216-RICR-40-20-9
216-RICR-40-20-9. Medical Use of Radioactive Material (version Adoption, 01/01/2019 to 01/04/2022)
9.1 Authority
A. This Part is promulgated
pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3 -5 .
B. This Part contains the
requirements and provisions for the medical use of radioactive
material. These requirements and provisions provide for the radiation
safety of workers, the general public, patients, and human research
subjects.
C. The requirements and
provisions of this Part are in addition to, and not in substitution
for, other requirements in this Subchapter. The requirements and
provisions of this Part apply to applicants and licensees subject to
this Subchapter unless specifically exempted.
9.2 Incorporated Material
A. Except as provided in this
Part, the requirements of 10
C.F.R. Part 35 (2018) are incorporated by reference, not
including any further editions or amendments thereof and only to the
extent that the provisions therein are not inconsistent with this
Part.
B. Notwithstanding the
provisions of § 9.2(A) of this Part, §§ 35.1, 35.5, 35.6, 35.7,
35.8, 35.10, 35.11, 35.12, 35.13, 35.14, 35.18, 35.19, 35.24, 35.26,
35.27, 35.40, 35.70, 35.75, 35.80, 35.1000, 35.2024, 35.2026,
35.2040, 35.2041, 35.206, 35.2061, 35.2063, 35.2067, 35.2070,
35.2075, 35.2080, 35,2092, 35.2204, 35.2310, 35.2404, 35.2406,
35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632,
35.2642,35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045 are not
incorporated by reference.
C. Effect of incorporation of
10 C.F.R. Part 35. To reconcile differences between this Part and the
incorporated sections of 10 C.F.R. Part 35, the following words and
phrases shall be substituted for the language in 10 C.F.R. Part 35 as
follows:
1. Any reference to NRC or
Commission shall be deemed to be a reference to the Agency.
2. Any reference to NRC or
agreement state shall be deemed to be a reference to the Agency, NRC
or agreement state.
3. Any reference to byproduct
material shall be deemed to be a reference to radioactive material.
4. Any reference to a medical
event shall be deemed to be a reference to a misadministration.
5. Any notifications, reports
or correspondence referenced in the incorporated parts of 10 C.F.R.
35 shall be directed to the Agency using contact information
specified in § 1.4 of this Subchapter.
6. Any reference to the
Advisory Committee on the Medical Uses of Isotopes (ACMUI) shall be
deemed to be a reference to the Agency’s Radiation Advisory
Commission.
9.3 Definitions
A. In addition to the
definitions contained in 10 C.F.R. § 35.2, whenever used in this
Part, the following terms shall be construed as follows:
1. “Act” means R.I. Gen.
Laws Chapter 23-1.3 entitled "Radiation Control".
2. “Agency” means Rhode
Island Radiation Control Agency (RCA), Center for Health Facilities
Regulation - Radiation Control Program, Rhode Island Department of
Health.
3. “Misadministration”
means an event that meets the criteria in § 9.5.9(A) of this Part.
4. “NARM” means any
naturally occurring or accelerator-produced radioactive material. It
does not include byproduct, source, or special nuclear material.
5. “Radioactive material”
means any material (solid, liquid, or gas) which emits radiation
spontaneously.
6. “Therapeutic medical
unit” means any remote afterloader unit, teletherapy unit, gamma
stereotactic radiosurgery unit or similar beam therapy device
authorized pursuant to § 9.11.1 of this Part.
9.4 General Requirements
9.4.1 Provisions for
Research Involving Human Subjects
A. A licensee may conduct
research involving human subjects using radioactive material
provided:
1. That the research is
conducted, funded, supported, or regulated by a Federal agency which
has implemented the Federal Policy for the Protection of Human
Subjects. Otherwise, a licensee shall apply for and receive approval
of a specific amendment to its Agency license before conducting such
research. Both types of licensees shall, at a minimum, obtain prior
informed consent from the human subjects and obtain prior review and
approval of the research activities by an "Institutional Review
Board" in accordance with the meaning of these terms as defined
and described in the Federal Policy for the Protection of Human
Subjects;
2. The research involving
human subjects authorized in § 9.4.1(A)(1) shall be conducted using
radioactive material authorized for medical use in the license; and
3. Nothing in this section
relieves licensees from complying with the other requirements in this
Part.
9.4.2 FDA, Other Federal
and State Requirements
Nothing in this Part relieves
the licensee from complying with applicable FDA, other Federal, and
State requirements governing radioactive drugs or devices.
9.4.3 License Required
A. A person shall manufacture,
produce, acquire, receive, possess, use or transfer radioactive
material for medical use only in accordance with a specific license
issued by the Agency, the U.S. Nuclear Regulatory Commission or
another Agreement State, or as allowed by §§ 9.5.3(A) and (B) of
this Part. A specific license is not needed for an individual who:
1. Receives, possesses, uses,
or transfers radioactive material in accordance with this Subchapter
under the supervision of an Authorized User as provided in § 9.5.3
of this Part, unless prohibited by license condition; or
2. Prepares unsealed
radioactive material for medical use in accordance with this Part
under the supervision of an Authorized Nuclear Pharmacist or
Authorized User as provided in § 9.5.3 of this Part, unless
prohibited by license condition.
B. Human Use of Radioactive
Material. In addition to the requirements set forth in § 7.6.2(A) of
this Subchapter and other sections of this Part, a specific license
for human use of radioactive material will be issued under the
following conditions:
1. If the application is for
human use sited in a medical institution, only the institution's
management may apply. If the application is for human use not cited
in a medical institution, the applicant or a person duly authorized
to act for and on their behalf may apply.
2. The application includes
the facility diagram, equipment, and training and experience
qualifications of the Radiation Safety Officer, Authorized User(s),
Authorized Medical Physicist(s), and Authorized Nuclear
Pharmacist(s).
3. The application includes
procedures required by §§ 9.11.2, 9.11.4, 9.11.10, 9.11.11, and
9.11.12 of this Part, as applicable.
4. An application for human
use of radioactive material as described in § 9.12.1 of this Part
must also include information regarding any radiation safety aspects
of the human use of the material that is not addressed in this Part.
The applicant shall also provide specific information on:
a. Radiation safety
precautions and instructions;
b. Methodology for measurement
of dosages or doses to be administered to patients or human research
subjects; and
c. Calibration, maintenance,
and repair of instruments and equipment necessary for radiation
safety.
9.4.4 Maintenance of
Records
Each record required by this
Part shall be legible throughout the specified retention period
specified by each Agency regulation. The record may be the original,
a reproduced copy, or a microform if 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, shall include all pertinent information such as
stamps, initials, and signatures. The licensee shall maintain
adequate safeguards against tampering with and loss of records.
9.4.5 License Amendments
A. A licensee shall apply for
and receive a license amendment:
1. Before it receives or uses
radioactive material for a type of use that is permitted under this
Part, but that is not authorized on the licensee's current license
issued pursuant to this Part;
2. Before permitting anyone,
except a Visiting Authorized User, Visiting Authorized Medical
Physicist or Visiting Authorized Nuclear Pharmacist as described §§
9.5.3 or 9.5.6 of this Part, to work as an Authorized User,
Authorized Medical Physicist or Authorized Nuclear Pharmacist under
the license;
3. Before changing a Radiation
Safety Officer, except as provided in § 9.5.1(C) of this Part, or
Authorized Medical Physicist;
4. Before ordering radioactive
material in excess of the amount, or radionuclide or form different
than authorized on the license;
5. Before adding to or
changing the areas of use or address or addresses of use identified
in the application or on the license;
6. Before changing statements,
representations, and procedures which are incorporated into the
license, except as provided for in § 9.5.15 of this Part;
7. Before it releases licensed
facilities for unrestricted use.
8. In addition to the
requirements specified above, a therapeutic medical unit licensee
shall apply for and receive a license amendment before:
a. Making any change in the
treatment room shielding;
b. Making any change in the
location of the therapeutic medical unit within the treatment room;
c. Using the therapeutic
medical unit in a manner that could result in increased radiation
levels in areas outside the treatment room;
d. Relocating the therapeutic
medical unit; or
e. Allowing an individual not
listed on the licensee's license to perform the duties of the
Authorized Medical Physicist, except as provided in § 9.5.6(B) of
this Part.
9.4.6 Notifications
A. A licensee shall notify the
Agency by letter no later than thirty (30) days after:
1. An Authorized User, an
Authorized Nuclear Pharmacist, Radiation Safety Officer, or
Authorized Medical Physicist permanently discontinues performance of
duties under the license or has a name change; or
2. The licensee's mailing
address changes; or
3. The licensee’s name
changes, but the name change does not constitute a transfer of
control of the license as described in § 7.6.3 of this Subchapter;
or
4. The licensee has added to
or changed the areas of use identified in the application or on the
license where radioactive material is used in accordance with either
§§ 9.7.1 or 9.7.3 of this Part if the change does not include
addition or relocation of either an area where PET radionuclides are
produced or a PET radioactive drug delivery line from the PET
radionuclide/PET radioactive drug production area.
9.4.7 Exemptions Regarding
Type A Specific Licenses of Broad Scope
For the purpose of this Part,
exemptions regarding Type A specific licenses of
broad scope are defined by 10 C.F.R. § 35.15.
9.5 General Administrative
Requirements
9.5.1 Authority and
Responsibilities for the Radiation Protection Program
A. In addition to the
radiation protection program requirements of § 1.6 of this
Subchapter, a licensee's management shall approve in writing:
1. Requests for a license
application, renewal, or amendments before submittal to the Agency;
2. Any individual before
allowing that individual to work as a Visiting Authorized User,
Visiting Authorized Medical Physicist, or Visiting Authorized Nuclear
Pharmacist; and
3. Radiation protection
program changes that do not require a license amendment and are
permitted under § 9.5.15 of this Part;
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.
C. For up to sixty (60) days
each year, a licensee may permit an Authorized User or an individual
qualified to be a Radiation Safety Officer under §§ 9.5.10 and
9.5.14 of this Part, to function as a temporary Radiation Safety
Officer and to perform the functions of a Radiation Safety Officer,
as provided in § 9.5.1(E) of this Part, if the licensee takes the
actions required in §§ 9.5.1(B), (D), (E) and (H) of this Part, and
notifies the Agency in accordance with § 9.4.6 of this Part.
D. A licensee may
simultaneously appoint more than one temporary Radiation Safety
Officer, if needed to ensure that the licensee has a temporary
Radiation Safety Officer that satisfies the requirements to be a
Radiation Safety Officer for each of the different types of use of
radioactive material permitted by the license.
E. A licensee shall establish
in writing the authority, duties and responsibilities of the
Radiation Safety Officer.
F. 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.
G. Licensees that are
authorized for two (2) or more different types of uses of radioactive
material under §§ 9.8.1, 9.9.1 or 9.11.1 of this Part, or two (2)
or more types of units under § 9.11.1 of this Part, shall establish
a Radiation Safety Committee to oversee all uses of radioactive
material permitted by the license. The Committee shall 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.
H. A licensee shall retain a
record of actions taken by the licensee's management in accordance
with § 9.5.1(A) of this Part for five (5) years. The record shall
include a summary of the actions taken and a signature of licensee
management.
I. The licensee shall retain a
copy of both authority, duties and responsibilities of the Radiation
Safety Officer as required by § 9.5.1(E) of this Part, and a signed
copy of each Radiation Safety Officer's agreement to be responsible
for implementing the radiation safety program, as required by §
9.5.1(B) of this Part, for the duration of the license. The records
shall include the signature of the Radiation Safety Officer and
licensee management.
J. A licensee's Radiation
Safety Committee shall meet as necessary, but at a minimum shall meet
at intervals not to exceed six (6) months. The licensee shall
maintain minutes of each Radiation Safety Committee meeting which
shall include the date of the meeting, members present, members
absent and a summary of deliberations and discussions.
9.5.2 Duties of Authorized
User and Authorized Medical Physicist
A. A licensee shall ensure
that only Authorized Users for the type of radioactive material used:
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; and
2. Direct, as specified in §§
9.5.3 and 9.5.4 of this Part, or in license conditions, the
administration of radioactive material for medical use to patients or
human research subjects;
3. Prepare and administer, or
supervise the preparation and administration of radioactive material
for medical use, in accordance with §§ 9.4.3(A)(1), (2) and 9.5.3
of this Part.
B. A licensee shall ensure
that only Authorized Medical Physicists perform, as applicable:
1. Full calibration
measurements as described in §§ 9.11.7, 9.11.8 and 9.11.9 of this
Part;
2. Periodic spot-checks as
described in §§ 9.11.10, 9.11.11 and 9.11.12 of this Part; and
3. Radiation surveys as
described in § 9.11.14 of this Part.
9.5.3 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, as allowed by
§ 9.4.3(A) of this Part, shall:
1. In addition to the
requirements in § 2.5 of this Subchapter, instruct the supervised
individual in the licensee's written radiation protection procedures,
written directive procedures, regulations of this Part and license
conditions with respect to the use of radioactive material;
2. Require the supervised
individual to follow the instructions of the supervising Authorized
User for medical uses of radioactive material, written radiation
protection procedures established by the licensee, written directive
procedures, this Subchapter, and license conditions with respect to
the medical use of radioactive material; and;
3. If the individual is
involved in administration of radiation/radioactive materials to
humans, ensure that the individual possesses a current license in
accordance with Licensure of Radiographers, Nuclear Medicine
Technologists, Radiation Therapists and Radiologist Assistants
[Subchapter 05 Part 34 of this Chapter], unless the individual is
specifically exempted from licensure by said regulations;
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 § 9.4.3(A)(2) of
this Part, shall:
1. In addition to the
requirements in § 2.5 of this Subchapter, 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, written radiation protection
procedures established by the licensee, this Subchapter, and license
conditions.
C. A licensee that permits
supervised activities under §§ 9.5.3(A) and (B) of this Part is
responsible for the acts and omissions of the supervised individual.
9.5.4 Written Directives
A. A written directive shall
be dated and signed by an Authorized User prior to administration of
I-131 sodium iodide greater than 1.11 MBq (30 ? Ci),
any therapeutic dosage of unsealed 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 is acceptable. The information contained in the oral
directive shall be documented as soon as possible in writing in the
patient's record. A written directive shall be prepared within
forty-eight (48) hours of the oral directive.
B. The written directive shall
contain the patient or human research subject's name and the
following information:
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 values for the
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; or
5. For all other brachytherapy
including low, medium and pulsed dose rate remote afterloaders:
a. Prior to implantation:
treatment site, the radionuclide and dose; and
b. After implantation but
before completion of the procedure: the radioisotope, treatment site,
number of sources, and total source strength and exposure time (or,
the total dose).
C. 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.
1. 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 is
acceptable. The oral revision shall be documented as soon as possible
in the patient's record. A revised written directive shall be signed
by the Authorized User within forty-eight (48) hours of the oral
revision.
D. The licensee shall retain a
copy of each written directive for three (3) years.
9.5.5 Procedures for
Administrations Requiring a Written Directive
A. For the purpose of this
Part, procedures for administrations requiring a written directive
are defined by 10 C.F.R. § 35.41.
B. A licensee shall retain a
copy of the procedures required under § 9.5.5(A) of this Part for
the duration of the license.
9.5.6 Visiting Authorized
User, Visiting Authorized Medical Physicist and Visiting Authorized
Nuclear Pharmacist
A. A licensee may permit any
Visiting Authorized User to use licensed material for medical use
under the terms of the licensee's license for sixty (60) days each
year if:
1. The Visiting Authorized
User has the prior written permission of the licensee's management
and Radiation Safety Committee if one is required;
2. The licensee has a copy of
an Agency, Agreement State or U.S. Nuclear Regulatory Commission
license that identifies the Visiting Authorized User by name as an
Authorized User for medical use; and
3. Only those procedures for
which the Visiting Authorized User is specifically authorized by an
Agency, Agreement State or U.S. Nuclear Regulatory Commission license
are performed by that individual.
B. A licensee may permit a
medical physicist to act as a Visiting Authorized Medical Physicist,
and perform the duties of a medical physicist under the terms of the
licensee's license for sixty (60) days each calendar year if:
1. The medical physicist is
registered with the Agency, under the provisions of § 3.6 of this
Subchapter, as a provider of Radiation Physics Services in the area
of calibration and compliance surveys of therapeutic medical units;
and
2. The Visiting Authorized
Medical Physicist has the prior written permission of the licensee's
management and Radiation Safety Committee, if one is required; and
3. The licensee has a copy of:
a. An Agency, NRC or Agreement
State license that identifies the individual as an Authorized Medical
Physicist; or
b. A permit issued by an
Agency, NRC or Agreement State specific license of broad scope that
identifies the medical physicist by name as an Authorized Medical
Physicist.
C. A licensee may permit a
nuclear pharmacist to act as a Visiting Authorized Nuclear
Pharmacist, and to perform the duties of a nuclear pharmacist under
the terms of the licensee's license for sixty (60) days each calendar
year if:
1. The nuclear pharmacist
possesses a current license as a pharmacist in accordance with
Pharmacists, Pharmacies and Manufacturers, Wholesalers and
Distributors [Subchapter 15 Part 1 of this Chapter]; and
2. The visiting Authorized
Nuclear Pharmacist has the prior written permission of the licensee's
management and Radiation Safety Committee, if one is required; and
3. The licensee has a copy of:
a. An Agency, NRC or Agreement
State license that identifies the individual as an Authorized Nuclear
Pharmacist; or
b. A permit issued by an
Agency, NRC or Agreement State specific license of broad scope that
identifies the nuclear pharmacist by name as an Authorized Nuclear
Pharmacist.
D. A licensee need not apply
for a license amendment in order to permit:
1. A Visiting Authorized User
to use licensed material as described in § 9.5.6(A) of this Part;
2. A Visiting Authorized
Medical Physicist to perform licensed duties as described in §
9.5.6(B) of this Part;
3. A Visiting Authorized
Nuclear Pharmacist to perform licensed duties as described in §
9.5.6(B) of this Part.
E. A licensee shall retain
copies of the records specified in §§ 9.5.6(A), (B) and (C) of this
Part for three (3) years from the date of the last visit.
9.5.7 Requirements for
Suppliers of Sealed Sources or Devices for Medical Use
For the purpose of this Part,
requirements for suppliers of sealed sources or devices for medical
use are defined by 10 C.F.R. § 35.49.
9.5.8 Quality Control of
Diagnostic Equipment
Each licensee shall establish
written quality control procedures for all diagnostic equipment used
for radionuclide studies. The licensee shall conduct quality control
procedures in accordance with written procedures.
9.5.9 Report and
Notification of a Misadministration
A. Other than events that
result from intervention by a patient or human research subject, a
licensee shall report any event in which the administration of
radioactive material or radiation from radioactive material results
in:
1. A dose that differs from
the prescribed dose or dose that would have resulted from the
prescribed dosage 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
a. The total dose delivered
differs from the prescribed dose by twenty percent (20%) or more;
b. The total dosage delivered
differs from the prescribed dosage by twenty percent (20%) or more or
falls outside the prescribed dosage range; or
c. The fractionated dose
delivered differs from the prescribed dose, for a single fraction, by
fifty percent (50%) 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:
a. An administration of a
wrong radioactive drug;
b. An administration of a
radioactive drug containing radioactive material by the wrong route
of administration;
c. An administration of a dose
or dosage to the wrong individual or human research subject;
d. An administration of a dose
or dosage delivered by the wrong mode of treatment; or
e. A leaking sealed source.
3. A dose to the skin or an
organ or tissue other than the treatment site that exceeds by 0.5 Sv
(50 rem) to an organ or tissue and fifty percent (50%) or more of the
dose expected from the administration defined in the written
directive (excluding, for permanent implants, seeds that were
implanted in the correct site but migrated outside the treatment
site).
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. A licensee shall notify the
Agency by telephone no later than the next calendar day after
discovery of the misadministration.
1. All required notifications
shall use Agency contact information specified in § 1.4 of this
Subchapter.
D. The licensee shall submit a
written report to the Agency within fifteen (15) days after discovery
of the misadministration.
1. The written report shall
include:
a. The licensee's name;
b. The prescribing physician's
name;
c. A brief description of the
event;
d. Why the event occurred;
e. The effect, if any, on the
individual(s) who received the administration;
f. What actions, if any, have
been taken, or are planned, to prevent recurrence;
g. Verification that the
licensee notified the individual (or the individual's responsible
relative or guardian), and if not, why not.
2. The report shall not
contain the individual's name or other information that could lead to
identification of the individual.
E. The licensee shall provide
notification of the event to the referring physician and also notify
the individual who is the subject of the misadministration no later
than twenty-four (24) hours after its discovery, unless the referring
physician personally informs the licensee either that he/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 affected individual cannot be reached
within twenty-four (24) hours, the licensee shall notify the
individual as soon as possible thereafter. The licensee shall 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, individuals
affected by the misadministration, or that individual's responsible
relatives or guardians.
G. A licensee shall retain a
record of misadministrations reported in accordance with this section
for three (3) years. The record shall contain:
1. The licensee's name;
2. Names of the individuals
involved;
3. The social security number
or other identification number if one has been assigned, of the
individual who is the subject of the misadministration;
4. A brief description of the
event; why it occurred; the effect, if any, on the individual;
5. The actions, if any, taken,
or planned, to prevent recurrence; and
6. 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.
H. The licensee shall provide
a copy of the record required by § 9.5.9(G) of this Part to the
referring physician, if other than the licensee, no later than
fifteen (15) days after the discovery of the misadministration.
9.5.10 Training for a
Radiation Safety Officer
For the purpose of this Part,
training requirements for a radiation safety officer are defined by
10 C.F.R. § 35.50.
9.5.11 Training for an
Authorized Medical Physicist
A. For the purpose of this
Part, training requirements for an Authorized Medical Physicist are
defined by 10 C.F.R. § 35.51.
B. In addition to the
requirements in § 9.5.11 of this Part, an Authorized Medical
Physicist must be registered with the Agency, under the provisions of
§ 3.6 of this Subchapter, as a provider of Radiation Physics
Services for the therapeutic modality(s) in which the individual is
seeking approval as an Authorized Medical Physicist.
9.5.12 Training for an
Authorized Nuclear Pharmacist
A. For the purpose of this
Part, training requirements for an Authorized Nuclear Pharmacist are
defined by 10 C.F.R. § 35.55.
B. In addition to the
requirements in § 9.5.12(A) of this Part, an Authorized Nuclear
Pharmacist must possess a current license as a pharmacist in
accordance with Pharmacists, Pharmacies and Manufacturers,
Wholesalers and Distributors [Subchapter 15 Part 1 of this Chapter].
9.5.13 Training for
Experienced Radiation Safety Officer, Teletherapy or Medical
Physicist, Authorized Medical Physicist, Authorized User, Nuclear
Pharmacist, and Authorized Nuclear Pharmacist
A. For the purpose of this
Part, training requirements for an experienced Radiation Safety
Officer, teletherapy or medical physicist, Authorized Medical
Physicist, Authorized User, nuclear pharmacist, and Authorized
Nuclear Pharmacist are defined by 10 C.F.R. § 35.57.
B. An individual who does not
qualify as an experienced medical physicist pursuant to § 9.5.13(A)
of this Part, but has, prior to 24 October 2004, registered with the
Agency, under the provisions of § 3.6 of this Subchapter, as a
provider of Radiation Physics Services for the therapeutic
modality(s) in which the individual is seeking approval as an
Authorized Medical Physicist need not comply with the training
requirements of § 9.5.11 of this Part. Individuals who need not
comply with training requirements as described in this section may
serve as preceptors for, and supervisors of, applicants seeking
authorization on Agency licenses for the same uses for which these
individuals are authorized.
9.5.14 Recentness of
Training.
For the purpose of this Part,
training requirements regarding recentness of training are defined by
10 C.F.R. § 35.59.
9.5.15 Radiation Protection
Program Changes.
A. A licensee may revise its
radiation protection program without prior Agency approval if:
1. The revision does not
require an amendment under § 9.4.5 of this Part;
2. The revision is in
compliance with this Subchapter 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 for five (5) years. The record shall include
the effective date of the change, a copy of the old and new
procedures, the reason for the change, a summary of radiation safety
matters that were considered before making the change and the
signature of the licensee management representative that reviewed and
approved the change.
C. A copy of the record
required by § 9.5.15(B) of this Part shall be submitted to the
Agency within thirty (30) days of adopting said change(s).
9.5.16 Release of
Individuals Containing Unsealed Radioactive Material or Implants
Containing Radioactive Material
A. A licensee may authorize
the release from its control of any individual who has been
administered radioactive drugs or implants containing radioactive
material if the total effective dose equivalent to any other
individual from exposure to the released individual is not likely to
exceed 5 mSv (0.5 rem).
1. NRC NUREG 1556-Vol. 9
"Consolidated Guidance About Materials Licenses: Program
Specific Guidance About Medical Licenses" describes methods for
calculating doses to other individuals and contains tables of
activities not likely to cause doses exceeding 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 oral and written instructions on actions
recommended to maintain doses to other individuals as low as
reasonably achievable if the total effective dose equivalent to any
other individual is likely to exceed 1 mSv (0.1 rem). If the total
effective dose equivalent to a breast-feeding infant or child could
exceed 1 mSv (0.1 rem) assuming there were no interruption of
breast-feeding, the instructions shall also include:
1. Guidance on the
interruption or discontinuation of breast-feeding; and
2. Information on the
consequences, if any, of failure to follow the guidance.
C. For patients administered
radioactive material for which a written directive is required, the
licensee shall maintain a record, for three (3) years after the date
of release, of the basis for authorizing the release of an
individual.
D. The licensee shall maintain
a record, for three (3) years after the date of release, that
instructions required by § 9.5.16(B) of this Part were provided to a
breast-feeding woman if the radiation dose to the infant or child
from continued breast-feeding could result in a total effective dose
equivalent exceeding 1 mSv (0.1 rem).
E. The licensee shall
immediately notify the Agency in accordance with § 9.5.17 of this
Part if a patient departs prior to an authorized release.
F. The licensee shall notify
the Agency in accordance with § 9.5.19 of this Part:
1. When they are aware that a
patient containing radioactive material and who has been released in
accordance with § 9.6.9 of this Part dies; and
2. If it is possible that any
individual could receive an effective dose equivalent in excess of 5
mSv (0.5 rem) as a result of the deceased's body.
9.5.17 Reports of Patient
Departure Prior to Authorized Release
A. The licensee shall notify
the Agency by telephone immediately upon discovery that a patient or
human research subject has departed from the licensee's facility
without authorization under § 9.5.16(A) of this Part.
B. The licensee shall submit a
written report to the Agency within thirty (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.
9.5.18 Report and
Notification of a Dose to an Embryo/Fetus or a Nursing Child
For the purpose of this Part,
training requirements for report and notification of a dose to an
embryo/fetus or a nursing child are defined by 10 C.F.R. § 35.3047.
9.5.19 Notification of
Deceased Patients or Human Research Subjects Containing Radioactive
Material
A. The licensee shall notify
the Agency by telephone immediately upon discovery that a patient or
human research subject containing radioactive material has died, and
it is possible that any individual could receive an effective dose
equivalent in excess of § 1.8.1 of this Subchapter as a result of
the deceased's body.
B. The licensee shall submit a
written report to the Agency within thirty (30) days after discovery
that the patient or human research subject referenced in § 9.5.18 of
this Part has died. The written report shall 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 a TEDE
exceeding 5 mSv (0.5 rem).
9.6 General Technical Requirements
9.6.1 Possession, Use, and
Calibration of Instruments Used to Measure the Activity of Unsealed
Radioactive Material
For the purpose of this Part,
requirements for possession, use, and calibration of instruments used
to measure the activity of unsealed radioactive material are defined
by 10 C.F.R. § 35.60.
9.6.2 Calibration of Survey
Instruments
A. For the purpose of this
Part, requirements for calibration of survey instruments are defined
by 10 C.F.R. § 35.61.
B. The licensee shall retain a
record of each calibration required in § 9.6.2(A) of this Part for
three (3) years. The record shall include:
1. The model and serial number
of the instrument;
2. The results of the
calibration;
3. The name of the individual
who performed the calibration; and
4. The date of calibration.
9.6.3 Determination of
Dosages of Unsealed Radioactive Materials for Medical Use
A. For the purpose of this
Part, requirements for determination of dosages of unsealed
radioactive materials for medical use are defined by 10 C.F.R. §
35.63.
B. Retain a record of the
dosage determinations required by § 9.6.3(A) of this Part for three
(3) years. To satisfy this requirement, the record shall contain:
1. The radiopharmaceutical;
2. Patient's or human research
subject's name, and identification number if one has been assigned;
3. Prescribed dosage and
determined dosage, or a notation that the total activity is less than
1.1 MBq (30 ? Ci);
4. Date and time of the dosage
determination; and
5. Name of the individual who
determined the dosage.
9.6.4 Authorization for
Calibration, Transmission and Reference Sources
For the purpose of this Part,
authorization for calibration, transmission and reference sources is
defined by 10 C.F.R. § 35.65.
9.6.5 Requirements for
Possession of Sealed Sources and Brachytherapy Sources
A. For the purpose of this
Part, requirements for possession of sealed sources and brachytherapy
sources are defined by 10 C.F.R. § 35.67.
B. A licensee in possession of
sealed sources or brachytherapy sources, except for gamma
stereotactic radiosurgery sources, shall conduct a physical inventory
of all such sources at intervals not to exceed six (6) months.
1. The licensee shall retain
each inventory record for three (3) years.
2. The inventory records shall
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, date of the inventory,
and the signature of the Radiation Safety Officer or the individual
who performed the inventory.
9.6.6 Vial Shields
A licensee shall require each
individual preparing or handling a vial that contains a
radiopharmaceutical to keep the vial in a vial radiation shield.
9.6.7 Labeling of Vials and
Syringes
For the purpose of this Part,
requirements for labeling of vials and syringes are defined by 10
C.F.R. § 35.69.
9.6.8 Surveys for
Contamination and Ambient Radiation Dose Rate
A. 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 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 containing radioactive material or
radioactive wastes are stored.
C. A licensee shall conduct
the surveys required by §§ 9.6.8(A) and (B) of this Part so as to
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 §§ 9.6.8(A) and
(B) of this Part and shall require that the individual performing the
survey immediately notify the Radiation Safety Officer if a dose rate
exceeds an action level.
E. A licensee shall survey for
removable contamination at least once each week all areas where
generators and radioactive drugs containing radioactive material are
prepared for use or administered or radioactive materials are stored.
F. A licensee shall conduct
the surveys required by § 9.6.8(E) of this Part so as to be able to
detect contamination on each wipe sample 33.3 Bq (2000 dpm).
G. A licensee shall establish
removable contamination action levels for the surveys required by §
9.6.8(E) of this Part 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 § 9.6.8(A) of this Part in an
area(s) where patients or human research subjects are confined when
they cannot be released pursuant to § 9.6.9 of this Part.
I. A licensee shall retain a
record of each survey for three (3) years. The record shall 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.
9.6.9 Mobile Nuclear
Medicine Service Requirements
A. The Agency shall license
mobile nuclear medicine services or clients of such services. The
mobile nuclear medicine service shall be licensed if the service
receives, uses or possesses radioactive material. The client of the
mobile nuclear medicine service shall be licensed if the client
receives or possesses radioactive material to be used by a mobile
nuclear medicine service.
B. A licensee providing mobile
nuclear medicine service shall:
1. Obtain a letter signed by
the management of each client for which services are rendered that
permits the use of radioactive material at the client's address and
clearly delineates the authority and responsibility of the mobile
nuclear medicine service and the client. 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 nuclear
medicine service;
2. 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.
3. Maintain all records
required by this Part and Parts 1 and 2 of this Subchapter at a
location within the Agency's jurisdiction that is:
a. A single address of use:
(1) Identified as the records
retention location; and
(2) Staffed at all reasonable
hours by individual(s) authorized to provide the Agency with access
for purposes of inspection; or
b. When no address of use is
identified on the license for records retention, the mobile unit:
(1) Identified in the license;
and
(2) Whose current client's
address schedule and location schedule is reported to the Agency.
4. 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, this check for
proper function shall include a constancy check;
5. 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;
6. Bring into each client's
address all radioactive material to be used and, before leaving,
remove all unused radioactive material and associated radioactive
waste;
7. Secure or keep under
constant surveillance and immediate control all radioactive material
when in transit or at a client's address;
8. 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;
9. Check survey instruments
for consistent response with a dedicated check source before use at
each client's address;
10. Prior to leaving a
client's address, perform area surveys and survey for removable
contamination in all areas of use, to ensure compliance with the
requirements in Parts 1 and 2 of this Subchapter;
11. Use radioactive gases only
in areas of use and under conditions which have been evaluated and
approved by the Agency pursuant to § 9.7.6 of this Part; and,
C. A mobile nuclear medical
service shall not have radioactive material delivered 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 licensee providing mobile
nuclear medical services shall retain a copy of each letter required
by § 9.6.9(B)(1) of this Part. Each letter shall clearly delineate
the authority and responsibility of the licensee and the client and
shall be retained for three (3) years after the last provision of
service.
E. A licensee providing mobile
nuclear medical services shall retain the record of each survey
required by § 9.6.9(B)(8) of this Part for three (3) years. The
record shall 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.
F. A licensee providing mobile
nuclear medical services shall, at a minimum, maintain the following
documents on each mobile unit:
1. The current operating and
emergency procedures;
2. A copy of the license;
3. Copies of the letter(s)
required by § 9.6.9(B)(1) of this Part;
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 thirty (30) calendar days.
9.6.10 Decay in Storage
A. For the purpose of this
Part, requirements for decay in storage are defined by 10 C.F.R. §
35.92(a).
B. For radioactive material
disposed in accordance with § 9.6.10(A) of this Part, the licensee
shall retain a record of each disposal for three (3) years. The
record shall include the date of the disposal, the model and serial
number of 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.
9.6.11 Survey Instruments
A. Licensees authorized for
radioactive material use under §§ 9.7.1, 9.7.3, 9.8.1, 9.9.1 and/or
9.11.1 of this Part shall possess an operable survey instrument that
has been calibrated in accordance with § 9.6.2 of this Part and
meets the following criteria:
AUTHORIZED
USE
SURVEY
INSTRUMENT
9.7.1
- Uptake, dilution, and excretion studies
Portable
radiation detection survey instrument capable of detecting dose
rates over the range 1.0 ? Sv
(0.1 mrem) per hour to 500 ? Sv
(50 mrems) per hour
9.7.3
- Imaging & localization studies; or
9.8.1
- Unsealed radioactive material for diagnostic or therapeutic
medical use for which a written directive is required; or
9.9.1
- Manual brachytherapy
Portable
radiation detection survey instrument capable of detecting dose
rates over the range 1.0 ? Sv
(0.1 mrem) per hour to 500 ? Sv
(50 mrems) per hour; and
Portable
radiation measurement survey instrument capable of measuring dose
rates over the range 10 ? Sv (1
mrem) per hour to 10 mSv (1000 mrems) per hour.
9.11.1-
Remote afterloader unit, teletherapy unit and/or gamma
stereotactic radiosurgery unit
Portable
radiation measurement survey instrument capable of measuring dose
rates over the range 10 ? Sv (1
mrem) per hour to 10 mSv (1000 mrems) per hour.
B. A licensee authorized to
use radioactive material as a sealed source for diagnostic purposes
pursuant to § 9.10.1 of this Part shall have available for use a
portable radiation detection survey instrument capable of detecting
dose rates over the range 1.0 ? Sv
(0.1 mrem) per hour to 500 ? Sv
(50 mrems) per hour or a portable radiation measurement survey
instrument capable of measuring dose rates over the range 10 ? Sv
(1 mrem) per hour to 10 mSv (1000 mrems) per hour. The instrument
shall be operable and calibrated in accordance with § 9.6.2 of this
Part.
9.7 Unsealed Radioactive Material
- Written Directive Not Required
9.7.1 Use of Unsealed
Radioactive Material for Uptake, Dilution, or Excretion Studies for
Which a Written Directive is Not Required
For the purpose of this Part,
requirements for use of unsealed radioactive material for uptake,
dilution, and excretion studies for which a written directive is not
required are defined by 10 C.F.R. § 35.100.
9.7.2 Training for Uptake,
Dilution, and Excretion Studies
For the purpose of this Part,
training requirements for uptake, dilution, and excretion studies are
defined by 10 C.F.R. § 35.190.
9.7.3 Use of Unsealed
Radioactive Material for Imaging and Localization Studies for Which a
Written Directive is Not Required
A. For the purpose of this
Part, requirements for use of unsealed radioactive material for
imaging and localization studies for which a written directive is not
required are defined by 10 C.F.R. § 35.200.
B. Provided the conditions of
§ 9.7.6 of this Part are met, a licensee shall use radioactive
aerosols or gases only if specific application is made to and
approved by the Agency.
C. Technetium-99m
pertechnetate as an aerosol for lung function studies is not subject
to the restrictions in § 9.7.3(B) of this Part.
9.7.4 Permissible
Molybdenum-99, Strontium-82, and Strontium-85 Concentrations
A. For the purpose of this
Part, permissible Molybdenum-99, Strontium-82, and Strontium-85
concentrations are defined by 10 C.F.R. § 35.204(a) through (c).
B. A licensee who must measure
radionuclide contaminant concentration shall retain a record of each
measurement for three (3) years. The record shall 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 (microcuries/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.
C. A licensee shall report
immediately to the Agency each occurrence of radio-nuclide
contaminant concentration exceeding the limits specified in §
9.7.4(A) of this Part.
9.7.5 Training for Imaging
and Localization Studies
For the purpose of this Part,
training requirements for imaging and localization studies are
defined by 10 C.F.R. § 35.290.
9.7.6 Control and Storage
of Volatiles, Aerosols and Gases
A. A licensee who administers
radioactive aerosols or gases shall do so with a system that will
keep airborne concentrations within the limits prescribed by §§
1.7.1 and 1.8.1 of this Subchapter.
B. 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.
C. A licensee shall only
administer radioactive gases in rooms that are at negative pressure
compared to surrounding rooms.
D. Before receiving, using, or
storing a radioactive gas, the licensee shall calculate the amount of
time needed after a release to reduce the concentration in the area
of use to the occupational limit listed in § 1.18 of this
Subchapter. The calculation shall be based on the highest activity of
gas handled in a single container and the measured available air
exhaust rate.
E. A licensee shall post the
time calculated in § 9.7.6(D) of this Part at the area of use and
require that, in case of a gas spill, individuals evacuate the room
until the posted time has elapsed.
F. A licensee shall check the
operation of collection systems monthly and measure the ventilation
rates in areas of use at intervals not to exceed six (6) months.
Records of these checks and measurements shall be maintained for
three (3) years.
G. A copy of the calculations
required in § 9.7.6(D) of this Part shall be recorded and retained
for the duration of the license.
H. A licensee shall store
volatile radioactive materials and radioactive gases in a radiation
shield and container.
I. A licensee shall store and
use a multidose container in a properly functioning fume hood.
9.8 Unsealed Radioactive Material
- Written Directive Required
9.8.1 Use of Unsealed
Radioactive Material for Which a Written Directive is Required
For the purpose of this Part,
requirements for use of unsealed radioactive material for which a
written directive is required are defined by 10 C.F.R. § 35.300.
9.8.2 Safety Instruction
A. For the purpose of this
Part, requirements for safety instruction are defined by 10 C.F.R. §
35.310(a).
B. A licensee shall keep a
record of individuals receiving instruction required by in §
9.8.2(A) of this Part for three (3) years. The record shall include a
list of the topic(s) covered, the date of instruction or training the
name(s) of the attendees, and the name(s) of the individual(s) who
provided the instruction.
9.8.3 Safety Precautions
For the purpose of this Part,
requirements for safety precautions are defined by 10 C.F.R. §
35.315.
9.8.4 Training for Use of
Unsealed Radioactive Material for Which a Written Directive Is
Required
For the purpose of this Part,
training requirements for use of unsealed radioactive material for
which a written directive is required are defined by 10 C.F.R. §
35.390.
9.8.5 Training for the Oral
Administration of Sodium Iodide I-131 Requiring a Written Directive
in Quantities Less Than or Equal to 1.22 gigabecquerels (33
millicuries)
For the purpose of this Part,
training requirements for the oral administration of sodium iodide
I-131 requiring a written directive in quantities less than or equal
to 1.22 gigabecquerels (33 millicuries) are defined by 10 C.F.R. §
35.392.
9.8.6 Training for the Oral
Administration of Sodium Iodide I-131 Requiring a Written Directive
in Quantities Greater Than 1.22 gigabecquerels (33 millicuries)
For the purpose of this Part,
training requirements for the oral administration of sodium iodide
I-131 requiring a written directive in quantities greater than 1.22
gigabecquerels (33 millicuries) are defined by 10 C.F.R. § 35.394.
9.8.7 Training for the
Parenteral Administration of Unsealed Radioactive Material Requiring
a Written Directive
For the purpose of this Part,
training requirements for the parenteral administration of unsealed
radioactive material requiring a written directive are defined by 10
C.F.R. § 35.396.
9.9 Manual Brachytherapy
9.9.1 Use of Sources for
Manual Brachytherapy
For the purpose of this Part,
requirements for use of sources for manual brachytherapy are defined
by 10 C.F.R. § 35.400.
9.9.2 Surveys after Source
Implant and Removal
A. For the purpose of this
Part, requirements for surveys after source implant and removal are
defined by 10 C.F.R. §§ 35.404(a) and (b).
B. A licensee shall retain a
record of the surveys required by § 9.9.2(A) of this Part for three
(3) years. Each record shall include the date and results of the
survey, the serial number and the model number of the survey
instrument used, and the name of the individual who made the survey.
9.9.3 Brachytherapy Sources
Accountability
A. For the purpose of this
Part, requirements for brachytherapy sources accountability are
defined by 10 C.F.R. §§ 35.406(a) and (b).
B. A licensee shall maintain a
record of the brachytherapy source accountability as follows:
1. For temporary implants, the
record shall include:
a. 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;
b. The number and activity of
sources not implanted, the time and date they were returned to
storage, and the name of the individual who returned them to storage;
and
c. The number and activity of
sources temporarily implanted in the patient or human research
subject.
2. For permanent implants, the
record shall include:
a. 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;
b. The number and activity of
sources returned to storage, the date they were returned to storage,
and the name of the individual who returned them to storage; and
c. The number and activity of
sources permanently implanted in the patient or human research
subject.
C. A licensee shall maintain
the records required in § 9.9.3(B) of this Part for three (3) years.
9.9.4 Safety Instruction
A. For the purpose of this
Part, requirements for safety instruction are defined by 10 C.F.R. §
35.410(a).
B. A licensee shall keep a
record of individuals receiving instruction required by in §
9.9.4(A) of this Part for three (3) years. The record shall include a
list of the topic(s) covered, the date of instruction or training the
name(s) of the attendees, and the name(s) of the individual(s) who
provided the instruction.
9.9.5 Safety Precautions
For the purpose of this Part,
requirements for safety precautions are defined by 10 C.F.R. §
35.415.
9.9.6 Calibration
Measurements of Brachytherapy Sources
A. For the purpose of this
Part, requirements for calibration measurements of brachytherapy
sources are defined by 10 C.F.R. § 35.432.
B. A licensee shall retain a
record of each calibration of brachytherapy sources required by §
9.9.6(A) of this Part for three (3) years after the last use of the
source. The record shall include:
1. The date of the
calibration;
2. The manufacturer's name,
model number, and serial number for the source and the instruments
used to calibrate the source;
3. The source output or
activity;
4. Source positioning accuracy
within applicators;
5. The signature of the
Authorized Medical Physicist; and
6. For surface applicators
where the calibration was performed by the source manufacturer or by
a calibration laboratory accredited by the American Association of
Physicists, a complete copy of all calibration measurements provided
for that source.
9.9.7 Decay of Strontium-90
Sources for Ophthalmic Treatments
A. For the purpose of this
Part, requirements for decay of Strontium-90 sources for ophthalmic
treatments are defined by 10 C.F.R. § 35.433.
B. A licensee shall retain a
record of decay calculations required by § 9.9.7(A) of this Part for
three (3) years after the last use of the source. The record shall
include:
1. The date and initial source
output or activity as determined under § 9.9.6(A) of this Part;
2. For each decay calculation,
the date and the source output or activity as determined under §
9.9.7(A) of this Part; and
3. The signature of the
Authorized Medical Physicist.
9.9.8 Therapy-related
Computer Systems
A. For the purpose of this
Part, requirements for acceptance testing on the treatment planning
system of therapy-related computer systems are defined by 10 C.F.R. §
35.457.
B. In addition to the
requirements of § 9.9.8(A) of this Part, acceptance testing shall
include verification of the accuracy of electronic transfer of the
treatment delivery parameters to the treatment delivery unit from the
treatment planning system.
9.9.9 Training for Use of
Manual Brachytherapy Sources
For the purpose of this Part,
training requirements for use of
manual brachytherapy sources are defined by 10
C.F.R. § 35.490.
9.9.10 Training for
Ophthalmic Use of Strontium-90
For the purpose of this Part,
training requirements for ophthalmic use of Strontium-90 are defined
by 10 C.F.R. § 35.491.
9.10 Sealed Sources for Diagnosis
9.10.1 Use of Sealed
Sources for Diagnosis
For the purpose of this Part,
requirements for use of sealed sources for diagnosis are defined by
10 C.F.R. § 35.500.
9.10.2 Training for Use of
Sealed Sources for Diagnosis
For the purpose of this Part,
training requirements for use of sealed sources for diagnosis are
defined by 10 C.F.R. § 35.590.
9.11 Photon Emitting Remote
Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units
9.11.1 Use of a Sealed
Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma
Stereotactic Radiosurgery Unit
For the purpose of this Part,
requirements for use of a sealed source in a remote afterloader unit,
teletherapy unit, or gamma stereotactic radiosurgery unit are defined
by 10 C.F.R. § 35.600.
9.11.2 Surveys of Patients
and Human Research Subjects Treated with a Remote Afterloader Unit
A. For the purpose of this
Part, requirements for surveys of patients and human research
subjects treated with a remote afterloader unit are defined by 10
C.F.R. § 35.604.
B. A licensee shall retain a
record of the surveys required by § 9.11.2(A) of this Part for three
(3) years. Each record shall include the date and results of the
survey, the serial number and the model number of the survey
instrument used, and the name of the individual who made the survey.
9.11.3 Installation,
Maintenance, Adjustment, and Repair
A. For the purpose of this
Part, requirements for installation, maintenance, adjustment, and
repair are defined by 10 C.F.R. § 35.605.
B. A licensee shall retain a
record of the installation, maintenance, adjustment and repair of
remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units for three (3) years. For each installation,
maintenance, adjustment and repair, the record shall include the
date, description of the service, and name(s) of the individual(s)
who performed the work.
9.11.4 Safety Procedures
and Instructions for Remote Afterloader Units, Teletherapy Units, and
Gamma Stereotactic Radiosurgery Units
A. For the purpose of this
Part, requirements for safety procedures and instructions for remote
afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units are defined by 10 C.F.R. § 35.610.
B. A licensee shall retain a
copy of the procedures required by § 9.11.4(A) of this Part until
the licensee no longer possesses the remote afterloader, teletherapy
unit, or gamma stereotactic radiosurgery unit.
C. A licensee shall retain a
record of the surveys required by § 9.11.4(A) of this Part for three
(3) years. Each record shall include the date and results of the
survey, the serial number and the model number of the survey
instrument used, and the name of the individual who made the survey.
9.11.5 Safety Precautions
for Remote Afterloader Units, Teletherapy Units, and Gamma
Stereotactic Radiosurgery Units
For the purpose of this Part,
requirements for safety precautions for remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units are
defined by 10 C.F.R. § 35.615.
9.11.6 Dosimetry Equipment
A. For the purpose of this
Part, requirements for dosimetry equipment are defined by 10 C.F.R. §
35.630.
B. The licensee shall maintain
a record of each calibration, intercomparison, and comparison of its
dosimetry equipment for the duration of the license. For each
calibration, intercomparison, or comparison, the record shall
include:
1. The date;
2. The manufacturer's name,
model numbers and serial numbers of the instruments that were
calibrated, intercompared or compared as required by §§ 9.11.6(A)
and (B) of this Part;
3. The correction factor that
was determined from the calibration or comparison or the apparent
correction factor that was determined from an intercomparison; and
4. The names of the
individuals who performed the calibration, inter-comparison, or
comparison, and evidence that the intercomparison was performed by or
under the direct supervision of an Authorized Medical Physicist.
9.11.7 Full Calibration
Measurements on Teletherapy Units
A. For the purpose of this
Part, requirements for full calibration measurements on teletherapy
units are defined by 10 C.F.R. § 35.632.
B. A licensee shall maintain a
record of each calibration for three (3) years. The record shall
include:
1. The date of the
calibration;
2. The manufacturer's name,
model number and serial number for both the teletherapy unit and the
source, and the model numbers and serial numbers of the instruments
used to calibrate the teletherapy unit;
3. The results and assessments
of the full calibrations; and
4. The signature of the
Authorized Medical Physicist who reviewed or performed the full
calibration.
9.11.8 Full Calibration
Measurements on Remote Afterloader Units
A. For the purpose of this
Part, requirements for full calibration measurements on remote
afterloader units are defined by 10 C.F.R. § 35.633.
B. A licensee shall retain a
record of each calibration for three (3) years. The record shall
include:
1. The date of the
calibration;
2. The manufacturer's name,
model number, and serial number for both the remote afterloader unit
and the source(s), and the model number and serial number of the
instrument 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 reviewed or performed the full
calibration.
9.11.9 Full Calibration
Measurements on Gamma Stereotactic Radiosurgery Units
A. For the purpose of this
Part, requirements for full calibration measurements on gamma
stereotactic radiosurgery units are defined by 10 C.F.R. § 35.635.
B. A licensee shall retain a
record of each calibration for three (3) years. The record shall
include:
1. The date of the
calibration;
2. The manufacturer's name,
model number, and serial number for both the gamma stereotactic
radiosurgery unit and the sources, and the model number and serial
number of the instrument used to calibrate the unit;
3. The results and assessments
of the full calibrations; and
4. The signature of the
Authorized Medical Physicist who reviewed or performed the full
calibration.
9.11.10 Periodic
Spot-checks on Teletherapy Units
A. For the purpose of this
Part, requirements for periodic spot-checks on teletherapy units are
defined by 10 C.F.R. § 35.642.
B. A licensee shall maintain a
record of each spot-check and a copy of the procedures required by §
9.11.10(A) of this Part for three (3) years. The record shall
include:
1. The date of the spot-check;
2. The manufacturer's name,
model number, and serial number for the teletherapy unit, source and
the instrument used to measure the output of the teletherapy unit;
3. An assessment of timer
constancy and linearity;
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 or 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 signature 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.
9.11.11 Periodic
Spot-checks on Remote Afterloader Units
A. For the purpose of this
Part, requirements for periodic spot-checks on remote afterloader
units are defined by 10 C.F.R. § 35.643.
B. A licensee shall retain a
record of each check and a copy of the procedures required by §
9.11.11(A) of this Part for three (3) years. The record shall
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 signature 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.
9.11.12 Periodic
Spot-checks on Gamma Stereotactic Radiosurgery Units
A. For the purpose of this
Part, requirements for periodic spot-checks on gamma stereotactic
radiosurgery units are defined by 10 C.F.R. § 35.645.
B. A licensee shall retain a
record of each check and a copy of the procedures required by §
9.11.12(A) of this Part for three (3) years. The record shall
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 signature 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.
9.11.13 Additional
Technical Requirements for Mobile Remote Afterloader Units
A. For the purpose of this
Part, additional technical requirements for mobile remote afterloader
units are defined by 10 C.F.R. § 35.647.
B. A licensee shall retain a
record of each check required by § 9.11.13(A) of this Part for three
(3) years. The record shall 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.
9.11.14 Radiation Surveys
A. For the purpose of this
Part, requirements for radiation surveys are defined by 10 C.F.R. §
35.652.
B. A licensee shall maintain a
record of the surveys required by § 9.11.14(A) of this Part for the
duration of the license. The record shall include:
1. The date of the
measurements;
2. The manufacturer's name,
model number and serial number of the treatment unit, the source, and
the instrument used to measure radiation levels;
3. Each dose rate measured
around the source while in the "off" position and the
average of all measurements, and
4. The signature of the
Authorized Medical Physicist who reviewed or performed the survey.
9.11.15 Five-Year
Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units
A. For the purpose of this
Part, requirements for five-year inspection for teletherapy and gamma
stereotactic radiosurgery units are defined by 10 C.F.R. § 35.655.
B. A licensee shall maintain a
record of the inspection and servicing for the duration of use of the
unit. The record shall contain:
1. The inspector's name;
2. The inspector's radioactive
materials license number;
3. The date of inspection;
4. The manufacturer's name and
model number and serial number for both the treatment unit and
source;
5. A list of components
inspected and serviced, and the type of service; and
6. The signature of the
inspector.
9.11.16 Therapy-related
Computer Systems
For the purpose of this Part,
requirements for acceptance testing on the treatment planning system
of therapy-related computer systems are defined by 10 C.F.R. §
35.657.
9.11.17 Training for Use of
Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units
For the purpose of this Part,
training requirements for use of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units are
defined by 10 C.F.R. § 35.690.
9.12 Other Medical Uses of
Radioactive Material or Radiation from Radioactive Material
9.12.1 Other Medical Uses
of Radioactive Material or Radiation from Radioactive Material
A. A licensee may use
radioactive material or a radiation source approved for medical use
which is not specifically addressed elsewhere in this Part if:
1. The applicant or licensee
has submitted:
a. Information regarding any
radiation safety aspects of the medical use of the material that is
not addressed elsewhere in this Part; and
b. 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; and
c. Any other information
requested by the Agency in its review of the application; and
2. The applicant or licensee
has received written approval from the Agency in a license or license
amendment and uses the material in accordance with this Subchapter
and specific conditions the Agency considers necessary for the
medical use of the material.