Ga. Comp. R. & Regs. R. 391-3-17-.05 - Use of Radionuclides in the Healing Arts
(1)
Purpose and Scope. This Rule,
391-3-17-.05, establishes
requirements and provisions for the production, preparation, compounding and
use of radionuclides in the healing arts and for issuance of licenses
authorizing these activities. These requirements and provisions provide for the
radiation safety of workers, the general public, patients, and human research
subjects. The requirements and provisions of this Rule are in addition to, and
not in substitution for, others in these regulations unless specifically
exempted. All numbered and lettered references within this Rule refer to parts
of this Rule, unless stated otherwise.
(2)
Definitions.
(a) "Accredited institution," means a
teaching facility for nuclear medicine technology or radiation therapy
technology whose standards are accepted by the United States Department of
Education.
(b) "Address of use,"
means the building or buildings that are identified on the license and where
radioactive material may be produced, prepared, received, used, or
stored.
(c) "Area of use," means a
portion of an address of use that has been set aside for the purpose of
receiving, using, or storing radioactive material.
(d) "Authorized medical physicist," means an
individual who:
2. Is identified as an
authorized medical physicist on a license or equivalent permit issued by the
Director, Nuclear Regulatory Commission or Agreement State; or
3. Is identified as an authorized medical
physicist on a permit issued by the Director, Nuclear Regulatory Commission or
Agreement State specific license of broad scope that is authorized to permit
the use of radioactive material.
(e) "Authorized nuclear pharmacist," means a
pharmacist who:
2. Is identified as an
authorized nuclear pharmacist on a license or equivalent permit issued by the
Director, Nuclear Regulatory Commission or Agreement State; or
3. Is identified as an authorized nuclear
pharmacist on a permit issued by the Director, Nuclear Regulatory Commission or
Agreement State specific license of broad scope that is authorized to permit
the use of radioactive material.
(f) "Authorized user," means a physician,
dentist, or podiatrist who:
1. Meets the
requirements in Rule
.05(27) and
.05(43)(a),
.05(47)(a),
.05(52)(a),
.05(53)(a),
.05(54)(a),
.05(63)(a),
.05(66)(a), or
.05(84)(a);
or
2. Is identified as an
authorized user on a license or equivalent permit issued by the Director,
Nuclear Regulatory Commission or Agreement State; or
3. Is identified as an authorized user on a
permit issued by the Director, Nuclear Regulatory Commission or Agreement State
specific license of broad scope that is authorized to permit the use of
radioactive material.
(g)
"Brachytherapy," means a method of radiation therapy in which plated, embedded,
activated, or sealed sources are utilized to deliver a radiation dose at a
distance of up to a few centimeters, by surface, intracavitary, intraluminal or
interstitial application.
(h)
"Brachytherapy source," means a radioactive source or a manufacturer-assembled
source train or a combination of these sources that is designed to deliver a
therapeutic dose within a distance of a few centimeters.
(i) "Client's address," means the address of
use or a temporary jobsite for the purpose of providing mobile medical service
in accordance with Rule
.05(38).
(j) "Dedicated check source," means a
radioactive source that is used to assure the consistent response of a
radiation detection or measurement device over several months or
years.
(k) "Dentist," means an
individual licensed to engage in the practice dentistry under the Authority of
O.C.G.A. 43-11-40.
(l) "Diagnostic
clinical procedures manual," means a collection of written procedures that
describes each method (and other instructions and precautions) by which the
licensee performs diagnostic clinical procedures; where each diagnostic
clinical procedure has been approved by the authorized user and includes the
radiopharmaceutical, dosage, and route of administration, or in the case of
sealed sources for diagnosis, the procedure.
(m) "High dose-rate remote afterloader,"
(HDR) means a device that remotely delivers a dose rate in excess of 12 gray
(1200 rad) per hour at the treatment site.
(n) "Low dose-rate remote afterloader," (LDR)
means a device that remotely delivers a dose rate of less than or equal to 2
gray (200 rad) per hour at the treatment site.
(o) "Management," means the chief executive
officer or other individual having the authority to manage, direct, or
administer the licensee's activities, or those persons' delegate or
delegates.
(p) "Manual
brachytherapy," means a type of therapy in which brachytherapy sources are
manually applied or inserted.
(q)
"Medical institution," means an organization in which several medical
disciplines are practiced.
(r)
"Medical use," means the intentional internal or external administration of
radioactive material or the radiation from radioactive material to patients or
human research subjects under the supervision of an authorized user.
(s) "Medium dose-rate remote afterloader,"
(MDR) means a device that remotely delivers a dose rate of greater than 2 gray
(200 rad), but less than, or equal to, 12 gray (1200 rad) per hour at the
treatment site.
(t)
"Misadministration," means an event that meets the criteria in Rule
.05(115)(a).
(u) "Mobile medical
service," means the transportation of radioactive material or its medical use
at the client's address.
(v)
"Nuclear medicine technologist," means an individual who meets the requirements
of Rule .05(25)(a) and, is under the supervision of an authorized user, to
prepare or administers radioactive drugs to patients or human research
subjects, or perform in vivo or in vitro
measurements for medical purposes.
(w) "Nuclear medicine technology," means the
science and art of in vivo and in vitro detection and measurement of
radioactivity and the administration of radioactive drugs to patients or human
research subjects for diagnostic and therapeutic purposes.
(x) "Output," means the exposure rate, dose
rate, or a quantity related in a known manner to these rates from a
brachytherapy source, or a teletherapy, remote afterloader, or gamma
stereotactic radiosurgery unit for a specified set of exposure
conditions.
(y) "Patient
intervention," means actions by the patient or human research subject, whether
intentional or unintentional, such as dislodging or removing treatment devices
or prematurely terminating the administration.
(z) "Pharmacist," means any individual who is
licensed to practice Pharmacy in this State by the Georgia State Board of
Pharmacy.
(aa) "Physician," means
any person who is licensed to engage in the practice of medicine under the
Authority of O.C.G.A. 43-34-20 or the limited practice of medicine under
O.C.G.A. 43-35-1.
(bb)
"Podiatrist," means an individual licensed by the appropriate authority to
practice podiatry in the state of Georgia.
(cc) "Positron Emission Tomography (PET)
radionuclide production facility" is defined as a facility operating a
cyclotron or accelerator for the purpose of producing PET
radionuclides.
(dd) "Preceptor,"
means an individual who provides, directs or verifies training and experience
required for an individual to become an authorized user, an authorized medical
physicist, an authorized nuclear pharmacist, an Associate Radiation Safety
Officer or a Radiation Safety Officer.
(ee) "Prescribed dosage," means the specified
activity or range of activity of radioactive drug as documented:
1. In a written directive; or
2. In accordance with the directions of the
authorized user for procedures performed pursuant to Rule .05(41), (44) and
(48).
(ff) "Prescribed
dose," means:
1. For gamma stereotactic
radiosurgery, the total dose as documented in the written directive;
2. For teletherapy, the total dose and dose
per fraction as documented in the written directive;
3. For brachytherapy, either the total source
strength and exposure time or the total dose, as documented in the written
directive; or
4. For remote
brachytherapy afterloaders, the total dose and dose per fraction as documented
in the written directive.
(gg) "Pulsed dose-rate remote afterloader,"
(PDR) means a special type of remote afterloading device that uses a single
source capable of delivering dose rates in the "high dose-rate" range, but:
1. Is approximately one-tenth of the activity
of typical high dose-rate remote afterloader sources; and
2. Is used to simulate the radiobiology of a
low dose rate treatment by inserting the source for a given fraction of each
hour.
(hh) "Radiation
Safety Officer," means an individual who:
1.
Meets the requirements in Rule .05(22)(a) or .05(22)(c)1. And .05(27);
or
2. Is identified as a Radiation
Safety Officer on a Nuclear Regulatory Commission or Agreement State license or
other equivalent permit or license recognized by the Division for similar types
and uses of radioactive material.
(ii) "Radiation therapist," means an
individual who meets the requirements of Rule .05(25)(b) and is under the
supervision of an authorized user to perform procedures and apply radiation
emitted from sealed radioactive sources to human beings for therapeutic
purposes.
(jj) "Radiation therapy
technology," means the science and art of applying radiation emitted from
sealed radioactive sources to patients or human research subjects for
therapeutic purposes.
(kk)
"Radioactive drug," means any chemical compound containing radioactive material
that may be used on or administered to patients or human research subjects as
an aid in the diagnosis, treatment, or prevention of disease or other abnormal
condition.
(ll) "Sealed source,"
means any radioactive material that is encased in a capsule designed to prevent
leakage or escape of the radioactive material.
(mm) "Sealed Source and Device Registry,"
means the national registry that contains the registration certificates
maintained by the Nuclear Regulatory Commission, that summarize the radiation
safety information for the sealed sources and devices and describe the
licensing and use conditions approved for the product.
(nn) "Stereotactic radiosurgery," means the
use of external radiation in conjunction with a stereotactic guidance device to
very precisely deliver a dose to a treatment site.
(oo) "Structured educational program," means
an educational program designed to impart particular knowledge and practical
education through interrelated studies and supervised training.
(pp) "Teletherapy," as used in this Rule,
means a method of radiation therapy in which collimated gamma rays are
delivered at a distance from the patient or human research subject.
(qq) "Temporary jobsite," as used in this
Rule, means a location where mobile medical services are conducted other than
the location(s) of use authorized on the license.
(rr) "Therapeutic dosage," means a dosage of
unsealed radioactive material that is intended to deliver a radiation dose to a
patient or human research subject for palliative or curative
treatment.
(ss) "Therapeutic dose,"
means a radiation dose delivered from a sealed source containing radioactive
material to a patient or human research subject for palliative or curative
treatment.
(tt) "Treatment site,"
means the anatomical description of the tissue intended to receive a radiation
dose, as described in a written directive.
(uu) "Type of use," means use of radioactive
material as specified under Rule .05(41), (44), (48), (55), (65), (67) or
(85).
(vv) "Unit dosage," means a
dosage that:
1. Is obtained or prepared in
accordance with the regulations for uses described in Rule .05(41), (44), (48);
and
2. Is to be administered as a
single dosage to a patient or human research subject without any further
manipulation of the dosage after it is initially prepared.
(ww) "Written directive," means an authorized
user's written order for the administration of radioactive material or
radiation from radioactive material to a specific patient or human research
subject, as specified in Rule .05(19).
(xx) "Associate Radiation Safety Officer,"
means an individual who:
1. Meets the
requirements in
391-3-17-.05(22)
and .05(27); and
2. Is currently
identified as an Associate Radiation Safety Officer for the types of use of
byproduct material for which the individual has been assigned duties and tasks
by the Radiation Safety Officer on:
(i) A
specific medical use license issued by the Commission or an Agreement State;
or
(ii) A medical use permit issued
by a Commission master material licensee.
(yy) "Ophthalmic physicist," means an
individual who:
2. Is identified as an
ophthalmic physicist on a:
(i) Specific
medical use license issued by the Commission or an Agreement State;
(ii) Permit issued by a Commission or
Agreement State broad scope medical use licensee;
(iii) Medical use permit issued by a
Commission master material licensee; or
(iv) Permit issued by a Commission master
material licensee broad scope medical use permittee.
(3)
Maintenance of
Records. Each record required by Rule
.05 must be legible throughout the
retention period specified by each Division Rule. 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 that 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 Division license before
conducting such research. Both types of licensees shall, at a minimum, obtain
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 .05(4)(a) shall be conducted using radioactive material
authorized for medical use in the license; and
(5)
U.S. Food and Drug Administration,
Federal, and State Requirements. Nothing in Rule
.05 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) A licensee shall implement the provisions
in Rule .05 on July 1,
2003.
(b) When a requirement in
Rule .05 differs
from the requirement in an existing license condition, the requirement in Rule
.05 shall govern.
(c) Any existing license condition that is
not affected by a requirement in Rule
.05 remains in effect until there
is a license amendment or license renewal.
(d) If a license condition exempted a
licensee from a provision of Rule
.05 on July 1, 2003, it will
continue to exempt a licensee from the corresponding provision in Rule
.05.
(e) If a license condition cites provisions
in Rule .05 that will
be deleted on July 1, 2003, then the license condition remains in effect until
there is a license amendment or license renewal that modifies or removes this
condition.
(f) Licensees shall
continue to comply with any license condition that requires it to implement
procedures required by Rule
.05(70), (76), (77) and
(78) until there is a license amendment or
renewal that modifies the license condition.
(7)
License Required.
(a) A person may manufacture, produce,
prepare, acquire, receive, possess, use, or transfer radioactive material for
medical use only in accordance with a specific license issued by the Director,
the Nuclear Regulatory Commission or an Agreement State, or as allowed in Rule
.05(7)(b) or
(7)(c).
(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 Rule
.05(41), (44), (48), (55), (65), (67) or
(85) must be made by:
1. Filing an original Application for
Radioactive Materials License, and
2. Submitting procedures required by sections
Rule .05(70), (76), (77), and
(78), as applicable.
(c) A request for a license amendment or
renewal must be made by:
1. Submitting an
original in letter format.
2.
Submitting procedures required by sections Rule
.05(70), (76), (77) and
(78), as applicable.
(d) In addition to the requirements in (8)(b)
and (8)(c), an application for a license or amendment for medical use of
radioactive material as described in (85) of Rule
.05 must also include information
regarding any radiation safety aspects of the medical use of the material that
is not addressed in Rule
.05(1) through
Rule .05(40), 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
Division in its review of the application.
(f) An applicant that satisfies the
requirements specified in Rule
.02(10)(b) may
apply for a Type A specific license of broad scope.
(9)
Mobile Medical Service
Administrative Requirements.
(a) The
Director 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 clinic'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 Rule
.05(97).
(f) A mobile medical service licensee shall
maintain on each mobile unit:
1. The current
operating and emergency procedures;
2. A copy of the license;
3. Copies of the letter required by
.05(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 records required by Rules
.03 and
.05 of this Chapter at a location
within the Division'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 Division 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 Division.
(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
Rule .05, but that
is not authorized on the licensee's current license issued pursuant to Rule
.05;
(b) Before it permits anyone to work as an
authorized user, authorized nuclear pharmacist, or authorized medical physicist
under the license, except an individual who is:
1. For an authorized user, an individual who
meets the requirements in Rule
.05(27) and
(43)(a), Rule
.05(47)(a), (52)(a), (53)(a), (54)(a), (63)(a),
(64)(a), (66)(a), or (84)(a) or;
2. For an authorized nuclear pharmacist, an
individual who meets the requirements in Rule
.05(24)(a) and
(27);
3. For an authorized medical physicist, an
individual who meets the requirements in Rule
.05(23)(a) and
(27);
4. Identified as an authorized user, an
authorized nuclear pharmacist, or authorized medical physicist on a Nuclear
Regulatory Commission or Agreement State license or other equivalent permit or
license recognized by the Division that authorizes the use of radioactive
material in medical use or in the practice of nuclear pharmacy, respectively;
or
5. Identified as an authorized
user, an authorized nuclear pharmacist, or authorized medical physicist on a
permit issued by a Nuclear Regulatory Commission or Agreement State specific
licensee of broad scope that is authorized to permit the use of radioactive
material in medical use or in the practice of nuclear pharmacy,
respectively.
(c) Before
it changes Radiation Safety Officers, except as provided in (15)(c);
(d) Before it receives radioactive material
in excess of the amount, or in a different physical or chemical form than is
authorized on the license;
(e)
Before it adds to or changes the areas of use identified in the application or
on the license, except as specified in (11)(b)4.;
(f) Before it changes the address(es) of use
identified in the application or on the license;
(g) Before it changes statements,
representations, and procedures which are incorporated into the license;
and
(h) Before it releases licensed
facilities for unrestricted use.
(11)
Notifications.
(a) A licensee shall provide to the Division
a copy of the board certification, the Nuclear Regulatory Commission or
Agreement State license, or the permit issued by a licensee of broad scope for
each individual no later than 30 days after the date that the licensee permits
the individual to work as an authorized user, an authorized nuclear pharmacist
or an authorized medical physicist, pursuant to (10)(b).
(b) A licensee shall notify the Division by
letter no later than 30 days after:
1. A
Radiation Safety Officer permanently discontinues performance of duties under
the license or has a name change;
2. The licensee's mailing address
changes;
3. The licensee's name
changes, but the name change does not constitute a transfer of control of the
license as described in Rule
.02 (13)(b) of
these regulations; or
4. The
licensee has added to or changed the areas where radioactive material is used
in accordance with Rule
.05(41) and
(44).
(12)
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 (8)(d) of these
regulations, regarding the need to file an amendment to the license for medical
uses of radioactive material, as described in .05(85);
(b) The provisions of (10)(b) regarding the
need to file an amendment before permitting anyone to work as an authorized
user, an authorized nuclear pharmacist or an authorized medical physicist under
the license;
(c) The provisions of
(10)(e) regarding additions to or changes in the areas of use at the addresses
specified in the license;
(d) The
provisions of .05(11)(a) regarding notification to the Division for new
authorized users, new authorized nuclear pharmacists and new authorized medical
physicists; and
(e) The provisions
of .05(21)(a) regarding suppliers for sealed sources.
(13)
License Issuance.
(a) The Director shall issue a license for
the medical use of radioactive material if:
1.
The applicant has filed Application for Radioactive Materials License in
accordance with the instructions in .05(8);
2. The applicant has paid any applicable
fee;
3. The applicant meets the
requirements of Rule
.02 of this Chapter; and
4. The Director finds the applicant equipped
and committed to observe the safety standards established by the Division in
these Rules for the protection of the public health and safety.
(b) The Director shall issue a
license for mobile services if the applicant:
1. Meets the requirements in .05(13)(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 .05(37).
(14)
Specific Exemptions. The
Director may, upon application of any interested person or upon its own
initiative, grant such exemptions from the regulations in Rule
.05 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.
General Administrative Requirements
(15)
Authority and
Responsibilities for the Radiation Protection Program.
(a) In addition to the radiation protection
program requirements of Rule
.03(4), a
licensee's management must approve in writing:
1. Requests for license application, renewal,
or amendments before submittal to the Division;
2. Any individual before allowing that
individual to work as an authorized user, authorized nuclear pharmacist or
authorized medical physicist, and
3. Radiation protection program changes that
do not require a license amendment and are permitted under .05(16);
(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 sixty 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
.05(15)(e), provided the licensee takes the actions required in
.05(15)(b),(d),(e) and (h) A licensee may simultaneously appoint more than one
temporary RSO, if needed, to ensure that the licensee has a temporary RSO that
satisfies the requirements to be an RSO 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 Rule
.05(48), (55), (67), and
(85), or two or more types of units under
Rule .05(67) 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's Radiation Safety Committee
shall meet as necessary, but at a minimum shall meet at intervals not to exceed
six months. The licensee shall maintain minutes of each required meeting in
accordance with Rule
.05(86)(c).
(16)
Radiation Protection Program
Changes.
(a) A licensee may revise its
radiation protection program without Division approval if:
1. The revision does not require an amendment
under Rule
.05(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 Rule
.05(87).
(17)
Duties of Authorized
User and Authorized Medical Physicist.
(a) A licensee shall assure that only
authorized users for the type of radioactive material use:
1. Prescribe the radiopharmaceutical dosage
and/or dose to be administered through the issuance of a written directive or
reference to the diagnostic clinical procedures manual;
2. Direct, as specified in Rule
.05(18) and (19),
or in license conditions, the administration of radioactive material for
medical use to patients or human research subjects; and
3. Prepare and administer, or supervise the
preparation and administration of radioactive material for medical use, in
accordance with Rule
.05(7)(b) and (7)(c) and
(18).
(18)
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 Rule
.05(7)(b) shall:
1. In addition to the requirements in Rule
.07(3) of this
Chapter, instruct the supervised individual in the licensee's written radiation
protection procedures, written directive procedures, regulations of Rule
.05, 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 Rule
.05, 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 Rule
.05(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
Rule .05, and
license conditions.
(c)
Unless physical presence is required in other sections of Rule
.05, a licensee who permits
supervised activities under Rule
.05(18)(a) and
(18)(b) shall require an authorized user to
be immediately available to communicate with the supervised individual, and
when a written directive is required, be able to be physically present within
one hour of notification; and
(d) A
licensee that permits supervised activities under Rule
.05(18)(a) and
(18)(b) is responsible for the acts and
omissions of the supervised individual.
(19)
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 µCi), 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.
2. A written revision to an existing written
directive 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.
3. If, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
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.
(b) The written directive must
contain the patient or human research subject's name and the following:
1. For an administration of a dosage of
radioactive drug containing radioactive material, the radioactive drug
containing radioactive material, dosage, and route of administration;
2. For gamma stereotactic radiosurgery, the
total dose, treatment site, and number of target coordinate settings per
treatment for each anatomically distinct treatment site;
3. For teletherapy, the total dose, dose per
fraction, number of fractions, and treatment site;
4. For high dose rate remote afterloading
brachytherapy, the radionuclide, treatment site, dose per fraction, number of
fractions, and total dose;
5. 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; or
6. For permanent
implant brachytherapy:
(i) Before
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.
(c) The licensee shall retain the written
directive in accordance with Rule
.05
(88).
(20)
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 Rule
.05(20)(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 Rule
.05(67);
5. Determining if a medical event, as defined
in Rule .05(115), 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.
(c) A licensee shall retain a copy of the
procedures required under subparagraph (a) in accordance with
391-3-17-.05(20) and
(88).
(21)
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 Rule
.02 of this Chapter or the
equivalent requirements of the Nuclear Regulatory Commission or an Agreement
State; or
(b) Sealed sources or
devices non-commercially transferred from Rule
.05 licensee or a Nuclear
Regulatory Commission or an Agreement State medical use licensee.
(22)
Training for Radiation
Safety Officer. Except as provided in Rule
.05(26), 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 Rule
.05(15) to be an
individual who:
(a) Is certified by a
specialty board whose certification process includes all of the requirements in
Rule. 05(22)(d), and whose certification has been recognized by the Nuclear
Regulatory Commission or an Agreement State. (The names of board certifications
that have been recognized by the Nuclear Regulatory Commission or an Agreement
State will be posted on the NRC's 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 Nuclear Regulatory Commission or an Agreement State; or
(iii) Pass an
examination, administered by diplomates 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 RSO on a Nuclear Regulatory Commission, Agreement State license or
permit issued by a 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 on a Nuclear Regulatory Commission,
Agreement State license or permit issued by a Commission master material
licensee that authorizes similar type(s) of use(s) of radioactive byproduct
material. 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 dose calibrators, 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;
or
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 byproduct material 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 subparagraphs (b)1.
and (d) of this paragraph, 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 Nuclear Regulatory Commission
or an Agreement State under Rule
.05(23)(a) and has
experience in radiation safety for similar types of use of byproduct 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 .05(22)(d); or
2.
Is an authorized user, authorized medical physicist, or authorized nuclear
pharmacist identified on a Commission or an Agreement State license, a permit
issued by a Commission master material license, a permit issued by a Commission
or an Agreement State license broad scope permittee, has experience with the
radiation safety aspects of similar types of use of radioactive byproduct
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 in subparagraph
.05(22)(d);
or
3. Has experience with the
radiation safety aspects of the types of use of byproduct material for which
the individual is seeking simultaneous approval both as the Radiation Safety
Officer and the authorized user on the same new medical use license or new
medical use permit issued by a Commission master material licensee. The
individual must also meet the requirements in subparagraph
.05(22)(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.
(23)
Training for Authorized
Medical Physicist. Except as provided in Rule
.05(26) the
licensee shall require the authorized medical physicist to be an individual
who:
(a) Is certified by a specialty board
whose certification process includes all of the training and experience
requirements in .05(23)(c) and whose certification has been recognized by the
Nuclear Regulatory Commission or an Agreement State. (The names of board
certifications that have been recognized by the Nuclear Regulatory Commission
or an Agreement State will be posted on the NRC's 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 recognized
by the 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 Rule
.05(26),
.05(63) or
.05(84);
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 .05(23)(b)1. and
.05(23)(c) of this section, and has achieved a level of competency sufficient
to function independently 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 Rule
.05(23),
.05(26), or
equivalent 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.
(24)
Training for an
Authorized Nuclear Pharmacist. Except as provided in Rule
.05(26), 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 Nuclear Regulatory
Commission or an Agreement State. (The names of board certifications that have
been recognized by the Nuclear Regulatory Commission or an Agreement State will
be posted on the NRC's 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 Accreditation Council for Pharmacy Education (ACPE)
(previously named the American Council on Pharmaceutical Education) 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 4,000 hours of training/experience in nuclear pharmacy practice. Academic
training may be substituted for no more than 2,000 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 dose calibrators, 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 misadministrations 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 Rule
.05(24)(b)1. and
has achieved a level of competency sufficient to independently fulfill the
radiation safety-related duties as an authorized nuclear pharmacist and operate
a nuclear pharmacy, and
(c) Licensed as a Nuclear Pharmacist by the
Georgia Board of Pharmacy.
(25)
Training and Technical
Requirements for Nuclear Medicine Technologists and Radiation
Therapists.
(a) The licensee shall
require a nuclear medicine technologist using radioactive materials under the
supervision of an authorized user to be an individual who:
1. Is certified in:
(i) Nuclear Medicine by the Nuclear Medicine
Technology Certification Board;
(ii) Nuclear Medicine by the American
Registry of Radiologic Technologists with competency in Nuclear Medicine;
or,
2. Is board eligible
to take the CNMT or ARRT(N) examinations; or,
3. Has successfully completed a training
program in nuclear medicine which has resulted in a certificate, associate
degree, or baccalaureate degree in a nuclear medicine technology program from
an accredited institution; or,
4.
Has performed as a full-time nuclear medicine technologist for a minimum of two
years during the past five-year period under the supervision of an authorized
user who attests the experience in writing; or,
5. Has completed 80 hours of training and
experience in basic radionuclide handling techniques applicable to the medical
use of unsealed radioactive material that includes:
(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 involving:
(I) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(II) Quality Control
checking of 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) Administering
dosages to patients or human research subjects; and
(iii) Has obtained written attestation,
signed by a preceptor authorized user that the individual has satisfactorily
completed the requirements of this section and has achieved a level of
competency sufficient to independently function as a nuclear medicine
technologist.
(b) The licensee shall require a radiation
therapist using radioactive materials under the supervision of an authorized
user to be an individual who:
1. Is certified
in Radiation Therapy by the American Registry of Radiologic Technologists
(ARRT(T)); or
2. Is board eligible
to take the ARRT(T) examination; or,
3. Has successfully completed a training
program in radiation therapy which has resulted in a certificate, associate
degree, or baccalaureate degree in a radiologic technology program that
complies with the requirements of the Joint Review Committee on Education in
Radiologic Technology1 ; or,
4. Has performed as a full-time radiation
therapist for a minimum of two years during the past five-year period under the
supervision of an authorized user who attests the experience in writing;
or
5. Has completed 200 hours of
training and experience in basic radionuclide handling techniques applicable to
the medical use of radioactive material that includes:
(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; and
(IV) Radiation biology; and
(ii) Work experience, under the
supervision of an authorized user involving:
(I) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(II) Assisting the
authorized user in simulating the patient for treatment;
(III) Preparing the patient for
treatment;
(IV) Implementing
treatment plans as prescribed by the authorized user;
(V) Providing written documentation of
treatment setup and patient treatments;
(VI) Quality control checks to determine that
devices used to deliver the radiation doses are in compliance with
institutional standards and performing checks for proper operation of survey
meters;
(VII) Preparing or
assisting in the preparation of sources, and implantation and removal of sealed
sources;
(VIII) Delivering doses to
patients or human research subjects under the supervision of the authorized
user;
(IX) Preparing, implanting,
and removing sealed sources;
(X)
Delivering dose to patients or human research subjects;
(XI) Maintaining running inventories of
material on hand;
(XII) Using
administrative controls to prevent a misadministration involving the use of
radioactive material; and,
(XIII)
Properly implementing emergency procedures and
(iii) Has obtained written attestation,
signed by a preceptor authorized user that the individual has satisfactorily
completed the requirements of this section and has achieved a level of
competency sufficient to independently function as a radiation
therapist.
(c)
Individuals working as nuclear medicine technologists or radiation therapists
prior to July 1, 2003 for a facility holding a Division license need not comply
with the training requirements of this section.
(d) The licensee shall maintain records of
the above training as specified in Rule
.05(100).
(26)
Provisions for
Experienced Radiation Safety Officer, Teletherapy or Medical Physicist,
Authorized Medical Physicist, Authorized User, Nuclear Pharmacist, and
Authorized Nuclear Pharmacist.
(a)
1. An individual identified as a Radiation
Safety Officer, a teletherapy or medical physicist, an authorized medical
physicist, a nuclear pharmacist or an authorized nuclear pharmacist on a
Division, Nuclear Regulatory Commission or Agreement State license or on a
permit issued by the Division, Nuclear Regulatory commission or Agreement State
broad scope licensee or master material license permit or by a master material
license permittee of broad scope before the effective date of this rule, need
not comply with the training requirements of Rules
.05(22),
.05(23), or
.05(24),
respectively except the Radiation Safety Officers and authorized medical
physicists identified in this paragraph must meet the training requirements in
Rule .05(22)(d) or
.05(23)(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 Rule
.05(22) to be
identified as a Radiation Safety Officer or as an Associate Radiation Safety
Officer on a Division, 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 Rule
.05(23), for those
materials and uses that these individuals performed on or before October 24,
2005.
4. A Radiation Safety
Officer, a medical physicist, or a nuclear pharmacist, who used only
accelerator-produced radioactive materials, discrete sources of radium-226, or
both, for medical uses or in the practice of nuclear pharmacy at a Government
agency or Federally recognized Indian Tribe before November 30, 2007 or at all
other locations of use before August 8, 2009, or an earlier date as noticed by
the NRC, need not comply with the training requirements of Rules
.05(22),
.05(23) or
.05(24),
respectively, when performing the same uses. A nuclear pharmacist, who prepared
only radioactive drugs containing accelerator-produced radioactive materials,
or a medical physicist, who used only accelerator-produced radioactive
materials, at the locations and time period identified in this paragraph,
qualifies as an authorized nuclear pharmacist or an authorized medical
physicist, respectively, for those materials and uses performed before these
dates, for purposes of this chapter.
(b)
1.
Physicians, dentists, or podiatrists identified as authorized users for the
medical use of radioactive byproduct material on a license issued by the
Division, Nuclear Regulatory Commission or an Agreement State, a permit issued
by a Nuclear Regulatory Commission master material licensee, a permit issued by
a Division, Nuclear Regulatory Commission or an Agreement State broad scope
licensee, or a permit issued by a Nuclear Regulatory Commission master material
license broad scope permittee on or before March 17, 2020, who perform only
those medical uses for which they were authorized on that date need not comply
with the training requirements of Rules
.05(43),
.05(47),
.05(52),
.05(53),
.05(54),
.05 (54.1), .05(63), .05(64),
.05(66), and .05(84), respectively.
2. Physicians, dentists, or podiatrists
identified as authorized users for the medical use of radioactive byproduct
material on a license issued by the Division, Nuclear Regulatory Commission or
Agreement State, a permit issued by a Nuclear Regulatory Commission master
material licensee, a permit issued by a Division, Nuclear Regulatory Commission
or Agreement State broad scope licensee, or a permit issued in accordance with
a Nuclear Regulatory Commission master material license broad scope permittee
who perform only those medical uses for which they were authorized on or before
October 24, 2005, need not comply with the training requirements of Rules
.05(43),
.05(47),
.05(52),
.05(53),
.05(54),
.05 (54.1), .05(63), .05(64),
.05(66), and .05(84), as follows:
(i) For uses
authorized under Rules
.05(41) or
.05(44), 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 Rule
.05(48), 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 Rules
.05(55) or
.05(67), 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
Rules .05(65), a
physician who was certified on or before October 24, 2005, in radiology,
diagnostic 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.
3.
Physicians, dentists, or podiatrists who used only accelerator-produced
radioactive materials, discrete sources of radium-226, or both, for medical
uses performed at a Government agency or Federally recognized Indian Tribe
before November 30, 2007 or at all other locations of use before August 8,
2009, or an earlier date as noticed by the NRC, need not comply with the
training requirements of Rules
.05(43),
.05(47),
.05(52),
.05(53),
.05(54),
.05 (54.1), .05(63), .05(64),
.05(66), and .05(84) respectively, when performing the same medical uses. A
physician, dentist, or podiatrist, who used only accelerator-produced
radioactive materials, discrete sources of radium-226, or both, for medical
uses at the locations and time period identified in this paragraph, qualifies
as an authorized user for those materials and uses performed before these
dates, for purposes of this chapter.
(c) Individuals who need not comply with
training requirements as described in this paragraph may serve as preceptors
for, and supervisors of, applicants seeking authorization on the Division
licenses for the same uses for which these individuals are
authorized.
(27)
Recentness of Training. The training and experience specified in
Rule .05 must have
been obtained within the 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.
GENERAL TECHNICAL REQUIREMENTS
(28)
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
by equipment manufacturers or procedures that have been approved by the
Division. The licensee shall conduct quality control procedures in accordance
with written procedures.
(29)
Possession, Use, and Testing of Instruments to Measure the Activity of
Unsealed Radioactive Materials.
(a) For
direct measurements performed in accordance with Rule
.05(31), 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 test the instrumentation required in Rule
.05(29)(a) in
accordance with nationally recognized standards or the manufacturer's
instructions.
(c) The tests
required in Rule
.05(29)(b) shall
include tests for constancy, linearity, accuracy and geometry dependence, as
appropriate to demonstrate proper operation of the instrument.
(30)
Calibration of Survey
Instruments.
(a) A licensee shall
ensure that the survey instruments used to show compliance with Rule
.05 and Rule
.03 of this Chapter, have been
calibrated before first use, annually, and following any repair that will
affect the calibration.
(b) To
satisfy the requirements of Rule
.05(30)(a), the
licensee shall:
1. Calibrate all required
scale readings up to 10 millisievert (1,000 mrem) 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 millisievert (2 and 1,000 mrem) 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; and
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 Rule
.05(92).
(31)
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.
(b) For a unit dosage, this determination
must be made either by direct measurement or by a decay correction, based on
the measurement made by a manufacturer or preparer licensed pursuant to Rule
.02 of this Chapter or equivalent
provisions of the Nuclear Regulatory Commission or Agreement State.
(c) For other than unit dosages, 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 Rule
.02 of this Chapter or equivalent
provisions of the Nuclear Regulatory Commission or Agreement State.
(d) 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.
(32)
Authorization for
Calibration, Transmission and Reference Sources. Any person authorized
by Rule .05(7) for medical
use of radioactive material may receive, possess, and use the following
radioactive material for check, calibration and reference use:
(a) Sealed sources manufactured and
distributed by persons specifically licensed pursuant to Rule
.02 of this Chapter or equivalent
provisions of the Nuclear Regulatory Commission or Agreement State and that do
not exceed 1.11 gigabecquerel (30 mCi) each;
(b) Any radioactive material with a half-life
of 120 days or less in individual amounts not to exceed 555 megabecquerel (15
mCi);
(c) Any radioactive material
with a half-life greater than 120 days in individual amounts not to exceed the
smaller of:
1. 7.4 megabecquerel (200
µCi); or
2. 1,000 times the
quantities in Schedule B of Rule
.02(21)(b) of this
Chapter; and
(d)
Technetium-99m in amounts as needed.
(33)
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 Division.
(b) A licensee in
possession of a sealed source shall:
1. Test
the source for leakage in accordance with Rule
.03 of this Chapter.
2. Test the source for leakage at intervals
not to exceed 6 months or at other intervals approved by the Division, an
Agreement State, or the Nuclear Regulatory Commission in the Sealed Source and
Device Registry.
(c) If
the leak test reveals the presence of 185 becquerel (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 Rules
.02 and
.03 of this Chapter; and
2. File a report with the Division within 5
days of receiving the leak test results in accordance with Rule
.05(117).
(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 Rule
.05(94).
(34)
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.
(35)
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.
(36)
Surveys for Ambient Radiation Dose
Rate and Contamination.
(a) Except as
provided in Rule
.05(36)(h), a
licensee shall survey with a radiation detection survey instrument at the end
of each day of use all areas where radioactive drugs containing radioactive
material requiring a written directive were prepared for use or
administered.
(b) A licensee shall
survey with a radiation detection survey instrument at least once each week all
areas where radioactive drugs or radioactive wastes are stored.
(c) A licensee shall conduct the surveys
required by Rule
.05(36)(a) and (b)
so as to be able to measure dose rates as low as 1 microsievert (0.1 mrem) per
hour.
(d) A licensee shall
establish dose rate action levels for the surveys required by Rule
.05(36)(a) and
(36)(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 each day of use all areas
where generators and bulk radioactive drugs are prepared for use or
administered and each week where radioactive materials are stored.
(f) A licensee shall conduct the surveys
required by Rule
.05(36)(e) so as
to be able to detect contamination on each wipe sample of 33.3 becquerel (2,000
dpm).
(g) A licensee shall
establish removable contamination action levels for the surveys required by
Rule .05(36)(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 Rule
.05(36)(a) in
area(s) where patients or human research subjects are confined when they cannot
be released pursuant to Rule
.05(37).
(i) A licensee shall retain a record of each
survey in accordance with Rule
.05(95)
(37)
Release of Individuals
Containing Radioactive Drugs or Implants.
(a) A licensee may authorize the release 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 mSv (0.5 rem).
(b) For
patients administered radioactive material for which a written directive is
required, a licensee shall provide the released individual, or the individual's
parent or guardian, with instructions, including 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) The licensee shall maintain a record of
the basis for authorizing the release of an individual in accordance with Rule
.05(96).
(d) The licensee shall maintain a record of
instructions provided to breast-feeding women in accordance with Rule
.05(96).
(e) Notwithstanding Rule
.05(37)(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.
(f) The licensee shall
immediately notify the Division in accordance with Rule
.05(118) if a
patient departs prior to an authorized release.
(g) The licensee shall notify the Division in
accordance with Rule
.05(119):
1. When they are aware that a patient
containing radioactive material and who has been released in accordance with
Rule .05(37) dies;
and,
2. If it is possible that any
individual could receive exposures in excess of 5 millisievert (500 mrem) as a
result of the deceased's body.
(38)
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 Rule
.03 of this Chapter;
(g) Use radioactive gases only in areas of
use and under conditions which have been evaluated and approved by the Division
for compliance with airborne release standards; and,
(39)
Storage and Control of
Volatiles and Gases.
(a) A licensee
shall store volatile radioactive materials and radioactive gases in the
shippers' 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 Rule
.03 of this Chapter.
(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 check the operation of
collection systems monthly. Records of these checks shall be maintained for 3
years.
(40)
Decay-in-Storage.
(a) A licensee
may hold radioactive material with a physical half-life of less than 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 (40)(a) of this section, the licensee shall retain
a record of each disposal in accordance with Rule
.05(98).
SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED
(41)
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 Rule
.02 of this Chapter or equivalent
regulations of another Agreement State or the 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 Rule
.05(47) or
.05(52) and
.05(47)(c)1.(ii)(VII),
or an individual under the supervision of either as specified in Rule
.05(18);
or
(c) Obtained from and prepared
by a Division, Nuclear Regulatory Commission or 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 FDA; 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 FDA for
use in research.
(42)
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 mrem) per hour to 500 microsievert (50
mrem) per hour. The instrument shall be operable and calibrated in accordance
with Rule
.05(30).
(43)
Training for Uptake, Dilution, and
Excretion Studies. Except as provided in Rule
.05(26), the
licensee shall require an authorized user of a unsealed radioactive material
for the uses authorized under Rule
.05(41) to be a
physician who:
(a) Is certified by a medical
specialty board whose certification process has been recognized by the
Division, Nuclear Regulatory Commission or an Agreement State. (The names of
board certifications that have been recognized by the Commission or an
Agreement State will be posted on the NRC's 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 as described in Rule
.05(43)(c)1.(i)
through .05(43)(c)1.(ii)(VI);
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 Rule
.05(47) or
.05(52) or
equivalent Agreement State or Nuclear Regulatory Commission 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 that includes:
(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 Rules
.05(26), (43), (47) or
(52) or equivalent Agreement State or Nuclear
Regulatory Commission 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 medical event 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; and
2. Has obtained written attestation that the
individual has satisfactorily completed the requirements in Rule
.05(43)(c)1. and
is able to independently fulfill the radiation safety-related duties as an
authorized user for the medical uses authorized under Rule
.05(41). The
signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission requirements; or
(ii) A residency program director who affirms
in writing that the consensus of the residency program faculty where at least
one faculty member is an authorized user who meets the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission 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 subparagraph
.05(43)(c)1.
(44)
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 (except aerosol or
gaseous forms) prepared for medical use, in quantities that do not require a
written directive as described in Rule
.05(19) that is:
(a) Obtained from a manufacturer or preparer
licensed pursuant to Rule
.02 of this Chapter or equivalent
regulations of another Agreement State or the 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 Rule
.05(47) or
.05(52) and
.05(47)(c)1.(ii)(VII),
or an individual under the supervision of either as specified in Rule
.05(18);
or
(c) Obtained from and prepared
by the Division, Nuclear Regulatory Commission or 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 FDA; 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 FDA,
or
(e) Provided the conditions of
Rule .05(39) are met, a
licensee shall use radioactive aerosols or gases only if specific application
is made to and approved by the Division.
(45)
Permissible molybdenum-99,
strontium-82, and strontium-85 concentrations.
(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 Mo-99 per mCi of Tc-99m); or
2. More than 0.02 kilobecquerel of
strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02
µCi of Sr-82 per mCi of Rb-82 chloride); or
3. More than 0.2 kilobecquerel of
strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 µCi
of Sr-85 per mCi of Rb-82);
(b) To demonstrate compliance with Rule
.05(45)(a), the
licensee preparing radioactive drugs from radionuclide generators shall:
1. Measure the molybdenum-99 concentration in
each eluate from a generator to demonstrate compliance with subparagraph
.05(45)(a);
2. Before the first patient use of the day,
measure the concentration of radionuclides strontium-82 and strontium-85 to
demonstrate compliance with subparagraph
.05(45)(a).
(c) A licensee who must measure radionuclide
contaminant concentration shall retain a record of each measurement in
accordance with Rule
.05(99).
(d) A licensee shall report immediately to
the Division each occurrence of radionuclide contaminant concentration
exceeding the limits specified in Rule
.05(45)(a).
(46)
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 mrem) per hour to 500 microsievert (50 mrem) per hour, and a
portable radiation measurement survey instrument capable of measuring dose
rates over the range 10 microsievert (1 mrem) per hour to 10 millisievert
(1,000 mrem) per hour. The instruments shall be operable and calibrated in
accordance with Rule
.05(30).
(47)
Training for Imaging and
Localization Studies. Except as provided in Rule
.05(26), the
licensee shall require an authorized user of unsealed radioactive material for
the uses authorized under Rule
.05(44) to be a
physician who:
(a) Is certified by a medical
specialty board whose certification process has been recognized by the
Division, Nuclear Regulatory Commission or an Agreement State. (The names of
board certifications that have been recognized by the Nuclear Regulatory
Commission or an Agreement State will be posted on the NRC's 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 (c)1.(i) through
(c)1.(ii)(VII) of this rule; 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 listed as an authorized user under
Rule .05(52) and meets
the requirements in .05(47)(c)1.(ii)(VII) or equivalent Agreement State or
Nuclear Regulatory Commission 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 that includes, 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 Rule
.05(26),
.05(47) or
.05(47)(c)1.(ii)(VII)
and Rule .05(52), or
equivalent Agreement State or Nuclear Regulatory Commission requirements. An
authorized nuclear pharmacist who meets the requirements in
391-3-17-.05(24)
or 391-3-17-.05(26)
may provide the supervised work experience for subparagraph
.05(47)(c)1.(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 medical event involving the use of unsealed radioactive
material;
(V) Using procedures to
contain spilled radioactive material safely and using proper decontamination
procedures;
(VI) Administering
dosages 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 radiochemical 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 Rule .05(47)(c)1. and
is able to independently fulfill the radiation safety-related duties as an
authorized user for the medical uses authorized under Rules
.05(41) and
.05(44).
The signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission requirements; or
(ii) A residency program director who affirms
in writing that the consensus of the residency program faculty where at least
one faculty member is an authorized user who meets the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission 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 subparagraph
.05(47)(c)1.
SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED
(48)
Use
of Unsealed Radioactive Material for Which a Written Directive is
Required. A licensee may use any unsealed radioactive material
identified in subparagraph (52)(b)1.(ii)(VII) prepared for diagnostic or
therapeutic medical use for which a written directive is required that has
been:
(a) Obtained from a manufacturer or
preparer licensed pursuant to Rule
.02 of this Chapter or equivalent
regulations of another Agreement State or the 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 Rule
.05(47) or (52),
or an individual under the supervision of either as specified in Rule
.05(26);
or
(c) Obtained from and prepared
by the Division, Nuclear Regulatory Commission or Agreement State licensee in
accordance with a Radioactive Drug Research Committee-approved protocol or an
Investigational New Drug (IND) protocol accepted by the FDA 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 FDA for use in research.
(49)
Safety
Instruction. In addition to the requirements of Rule
.07(3) of this
Chapter:
(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 Rule
.05(37). 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 Rule
.03 of this Chapter;
(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 Rule
.05(101).
(50)
Safety
Precautions.
(a) For each patient or
human research subject receiving radiopharmaceutical therapy and hospitalized
for compliance with Rule
.05(37), 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 Rule
.05(37);
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
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 Division in accordance with Rule
.05(119) if it is
possible that any individual could receive exposures in excess of the limits in
Rule .03(5)(i) of this
Chapter as a result of the deceased's body.
(51)
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 mrem) per hour to 500 microsievert (50 mrem) per hour, and a
portable radiation measurement survey instrument capable of measuring dose
rates over the range 10 microsievert (1 mrem) per hour to 10 millisievert
(1,000 mrem) per hour. The instruments shall be operable and calibrated in
accordance with Rule
.05(30).
(52)
Training for Use of Unsealed
Radioactive Material for Which a Written Directive is Required. Except
as provided in Rule
.05(26), the
licensee shall require an authorized user of radioactive material for the uses
authorized under Rule
.05(48) to be a
physician who:
(a) Is certified by a medical
specialty board whose certification process has been recognized by the
Division, Nuclear Regulatory Commission or an Agreement State, and who meets
the requirements of Rule
.05(52)(b)1(ii)(VII).
(Specialty boards whose certification processes have been recognized by the
Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's
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 Rule
.05(52)(b)1.(i)
through .05(52)(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 that
includes:
(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 Rule
.05(26),
.05(52) or
equivalent Agreement State, or Nuclear Regulatory Commission requirements. 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 medical event 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 involving a
minimum of 3 cases in each of the following categories for which the individual
is requesting authorized user status. This experience may be obtained
concurrently with the supervised work experience required by Rule
.05(52)(b)1.(ii):
(i) Oral administration of less than or equal
to 1.22 gigabecquerel (33 millicurie) of sodium iodide I-131, for which a
written directive is required;
(ii)
Oral administration of greater than 1.22 gigabecquerel (33 millicurie) of
sodium iodide I-1312 ;
(iii) 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 less than 150 keV, for which a written
directive is required; and/or
(iv)
Parenteral administration of any other radionuclide, for which a written
directive is required; and
2. Has obtained written attestation that the
individual has satisfactorily completed the requirements in Rule
.05(52)(b)1., and
is able to independently fulfill the radiation safety-related duties as an
authorized user for the medical uses authorized under Rule
.05(48).
The signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission requirements and has experience in administering
dosages in the same dosage category or categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
as the individual requesting authorized user status; or
(ii) A residency program director who affirms
in writing that the consensus of the residency program faculty where at least
one faculty member is an authorized user who meets the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission requirements, have experience in administering
dosages in the same dosage category or categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
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
subparagraph
.05(52)(b)1.
(53)
Training for the Oral Administration of Sodium Iodide I-131 in Quantities
Less than or Equal to 1.22 Gigabecquerel (33 millicurie) for which a Written
Directive is Required. Except as provided in Rule
.05(26), the
licensee shall require an authorized user for the oral administration of sodium
iodide I-131 in quantities less than or equal to 1.22 gigabecquerel (33
millicurie), for which a written directive is required, to be a physician who:
(a) Is certified by a medical specialty board
whose certification process includes all of the requirements in .05(53)(c)1.
and .05(53)(c)2. and whose certification has been recognized by the Division,
an Agreement State or the Nuclear Regulatory Commission. (The names of board
certifications that have been recognized by the Nuclear Regulatory Commission
or an Agreement State will be posted on the NRC's Web page.); or
(b) Is an authorized user under Rule (52) for
uses listed in (52)(b)1.(ii)(VII)(i) or (ii), or (54), or equivalent Agreement
State or Nuclear Regulatory Commission requirements; or
(c)
1. Has
successfully completed 80 hours 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 Rule
.05(26), (52), (53) or
(54), or equivalent Agreement State or
Nuclear Regulatory Commission requirements. A supervising authorized user, who
meets the requirements of Rule
.05(52)(b) must
have experience in administering dosages as specified in Rule
.05(52)(b)1.(ii)(VII)(i) or
(ii); 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 for 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 gigabecquerel (33
millicurie) of sodium iodide I-131; and
3. Has obtained written attestation that the
individual has satisfactorily completed the requirements in Rule
.05(53)(c)1. and
(53)(c)2. and is able to independently
fulfill the radiation safety-related duties as an authorized user for medical
uses authorized under .05(48).
The signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission requirements and has experience in administering
dosages in the same dosage category or categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
as the individual requesting authorized user status; or
(ii) A residency program director who affirms
in writing that the consensus of the residency program faculty where at least
one faculty member is an authorized user who meets the requirements in Rules
.05(26), (43), (47), or
(52), or equivalent Agreement State or
Nuclear Regulatory Commission requirements, have experience in administering
dosages in the same dosage category or categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
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
subparagraphs .05(53)(c)1. and 2.
(54)
Training for the Oral
Administration of Sodium Iodide I-131 in Quantities Greater than 1.22
Gigabecquerel (33 millicurie) for which a Written Directive is Required.
Except as provided in Rule
.05(26), the
licensee shall require an authorized user for the oral administration of sodium
iodide I-131 in quantities greater than 1.22 gigabecquerel (33 millicurie), to
be a physician who:
(a) Is certified by a
medical specialty board whose certification process includes all of the
requirements in Rules
.05(54)(c)1. and
.05(54)(c)2. and
whose certification has been recognized by the Division, an Agreement State or
the Nuclear Regulatory Commission. (The names of board certifications that have
been recognized by the Nuclear Regulatory Commission or an Agreement State will
be posted on the NRC's Web page.); or
(b) Is an authorized user under Rule
.05(52) for uses
listed in Rule
.05(52)(b)1.(ii)(VII)(ii),
or equivalent Agreement State or Nuclear Regulatory Commission requirements;
or
(c)
1. Has successfully completed 80 hours
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 Rule
.05(26), (52), or
(54), or equivalent Agreement State or
Nuclear Regulatory Commission requirements. A supervising authorized user, who
meets the requirements of Rule
.05(52)(b), must
have experience in administering dosages as specified in Rule
.05(52)(b)1.(ii)(VII)(ii);
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 for 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 greater than 1.22 gigabecquerel (33
millicurie) of sodium iodide I-131; and
3. Has obtained written attestation that the
individual has satisfactorily completed the requirements in Rule
.05(54)(c)1. and
.05(54)(c)2. and
is able to independently fulfill the duties as an authorized user for medical
uses authorized under Rule
.05(48). The
written attestation must be signed by a preceptor authorized user, who meets
the requirements in Rule
.05(26),
.05(52), or
.05(54), or
equivalent Agreement State or Nuclear Regulatory Commission requirements. The
preceptor authorized user, who meets the requirements of Rule
.05(52)(b), must
have experience in administering dosages as specified in Rule
.05(52)(b)1.(ii)(VII)(ii).
(54.1) Except as provided
in Rule .05(26) 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 Rule
.05(52) for uses
listed in 05(52)(b)1.(ii)(VII)(iii) or .05(52)(b)1.(ii)(VII)(iv), or equivalent
Agreement State or Nuclear Regulatory Commission requirements; or
(b) Is an authorized user under Rules
.05(63),
.05(84), or
equivalent Agreement State or Nuclear Regulatory Commission requirements and
who meets the requirements in .05(54.1)(d); or
(c) Is certified by a medical specialty board
whose certification process has been recognized by the Division, Nuclear
Regulatory Commission or an Agreement State under Rules
.05(63) or
.05(84), and who
meets the requirements in paragraph
.05 (54.1)(d).
(d)
1. Has
successfully completed 80 hours of classroom and laboratory training,
applicable to parenteral administrations, for which a written directive is
required, of any beta emitter, or any photon-emitting radionuclide with a
photon energy less than 150 keV, and/or parenteral administration of any other
radionuclide for which a written directive is required. 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 byproduct 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 Rules
.05(26),
.05(52),
.05 (54.1) or equivalent Agreement
State or Nuclear Regulatory Commission requirements, in the parenteral
administration, for which a written directive is required, of any beta emitter,
or any photon-emitting radionuclide with a photon energy less than 150 keV,
and/or parenteral administration of any other radionuclide for which a written
directive is required. A supervising authorized user who meets the requirements
in Rule .05(52) or
.05 (54.1) must have experience in
administering dosages as specified in 05(52)(b)1.(ii)(VII)(iii) or
.05(52)(b)1.(ii)(VII)(iv). 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 medical event involving the use of unsealed byproduct material;
(v) Using procedures to contain spilled
byproduct 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, for which a written directive is required, of
any beta emitter, or any photon-emitting radionuclide with a photon energy less
than 150 keV and/or at least 3 cases involving the parenteral administration of
any other radionuclide, for which a written directive is required;
and
3. Has obtained
written attestation that the individual has satisfactorily completed the
requirements in .05(54.1)(d)1. and (d)2. 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 signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26), (52),
(54.1) or equivalent Agreement State or Nuclear Regulatory Commission
requirements and has experience in administering dosages in the same dosage
category or categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
as the individual requesting authorized user status; or
(ii) A residency program director who affirms
in writing that the consensus of the residency program faculty where at least
one faculty member is an authorized user who meets the requirements in Rules
.05(26), (52) or
(54.1), or equivalent Agreement State or Nuclear Regulatory Commission
requirements, have experience in administering dosages in the same dosage
category or categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
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
subparagraphs .05(54.1)(d)1. and 2.
Manual Brachytherapy
(55)
Use
of Sealed Sources for Manual Brachytherapy. A licensee shall use only
brachytherapy sources for therapeutic medical uses:
(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 Rule
.05(21)(a) are
met.
(56)
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 Rule
.05(102).
(57)
Brachytherapy Sources
Inventory.
(a) A licensee shall
maintain accountability at all times for all brachytherapy sources in storage
or use.
(b) Promptly 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 Rule
.05(103).
(58)
Safety
Instruction. In addition to the requirements of Rule
.07(3) of this
Chapter:
(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 Rule
.05(37).
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 Rule
.03(5)(i)1.(i) of
this Chapter; and
(ii) Visitation
authorized in accordance with Rule
.03(5)(i)2. of
this Chapter; 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 Division in accordance
with Rule
.05(119) if it is
possible for any individual to receive exposures in excess of 5 millisievert
(500 mrem) as a result of the deceased's body.
(b) A licensee shall retain a record of
individuals receiving instruction in accordance with Rule
.05(101).
(59)
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 Rule
.05(37), 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) Radiation Safety Officer, or his
designee, and the authorized user shall be notified immediately if the
hospitalized patient or human research subject dies or has a medical
emergency.
(60)
Calibration Measurements of Brachytherapy Sealed Sources.
(a) Prior to the first medical use of a
brachytherapy sealed source on or after July 1, 2003, a licensee shall perform
the following:
1. Determine the source output
or activity using a dosimetry system that meets the requirements of Rule
.05(72)(a);
2. Determine source positioning accuracy
within applicators; and
(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 Rule
.05(60)(a).
(c) A licensee shall mathematically correct
the outputs or activities determined in Rule
.05(60)(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
Rule .05(60)(a), (60)(b), or
(60)(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 Rule
.05(60)(a), (60)(b), and
(60)(c).
(f) A licensee shall retain a record of each
calibration in accordance with Rule
.05(104).
(61)
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.
(62)
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 mrem) per hour to
500 microsievert (50 mrem) per hour, and a portable radiation measurement
survey instrument capable of measuring dose rates over the range 10
microsievert (1 mrem) per hour to 10 millisievert (1,000 mrem) per hour. The
instruments shall be operable and calibrated in accordance with Rule
.05(30).
(63)
Training for Use of Manual
Brachytherapy Sources. Except as provided in Rule
.05(26), the
licensee shall require an authorized user of a manual brachytherapy source for
the uses authorized under Rule
.05(55) to be a
physician who:
(a) Is certified by a medical
specialty board whose certification process has been recognized by the
Division, an Agreement State or the Nuclear Regulatory Commission. (The names
of board certifications that have been recognized by the Nuclear Regulatory
Commission or an Agreement State will be posted on the NRC's 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 .05(26), (63) or equivalent Agreement State, or Nuclear
Regulatory Commission requirements at a medical institution authorized to use
byproduct material under Rule
.05(55),
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
material on hand;
(V) Using
administrative controls to prevent a misadministration involving the use of
radioactive material; and
(VI)
Using emergency procedures to control radioactive material; and
2. Has completed three
years of supervised clinical experience in radiation oncology, under an
authorized user who meets the requirements in Rule
.05(26),
.05(63) or
equivalent Agreement State or Nuclear Regulatory Commission 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 Rule
.05(63)(b)1.(ii);
and
3. Has obtained written
attestation that the individual has satisfactorily completed the requirements
in Rules .05(63)(b)1. and
(63)(b)2. 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 in Rule
.05(55).
The signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26) or (63),
or equivalent Agreement State or Nuclear Regulatory Commission requirements and
has experience in administering dosages in the same dosage category or
categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
as the individual requesting authorized user status; or
(ii) A residency program director who affirms
in writing that the consensus of the residency program faculty where at least
one faculty member is an authorized user who meets the requirements in Rules
.05(26) or (63),
or equivalent Agreement State or Nuclear Regulatory Commission requirements,
have experience in administering dosages in the same dosage category or
categories (i.e., in Rule
.05(52)(b)1.(ii)(VII))
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
subparagraphs .05(63)(b)1. and 2.
(64)
Training for Ophthalmic Use of
Strontium-90. Except as provided in Rule
.05(26), the
licensee shall require an authorized user of a strontium-90 source for
ophthalmic uses authorized under Rule
.05(55) to be a
physician who:
(a) Is an authorized user
under Rule
.05(63) or
equivalent Agreement State or Nuclear Regulatory Commission 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, and 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 Rule
.05(26),
.05(63) or
.05(64) or
equivalent Agreement State or Nuclear Regulatory Commission requirements, that
the individual has satisfactorily completed the requirements in Rule
.05(64)(b)1. and
2., and is able to independently fulfill the radiation safety-related duties as
an authorized user of strontium-90 for ophthalmic use.
(c) Licensees who use strontium-90 for
ophthalmic treatments must ensure that certain activities as specified in
subparagraph
.05(64)(d) 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 Commission or an Agreement
State; permit issued by a Commission or Agreement State broad scope medical use
licensee; medical use permit issued by a Commission master material licensee;
or permit issued by a 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
Rule .05(60).
(d) The
individuals who are identified in subparagraph
.05(64)(c) 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
Rule .05(60);
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 subparagraph
.05(64)(c) 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.
(e) Licensees must retain a record of the
activity of each strontium-90 source in accordance with Rule
.05(105).
Sealed Sources For Diagnosis
(65)
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 Rule
.05(20)(a) are
met.
(66)
Training
for Use of Sealed Sources for Diagnosis and Medical Devices for
Diagnosis. Except as provided in Rule
.05(26), the
licensee shall require the authorized user of a diagnostic sealed source for
the use in a device authorized under Rule
.05(65) to be a
physician, dentist, or podiatrist who:
(a) Is
certified by a specialty board whose certification process includes all of the
requirements in Rules
.05(66)(c) and
.05(66)(d) and
whose certification has been recognized by an Agreement State or the Nuclear
Regulatory Commission. (The names of board certifications that have been
recognized by the Nuclear Regulatory Commission or an Agreement State will be
posted on the NRC's Web page.); or
(b) Is an authorized user for uses listed in
Rule .05(44) or
equivalent Agreement State or Nuclear Regulatory Commission requirements;
or
(c) Has had 8 hours of classroom
and laboratory training in basic radionuclide handling techniques specifically
applicable to the use of the device that includes:
1. Radiation physics and
instrumentation;
2. Radiation
protection;
3. Mathematics
pertaining to the use and measurement of radioactivity; and
4. Radiation biology; and
(d) 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
(67)
Use of Sealed Sources
in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic
Radiosurgery Unit.
(a) A licensee must
only use sealed sources:
1. Approved and as
provided for 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 Rule
.05(21)(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 Rule
.05(21)(a) are
met.
(68)
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 Rule
.05(102).
(69)
Installation,
Maintenance, Adjustment, and Repair.
(a) Only a person specifically licensed by
the Director, the 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
Director, an Agreement State or the 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
units.
(c) For a low dose-rate
remote afterloader unit, only a person specifically licensed by the Director,
an Agreement State or the 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 Rule
.05(106).
(70)
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 when
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 Rule
.05(70)(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 Rule
.05(70)(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 for 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
vendor operational and safety training is provided to all individuals who will
operate the unit. 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 at the facility, as appropriate to the individual's assigned
duties. The instructions shall include instruction in:
(i) The procedures identified in Rule
.05(70)(a)4.;
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 Rule
.05(70)(d), in
accordance with Rule
.05(101).
(g) A licensee shall retain a copy of the
procedures required by subparagraphs .05(70)(a)4. and (d)2.(ii).
(71)
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 Rule .05(71)(a) through
(71)(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.
(72)
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 inter-compared 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
inter-comparison 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 inter-comparison result to change the calibration factor. When
inter-comparing 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 Rule
.05(72)(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 Rule
.05(72)(a).
(c) The licensee shall retain a record of
each calibration, inter-comparison, and comparison in accordance with Rule
.05(107).
(73)
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 1 year.
(b) To
satisfy the requirement of Rule
.05(73)(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 Rule
.05(72)(a) to
measure the output for one set of exposure conditions. The remaining radiation
measurements required in Rule
.05(73)(b)1. may
be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall make full calibration
measurements required by Rule
.05(73)(a) in
accordance with published protocols accepted by nationally recognized
bodies.
(e) A licensee shall
mathematically correct the outputs determined in Rule
.05(73)(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 Rule
.05(73)(a) and
physical decay corrections required by Rule
.05(73)(e) must be
performed by the authorized medical physicist.
(g) A licensee shall retain a record of each
calibration in accordance with Rule
.05(108).
(74)
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;
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 Rule
.05(74)(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) In addition to the requirements for full
calibrations for low dose-rate remote afterloader units in Rule
.05(74)(b), a
licensee shall perform an autoradiograph of the source(s) to verify inventory
and source(s) arrangement at intervals not exceeding one quarter.
(d) A licensee shall use the dosimetry system
described in Rule
.05(72)(a) to
measure the output.
(e) A licensee
shall make full calibration measurements required by Rule
.05(74)(a) in
accordance with published protocols accepted by nationally recognized
bodies.
(f) For low dose-rate
remote afterloader units, a licensee may use measurements provided by the
source manufacturer that are made in accordance with Rule
.05(74)(a) through
(74)(e).
(g) A licensee shall mathematically correct
the outputs determined in Rule
.05(74)(b)1. of
this section for physical decay at intervals consistent with 1 percent physical
decay.
(h) Full calibration
measurements required by Rule
.05(74)(a) and
physical decay corrections required by Rule
.05(74)(g) must be
performed by the authorized medical physicist.
(i) A licensee shall retain a record of each
calibration in accordance with Rule
.05(108).
(75)
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 Rule
.05(75)(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 Rule
.05(72)(a) to
measure the output for one set of exposure conditions. The remaining radiation
measurements required in Rule
.05(75)(b)1. may
be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall make full calibration
measurements required by Rule
.05(75)(a) in
accordance with published protocols accepted by nationally recognized
bodies.
(e) A licensee shall
mathematically correct the outputs determined in Rule
.05(75)(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
Rule .05(75)(a) and
physical decay corrections required by Rule
.05(75)(e) must be
performed by the authorized medical physicist.
(g) A licensee shall retain a record of each
calibration in accordance with Rule
.05(108).
(76)
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 Rule
.05(72)(b);
and
6. The difference between the
measurement made in Rule
.05(76)(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 Rule
.05(76)(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 Rule
.05(76)(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.
(77)
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 Rule
.05(77)(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 Rule
.05(77)(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
Rule .05(77)(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.
(78)
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 Rule
.05(78)(a);
and
2. Review the results of each
spot-check required by Rule
.05(78)(a)1.
within 15 days of the check. The authorized medical physicist need not actually
perform the spot-check measurements.
(c) To satisfy the requirements of Rule
.05(78)(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 Rule
.05(72)(b);
(ii) The difference between the measurement
made in Rule
.05(78)(c)2.(i) of
this paragraph 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 Rule
.05(78)(a)2. and
(78)(a)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 Rule
.05(78)(c) that is
not operating properly.
(f) If the
results of the checks required in Rule
.05(78)(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.
(79)
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,
whichever 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 Rule
.05(77), 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 Rule
.05(79)(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 Rule
.05(79)(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.
(80)
Radiation
Surveys.
(a) In addition to the survey
requirements in Rule
.03(8) of this
Chapter, a person licensed pursuant to Rule
.05 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 Rule
.05(80)(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).
(81)
Five-Year Inspection
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 or at intervals not to exceed 5 years, whichever
comes first, to assure proper functioning of the source exposure mechanism and
other safety components.
(b) This
inspection and servicing may only be performed by persons specifically licensed
to do so by the Director, an Agreement State or the Nuclear Regulatory
Commission.
(c) A licensee shall
keep a record of the inspection and servicing in accordance with Rule
.05(114).
(82)
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.
(83)
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 mrem) per hour to
500 microsievert (50 mrem) per hour, and a portable radiation measurement
survey instrument capable of measuring dose rates over the range 10
microsievert (1 mrem) per hour to 10 millisievert (1,000 mrem) per hour. The
instruments shall be operable and calibrated in accordance with Rule
.05(30).
(84)
Training for Use of Remote
Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery
Units. Except as provided in Rule
.05(26), the
licensee shall require an authorized user of a sealed source for a use
authorized under Rule
.05(67) to be a
physician who:
(a) Is certified by a medical
specialty board whose certification has been recognized by the Division, an
Agreement State or the Nuclear Regulatory Commission, and who meets the
requirements in .05(84)(c). (The names of board certifications that have been
recognized by the Nuclear Regulatory Commission or an Agreement State will be
posted on the NRC's 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 Rule
.05(26),
.05(84) or
equivalent Agreement State, or Nuclear Regulatory Commission requirements at a
medical institution that is authorized to use radioactive materials in Rule
.05(67),
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 three years of supervised
clinical experience in radiation oncology, under an authorized user who meets
the requirements in Rule
.05(26),
.05(84) or
equivalent Agreement State or Nuclear Regulatory Commission 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 Rule
.05(84)(b)1.(ii);
and
3. Has obtained written
attestation that the individual has satisfactorily completed the requirements
in Rule .05(84)(b)1. and
.05(84)(b)2., and
.05(84)(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; and
The signed attestation must be obtained from either:
(i) A preceptor authorized user, who meets
the requirements in Rules
.05(26), (84), or
equivalent Agreement State or Nuclear Regulatory Commission requirements;
or
(ii) A residency program
director who affirms in writing that the consensus of the residency program
faculty where at least one faculty member is an authorized user who meets the
requirements in Rules
.05(26), (84), or
equivalent Agreement State or Nuclear Regulatory Commission 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 subparagraphs .05(63)(b)1. and 2.
(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
(85)
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 Rule
.05 if:
(a) The applicant or licensee has submitted
the information required by Rule
.05(8)(b), (8)(c) and
(8)(d); and
(b) The applicant or licensee has received
written approval from the NRC or an Agreement State in a license and uses the
material in accordance with the regulations and specific conditions the NRC or
Agreement State considers necessary for the medical use of the material.
Records
(86)
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 Rule
.05(15)(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 Rule
.05(15)(d), and a
signed copy of the Radiation Safety Officer's agreement to be responsible for
implementing the radiation safety program, as required by Rule
.05(15)(b). The
record must include the signature of the Radiation Safety Officer and licensee
management.
(c) The minutes of each
Radiation Safety Committee meeting held in accordance with Rule
.05(15)(g) shall
include:
1. The date of the
meeting;
2. Members
present;
3. Members absent;
and
4. Summary of deliberations and
discussions.
(87)
Records of Radiation Protection
Program Safety Changes. A licensee shall retain a record of each
radiation protection program change made in accordance with Rule
.05(16)(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.
(88)
Records of Written
Directives. A licensee shall retain a copy of each written directive as
required by Rule
.05(19) for 3
years.
(89)
Records of
Misadministrations. A licensee shall retain a record of
misadministrations reported in accordance with Rule
.05(115) 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.
(90)
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 Rule
.05(116) 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.
(91)
Records of Calibrations of Instruments Used to Measure the Activity of
Unsealed Radioactive Material. A licensee shall maintain a record of
instrument calibrations required by Rule
.05(29) for 3
years. The records 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.
(92)
Records of Survey Instrument
Calibrations. A licensee shall maintain a record of instrument
calibrations required by Rule
.05(30) 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.
(93)
Records of Dosages of Unsealed
Radioactive Material for Medical Use. A licensee shall maintain a record
of dosage determinations required by Rule
.05(31) 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 1.11 MBq (30 µCi); the date and time of the dosage
determination; and the name of the individual who determined the
dosage.
(94)
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 Rule
.05(33)(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.
(95)
Records of Surveys for Ambient
Radiation Exposure Rate. A licensee shall retain a record of each survey
required by Rule
.05(36) 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.
(96)
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 Rule
.05(37)(b) were
provided to a breast-feeding woman.
(97)
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 Rule
.05(9)(b), for 3
years after the last provision of service.
(b) A licensee shall retain the record of
each survey required by Rule
.05(38)(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.
(98)
Records of
Decay-in-Storage. A licensee shall maintain records of the disposal of
licensed materials, as required by Rule
.05(40), 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.
(99)
Records of
Radionuclide Purity. A licensee shall maintain a record of the
radionuclide contaminant concentration tests required by Rule
.05(45) 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
kilobecquerel of contaminant per megabecquerel of desired radionuclide
(microcurie/millicurie), or microgram of contaminant per megabecquerel of
desired radionuclide (microgram/millicurie), the time and date of the
measurement, and the name of the individual who made the measurement.
(100)
Records of Training. A
licensee shall maintain records of training required by Rule
.05(25) for 3
years after the last date an individual was authorized to act as a nuclear
medicine technologist or radiation therapist at the licensee's
facility.
(101)
Records of
Safety Instruction and Training. A licensee shall maintain a record of
safety instructions and training required by Rules
.05(49), (58) and
(70) 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.
(102)
Records of Radiation Surveys of Patients and Human Research
Subjects. A licensee shall maintain a record of the surveys required by
Rule .05(56) and
(68) 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.
(103)
Records of Brachytherapy Source
Inventory.
(a) A licensee shall
maintain a record of brachytherapy source accountability required by Rule
.05(57) 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;
2. The number and
activity of unused sources returned to storage, the time and date they were
returned to storage, and the name of the individual who returned them to
storage; and
3. The number and
activity of temporarily implanted sources removed from the patient or human
research subject, 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 not
implanted, 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.
(104)
Records of
Calibration Measurements on Brachytherapy Sources. A licensee shall
maintain a record of the calibrations on brachytherapy sources required by Rule
.05(60) 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.
(105)
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 Rule
.05(60) for the
life of the source. The record must include the date and initial activity of
the source as determined under Rule
.05(60), and for
each decay calculation, the date, and the source activity and the signature of
the authorized medical physicist.
(106)
Records of Installation,
Maintenance, Adjustment, and Repair. 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 Rule .05(69) 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.
(107)
Records of Dosimetry
Equipment.
(a) A licensee shall retain
a record of the calibration, inter-comparison, and comparisons of its dosimetry
equipment done in accordance with Rule
.05(72) for the
duration of the license.
(b) For
each calibration, inter-comparison, 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, inter-compared, or
compared as required by Rule
.05(72)(a) and
(72)(b);
3. The correction factor that was determined
from the calibration or comparison or the apparent correction factor that was
determined from an inter-comparison; and
4. The names of the individuals who performed
the calibration, inter-comparison, or comparison.
(108)
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 Rule
.05(73), (74) and
(75) 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.
(109)
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 Rule
.05(76) 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.
(110)
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 Rule
.05(77) 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.
(111)
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 Rule
.05(78) 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.
(112)
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 Rule
.05(79) 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.
(113)
Records of Surveys of Therapeutic
Treatment Units.
(a) A licensee shall
maintain a record of radiation surveys of treatment units made in accordance
with Rule
.05(80) 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.
(114)
Records of Five-Year Inspection
for Teletherapy and Gamma Stereotactic Surgery Units.
(a) A licensee shall maintain a record of the
five-year inspections for teletherapy and gamma stereotactic radiosurgery units
required by Rule
.05(81) 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
(115)
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, except permanent implant
brachytherapy, results in:
1. A dose that
differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose
equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow
dose equivalent to the skin; and either
(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 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ
or tissue, or 0.5 Sv (50 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 brachytherapy
procedures;
(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) 0.5 Sv (50 rem) or more 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 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.
4.
For permanent implant brachytherapy, the administration of byproduct material
or radiation from byproduct 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;
(ii) The total source strength administered
outside of 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 0.5 Sv (50 rem) to an organ or
tissue.
(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 Division by
telephone no later than the next calendar day after discovery of the
misadministration.
(d) The licensee
shall submit a written report to the Division 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; and
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.
(116)
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 50 mSv (5 rem) 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 50 mSv (5 rem) total
effective dose equivalent; or
2.
Has resulted in unintended permanent functional damage to an organ or a
physiological system, as determined by a physician.
(c) The licensee shall notify by telephone
the Division no later than the next calendar day after discovery of a dose to
the embryo/fetus or nursing child that requires a report in Rule
.05(116)(a) or
(116)(b).
(d) The licensee shall submit a written
report to the Division within 15 days after discovery of a dose to the
embryo/fetus or nursing child that requires a report in Rule
.05(116)(a) or
(116)(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 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 of discovery of an
event that would require reporting under Rule
.05(116)(a) or
(116)(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.
(117)
Reports of Leaking
Sources. A licensee shall file a report with the Division within 5 days
if a leakage test required by Rule
.05(33) reveals
the presence of 185 Bq (0.005 µCi) 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.
(118)
Reports of Patient Departure
Prior to Authorized Release.
(a) A
licensee shall notify the Division by telephone immediately upon discovery that
a patient or human research subject has departed from the licensee's facility
without authorization under Rule
.05(37)(a).
(b) The licensee shall submit a written
report to the Division 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
release;
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.
(119)
Notification of Deceased Patients
or Human Research Subjects Containing Radioactive Material.
(a) The licensee shall notify the Division 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 limits specified in Rule
.03(5)(i) of this
Chapter as a result of the deceased's body.
(b) The licensee shall submit a written
report to the Division within 30 days after discovery that the patient or human
research subject referenced in (119)(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 millisievert
(500 mrem).
(120)
Report and Notification for an
Eluate Exceeding Permissible Molybdenum-99, Strontium-82, and Strontium-85
Concentrations.
(a) The licensee shall
notify by telephone the Georgia Department of Natural Resources, Environmental
Protection Division and the distributor of the generator within 7 calendar days
after discovery that an eluate exceeded the permissible concentration listed in
391-3-17-.05(45)(a)
at the time of generator elution. The telephone report to the Georgia EPD 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 or human research subjects, when
the distributor was notified, and the action taken.
(b) By an appropriate method listed in
391-3-17-.01(13),
the licensee shall submit a written report to Georgia Department of Natural
Resources, Environmental Protection Division 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 subparagraph
.05(120)(a).
Notes
"Essentials and guidelines of an Accredited Educational Program for the Radiation Therapy Technologist", Joint Review Committee on Education in Radiologic Technology, 1988.
Experience with at least 3 cases in category (VII)(ii) also satisfies the requirement in category (VII)(i).
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.