TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.10 PURPOSE AND SCOPE
Section 335.10 Purpose and
Scope
This Part contains the
requirements and provisions for the medical use of radioactive material and for
issuance of specific licenses authorizing the medical use of this material.
This Part allows use of radioactive material strictly for medical use as
authorized by an authorized user and does not allow use for training,
demonstration or other purposes unrelated to the treatment of patients. These
requirements and provisions provide for the radiation safety of workers, the
general public, patients and human research subjects. The requirements of this
Part are in addition to, and not in substitution for, others in 32 Ill. Adm.
Code: Chapter II, Subchapters b and d. The requirements of 32 Ill. Adm. Code:
Chapter II, Subchapters b and d apply to applicants and licensees subject to
this Part unless specifically exempted.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
 | TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.15 INCORPORATIONS BY REFERENCE
Section 335.15
Incorporations by Reference
All rules, standards and
guidelines of agencies of the United States or nationally recognized
organizations or associations that are incorporated by reference in this Part
are incorporated as of the date specified in the reference and do not include
any later amendments or editions. Copies of these rules, standards and
guidelines that have been incorporated by reference are available for public
inspection and copying at the Illinois Emergency Management Agency, 1035 Outer
Park Drive, Springfield, Illinois.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.20 DEFINITIONS
Section 335.20 Definitions
"Area of
use" means a portion of a physical structure that has been set aside for
the purpose of receiving, using or storing radioactive material.
"Associate
Radiation Safety Officer" means an individual who, for this Part only,
meets the requirements in Sections 335.9010 and 335.9180 and is currently
identified as an Associate Radiation Safety Officer for the types of use of radioactive
material for which the individual has been assigned duties and tasks by the
Radiation Safety Officer on a specific medical use license issued by the
Agency, U.S. Nuclear Regulatory Commission or an Agreement State or on medical
use permit issued by a U.S. Nuclear Regulatory Commission master material
licensee.
"Authorized
user" means a physician, dentist or podiatrist who meets the requirements
in Subpart J or is identified as being authorized to use radioactive material
on a specific medical use license issued by the Agency, the U.S. Nuclear
Regulatory Commission, or an Agreement State; a medical use permit issued by a
U.S. Nuclear Regulatory Commission master material licensee; a permit issued by
a U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use
licensee; or a permit issued by a U.S. Nuclear Regulatory Commission master
material license broad scope medical use permittee.
"Authorized medical physicist"
means an individual who meets the requirements in Sections 335.9150(a) and
335.9180; or is identified as an authorized medical physicist or teletherapy
physicist on a specific medical use license issued by the U.S. Nuclear
Regulatory Commission or an Agreement State, a medical use permit issued by a
U.S. Nuclear Regulatory Commission master material licensee, a permit issued by
a U.S. Nuclear Regulatory Commission or an Agreement State broad scope medical
use licensee, or a permit issued by a U.S. Nuclear Regulatory Commission master
material license broad scope medical use permittee.
"Case"
means the performance of a clinical procedure on a patient.
"Classroom
and laboratory training" means planned instruction outlined in a syllabus
and offered by an individual or organization. It is comprised of lectures,
demonstrations, hands-on laboratory exercises and tests.
"Client's address" means
the area of use or a temporary job site for the purpose of providing mobile
medical service in accordance with Section 335.2120.
"Clinical
procedure" means a method of using radioactive material for patient care
in which the material or its radiation is administered to the patient. A
specific clinical procedure specifies, either explicitly or in context, the
indication for the procedure, the purpose (diagnosis or therapy), the
radionuclide and its chemical and physical form, the dosage or dose and method
of administration and patient follow-up. Diagnostic clinical procedures also
include the method of collecting raw data, manipulating the data and
interpreting the final results, which may be images, graphs or numbers.
"Dentist"
means an individual licensed by a state or territory of the United States, the
District of Columbia or the Commonwealth of Puerto Rico to practice dentistry.
"Gamma stereotactic
radiosurgery" means the use of external radiation in conjunction with a
stereotactic guidance device to very precisely deliver a therapeutic dose to a
tissue volume.
"High dose
rate remote afterloader" means a brachytherapy device that remotely
delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or
surface where the dose is prescribed.
"Intravascular
brachytherapy" means a type of brachytherapy in which the brachytherapy
sources are placed into blood vessels at the point where the dose is prescribed
for the treatment of in-stent restenosis.
"Low dose rate remote afterloader" means a
brachytherapy device that remotely delivers a dose rate of less than or equal
to 2 gray (200 rads) per hour at the point or surface where the dose is
prescribed.
"Management"
means the chief executive officer or other individual having the authority to
manage or administer the licensee's activities, or those individuals' delegates.
"Manual brachytherapy"
means a type of brachytherapy in which the brachytherapy sources (e.g., seeds,
ribbons) are manually placed topically on or inserted either into the body
cavities that are in close proximity to a treatment site or directly into the
tissue volume.
"Medical event"
means an event that meets the criteria in Section 335.1080.
"Medical
institution" means an organization in which more than one medical
discipline is practiced.
"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.
"Medium dose rate remote
afterloader" means a brachytherapy device that remotely delivers a dose
rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12
gray (1200 rads) per hour at the point or surface where the dose is prescribed.
"Mobile medical service"
means the transportation of radioactive material to, and its medical use at,
the client's address.
"Ophthalmic
physicist" means an individual who meets the requirements in Sections
335.7100(b) and 335.9180; and is identified as an ophthalmic physicist on a
specific medical use license issued by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State; a medical use permit issued by a U.S.
Nuclear Regulatory Commission master material licensee; a permit issued by the
Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State broad
scope medical use licensee; or a permit issued by a U.S. Nuclear Regulatory
Commission master material license broad scope medical use permittee.
"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.
"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.
"Physically present"
means within audible range and in such proximity that immediate assistance can
be given if required.
"Podiatrist" means an
individual licensed by a state or territory of the United States, the District
of Columbia or the Commonwealth of Puerto Rico to practice podiatry.
"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, a Radiation Safety Officer, or an
Associate Radiation Safety Officer.
"Prescribed
dosage" means the specified activity or range of activity of unsealed
radioactive material as documented:
in a written
directive; or
in accordance
with the directions of the authorized user for procedures pursuant to Sections
335.3010 and 335.4010.
"Prescribed
dose" means:
for gamma
stereotactic radiosurgery, the total dose as documented in the written
directive;
for
teletherapy, the total dose and dose per fraction as documented in the written
directive;
for manual brachytherapy
and intravascular brachytherapy, either the total dose or the total source
strength and exposure time, as documented in the written directive; or
for remote brachytherapy
afterloaders, the total dose and dose per fraction as documented in the written
directive.
"Pulsed dose rate remote
afterloader" means a special type of remote afterloading brachytherapy
device that uses a single source capable of delivering dose rates in the "high
dose rate" range, and:
is approximately one-tenth of the
activity of typical high dose rate remote afterloader sources; and
is used to simulate the
radiobiology of a low dose rate treatment by inserting the source for a given
fraction of each hour.
"Radiation Safety
Officer" means an individual who:
meets the requirements in Sections
335.9010 and 335.9180; or
is identified as
a Radiation Safety Officer on:
a specific medical use license
issued by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement
State; or
a medical use permit issued by a
U.S. Nuclear Regulatory Commission master material licensee.
"Structured educational
program" means an educational program designed to impart particular
knowledge and practical education through interrelated studies and supervised
training.
"Teletherapy"
means a method of radiation therapy in which collimated gamma rays are
delivered at a distance from the patient or human research subject.
"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.
"Therapeutic dose" means
a radiation dose delivered from a source containing radioactive material to a
patient or human research subject for palliative or curative treatment.
"Treatment site" means
the anatomical description of the tissue intended to receive a radiation dose,
as described in a written directive.
"Type of use" means use
of radioactive material under Section 335.2140, 335.3010, 335.4010, 335.5010,
335.6010, 335.7010 or 335.8010.
"Unit dosage" means a
dosage prepared for medical use for administration as a single dosage to a
patient or human research subject without any further manipulation of the
dosage after it is initially prepared.
"Visiting authorized
user" means a temporary (i.e., less than 60 days each year) authorized
user who is not identified on the license of the licensee being visited and who
has been approved by the Radiation Safety Committee in accordance with Section
335.1060(b).
"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 Section 335.1110.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.30 LICENSE REQUIRED
Section 335.30 License
Required
a) A person shall manufacture, produce, acquire, receive,
possess, prepare, 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, an Agreement State, or as allowed by subsection (b)(1)
or (2) of this Section.
b) A specific license is
not needed for an individual who:
1) Receives,
possesses, uses or transfers radioactive material in accordance with this Part
under the supervision of an authorized user as provided in Section 335.1050
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 Section 335.1050 unless prohibited by license condition.
(Source: Amended at 35 Ill.
Reg. 884, effective December 30, 2010)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.35 SUPPLIERS FOR SEALED SOURCES OR DEVICES FOR MEDICAL USE
Section 335.35 Suppliers for Sealed Sources or Devices
for Medical Use
For medical use, a licensee shall only use:
a) Sealed
sources or devices manufactured, labeled, packaged, and distributed in
accordance with a license issued under 32 Ill. Adm. Code 330 or equivalent
requirements of the U.S. Nuclear Regulatory Commission or an Agreement State.
b) Sealed
sources or devices non-commercially transferred from an Agency, U.S. Nuclear
Regulatory Commission or an Agreement State medical use licensee.
c) Teletherapy
sources manufactured and distributed in accordance with a license issued under
32 Ill. Adm. Code 330 or equivalent requirements of the U.S. Nuclear Regulatory
Commission or an Agreement State.
(Source: Added at 46 Ill. Reg. 966,
effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.40 LICENSE AMENDMENTS
Section 335.40 License
Amendments
For specific licenses issued
pursuant to 32 Ill. Adm. Code 330.260(a) or 330.260(b), a licensee's management
shall apply for and shall receive a license amendment:
a) Before using radioactive material for any use not permitted by
the license;
b) Before permitting anyone to work as an authorized user,
authorized medical physicist, or ophthalmic physicist under the license,
except:
1) For a visiting
authorized user, as described in Section 335.1060;
2) For an authorized user,
an individual who meets:
A) The
requirements in 335.9180; and
B) The
applicable board certification requirements in subsections 335.9030(a),
335.9040(a), 335.9050(a), 335.9060(a), 335.9070(a), 335.9100(a), 335.9130(a),
and 335.9140(a);
3) For
an authorized medical physicist, an individual who meets the requirements in subsection
335.9150(a) and Section 335.9180;
4) An individual who is identified as an authorized user, an
authorized medical physicist, or an ophthalmic physicist on an Agency, U.S.
Nuclear Regulatory Commission, or Agreement State license or other equivalent
permit recognized by the Agency that authorizes the use of byproduct material
in medical use, on a permit issued by the Agency, the U.S. Nuclear Regulatory
Commission or an Agreement State specific license of broad scope that is
authorized to permit the use of byproduct material in medical use, or on a
permit issued by the U.S. Nuclear Regulatory Commission master material
licensee that is authorized to permit the use of byproduct material in medical
use;
c) Before changing the Radiation Safety Officer, except as
provided in subsection 335.1040(c);
d) Before permitting anyone to work as an Associate Radiation
Safety Officer or before the Radiation Safety Officer assigns duties and tasks
to an Associate Radiation Safety Officer that differ from those for which this
individual is authorized on the license;
e) Before receiving radioactive material in excess of the amount,
in a different form, or a different radionuclide than is authorized on the
license;
f) Before adding to or changing any area of use identified on the
license, including changing the shielding in any area approved on the license.
This includes areas used in accordance with Section 335.3010 or 335.4010 if the
change includes addition or relocation of an area where PET radionuclides are
used, administered, produced, or stored. Other areas of use where radioactive
material is used only in accordance with either Section 335.3010 or 335.4010
are exempt;
g) Before changing the addresses of use identified in the
license;
h) Before changing statements, representations and procedures
that are incorporated into the license;
i) Before receiving a sealed source from a different
manufacturer or of a different model number than authorized by the license,
unless the sealed source is used for manual brachytherapy, listed in the Sealed
Source and Device Registry, and is in a quantity and for an isotope authorized
by the license.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.45 NOTIFICATIONS
Section 335.45 Notifications
a) For
specific licenses issued pursuant to 32 Ill. Adm. Code 330.260(a) or (b), a
licensee shall provide the Agency, no later than 30 days after the date that
the licensee permits an individual to work under the provisions of subsection
335.40(b) as an authorized user, authorized medical physicist, or ophthalmic
physicist:
1) A
copy of the board certification and, as appropriate, verification of completion
of:
A) Training
for the authorized medical physicist under subsection 335.9150(d);
B) Any
additional case experience required in subsection 335.9050(b)(2)(F) for an
authorized user under Section 335.5010; or
C) Device
specific training in subsection 335.9140(d) for the authorized user under
Section 335.8010; or
2) A
copy of the Agency, U.S. Nuclear Regulatory Commission or Agreement State
license, the permit issued by a U.S. Nuclear Regulatory Commission master
material licensee, the permit issued by the Agency, U.S. Nuclear Regulatory
Commission or Agreement State licensee of broad scope, or the permit issued by
a U.S. Nuclear Regulatory Commission master material license broad scope
permittee for each individual whom the licensee permits to work under the
provisions of this Part.
b) A licensee shall
notify the Agency no later than 30 days after:
1) An
authorized user, Radiation Safety Officer, Associate Radiation Safety Officer,
authorized medical physicist, or ophthalmic physicist permanently discontinues
performance of duties under the license or has a name change;
2) The
licensee permits an individual qualified to be a Radiation Safety Officer under
Sections 335.9010 and 335.9180 to function as a temporary Radiation Safety
Officer and to perform the functions of a Radiation Safety Officer in
accordance with subsection 335.1040(c);
3) The
licensee's mailing address changes;
4) The
licensee's name changes, but the name change does not constitute a transfer of
control of the license as described in 32 Ill. Adm. Code 330.310(c);
5) The
licensee has added to or changed the areas of use identified in the license
where byproduct material is used in accordance with either Section 335.3010 or
335.4010 if the change does not include an area where PET radionuclides are
used, administered, produced, or stored; or
6) The
licensee obtains a sealed source for use in manual brachytherapy from a
different manufacturer or with a different model number than authorized by its
license for which it did not require a license amendment as provided in
subsection 335.40(i). The notification must include the manufacturer and model
number of the sealed source, the isotope, and the quantity per sealed source.
(Source: Added at 46 Ill. Reg. 966,
effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.50 WRITTEN DIRECTIVES (REPEALED)
Section 335.50 Written Directives (Repealed)
(Source:
Repealed at 30 Ill. Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.60 PROVISIONS FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS
Section 335.60 Provisions for the Protection of Human
Research Subjects
a) A
licensee may conduct research involving human research subjects only if it uses
the radioactive materials specified on its license for the uses authorized on
its license.
b) If
the research is conducted, funded, supported or regulated by another Federal
agency that has implemented the Federal Policy for the Protection of Human
Subjects (Federal Policy), the licensee shall, before conducting research:
1) Obtain
review and approval of the research from an Institutional Review Board, as
defined and described in the Federal Policy; and
2) Obtain
informed consent, as defined and described in the Federal Policy, from the
human research subject.
c) If
the research will not be conducted, funded, supported, or regulated by another
Federal agency that has implemented the Federal Policy, the licensee shall,
before conducting research, apply for and receive a specific amendment to its
Agency, U.S. Nuclear Regulatory Commission, Agreement State or Licensing State
medical use license. The amendment request must include a written commitment
that the licensee will, before conducting research:
1) Obtain
review and approval of the research from an Institutional Review Board, as defined
and described in the Federal Policy; and
2) Obtain
informed consent, as defined and described in the Federal Policy, from the
human research subject.
d) Nothing
in this Section relieves licensees from complying with the other requirements
in this Part.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
SUBPART B: GENERAL ADMINISTRATIVE REQUIREMENTS
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1010 ALARA PROGRAM (REPEALED)
Section 335.1010 ALARA
Program (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1020 RADIATION SAFETY OFFICER (REPEALED)
Section 335.1020 Radiation
Safety Officer (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1030 RADIATION SAFETY COMMITTEE (REPEALED)
Section 335.1030 Radiation
Safety Committee (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1040 AUTHORITIES AND RESPONSIBILITIES FOR THE RADIATION PROTECTION PROGRAM
Section 335.1040 Authorities
and Responsibilities for the Radiation Protection Program
a) In addition to the radiation protection program requirements
of 32 Ill. Adm. Code 340.110, a licensee's management shall approve in writing:
1) Requests for a license application, renewal or amendment
before submittal to the Agency.
2) Any individual before allowing that individual to work as an
authorized user or authorized medical physicist.
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, shall assign the
specific duties and tasks to each Associate Radiation Safety Officer. These
duties and tasks are restricted to the types of use for which the Associate
Radiation Safety Officer is listed on a license. The Radiation Safety Officer
may delegate duties and tasks to the Associate Radiation Safety Officer but
shall not delegate the authority or responsibilities for implementing the
radiation protection program.
c) For
up to 60 days each year, a licensee may permit an individual qualified to be a
Radiation Safety Officer, under Sections 335.9010 and 335.9180, to function as
a temporary Radiation Safety Officer and to perform the functions of a
Radiation Safety Officer, as provided in subsection (g), if the licensee takes
the actions required in subsections (b), (e), (g), (h) and (i). The licensee
shall provide notification to the Agency in accordance with subsection
335.45(b).
d) A
licensee may simultaneously appoint more than one temporary Radiation Safety
Officer in accordance with subsection (c), 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 uses of radioactive material permitted by the license.
e) A
licensee shall establish the authority, duties and responsibilities of the
Radiation Safety Officer in writing.
f) Licensees
that are authorized for two or more different types of uses of radioactive
material under Subparts F, H and I or Section 335.2140 for emerging
technologies, or two or more types of units under Subpart I, 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. The Committee
may include other members the licensee considers appropriate.
g) A
licensee shall provide the Radiation Safety Officer sufficient authority,
organizational freedom, time, resources and management prerogative to:
1) Identify radiation
safety problems;
2) Initiate, recommend or
provide corrective actions;
3) Stop
unsafe operations; and
4) Verify
implementation of corrective actions.
h) A
licensee shall retain a record of actions taken by the licensee's management in
accordance with subsection (a) for 5 years. The record shall include a summary
of the actions taken and a signature of licensee's management.
i) The
licensee shall retain a copy of the authority, duties and responsibilities of
the Radiation Safety Officer as required by subsection (e) and a signed copy of
each Radiation Safety Officer's agreement to be responsible for implementing
the radiation safety program, as required by subsection (b), for the duration
of the license. The records shall include the signature of the Radiation
Safety Officer and licensee's management.
j) For
each Associate Radiation Safety Officer appointed under subsection (b), the
licensee shall retain a copy of the written document appointing the Associate
Radiation Safety Officer, signed by the licensee's management, for 5 years
after the Associate Radiation Safety Officer is removed from the license.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1050 SUPERVISION
Section 335.1050 Supervision
a) A licensee who permits the receipt, possession, use or
transfer of radioactive material by an individual other than a physician under
the supervision of an authorized user as allowed by Section 335.30 of this Part
shall:
1) Document instruction provided to the supervised individual,
prior to assuming duties requiring the handling of radioactive materials,
regarding the principles of radiation safety appropriate to that individual's
use of radioactive material;
2) Review the supervised individual's use of radioactive
material, provide reinstruction and review records kept to reflect this use;
3) Require the authorized user or Radiation Safety Officer to be
available to communicate with the supervised individual; and
4) Allow only those individuals who are accredited by the Agency
pursuant to 32 Ill. Adm. Code 401.100 or exempt from accreditation by 32 Ill.
Adm. Code 401.30, and designated in writing by the licensee, to administer
radionuclides or radiation to patients.
b) A licensee who permits the receipt, possession, use or
transfer of radioactive material by a physician under the supervision of an
authorized user as allowed by Section 335.30 of this Part shall:
1) Review the supervised individual's use of radioactive
material, provide reinstruction and review records kept to reflect this use;
2) Require the authorized user to be available to communicate
with the supervised individual; and
3) Maintain a record of each supervised individual for a period
of 5 years from the initiation of the supervised training. This record shall
include the name of each supervised individual, the results of reviews required
by subsection (b)(1) of this Section, a description of what procedures the
supervised individual is approved to perform and the signature of the
supervising authorized user.
c) A licensee shall require the supervised individual receiving,
possessing, using or transferring radioactive material under Section 335.30 of
this Part to:
1) Follow the instructions of the supervising authorized user;
2) Follow the procedures established by the Radiation Safety
Officer; and
3) Comply with this Part and 32 Ill. Adm. Code 310, 330, 340,
341, 400 and 401 and the license conditions with respect to the use of
radioactive material.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1060 AUTHORIZED USER AND VISITING AUTHORIZED USER
Section 335.1060 Authorized
User and Visiting Authorized User
a) A licensee shall assure that only authorized users of
radioactive material:
1) Select or establish written criteria for the selection of the
patients to receive radioactive material or radiation therefrom; and
2) Prescribe the radiopharmaceutical dosage or radiation dose to
be administered.
b) A licensee may permit any visiting authorized user to use
licensed material for medical use under the terms of the licensee's license for
up to 60 days each year without applying for a license amendment if:
1) The physician is licensed in accordance with the Medical
Practice Act of 1987;
2) The visiting authorized user has the prior written permission
of the licensee's management and, if the use occurs on behalf of an
institution, the institution's Radiation Safety Committee;
3) The licensee has a copy of a license issued by the Agency, the
U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State
that identifies the visiting authorized user by name as an authorized user; and
4) The visiting authorized user performs only those procedures
for which the visiting authorized user is specifically authorized by a license
described in subsection (b)(3).
c) A licensee shall retain copies of the records specified in
subsection (b) for 5 years.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1070 MOBILE NUCLEAR MEDICINE SERVICE ADMINISTRATIVE REQUIREMENTS (REPEALED)
Section 335.1070 Mobile
Nuclear Medicine Service Administrative Requirements (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1080 REPORT AND NOTIFICATION OF A MEDICAL EVENT
Section 335.1080 Report and
Notification of a Medical Event
a) A
licensee shall report any event as a medical event, except for an event that
results from patient intervention, in which:
1) The
administration of a radioactive material or radiation from radioactive
material, except permanent implant brachytherapy, results in:
A) 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
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.
B) 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 containing radioactive material or
the wrong radionuclide for a brachytherapy procedure;
ii) An
administration of a radioactive drug containing radioactive material by the
wrong route of administration;
iii) An
administration of a dose or dosage to the wrong individual or human research
subject;
iv) An
administration of a dose or dosage delivered by the wrong mode of treatment; or
v) A
leaking sealed source.
C) A dose
to the skin or an organ or tissue other than the treatment site that exceeds:
i) By
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) By
50 percent or more of 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.
2) For
permanent implant brachytherapy, the administration of radioactive material or
radiation from radioactive material (excluding sources that were implanted in
the correct site but migrated outside the treatment site) that results in:
A) 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;
B) 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
C) An administration that
includes any of the following:
i) The wrong
radionuclide;
ii) The
wrong individual or human research subject;
iii) Sealed
sources 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 by telephone the Agency no later
than the next calendar day after discovery of the medical event.
d) By an
appropriate method listed in 32 Ill. Adm. Code 310.110, the licensee shall
submit a written report to the Agency within 15 days after discovery of the
medical event.
1) The
written report shall include:
A) The
licensee's name;
B) The
name of the prescribing physician;
C) A brief
description of the event;
D) Why the
event occurred;
E) The
effect, if any, on the individual who received the administration;
F) What
actions, if any, have been taken or are planned to prevent recurrence; and
G) Certification
that the licensee notified the individual (or the individual's responsible
relative or guardian) and, if not, why not.
2) The
report may not contain the individual's name or any other information that
could lead to identification of the individual.
e) The
licensee shall provide notification of the event to the referring physician and
also notify the individual who is the subject of the medical event 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 medical event, because of any delay in notification. To meet the
requirements of this subsection, the notification of the individual who is the
subject of the medical event 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 medical event, or to those individuals' responsible relatives
or guardians.
g) A licensee shall:
1) Annotate a copy of the
report provided to the Agency with the:
A) Name of the individual
who is the subject of the event; and
B) Identification
number, or if no other identification number is available the social security
number, of the individual who is the subject of the event; and
2) Provide
a copy of the annotated report to the referring physician, if other than the
licensee, no later than 15 days after the discovery of the event.
h) A
licensee shall report to the Agency immediately upon discovery of any
irregularities pertaining to identification, labeling, quality or assay of any
radiopharmaceutical received under the authority of the license.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1090 MATERIALS AUTHORIZED FOR MEDICAL USE (REPEALED)
Section 335.1090 Materials
Authorized for Medical Use (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1100 REPORT AND NOTIFICATION OF A DOSE TO AN EMBRYO/FETUS OR A NURSING CHILD
Section 335.1100 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 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 of the child, as determined by a physician.
c) The
licensee shall notify by telephone the Agency no later than the next calendar
day after discovery of a dose to the embryo/fetus or nursing child that
requires a report in subsection (a) or (b).
d) The
licensee shall submit a written report to the Agency within 15 days after
discovery of a dose to the embryo/fetus or nursing child that requires a report
in subsection (a) or (b).
1) The
written report shall include:
A) The
licensee's name;
B) The
name of the prescribing physician;
C) A brief
description of the event;
D) Why the
event occurred;
E) The
effect, if any, on the embryo/fetus or the nursing child;
F) What
actions, if any, have been taken or are planned to prevent recurrence; and
G) 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 shall 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 provide notification of the event to the referring physician and
also notify the pregnant individual or mother, both hereafter referred to as
the mother, no later than 24 hours after discovery of an event that would
require reporting under subsection (a) or (b), unless the referring physician
personally informs the licensee either that he or she will inform the mother or
that, based on medical judgment, telling the mother would be harmful. The
licensee is not required to notify the mother without first consulting with the
referring physician. If the referring physician or mother cannot be reached
within 24 hours, the licensee shall make the appropriate notifications as soon
as possible thereafter. The licensee may not delay any appropriate medical care
for the embryo/fetus or for the nursing child, including any necessary remedial
care as a result of the event, because of any delay in notification. To meet
the requirements of this subsection (e), the notification may be made to the
mother's or child's responsible relative or guardian instead of the mother. 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 a written description if requested.
f) A licensee shall:
1) Annotate
a copy of the report provided to the Agency with the:
A) Name
of the pregnant individual or the nursing child who is the subject of the
event; and
B) Identification
number, or if no other identification number is available the social security
number, of the individual who is the subject of the event; and
2) Provide
a copy of the annotated report to the referring physician, if other than the
licensee, no later than 15 days after the discovery of the event.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1110 WRITTEN DIRECTIVES
Section 335.1110 Written Directives
a) A
written directive shall be dated and signed by an authorized user before the
administration of I-131 sodium iodide greater than 1.11 MBq (30 μCi), any
therapeutic dosage of unsealed radioactive material or any therapeutic dose of
radiation from radioactive material. 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 48 hours after the oral directive.
b) The
written directive shall contain the patient's or human research subject's name
and the following information:
1) For
any administration of quantities greater than 1.11 MBq (30 μCi) of sodium
iodide I-131, the dosage.
2) For
an administration of a therapeutic dosage of unsealed radioactive material
other than sodium iodide I-131, the radioactive drug, dosage and route of
administration.
3) For
gamma stereotactic radiosurgery, the total dose, treatment site, and values for
the target coordinate settings per treatment for each anatomically distinct
treatment site.
4) For
teletherapy, the total dose, dose per fraction, number of fractions and
treatment site.
5) For
high dose-rate remote afterloading brachytherapy, the radionuclide, treatment
site, dose per fraction, number of fractions and total dose.
6) For
permanent implant brachytherapy:
A) Before
implantation: the treatment site, the radionuclide, and the total source
strength; and
B) After
implantation but before the patient leaves the post-treatment recovery area:
the treatment site, the number of sources implanted, the total source strength
implanted, and the date; or
7) For
all other brachytherapy, including low, medium and pulsed dose rate remote
afterloaders:
A) Before
implantation: treatment site, the radionuclide and dose; and
B) After
implantation but before completion of the procedure: the radionuclide,
treatment site, number of sources, total source strength, and exposure time (or
the total dose) and date.
c) A
written revision to an existing written directive may be made if the revision
is dated and signed by an authorized user before the administration of the
dosage of unsealed radioactive material, the brachytherapy dose, the gamma
stereotactic radiosurgery dose, the teletherapy dose or the next fractional
dose. 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 48 hours after the oral revision.
d) A
licensee shall retain a copy of each written directive as required by
subsections (a) and (c) for 5 years.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.1120 PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE
Section 335.1120 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) At a minimum, the
procedures required by subsection (a) shall
address the following items that
are applicable to the licensee's use of radioactive material:
1) Verifying
the identity of the patient or human research subject;
2) Verifying
that the administration is 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 Section 335.2140 or 335.8010;
5) Determining
if a medical event, as described in Section 335.1080, has occurred;
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; and
7) Determining,
for administrations of I-131 in quantities greater than 1.11 MBq (30 μCi),
the criteria to be used to identify patients required to be tested for
pregnancy in accordance with subsection 335.5010(b), including type of
pregnancy testing permitted, time in advance of I-131 administration in which
the tests shall be conducted, age range of patients to be tested, and criteria
a physician may use to determine that a patient is not capable of childbirth.
c) A
licensee shall retain a copy of the procedures required by subsection (a) for
the duration of the license.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
SUBPART C: GENERAL TECHNICAL REQUIREMENTS
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2010 POSSESSION, USE AND CALIBRATION OF INSTRUMENTS USED TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIAL
Section 335.2010 Possession,
Use and Calibration of Instruments Used to Measure the Activity of Unsealed
Radioactive Material
a) For direct measurements performed in accordance with Section
335.2030, the licensee shall possess and use instrumentation to measure the activity
of unsealed byproduct material before it is administered to each patient or
human research subject.
b) A licensee shall calibrate the instrumentation required in
subsection (a) in accordance with nationally recognized standards or the
manufacturer's instructions.
c) A licensee shall maintain a record of instrument calibrations
required by subsection (b) for 5 years. The records shall include the model
and serial number of the instrument, the date of the calibration, the results
of the calibration, the name of the individual who performed the calibration
and a copy of the national standard or manufacturer's instructions used to
perform the calibration.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2020 POSSESSION, CALIBRATION AND CHECK OF SURVEY INSTRUMENTS (REPEALED)
Section 335.2020 Possession,
Calibration and Check of Survey Instruments (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2030 ASSAY OF RADIOPHARMACEUTICAL DOSAGES
Section 335.2030 Assay of
Radiopharmaceutical Dosages
a) A licensee shall determine and record the activity of each
dosage before medical use.
b) For
a unit dosage, this determination shall be made by:
1) Direct
measurement of radioactivity by the licensee; or
2) For
radiopharmaceuticals with a photon emitting radionuclide not requiring a
written directive, a decay correction based on the activity or activity
concentration determined by:
A) A
manufacturer or preparer authorized under Section 335.30 or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements; or
B) An
Agency, U.S. 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
C) A PET radioactive drug producer licensed under 32 Ill. Adm.
Code 330.260(c)(23) or the equivalent regulations of the U.S. Nuclear
Regulatory Commission or an Agreement State.
c) For other than unit
dosages, this determination shall be made by:
1) Direct
measurement of radioactivity by the licensee;
2) A
combination of measurement of radioactivity and mathematical calculations; or
3) A
combination of volumetric measurements and mathematical calculations based on
the measurement made by a manufacturer or preparer licensed under Section
335.30 or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements.
d) Unless
otherwise directed by the authorized user, a licensee may not use a dosage if
the dosage does not fall within the prescribed dosage range or if the dosage
differs from the prescribed dosage by more than 20 percent.
e) A
licensee shall maintain a record of dosage determinations required by
subsection (a) of this Section for 5 years.
f) The
record shall contain:
1) The
radiopharmaceutical;
2) The
patient's or human research subject's name, or identification number if one has
been assigned;
3) The
prescribed dosage, the determined dosage, or a notation that the total activity
is less than 1.1 MBq (30 mCi);
4) The
date and time of the dosage determination;
5) If
more than 15 minutes have elapsed between the time of dosage determination and
dosage administration, the date and time of dosage administration; and
6) The
name of the individual who determined the dosage.
AGENCY NOTE:
If a unit dose has been manipulated in any way, it is no longer considered a
unit dose and shall be measured by the licensee before administration.
(Source: Amended at 35 Ill.
Reg. 884, effective December 30, 2010)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2040 AUTHORIZATION FOR CALIBRATION, TRANSMISSION, ATTENUATION CORRECTION AND REFERENCE SOURCES
Section 335.2040
Authorization for Calibration, Transmission, Attenuation Correction and
Reference Sources
Any person authorized by Section
335.30 for medical use of radioactive material may receive, possess and use the
following radioactive material for check, calibration, transmission,
attenuation correction and reference use. Reference sources containing
radioactive material authorized under this Part shall not be used for medical
use except in accordance with the requirements in Section 335.6010. Sealed
sources shall not be combined (i.e. bundled or aggregated) to create an
activity greater than the maximum activity of any single sealed source
authorized under this Section. Sealed sources are authorized as follows:
a) Sealed sources not exceeding 1.11 GBq (30 mCi) each, manufactured
and distributed by a person licensed under 32 Ill. Adm. Code 330.280(k) or
equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations.
b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each,
redistributed by a licensee authorized to redistribute the sealed sources
manufactured and distributed by a person licensed under 32 Ill. Adm. Code
330.280(k) or equivalent U.S. Nuclear Regulatory Commission or Agreement State
regulations, providing the redistributed sealed sources are in the original
packaging and shielding and are accompanied by the manufacturer's approved
instructions.
c) Any radioactive material with a half-life not greater than 120
days in individual amounts not to exceed 0.56 GBq (15 mCi).
d) Any radioactive material with a half-life longer than 120 days
in individual amounts not to exceed the smaller of 7.4 MBq (200 mCi) or 1000 times the quantities in Appendix
B of 32 Ill. Adm. Code 330.
e) Technetium-99m in amounts as needed.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2050 REQUIREMENTS FOR POSSESSION OF SEALED SOURCES (REPEALED)
Section 335.2050
Requirements for Possession of Sealed Sources (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2060 LABELING AND USE OF VIALS AND SYRINGES
Section 335.2060 Labeling
and Use of Vials and Syringes
a) Each syringe and vial that contains unsealed radioactive
material shall be labeled to identify the radiopharmaceutical. Each syringe
shield and vial shield shall also be labeled unless the label on the syringe or
vial is visible when shielded.
b) A licensee shall use syringe radiation shields unless the use
of a shield is contraindicated for an individual patient.
AGENCY NOTE: The use of a syringe radiation shield could be
contraindicated if a patient presented a venous anatomy poorly suited for
venipuncture.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2070 VIAL SHIELDS AND VIAL SHIELD LABELS (REPEALED)
Section 335.2070 Vial
Shields and Vial Shield Labels (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2080 MONITORING FOR CONTAMINATION AND AMBIENT RADIATION DOSE RATE
Section 335.2080 Monitoring
for Contamination and Ambient Radiation Dose Rate
a) In addition to the monitoring required by 32 Ill. Adm. Code
340, the licensee shall measure with a radiation detection survey instrument
all areas where unsealed radioactive material was prepared for use or
administered at the end of use each day. However, the licensee does not need
to perform the monitoring required by this Section in areas where patients or
human research subjects are confined until release under Section 335.2110. The
instrument shall be operable and calibrated in accordance with the requirements
of 32 Ill. Adm. Code 340.510(b) and (c).
b) At least once each week, a licensee shall measure with a
radiation detection survey instrument all areas where radiopharmaceuticals or
radioactive wastes are stored to ensure compliance with 32 Ill. Adm. Code
340.210 and 340.310. The instrument shall be operable and calibrated in
accordance with the requirements of 32 Ill. Adm. Code 340.510(b) and (c).
c) At least once each week, a licensee shall measure for
removable contamination in all areas where unsealed radioactive materials are
prepared for use, administered or stored.
d) A licensee shall conduct the measurements required by subsections
(b) and (c) in a manner that permits detection of both external exposure rates
and removable contamination that would give rise to exposures in excess of the
limits specified in 32 Ill. Adm. Code 340.210 and 340.310.
e) A licensee shall retain a record of each survey required by
this Section for 5 years. The record shall include the monitoring date, a description
of each area monitored, the measurement results, the manufacturer, model and
serial number of the instruments, and the identity of the individual who
performed the monitoring.
AGENCY NOTE: For
the purposes of this Section, 2000 dpm (disintegrations per minute) per 100
square centimeters of surface area may be utilized as a sufficiently sensitive
detection limit for removable contamination unless the licensee has developed
alternate removable contamination limits which take into consideration the
unsealed radionuclides in use, their respective contribution to the dose limits
in 32 Ill. Adm. Code 340.210 and 340.310, and the detection capability of the
radiation detection survey instruments in use. Measurement of removable
contamination shall only be performed with a survey instrument, in lieu of
wipes, if the instrument is sufficiently sensitive to detect the contamination
at the limits specified in this Section.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2090 SAFETY INSTRUCTIONS FOR PATIENTS NOT HOSPITALIZED AND CONTAINING THERAPEUTIC DOSES OF RADIOPHARMACEUTICALS OR PERMANENT IMPLANTS (REPEALED)
Section 335.2090 Safety
Instructions for Patients Not Hospitalized and Containing Therapeutic Doses of
Radiopharmaceuticals or Permanent Implants (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2100 ADMISSION OF PATIENTS BEING TREATED WITH RADIOPHARMACEUTICALS OR PERMANENT IMPLANTS (REPEALED)
Section 335.2100 Admission
of Patients Being Treated with Radiopharmaceuticals or Permanent Implants (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2110 RELEASE OF INDIVIDUALS CONTAINING UNSEALED RADIOACTIVE MATERIAL OR IMPLANTS CONTAINING RADIOACTIVE MATERIAL
Section 335.2110 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 unsealed radioactive material 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) following assessment of the patient's medical, living
and working conditions.
AGENCY NOTE: U.S. Nuclear
Regulatory Commission Regulatory Guide 8.39, Rev. 1, "Release of Patients
Administered Radioactive Material", published April 2020, exclusive of
subsequent amendments or editions, 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) If the total effective dose equivalent to any other individual
is likely to exceed 1 mSv (0.1 rem), the licensee shall provide the released
individual and, as determined appropriate by the authorized physician user, the
individual's spouse, parent, guardian or other primary caregiver with verbal
and written instructions on actions recommended to maintain doses to other individuals
as low as is reasonably achievable. If the total effective dose equivalent to
a minor, pregnant individual or nursing infant or child could exceed 1 mSv (0.1
rem), assuming there were no interruptions of breast-feeding, the instructions
shall also include:
1) Guidance
on the interruption or discontinuation of breast-feeding;
2) Guidance
on minimizing close or extended contact; and
3) Information
on the potential consequences, if any, of failure to follow the guidance.
c) Release of the patient pursuant to this Section shall be
approved by an authorized physician user who is approved for the applicable use
of radioactive material under Subpart F or H. The authorized user physician
shall state in writing that he or she is satisfied that patient compliance with
necessary instructions is likely and that the patient is suitable for release.
d) A
licensee shall retain a record for five years after the release of the
individual for the following:
1) The
basis for authorizing the release of an individual in accordance with
subsections (a) and (b) of this Section to include the assessment and
evaluation criteria for the patient's medical, living and working conditions,
activities of radioactive material used (i.e., retained or administered
activity), occupancy factors, biological or effective half-life of radioactive
material, shielding by tissue, and means of estimating doses to any other
individual and the physicians.
2) The instructions for each patient required by subsection (b)
of this Section.
3) The
physician's certification for patient release required by subsection (c) of
this Section.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2120 MOBILE MEDICAL SERVICE REQUIREMENTS
Section 335.2120 Mobile Medical
Service Requirements
A licensee providing mobile medical
service shall:
a) Prior
to bringing radioactive material into a remote use location, obtain a letter,
signed by the management of the client for whom services are rendered, that
clearly delineates the authority and responsibility of the licensee and the
client and authorizes use of radioactive material at the client's address of
use.
b) Transport to each address of use only those syringes or vials
containing prepared radiopharmaceuticals or radiopharmaceuticals that are
intended for reconstitution of radiopharmaceutical kits.
c) Provide services in accordance with the client's specific
medical license, when providing services that the client is also authorized to
provide.
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 required by this subsection shall include a constancy
check.
e) Before releasing a use location for unrestricted use, monitor
all areas of use with a radiation detection survey instrument to ensure that
all radioactive materials and all associated radioactive wastes have been
removed.
AGENCY NOTE:
32 Ill. Adm. Code 340, Appendix A may be used as a guideline for this purpose.
f) Check survey instruments for proper operation with a dedicated
check source before use at each client's address.
g) Secure
or keep under constant surveillance and control all radioactive material when
in transit and at a location of use.
h) 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.
i) Retain
the letter required in subsection (a) of this Section and the record of
monitoring required in this Section in accordance with Section 335.2080(e) of
this Part.
j) Retain
a copy of each letter that permits the use of radioactive material at a client's
address as required by subsection (a) of this Section. Each letter must clearly
delineate the authority and responsibility of the licensee and the client and
shall be retained for 5 years after the last provision of service.
k) Retain
the record of monitoring required by subsection (e) of this Section for 5
years. The record shall include the monitoring date, an annotated diagram of
each area that was monitored, the measured dose rate at several points in each
area of use expressed in units, multiples or subunits of Sieverts (or rem) per
hour, the manufacturer, model and serial number of the instrument used to
perform the monitoring and the identity of the individual who performed the
monitoring.
l) Retain
a record of all dosages administered under the service's license for 5 years
after the date of administration. This record shall include the
radiopharmaceutical name, the clinical procedure, the activity administered,
the name of the authorized user, the date of administration and the identity of
the individual performing the administration.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2130 STORAGE OF VOLATILES AND GASES (REPEALED)
Section 335.2130 Storage of
Volatiles and Gases (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2140 OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL (EMERGING TECHNOLOGIES)
Section 335.2140 Other
Medical Uses of Radioactive Material or Radiation from Radioactive Material
(Emerging Technologies)
A licensee may use radioactive material or a radiation
source that is not specifically addressed in Subparts D through I, or if the
use is inconsistent with those Subparts, if:
a) The
licensee has submitted the information required by 32 Ill. Adm. Code 330.250
and any other necessary information consistent with 32 Ill. Adm. Code 330;
b) The
application contains at least the following:
1) A request signed by management that is consistent with the
requirements of 32 Ill. Adm. Code 340.310(b);
2) A
description of:
A) The
facilities, with a diagram;
B) The
necessary equipment and its calibration or maintenance; and
C) Training
and experience qualifications of the Radiation Safety Officer, Associate
Radiation Safety Officers, authorized users, authorized medical physicists, and
ophthalmic physicists, if not already previously submitted;
3) Procedures,
as applicable, that describe:
A) The
radionuclide, form and activity;
B) The
expected levels of contamination and the procedures to control them;
C) The
general safety precautions;
D) The
safety instructions to be provided to staff that are specific to the proposed
use; and
E) The
methodology for measurement of dosages or doses to be administered to patients
or human research subjects;
4) If applicable, a description of the sealed source and/or
device as per 32 Ill. Adm. Code 330.280(i) and (k), as applicable, or, alternately,
identification of the product in the Sealed Source and Device Registry.
c) In
addition to the requirements in subsection (b)(2), an application for a license
or amendment for medical use of radioactive material as described in this
Section shall also include information regarding any aspects of the medical use
of radioactive material that are applicable to radiation safety that is not
addressed in Subparts A through C.
d) The
applicant or licensee has provided any other information requested by the
Agency in its review of the application.
e) The
licensee has received written approval from the Agency in the form of a license
amendment and uses the material in accordance with the regulations and specific
conditions the Agency considers necessary for the safe use of the material.
AGENCY NOTE: The FDA accepted
protocols may be submitted as partial application towards the information
requested in this Section.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.2150 ADDITIONAL TECHNICAL REQUIREMENTS FOR INTRAVASCULAR BRACHYTHERAPY UNITS
Section 335.2150 Additional Technical Requirements for
Intravascular Brachytherapy Units
In addition to other provisions required by this Part, the
licensee authorized to use an intravascular brachytherapy unit for medical use
shall:
a) Have
a treatment team consisting of, at a minimum, an interventional cardiologist,
an authorized user and an authorized medical physicist and that, at a minimum,
an interventional cardiologist and an authorized user will be physically
present in the treatment suite during all radioactive procedures.
AGENCY NOTE: The requirements of
32 Ill. Adm. Code 401 regarding radiation therapists must also be met.
b) Independently
verify source strength and uniformity. Dwell time at the treatment location
must be monitored and recorded. Source uniformity or strength must not differ
by more that 10 percent of the expected values.
c) For
devices requiring additional shielding, demonstrate compliance with 32 Ill.
Adm. Code 340.210 and 340.310 requirements.
d) Inspect
sealed sources, source trains or ribbons before each use and ensure sources are
removed from service at intervals established by the manufacturer (i.e.,
confirm that source trains will not be used after the "use by" date,
at intervals not to exceed two months from the date of shipment, or when
evidence of degradation is observed, whichever comes first).
e) Inspect
and service devices containing sealed sources at intervals established by the
manufacturer, and ensure that maintenance and repair of the device is performed
only by the manufacturer or persons specifically authorized by the Agency, the
U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to
perform such service.
f) Prohibit
cuts, alterations or splicing of the sealed sources, source trains or ribbons,
except in situations involving an emergency where the source wire cannot be
returned to its normal safe position. If such cuts, alterations or splicing are
necessary, notification in accordance with Section 335.1080 or 32 Ill. Adm.
Code 340.1220 shall be made to the Agency.
g) Use
only manufacturer provided inducer sheaths, catheters and accessories to ensure
their demonstrated equivalents will be used with the devices.
h) Ensure
the daily operational checks will be performed prior to patient treatment. At
a minimum, they should include position verification, source uniformity, dwell
time function, indicator lamps and other status/operational displays, and
visual inspection for integrity of all applicators and catheters to be used for
the treatment.
i) Perform
tests following source or device exchange in accordance with the manufacturer's
instruction manual for:
1) Timer
accuracy/constancy, if appropriate;
2) Calibration
of the source output following the manufacturer's instructions; and
3) Interlock/interrupt
checks (i.e., interrupt test, cartridge lock test, emergency retraction test
and catheter connection test), if appropriate.
j) The
licensee shall retain a record of each item in subsections (b), (d), (e), (h)
and (i) for intravascular brachytherapy units for five years. The records shall
include:
1) The date of the
verification, inspection or check.
2) The
manufacturer's name, model and serial number of the intravascular brachytherapy
unit.
3) Results of the
verification, inspection or check.
4) Notations indicating
the operability of each component.
5) The identity of the
individual who performed the check.
(Source: Amended at 48 Ill. Reg. 13672,
effective August 29, 2024)
SUBPART D: UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND EXCRETION STUDIES – WRITTEN DIRECTIVE NOT REQUIRED
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.3010 USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED
Section 335.3010 Use of Unsealed Radioactive
Material for Uptake, Dilution and Excretion Studies for Which a Written
Directive is Not Required
Except for quantities that require a written directive under
subsection 335.1110(a), a licensee may use any unsealed radioactive material
prepared for medical use for uptake, dilution or excretion studies that is:
a) Obtained
from a person specified in Section 335.30, or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements; 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 in Section
335.9040, or a combination of Section 335.9050 and subsection 335.9040(c)(1)(B)(vii)
or an individual under the supervision of either as specified in Section
335.1050; or
c) Obtained
from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement
State licensee for use in research in accordance with a Radioactive Drug
Research Committee-approved protocol or an application or protocol accepted by
the FDA; or
d) Prepared
by the licensee for use in research in accordance with a Radioactive Drug
Research Committee-approved application or an application or a protocol
accepted by the FDA.
AGENCY NOTE: Participation in FDA
research trials involving human subjects does not relieve the licensee from
following all Agency regulations, whether or not they are included in the trial
protocols. This includes participation in trials using "blind"
research protocols.
(Source: Amended at 35 Ill.
Reg. 884, effective December 30, 2010)
SUBPART E: UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.4010 USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED
Section 335.4010 Use of Unsealed Radioactive
Material for Imaging and Localization Studies for Which a Written Directive is
Not Required
Except for quantities that require a written directive under
subsection 335.1110(a), a licensee may use any unsealed radioactive material
prepared for medical use for imaging and localization studies that is:
a) Obtained
from a person specified in Section 335.30 of this Part, or equivalent U.S.
Nuclear Regulatory Commission or Agreement State requirements; 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 Section 335.9040 or a combination of Section 335.9050 and subsection 335.9040(c)(1)(B)(vii)
or an individual under the supervision of either as specified in Section
335.1050; or
c) Obtained
from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement
State licensee for use in research in accordance with a Radioactive Drug
Research Committee-approved protocol or an application or protocol accepted by
the FDA; or
d) Prepared
by the licensee for use in research in accordance with a Radioactive Drug
Research Committee-approved application or an application or a protocol
accepted by the FDA.
(Source: Amended at 35 Ill.
Reg. 884, effective December 30, 2010)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.4020 PERMISSIBLE CONCENTRATIONS OF MOLYBDENUM-99, STRONTIUM-82 AND STRONTIUM-85
Section 335.4020 Permissible
Concentrations of Molybdenum-99, Strontium-82 and Strontium-85
a) A licensee shall not administer to humans a
radiopharmaceutical that contains more than:
1) 0.15
kBq of molybdenum-99 per MBq of technetium-99m (0.15µCi of molybdenum-99 per
mCi of technetium-99m);
2) 0.02
kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of
strontium-82 per mCi of rubidium-82); or
3) 0.2
kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 µCi of
strontium-85 per mCi of rubidium-82.
b) To demonstrate compliance with subsection (a), a licensee
shall measure:
1) The
concentration of molybdenum-99 in each eluate from a
molybdenum-99/technetium-99m generator; and
2) The
concentration of strontium-82 and strontium-85 before the first patient use of
the day on each day that a strontium-82/rubidium-82 generator is used.
c) A licensee shall maintain a record of the concentration tests
required by subsection (b) for 5 years. The record shall include for each
measurement, the time and date of the measurement, the name of the individual
who made the measurement and, for the corresponding measurement in subsection
(b):
1) The
ratio of the measure expressed as kBq of molybdenum per MBq of technetium-99m
(or µCi of molybdenum per mCi of technetium); or
2) The
ratios of the measures expressed as kBq of strontium-82 per MBq of rubidium-82
and kBq of strontium-85 per MBq of rubidium-82 (or µCi of strontium per mCi of
rubidium).
d) A licensee shall notify the Agency and the distributor of the
generator for each occurrence of a concentration exceeding the limits specified
in subsection (a) as follows:
1) Notification
by telephone within 7 days after the discovery that an eluate exceeded the
permissible concentration. The notification shall 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.
2) By an
appropriate method listed in 32 Ill. Adm. Code 310.110, the licensee shall
submit a written report to the Agency within 30 days after discovery that an
eluate exceeded the permissible concentration at the time of generator
elution. The written report shall 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 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 subsection (d)(1).
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.4030 CONTROL OF AEROSOLS AND GASES (REPEALED)
Section 335.4030 Control of
Aerosols and Gases (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
SUBPART F: UNSEALED RADIOACTIVE MATERIAL – WRITTEN DIRECTIVE REQUIRED
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.5010 USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED
Section 335.5010 Use of Unsealed
Radioactive Material for Which a Written Directive is Required
a) A licensee may use any unsealed radioactive material identified
in subsection 335.9050(b)(2)(F) prepared for medical use and for which a
written directive is required that is:
1) Obtained
from a person specified in Section 335.30 or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements;
2) 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 Section 335.9040, 335.9050, or an individual under the supervision of either
as specified in Section 335.1050; or
3) Obtained
from and prepared by an Agency, U.S. Nuclear Regulatory Commission or Agreement
State licensee for use in research in accordance with a protocol accepted by
FDA; or
4) Prepared
by the licensee for use in research in accordance with an application or a
protocol accepted by FDA.
b) Prior
to any administration of quantities greater than 1.11 MBq (30 μCi) of
sodium iodide I-131 to a patient capable of childbirth, the licensee shall
conduct a pregnancy test and obtain those results to determine pregnancy. If
the delay caused by conducting a pregnancy test would jeopardize the patient's
health, the test may be forgone provided that action is noted by the authorized
user on the written directive required by Section 335.1110. The written
directive must also indicate the patient was informed of the decision to forego
the pregnancy test or the reason for omission of the patient notification.
Nothing in this Section relieves the licensee from meeting the requirements of Section
335.1100 regarding reporting of exposures to a fetus/embryo.
c) Records
of the pregnancy test in subsection (b) shall contain the patient's name, identification
number if one has been assigned, the type of test performed, results of the
test, the date of the test, date the results became available if different from
the test date, and identity of the licensee's staff interpreting the test or,
as applicable, the determination by a physician that pregnancy test was not
required.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.5020 SAFETY INSTRUCTION
Section 335.5020 Safety
Instruction
In addition to the requirements of 32 Ill. Adm. Code
400.120:
a) A licensee shall provide radiation safety instruction, prior
to beginning work and at least annually, to personnel caring for patients or
human research subjects who have been administered radioactive materials
requiring a written directive. To satisfy this requirement, the instructions shall
be commensurate with the duties of the personnel and shall include:
1) Patient or human research subject control;
2) Visitor control, including:
A) Routine visitation to hospitalized individuals in accordance
with 32 Ill. Adm. Code 340.310(a)(1); and
B) Visitation authorized in accordance with 32 Ill. Adm. Code
340.310(c);
3) Contamination control;
4) Waste control; and
5) Notification of the Radiation Safety Officer or his or her
designee and the authorized user if the patient or the human research subject
has a medical emergency or dies.
b) A licensee shall maintain a record of safety instructions
required by this Section for 5 years. The record shall include a list of the
topics covered, the date of the instruction, the names of the attendees and the
names of the individuals who provided the instruction.
(Source: Amended at 35 Ill.
Reg. 884, effective December 30, 2010)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.5030 SAFETY PRECAUTIONS
Section 335.5030 Safety
Precautions
a) For each patient or human research subject who cannot be
released under Section 335.2110 of this Part, the licensee shall:
1) Perform radiation monitoring as required by 32 Ill. Adm. Code
340.510 for use in determining when the licensee shall supply appropriate
personnel with individual monitoring devices as required by 32 Ill. Adm. Code
340.520. Records of the radiation monitoring indicating the date and time of
the monitoring, an annotated diagram of the area and a list of points
monitored, the measured dose rate, the manufacturer, model and serial number of
the instrument used to perform the monitoring and the identity of the individual
who performed the monitoring shall be maintained for 5 years. This radiation
monitoring shall include, as a minimum, the dose rate in units, multiples or
subunits of Sieverts or rem per hour at:
A) The patient's bedside;
B) 1 meter from the patient;
C) The patient's hospital room door; and
D) Contiguous restricted and unrestricted areas. However,
radiation monitoring of adjoining rooms is not required if a calculation of the
dose rate to a patient in the adjoining room is made based on measurements
obtained pursuant to subsection (a)(1)(A) or (B) of this Section.
2) Prevent any patient who is not receiving radiopharmaceutical
therapy, but who is occupying a room that adjoins the room of a patient who is
receiving radiopharmaceutical therapy, to receive a dose greater than 1 mSv
(100 mrem) during the patient's entire stay from radiation emitted by any
therapy patient. The licensee shall verify compliance by performing radiation
surveys based on the monitoring required by subsection (a)(1) of this Section.
3) Prevent the placement of a therapy patient in the same room
with a patient who is not receiving radiopharmaceutical therapy unless the
licensee demonstrates, by monitoring or surveys, compliance with the
requirements of 32 Ill. Adm. Code 340.310 at a distance of 1 meter from the
therapy patient.
4) Provide each therapy patient's room with a private sanitary
facility.
5) Post the patient's door with a "Caution: Radioactive
Materials" sign. The posted sign shall indicate that pregnant women, or
women who suspect that they are pregnant, shall contact the attendant staff for
additional safety instructions or precautions. Also, a note shall appear on the
door and on the patient's chart which states where and how long visitors may
stay in the patient's room.
6) Authorize visits by individuals under age 18 only on a
patient-by-patient basis with the approval of the radiation therapy physician
after consultation with the Radiation Safety Officer.
7) Maintain and make available nursing instructions for the
attendant nursing staff that list any restrictions and instructions that shall
be followed regarding the care of therapy patients.
8) Either monitor all items removed from the patient's room to
determine that any contamination 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 other than a plastic
or cloth bag or handle all items removed from the patient's room as radioactive
waste.
9) Advise attendant nursing staff to notify the Radiation Safety
Officer or the radiation therapy physician immediately if the therapy patient
dies or has a medical emergency.
10) Monitor the patient's room and sanitary facility for
removable contamination. The room shall not be re-assigned until the
requirements of 32 Ill. Adm. Code 340.320 and 340.510 have been met.
b) The licensee shall implement the precautions required by subsections
(a)(1) through (10) of this Section until all of the requirements of Section
335.2110 of this Part can be met.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
SUBPART G: SEALED SOURCES FOR DIAGNOSIS
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.6010 USE OF SEALED SOURCES FOR DIAGNOSIS
Section 335.6010 Use of
Sealed Sources for Diagnosis
a) A licensee shall 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 shall be used in accordance with
the radiation safety conditions and limitations described in the Sealed Source
and Device Registry.
b) A licensee shall 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 shall 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 Section 335.35 are met.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
SUBPART H: MANUAL BRACHYTHERAPY
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7010 USE OF SEALED SOURCES FOR BRACHYTHERAPY
Section 335.7010 Use of
Sealed Sources for Brachytherapy
A licensee shall use only
brachytherapy sources for therapeutic medical uses:
a) That are:
1) Obtained from a person specified in Section 335.35, or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
and
2) 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) That are used 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 Section 335.35 are met.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7020 SAFETY INSTRUCTION
Section 335.7020 Safety
Instruction
In addition to the requirements of 32 Ill. Adm. Code
400.120:
a) The licensee shall provide radiation safety instruction, prior
to their assuming duties and at least annually, to personnel caring for patients
or human research subjects who are receiving brachytherapy and cannot be
released under Section 335.2110 of this Part. To satisfy this requirement, the
instructions must be commensurate with the duties of the personnel and include
the:
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:
A) Routine visitation of hospitalized individuals in accordance
with 32 Ill. Adm. Code 340.310(a)(1); and
B) Visitation authorized in accordance with 32 Ill. Adm. Code
340.310(c); 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
has a medical emergency or dies.
b) A licensee shall maintain a record of safety instructions
required by this Section for 5 years. The record must include a list of the
topics covered, the date of the instruction, the names of the attendees and the
names of the individuals who provided the instruction.
(Source: Amended
at 30 Ill. Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7030 SAFETY PRECAUTIONS
Section 335.7030 Safety
Precautions
a) For each patient or human research subject who is receiving
brachytherapy and cannot be released under Section 335.2110 of this Part, a
licensee shall:
1) Not
quarter the patient or the human research subject in the same room as an
individual who is not receiving brachytherapy;
2) Authorize
visits by individuals under age 18 only on a patient-by-patient basis with the
approval of the authorized user after consultation with the Radiation Safety
Officer;
3) Conspicuously
post the patient's or human research subject's room with a "Caution –
Radioactive Materials" sign bearing the radiation symbol;
4) 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; and
5) Note
on the door or in the patient's or human research subject's chart safety
instruction noted in Section 335.7020 of this Part.
b) A licensee shall have applicable emergency response equipment
available near each treatment room to respond to a source:
1) Dislodged
from the patient; and
2) Lodged
within the patient following removal of the source applicators.
c) A licensee shall 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 or dies.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7040 ACCOUNTABILITY AND SECURITY OF BRACHYTHERAPY SOURCES
Section 335.7040
Accountability and Security of Brachytherapy Sources
a) A licensee shall maintain security and accountability at all
times for all brachytherapy sources in storage or use.
b) As soon as possible after removing sources from a patient or a
human research subject, a licensee shall return brachytherapy sources to a
secure storage area.
c) A licensee shall maintain a record of brachytherapy source
accountability required by this Section for 5 years. The record must include:
1) For
temporary implants:
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; and
B) The
number and activity of sources returned to storage, the time and date they were
returned to storage and the name of the individual who returned them to
storage.
2) For
permanent implants:
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 not implanted, 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.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7050 DISCHARGE OF PATIENTS TREATED WITH TEMPORARY IMPLANTS (REPEALED)
Section 335.7050 Discharge
of Patients Treated With Temporary Implants (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7060 SURVEYS AFTER SOURCE IMPLANT AND REMOVAL
Section 335.7060 Surveys After Source Implant and
Removal
a) Immediately
after implanting sources in a patient or a human research subject, the licensee
shall monitor the area 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 monitor 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 maintain a record of the monitoring required by this Section for
5 years. The record shall include the monitoring date, the measured dose rate
at several points in each area, expressed in units, multiples or subunits of Sieverts
or rem per hour, the manufacturer, model and serial number of the survey
instrument used to perform the monitoring, and the identity of the person who
performed the monitoring.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7070 CALIBRATION MEASUREMENTS OF BRACHYTHERAPY SOURCES
Section 335.7070 Calibration Measurements of
Brachytherapy Sources
a) Before
the first medical use of a brachytherapy source, a licensee shall have:
1) Determined
the source output or activity using a dosimetry system that meets the
requirements of subsection 335.8080(a);
2) Determined
source positioning accuracy within applicators; and
3) Used
published protocols currently accepted by nationally recognized bodies to meet
the requirements of subsections (a)(1) and (a)(2). Copies of these protocols
shall be maintained on file by the licensee for 5 years after the
discontinuation of use of brachytherapy sources.
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 or other calibration laboratory approved by the Agency that are made
in accordance with subsection (a).
c) A
licensee shall mathematically correct the outputs or activities determined in
subsection (a) for physical decay at intervals consistent with 1 percent
physical decay.
d) A
licensee shall maintain a record of the calibrations of brachytherapy sources
required by this Section for 5 years after the last use of the source. The
record shall include the:
1) Date of
the calibration;
2) Manufacturer's
name, model number, and serial number for the source, and the instruments used
to calibrate the source;
3) Source
output or activity;
4) Source
positioning accuracy within the applicators; and
5) Name
of the individual, source manufacturer, or the calibration laboratory that
performed the calibration.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7080 DECAY OF BRACHYTHERAPY SOURCES
Section 335.7080 Decay of Brachytherapy Sources
a) Only
an authorized user qualified under Section 335.9100 or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements, or an authorized medical
physicist shall calculate the activity of each brachytherapy source that is
used to determine the treatment times for brachytherapy treatments. The decay
must be based on the activity determined under Section 335.7070 of this Part.
b) A
licensee shall maintain a record of the activity of all brachytherapy sources
required by this Section for the life of the source. The record must include:
1) The
manufacturer, model and serial number (or lot number for permanent implants) of
the sources;
2) The
date and initial activity of the source as determined under Section 335.7070 of
this Part; and
3) For
each decay calculation, the date and the source activity as determined under
this Section.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7090 THERAPY-RELATED COMPUTER SYSTEMS FOR MANUAL BRACHYTHERAPY
Section 335.7090 Therapy-related Computer Systems for
Manual Brachytherapy
The licensee shall:
a) Perform
acceptance testing on the treatment planning system of therapy-related computer
systems in accordance with published protocols accepted by nationally
recognized bodies. At a minimum, the acceptance testing must include, as
applicable, verification of:
1) The
source-specific input parameters required by the dose calculation algorithm;
2) The
accuracy of dose, dwell time, and treatment time calculations at representative
points;
3) The
accuracy of isodose plots and graphic displays; and
4) The
accuracy of the software used to determine sealed source positions from
radiographic images.
b) Maintain
a record of acceptance testing and copies of the protocols used for acceptance
testing in accordance with this Section for 5 years after discontinuation of
use of the treatment planning system.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.7100 STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS
Section 335.7100 Strontium-90 Sources for Ophthalmic
Treatments
Licensees who use strontium-90 for ophthalmic treatments
must ensure that certain activities as specified in subsection (c) are
performed by either:
a) An
authorized medical physicist; or
b) An
individual who:
1) is
identified as an ophthalmic physicist on a specific medical use license issued
by the Agency, U.S. Nuclear Regulatory Commission,
or Agreement State; a permit issued by the Agency, U.S.
Nuclear Regulatory Commission, or Agreement State broad scope
medical use licensee; a medical use permit issued by a U.S. Nuclear
Regulatory Commission master material licensee; or permit issued
by a U.S. Nuclear Regulatory Commission master material
licensee broad scope medical use permittee; and
2) 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
3) has
successfully completed one 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
4) Has
documented training in:
A) The
creation, modification, and completion of written directives;
B) Procedures
for administrations requiring a written directive; and
C) Performing
the calibration measurements of brachytherapy sources as detailed in Section
335.7070.
c) The
individuals who are identified in subsections (a) and (b) shall:
1) Calculate
the activity of each strontium-90 source that is used to determine the
treatment times for ophthalmic treatments. The decay shall be based on the
activity determined under Section 335.7070; 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 shall include the frequencies that the
individual meeting the requirements in subsection (a) or (b) 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.
d) Licensees
must retain a record of the activity of each strontium-90 source. The record
shall include:
1) The date and initial activity of
the source as determined under Section 335.7070; and
2) For each decay calculation, the
date and the source activity as determined under this section.
(Source: Added at 46 Ill. Reg. 966,
effective December 21, 2021)
SUBPART I: REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8010 USE OF A SEALED SOURCE IN REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS OR GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8010 Use of a
Sealed Source in Remote Afterloader Units, Teletherapy Units or
Gamma Stereotactic Radiosurgery Units
a) A
licensee shall only use sealed sources:
1) Obtained from a person specified in Section 335.35, or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
or
2) 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
3) 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 Section 335.35 are met.
b) A
licensee shall 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 U.S. Food and Drug
Administration provided the requirements of Section 335.35 are met.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8020 INSTALLATION, MAINTENANCE, ADJUSTMENT AND REPAIR RESTRICTIONS
Section 335.8020 Installation,
Maintenance, Adjustment and Repair Restrictions
a) Only a person specifically licensed by the Agency, the U.S.
Nuclear Regulatory Commission, an Agreement State or a Licensing State shall
install, maintain, adjust or repair a remote afterloader unit, intravascular
brachytherapy unit, teletherapy unit or gamma stereotactic radiosurgery unit
that involves work on the sources shielding, the sources driving unit or other
electronic or mechanical component that could expose the sources, reduce the
shielding around the sources, or compromise the radiation safety of the unit or
the sources.
b) Except
for a low dose-rate remote afterloader unit and intravascular brachytherapy
unit, only a person specifically licensed by the Agency, the U.S. Nuclear
Regulatory Commission, an Agreement State or a Licensing State shall install,
replace, relocate, or remove a sealed source or source contained in other
remote afterloader units, intravascular brachytherapy units, teletherapy units
or gamma stereotactic radiosurgery units.
c) For
a low dose-rate remote afterloader unit and intravascular brachytherapy unit,
only a person specifically licensed by the Agency, the U.S. Nuclear Regulatory
Commission, an Agreement State or a Licensing State or an authorized medical
physicist shall install, replace, relocate or remove a sealed source contained
in the unit.
d) A
licensee shall retain a record of the installation, maintenance, adjustment and
repair of remote afterloader units, intravascular brachytherapy units,
teletherapy units and gamma stereotactic radiosurgery units as required by this
Section for 5 years. For each installation, maintenance, adjustment and
repair, the record must include the date, description of the service, names of
the individuals who performed the work, and a copy of the specific license
authorizing the service.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8030 AMENDMENTS TO TELETHERAPY LICENSES (REPEALED)
Section 335.8030 Amendments
to Teletherapy Licenses (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8040 SAFETY PROCEDURES AND INSTRUCTIONS FOR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8040 Safety Procedures
and Instructions for Remote Afterloader Units, Teletherapy Units and Gamma
Stereotactic Radiosurgery Units
a) A licensee using sealed sources in remote afterloader units,
teletherapy units or gamma stereotactic radiosurgery units for therapeutic
medical uses shall:
1) Secure the unit, the console, the console keys and the
treatment room when not in use or unattended, if applicable;
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 or emergencies with the sources;
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 sources in the shielded
position, or remove the patient or human research subject from the radiation
field with controls from outside the treatment room. These procedures shall
include:
A) Instructions
for responding to equipment failures and the names of the individuals
responsible for implementing corrective actions;
B) The
process for restricting access to and posting of the treatment area to minimize
the risk of inadvertent exposure; and
C) 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 subsection (a)(4) and the
manufacturer's instruction manual shall be physically located at the unit
console.
c) A licensee shall post instructions at the unit console to
inform the operator of:
1) The
procedures located there as required by subsection (b); 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) Operational and Safety
Training
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, the
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) Initially
and at least annually, the licensee shall provide operational and safety
instructions to all individuals who operate the unit at the facility, as
appropriate to the individual's assigned duties, in:
A) The
procedures identified in subsection (a)(4); and
B) 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 the instruction required by subsection (d).
The record shall be retained for five years and include a list of the topics
covered, the date of the instruction, the names of the attendees and the names
of the individuals who provided instruction.
g) A
licensee shall retain a copy of the procedures required by subsections (a)(4)
and (d)(2)(B) until the licensee no longer possesses the remote afterloader,
teletherapy unit or gamma stereotactic radiosurgery unit.
h) A
licensee shall maintain a copy of the record documenting results of the drills
of emergency procedures required by subsection (e) for five years.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8050 SAFETY PRECAUTIONS FOR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8050 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 shall:
1) Prevent the operator from initiating the treatment cycle
unless each treatment room entrance door is closed;
2) Cause the sources to be shielded when an entrance door is
opened; and
3) Prevent the sources from being exposed following an interlock
interruption until all treatment room entrance doors are closed and the sources
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 that allow for expeditious removal of a decoupled or jammed source.
f) In
addition to the requirements specified in subsections (a) through (e) of this
Section, a licensee shall:
1) For medium
dose-rate and pulsed dose-rate remote afterloader units, require:
A) 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 of, and emergency response for, the unit to be physically present
during the initiation of all patient treatments involving the unit; and
B) 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 applicators 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 units, require:
A) An authorized
user and an authorized medical physicist to be physically present during the
initiation of all patient treatments involving the unit; and
B) 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/her designee, and an authorized user as
soon as possible if the patient or human research subject has a medical
emergency or dies.
g) A
licensee shall have applicable emergency response equipment available near each
treatment room to respond to a source:
1) Remaining
in the unshielded position; or
2) Lodged
within the patient following completion of the treatment.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8060 RADIATION MONITORING DEVICE FOR TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8060 Radiation
Monitoring Device for Teletherapy Units and Gamma Stereotactic
Radiosurgery Units
a) A licensee shall have in each teletherapy or gamma
stereotactic radiosurgery room a permanent radiation monitor capable of
continuously monitoring the status of the beam.
b) Each radiation monitor shall be capable of providing visible
indication of a teletherapy or gamma stereotactic radiosurgery unit malfunction
that results in an exposed or partially exposed source. The visible indicator
of high radiation levels shall be observable by an individual entering the
teletherapy or gamma stereotactic radiosurgery room.
c) Each radiation monitor shall be equipped with an auxiliary power
supply separate from the power supply to the teletherapy or gamma stereotactic
radiosurgery unit. This auxiliary power supply may be a battery system.
d) The radiation monitor shall be checked with a dedicated check
source for proper operation each day before the teletherapy or gamma
stereotactic radiosurgery unit is used for treatment of patients.
AGENCY NOTE:
Exposing the source and remotely viewing the instrument response is an
acceptable method for checking the monitor with a "dedicated check source".
e) A licensee shall maintain a record of the check required by
subsection (d) of this Section for 5 years. The record shall include the date
of the check, a notation that the monitor indicated when the source was exposed
and the identity of the individual who performed the check.
f) If the radiation monitor is inoperable, the licensee shall
require any individual entering the teletherapy or gamma stereotactic
radiosurgery room to use either a survey instrument or a personal dosimeter
with an audible alarm to monitor for any malfunction of the source exposure
mechanism that may result in an exposed or partially exposed source. The
instrument or dosimeter shall be checked with a dedicated check source for
proper operation at the beginning of each day of use. The licensee shall keep a
record as described in subsection (e) of this Section.
g) If the radiation monitor is inoperable, the licensee shall
take action within 24 hours to repair or replace the radiation monitor. At a
minimum, such action shall include the scheduling for the repair or replacement
of the inoperable monitor.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8070 VIEWING SYSTEM FOR TELETHERAPY (REPEALED)
Section 335.8070 Viewing
System for Teletherapy (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8080 DOSIMETRY EQUIPMENT
Section 335.8080 Dosimetry
Equipment
a) A licensee shall have a calibrated dosimetry system available
for use. To satisfy this requirement, one of the following two conditions shall
be met:
1) The system shall have been calibrated by the National Bureau
of Standards, by the National Institute of Standards and Technology or by a
calibration laboratory accredited by the American Association of Physicists in
Medicine (AAPM). The calibration shall have been performed within the previous
2 years and after any servicing that may have affected system calibration; or
2) The system shall have been calibrated within the previous 4
years; 18 to 30 months after that calibration, the system shall have been
compared with another dosimetry system that was calibrated within the past 24
months by the National Bureau of Standards, by the National Institute of
Standards and Technology or by a calibration laboratory accredited by the AAPM.
The dosimetry system shall be considered calibrated if a comparison is
performed at a meeting sanctioned by a calibration laboratory or radiological
physics center accredited by the AAPM and the results of the comparison
indicate that the calibration factor of the licensee's system has not changed
by more than two percent. The licensee shall not use the comparison result to
change the calibration factor. When comparing dosimetry systems to be used for
calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy
unit with a cobalt-60 source. When intercomparing dosimetry systems to be used
for calibrating sealed sources for therapeutic units, the licensee shall use a
comparable unit with beam attenuators or collimators, as applicable, and
sources of the same radionuclide as the source used at the licensee's facility.
b) The
licensee shall have available for use a calibrated dosimetry system for
spot-check measurements. To meet this requirement, the system may be compared
with a system that has been calibrated in accordance with subsection (a) of
this Section. This comparison shall have been performed within the previous
year and after each servicing that may have affected calibration of the
calibrated system. The spot-check system may be the same system used to meet
the requirements in subsection (a) of this Section.
c) The licensee shall retain a record of each calibration and
comparison for the duration of the license. For each calibration or comparison,
the record shall include the date, the manufacturer, the model and serial number
of the instruments that were calibrated or compared as required by subsections
(a) and (b) of this Section, the correction factors that were deduced, the
names of the individuals who performed the calibration or comparison and
evidence that the comparison meeting was sanctioned by a calibration laboratory
or radiological physics center accredited by AAPM.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8090 FULL CALIBRATION MEASUREMENTS FOR TELETHERAPY
Section 335.8090 Full
Calibration Measurements for Teletherapy
a) A licensee authorized to use a teletherapy unit for medical
use shall perform full calibration measurements as described in subsection (b) of
this Section, on each teletherapy unit:
1) Before the first medical use of the unit; and
2) Before medical use under the following conditions:
A) Whenever spot-check measurements indicate that the output
differs by more than five percent from the output obtained at the last full
calibration, corrected mathematically for radioactive decay;
B) Following replacement of the source or following reinstallation
of the teletherapy unit in a new location;
C) 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 subsection (a) of this Section,
full calibration measurements shall include determination of:
1) The output, within three 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 constancy 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 Section
335.8080 of this Part to measure the output for one set of exposure conditions.
The remaining radiation measurements required by subsection (b)(1) of this
Section may then be made using a dosimetry system that indicates relative dose
rates.
d) A licensee shall make full calibration measurements required
by subsection (a) of this Section in accordance with published protocols
accepted by nationally recognized bodies.
e) A licensee shall mathematically correct for physical decay the
outputs determined in subsection (b)(1) of this Section. These corrections
shall be for intervals not exceeding 1 month for cobalt-60 and intervals not
exceeding 6 months for cesium-137 or at intervals consistent with 1 percent
decay for all other nuclides.
f) Full calibration measurements required by subsection (a) of
this Section and physical decay corrections required by subsection (e) of this
Section shall be performed by an authorized medical physicist.
g) A licensee shall retain a record of each calibration for the
duration of the license. The record shall include the date of the calibration,
the manufacturer's name, model and serial numbers for both the teletherapy unit
and the source, the model and serial numbers of the instruments used to
calibrate the teletherapy unit, tables that describe the output of the unit
over the range of field sizes and for the range of distance used in radiation
therapy, a determination of the coincidence of the radiation field and the
field indicated by the light beam localizing device, an assessment of timer
constancy and linearity, the calculated on-off error, the determined accuracy
of each distance measuring or localization device and the signature or initials
of the authorized medical physicist.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8100 PERIODIC SPOT-CHECKS FOR TELETHERAPY
Section 335.8100 Periodic
Spot-Checks for Teletherapy
a) A licensee authorized to use teletherapy units for medical use
shall perform spot-checks on each teletherapy unit at intervals not to exceed 1
month.
b) To satisfy the requirement of subsection (a) of this Section,
spot-checks shall include the taking of measurements that permit the
determination of:
1) Timer constancy and 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 localization 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; and
6) The difference between the measurement made in subsection (b)(5)
of this Section and the anticipated output, expressed as a percentage of the
anticipated value obtained at the last full calibration corrected
mathematically for physical decay.
c) A licensee shall use the dosimetry system described in Section
335.8080 of this Part to make the measurement required in subsection (b)(5) of
this Section.
d) A licensee shall perform measurements required by subsection
(a) of this Section in accordance with written procedures established by the authorized
medical physicist. The authorized medical physicist does not need to actually
perform the spot-check measurements.
e) A licensee shall have the authorized medical physicist review
the results of each spot-check within 15 days. The authorized medical physicist
shall, within 15 days, notify the licensee in writing of the results of each
spot-check. The licensee shall keep a copy of each written notification for 5
years.
f) A licensee authorized to use a teletherapy unit for medical
use shall perform safety spot-checks of each teletherapy facility at intervals
not to exceed 1 month. To satisfy this requirement, checks shall 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 (i.e., restriction of source
housing angulation or elevation, carriage or stand travel, operation of the
beam on-off mechanism);
3) Beam condition indicator lights on the teletherapy unit, on
the control console and in the facility;
4) Viewing 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.
g) If the results of the checks required in subsection (f) of
this Section 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.
h) A licensee shall retain a record of each spot-check required
by subsections (a) and (f) of this Section for 5 years. The record shall
include the date of the spot-check, the model and serial number for both the
teletherapy unit and source, the model and serial number of the instrument used
to measure the output of the teletherapy unit, a determination of the
coincidence of the radiation field and the field indicated by the light beam
localizing device, an assessment of timer constancy and linearity, the
calculated on-off error, the determined accuracy of each distance measuring or
localization device, the difference between the anticipated output and the
measured output, notations indicating the operability of each entrance door
electrical interlock, each electrical or mechanical stop, each beam condition
indicator light, the viewing system and doors and the identity 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.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8110 RADIATION MONITORING
Section 335.8110 Radiation
Monitoring
a) In addition to the monitoring requirements in 32 Ill. Adm.
Code 340.510, a person licensed under this Subpart shall monitor to ensure that
the maximum radiation levels and average radiation levels from the surface of
the main source safe with the sources in the shielded position do not exceed
the levels stated in the Sealed Source and Device Registry.
b) The licensee shall monitor, as required by subsection (a) of
this Section, at installations 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, or compromise the radiation safety of the unit or the source.
c) A licensee shall maintain a record of the radiation monitoring
of treatment units made in accordance with this Section for the duration of use
of the unit. The record must include:
1) The date of the measurement;
2) The manufacturer's name, model 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.
(Source: Amended at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8120 SAFETY CHECKS FOR TELETHERAPY FACILITIES (REPEALED)
Section 335.8120 Safety
Checks for Teletherapy Facilities (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8130 MODIFICATION OF TELETHERAPY UNIT OR ROOM BEFORE BEGINNING A TREATMENT PROGRAM (REPEALED)
Section 335.8130
Modification of Teletherapy Unit or Room Before Beginning a Treatment Program
(Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8140 REPORTS OF TELETHERAPY MONITORING, CHECKS, TESTS AND MEASUREMENTS (REPEALED)
Section 335.8140 Reports of
Teletherapy Monitoring, Checks, Tests and Measurements (Repealed)
(Source: Repealed at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8150 FULL-INSPECTION SERVICING FOR TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8150 Full-Inspection
Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units
a) A licensee shall have each teletherapy unit and gamma
stereotactic radiosurgery unit fully inspected and serviced during each source
replacement to assure proper functioning of the source exposure mechanism and
other safety components. The interval between each full-inspection servicing
shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years
for each gamma stereotactic radiosurgery unit.
b) This inspection and servicing may only be performed by persons
specifically licensed to do so by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State.
c) A licensee shall maintain a record of the inspection and
servicing for teletherapy and gamma stereotactic radiosurgery units required by
this Section for the duration of use of the unit.
d) The record shall
contain:
1) The
inspector's radioactive materials license number;
2) The
date of the 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.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8160 FULL CALIBRATION MEASUREMENTS ON REMOTE AFTERLOADER UNITS
Section 335.8160 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:
A) Following
replacement of the source or following reinstallation of the unit in a new
location outside the facility;
B) 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 subsection (a) of this Section, full calibration
measurements shall 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;
4) Length
of the source transfer tubes;
5) Timer
accuracy and linearity over the typical range of use;
6) Length
of the applicators; and
7) Function
of the source transfer tubes, applicators and transfer tube-applicator
interfaces.
c) A
licensee shall use the dosimetry system described in subsection 335.8080(a) to
measure the output.
d) A
licensee shall make full calibration measurements required by subsection (a) of
this Section in accordance with published protocols accepted by nationally
recognized bodies.
e) In
addition to the requirements for full calibrations for low dose-rate remote
afterloader units in subsection (b) of this Section, a licensee shall perform
an autoradiograph of the sources to verify inventory and sources arrangement at
intervals not exceeding 1 quarter.
f) For
low dose-rate remote afterloader units, a licensee may use measurements
provided by the source manufacturer that are made in accordance with
subsections (a) through (e) of this Section.
g) A
licensee shall mathematically correct the outputs determined in subsection
(b)(1) of this Section for physical decay at intervals consistent with 1
percent physical decay.
h) Full
calibration measurements required by subsection (a) of this Section and
physical decay corrections required by subsection (g) of this Section shall be
performed by the authorized medical physicist.
i) A
licensee shall maintain a record of the remote afterloader unit full
calibrations required by this Section for 5 years.
j) The records
shall include for each full calibration required by subsection (a) of this
Section:
1) The
date of the calibration;
2) The
manufacturer's name, model and serial number of the remote afterloader unit, together
with the sources and the instruments used to calibrate it;
3) The
results and an assessment 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.
(Source: Amended at 35 Ill.
Reg. 884, effective December 30, 2010)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8170 PERIODIC SPOT-CHECKS FOR REMOTE AFTERLOADER UNITS
Section 335.8170
Periodic Spot-Checks for Remote Afterloader Units
a) A
licensee authorized to use a remote afterloader unit for medical use shall
perform spot-checks of each remote afterloader facility and on each unit:
1) Before
the first use of a high dose-rate, medium dose-rate or pulsed dose‑rate
remote afterloader unit on a given day;
2) Before
each patient treatment with a low dose-rate remote afterloader unit; and
3) After
each source installation.
b) A
licensee shall perform the measurements required by subsection (a) of this
Section in accordance with written 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 notify
the licensee as soon as possible in writing of the results of each spot-check.
d) To
satisfy the requirements of subsection (a) of this Section, 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
sources activity in the unit's computer.
e) If
the results of the checks required in subsection (d) of this Section indicate
the malfunction of any system, a licensee shall lock the control console in the
off position and not use the unit except as may be necessary to repair, replace
or check the malfunctioning system.
f) A
licensee shall retain a record of each spot-check for remote afterloader units
required by this Section for 5 years.
g) The record must include,
as applicable:
1) The
date of the spot-check;
2) The
manufacturer's name, model 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.
h) A
licensee shall retain a copy of the procedures required by subsection (b) of
this Section until the licensee no longer possesses the remote afterloader unit.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8180 MONITORING OF PATIENTS AND HUMAN RESEARCH SUBJECTS TREATED WITH A REMOTE AFTERLOADER UNIT OR INTRAVASCULAR BRACHYTHERAPY UNIT
Section 335.8180 Monitoring
of Patients and Human Research Subjects Treated with a Remote Afterloader Unit
or Intravascular Brachytherapy Unit
a) Before
releasing a patient or a human research subject from licensee control, a
licensee shall monitor the patient or the human research subject and the remote
afterloader or intravascular brachytherapy unit with a portable radiation
detection survey instrument to confirm that the sources have been removed from
the patient or human research subject and returned to the safe shielded
position.
b) A
licensee shall maintain a record of the monitors required by this Section for 5
years. Each record must include the date and results of the monitoring, the
manufacturer, model and serial numbers of the survey instrument used and the
name of the individual who performed the monitoring.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8190 FULL CALIBRATION MEASUREMENTS ON GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8190 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:
A) 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;
B) Following
replacement of the sources or following reinstallation of the gamma
stereotactic radiosurgery unit in a new location; and
C) 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 subsection (a) of this Section, 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 Section 335.8080(a) of
this Part to measure the output for one set of exposure conditions. The
remaining radiation measurements required in subsection (b)(1) of this Section
may be made using a dosimetry system that indicates relative dose rates.
d) A
licensee shall make full calibration measurements required by subsection (a) of
this Section in accordance with published protocols accepted by nationally
recognized bodies.
e) A
licensee shall mathematically correct the outputs determined in subsection
(b)(1) of this Section 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 subsection (a) of this Section and
physical decay corrections required by subsection (e) of this Section must be
performed by the authorized medical physicist.
g) A
licensee shall maintain a record of the gamma stereotactic radiosurgery unit
full calibrations required by this Section for 5 years.
h) The record must include:
1) The
date of the calibration;
2) The
manufacturer's name, model and serial number of the gamma stereotactic
radiosurgery units, the sources, and the instruments used to calibrate the
units;
3) The
results and an assessment of the full calibrations; and
4) The
signature of the authorized medical physicist who performed the full
calibration.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8200 PERIODIC SPOT-CHECKS FOR GAMMA STEREOTACTIC RADIOSURGERY UNITS
Section 335.8200
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) Before
the first use of the unit on a given day; and
3) After
each source installation.
b) A licensee shall:
1) Perform
the measurements required by subsection (a) of this Section in accordance with
written procedures established by the authorized medical physicist. That
individual need not actually perform the spot-check measurements.
2) 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.
c) To satisfy
the requirements of subsection (a)(1) of this Section, spot-checks must, at a
minimum:
1) Assure
proper operation of:
A) Treatment
table retraction mechanism, using backup battery power or hydraulic backups
with the unit off;
B) Helmet
microswitches;
C) Emergency
timing circuits; and
D) Stereotactic
frames and localizing devices (trunnions).
2) Determine:
A) The
output for one typical set of operating conditions measured with the dosimetry
system described in Section 335.8080(b) of this Part;
B) The
difference between the measurement made in subsection (c)(2)(A) of this Section
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);
C) Source
output against computer calculation;
D) Timer
accuracy and linearity over the range of use;
E) On-off
error; and
F) Trunnion
centricity.
d) To
satisfy the requirements of subsections (a)(2) and (a)(3) of this Section, 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 the repair of any system identified in subsection
(c) of this Section that is not operating properly as soon as possible.
f) If
the results of the checks required in subsection (d) of this Section indicate
the malfunction of any system, a licensee shall lock the control console in the
off position and not use the unit except as may be necessary to repair, replace
or check the malfunctioning system.
g) A
licensee shall retain a record of each spot-check for gamma stereotactic
radiosurgery units required by this Section for 5 years.
1) The record must
include:
A) The
date of the spot-check;
B) The
manufacturer's name, model and serial number for the gamma stereotactic
radiosurgery unit and the instrument used to measure the output of the unit;
C) An
assessment of timer linearity and accuracy;
D) The
calculated on-off error;
E) A determination
of trunnion centricity;
F) The
difference between the anticipated output and the measured output;
G) An
assessment of source output against computer calculations;
H) 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
I) 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.
2) A
licensee shall retain a copy of the procedures required by subsection (b) of
this Section until the licensee no longer possesses the gamma stereotactic
radiosurgery unit.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8210 ADDITIONAL TECHNICAL REQUIREMENTS FOR MOBILE REMOTE AFTERLOADER UNITS
Section 335.8210 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 Section 335.8170 of this Part,
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 subsection (b) of this Section, 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 subsections (b) and (c) of this Section
indicate the malfunction of any system, a licensee shall lock the control
console in the off position and not use the unit except as may be necessary to
repair, replace or check the malfunctioning system.
e) A
licensee shall retain a record of each check for mobile remote afterloader
units required by this Section for 5 years.
f) The record must include:
1) The
date of the check;
2) The
manufacturer's name, model 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, source transfer tubes, transfer tube applicator
interfaces, and source positioning accuracy; and
5) The
signature of the individual who performed the check.
(Source: Added at 30 Ill.
Reg. 9029, effective April 28, 2006)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8220 ADDITIONAL TECHNICAL REQUIREMENTS FOR INTRAVASCULAR BRACHYTHERAPY UNITS (REPEALED)
Section 335.8220 Additional Technical Requirements for
Intravascular Brachytherapy Units (Repealed)
(Source: Repealed at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.8230 THERAPY-RELATED COMPUTER SYSTEMS FOR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC UNITS
Section 335.8230 Therapy-related Computer Systems for
Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Units
The licensee shall perform acceptance testing on the
treatment planning system of therapy-related computer systems 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 sealed 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.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
SUBPART J: TRAINING AND EXPERIENCE REQUIREMENTS
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.9010 TRAINING FOR RADIATION SAFETY OFFICER AND ASSOCIATE RADIATION SAFETY OFFICER
Section 335.9010 Training
for Radiation Safety Officer and Associate Radiation Safety Officer
Except as provided in Section 335.9160,
the licensee shall require an individual fulfilling the responsibilities of the
Radiation Safety Officer or an individual assigned duties and tasks as an
Associate Radiation Safety Officer under the requirement in subsection 335.1040(b)
to be an individual who:
a) Is certified by a specialty board whose certification process
has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an
Agreement State and who meets the requirements described in subsection (f). To
have its certification process recognized, a specialty board shall require all
candidates for certification to meet the following requirements:
1) The candidate shall:
A) 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;
B) Have
five or more years of professional experience in health physics (graduate
training may be substituted for no more than two years of the required
experience) including at least three years in applied health physics; and
C) Pass
an examination administered by diplomates of the specialty board that 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) The candidate shall:
A) Hold
a master's or doctorate degree in physics, medical physics, other physical
science, engineering, or applied mathematics from an accredited college or
university;
B) Have
two years of full-time practical training 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 Commission or an Agreement State; or
ii) In
clinical nuclear medicine facilities providing diagnostic or therapeutic
services under the direction of physicians who meet the requirements for
authorized users in Sections 335.9040, 335.9050 or 335.9160; and
iii) Pass
an examination administered by diplomates of the specialty board that evaluates
knowledge and competence in clinical diagnostic radiological or nuclear
medicine physics and in radiation safety; or
b) Has successfully
completed a structured educational program consisting of both subsections
(b)(1) and (b)(2):
1) 200 hours of classroom and laboratory training in the following
areas:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity;
D) Radiation biology; and
E) Radiation dosimetry; and
2) One year of full-time radiation safety experience under the
supervision of the individual identified as the Radiation Safety Officer on an
Agency, U.S. Nuclear Regulatory Commission, or Agreement State license or
permit issued by a U.S. Nuclear Regulatory Commission master material licensee
that authorizes similar types and uses of radioactive material. An Associate
Radiation Safety Officer may provide supervision for those areas for which the
Associate Radiation Safety Officer is authorized on an Agency, U.S. Nuclear
Regulatory Commission, or Agreement State license or permit issued by a master
material licensee. The full-time radiation safety experience shall involve the
following:
A) Shipping,
receiving and performing related radiation monitoring;
B) Using
and performing checks for proper operation of instruments used to determine the
activity of dosages, instruments used to measure radionuclides and survey
meters;
C) Securing
and controlling radioactive material;
D) Using
administrative controls to avoid mistakes in the administration of radioactive
material;
E) Using
procedures to prevent or minimize radioactive contamination and using proper
decontamination procedures;
F) Using
emergency procedures to control radioactive material;
G) Disposing
of radioactive material; and
3) This
individual must obtain a written attestation, signed by a preceptor Radiation
Safety Officer or Associate Radiation Safety Officer who has experience with
the radiation safety aspects of similar types of use of radioactive material
for which the individual is seeking approval as a Radiation Safety Officer or
an Associate Radiation Safety Officer, that the individual has satisfactorily
completed the requirements in subsections (b)(1), (b)(2) and (f) 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) Is a
medical physicist who has been certified by a specialty board whose
certification process has been recognized by the Agency under subsection
335.9150(a) or the U.S. Nuclear Regulatory Commission or an Agreement State and
has experience with the radiation safety aspects of similar types of use of radioactive
material for which approval of the individual as Radiation Safety Officer or
Associate Radiation Safety Officer is sought and meets the requirements in
subsection (f); or
d) Is an authorized user, authorized medical physicist, or
authorized nuclear pharmacist identified on an Agency, U.S. Nuclear Regulatory
Commission, or Agreement State license, a permit issued by a U.S. Nuclear
Regulatory Commission master material licensee, a permit issued by an Agency,
U.S. Nuclear Regulatory Commission, or an Agreement State licensee of broad
scope, or a permit issued by a U.S. Nuclear Regulatory Commission master
material license broad scope permittee; has experience with the radiation
safety aspects of similar types of use of radioactive material for which the licensee
seeks the approval of the individual as Radiation Safety Officer or an
Associate Radiation Safety Officer; and meets the requirements in subsection (f);
or
e) Has experience with the radiation safety aspects of the types
of use of radioactive material for which the individual is seeking simultaneous
approval both as the Radiation Safety Officer and the authorized user on the
same new medical use license or new medical use permit issued by a U.S. Nuclear
Regulatory Commission master material licensee. The individual must also meet
the requirements in paragraph (f) of this Section.
f) Has received
training in radiation safety, regulatory issues and emergency procedures for
the types of use for which approval is sought. This training requirement may
be satisfied by completing training that is supervised by a Radiation Safety
Officer, Associate Radiation Safety Officer, authorized medical physicist,
authorized nuclear pharmacist, or authorized user, as appropriate, who is
authorized for the types of use for which the licensee is seeking approval.
AGENCY NOTE: Specialty boards
whose certification processes have been recognized by the Agency, the U.S.
Nuclear Regulatory Commission, or an Agreement State will be posted on the
NRC's website.
(Source: Amended at 48 Ill.
Reg. 13672, effective August 29, 2024)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.9020 TRAINING FOR EXPERIENCED RADIATION SAFETY OFFICER (REPEALED)
Section 335.9020 Training
for Experienced Radiation Safety Officer (Repealed)
(Source: Repealed at 27 Ill.
Reg. 10057, effective June 30, 2003)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.9030 TRAINING FOR UPTAKE, DILUTION OR EXCRETION STUDIES
Section 335.9030 Training
for Uptake, Dilution or Excretion Studies
Except as provided in Section
335.9160, a licensee shall require the authorized user of unsealed radioactive
material for the uses authorized under Section 335.3010 not requiring a written
directive to be a physician who:
a) Is certified by a medical specialty board whose certification
process has been recognized by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State. To have its certification process
recognized, a specialty board shall require all candidates for certification to
meet the following requirements:
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 subsections
(c)(1) and (2); and
2) Pass
an examination administered by diplomates of the specialty board, that evaluates
knowledge and competence in radiation safety, radionuclide handling and quality
control; or
b) Is an
authorized user who meets the requirements of Section 335.9040 or 335.9050 or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
or
c) Has successfully completed a structured educational program
consisting of:
1) 60 hours of training and experience, including a minimum of 8
hours of classroom and laboratory training, in basic radionuclide handling
techniques applicable to the medical use of unsealed radioactive material for
uptake, dilution and excretion studies. The classroom and laboratory training
shall include, at a minimum:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity;
D) Chemistry of radioactive material for medical use;
E) Radiation biology; and
2) Work experience under the supervision of an authorized user
who meets the requirements in this Section, Section 335.9040, 335.9050 or
335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements involving:
A) Ordering,
receiving, and unpacking radioactive materials safely and performing the
related radiation monitoring;
B) Performing
quality control procedures on instruments used to determine the activity of
dosages and performing checks for proper operation of survey instruments;
C) Calculating,
measuring and safely preparing patient or human research subject dosages;
D) Using
administrative controls to prevent a medical event involving the use of
unsealed radioactive material;
E) Using
procedures to contain spilled radioactive material safely and using proper
decontamination procedures; and
F) Administering
dosages of radioactive drugs to patients or human research subjects; and
3) Has
obtained written attestation that the individual has satisfactorily completed
the requirements in subsection (c) and is able to independently fulfill the
radiation safety-related duties as an authorized user for the medical uses
authorized by Section 335.3010. The attestation shall be obtained from either:
A) A
preceptor authorized user who meets the requirements in this Section or Section
335.9040, 335.9050 or 335.9160, or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements; or
B) A
residency program director who affirms in writing that the attestation
represents the consensus of the residency program faculty where at least one
faculty member is an authorized user who meets the requirements in this
Section, Sections 335.9040, 335.9050 or 335.9160, or equivalent Agreement State
requirements, and concurs with the attestation provided by the residency
program director. The residency training program shall 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 shall
include training and work experience specified in subsections (c)(1) and
(c)(2).
AGENCY NOTE: Specialty boards
whose certification processes have been recognized by the Agency, the U.S.
Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's
website.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.9040 TRAINING FOR IMAGING AND LOCALIZATION STUDIES
Section 335.9040 Training
for Imaging and Localization Studies
Except as provided in Section
335.9160, a licensee shall require the authorized user of unsealed radioactive
material for the uses authorized under Section 335.4010 not requiring a written
directive to be a physician who:
a) Is certified by a medical specialty board whose certification
process has been recognized by the Agency, the U.S. Nuclear Regulatory
Commission, or an Agreement State. To have its certification process
recognized, a specialty board shall require all candidates for certification to
meet the following requirements:
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 subsection (c);
and
2) Pass
an examination administered by diplomates of the specialty board, that evaluates
knowledge and competence in radiation safety, radionuclide handling and quality
control; or
b) Is an
authorized user who meets the requirements of Section 335.9050 and meets the
requirements in subsection (c)(1)(B)(vii) or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements; or
c) Has successfully completed 700 hours of training and
experience, including 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.:
1) The
training and experience shall include at a minimum:
A) 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
B) Work
experience under the supervision of an authorized user who meets the
requirements in this Section, Section 335.9160 or Section 335.9050, together
with subsection (c)(1)(B)(vii), or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements, involving:
i) Ordering,
receiving and unpacking radioactive materials safely and performing the related
radiation monitoring;
ii) Performing
quality control procedures on instruments used to determine the activity of
dosages and performing checks for proper operation of survey instruments;
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 of radioactive drugs to patients or human research subjects;
vii) Eluting
generator systems appropriate for preparation of radioactive drugs for imaging
and localization studies, measuring, and testing the eluate for radionuclidic
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 described in subsection (c)(1) and is able to independently
fulfill the radiation safety-related duties as an authorized user for the
medical uses authorized under Sections 335.3010 and 335.4010. The attestation
shall be obtained from either:
A) A
preceptor authorized user who meets the requirements in this Section, Section
335.9160 or Section 335.9050 together with subsection (c)(1)(B)(vii) or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
or
B) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty where at
least one faculty member is an authorized user who meets the requirements in
this Section, Section 335.9160 or Section 335.9050, together with subsection
(c)(1)(B)(vii) or equivalent U.S. Nuclear Regulatory Commission or Agreement
State requirements, and concurs with the attestation provided by the residency
program director. The residency training program shall 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 shall
include training and experience specified in subsections (c) and (c)(1).
AGENCY NOTE:
Specialty boards whose certification processes have been recognized by the
Agency, the U.S. Nuclear Regulatory Commission or an Agreement State will be
posted on the NRC's website.
(Source: Amended at 46 Ill.
Reg. 966, effective December 21, 2021)
| TITLE 32: ENERGY
CHAPTER II: ILLINOIS EMERGENCY MANAGEMENT AGENCY AND OFFICE OF HOMELAND SECURITY
SUBCHAPTER b: RADIATION PROTECTION
PART 335
MEDICAL USE OF RADIOACTIVE MATERIAL
SECTION 335.9050 TRAINING FOR USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED
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