Section
335.1010 ALARA Program
335.1020 Radiation Safety Officer
335.1030 Radiation Safety Committee
335.1040 Statement of Authorities and Responsibilities
335.1050 Supervision
335.1060 Authorized User and Visiting Authorized User
335.1070 Mobile Nuclear Medicine Service Administrative Requirements
335.1080 Notifications, Reports, and Records of Reportable Events
335.1090 Materials Authorized for Medical Use
SUBPART C: General Technical Requirements
Section
335.2010 Possession, Use, Calibration and Check of Dose Calibrators
335.2020 Possession, Calibration and Check of Survey Instruments
335.2030 Assay of Radiopharmaceutical Dosages
335.2040 Authorization for Calibration and Reference Sources
335.2050 Requirements for Possession of Sealed Sources
335.2060 Syringe Shields and Syringe Shield Labels
335.2070 Vial Shields and Vial Shield Labels
335.2080 Surveys for Contamination and Ambient Radiation Dose Rate
335.2090 Safety Instructions for Patients Not Hospitalized and Containing
Therapeutic Doses of Radiopharmaceuticals or Permanent Implants
335.2100 Admission of Patients Being Treated with Radiopharmaceuticals or
Permanent Implants
335.2110 Discharge of Patients Being Treated with Therapeutic Doses of
Radiopharmaceuticals or Permanent Implants
335.2120 Mobile Nuclear Medicine Service Technical Requirements
335.2130 Storage of Volatiles and Gases
SUBPART D: Uptake, Dilution and Excretion
Section
335.3010 Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion
Studies
SUBPART E: Imaging and Localization
Section
335.4010 Use of Radiopharmaceuticals, Generators and Reagent Kits for Imaging
and Localization Studies
335.4020 Permissible Molybdenum-99 Concentration
335.4030 Control of Aerosols and Gases
SUBPART F: Radiopharmaceuticals for Therapy
Section
335.5010 Use of Radiopharmaceuticals for Therapy
335.5020 Safety Instruction
335.5030 Safety Precautions for Radiopharmaceutical Therapy
SUBPART G: Sealed Sources for Diagnosis
Section
335.6010 Use of Sealed Sources for Diagnosis
SUBPART H: Sealed Sources for Brachytherapy
Section
335.7010 Use of Sealed Sources for Brachytherapy
335.7020 Safety Instruction
335.7030 Safety Precautions
335.7040 Accountability of Brachytherapy Sources
335.7050 Discharge of Patients Treated With Temporary Implants
SUBPART I: Teletherapy
Section
335.8010 Use of a Sealed Source in a Teletherapy Unit
335.8020 Maintenance and Repair Restrictions
335.8030 Amendments to Teletherapy Licenses
335.8040 Safety Instructions for Teletherapy
335.8050 Doors, Interlocks and Safety Related Systems
335.8060 Radiation Monitoring Device for Teletherapy
335.8070 Viewing System for Teletherapy
335.8080 Teletherapy Dosimetry Equipment
335.8090 Full Calibration Measurements for Teletherapy
335.8100 Periodic Spot-Checks for Teletherapy
335.8110 Radiation Surveys for Teletherapy Facilities
335.8120 Safety Checks for Teletherapy Facilities
335.8130 Modification of Teletherapy Unit or Room Before Beginning a
Treatment Program
335.8140 Reports of Teletherapy Surveys, Checks, Tests and Measurements
335.8150 Five-year Teletherapy Inspection
SUBPART J: Training and Experience Requirements
Section
335.9010 Radiation Safety Officer
335.9020 Training for Experienced Radiation Safety Officer
Section
335.9030 Training for Uptake, Dilution, or Excretion Studies
335.9040 Training for Imaging and Localization Studies
335.9050 Training for Therapeutic Use of Radiopharmaceuticals
335.9060 Training for Treatment of Hyperthyroidism
335.9070 Training for Treatment of Thyroid Carcinoma
335.9080 Training for Therapeutic Use of Soluble Phosphorus-32
335.9090 Training for Therapeutic Use of Colloidal Chromic Phosphorus-32
Labeled Phosphate Compound or Gold-198
335.9100 Training for Use of Sources for Brachytherapy
335.9120 Training for Ophthalmic Use of Strontium-90
335.9130 Training for Use of Sealed Sources for Diagnosis
335.9140 Training for Teletherapy
335.9150 Training for Teletherapy Physicist
335.9160 Training for Experienced Authorized Users
335.9170 Physician Training in a Three Month Program
335.9180 Recentness of Training
335.9190 Resolution of Conflicting Requirements During Transition Period
AUTHORITY: Implementing and authorized by the Radiation Protection Act of 1990
(Ill. Rev. Stat. 1990 Supp., ch. 111�, pars. 210-1 et seq.).
SOURCE: Adopted at 15 Ill. Reg. 10763, effective July 15, 1991.
SUBPART A: General Information
Section 335.10 Purpose and Scope
This Part establishes requirements for the use of radionuclides in the healing
arts and for issuance of licenses authorizing the medical use of this material.
These requirements provide for the protection of the public health and safety.
The requirements of this Part are in addition to, and not in substitution for,
others in 32 Ill. Adm. Code: Chapter II, Subchapter b. The requirements of 32
Ill. Adm. Code: Chapter II, Subchapter b apply to applicants and licensees
subject to this Part unless specifically exempted.
Section 335.20 Definitions
"ALARA program" means a program designed to maintain effluents to
unrestricted areas, occupational doses, and doses to the general
public as low as is reasonably achievable.
"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.
"As low as is reasonably achievable or 'ALARA'" means as low as is
reasonably achievable taking into account the state of technology,
and the costs of improvements in relation to benefits to the public
health and safety, and other societal and socioeconomic
considerations, and in relation to the use of ionizing radiation in
the public interest.
"Authorized user" means an individual who is identified as being
authorized to use radioactive material on a Department of Nuclear
Safety (Department), Agreement State, Licensing State, or U.S.
Nuclear Regulatory Commission license.
"Brachytherapy" means a method of radiation therapy in which sealed
sources are used to deliver a radiation dose at a distance of less
than 6 centimeters (cm), by surface, intracavitary, or interstitial
application.
"Calculated weekly administered dose" means the portion of the
calculated administered dose received by the patient in 7
consecutive days.
"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.
"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.
"Dedicated check source" means a radioactive source, with a half-
life greater than 5 years, that is used to assure the constant
operation of a radiation detection or measurement device.
"Diagnostic clinical procedures manual" means a collection of
written procedures that describes each method (and other
instructions and precautions) by which the licensee performs
diagnostic clinical procedures. Each diagnostic clinical procedure
included in this manual must be approved by the authorized user and
must include the radiopharmaceutical, dosage, and route of
administration.
"Licensed practitioner of the healing arts" means a person licensed
under the Medical Practice Act of 1987 (Ill. Rev. Stat. 1989, ch.
111, par. 4400-1 et seq.), The Illinois Dental Practice Act (Ill.
Rev. Stat. 1989, ch. 111, par. 2301 et seq.), or the Podiatric
Medical Practice Act of 1987 (Ill. Rev. Stat. 1989, ch. 111, par.
4801 et seq.).
"Management" means the chief executive officer or that individual's
designee.
"Medical institution" means:
An organization, other than a medical clinic, private medical
practice, or mobile nuclear medicine service, that holds a
specific license issued by the Department and that practices
more than two medical disciplines; or
A medical clinic, private practice, or mobile nuclear medicine
service that holds a specific license issued by the Department
and is authorized under Sections 335.5010, 335.7010, or
335.8010 to use radioactive material.
"Medical use" means the intentional internal or external
administration of radioactive material, or the radiation therefrom,
to humans in the practice of the healing arts.
"Output" means the exposure rate, dose rate, or a quantity related
in a known manner to these rates from a teletherapy unit for a
specified set of exposure conditions.
"Personal participation in a complete case" means performing or
observing all the steps required to perform a clinical procedure on
a patient under the supervision of an authorized user. This means
selection and preparation of the radiopharmaceutical, calculation,
measurement, and administration of the dosage or dose, operation of
all the equipment used during the clinical procedure, collection and
manipulation of the raw data, performing or observing the patient
examination, case history review, determination of suitability for
radionuclide diagnosis, interpretation of the results, and follow-up
for the case. For purposes of meeting training requirements, mere
interpretation of the results does not constitute personal
participation in a case.
"Personally performing a complete case" means performing all the
steps required to perform a clinical procedure on a patient. This
means selection and preparation of the radiopharmaceutical,
calculation, measurement, and administration of the dosage or dose,
operation of all the equipment used during the clinical procedure,
collection and manipulation of the raw data, performing or observing
the patient examination, case history review, determination of
suitability for radionuclide diagnosis, interpretation of the
results, and follow-up for the case. For purposes of meeting
training requirements, mere interpretation of the results does not
constitute personal performance in a case.
"Prescribed dosage" means the radiopharmaceutical activity as
documented:
in a written directive, or
either in the diagnostic clinical procedures manual for
diagnostic procedures, or as otherwise directed by the
authorized user for diagnostic procedures.
"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; or
for brachytherapy, either the total dose or the total source
strength and exposure time, as documented in the written
directive.
"Recordable event" means the administration of:
radioactive material or radiation therefrom without a written
directive by a procedure listed in the definition of the term
"written directive";
radioactive material or radiation therefrom pursuant to a
written directive without daily recording the administered
radiation dose or radiopharmaceutical dosage;
a therapeutic radiopharmaceutical dosage, other than I-125 or
I-131 as sodium iodide, when the administered dosage differs
from the prescribed dosage by more than 10 percent of the
prescribed dosage;
a radiopharmaceutical procedure involving greater than 30 uCi
(1.11 MBq) of I-125 or I-131 as sodium iodide, when both the
administered dosage differs from the prescribed dosage by more
than 10 percent of the prescribed dosage, and the difference
between the administered dosage and prescribed dosage exceeds
15 uCi (555 kBq);
a teletherapy radiation dose when the calculated weekly
administered dose is 15 percent greater then the weekly
prescribed dose; or
a brachytherapy radiation dose when the calculated
administered total dose differs from the prescribed dose by
more than 10 percent of the prescribed dose.
"Reportable event" means the administration of:
a therapeutic radiopharmaceutical dosage other than I-125 or
I-131 as sodium iodide:
involving the wrong patient, wrong radiopharmaceutical,
the wrong route of administration; or
when the administered dosage differs from the prescribed
dosage by more than 20 percent of the prescribed dosage;
a radiopharmaceutical dosage in quantities greater than 30 uCi
(1.11 MBq) of I-125 or I-131 as sodium iodide:
involving the wrong patient, wrong radiopharmaceutical,
the wrong route of administration; or
when both the total administered dosage differs from the
prescribed dosage by more than 20 percent of the
prescribed dosage, and the difference between the
administered dosage and prescribed dosage exceeds 30 uCi
(1.11 MBq);
a gamma stereotactic radiosurgery radiation dose:
involving the wrong patient or wrong treatment site; or
when the calculated total administered dose differs from
the total prescribed dose by more than 10 percent of the
total prescribed dose;
a teletherapy radiation dose:
involving the wrong patient, wrong treatment modality,
the wrong treatment site;
when the treatment consists of three or fewer fractions
and the calculated total administered dose differs from
the total prescribed dose by more than 10 percent of the
total prescribed dose;
when the calculated weekly administered dose is 30
percent greater than the weekly prescribed dose; or
the calculated total administered dose differs from the
prescribed dose by more than 20 percent of the
prescribed dose;
a brachytherapy radiation dose:
involving the wrong patient, wrong radioisotope, or the
wrong treatment site (excluding, for permanent implants,
seeds that were implanted in the correct site but
migrated outside the treatment site);
involving a sealed source that is leaking;
when, for a temporary implant, one or more sealed
sources are not removed upon completion of the
procedure; or
when the calculated total administered dose differs from
the prescribed dose by more than 20 percent of the
prescribed dose;
a diagnostic radiopharmaceutical dosage, other than I-125 or
I-131 in quantities greater than 30 uCi (1.11 MBq) of I-125 or
I-131 as sodium iodide, both:
involving the wrong patient, the wrong pharmaceutical,
the wrong route of administration, or the wrong
radiopharmaceutical dosage; and
when the dose to the patient exceeds 5 rem (50 mSv)
effective dose equivalent or 50 rem (500 mSv) dose
equivalent to any individual organ.
"Supervised clinical experience" means performing specified tasks in
the clinical setting during the work day. Supervised clinical
experiences provide the student with the medical knowledge and
facility necessary to assure that clinical procedures will be of
benefit to the patient. It is provided in the clinic, as contrasted
to the classroom, because that is the most efficient way to provide
the instruction. However, continuing education courses, seminars,
journal clubs, and other methods of clinical instruction may
comprise up to 20% of this training and experience.
"Supervised handling experience" means performing specified tasks
with equipment in the clinical setting during the work day. It is
required so that the student will develop facility in performing
those tasks in the work setting, as contrasted to the classroom and
laboratory setting. This is usually accomplished during the
"supervised clinical experience" period.
"Teletherapy" means a method of radiation therapy in which the
source of radiation is at a distance of 6 cm or more from the area
being treated.
"Teletherapy physicist" means the individual identified as the
teletherapy physicist on a radioactive material license.
"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).
"Weekly prescribed dose" means the portion of the prescribed dose to
be delivered in 7 consecutive days.
"Written directive" means a written order for a specific patient,
dated and signed by an authorized user prior to the administration
of a radiopharmaceutical or radiation except as authorized under
"all other brachytherapy" below, containing the following
information:
therapeutic administration of a radiopharmaceutical other than
I-125 or I-131 as sodium iodide: the radiopharmaceutical,
dosage, and route of administration;
any administration of I-125 or I-131 as sodium iodide
involving quantities greater than 30 uCi (1.11 MBq): the
dosage;
gamma stereotactic radiosurgery: target coordinates,
collimator size, plug pattern, and total dose;
teletherapy: the total dose, dose per fraction, treatment
site, and overall treatment period;
high dose rate remote afterloading brachytherapy: the
radionuclide, treatment site, and total dose; or
all other brachytherapy:
prior to implantation, the radionuclide, number of
sources, and source strengths; and
after implantation but prior to completion of the
procedure, the radionuclide, treatment site, and total
source strength and exposure time (or equivalently, the
total dose).
Section 335.30 License Required
a) No person shall manufacture, produce, acquire, receive, possess,
use, or transfer radioactive material for medical use except in
accordance with a specific license issued in accordance with 32 Ill.
Adm. Code 330.
b) Unless prohibited by license condition, an individual may receive,
possess, use, or transfer radioactive material in accordance with
this Part under the supervision of an authorized user as provided in
Section 335.1050.
Section 335.40 License Amendments
For specific licenses issued pursuant to 32 Ill. Adm. Code 330.260(a) or (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, except a visiting authorized user
described in Section 335.1060, to work as an authorized user under
the license;
c) Before changing the Radiation Safety Officer or teletherapy
physicist. If the teletherapy physicist named on the license is no
longer performing his duties, the Radiation Safety Committee may
have the duties performed by an individual who is listed by name as
a teletherapy physicist on a Department, Agreement State or U.S.
Nuclear Regulatory Commission license, and meets the training
criteria listed in Section 335.9150 for up to 90 days while an
amendment is being obtained;
d) Before receiving radioactive material in excess of the amount
authorized on the license;
e) Before adding to or changing any area of use identified on the
license;
f) Before changing statements, representations and procedures that are
incorporated into the license; and
g) Within 30 days after a Radiation Safety Officer or teletherapy
physicist permanently discontinues performance of duties under the
license, or after changing the name or the mailing address of the
licensee as it appears on the license.
SUBPART B: General Administrative Requirements
Section 335.1010 ALARA Program
a) Each licensee shall develop and implement a written program designed
to maintain radiation doses and releases of radioactive material in
effluents to unrestricted areas as low as is reasonably achievable.
The licensee shall retain a current written description of the ALARA
program for the duration of the license. The written description
shall include:
1) A commitment by management to keep occupational doses and
releases of radioactive material in effluents as low as is
reasonably achievable;
2) A requirement that the Radiation Safety Officer brief
management at least once each year on the radiation safety
program;
3) Personnel dose investigational levels that, when exceeded,
will initiate an investigation by the Radiation Safety Officer
of the cause of the dose; and
4) Personnel dose investigational levels that, when exceeded,
will within 24 hours initiate an investigation by the
Radiation Safety Officer of the cause of the dose and a
consideration of actions that might be taken to reduce the
probability of recurrence.
b) To satisfy the requirement of subsection (a):
1) The management, Radiation Safety Officer and all authorized
users shall participate in the establishment, implementation
and operation of the ALARA program as required by 32 Ill. Adm.
Code 340.1000(b).
2) For licensees that are not medical institutions, management
and all authorized users shall participate in the program as
requested by the Radiation Safety Officer.
3) The ALARA program shall include notice to workers of the
program's existence and workers' responsibility to help keep
radiation doses as low as is reasonably achievable.
c) The ALARA program shall include an annual review by the Radiation
Safety Committee for medical institutions, or management and the
Radiation Safety Officer for licensees that are not medical
institutions. The annual review shall include summaries of:
1) the types and amounts of radioactive material used;
2) occupational dose reports;
3) all license conditions and regulations as they relate to the
licensee's program; and
4) continuing education and training provided to personnel as
required by 32 Ill. Adm. Code 400.120.
d) The purpose of the review is to ensure that individuals make every
effort to maintain occupational doses, doses to the general public
and releases of radioactive material as low as is reasonably
achievable.
Section 335.1020 Radiation Safety Officer
a) A licensee shall appoint a Radiation Safety Officer responsible for
implementing the radiation safety program. The licensee, through
the Radiation Safety Officer, shall ensure that radiation safety
activities are being performed in accordance with the license
provisions and regulatory requirements in the daily operation of the
licensee's radioactive material program.
b) The Radiation Safety Officer shall:
1) Investigate overexposures, accidents, recordable and
reportable events, spills, losses, thefts, unauthorized
receipts, unauthorized uses, unauthorized transfers,
unauthorized disposals and other deviations from radiation
safety practices approved by the Radiation Safety Officer or
the Department, and implement corrective actions as necessary;
2) Implement written policy and procedures for:
A) Authorizing the purchase of radioactive material;
B) Receiving and opening packages of radioactive material;
C) Storing radioactive material;
D) Keeping an inventory record of radioactive material;
E) Using radioactive material safely;
F) Taking emergency action if control of radioactive
material is lost;
G) Performing radiation surveys as required by the license,
or this Part, or 32 Ill. Adm. Code 330 or 340;
H) Performing operability checks of survey instruments and
other safety equipment;
I) Disposing of radioactive material in accordance with the
requirements of 32 Ill. Adm. Code 340.3010;
J) Providing or supervising the provision of radiation
safety training to personnel who work in or frequent
areas where radioactive material is used or stored; and
K) Keeping copies of the license and 32 Ill. Adm. Code:
Chapter II and all records, reports and written policies
and procedures required thereunder.
3) For medical use at a facility other than a medical
institution, approve or disapprove radiation safety program
changes with the advice and consent of management prior to
submittal to the Department for licensing action.
4) For medical use at a medical institution, assist the Radiation
Safety Committee in the performance of its duties as specified
in Section 335.1030.
5) Maintain, for a period of five years, records of all
individuals designated by the Radiation Safety Officer to
perform duties or meet regulatory requirements that would
otherwise be required as a duty or responsibility of the
Radiation Safety Officer. These records shall include:
A) The name of the designated individual;
B) A list of all duties and responsibilities the Radiation
Safety Officer's designee is authorized to perform;
C) The date upon which the designation became effective;
D) The signature of the Radiation Safety Officer's
designee; and
E) The signature of the Radiation Safety Officer.
6) The Radiation Safety Officer shall review records generated by
designees and the performance of designees at least once in
each calendar quarter. In addition, the licensee shall
maintain records, for a period of five years, of these
quarterly reviews and Radiation Safety Officer's designee
reviews for Departmental inspection. These records shall
include:
A) The date of the review;
B) The records being reviewed or the name of the designee
being reviewed;
C) A list of all duties and responsibilities reviewed by
the Radiation Safety Officer for the designee review;
D) The results of the Radiation Safety Officer's review and
any corrective measures taken, if applicable, based on
the review; and
E) The signature of the Radiation Safety Officer.
Section 335.1030 Radiation Safety Committee
Each medical institution licensee shall establish a Radiation Safety Committee
to oversee the use of radioactive material.
a) The Committee shall meet the following administrative requirements:
1) Membership shall consist of at least three individuals and
shall include an authorized user of each type of use permitted
by the license, the Radiation Safety Officer for each medical
license, a representative of the nursing service and a
representative of management who is neither an authorized user
nor a Radiation Safety Officer.
2) The Committee shall meet at least once each calendar quarter.
3) To establish a quorum and to conduct business, at least one-
half of the Committee membership must be in attendance, and
shall include the management's representative, an authorized
user and the Radiation Safety Officer. However, no more than
once per year, the Radiation Safety Officer's designee may
substitute for the Radiation Safety Officer, provided that the
designee has a written report from the Radiation Safety
Officer.
AGENCY NOTE: The written report referenced above includes all
information otherwise required to have been submitted by the
Radiation Safety Officer at that meeting, such as information
specified in subsections (b)(5) and (6) below.
4) The minutes of each Radiation Safety Committee meeting shall
include:
A) The date of the meeting;
B) Members in attendance;
C) Members absent;
D) Summary of deliberations and discussions;
E) Recommended actions and the numerical results of all
votes; and
F) Documentation of any reviews required by subsection (b)
below and Section 335.1010(b).
5) The Committee shall provide each member with a copy of the
meeting minutes before the next meeting, and retain one copy
for 5 years from the meeting date.
b) To oversee the use of licensed material, the Committee shall:
1) Monitor the institutional program to maintain individual and
collective doses as low as is reasonably achievable;
2) Review and approve or disapprove any individual who is to be
listed as an authorized user, Radiation Safety Officer, or
Teletherapy Physicist before submitting a license application
or request for amendment or renewal. Such review and approval
shall be on the basis of safety and with regard to the
training and experience standards of this Part;
3) Review on the basis of safety and approve or disapprove each
proposed method of use of radioactive material;
4) Submit to the Department, for licensing action, only those
procedures and radiation safety program changes that have been
reviewed by the Committee on the basis of safety, and have
been approved with the advice and consent of the Radiation
Safety Officer and the management representative;
AGENCY NOTE: This approval may be obtained either by vote at
a meeting of the Radiation Safety Committee or by written
approval of the individual members of the Committee.
5) Review quarterly, with the assistance of the Radiation Safety
Officer, occupational radiation exposure records of all
personnel working in the vicinity of radioactive material;
6) Review quarterly all recordable and reportable events and
incidents involving radioactive material with respect to cause
and subsequent actions taken. These reviews shall be with the
assistance of the Radiation Safety Officer;
7) Review annually the radiation safety program. These reviews
shall be with the assistance of the Radiation Safety Officer;
and
8) Establish a table of investigational levels for occupational
dose that, when exceeded, shall initiate investigations and
considerations of action by the Radiation Safety Officer.
Section 335.1040 Statement of Authorities and Responsibilities
a) A licensee shall provide the Radiation Safety Officer, and also at
a medical institution the Radiation Safety Committee, authority,
organizational freedom and management prerogative to:
1) Identify actual or potential radiation safety hazards;
2) Initiate, recommend, or provide solutions to actual or
potential radiation safety hazards; and
3) Verify implementation of corrective actions.
b) A licensee shall establish, in writing, the authorities, duties,
responsibilities and radiation safety activities of the Radiation
Safety Officer, and also at a medical institution the Radiation
Safety Committee.
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
shall:
1) Instruct the supervised individual, prior to assuming duties
requiring the handling of radioactive materials, in 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
Department 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 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 their supervised training.
This record shall include the name of each supervised
individual, the results of reviews required by subsection
(b)(1) above, 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 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.
Section 335.1060 Authorized User and Visiting Authorized User
a) A licensee shall assure that only authorized users of radioactive
material who are licensed practitioners of the healing arts:
1) Select or establish written criteria for the selection of the
patients to receive radioactive material or radiation
therefrom;
2) Prescribe the radiopharmaceutical dosage or radiation dose to
be administered; and
3) Interpret the results of tests, studies, or treatments.
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 Department, Agreement State,
Licensing State, or U.S. Nuclear Regulatory Commission license
that identifies the visiting authorized user by name as an
authorized user; and
4) Only those procedures for which the visiting authorized user
is specifically authorized by a Department, Agreement State,
Licensing State, or U.S. Nuclear Regulatory Commission license
are performed by that individual.
c) A licensee shall retain copies of the records specified in
subsection (b) for 5 years.
Section 335.1070 Mobile Nuclear Medicine Service Administrative Requirements
a) Prior to bringing radioactive material into a client's facility,
mobile nuclear medicine service licensees shall obtain a letter,
signed by the management of the client for whom services are
rendered, that authorizes use of radioactive material at the
client's address of use. The mobile nuclear medicine service
licensee shall retain the letter for 5 years after the last
provision of service.
b) If a mobile nuclear medicine service provides services that the
client is also authorized to provide, then the mobile nuclear
medicine service shall provide those services in accordance with 32
Ill. Adm. Code: Chapter II and the requirements of the mobile
nuclear medicine service's license.
c) A mobile nuclear medicine service shall not have radioactive
material delivered directly from the manufacturer or the distributor
to the mobile nuclear medicine service company's client.
d) The mobile nuclear medicine service shall 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 initials of the individual performing the
administration.
e) A mobile nuclear medicine licensee may permit a physician to use
licensed material for medical use under the terms of the mobile
nuclear medicine service's license without applying for a license
amendment if:
1) The physician has the prior written permission of the mobile
nuclear medicine service's management;
2) The mobile nuclear medicine service has a copy of a
Department, Agreement State, Licensing State, or U.S. Nuclear
Regulatory Commission license that identifies the physician by
name as an authorized user for medical use; and
3) Only those procedures for which the physician is specifically
authorized by a Department, Agreement State, Licensing State,
or U.S. Nuclear Regulatory Commission license are performed by
that individual.
f) Mobile nuclear medicine licensees shall comply with the ALARA
program requirements of Section 335.1010.
Section 335.1080 Notifications, Reports, and Records of Reportable Events
a) For any administration of radioactive material or radiation that
results in a reportable event:
1) The licensee shall notify the Department by telephone no later
than the next day after the licensee ascertains and confirms
that a reportable event has occurred.
2) The licensee shall submit a written report to the Department
within 15 days after the licensee ascertains and confirms that
a reportable event has occurred. The written report must
include the licensee's name; the prescribing physician's name;
a brief description of the reportable event; why the
reportable event occurred; the effect on the patient; what
improvements are needed to prevent recurrence; actions taken
to prevent recurrence; whether the licensee informed the
patient (or the patient's responsible relative or guardian),
and if not, why not; and if the patient was informed, what
information was provided to the patient. The report must not
include the patient's name or other information that could
lead to identification of the patient.
3) The licensee shall notify the patient of the reportable event
within 15 days after the licensee ascertains and confirms that
a reportable event has occurred, unless the referring
physician agrees to inform the patient or believes, based on
medical judgment, that telling the patient would be harmful.
If the referring physician or patient cannot be reached within
15 days, the licensee shall notify them as soon as
practicable. The licensee is not required to notify the
patient without first consulting the referring physician;
however, the licensee shall not delay any appropriate medical
care for the patient because of any delay in notification.
4) If the patient was notified, the licensee shall also furnish
a written report to the patient within 15 days after the
licensee ascertains and confirms that a reportable event has
occurred. The report to the patient shall be either a copy of
the report that was submitted to the Department, or a brief
description of both the event and the consequences, as they
may affect the patient, provided that a statement is included
that the report submitted to the Department can be obtained
from the licensee.
b) Each licensee shall retain a record of each reportable event for
five years. The record must contain the names of all individuals
involved in the reportable event (including the prescribing
physician, allied health personnel, the patient, and the patient's
referring physician), the patient's social security number or
identification number if one has been assigned, a brief description
of the reportable event, why the reportable event occurred, the
effect on the patient, what improvements are needed to prevent
recurrence, and the actions taken to prevent recurrence.
c) Aside from the notification requirement, nothing in this Section
affects any rights or duties of licensees and physicians in relation
to each other, patients, or the patient's responsible relatives or
guardians.
Section 335.1090 Materials Authorized for Medical Use
A licensee shall utilize only the following for medical use:
a) Radioactive material prepared, manufactured, labeled, packaged and
distributed in accordance with a license issued pursuant to 32 Ill.
Adm. Code 330 or the equivalent regulations of an Agreement State,
a Licensing State, or the U.S. Nuclear Regulatory Commission; and
b) Reagent kits that have been manufactured, labeled, packaged, and
distributed in accordance with an approval issued by the U.S.
Department of Health and Human Services, Food and Drug
Administration, the Department, an Agreement State, a Licensing
State, or the U.S. Nuclear Regulatory Commission.
SUBPART C: General Technical Requirements
Section 335.2010 Possession, Use, Calibration and Check of Dose Calibrators
a) A medical use licensee that is authorized to administer
radiopharmaceuticals shall possess a dose calibrator and use it to
measure the amount of activity administered to each patient.
b) A licensee shall:
1) Check each dose calibrator for constancy with a dedicated
check source at the beginning of each day of use. To satisfy
the requirement of this subsection, the check shall be done on
all settings to be used that day with a sealed source of not
less than 10 uCi (370 kBq) of radium-226 or 50 uCi (1.85 MBq)
of any other photon-emitting radionuclide with a half-life
greater than 90 days. The licensee shall also record the
results of these checks. The records shall include the model
and serial number of the dose calibrator, the identity of the
radionuclide contained in the check source, the date of the
check, the activity measured, the instrument settings and the
initials or signature of the individual who performed the
check;
2) Test each dose calibrator for accuracy upon installation, and
thereafter at intervals not to exceed 12 months. The licensee
shall maintain records of these tests which shall include the
model, serial number, radionuclide, assay activity and assay
date of each source used, the manufacturer, model and serial
number of the dose calibrator, the date and results of the
accuracy test and the signatures of the Radiation Safety
Officer and the individual who performed the test. These
tests shall be performed by assaying at least the following 3
sealed sources, the activity of which the manufacturer,
National Bureau of Standards, or the National Institute of
Standards and Technology has determined within 5 percent of
the stated activity:
A) Cesium-137, minimum 100 uCi (3.7 MBq) source;
B) Barium-133, minimum 100 uCi (3.7 MBq) source;
C) Cobalt-57, minimum 1 millicurie (37 MBq) source;
3) Test each dose calibrator for linearity upon installation, and
thereafter at intervals not to exceed 3 months, over the range
of use from the lowest to the highest dosage that will be
administered. The licensee shall also maintain records of
these tests. These records shall include the model and serial
number of the dose calibrator, the calculated activities, the
measured activities, the date(s) and time of the test, the
signature of the individual performing the test and the
signature of the Radiation Safety Officer; and
4) Test each dose calibrator for geometry dependence upon
installation or relocation over the range of volumes and
volume configurations for which it will be used. The licensee
shall keep a record of this test for the duration of the use
of the dose calibrator. The licensee shall also maintain
records of these tests. These records shall include the
model and serial number of the dose calibrator, the activity
and configuration of the source measured, the activity
measured for each volume measured, the instrument setting for
each volume measured, the date of the test, the signature of
the individual performing the test and the signature of the
Radiation Safety Officer.
c) A licensee shall mathematically correct dosage readings for any
geometry or linearity error that exceeds 10 percent if the dosage is
greater than 10 uCi (370 kBq) and shall repair or replace the dose
calibrator if the accuracy or constancy error exceeds 10 percent.
d) A licensee shall also perform checks and tests required by
subsection (b) following adjustment or repair of the dose
calibrator, such as replacement of electronic components, that will
affect constancy, linearity, accuracy or geometry dependance.
e) A licensee shall retain a record of each check and test required by
this Section for 5 years.
Section 335.2020 Possession, Calibration and Check of Survey Instruments
a) A licensee authorized to use radioactive material for uptake,
dilution and excretion studies shall have in its possession a
portable radiation detection survey instrument capable of detecting
dose rates over the range 0.1 mrem (1.0 uSv) per hour to 50 mrem
(500 uSv) per hour. The instrument shall be operable and calibrated
in accordance with the requirements of this Section.
b) A licensee authorized to use radioactive material for imaging and
localization studies, for radiopharmaceutical therapy or for implant
therapy shall have in its possession a portable radiation detection
survey instrument capable of detecting dose rates over the range 0.1
mrem (1.0 uSv) per hour to 50 mrem (500 uSv) per hour, and a
portable radiation measurement survey instrument capable of
measuring dose rates over the range 1 mrem (10 uSv) per hour to 1000
mrem (10 mSv) per hour. The instruments shall be operable and
calibrated in accordance with the requirements of this Section.
c) A licensee authorized to use radioactive material as a sealed
source:
1) In a teletherapy unit shall have in its possession either a
portable radiation detection survey instrument capable of
detecting dose rates over the range 0.1 mrem (1.0 uSv) per
hour to 50 mrem (500 uSv) per hour or a portable radiation
measurement survey instrument capable of measuring dose rates
over the range 1 mrem (10 uSv) per hour to 1000 mrem (10 mSv)
per hour. The instrument shall be operable and calibrated in
accordance with the requirements of this Section.
2) For diagnostic purposes shall use either a portable radiation
detection survey instrument capable of detecting dose rates
over the range 0.1 mrem (1.0 uSv) per hour to 50 mrem (500
uSv) per hour or a portable radiation measurement survey
instrument capable of measuring dose rates over the range 1
mrem (10 uSv) per hour to 1000 mrem (10 mSv) per hour. The
instrument shall be operable and calibrated in accordance with
the requirements of this Section.
d) A licensee shall ensure that the survey instruments used to show
compliance with this Part have been calibrated before first use,
annually and following repair.
e) To satisfy the requirement of subsection (d) the licensee shall:
1) Calibrate all required scale readings up to 1000 mrem (10 mSv)
per hour with a radiation source;
2) Calibrate two readings, separated by at least 50 percent of
the full-scale reading, for each scale to be calibrated;
3) Post a legible note on the instrument with the apparent
exposure rate from a dedicated check source as determined at
the time of calibration, or immediately upon receipt of a
calibrated instrument and with the date of calibration; and
4) Ensure that survey instrument calibrations are performed by
persons specifically licensed by the Department, an Agreement
State, a Licensing State, or the U.S. Nuclear Regulatory
Commission to perform such services.
f) To satisfy the requirements of subsection (e)(1) and (2), the
licensee shall:
1) Consider a point as calibrated if the indicated exposure rate
differs from the calculated exposure rate by not more than 10
percent; or
2) Consider a point as calibrated if the indicated exposure rate
differs from the calculated exposure rate by not more than 20
percent and a correction chart or graph is conspicuously
attached to the instrument.
g) Prior to using radioactive material, a licensee shall check the
survey instrument to be used for required surveys with a dedicated
check source on each day that instrument is used. This check source
shall have a half-life greater than 5 years. These checks shall be
taken with the check source placed in a specific geometry relative
to the detector. If any check source reading varies greater than 20
percent from the reading measured immediately after calibration the
licensee shall require that the instrument be repaired or re-
calibrated before use to determine compliance with this Part or 32
Ill. Adm. Code 340. The results of these checks shall be recorded:
1) After repair, battery change, or instrument calibration; and
2) At intervals not to exceed 3 months.
h) The licensee shall retain a record, for 5 years, of each calibration
required in subsection (d). The record shall include:
1) A copy of the licensee's calibration procedures or a copy of
a Department, Agreement State, Licensing State, or U.S.
Nuclear Regulatory Commission license authorizing the person
that performed the calibration to perform calibrations as a
customer service; and
2) The model, serial number, radionuclide, assay activity and
assay date of the source used and the exposure rates from the
source as provided in, or calculated from, information
provided by the source supplier, and the rates indicated by
the instrument being calibrated, the correction factors
deduced from the calibration data, the signature of the
individual who performed the calibration and the date of
calibration.
i) The licensee shall retain a record of each check required in
subsection (g) for 5 years. The record shall include a description
of the source used, the radiation level indicated by the instrument
being checked, the signature of the individual who performed the
check and the date of the check.
Section 335.2030 Assay of Radiopharmaceutical Dosages
A licensee shall:
a) Assay, before medical use, the activity of each radiopharmaceutical
dosage that contains more than 10 uCi (370 kBq) of a photon-emitting
radionuclide;
b) Assay, before medical use, the activity of each radiopharmaceutical
dosage with a desired activity of 10 uCi (370 kBq) or less of a
photon-emitting radionuclide to verify that the dosage does not
exceed 10 uCi (370 kBq);
c) Retain a record of the assays required by this Section for 5 years.
To satisfy this requirement, the record shall contain:
1) The generic name, trade name, or abbreviation of the
radiopharmaceutical, its lot number and expiration date or
time and the radionuclide;
2) The patient's name and identification number if one has been
assigned;
3) The prescribed dosage and activity of the dosage at the time
of assay, or a notation that the total activity is less than
10 uCi (370 kBq);
4) The date and time of the assay;
5) The date and time of administration of the
radiopharmaceutical; and
6) The initials of the individual who performed the assay.
d) A report of any irregularities pertaining to identification,
labeling, quality, or assay of any radiopharmaceutical received
under the authority of this license shall be filed within ten (10)
days of occurrence with the Department, Division of Radioactive
Materials.
Section 335.2040 Authorization for Calibration 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 and reference use:
a) Sealed sources manufactured and distributed by persons specifically
licensed in accordance with 32 Ill. Adm. Code 330 or equivalent
provisions of an Agreement State, a Licensing State, or the U.S.
Nuclear Regulatory Commission and that do not exceed 15 mCi (555
MBq) each, except radioactive material with atomic number 83 or
above shall not exceed 5 uCi (185 kBq) per source and the total of
such sources shall not exceed 50 uCi (1.85 MBq). The licensee need
not submit in license applications the information required by 32
Ill. Adm. Code 330.240(g)(1) provided that the licensee maintains a
record for each sealed source possessed under this authorization.
The record shall identify the source by manufacturer and model as
indicated in an evaluation sheet issued by an Agreement State, a
Licensing State, or the U.S. Nuclear Regulatory Commission;
b) Any radioactive material with a half-life of 100 days or less in
individual amounts not to exceed 15 mCi (555 MBq);
c) Any radioactive material with a half-life greater than 100 days in
individual amounts not to exceed 200 uCi (7.4 MBq) each; and
d) Technetium-99m in individual amounts not to exceed 50 mCi (1.85
gigabecquerels (GBq)).
Section 335.2050 Requirements for Possession of Sealed Sources
a) A licensee in possession of any sealed source shall post and follow
the radiation safety and handling instructions supplied by the
manufacturer or equivalent instructions approved by the Department
for the duration of source use. If posting of the instructions is
not practicable, the licensee shall post a notice that describes
where users may access the instructions.
b) A licensee in possession of a sealed source shall assure that:
1) The source is tested for leakage before its first use unless
the licensee has a certificate from the supplier indicating
that the source was tested within 6 months before transfer to
the licensee; and
2) The source is tested for leakage at intervals not to exceed 6
months or at intervals approved by the Department, an
Agreement State, a Licensing State, or the U.S. Nuclear
Regulatory Commission. Sources designed to emit alpha
particles are tested for leakage or contamination at intervals
not to exceed 3 months or at intervals approved by the
Department, an Agreement State, a Licensing State, or the U.S.
Nuclear Regulatory Commission.
c) To satisfy the leak test requirements of this Section, the licensee
shall assure that:
1) Leak tests are capable of detecting the presence of 0.005 uCi
(185 Bq) of radioactive material on the test sample, or in the
case of radium, either the presence of 0.005 uCi (185 Bq) of
radioactive material on the test sample or the escape of radon
at the rate of 0.001 uCi (37 Bq) per 24 hours;
2) Test samples are taken from the source or from the surfaces of
the device in which the source is mounted or stored on which
radioactive contamination might be expected to accumulate;
3) For a sealed source contained in a device, test samples are
obtained when the source is in the "off" position; and
4) Tests for both leakage and contamination are performed by
persons specifically licensed by the Department, an Agreement
State, a Licensing State, or the U.S. Nuclear Regulatory
Commission to perform such services.
d) A licensee shall retain leak test records for 5 years. The records
shall contain the model and serial number, if assigned, of each
source tested, the identity of each source radionuclide and its
estimated activity, the measured activity of each test sample
expressed in uCi or Bq, a copy of the licensee's leak test
procedures or a copy of a Department, Agreement State, Licensing
State, or U.S. Nuclear Regulatory Commission license authorizing the
person that performed the leak test to perform leak tests as a
customer service, the date of the test and the signature of the
Radiation Safety Officer.
e) If the leak test reveals the presence of 0.005 uCi (185 Bq) or more
of removable contamination or in the case of radium, either the
presence of 0.005 uCi (185 Bq) of radioactive material on the test
sample or the escape of radon at the rate of 0.001 uCi (37 Bq) per
24 hours, the licensee shall:
1) Immediately withdraw the sealed source from use and store it
in accordance with the requirements of 32 Ill. Adm. Code 340;
and
2) File a report, with the Department, within 5 days of receiving
the leak test results. This report shall describe the
equipment involved, the test results and the action taken.
f) A licensee need not perform a leak test on the following sources:
1) Sources containing only radioactive material with a half-life
of less than 30 days;
2) Sources containing only radioactive material as a gas;
3) Sources containing 100 uCi (3.7 MBq) or less of beta or
photon-emitting material or 10 uCi (370 kBq) or less of alpha-
emitting material;
4) Seeds of iridium-192 encased in nylon ribbon; and
5) Sources, except teletherapy and brachytherapy sources, which
are stored, not being used and identified as in storage. The
licensee shall, however, test each such source for leakage
before any use or transfer unless it has been tested for
leakage within 6 months before the date of use or transfer.
AGENCY NOTE: The leak test exemptions in subsection (f) do
not exempt the licensee from the physical inventory
requirements of subsection (g).
g) A licensee in possession of a sealed source, except sealed sources
in teletherapy machines, shall conduct a physical inventory of all
such sources at intervals not to exceed 3 months. The licensee
shall retain each inventory record for 5 years. The inventory
record shall include the radionuclide, assay activity, manufacturer,
model and serial number and activity assay date, the location of the
sealed source(s), date of the inventory, the signature of the
person(s) who performed the inventory and the signature of the
Radiation Safety Officer.
h) A licensee in possession of a sealed source shall:
1) Survey, with a radiation survey instrument, all areas where
such sources are stored. These surveys shall be performed at
intervals not to exceed 3 months. This survey requirement
does not apply to teletherapy sources in teletherapy units or
sealed sources in diagnostic devices.
2) Retain a record of each survey required in subsection (h)(1)
for 5 years. The record shall include the date of the survey,
a sketch of each area that was surveyed, the measured dose
rate at several points in each area expressed in mrem or uSv
per hour, the model and serial number of the survey instrument
used to make the survey, the signature of the person who
performed the survey and the signature of the Radiation Safety
Officer.
i) A licensee shall submit to the Department, at intervals not to
exceed 3 months, a record of all brachytherapy and teletherapy
sources not being used and identified as in storage. This record
shall include copies of the inventory records required by subsection
(g) and the survey records required by subsection (h)(2).
Section 335.2060 Syringe Shields and Syringe Shield Labels
a) A licensee shall keep, in a radiation shield, syringes that contain
radioactive material to be administered.
b) A licensee shall require each individual who prepares or administers
radiopharmaceuticals to use a syringe radiation shield unless the
use of the shield is contraindicated for that patient.
c) Notwithstanding the provisions of 32 Ill. Adm. Code 340.2030(f) (1),
(2) and (3), a licensee shall label each syringe, or syringe
radiation shield that contains a syringe with a radiopharmaceuti-
cal, with either the radiopharmaceutical name or its abbreviation or
the procedure to be performed or the patient's name.
Section 335.2070 Vial Shields and Vial Shield Labels
a) A licensee shall require each individual preparing or handling a
vial that contains a radiopharmaceutical to keep the vial in a vial
radiation shield.
b) Notwithstanding the provisions of 32 Ill. Adm. Code 340.2030(f) (1),
(2) and (3), a licensee shall label each vial radiation shield that
contains a vial of a radiopharmaceutical with the
radiopharmaceutical name or its abbreviation.
Section 335.2080 Surveys for Contamination and Ambient Radiation Dose Rate
a) At the end of each day of use, the licensee shall survey, with a
radiation detection survey instrument, all areas where liquid
radiopharmaceuticals are prepared for use or administered. However,
when diagnostic radiopharmaceuticals are administered to a
hospitalized patient in the patient's room, the licensee need not
survey the area where the radiopharmaceuticals were administered.
b) At least once each week, a licensee shall survey with a radiation
detection survey instrument all areas where radiopharmaceuticals or
radioactive wastes are stored.
c) A licensee shall conduct the surveys required by subsections (a) and
(b) in a manner that allows measurement of dose rates as low as 0.1
mrem (1 uSv) per hour.
d) At least once each week, a licensee shall survey for removable
contamination all areas where radiopharmaceuticals are prepared for
use, administered, or stored.
e) A licensee shall conduct the surveys required by subsection (d) in
a manner that permits detection of contamination on each wipe sample
of 2000 disintegrations per minute (dpm) (33 Bq) per 100 cm2 wiped.
f) A licensee shall retain a record of each survey required by this
Section for 5 years. The record shall include the date of the
survey, a sketch of each area surveyed, the measured dose rate at
several points in each area expressed in mrem or uSv per hour or the
removable contamination in each area expressed in dpm or Bq per 100
cm2 wiped, the model and serial number of the instrument used to
make the survey or analyze the samples and the signature of the
individual who performed the survey.
Section 335.2090 Safety Instructions for Patients Not Hospitalized and
Containing Therapeutic Doses of Radiopharmaceuticals or Permanent Implants
The licensee shall provide safety instructions to patients who are not
hospitalized for compliance with Section 335.2100 and to any therapy patient
administered 15 mCi (555 MBq) or more of iodine-131, or to the family or guardian
of such patient. This information shall be provided orally or in writing.
AGENCY NOTE: Because the patient is a source of radiation exposure to other
members of the public, it is necessary that the patient receive instruction in
precautions to be followed in order to minimize radiation exposure to others.
Section 335.2100 Admission of Patients Being Treated with Radiopharmaceuticals
or Permanent Implants
A licensee shall admit any patient for administration of a permanent implant or
30 mCi (1.11 GBq) or more of a therapeutic radiopharmaceutical if the patient's
dose rate at 1 meter is expected to exceed 5 mrem (50 uSv) per hour.
Section 335.2110 Discharge of Patients Being Treated with Therapeutic Doses of
Radiopharmaceuticals or Permanent Implants
Patients administered a permanent implant or 30 mCi (1.11 GBq) or more of a
therapeutic radiopharmaceutical may be discharged from the hospital only after
all of the following conditions have been met:
a) A physician, authorized to perform therapeutic procedures using
radiopharmaceuticals or permanent implants, has authorized the
discharge;
b) The measured dose rate from the patient is less than either 5 mrem
(50 uSv) per hour at a distance of 1 meter or the radioactive
material remaining in the patient is calculated to be less than 30
mCi (1.11 GBq); and
c) For any therapy patient whose measured dose rate at 1 meter is
greater than 2 mrem (20 uSv) per hour, the licensee has provided
instruction orally or in writing to the patient, or the family or
guardian of the patient.
AGENCY NOTE: Because the patient is a source of radiation exposure
to other members of the public, it is necessary that the patient
receive instruction in precautions to be followed in order to
minimize radiation exposure to others.
Section 335.2120 Mobile Nuclear Medicine Service Technical Requirements
A licensee providing mobile nuclear medicine service shall:
a) Transport to each address of use only those syringes or vials
containing prepared radiopharmaceuticals or radiopharmaceuticals
that are intended for reconstitution of radiopharmaceutical kits;
b) Bring into each location of use all radioactive material to be used
and, before leaving, remove all unused radioactive material and
associated radioactive waste;
c) Secure or keep under constant surveillance and immediate control all
radioactive material when in transit or at a location of use;
d) Check survey instruments and dose calibrators for proper function
before medical use at each location of use, as required in Sections
335.2010(b)(1), (d) and 335.2020(d);
e) Carry a calibrated survey instrument in each vehicle that is being
used to transport radioactive material, and, before leaving a client
location of use, survey all areas of radiopharmaceutical use with a
radiation detection survey instrument to ensure that all
radiopharmaceuticals and all associated radioactive wastes have been
removed; and
f) Retain a record of each survey required by subsection (e) for 5
years. The record shall include the date of the survey, a plan of
each area that was surveyed, the measured dose rate at several
points in each area of use expressed in mrem or uSv per hour, the
model and serial number of the instrument used to make the survey
and the signature of the individual who performed the survey.
Section 335.2130 Storage of Volatiles and Gases
a) A licensee shall store radioactive gases and volatile
radiopharmaceuticals, including iodine as sodium iodide, in the
shipper's radiation shield and container, or
b) A licensee shall store and use a container in a properly
functioning, ventilated device such as a glove box or fume hood.
SUBPART D: Uptake, Dilution and Excretion
Section 335.3010 Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion
Studies
A licensee may use any radioactive material in a radiopharmaceutical for a
diagnostic use involving measurements of uptake, dilution, or excretion provided
that the Food and Drug Administration (FDA) has either accepted an
"Investigational New Drug Application" (IND) or approved a "New Drug Application"
(NDA).
SUBPART E: Imaging and Localization
Section 335.4010 Use of Radiopharmaceuticals, Generators and Reagent Kits for
Imaging and Localization Studies
a) A licensee may use any radioactive material in a diagnostic
radiopharmaceutical, or any generator, or any reagent kit for
preparation and diagnostic use of a radiopharmaceutical containing
radioactive material provided that the Food and Drug Administration
has either accepted an "Investigational New Drug Application" (IND)
or approved a "New Drug Application" (NDA).
b) A licensee shall elute generators in compliance with Section
335.4020.
a) A licensee shall not administer to humans a radiopharmaceutical
containing more than 0.15 uCi of molybdenum-99 per mCi of
technetium-99m, or more than 5.55 kBq of molybdenum-99 per 37 MBq of
technetium-99m, or more than 5 uCi (185 kBq) of molybdenum-99 per
administered dose at the time of administration.
b) A licensee preparing technetium-99m radiopharmaceuticals from
molybdenum-99/technetium-99m generators shall measure the
molybdenum-99 concentration in each eluate or extract.
c) A licensee who is required to measure molybdenum concentration shall
retain a record of each measurement for 5 years. The record shall
include, for each elution or extraction of technetium-99m, the
measured activity of the technetium expressed in mCi or MBq, the
measured activity of the molybdenum expressed in uCi or kBq, the
ratio of the measures expressed as uCi or kBq of molybdenum per mCi
or MBq of technetium, the time and date of the test and the initials
or signature of the individual who performed the test.
d) A licensee shall report immediately to the Department each
occurrence of molybdenum-99 concentration exceeding the limits
specified in subsection (a).
Section 335.4030 Control of Aerosols and Gases
a) A licensee who administers radioactive aerosols or gases shall do so
with a system that will keep airborne concentrations within the
limits prescribed by 32 Ill. Adm. Code 340.1030 and 340.1060.
b) The system shall either be directly vented to the atmosphere through
an air exhaust or provide for collection and decay or disposal of
the aerosol or gas in a shielded container.
c) A licensee shall administer radioactive gases only in rooms that are
at negative pressure compared to surrounding rooms or hallways.
d) Before receiving, using, or storing a radioactive gas, the licensee
shall calculate the amount of time needed after a release to reduce
the concentration in the area of use to the occupational limit
listed in 32 Ill. Adm. Code 340.Appendix A. The calculation shall
be based on the highest activity of gas handled in a single
container and the measured available air exhaust rate.
e) A licensee shall, at the area of use, post the time calculated in
accordance with subsection (d) and require that, in the event of a
gas spill, individuals evacuate the room until the posted time has
elapsed.
f) In the event of a spill, the licensee shall use a radiation
detection survey instrument upon room re-entry to ensure radiation
levels return to background levels.
g) A licensee shall check the operation of reusable collection systems
monthly and measure the ventilation rates available in areas of use
at intervals not to exceed 6 months. The licensee shall maintain a
record of these checks for 5 years. The record shall include the
model and serial number of the collection system, results of all
checks recommended by the manufacturer of the collection system, the
date of the checks and the signature of the individual who performed
the checks.
h) A copy of the calculations required in subsection (d) shall be
recorded and retained for 5 years from the date of the last use of
the area.
i) Contaminated charcoal trap filters, system tubing and masks shall be
disposed of in accordance with 32 Ill. Adm. Code 340.
SUBPART F: Radiopharmaceuticals for Therapy
Section 335.5010 Use of Radiopharmaceuticals for Therapy
A licensee may use any radioactive material in a radiopharmaceutical for a
therapeutic use provided that the Food and Drug Administration has either
accepted an "Investigational New Drug Application" (IND) or approved a "New Drug
Application" (NDA).
Section 335.5020 Safety Instruction
a) Patients shall be instructed in radiation safety precautions
relating to patient control, visitor control, contamination control,
and waste control.
b) Persons who enter a patient's room shall be instructed in radiation
safety precautions and procedures related to visitor control and
contamination control.
c) Attendant hospital staff shall receive annual instruction in the
licensee's procedures for:
1) Patient control;
2) Visitor control;
3) Contamination control;
4) Waste control; and
5) Notification of the Radiation Safety Officer or authorized
user in case of the patient's death or medical emergency.
d) A licensee shall keep for 5 years a list of the attendant hospital
staff receiving instruction required by subsection (c), a
description of the instruction, the date of instruction and the name
of the individual who gave the instruction.
Section 335.5030 Safety Precautions for Radiopharmaceutical Therapy
a) For any hospitalized patient receiving treatment with a therapeutic
radiopharmaceutical, the licensee shall:
1) Perform radiation surveys required by 32 Ill. Adm. Code
340.2010 for use in determining when the licensee shall supply
appropriate personnel with personnel monitoring equipment as
required by 32 Ill. Adm. Code 340.2020. Records of these
surveys, indicating the date and time of the survey, a plan of
the area or list of points surveyed, the measured dose rate,
the model and serial number of the instrument used to make the
survey and the initials of the individual who made the survey
shall be maintained for 5 years. These radiation surveys
shall include as a minimum, the dose rate in mrem or uSv 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,
physical radiation surveys of adjoining rooms are not
required if a calculation of the dose rate to a patient
in the adjoining room is made based on measurements
obtained pursuant to subsections (a)(1)(A) or (B).
2) Not permit any patient who is not receiving radiation therapy,
but who is occupying an adjoining room with a patient who is
receiving radiation therapy, to receive a dose greater than
100 mrem (1 mSv) during the patient's entire stay from
radiation any therapy patient is emitting. The licensee shall
verify compliance by performing radiation surveys or
calculations based on surveys required by subsection (a)(1).
3) Provide each therapy patient's room with a private sanitary
facility.
4) Post the patient's door in accordance with 32 Ill. Adm. Code
340.2030(b). 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.
5) 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.
6) 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.
7) 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.
8) 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.
9) Survey the patient's room and sanitary facility for removable
contamination with a radiation detection survey instrument.
The room shall not be re-assigned until removable
contamination is less than 2000 dpm (900 kBq) per 100 cm2.
10) Measure the thyroid burden of each individual who helped
prepare or administer a dosage of iodine-131 within the
interval of 12 hours to 3 days after administering the dosage.
Retain, for the period required by 32 Ill. Adm. Code
340.4010(c)(1), a record that includes each thyroid burden
measurement, the name of the individual whose thyroid burden
was measured, the signature of the individual who made the
measurements and either the thyroid burden in uCi (or Bq) or
dose to the thyroid gland.
b) The licensee shall implement the precautions required by subsections
(a)(1), (2), (3), (4), (5), (6), (7) and (8) until all of the
following conditions have been met:
1) The measured dose rate at 1 meter from the therapy patient is
less than 5 mrem (50 uSv) per hour.
2) Radiation surveys of potentially contaminated items indicate
no contamination.
3) 48 hours have passed since the administration of I-125 or I-
131 as a therapeutic radiopharmaceutical.
c) Records of surveys required by subsections (a)(7), (9) and (b)(1)
shall include the survey date, the type of survey (i.e., room, item,
patient, etc.), the radiation level detected, the model and serial
number of the radiation detection survey instrument used and the
signature of the individual who performed the survey.
SUBPART G: Sealed Sources for Diagnosis
Section 335.6010 Use of Sealed Sources for Diagnosis
A licensee shall use the following sealed sources in accordance with the
manufacturer's radiation safety and handling instructions:
a) Iodine-125 as a sealed source in a device for bone mineral analysis;
b) Americium-241 as a sealed source in a device for bone mineral
analysis;
c) Gadolinium-153 as a sealed source in a device for bone mineral
analysis; and
d) Iodine-125 as a sealed source in a portable device for imaging.
SUBPART H: Sealed Sources for Brachytherapy
Section 335.7010 Use of Sealed Sources for Brachytherapy
A licensee shall use the following sources in accordance with the manufacturer's
radiation safety and handling instructions:
a) Cesium-137 as a sealed source in needles and applicator cells for
topical, interstitial and intracavitary treatment of cancer;
b) Cobalt-60 as a sealed source in needles and applicator cells for
topical, interstitial and intracavitary treatment of cancer;
c) Gold-198 as a sealed source in seeds for interstitial treatment of
cancer;
d) Iodine-125 as a sealed source in seeds for interstitial treatment of
cancer;
e) Iridium-192 as seeds encased in nylon ribbon for interstitial
treatment of cancer;
f) Palladium-103 as a sealed source in seeds for interstitial treatment
of cancer;
g) Radium-226 as a sealed source in needles or applicator cells for
topical, interstitial and intracavitary treatment of cancer;
h) Radon-222 as seeds for interstitial treatment of cancer; and
i) Strontium-90 as a sealed source in an applicator for treatment of
superficial eye conditions.
Section 335.7020 Safety Instruction
a) The licensee shall provide oral and written radiation safety
instruction to all personnel prior to their assuming independent
care (i.e., care provided when an authorized user or Radiation
Safety Officer is not physically present) of a patient receiving
implant therapy. Refresher training shall be provided at intervals
not to exceed 1 year.
b) To satisfy the requirements of subsection (a), the instruction shall
describe:
1) Size and appearance of the brachytherapy sources;
2) Safe handling and shielding instructions in case of a
dislodged source;
3) Procedures for control of patients who are not receiving
radiation therapy that establish compliance with 32 Ill. Adm.
Code 340.1050;
4) Procedures for control of visitors that establish compliance
with 32 Ill. Adm. Code 340.1050; and
5) Procedures for notification of the Radiation Safety Officer or
authorized user if the patient dies or has a medical
emergency.
c) A licensee shall retain for 5 years a record of individuals
receiving instruction required by subsection (a), a description of
the instruction, the date of instruction and the signature of the
individual who gave the instruction.
Section 335.7030 Safety Precautions
A licensee shall, for each patient receiving implant therapy:
a) Prohibit the placement of that patient in the same room with a
patient who is not receiving radiation therapy unless the licensee
demonstrates, by survey measurements or calculations, compliance
with the requirement of 32 Ill. Adm. Code 340.1050(a) at a distance
of one meter from the implant;
b) Post the patient's door with a "Caution: Radioactive Materials" sign
and note on the door or in the patient's chart where and how long
visitors may stay in the patient's room. In addition, 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;
c) 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;
d) Within 1 hour after implanting the sources, measure the dose rates
in contiguous restricted and unrestricted areas with a radiation
measurement survey instrument to demonstrate compliance with 32 Ill.
Adm. Code 340.1050(a), and retain for 5 years a record of each
survey that includes the time and date of the survey, a sketch of
the area or list of points surveyed, the measured dose rate at
several points expressed in mrem or uSv per hour, the instrument
used to make the survey and the signature of the individual who
performed the survey;
e) Advise attendant nursing staff to notify the Radiation Safety
Officer or the radiation therapy physician immediately if the
patient dies or has a medical emergency;
f) Include the following information in the patient's chart:
1) The radionuclide administered, the number of sources
implanted, the activity in mCi or GBq implanted and the time
and date of administration;
2) The exposure rate at 1 meter from the patient, the time the
determination was made and the signature of the individual who
made the determination;
3) The radiation symbol; and
4) Precautionary instructions to assure that the exposure of
individuals does not exceed that permitted under 32 Ill. Adm.
Code 340.1010.
Section 335.7040 Accountability of Brachytherapy Sources
a) A licensee shall make, and retain for 5 years from the date of use,
a record of the use of brachytherapy sources. This record shall
include:
1) The names of the individuals permitted to handle the sources;
2) The number, radionuclide and activity of sources removed from
storage; the time and date the sources were removed from
storage; the number and activity the sources remaining in
storage after the removal; the room number where the sources
are being used; the name of the patient for whom the sources
were used; and the signature of the individual removing the
sources from storage.
3) The number, radionuclide and activity of sources returned to
storage; the time and date the sources were returned to
storage; the number and activity of sources in storage after
the return; the room number where the sources were used; the
name of the patient for whom the sources were used; and the
signature of the individual who returned the sources to
storage.
b) Immediately after implanting sources in a patient and immediately
after removal of sources from a patient the licensee shall make a
radiation survey of the patient and the area of use to confirm that
no sources have been misplaced.
c) Each time brachytherapy sources are returned to an area of storage
from an area of use, the licensee shall immediately count the number
returned to ensure that all sources taken from the storage area have
been returned. If all sources are not accounted for, the licensee
shall notify the Radiation Safety Officer and a search for the
sources shall be started immediately. If at the conclusion of the
search all sources are not accounted for, the licensee shall notify
the Department in accordance with 32 Ill. Adm. Code 340.4020.
d) A licensee shall make and retain a record of the surveys required by
subsection (b) for 5 years. Each record shall include the date of
the survey, the name of the patient, the dose rate expressed as mrem
or uSv per hour as measured at 1 meter from the patient, the model
and serial number of the radiation survey instrument used and the
signature of the individual who performed the survey.
Section 335.7050 Discharge of Patients Treated With Temporary Implants
The licensee shall not authorize discharge of a patient treated by temporary
implant until all sources have been removed and surveys have been completed in
accordance with Section 335.7040(b).
SUBPART I: Teletherapy
Section 335.8010 Use of a Sealed Source in a Teletherapy Unit
a) A licensee shall use cobalt-60 or cesium-137 as a sealed source in
a teletherapy unit for medical use in accordance with the
manufacturer's radiation safety and operating instructions.
b) Teletherapy sources shall be tested for leakage and contamination in
accordance with Sections 335.2050(b), (c), (d), (e) and (f). Tests
of leakage may be made by wiping accessible surfaces of the housing
port or collimator while the source is in the "off" position and
measuring these wipes for transferred contamination.
Section 335.8020 Maintenance and Repair Restrictions
Only a person specifically licensed by the Department, an Agreement State, or the
U.S. Nuclear Regulatory Commission to perform teletherapy unit maintenance and
repair shall install, relocate, or remove a teletherapy sealed source or a
teletherapy unit that contains a sealed source or maintain, adjust, or repair the
source drawer, the shutter, or other mechanism of a teletherapy unit that could
expose the source, reduce the shielding around the source, or result in increased
radiation levels.
Section 335.8030 Amendments to Teletherapy Licenses
In addition to the requirements specified in Section 335.40, a teletherapy
licensee shall apply for and shall receive a license amendment before:
a) Making any change in the treatment room shielding;
b) Making any change in the location of the teletherapy unit within the
treatment room;
c) Using the teletherapy unit in a manner that could result in
increased radiation levels in areas outside the teletherapy
treatment room;
d) Relocating the teletherapy unit; or
e) Allowing an individual not listed on the licensee's license to
perform the duties of the teletherapy physicist. If the teletherapy
physicist named on the license is no longer performing his duties,
the Radiation Safety Committee may have the duties performed by an
individual who is listed by name as a teletherapy physicist on a
Department, Agreement State or U.S. Nuclear Regulatory Commission
license, and meets the training criteria listed in Section 335.9150
for up to 90 days while an amendment is being obtained.
Section 335.8040 Safety Instructions for Teletherapy
a) A licensee shall post instructions at the teletherapy unit console.
To satisfy this requirement, these instructions shall inform the
operator of:
1) The procedure to be followed to ensure that only the patient
is in the treatment room before turning on the primary beam of
radiation to begin a treatment or after a door interlock
interruption;
2) The procedure to be followed if the operator is unable to turn
off the primary beam of radiation with controls outside the
treatment room or any other abnormal operation occurs; and
3) The names and telephone numbers of the authorized users and
Radiation Safety Officer who are to be contacted immediately
if the teletherapy unit or console operates abnormally.
b) A licensee shall provide instruction in the topics identified in
subsection (a) to all individuals prior to their independent
operation of a teletherapy unit and shall provide refresher training
to such individuals at intervals not to exceed 1 year.
c) A licensee shall retain for 5 years a record of individuals
receiving instruction required by subsection (b), a description of
the instruction, the date of instruction and the signature of the
individual who gave the instruction.
Section 335.8050 Doors, Interlocks and Safety Related Systems
a) A licensee shall control access to the teletherapy room by a door at
each entrance.
b) A licensee shall equip each entrance to the teletherapy room with an
electrical interlock system that shall:
1) Prevent the operator from turning on the primary beam of
radiation unless each treatment room entrance door is closed;
2) Turn off the primary beam of radiation immediately when an
entrance door is opened; and
3) Prevent the primary beam of radiation from being turned on
following an interlock interruption until all treatment room
entrance doors are closed and the beam on-off control is reset
at the console.
c) A licensee shall equip each entrance to the teletherapy room with a
light that indicates the beam condition.
d) A licensee shall lock the control console in the "off" position if
any door interlock malfunctions. The licensee shall not permit the
unit to be used until the interlock system is repaired, unless
specifically authorized by the Department.
AGENCY NOTE: The Department might issue such authorization if
necessary to continue a treatment that was initiated prior to the
malfunction, provided that the licensee takes measures to compensate
for the failed interlock.
e) A licensee shall cease treatment of patients with any teletherapy
unit if a safety related system of the teletherapy unit (e.g.,
source drive mechanisms, treatment timing systems or safety
interlocks) is found inoperative. The licensee shall report to the
Department any malfunction that requires the termination of patient
treatment for more that 24 hours and shall submit to the Department,
within 7 days, a written report of the incident and corrective
actions taken.
Section 335.8060 Radiation Monitoring Device for Teletherapy
a) A licensee shall have in each teletherapy 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 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 room.
c) Each radiation monitor shall be equipped with an auxiliary power
supply separate from the power supply to the teletherapy 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 unit is used
for treatment of patients.
AGENCY NOTE: Exposing the teletherapy 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) for 5 years. The record shall include the date of
the check, notation that the monitor indicates when the source is
exposed and the initials of the individual who performed the check.
f) If the radiation monitor is inoperable, the licensee shall require
any individual entering the teletherapy 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).
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.
Section 335.8070 Viewing System for Teletherapy
A licensee shall construct or equip each teletherapy room to permit continuous
observation of the patient from the teletherapy unit console during irradiation.
Section 335.8080 Teletherapy 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 radiologic 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 2 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 comparing dosimetry
systems to be used for calibrating cesium-137 teletherapy
units, the licensee shall use a teletherapy unit with a
cesium-137 source.
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). This comparison shall have been
performed within the previous year and after each servicing that may
have affected calibration of the calibrated system.
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 model and
serial numbers of the instruments that were calibrated, or compared
as required by subsections (a) and (b), 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 radiologic physics
center accredited by AAPM.
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), 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 5 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), full calibration
measurements shall include determination of:
1) The output, within 3 percent, for the range of field sizes and
for the distance or range of distances used for medical use;
2) The coincidence of the radiation field and the field indicated
by the light beam localizing device;
3) The uniformity of the radiation field and its dependence on
the orientation of the useful beam;
4) Timer 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 to measure the output for one set of exposure conditions.
The remaining radiation measurements required in subsection (b)(1)
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) in accordance with either the procedures recommended
by the Scientific Committee on Radiation Dosimetry of the American
Association of Physicists in Medicine that are described in "Physics
in Medicine and Biology" (Vol. 16, No. 3, 1971, pp. 379-396),
exclusive of any subsequent amendments or editions, or by Task Group
21 of the Radiation Therapy Committee of the American Association of
Physicists in Medicine that are described in "Medical Physics" (Vol.
10, No. 6, 1983, pp. 741-771 and Vol. 11, No. 2, 1984, p. 213),
exclusive of any subsequent amendments or editions.
AGENCY NOTE: Copies of these documents are available for review at
the Department.
e) A licensee shall mathematically correct for physical decay the
outputs determined in subsection (b)(1). These corrections shall be
for intervals not exceeding one month for cobalt-60 and intervals
not exceeding 6 months for cesium-137.
f) Full calibration measurements required by subsection (a) and
physical decay corrections required by subsection (e) shall be
performed by a teletherapy 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 distances 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 of the teletherapy physicist.
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 one month.
b) To satisfy the requirement of subsection (a), 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) and the anticipated output, expressed as a percentage
of the anticipated value obtained at last full calibration
corrected mathematically for physical decay.
c) A licensee shall use the dosimetry system described in Section
335.8080 to make the measurement required in subsection (b)(5)
above.
d) A licensee shall perform measurements required by subsection (a) in
accordance with written procedures established by the teletherapy
physicist. The teletherapy physicist does not need to actually
perform the spot-check measurements.
e) A licensee shall have the teletherapy physicist review the results
of each spot-check within 15 days. The teletherapy 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 (such as
restriction of source housing angulation or elevation,
carriage or stand travel and 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) A licensee shall repair or replace any system identified in
subsection (f) that is not operating properly.
h) A licensee shall retain a record of each spot-check required by
subsections (a) and (f) 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 signature of the individual who performed the periodic
spot-check.
Section 335.8110 Radiation Surveys for Teletherapy Facilities
a) Before medical use, after each installation of a teletherapy source
and after making any change for which an amendment is required by
Section 335.8030(a), (b), (c), or (d), the licensee shall perform
radiation surveys with an operable radiation measurement survey
instrument calibrated in accordance with Section 335.2020 to verify
that:
1) The maximum radiation level at 1 meter from the teletherapy
source with the source in the off position and the collimators
set for a normal treatment field does not exceed 10 mrem (100
uSv) per hour and the average radiation level for the same
measurement conditions does not exceed 2 mrem (20 uSv) per
hour; and
2) With the teletherapy source in the on position, with the
largest clinically available treatment field and with a
scattering phantom in the primary beam of radiation, that:
A) Radiation levels in restricted areas will not cause
personnel exposures in excess of the limits specified in
32 Ill. Adm. Code 340.1010; and
B) Radiation levels in unrestricted areas do not exceed the
limits specified in 32 Ill. Adm. Code 340.1050(a).
b) If the results of the surveys required in subsection (a) indicate
any radiation levels in excess of the respective limit specified in
that subsection, the licensee shall lock the control in the off
position and not use the unit except as may be necessary to repair,
replace, or test the teletherapy unit, the teletherapy unit
shielding, or the treatment room shielding. The licensee may
reinitiate medical use of the unit when measurements indicate the
requirements of subsection (a) have been met.
c) A licensee shall retain a record of the radiation measurements made
following installation of a source for the duration of the license.
The record shall include the date of the measurements, the reason
the survey is performed, the manufacturer's name, model and serial
number of the teletherapy unit, the source and the instrument used
to measure radiation levels, each dose rate measured around the
teletherapy source while in the off position and the average of all
measurements, a plan of the areas surrounding the treatment room
that were surveyed, the measured dose rate at several points in each
area expressed in mrem or uSv per hour, the calculated maximum level
of radiation over a period of 1 week for each restricted and
unrestricted area and the signature of the Radiation Safety Officer
or teletherapy physicist.
Section 335.8120 Safety Checks for Teletherapy Facilities
a) A licensee shall check all systems specified in Section 335.8100 for
proper function after each installation of a teletherapy source and
after making any change for which an amendment is required by
Section 335.8030(b), (c), or (d). Such check shall be completed
before any patient is treated.
b) If the results of the checks required in subsection (a) indicate the
malfunction of any system specified in Section 335.8100, the
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.
c) A licensee shall retain, for 5 years, a record of the facility
checks following installation of a source. The record shall include
notations indicating the operability of each entrance door
interlock, each electrical or mechanical stop, each beam condition
indicator light, the viewing system, and doors and the signature of
the Radiation Safety Officer or teletherapy physicist.
Section 335.8130 Modification of Teletherapy Unit or Room Before Beginning a
Treatment Program
If the survey required by Section 335.8110(a)(2)(B) indicates that an individual
in an unrestricted area may be exposed to levels of radiation greater than those
permitted by 32 Ill. Adm. Code 340.1050(a), before beginning the treatment
program the licensee shall either:
a) Undertake the following:
1) Either equip the unit with stops or add additional radiation
shielding to ensure compliance with 32 Ill. Adm. Code
340.1050(a);
2) Perform the surveys required by Section 335.8110 again; and
3) Include in the report required by Section 335.8140 the results
of the initial survey, a description of the modification made
to comply with subsection (a)(1) and the results of the second
survey; or
b) Request and receive a license amendment under 32 Ill. Adm. Code
340.1050(b) that authorizes radiation levels in unrestricted areas
greater than those permitted by 32 Ill. Adm. Code 340.1050(a).
Section 335.8140 Reports of Teletherapy Surveys, Checks, Tests and Measurements
A licensee shall submit a copy of the records required in Sections 335.8110,
335.8120, 335.8130 and the output from the teletherapy source within 30 days
following completion of the action that caused a record to be required. The
output shall be expressed as roentgens, coulombs/kilogram, rads or grays per
hour, at either one meter or the usual treatment distance from the source and
determined during the full calibration required by Section 335.8090. The record
shall be sent to the Department of Nuclear Safety, Office of Radiation Safety,
1035 Outer Park Drive, Springfield, IL 62704.
Section 335.8150 Five-Year Teletherapy Inspection
a) A licensee shall have each teletherapy unit fully inspected and
serviced during teletherapy source replacement or at intervals not
to exceed 5 years, whichever comes first, to assure proper
functioning of the source exposure mechanism.
b) This inspection and servicing shall only be performed by persons
specifically licensed to do so by the Department, an Agreement
State, or the U.S. Nuclear Regulatory Commission.
c) A licensee shall keep a record of the inspection and servicing for
the duration of the license. The record shall contain the
inspector's name, the inspector's license number, the date of
inspection, the manufacturer's name and model and serial number for
both the teletherapy unit and source, a list of components
inspected, a list of components serviced and the type of service, a
list of components replaced and the signature of the inspector.
SUBPART J: Training and Experience Requirements
Section 335.9010 Radiation Safety Officer
Except as provided in Section 335.9020, an individual fulfilling the
responsibilities of the Radiation Safety Officer as provided in Section 335.1020
shall:
a) Be certified by either:
1) American Board of Health Physics in Comprehensive Health
Physics; or
2) American Board of Radiology in Radiological Physics,
Therapeutic Radiological Physics, or Medical Nuclear Physics;
or
3) American Board of Nuclear Medicine; or
4) American Board of Science in Nuclear Medicine; or
5) Board of Pharmaceutical Specialties in Nuclear Pharmacy or
Science; or
b) Hold a master's degree or doctorate degree in physics, biophysics,
radiological sciences, radiological physics, or health physics and
have 6 months of full time work experience under the supervision of
a radiation safety officer at a medical institution; or
c) Have had:
1) 200 hours of classroom and laboratory training as follows:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity;
D) Radiation biology;
E) Radiopharmaceutical chemistry; and
2) 1 year of full time experience in radiation safety at a
medical institution under the supervision of the individual
identified as the Radiation Safety Officer on a Department,
Agreement State, Licensing State, or U.S. Nuclear Regulatory
Commission license that authorizes the medical use of
radioactive material; or
d) Be an authorized user for those radioactive material uses that come
within the Radiation Safety Officer's responsibilities.
Section 335.9020 Training for Experienced Radiation Safety Officer
An individual identified as a Radiation Safety Officer on a Department, Agreement
State, Licensing State, or U.S. Nuclear Regulatory Commission license on the
effective date of this Part who oversees only the use of radioactive material for
which the licensee was authorized on that date need not comply with the training
requirements of Section 335.9010.
Section 335.9030 Training for Uptake, Dilution, or Excretion Studies
Except as provided in Section 335.9160 or 335.9170, a licensee shall require the
authorized user of a radiopharmaceutical specified in Section 335.3010 to be a
physician who:
a) Is certified in:
1) Nuclear medicine by the American Board of Nuclear Medicine; or
2) Nuclear medicine by the American Board of Osteopathic Nuclear
Medicine; or
3) Diagnostic radiology by the American Board of Radiology; or
4) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology; or
b) Has completed 40 hours of instruction in basic radionuclide handling
techniques applicable to the use of prepared radiopharmaceuticals,
and 20 hours of supervised clinical experience.
1) To satisfy the basic instruction requirement, 40 hours of
classroom and laboratory instruction shall include:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity;
D) Radiation biology; and
E) Radiopharmaceutical chemistry.
2) To satisfy the requirement for 20 hours of supervised clinical
experience, training shall be under the supervision of an
authorized user at a medical institution and shall include:
A) Examining patients and reviewing their case histories to
determine their suitability for radionuclide diagnosis,
limitations, or contraindications;
B) Selecting the suitable radiopharmaceuticals and
calculating and measuring the dosages;
C) Administering dosages to patients and using syringe
radiation shields;
D) Collaborating with the authorized user in the
interpretation of radionuclide test results; and
E) Patient follow-up; or
c) Has successfully completed a 6 month training program in nuclear
medicine as part of a training program that has been approved by the
Accreditation Council for Graduate Medical Education and that
included classroom and laboratory training, work experience and
supervised clinical experience in all the topics identified in
subsection (b).
Section 335.9040 Training for Imaging and Localization Studies
Except as provided in Section 335.9160 or 335.9170, a licensee shall require the
authorized user of a radiopharmaceutical, generator, or reagent kit specified in
Section 335.4010 to be a physician who:
a) Is certified in:
1) Nuclear medicine by the American Board of Nuclear Medicine; or
2) Nuclear medicine by the American Board of Osteopathic Nuclear
Medicine; or
3) Diagnostic radiology by the American Board of Radiology; or
4) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology; or
b) Has completed 200 hours of instruction in basic radionuclide
handling techniques applicable to the use of prepared
radiopharmaceuticals, generators, and reagent kits, 500 hours of
supervised work experience and 500 hours of supervised clinical
experience.
1) To satisfy the basic instruction requirement, 200 hours of
classroom and laboratory training shall include:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity;
D) Radiopharmaceutical chemistry; and
E) Radiation biology.
2) To satisfy the requirement for 500 hours of supervised work
experience, training shall be under the supervision of an
authorized user at a medical institution and shall include:
A) Ordering, receiving and unpacking radioactive materials
safely and performing the related radiation surveys;
B) Calibrating dose calibrators and diagnostic instruments
and performing checks for proper operation of survey
instruments;
C) Calculating and safely preparing patient dosages;
D) Using administrative controls to prevent the
misadministration of radioactive material;
E) Using emergency procedures to contain spilled
radioactive material safely and using proper
decontamination procedures; and
F) Eluting technetium-99m from generator systems, assaying
and testing the eluate for molybdenum-99 and alumina
contamination and processing the eluate with
reagent kits to prepare technetium-99m labeled
radiopharmaceuticals.
3) To satisfy the requirement for 500 hours of supervised
clinical experience, training shall be under the supervision
of an authorized user at a medical institution and shall
include:
A) Examining patients and reviewing their case histories to
determine their suitability for radionuclide diagnosis,
limitations, or contraindications;
B) Selecting the suitable radiopharmaceuticals and
calculating and measuring the dosages;
C) Administering dosages to patients and using syringe
radiation shields;
D) Collaborating with the authorized user in the
interpretation of radionuclide test results; and
E) Patient follow-up; or
c) Has successfully completed a 6 month training program in nuclear
medicine that has been approved by the Accreditation Council for
Graduate Medical Education and that included classroom and
laboratory training, work experience and supervised clinical
experience in all the topics identified in subsection (b).
Section 335.9050 Training for Therapeutic Use of Radiopharmaceuticals
Except as provided in Section 335.9160, a licensee shall require the authorized
user of a radiopharmaceutical specified in Section 335.5010 for therapy to be a
physician who:
a) Is certified by:
1) The American Board of Nuclear Medicine; or
2) The American Board of Radiology in radiology, therapeutic
radiology, or radiation oncology; or
b) Has completed 80 hours of instruction in basic radionuclide handling
techniques applicable to the use of therapeutic radiopharmaceuti-
cals, and has had supervised clinical experience.
1) To satisfy the requirement for instruction, 80 hours of
classroom and laboratory training shall include:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity; and
D) Radiation biology;
2) To satisfy the requirement for supervised clinical experience,
training shall be under the supervision of an authorized user
at a medical institution and shall include:
A) Use of iodine-131 for diagnosis of thyroid function and
the treatment of hyperthyroidism or cardiac dysfunction
in ten individuals; and
B) Use of iodine-131 for treatment of thyroid carcinoma in
three individuals.
Section 335.9060 Training for Treatment of Hyperthyroidism
Except as provided in Section 335.9160, the licensee shall require the authorized
user of only iodine-131 for the treatment of hyperthyroidism to be a physician
with experience in the diagnosis and treatment of thyroid disease, who has had
classroom and laboratory training in basic radionuclide handling techniques
applicable to the use of iodine-131 for treatment of hyperthyroidism, and
supervised clinical experience as follows:
a) 80 hours of classroom and laboratory training that includes:
1) Radiation physics and instrumentation;
2) Radiation protection;
3) Mathematics pertaining to the use and measurement of
radioactivity;
4) Radiation biology; and
b) Supervised clinical experience under the supervision of an
authorized user that includes the use of iodine-131 for diagnosis of
thyroid function, and the treatment of hyperthyroidism in 10
individuals.
Section 335.9070 Training for Treatment of Thyroid Carcinoma
Except as provided in Section 335.9160, the licensee shall require the authorized
user of only iodine-131 for the treatment of thyroid carcinoma to be a physician,
with experience in the diagnosis and treatment of thyroid disease, who has had
classroom and laboratory training in basic radionuclide handling techniques
applicable to the use of iodine-131 for treatment of thyroid carcinoma, and
supervised clinical experience as follows:
a) 80 hours of classroom and laboratory training that includes:
1) Radiation physics and instrumentation;
2) Radiation protection;
3) Mathematics pertaining to the use and measurement of
radioactivity;
4) Radiation biology; and
b) Supervised clinical experience under the supervision of an
authorized user that includes the use of iodine-131 for the
treatment of thyroid carcinoma in 3 individuals.
Section 335.9080 Training for Therapeutic Use of Soluble Phosphorus-32
Except as provided in Section 335.9160, the licensee shall require the authorized
user of only soluble phosphorus-32 for therapy to be a physician who has had
classroom and laboratory training in basic radionuclide handling techniques
applicable to the use of soluble phosphorus-32 for therapy and supervised
clinical experience as follows:
a) 80 hours of classroom and laboratory training that includes:
1) Radiation physics and instrumentation;
2) Radiation protection;
3) Mathematics pertaining to the use and measurement of
radioactivity;
4) Radiation biology; and
b) Use of soluble phosphorus-32 for therapy, such as the treatment of
ascites, polycythemia vera, leukemia, or bone metastasis, in 3
individuals.
Section 335.9090 Training for Therapeutic Use of Colloidal Chromic Phosphorus-32
Labeled Phosphate Compound or Gold-198
Except as provided in Section 335.9160, the licensee shall require the authorized
user of only colloidal chromic phosphorus-32 labeled phosphate compound or of
colloidal gold-198 for therapy to be a physician who has had classroom and
laboratory training in basic radionuclide handling techniques applicable to the
use of colloidal chromic phosphorus-32 labeled phosphate compound or of colloidal
gold-198 for therapy and supervised clinical experience as follows:
a) 80 hours of classroom and laboratory training that includes:
1) Radiation physics and instrumentation;
2) Radiation protection;
3) Mathematics pertaining to the use and measurement of
radioactivity;
4) Radiation biology; and
b) Use of colloidal chromic phosphorus-32 labeled phosphate compound or
of colloidal gold-198 for therapy, such as intracavitary treatment
of malignant effusions, in 3 individuals.
Section 335.9100 Training for Use of Sources for Brachytherapy
Except as provided in Section 335.9160, the licensee shall require the authorized
user using a source specified in Section 335.7010 for brachytherapy to be a
physician who:
a) Is certified in:
1) Radiology, therapeutic radiology, or radiation oncology by the
American Board of Radiology; or
2) Radiation oncology by the American Osteopathic Board of
Radiology; or
3) Radiology, with a specialization in radiation therapy, as a
British "Fellow of the Faculty of Radiology" or "Fellow of the
Royal College of Radiology"; or
4) Therapeutic radiology by the Canadian Royal College of
Physicians and Surgeons; or
b) Is in the practice of therapeutic radiology, has completed 200 hours
of instruction in basic radionuclide handling techniques applicable
to the therapeutic use of brachytherapy sources and 500 hours of
supervised work experience and a minimum of 3 years of supervised
clinical experience.
1) To satisfy the requirement for instruction, 200 hours of
classroom and laboratory training shall include:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity; and
D) Radiation biology.
2) To satisfy the requirement for 500 hours of supervised work
experience, training shall be under the supervision of an
authorized user at an institution and shall include:
A) Ordering, receiving, and unpacking radioactive materials
safely and performing the related radiation surveys;
B) Performing checks for proper operations of survey
instruments;
C) Preparing, implanting, and removing sealed sources;
D) Maintaining inventories and accountability of
radioactive material possessed;
E) Using administrative controls to prevent the
misadministration of radioactive material; and
F) Using emergency procedures to control radioactive
material.
3) To satisfy the requirement for a period of supervised clinical
experience, training shall include 1 year in a training
program approved by the Residency Review Committee for
Radiology of the Accreditation Council for Graduate Medical
Education or the Committee on Postdoctoral Training of the
American Osteopathic Association, and an additional 2 years of
clinical experience in therapeutic radiology under the
supervision of an authorized user at a medical institution.
The supervised clinical experience shall include:
A) Examining individuals and reviewing their case histories
to determine their suitability for brachytherapy
treatment, and any limitations or contraindications;
B) Selecting the proper brachytherapy sources, dose and
method of administration;
C) Calculating the dose; and
D) Post-administration follow-up and review of case
histories in collaboration with an authorized user.
Section 335.9120 Training for Ophthalmic Use of Strontium-90
Except as provided in Section 335.9160, the licensee shall require the authorized
user using only strontium-90 for ophthalmic radiation therapy to be a physician
who:
a) Is certified in radiology or therapeutic radiology by the American
Board of Radiology; or
b) Is in the practice of therapeutic radiology or ophthalmology, and
has completed 24 hours of instruction in basic radionuclide handling
techniques applicable to the use of strontium-90 for ophthalmic
radiation therapy and supervised clinical training in ophthalmic
radiation therapy.
1) To satisfy the requirement for instruction, the classroom and
laboratory training shall include:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity; and
D) Radiation biology.
2) To satisfy the requirement for supervised clinical training in
ophthalmic radiation therapy, training shall be under the
supervision of an authorized user at a medical institution and
must include the use of strontium-90 for the ophthalmic
treatment of 5 individuals that includes:
A) Examination of each individual to be treated;
B) Calculation of the dose to be administered;
C) Administration of the dose; and
D) Follow-up and review of each individual's case history.
Section 335.9130 Training for Use of Sealed Sources for Diagnosis
Except as provided in Section 335.9160, the licensee shall require the authorized
user using a sealed source in a device specified in Section 335.6010 to be a
physician, dentist, or podiatrist who:
a) Is certified in:
1) Radiology, diagnostic radiology, therapeutic radiology, or
radiation oncology by the American Board of Radiology; or
2) Nuclear medicine by the American Board of Nuclear Medicine; or
3) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology; or
b) Has completed 8 hours of instruction in basic radionuclide handling
techniques specifically applicable to the use of the device. To
satisfy the requirement for instruction, the training shall include:
1) Radiation physics, mathematics pertaining to the use and
measurement of radioactivity and instrumentation;
2) Radiation biology; and
3) Radiation protection and training in the use of the device for
the purposes authorized by the license.
Section 335.9140 Training for Teletherapy
Except as provided in Section 335.9160, the licensee shall require the authorized
user of a sealed source specified in Section 335.8010 in a teletherapy unit to
be a physician who:
a) Is certified in:
1) Radiology, therapeutic radiology, or radiation oncology by the
American Board of Radiology; or
2) Radiation oncology by the American Osteopathic Board of
Radiology; or
3) Radiology, with specialization in radiation therapy, as a
British "Fellow of the Faculty of Radiology" or "Fellow of the
Royal College of Radiology"; or
4) Therapeutic radiology by the Canadian Royal College of
Physicians and Surgeons; or
b) Is in the practice of therapeutic radiology, and has completed 200
hours of instruction in basic radionuclide techniques applicable to
the use of a sealed source in a teletherapy unit, 500 hours of
supervised work experience and a minimum of 3 years of supervised
clinical experience.
1) To satisfy the requirement for instruction, the classroom and
laboratory training shall include:
A) Radiation physics and instrumentation;
B) Radiation protection;
C) Mathematics pertaining to the use and measurement of
radioactivity; and
D) Radiation biology.
2) To satisfy the requirement for supervised work experience,
training shall be under the supervision of an authorized user
at an institution and shall include:
A) Review of the full calibration measurements and periodic
spot checks;
B) Preparing treatment plans and calculating treatment
times;
C) Using administrative controls to prevent
misadministrations;
D) Implementing emergency procedures to be followed in the
event of the abnormal operation of a teletherapy unit or
console; and
E) Performing checks for proper operation of survey
instruments.
3) To satisfy the requirement for a period of supervised clinical
experience, training shall include 1 year in a training
program approved by the Residency Review Committee for
Radiology of the Accreditation Council for Graduate Medical
Education or the Committee on Postdoctoral Training of the
American Osteopathic Association and an additional 2 years of
clinical experience in therapeutic radiology under the
supervision of an authorized user at a medical institution.
The supervised clinical experience shall include:
A) Examining individuals and reviewing their case histories
to determine their suitability for teletherapy
treatment, and any limitations or contraindications;
B) Selecting the proper dose and how it is to be
administered;
C) Calculating the teletherapy doses and collaborating with
the authorized user in the review of patients' progress
and consideration of the need to modify originally
prescribed doses as warranted by patients' reaction to
radiation; and
D) Post-administration follow-up and review of case
histories.
Section 335.9150 Training for Teletherapy Physicist
The licensee shall require the teletherapy physicist to:
a) Be certified by the American Board of Radiology in:
1) Therapeutic radiological physics; or
2) Roentgen ray and gamma ray physics; or
3) X-ray and radium physics; or
4) Radiological physics; or
b) Hold a master's degree or doctorate in physics, biophysics, radio-
logical physics, or health physics, and have completed 1 year of
full-time training in therapeutic radiological physics and also 1
year of full-time work experience under the supervision of a
teletherapy physicist at a medical institution. To meet this
requirement, the individual shall have performed the tasks specified
in Sections 335.2070, 335.9020, 335.9030, and 335.9040 under the
supervision of a teletherapy physicist during the year of work
experience.
Section 335.9160 Training for Experienced Authorized Users
Practitioners of the healing arts identified as authorized users for the human
use of radioactive material on a Department, an Agreement State, a Licensing
State, or U.S. Nuclear Regulatory Commission license on July 15, 1991, who
perform only those methods of use for which they were authorized on that date
need not comply with the training requirements of Sections 335.9010 through
335.9180.
Section 335.9170 Physician Training in a Three Month Program
A physician who, before July 1, 1984, began a 3 month nuclear medicine training
program approved by the Accreditation Council for Graduate Medical Education and
who has successfully completed the program is exempted from the requirements of
Sections 335.9030 or 335.9040.
Section 335.9180 Recentness of Training
The training and experience specified in Sections 335.9010 through 335.9150 shall
have been obtained within the 5 years preceding the date of application or the
individual shall have had related continuing education and experience in the
items listed in the applicable section since the required training and experience
was completed.
AGENCY NOTE: Individuals specifically listed on an active Department, Agreement
State, Licensing State, or U.S. Nuclear Regulatory Commission license as an
authorized user, Radiation Safety Officer or teletherapy physicist are considered
to have met the recentness in training requirements for only those procedures for
which they were authorized.
Section 335.9190 Resolution of Conflicting Requirements During Transition Period
If the rules in this Part conflict with the licensee's radiation safety program
as identified in its license, this Part shall apply, unless the statements,
representations, conditions and procedures in the license are more restrictive.
However, if that licensee exercises its privilege to amend its license, the
portion amended must comply with the requirements of this Part.
