Wis. Admin. Code Department of Health Services DHS 157.65 - Manual brachytherapy
(1) USE OF SOURCES FOR MANUAL BRACHYTHERAPY.
A licensee shall use only brachytherapy sources for therapeutic medical uses
under either of the following criteria:
(a)
As approved in the sealed source and device registry for manual brachytherapy
medical use. The manual brachytherapy sources may be used for manual
brachytherapy uses that are not explicitly listed in the Sealed Source and
Device Registry, but must be used in accordance with the radiation safety
conditions and limitations described in the SSDR.
(b) In research to deliver therapeutic doses
for medical use in accordance with an active investigational device exemption
application accepted by the FDA, provided the requirements of s. DHS 157.61 (6)
(a) are met.
(2) SOURCE
IMPLANT AND REMOVAL REQUIREMENTS.
(a)
Immediately after implanting sources in a patient or a human research subject,
a licensee shall make a survey to locate and account for all sources that have
not been implanted.
(b) Immediately
after removing the last temporary implant source from a patient or a human
research subject, a licensee shall conduct a survey of the patient or the human
research subject with a radiation detection survey instrument, with the sources
shielded and outside the room, to confirm that all sources have been removed
from the patient.
(c) A licensee
shall retain a record of the surveys under s. DHS 157.71 (16).
(3) BRACHYTHERAPY
SOURCES INVENTORY.
(a) A licensee shall
maintain accountability at all times for all brachytherapy sources in storage
or use.
(b) Promptly after removing
sources from a patient or a human research subject, a licensee shall return
brachytherapy sources to a secure storage area.
(c) A licensee shall maintain a record of the
brachytherapy source accountability under s. DHS 157.71 (17).
(4) SAFETY
INSTRUCTION. In addition to the requirements of subch. X, a licensee shall do
both of the following:
(a) Provide radiation
safety instruction, initially and at least once in each year, at intervals no
greater than 13 months, to personnel caring for patients or human research
subjects undergoing implant therapy and cannot be released under s. DHS 157.62 (8). To satisfy this requirement, the instruction shall be commensurate with
the duties of the personnel and include all of the following:
1. Size and appearance of the brachytherapy
sources.
2. Safe handling and
shielding instructions.
3. Patient
or human research subject control.
4. Visitor control, including both of the
following:
a. Routine visitation of
hospitalized individuals under s. DHS 157.23 (1) (a) 1.
b. Visitation authorized under s. DHS 157.23 (1) (b).
5. Notification
of the radiation safety officer or his or her designee and an authorized user
if the patient or the human research subject dies or has a medical emergency
that causes the patient's condition to suddenly
deteriorate.
(b) Retain a
record under s. DHS 157.71 (15) of individuals receiving
instruction.
(5) SAFETY
PRECAUTIONS.
(a) For each patient or human
research subject receiving brachytherapy who may not be released under s. DHS 157.62 (8), a licensee shall do both the following:
1. Not quarter the patient or the human
research subject in the same room as a person who is not receiving
brachytherapy.
2. Visibly post a
"Radioactive Materials" sign on the door of the patient's or human research
subject's room and note on the door or in the patient's or human research
subject's chart where and how long visitors may stay in the patient's or human
research subject's room.
(b) A licensee shall have available, near
each treatment room, emergency response equipment to respond to a source that
is any of the following:
1. Inadvertently
dislodged from the patient.
2.
Inadvertently lodged within the patient following removal of the source
applicators.
(c) A
licensee shall notify the radiation safety officer or his or her designee and
an authorized user as soon as possible if the patient or human research subject
has a medical emergency, and immediately if the patient dies.
(6) CALIBRATION MEASUREMENTS OF
BRACHYTHERAPY SOURCES.
(a) Prior to the first
medical use of brachytherapy sources, a licensee shall either comply with par.
(b) or do all of the following:
1. Determine
the source output or activity using a dosimetry system that meets the
requirements of s. DHS 157.67 (6).
2. Determine source positioning accuracy
within applicators.
3. Use
published protocols accepted by nationally recognized bodies to meet the
requirements of subds. 1. and 2.
(b) Instead of a licensee making its own
measurements as required in par. (a), the licensee may use measurements
provided by the source manufacturer or by a calibration laboratory accredited
by the American Association of Physicists in Medicine that are made in
accordance with par. (a).
(c) A
licensee shall mathematically correct the outputs or activities determined in
par. (a) for physical decay at intervals consistent with one percent physical
decay.
(d) A license shall retain a
record of each calibration under s. DHS 157.71 (18).
(6m) STRONTIUM-90 SOURCES FOR OPHTHALMIC
TREATMENTS.
(a) Licensees who use strontium-90
for ophthalmic treatments must ensure that certain activities as specified in
par. (b) of this section are performed by either of the following:
1. An authorized medical physicist.
2. An individual who meets all of the
following:
a. Is identified as an ophthalmic
physicist on a specific medical use license issued by the department, the NRC
or an agreement state, or permit issued by the NRC or an agreement state broad
scope medical use licensee, medical use permit issued by an NRC master material
licensee, or permit issued by an NRC master material licensee broad scope
medical use permittee.
b. Holds a
master's or doctor's degree in physics, medical physics, other physical
sciences, engineering, or applied mathematics from an accredited college or
university.
c. Has successfully
completed one year of full-time training in medical physics and an additional
year of full-time work experience under the supervision of a medical
physicist.
d. Has documented
training in the creation, modification, and completion of written
directives.
e. Has documented
training in procedures for administrations requiring a written
directive.
f. Has documented
training in performing the calibration measurements of brachytherapy sources as
detailed in sub. (6).
(b) The individuals who are identified in
par. (a) 1. or 2. shall do all of the following:
1. Calculate the activity of each
strontium-90 source that is used to determine the treatment times for
ophthalmic treatments. The decay must be based on the activity determined under
sub. (6).
2. Assist the licensee in
developing, implementing, and maintaining written procedures to provide high
confidence that the administration is in accordance with the written directive.
These procedures shall include the frequencies that the individual meeting the
requirements in par. (a) will observe treatments, review the treatment
methodology, calculate treatment time for the prescribed dose, and review
records to verify that the administrations were in accordance with the written
directives.
(c) Licensees
shall retain a record of the activity of each strontium-90 source in accordance
with s. DHS 157.71 (18).
(7) THERAPY-RELATED COMPUTER SYSTEMS. A
licensee shall perform acceptance testing on the treatment planning system of
therapy-related computer systems under published protocols accepted by
nationally recognized bodies. At a minimum, the acceptance testing shall
include, as applicable, verification of all of the following:
(a) Source-specific input parameters required
by the dose calculation algorithm.
(b) Accuracy of dose, dwell time and
treatment time calculations at representative points.
(c) Accuracy of isodose plots and graphic
displays.
(d) Accuracy of the
software used to determine radioactive source positions from radiographic
images.
Note: An example of a nationally recognized body is the American Association of Physicists in Medicine.
(8)
TRAINING FOR USE OF MANUAL BRACHYTHERAPY SOURCES. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of a manual
brachytherapy source for the uses authorized under sub. (1) to be a physician
who meets any of the following requirements:
(a) Is certified by a medical specialty board
whose certification process has been recognized by the department, the NRC or
an agreement state. To have its certification process recognized, a specialty
board shall require all candidates for certification to do all of the
following:
1. Successfully complete a minimum
of 3 years of residency training in a radiation oncology program approved by
the residency review committee of the accreditation council for graduate
medical education or royal college of physicians and surgeons of Canada or the
council on postdoctoral training of the American osteopathic
association.
2. Pass an
examination, administered by diplomates of the specialty board, that tests
knowledge and competence in radiation safety, radionuclide handling, treatment
planning, quality assurance, and clinical use of manual brachytherapy.
Note: Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
(b) Has completed a structured educational
program in basic radionuclide handling techniques applicable to the use of
manual brachytherapy sources that includes all of the following:
1. Two hundred hours of classroom and
laboratory training in all of the following areas:
a. Radiation physics and
instrumentation.
b. Radiation
protection.
c. Mathematics
pertaining to the use and measurement of radioactivity.
d. Radiation biology.
2. Five hundred hours of work experience,
under the supervision of an authorized user who meets the requirements in this
subsection, s. DHS 157.61 (10), or equivalent NRC or agreement state
requirements at a medical facility authorized to use byproduct materials under
sub. (1), involving all of the following:
a.
Ordering, receiving and unpacking radioactive materials safely and performing
the related radiation surveys.
b.
Checking survey meters for proper operation.
c. Preparing, implanting and removing
brachytherapy sources.
d.
Maintaining running inventories of material on hand.
e. Using administrative controls to prevent a
medical event involving the use of radioactive material.
f. Using emergency procedures to control
radioactive material.
3.
Three years of supervised clinical experience in radiation oncology, under an
authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, as part of a formal
training program approved by the Residency Review Committee for Radiation
Oncology of the Accreditation Council for Graduate Medical Education or the
Royal College of Physicians and Surgeons of Canada or the Council on
Postdoctoral Training of the American Osteopathic Association. The experience
may be obtained concurrently with the supervised work experience required by
subd. 2.
4. A written attestation
under sub. (10) (a).
(9) TRAINING FOR OPHTHALMIC USE OF
STRONTIUM-90. Except as provided in s. DHS 157.61 (10), a licensee shall
require an authorized user of strontium-90 for ophthalmic radiotherapy to be a
physician who meets any of the following requirements:
(a) Is an authorized user under sub. (8) or
equivalent NRC or agreement state requirement.
(b) Has had classroom and laboratory training
applicable to the use of strontium-90 for ophthalmic radiotherapy and a period
of supervised clinical training in ophthalmic radiotherapy that includes all of
the following:
1. Twenty-four hours of
classroom and laboratory training that includes all of the following:
a. Radiation physics and
instrumentation.
b. Radiation
protection.
c. Mathematics
pertaining to the use and measurement of radioactivity.
d. Radiation biology.
2. Supervised clinical training in ophthalmic
radiotherapy under the supervision of an authorized user at a medical
institution, clinic, or private practice that includes the use of strontium-90
for the ophthalmic treatment of 5 individuals. The supervised clinical training
shall include all of the following:
a.
Examination of each person to be treated.
b. Calculation of the dose to be
administered.
c. Administration of
the dose.
d. Follow up and review
of each individual's case history.
3. A written attestation under sub. (10)
(b).
(10)
WRITTEN ATTESTATION.
(a)
Manual
brachytherapy sources. As required by sub. (8) (b) 4., a licensee
shall require an authorized user of a manual brachytherapy source for the uses
authorized under sub. (1) to have obtained written attestation, signed by a
preceptor authorized user who meets the requirements in sub. (8), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, that the individual
has successfully completed the requirements in sub. (8) (b) and is able to
independently fulfill the radiation safety-related duties as an authorized user
of manual brachytherapy sources for the medical uses authorized under sub. (1).
The attestation must be obtained from any of the following:
1. A preceptor authorized user who meets the
requirements in sub. (8), s. DHS 157.61 (10), or equivalent NRC or agreement
state requirements.
2. A residency
program director who affirms in writing that the attestation represents the
consensus of the residency program faculty where at least one faculty member is
an authorized user who meets the requirements in sub. (8), s. DHS 157.61 (10),
or equivalent NRC or agreement state requirements and concurs with the
attestation provided by the residency program director. The residency training
program must be approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Council on Postdoctoral Training of the American
Osteopathic Association and must include training and experience specified in
sub (8) (b).
(b)
Ophthalmic use of strontium-90. As required by sub. (9) (b)
3., a licensee shall require an authorized user for ophthalmic use of
strontium-90 to have obtained written attestation, signed by a preceptor
authorized user who meets the requirements in sub. (8) or (9), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, that the individual
has successfully completed the requirements in sub. (9) (b) and is able to
independently fulfill the radiation safety-related duties as an authorized user
of strontium-90 for ophthalmic use.
Notes
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