloaders for medical use shall perform checks on each remote
afterloader unit before use at each address of use. At a minimum, checks must
be made to verify the operation of:
1.
Electrical interlocks on treatment area access points;
2. Source exposure indicator lights on the
remote afterloader unit, on the control console, and in the facility;
3. Viewing and intercom systems;
4. Applicators, source transfer tubes, and
transfer tube-applicator interfaces;
5. Radiation monitors used to indicate room
exposures;
6. Source positioning
(accuracy); and
7. Radiation
monitors used to indicate whether the source has returned to a safe shielded
position.
(c) In addition
to the requirements for checks in 420-3-26-.07(84)(b), a licensee shall ensure
overall proper operation of the remote afterloader unit by conducting a
simulated cycle of treatment before use at each address of use.
(d) If the results of the checks required in
420-3-26-.07(84)(b) indicate the malfunction of any system, a licensee shall
lock the control console in the off position and not use the unit except as may
be necessary to repair, replace, or check the malfunctioning system.
(e) A licensee shall retain a record of each
check required by 420-3-26-.07(84)(b) in accordance with 420-3-26-.07
(117).
(85)
Radiation Surveys.
(a) In
addition to the survey requirements in
420-3-26-.03
of these regulations, a person licensed pursuant to this rule shall make
surveys to ensure that the maximum radiation levels and average radiation
levels from the surface of the main source safe with the source(s) in the
shielded position does not exceed the levels stated in the Sealed Source and
Device Registry.
(b) The licensee
shall make the survey required by 420-3-26-.07(85)(a) at installation of a new
source and following repairs to the source(s) shielding, the source(s) driving
unit, or other electronic or mechanical component that could expose the source,
reduce the shielding around the source(s), or compromise the radiation safety
of the unit or the source(s).
(c) A
licensee shall retain a record of the radiation surveys required by
paragraph(a) of this section in accordance with 420-3-26-.07
(118).
(86)
Full
Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery
Units.
(a) A licensee shall have each
teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and
serviced during source replacement to assure proper functioning of the source
exposure mechanism and other safety components. The interval between each full
inspection servicing shall not exceed 5 years for each teletherapy unit and
shall not exceed 7 years for each gamma stereotactic radiosurgery
unit.
(b) This inspection and
servicing may only be performed by persons specifically licensed to do so by
the Agency, an Agreement State or the U.S. Nuclear Regulatory
Commission.
(c) A licensee shall
keep a record of the inspection and servicing in accordance with 420-3-26-.07
(119).
(87)
Therapy-Related Computer Systems. The licensee shall perform
acceptance testing on the treatment planning system in accordance with
published protocols accepted by nationally recognized bodies. At a minimum, the
acceptance testing must include, as applicable, verification of:
(a) The source-specific input parameters
required by the dose calculation algorithm;
(b) The accuracy of dose, dwell time, and
treatment time calculations at representative points;
(c) The accuracy of isodose plots and graphic
displays;
(d) The accuracy of the
software used to determine radioactive source positions from radiographic
images; and
(e) The accuracy of
electronic transfer of the treatment delivery parameters to the treatment
delivery unit from the treatment planning system.
(88)
Possession of Survey
Instruments.
A licensee authorized to use radioactive material in remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
shall possess a portable radiation detection survey instrument capable of
detecting dose rates over the range of 1 microsievert (0.1 millirem) per hour
to 500 microsieverts (50 millirems) per hour, and a portable radiation
measurement survey instrument capable of measuring dose rates over the range 10
microsieverts (1 millirem) per hour to 10 millisieverts (1000 millirems) per
hour. The instruments shall be operable and calibrated in accordance with
420-3-26-.07(33).
(89)
Training for Use of Remote Afterloader Units, Teletherapy Units, and
Gamma Stereotactic Radiosurgery Units. Except as provided in
420-3-26-.07(29), the licensee shall require an authorized user of a sealed
source for a use authorized under 420-3-26-.07(72) to be a physician who:
(a) Is certified by a medical specialty board
whose certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State and who meets the requirements in
420-3-26-.07(89)(c). The names of board certifications that have been
recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an
Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.
To have its certification process recognized, a specialty board shall require
all candidates for certification to:
1.
Successfully complete a minimum of 3 years of residency training in a radiation
therapy program approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Council on Postdoctoral Training of the American
Osteopathic Association; and
2.
Pass an examination, administered by diplomates of the specialty board, which
tests knowledge and competence in radiation safety, radionuclide handling,
treatment planning, quality assurance, and clinical use of stereotactic
radiosurgery, remote afterloaders and external beam therapy; or
(b)
1. Has completed a structured educational
program in basic radionuclide techniques applicable to the use of a sealed
source in a therapeutic medical unit that includes:
(i) 200 hours of classroom and laboratory
training in the following areas:
(I) Radiation
physics and instrumentation;
(II)
Radiation protection;
(III)
Mathematics pertaining to the use and measurement of radioactivity;
and
(IV) Radiation biology;
and
(ii) 500 hours of
work experience, under the supervision of an authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(89), or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements at a medical facility
that is authorized to use radioactive material in 420-3-26-.07(72), involving:
(I) Reviewing full calibration measurements
and periodic spot-checks;
(II)
Preparing treatment plans and calculating treatment doses and times;
(III) Using administrative controls to
prevent a misadministration involving the use of radioactive
material;
(IV) Implementing
emergency procedures to be followed in the event of the abnormal operation of
the medical unit or console;
(V)
Checking and using survey meters; and
(VI) Selecting the proper dose and how it is
to be administered; and
2. Has completed 3 years of supervised
clinical experience in radiation therapy, under an authorized user who meets
the requirements in 420-3-26-.07(29), 420-3-26-.07(89), or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements, as part of a
formal training program approved by the Residency Review Committee for
Radiation Oncology of the Accreditation Council for Graduate Medical Education
or the Royal College of Physicians and Surgeons of Canada or the Council on
Postdoctoral Training of the American Osteopathic Association. This experience
may be obtained concurrently with the supervised work experience required by
paragraph 420-3-26-.07(89)(b)1.(ii); and
3. Has obtained written attestation that the
individual has satisfactorily completed the requirements in paragraphs
420-3-26-.07(89)(b) l., (b)2., and (c), and is able to independently fulfill
the radiation safety-related duties as an authorized user of each type of
therapeutic medical unit for which the individual is requesting authorized user
status. The written attestation must be obtained from either:
(i) A preceptor authorized user who meets the
requirements in 420-3-26-.07(29), 420-3-26-.07(89), or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements for an authorized user
for each type of therapeutic medical unit for which the individual is
requesting authorized user status; or
(ii) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in 420-3-26-.07(29), 420-3-26-.07(89), or equivalent
U.S. Nuclear Regulatory Commission or Agreement State requirements, for the
type(s) of therapeutic medical unit for which the individual is requesting
authorized user status, and concurs with the attestation provided by the
residency program director. The residency training program must be approved by
the Residency Review Committee of the Accreditation Council for Graduate
Medical Education or the Royal College of Physicians and Surgeons of Canada or
the Council on Postdoctoral Training of the American Osteopathic Association
and must include training and experience specified in paragraph (b)1 and (b)2
of this section.
(c) Has received training in device
operation, safety procedures, and clinical use for the type(s) of use for which
authorization is sought. This training requirement may be satisfied by
satisfactory completion of a training program provided by the vendor for new
users or by receiving training supervised by an authorized user or authorized
medical physicist, as appropriate, who is authorized for the type(s) of use for
which the individual is seeking authorization.
Other Medical Uses of Radioactive Material or Radiation
from Radioactive Material
(90)
Other Medical Uses of Radioactive
Material or Radiation From Radioactive Material. A licensee may use
radioactive material or a radiation source approved for medical use that is not
specifically addressed in this rule if:
(a)
The applicant or licensee has submitted the information required by
420-3-26-.07(8)(b), 420-3-26-.07(8)(c) and 420-3-26-.07(8)(d); and
(b) The applicant or licensee has received
written approval from the Agency in a license and uses the material in
accordance with the regulations and specific conditions the Agency considers
necessary for the medical use of the material.
Records
(91)
Records of Authority and
Responsibilities for Radiation Protection Programs.
(a) A licensee shall retain a record of
actions taken by the licensee's management in accordance with 420-3-26-.07(19)
(a) for 5 years. The record must include a summary of the actions taken and a
signature of licensee management.
(b) The licensee shall retain a current copy
of the authorities, duties and responsibilities of the Radiation Safety Officer
as required by 420-3-26-.07(19)(d), and a signed copy of the Radiation Safety
Officer's agreement to be responsible for implementing the radiation safety
program, as required by 420-3-26-.07(19)(b). The record must include the
signature of the Radiation Safety Officer and licensee management.
(c) For each Associate Radiation Safety
Officer appointed under 420-3-26-.07(19)(b), the licensee shall retain, for 5
years after the Associate Radiation Safety Officer is removed from the license,
a copy of the written document appointing the Associate Radiation Safety
Officer signed by the licensee's management.
(d) The minutes of each Radiation Safety
Committee meeting held in accordance with 420-3-26-.07(19)(g) shall include:
1. The date of the meeting;
2. Members present;
3. Members absent; and
4. Summary of deliberations and
discussions.
(92)
Records of Radiation Protection
Program Safety Changes. A licensee shall retain a record of each
radiation protection program change made in accordance with 420-3-26-.07(20)(a)
for 5 years. The record must include a copy of the old and new procedures; the
effective date of the change; and the signature of the licensee management that
reviewed and approved the change.
(93)
Records of Written
Directives. A licensee shall retain a copy of each written directive as
required by 420-3-26-.07(23) for 3 years.
(94)
Records of
Misadministrations. A licensee shall retain a record of
misadministrations reported in accordance with 420-3-26-.07 (120) for 3 years.
The record must contain the licensee's name; names of the individuals involved;
the social security number or other identification number if one has been
assigned, of the individual who is the subject of the misadministration; a
brief description of the event; why it occurred; the effect, if any, on the
individual; the actions, if any, taken, or planned, to prevent recurrence; and,
whether the licensee notified the individual (or the individual's responsible
relative or guardian) and, if not, whether such failure to notify was based on
guidance from the referring physician.
(95)
Record of a Dose to an
Embryo/Fetus or a Nursing Child. A licensee shall retain a record of a
dose to an embryo/fetus or a nursing child reported in accordance with
420-3-26-.07 (121) for 3 years. The record must contain the licensee's name;
names of all the individuals involved; social security number or other
identification number if one has been assigned to the pregnant individual or
nursing child who is the subject of the event; a brief description of the
event; why it occurred; the effect, if any, on the embryo/fetus or nursing
child; the actions, if any, taken, or planned, to prevent recurrence; and
whether the licensee notified the pregnant individual or mother (or the
mother's or child's responsible relative or guardian) and, if not, whether such
failure to notify was based on guidance from the referring physician.
(96)
Records of Calibrations of
Instruments Used to Measure the Activity of Unsealed Radioactive
Material. A licensee shall maintain a record of instrument tests
required by 420-3-26-.07(32) for 3 years. The records must include the model
and serial number of the instrument, the date of the test, the results of the
test, and the name of the individual who performed the test.
(97)
Records of Survey Instrument
Calibrations. A licensee shall maintain a record of survey instrument
calibrations required by 420-3-26-.07(33) for 3 years. The record must include
the model and serial number of the instrument, the date of the calibration, the
results of the calibration, and the name of the individual who performed the
calibration.
(98)
Records of
Dosages of Unsealed Radioactive Material for Medical Use. A licensee
shall maintain a record of dosage determinations required by 420-3-26-.07(34)
for 3 years. The record must contain the radioactive drug; the patient's or
human research subject's name, or identification number if one has been
assigned; prescribed dosage; the determined dosage, or a notation that the
total activity is less than 1.1 megabecquerel (30 microcuries); the date and
time of the dosage determination; and the name of the individual who determined
the dosage.
(99)
Records of
Possession of Sealed Sources and Brachytherapy Sources. A licensee shall
retain a record of the semi-annual physical inventory of sealed sources and
brachytherapy sources required by 420-3-26-.07(36)(d) for 3 years. The
inventory record must contain the model number of each source, and serial
number if one has been assigned, the identity of each source radionuclide and
its nominal activity, the location of each source, and the name of the
individual who performed the inventory.
(100)
Records of Surveys for Ambient
Radiation Exposure Rate. A licensee shall retain a record of each survey
required by 420-3-26-.07(40) for 3 years. The record must include the date of
the survey, the results of the survey, the instrument used to make the survey,
and the name of the individual who performed the survey.
(101)
Records of the Release of
Individuals Containing Radioactive Drugs or Implants Containing Radioactive
Material.
(a) A licensee shall retain a
record, signed by the authorized user, of the basis for authorizing the release
of an individual, for 3 years after the date of release.
(b) A licensee shall retain a record, for 3
years after the date of release, that the instructions required by
420-3-26-.07(41)(b) were provided to a breast-feeding woman.
(102)
Records of
Administrative and Technical Requirements that Apply to the Provision of Mobile
Services.
(a) A licensee shall retain a
copy of the letter(s) that permits the use of radioactive material at a
client's address of use, as required by 420-3-26-.07(9)(b), for 3 years after
the last provision of service.
(b)
A licensee shall retain the record of each survey required by
420-3-26-.07(42)(f) for 3 years. The record must include the date of the
survey, the results of the survey, the instrument used to make the survey, and
the name of the individual who performed the survey.
(103)
Records of
Decay-in-Storage. A licensee shall maintain records of the disposal of
licensed materials, as required by 420-3-26-.07(44), for 3 years. The record
must include the date of the disposal, the survey instrument used, the
background radiation level, the radiation level measured at the surface of each
waste container, and the name of the individual who performed the
survey.
(104)
Records of
Radionuclide Purity. A licensee shall maintain a record of the
radionuclide contaminant concentration tests required by 420-3-26-.07(49) for 3
years. The record must include, for each measured elution of radionuclide used
to prepare a radioactive drug, the ratio of the measures expressed as
microcuries of contaminant per millicurie of desired radionuclide
(kilobecquerel/megabecquerel), or microgram of contaminant per millicurie of
desired radionuclide (microgram/megabecquerel), the time and date of the
measurement, and the name of the individual who made the measurement.
(105)
Records of Safety Instruction and
Training. A licensee shall maintain a record of safety instructions and
training required by 420-3-26-.07(53), 420-3-26-.07(63), and operational and
safety instruction required by 420-3-26-.07(75) for 3 years. The record must
include a list of the topics covered, the date of the instruction or training,
the name(s) of the attendee(s), and the name(s) of the individual(s) who
provided the instruction.
(106)
Records of Radiation Surveys of Patients and Human Research
Subjects. A licensee shall maintain a record of the surveys required by
420-3-26-.07(61) and 420-3-26-.07(73) for 3 years. Each record must include the
date and results of the survey, the survey instrument used, and the name of the
individual who made the survey.
(107)
Records of Brachytherapy Source
Inventory.
(a) A licensee shall
maintain a record of brachytherapy source accountability required by
420-32-6-.07(62) for 3 years.
(b)
For temporary implants, the record must include:
1. The number and activity of sources removed
from storage, the time and date they were removed from storage, the name of the
individual who removed them from storage, and the location of use;
and
2. The number and activity of
sources not implanted, the time and date they were returned to storage, and the
name of the individual who returned them to storage.
(c) For permanent implants, the record must
include:
1. The number and activity of sources
removed from storage, the date they were removed from storage, and the name of
the individual who removed them from storage;
2. The number and activity of sources
returned to storage, the date they were returned to storage, and the name of
the individual who returned them to storage; and 3. The number and activity of
sources permanently implanted in the patient or human research
subject.
(108)
Records of Calibration Measurements on Brachytherapy Sources. A
licensee shall maintain a record of the calibrations on brachytherapy sources
required by 420-3-26-.07(65) for 3 years after the last use of the source. The
record must include the date of the calibration; the manufacturer's name, model
number, and serial number for the source and the instruments used to calibrate
the source; the source output or activity; source positioning accuracy within
applicators; and the signature of the authorized medical physicist.
(109)
Records of Decay of Strontium-90
Sources for Ophthalmic Treatments. The licensee shall maintain a record
of the activity of a strontium-90 source required by 420-3-26-.07(65) for the
life of the source. The record must include the date and initial activity of
the source as determined under 420-3-26-.07(65), and for each decay
calculation, the date, the source activity and the signature of the authorized
medical physicist.
(110)
Records of Installation, Maintenance, Adjustment, and Repair of Remote
Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery
Units. A licensee shall retain a record of the installation,
maintenance, adjustment, and repair of remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units as required by
420-3-26-.07(74) for 3 years. For each installation, maintenance, adjustment
and repair, the record must include the date, description of the service, and
name(s) of the individual(s) who performed the work.
(111)
Records of Safety
Procedures. A licensee shall retain a copy of the procedures required by
420-3-26-.07(75)(a)4. and 420-3-26-.07(75)(d)2. until the licensee no longer
possesses the remote afterloader, teletherapy unit, or gamma stereotactic
radiosurgery unit.
(112)
Records of Dosimetry Equipment.
(a) A licensee shall retain a record of the
calibration, intercomparison, and comparisons of its dosimetry equipment done
in accordance with 420-3-26-.07(77) for the duration of the license.
(b) For each calibration, intercomparison, or
comparison, the record must include:
1. The
date;
2. The manufacturer's name,
model numbers and serial numbers of the instruments that were calibrated,
intercompared, or compared as required by 420-3-26-.07(77)(a) and
(b);
3. The correction factor that
was determined from the calibration or comparison or the apparent correction
factor that was determined from an intercomparison; and
4. The names of the individuals who performed
the calibration, intercomparison, or comparison.
(113)
Records of Teletherapy, Remote
Afterloader, and Gamma Stereotactic Radiosurgery Full Calibrations.
(a) A licensee shall maintain a record of the
teletherapy, remote afterloader, and gamma stereotactic radiosurgery full
calibrations required by 420-3-26-.07(78), 420-3-26-.07(79) and
420-3-26-.07(80) for 3 years.
(b)
The record must include:
1. The date of the
calibration;
2. The manufacturer's
name, model number, and serial number for the teletherapy, remote afterloader,
and gamma stereotactic radiosurgery unit(s), the source(s), and instruments
used to calibrate the unit;
3. The
results and assessments of the full calibrations;
4. The results of the autoradiograph required
for low dose-rate remote afterloader units; and 5. The signature of the
authorized medical physicist who performed the full calibration.
(114)
Records of
Periodic Spot-Checks for Teletherapy Units.
(a) A licensee shall retain a record of each
periodic spot-check for teletherapy units required by 420-3-26-.07(81) for 3
years.
(b) The record must include:
1. The date of the spot-check;
2. The manufacturer's name, model number, and
serial number for the teletherapy unit, source and instrument used to measure
the output of the teletherapy unit;
3. An assessment of timer linearity and
constancy;
4. The calculated on-off
error;
5. A determination of the
coincidence of the radiation field and the field indicated by the light beam
localizing device;
6. The
determined accuracy of each distance measuring and localization
device;
7. The difference between
the anticipated output and the measured output;
8. Notations indicating the operability of
each entrance door electrical interlock, each electrical or mechanical stop,
each source exposure indicator light, and the viewing and intercom system and
doors; and
9. The name of the
individual who performed the periodic spot-check and the signature of the
authorized medical physicist who reviewed the record of the
spot-check.
(115)
Records of Periodic Spot-Checks
for Remote Afterloader Units.
(a) A
licensee shall retain a record of each spot-check for remote afterloader units
required by 420-3-26-.07(82) for 3 years.
(b) The record must include, as applicable:
1. The date of the spot-check;
2. The manufacturer's name, model number, and
serial number for the remote afterloader unit and source;
3. An assessment of timer accuracy;
4. Notations indicating the operability of
each entrance door electrical interlock, radiation monitors, source exposure
indicator lights, viewing and intercom systems, and clock and decayed source
activity in the unit's computer; and 5. The name of the individual who
performed the periodic spot-check and the signature of the authorized medical
physicist who reviewed the record of the spot-check.
(116)
Records of Periodic
Spot-Checks for Gamma Stereotactic Radiosurgery Units.
(a) A licensee shall retain a record of each
spot-check for gamma stereotactic radiosurgery units required by
420-3-26-.07(83) for 3 years.
(b)
The record must include:
1. The date of the
spot-check;
2. The manufacturer's
name, model number, and serial number for the gamma stereotactic radiosurgery
unit and the instrument used to measure the output of the unit;
3. An assessment of timer linearity and
accuracy;
4. The calculated on-off
error;
5. A determination of
trunnion centricity;
6. The
difference between the anticipated output and the measured output;
7. An assessment of source output against
computer calculations;
8. Notations
indicating the operability of radiation monitors, helmet microswitches,
emergency timing circuits, emergency off buttons, electrical interlocks, source
exposure indicator lights, viewing and intercom systems, timer termination,
treatment table retraction mechanism, and stereotactic frames and localizing
devices (trunnions); and
9. The
name of the individual who performed the periodic spot-check and the signature
of the authorized medical physicist who reviewed the record of the
spot-check.
(117)
Records of Additional Technical
Requirements for Mobile Remote Afterloader Units.
(a) A licensee shall retain a record of each
check for mobile remote afterloader units required by 420-3-26-.07(84) for 3
years.
(b) The record must include:
1. The date of the check;
2. The manufacturer's name, model number, and
serial number of the remote afterloader unit;
3. Notations accounting for all sources
before the licensee departs from a facility;
4. Notations indicating the operability of
each entrance door electrical interlock, radiation monitors, source exposure
indicator lights, viewing and intercom system, applicators and source transfer
tubes, and source positioning accuracy; and
5. The signature of the individual who
performed the check and the signature of the authorized medical physicist who
reviewed the record of the spot-check.
(118)
Records of Surveys of Therapeutic
Treatment Units.
(a) A licensee shall
maintain a record of radiation surveys of treatment units made in accordance
with 420-3-26-.07(85) for the duration of use of the unit.
(b) The record must include:
1. The date of the measurements;
2. The manufacturer's name, model number and
serial number of the treatment unit, source, and instrument used to measure
radiation levels;
3. Each dose rate
measured around the source while the unit is in the off position and the
average of all measurements; and
4.
The signature of the individual who performed the test.
(119)
Records of Full
Inspection Servicing for Teletherapy and Gamma Stereotactic Surgery
Units.
(a) A licensee shall maintain a
record of the full inspections servicing for teletherapy and gamma stereotactic
radiosurgery units required by 420-3-26-.07(86) for the duration of use of the
unit.
(b) The record must contain:
1. The inspector's radioactive materials
license number;
2. The date of
inspection;
3. The manufacturer's
name and model number and serial number of both the treatment unit and
source;
4. A list of components
inspected and serviced, and the type of service; and 5. The signature of the
inspector.
Reports
(120)
Reports and Notifications of
Misadministrations.
(a) Other than
events that result from intervention by a patient or human research subject, a
licensee shall report any event in which the administration of radioactive
material or radiation from radioactive material results in:
1. A dose that differs from the prescribed
dose or dose that would have resulted from the prescribed dose by more than 5
millisieverts (500 millirem) effective dose equivalent, 0.05 sieverts (5 rem)
to an organ or tissue, or 0.05 sieverts (5 rem) shallow dose equivalent to the
skin; and
(i) The total dose delivered differs
from the prescribed dose by 20 percent or more;
(ii) The total dosage delivered differs from
the prescribed dosage by 20 percent or more or falls outside the prescribed
dosage range; or
(iii) The
fractionated dose delivered differs from the prescribed dose, for a single
fraction, by 50 percent or more.
2. A dose that exceeds 5 millisieverts (500
millirem) effective dose equivalent, 0.05 sieverts (5 rem) to an organ or
tissue, or 0.05 sieverts (5 rem) shallow dose equivalent to the skin from any
of the following:
(i) An administration of a
wrong radioactive drug or the wrong radionuclide for a brachytherapy
procedure;
(ii) An administration
of a radioactive drug containing radioactive material by the wrong route of
administration;
(iii) An
administration of a dose or dosage to the wrong individual or human research
subject;
(iv) An administration of
a dose or dosage delivered by the wrong mode of treatment; or
(v) A leaking sealed source.
3. A dose to the skin or an organ
or tissue other than the treatment site that exceeds by:
(i) 0.05 sieverts (5 rem) or more than the
expected dose to that site from the procedure if the administration had been
given in accordance with the written directive prepared or revised before
administration; and
(ii) 50 percent
or more than the dose expected to that site from the procedure if the
administration had been given in accordance with the written directive prepared
or revised before administration.
4. For permanent implant brachytherapy, the
administration of radioactive material or radiation from radioactive material
(excluding sources that were implanted in the correct site but migrated outside
the treatment site) that results in:
(i) The
total source strength administered differing by 20 percent or more from the
total source strength documented in the post-implantation portion of the
written directive; or
(ii) The
total source strength administered outside the treatment site exceeding 20
percent of the total source strength documented in the post-implantation
portion of the written directive; or
(iii) An administration that includes any of
the following:
(I) The wrong
radionuclide;
(II) The wrong
individual or human research subject;
(III) Sealed source(s) implanted directly
into a location discontiguous from the treatment site, as documented in the
post-implantation portion of the written directive; or
(IV) A leaking sealed source resulting in a
dose that exceeds 0.05 Sv (5 rem) to an organ or tissues
(b) A licensee shall
report any event resulting from intervention of a patient or human research
subject in which the administration of radioactive material or radiation from
radioactive material results, or will result in, unintended permanent
functional damage to an organ or a physiological system, as determined by a
physician.
(c) The licensee shall
notify the Agency by telephone no later than the next calendar day after
discovery of the misadministration.
(d) The licensee shall submit a written
report to the Agency within 15 days after discovery of the misadministration.
1. The written report must include:
(i) The licensee's name;
(ii) The name of the prescribing
physician;
(iii) A brief
description of the event;
(iv) Why
the event occurred;
(v) The effect,
if any, on the individual(s) who received the administration;
(vi) Actions, if any, that have been taken,
or are planned, to prevent recurrence;
(vii) Certification that the licensee
notified the individual (or the individual's responsible relative or guardian),
and if not, why not.
2.
The report may not contain the individual's name or any other information that
could lead to identification of the individual.
(e) The licensee shall provide notification
of the misadministration to the referring physician and also notify the
individual who is the subject of the misadministration no later than 24 hours
after its discovery, unless the referring physician personally informs the
licensee either that he or she will inform the individual or that, based on
medical judgment, telling the individual would be harmful. The licensee is not
required to notify the individual without first consulting the referring
physician. If the referring physician or the affected individual cannot be
reached within 24 hours, the licensee shall notify the individual as soon as
possible thereafter. The licensee may not delay any appropriate medical care
for the individual, including any necessary remedial care as a result of the
misadministration, because of any delay in notification. To meet the
requirements of this paragraph, the notification of the individual who is the
subject of the misadministration may be made instead to that individual's
responsible relative or guardian. If a verbal notification is made, the
licensee shall inform the individual, or appropriate responsible relative or
guardian, that a written description of the event can be obtained from the
licensee upon request. The licensee shall provide such a written description if
requested.
(f) Aside from the
notification requirement, nothing in this section affects any rights or duties
of licensees and physicians in relation to each other, to individuals affected
by the misadministration, or to that individual's responsible relatives or
guardians.
(g) A licensee shall:
1. Retain a record of a misadministration in
accordance with 420-3-26-.07(94).
2. Annotate a copy of the report provided to
the Agency with the:
(i) Name of the
individual subject to the misadministration; and
(ii) Identification number or if no other
number is available, the social security number of the individual subject to
the misadministration;
3.
Provide a copy of the annotated report to the referring physician, if other
than the licensee, no later than 15 days after discovery of the
misadministration.
(121)
Report and Notification of a Dose
to an Embryo/Fetus or a Nursing Child.
(a) A licensee shall report any dose to an
embryo/fetus that is greater than 5 millisieverts (500 millirem) dose
equivalent that is a result of an administration of radioactive material or
radiation from radioactive material to a pregnant individual unless the dose to
the embryo/fetus was specifically approved, in advance, by the authorized
user.
(b) A licensee shall report
any dose to a nursing child, that was not specifically approved, in advance, by
the authorized user, that is a result of an administration of radioactive
material to a breast feeding individual that:
1. Is greater than 5 millisieverts (500
millirem) total effective dose equivalent; or
2. Has resulted in unintended permanent
functional damage to an organ or a physiological system of the child, as
determined by a physician.
(c) The licensee shall notify by telephone
the Agency no later than the next calendar day after discovery of a dose to the
embryo/fetus or nursing child that requires a report in 420-3-26-.07 (121)(a)
or (b).
(d) The licensee shall
submit a written report to the Agency within 15 days after discovery of a dose
to the embryo/fetus or nursing child that requires a report in 420-3-26-.07
(121)(a) or (b).
1. The written report must
include:
(i) The licensee's name;
(ii) The name of the prescribing
physician;
(iii) A brief
description of the event;
(iv) Why
the event occurred;
(v) The effect,
if any, on the embryo/fetus or the nursing child;
(vi) What actions, if any, have been taken,
or are planned, to prevent recurrence; and
(vii) Certification that the licensee
notified the pregnant individual or mother (or the mother's or child's
responsible relative or guardian), and if not, why not.
2. The report must not contain the
individual's or child's name or any other information that could lead to
identification of the individual or child.
(e) The licensee shall notify the referring
physician and also notify the pregnant individual or mother, both hereafter
referred to as the mother, no later than 24 hours after discovery of an event
that would require reporting under 420-3-26-.07 (121) (a) or (b), unless the
referring physician personally informs the licensee either that he or she will
inform the mother or that, based on medical judgment, telling the mother would
be harmful. The licensee is not required to notify the mother without first
consulting with the referring physician. If the referring physician or mother
cannot be reached within 24 hours, the licensee shall make the appropriate
notifications as soon as possible thereafter. The licensee may not delay any
appropriate medical care for the embryo/fetus or for the nursing child,
including any necessary remedial care as a result of the event, because of any
delay in notification. To meet the requirements of this paragraph, the
notification may be made to the mother's or child's responsible relative or
guardian instead of the mother, when appropriate. If a verbal notification is
made, the licensee shall inform the mother, or the mother's or child's
responsible relative or guardian, that a written description of the event can
be obtained from the licensee upon request. The licensee shall provide such a
written description if requested.
(f) A licensee shall:
1. Retain a record of a dose to an
embryo/fetus or a nursing child in accordance with 420-3-26-.07(95).
2. Annotate a copy of the report provided to
the Agency with the:
(i) Name of the pregnant
individual or the nursing child that is subject to the event; and
(ii) Identification number or if no other
identification number is available, the social security number of the
individual who is subject to the event; and
3. Provide a copy of the annotated report to
the referring physician, if other than the licensee, no later than 15 days
after the discovery of the event.
(122)
Reports of Leaking
Sources. A licensee shall file a report with the Agency within 5 days if
a leakage test required by 420-3-26-.07(36) reveals the presence of 185
becquerel (0.005 microcuries) or more of removable contamination. The written
report must include the model number and serial number if assigned, of the
leaking source; the radionuclide and its estimated activity; the results of the
test; the date of the test; and the action taken.
(123)
Reports of Patient Departure
Prior to Authorized Release.
(a) The
licensee shall notify the Agency by telephone immediately upon discovery that a
patient or human research subject has departed from the licensee's facility
without authorization under 420-3-26-.07(41)(a).
(b) The licensee shall submit a written
report to the Agency within 30 days after discovery of the unauthorized
departure. The written report must include:
1.
The licensee's name;
2. The date
and time of the unauthorized departure;
3. The projected date and time when release
would have occurred;
4. The address
of the patient's or human research subject's home or anticipated destination
following departure;
5. The
radionuclide, chemical and physical form and calculated activity at time of
departure;
6. The apparent
reason(s) for the departure prior to authorized release; and 7. A description
of any changes in the licensee's patient release criteria or patient
instructions that are designed to avoid a recurrence of such an
event.
(124)
Notification of Deceased Patients or Human Research Subjects Containing
Radioactive Material.
(a) The licensee
shall notify the Agency by telephone immediately upon discovery that a patient
or human research subject containing radioactive material has died, and it is
possible that any individual could receive exposures in excess of 5
millisieverts (500 millirem) as a result of the deceased's body.
(b) The licensee shall submit a written
report to the Agency within 30 days after discovery that the patient or human
research subject referenced in 420-3-26-.07 (124)(a) has died. The written
report must include:
1. The licensee's
name;
2. The date of
death;
3. The radionuclide,
chemical and physical form and calculated activity at time of death;
and,
4. The names (or titles) and
address(es) of known individuals who might have received exposures exceeding 5
millisieverts (500 millirem).
(125)
Report and
Notification for an Eluate Exceeding Permissible Molybdenum- 99, Strontium-82,
and Strontium-85 Concentrations.
(a) The licensee shall notify by telephone
the Agency and the distributor of the generator within 7 calendar days after
discovery that an eluate exceeded the permissible concentration listed in
420-3-26-.07(49)(a) at the time of generator elution. The telephone report to
the Agency must include the manufacturer model number, and serial number (or
lot number) of the generator the results of the measurement; the date of the
measurement; whether dosages were administered to patients of human research
subjects; when the distributor was notified; and the action plan
taken.
(b) The licensee shall
submit a written report to the Agency within 30 calendar days after discovery
of an eluate exceeding the permissible concentration at the time of generator
elution. The written report must include the action taken by the licensee; the
patient dose assessment; the methodology used to make this dose assessment if
the eluate was administered to patients or human research subjects; and the
probable cause and an assessment of failure in the licensee's equipment,
procedures, or training that contributed to the excessive readings if an error
occurred in the licensee's breakthrough determination; and the information in
the telephone report as required by paragraph (a) of this section.
24 Experience with at least 3 cases
in (56)(b)1.(ii)(VII)(B) also satisfies the requirement in
(56)(b)1.(ii)(VII)(A).
Filed September 1, 1982. Readopted with
amendments filed October 24, 1983. Amended: Filed July 20, 1988.
Amended: Filed January 19,
1990.
Authors: Karl David Walter; David A.
Turberville
Statutory Authority:
Code of Ala.
1975, §§
22-14-4,
22-14-6,
22-14-7,
22-14-8,
22-14-9,
as amended.