(1) AUTHORITY AND
RESPONSIBILITIES FOR THE RADIATION PROTECTION PROGRAM.
(a) In addition to the radiation protection
program requirements of s.
DHS 157.21, a licensee's management shall approve in
writing any of the following:
1. A request
for license application, renewal or amendment before submittal to the
department.
2. Authorization prior
to using licensed materials for any individual to work as an authorized user,
authorized nuclear pharmacist or authorized medical physicist.
3. A radiation protection program change that
does not require a license amendment and is permitted under sub.
(2).
(b) A licensee's
management shall appoint a radiation safety officer who agrees in writing to be
responsible for implementing the radiation protection program. A licensee,
through the radiation safety officer, shall ensure that radiation safety
activities are being performed under licensee-approved procedures and
regulatory requirements. A licensee's management may appoint, in writing, one
or more associate radiation safety officers to support the radiation safety
officer. The radiation safety officer, with written agreement of the licensee's
management, must assign the specific duties and tasks to each associate
radiation safety officer. These duties and tasks are restricted to the types of
use for which the associate radiation safety officer is listed on a license.
The radiation safety officer may delegate duties and tasks to the associate
radiation safety officer but shall not delegate the authority or
responsibilities for implementing the radiation protection program.
(c) For up to 60 days each year, a licensee
may permit an individual qualified to be a radiation safety officer to function
as a temporary radiation safety officer and to perform the functions of a
radiation safety officer, as provided in par. (f), provided the licensee takes
the actions required in pars. (b), (d), (f), and (g) and notifies the
department in accordance with s.
DHS 157.13 (5) (c) 2. e. A licensee may
simultaneously appoint more than one temporary radiation safety officer if
needed to ensure that the licensee has a temporary radiation safety officer
that satisfies the requirements to be a radiation safety officer for each of
the different uses of radioactive material permitted by the license.
(d) A licensee shall establish in writing the
authority, duties and responsibilities of the radiation safety
officer.
(e) A licensee that is
authorized for 2 or more different types of uses of radioactive material under
ss.
DHS 157.64,
157.65 and
157.67 or 2 or more types of units under s.
DHS 157.67 shall establish a radiation safety committee to oversee all uses of
radioactive material permitted by the license. The committee shall include an
authorized user of each type of use permitted by the license, the radiation
safety officer, a representative of the nursing service and a representative of
management who is neither an authorized user nor a radiation safety officer,
and may include other members as the licensee deems appropriate.
(f) A licensee shall provide the radiation
safety officer sufficient authority, organizational freedom, time, resources
and management prerogative to perform all the following functions:
1. Identify radiation safety
problems.
2. Initiate, recommend or
provide corrective actions.
3. Stop
unsafe operations.
4. Verify
implementation of corrective actions.
(g) A licensee shall retain a record of
actions taken under pars. (a), (b) and (d) according to the record retention
requirements of s.
DHS 157.71 (1).
(2) RADIATION PROTECTION PROGRAM CHANGES.
(a) A licensee may revise its radiation
protection program without department approval if the revision meets all the
following criteria:
1. The revision does not
require a license amendment.
2. The
revision complies with the requirements of this chapter and the
license.
3. The revision has been
reviewed and approved by the radiation safety officer and licensee
management.
4. The affected
individuals are instructed on the revised program before the changes are
implemented.
(b) A
licensee shall retain a record of each change under s.
DHS 157.71 (2).
(3) SUPERVISION.
(a) A licensee who permits the receipt,
possession, use or transfer of radioactive material by an individual under the
supervision of an authorized user shall do all the following:
1. Instruct the supervised individual in the
licensee's written radiation protection procedures, written directive
procedures, requirements of this chapter and license conditions regarding the
use of radioactive material.
2.
Require the supervised individual to follow the instructions of the supervising
authorized user for medical uses of radioactive material, written radiation
protection procedures established by the licensee, requirements of this chapter
and license conditions regarding the medical use of radioactive
material.
(b) A licensee
who permits the preparation of radioactive material for medical use by an
individual under the supervision of an authorized nuclear pharmacist or
physician who is an authorized user shall do all of the following:
1. Instruct the supervised individual in the
preparation of radioactive material for medical use, as appropriate to that
individual's involvement with radioactive material.
2. Require the supervised person to follow
the instructions of the supervising authorized user or authorized nuclear
pharmacist regarding the preparation of radioactive material for medical use,
the written radiation protection procedures established by the licensee and the
regulations of this chapter, and license conditions.
(c) A licensee who permits supervised
activities under pars. (a) and (b) is responsible for the acts and omissions of
the supervised individual.
(4) WRITTEN DIRECTIVES.
(a)
1. A
written directive must be dated and signed by an authorized user prior to
administration of I-131 sodium iodide greater than 1.11 Megabecquerels (30
microcuries), any therapeutic dosage of unsealed radioactive material or any
therapeutic dose of radiation from radioactive material.
2. If, because of the emergent nature of the
patient's condition, a delay in providing a written directive would jeopardize
the patient's health, an oral directive from an authorized user is acceptable
provided the information contained in the oral directive is documented
immediately in writing in the patient's record and a written directive is
prepared within 48 hours of the oral directive.
3. A written revision to an existing written
directive may be made provided that the revision is dated and signed by an
authorized user prior to the administration of the dosage of radioactive drug
containing radioactive material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose or the next fractional dose.
4. If, because of the patient's condition, a
delay to provide a written revision to an existing written directive would
jeopardize the patient's health, an oral revision to an existing written
directive will be acceptable, provided that the oral revision is documented
immediately in the patient's record and a revised written directive is signed
by the authorized user within 48 hours of the oral
revision.
(b) The written
directive shall contain the patient or human research subject's name and all of
the following information:
1. For the
administration of a dosage of a radioactive drug, the name, dosage and
administration route of the radioactive drug.
2. For each anatomically distinct treatment
site exposed to gamma stereotactic radiosurgery, total dose, treatment site and
number of target settings per treatment.
3. For teletherapy, the total dose, dose per
fraction, number of fractions, treatment site and overall treatment
period.
4. For high dose rate
remote afterloading brachytherapy: the radionuclide, treatment site, dose per
fraction, number of fractions and total dose.
5. For permanent implant brachytherapy:
a. Before implantation, the written directive
shall include the treatment site, the radionuclide, and the total source
strength.
b. After implantation but
before the patient leaves the post-treatment recovery area, the written
directive shall include the treatment site, the number of sources implanted,
the total source strength implanted, and the date.
6. For all other brachytherapy including low
dose rate, medium dose rate and pulsed dose rate afterloaders:
a. Before implantation, the written directive
shall include the treatment site, radionuclide, and dose.
b. After implantation but before completion
of the procedure, the written directive shall include the radionuclide,
treatment site, number of sources, and total source strength and exposure time
(or the total dose), and date.
(c) A licensee shall retain the written
directive under s.
DHS 157.71 (3).
(5) PROCEDURES FOR ADMINISTRATIONS REQUIRING
A WRITTEN DIRECTIVE.
(a) For any
administration requiring a written directive, a licensee shall develop,
implement and maintain written procedures to help ensure both of the following:
1. The patient's or human research subject's
identity is verified by more than one method before each
administration.
2. Each
administration is performed according to the provisions of a written
directive.
(b) The
procedures required by par. (a) shall address all of the following items that
are applicable for the licensee's use of radioactive material:
1. Verifying the identity by more than one
method of the patient or human research subject.
2. Verifying that the specific details of the
administration are under the treatment plan, if applicable, and the written
directive.
3. Checking both manual
and computer-generated dose calculations.
4. Verifying that any computer-generated dose
calculations are correctly transferred into the consoles of therapeutic medical
units authorized by s.
DHS 157.67 or
157.70.
5. Determining if a medical event under s.
DHS 157.72 (1) has occurred.
6.
Determining, for permanent implant brachytherapy, within 60 calendar days from
the date the implant was performed, the total source strength administered
outside of the treatment site compared to the total source strength documented
in the post-implantation portion of the written directive, unless a written
justification of patient unavailability is
documented.
(6)
SUPPLIERS FOR SEALED SOURCES OR DEVICES FOR MEDICAL USE. For medical use, a
licensee may only use the following:
(a)
Sealed sources or devices manufactured, labeled, packaged and distributed under
a license issued under subch. II or the equivalent requirements of the NRC or
another agreement state.
(b)
Teletherapy sources manufactured and distributed under a license issued under
subch. II or the equivalent requirements of the NRC or another agreement
state.
(c) Sealed sources or
devices non-commercially transferred from a medical
licensee.
(7) TRAINING
FOR RADIATION SAFETY OFFICER AND ASSOCIATE RADIATION SAFETY OFFICER. Except as
provided in sub. (10), a licensee shall ensure that an individual fulfilling
the responsibilities of the radiation safety officer, or an individual assigned
duties and tasks as an associate radiation safety officer as provided in this
section, is an individual who has training in radiation safety, regulatory
issues and emergency procedures for the types of use for which a licensee seeks
approval. This training requirement may be satisfied by completing training
that is supervised by a radiation safety officer, associate radiation safety
officer, authorized medical physicist, authorized nuclear pharmacist or
authorized user, as appropriate, who is authorized for the type of use for
which the licensee is seeking approval. A licensee shall also require the
radiation safety officer or an associate radiation safety officer to be a
person who meets any of the following requirements:
(a) Is certified by a specialty board whose
certification process has been recognized by the department, the NRC or another
agreement state. To have its certification process recognized, a specialty
board shall require all candidates for certification to have either of the
following:
1.
a. A bachelor's or graduate degree from an
accredited college or university in physical science or engineering or
biological science with a minimum of 20 college credits in physical
science.
b. Five or more years of
professional experience in health physics (graduate training may be substituted
for no more than 2 years of the required experience) including at least 3 years
in applied health physics.
c.
Passed an examination administered by diplomates of the specialty board, which
evaluates knowledge and competence in radiation physics and instrumentation,
radiation protection, mathematics pertaining to the use and measurement of
radioactivity, radiation biology, and radiation dosimetry.
2.
a.
Master's or doctor's degree in physics, medical physics, other physical
science, engineering, or applied mathematics from an accredited college or
university.
b. Two years of
full-time practical training and/or supervised experience in medical physics
either under the supervision of a medical physicist who is certified in medical
physics by a specialty board recognized by the department, the NRC, or another
agreement state or in clinical nuclear medicine facilities providing diagnostic
and/or therapeutic services under the direction of physicians who meet the
requirements for authorized users in s.
DHS 157.61 (10),
157.63 (5) or
157.64 (4).
c. Pass an examination,
administered by diplomates of the specialty board, that assesses knowledge and
competence in clinical diagnostic radiological or nuclear medicine physics and
in radiation safety.
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 consisting of all the following:
1.
200 hours of classroom and laboratory training in all the following areas:
a. Radiation physics and
instrumentation.
b. Radiation
protection.
c. Mathematics
pertaining to the use and measurement of radioactivity.
d. Radiation biology.
e. Radiation dosimetry.
2. One year of full-time radiation safety
experience under the supervision of the individual identified as the radiation
safety officer on a department, NRC or another agreement state license, or a
permit issued by a NRC master material licensee that authorizes similar types
of uses of radioactive material. An associate radiation safety officer may
provide supervision for those areas for which the associate radiation safety
officer is authorized on a department, NRC, or an agreement state license or
permit issued by a NRC master material licensee. The full-time radiation safety
experience must involve all of the following:
a. Shipping, receiving, and performing
related radiation surveys.
b. Using
and performing checks for proper operation of instruments used to determine the
activity of dosages, survey meters and instruments used to measure
radionuclides.
c. Securing and
controlling radioactive material.
d. Using administrative controls to avoid
mistakes in the administration of radioactive material.
e. Using procedures to prevent or minimize
radioactive contamination and using proper decontamination
procedures.
f. Using emergency
procedures to control radioactive material.
g. Disposing of radioactive
material.
3. Has obtained
written attestation under sub. (12) (a).
(c) Is any one of the following:
1. A medical physicist who has been certified
by a specialty board whose certification process has been recognized by the
department, NRC, or another agreement state under sub. (8) (a), and has
experience in radiation safety aspects of similar types of use of radioactive
material for which the licensee seeks the approval of the individual as the
radiation safety officer or an associate radiation safety officer.
2. An authorized user, authorized medical
physicist, or authorized nuclear pharmacist identified on a department, NRC, or
an agreement state license, or medical use permit issued by an NRC master
material licensee, and has experience with the radiation safety aspects of
similar types of use of radioactive material for which the licensee seeks the
approval of the individual as the radiation safety officer or associate
radiation safety officer.
3. An
individual who has experience with the radiation safety aspects of the types of
use of radioactive material for which the individual is seeking simultaneous
approval both as the radiation safety officer and the authorized user on the
same new medical use license.
(8) TRAINING FOR AN AUTHORIZED MEDICAL
PHYSICIST. Except as provided in sub. (10), a licensee shall require the
authorized medical physicist to have training for the type of use for which
authorization is sought that includes hands-on device operation, safety
procedures, clinical use, and the operation of a treatment planning system.
This training requirement may be satisfied by successfully completing either a
training program provided by the vendor of the applicable system or device, or
by training supervised by an authorized medical physicist authorized for the
type of use for which the individual is seeking authorization. A licensee shall
also require the authorized medical physicist to be an individual who meets
either of the following requirements:
(a) Is
certified by a 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 have all of the following:
1. A master's or doctor's degree in physics,
medical physics, other physical science, engineering, or applied mathematics
from an accredited college or university.
2. Attained two years full-time practical
training or supervised experience in medical physics that meets either of the
following requirements:
a. Completed under the
supervision of a medical physicist who is certified in medical physics by a
specialty board recognized under this section by the department, the NRC, or an
agreement state.
b. Completed in
clinical radiation facilities providing high-energy, external beam therapy
(photons and electrons with energies greater than or equal to 1 million
electron volts) and brachytherapy services under the direction of physicians
who meet the requirements for authorized users in sub. (10) or s.
DHS 157.65 (8) or
157.67 (17).
3.
Passed an examination, administered by diplomates of the specialty board, that
assesses knowledge and competence in clinical radiation therapy, radiation
safety, calibration, quality assurance, and treatment planning for external
beam therapy, brachytherapy, and stereotactic radiosurgery.
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)
1.
Holds a master's or doctorate degree in physics, medical physics, other
physical science, engineering, or applied mathematics from an accredited
college or university and completed one year of full-time training in medical
physics and an additional year of full-time work experience under the
supervision of an individual who meets the requirements for an authorized
medical physicist for the type of use for which the individual is seeking
authorization. This training and work experience shall be conducted in clinical
radiation facilities that provide high energy, external beam therapy (photons
and electrons with energies greater than or equal to 1 million electron volts)
and brachytherapy services and shall include all of the following:
a. Performing sealed source leak tests and
inventories.
b. Performing decay
corrections.
c. Performing full
calibration and periodic spot checks of external beam treatment units,
stereotactic radiosurgery units, and remote afterloading units as
applicable.
d. Conducting radiation
surveys around external beam treatment units, stereotactic radiosurgery units,
and remote afterloading units as applicable.
2. Has obtained written attestation under
sub. (12) (b).
(9) TRAINING FOR AN AUTHORIZED NUCLEAR
PHARMACIST. Except as provided in sub. (10), the licensee shall require the
authorized nuclear pharmacist to be a pharmacist who meets either of the
following requirements:
(a) Is certified by a
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
have all of the following:
1. Graduated from a
pharmacy program accredited by the Accreditation Council for Pharmacy Education
or have passed the foreign pharmacy graduate examination committee
examination.
2. A current, active
license to practice pharmacy.
3.
Evidence of having acquired at least 4000 hours of training and experience in
nuclear pharmacy practice. Academic training may be substituted for no more
than 2000 hours of the required training and experience.
4. Evidence of having passed an examination
in nuclear pharmacy administered by diplomates of the specialty board, that
assesses knowledge and competency in the procurement, compounding, quality
assurance, dispensing, distribution, health and safety, radiation safety,
provision of information and consultation, monitoring patient outcomes,
research and development.
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 700 hours in a structured
educational program including all of the following requirements:
1. Two hundred hours of classroom and
laboratory training covering all of the following areas:
a. Radiation physics and
instrumentation.
b. Radiation
protection.
c. Mathematics
pertaining to the use and measurement of radioactivity.
d. Chemistry of radioactive material for
medical use.
e. Radiation
biology.
2. Supervised
practical experience in a nuclear pharmacy involving all the following:
a. Shipping, receiving and performing related
radiation surveys.
b. Using and
performing checks for proper operation of instruments used to determine the
activity of dosages, survey meters, and if appropriate, instruments used to
measure alpha-emitting or beta-emitting radionuclides.
c. Calculating, assaying and safely preparing
dosages for patients or human research subjects.
d. Using administrative controls to avoid
medical events in the administration of radioactive material.
e. Using procedures to prevent or minimize
radioactive contamination and using proper decontamination
procedures.
3. Has
obtained written attestation under sub. (12) (c).
(10) TRAINING FOR EXPERIENCED RADIATION
SAFETY OFFICER, TELETHERAPY OR MEDICAL PHYSICIST, AUTHORIZED USER, NUCLEAR
PHARMACIST, AND AUTHORIZED NUCLEAR PHARMACIST.
(a)
1. An
individual identified as a radiation safety officer, a teletherapy or medical
physicist, an authorized medical physicist, a nuclear pharmacist, or an
authorized nuclear pharmacist on a department, NRC or another agreement state
license, or permit issued by a NRC or agreement state broad scope licensee or
master material license permit or by a master material license permittee of
broad scope on or before January 14, 2019, is exempt from the training
requirements of subs. (7) to (9), respectively, except the radiation safety
officers and authorized medical physicists identified in this paragraph must
meet the training requirements of sub. (7) or (8), as appropriate, for any
material uses for which they were not authorized prior to this date.
2. Any individual certified by the American
Board of Health Physics in Comprehensive Health Physics; American Board of
Radiology; American Board of Nuclear Medicine; American Board of Science in
Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy;
American Board of Medical Physics in radiation oncology physics; Royal College
of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic
Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or
before October 24, 2005, is exempt from the training requirements of sub. (7)
to be identified as a radiation safety officer or as an associate radiation
safety officer on a department, NRC, or an agreement state license or NRC
master material license permit for those materials and uses that these
individuals performed on or before October 24, 2005.
3. Any individual certified by the American
Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma
ray physics, x-ray and radium physics, or radiological physics, or certified by
the American Board of Medical Physics in radiation oncology physics, on or
before October 24, 2005, is exempt from the training requirements for an
authorized medical physicist described in sub. (8), for those materials and
uses that these individuals performed on or before October 24, 2005.
4. A radiation safety officer, a medical
physicist, or a nuclear pharmacist, who used only accelerator-produced
radioactive materials, discrete sources of radium-226, or both, for medical
uses or in the practice of nuclear pharmacy at a government agency or federally
recognized Indian Tribe before November 30, 2007, or at all other locations of
use before August 8, 2009, or an earlier date as noticed by the department, is
exempt from the training requirements of subs. (7) to (9), respectively, when
performing the same uses. A nuclear pharmacist, who prepared only radioactive
drugs containing accelerator-produced radioactive materials, or a medical
physicist, who used only accelerator-produced radioactive materials, at the
locations and during the time period identified in this paragraph, qualifies as
an authorized nuclear pharmacist or an authorized medical physicist,
respectively, for those materials and uses performed before these dates, for
the purposes of this chapter.
(b) An individual identified as a radiation
safety officer, an authorized medical physicist, or an authorized nuclear
pharmacist on a department, NRC or another agreement state license, the permit
issued by a licensee of broad scope or the permit issued by NRC master material
licensee between October 24, 2002 and April 29, 2005 is exempt from the
training requirements of sub. (7), (8) or (9).
(c)
1.
Physicians, dentists, or podiatrists who are identified as authorized users for
the medical use of radioactive material on a license issued by the department,
the NRC, an agreement state, a permit issued by a NRC master material licensee,
a permit issued by a NRC or an agreement state broad scope licensee, or a
permit issued by a NRC master material license broad scope permittee on or
before January 14, 2019, who perform only those medical uses for which they
were authorized on or before that date is exempt from the training requirements
of ss.
DHS 157.63 to
157.67.
2.
Physicians, dentists, or podiatrists not identified as authorized users for the
medical use of radioactive material on a license issued by the department, the
NRC, an agreement state, a permit issued by a NRC master material licensee, a
permit issued by a NRC or an agreement a state broad scope licensee, or a
permit issued in accordance with a NRC master material broad scope license on
or before October 24, 2005, is exempt from the training requirements of ss.
DHS 157.63 to
157.67 for any of the following materials and uses that these
individuals performed on or before October 24, 2005:
a. For uses authorized under s.
DHS 157.63 (1) or (2), or oral administration of sodium iodide I-131 requiring a written
directive for imaging and localization purposes, a physician who was certified
on or before October 24, 2005, by the American Board of Nuclear Medicine in
nuclear medicine, the American Board of Radiology in diagnostic radiology, the
American Osteopathic Board of Radiology in diagnostic radiology or radiology
the Royal College of Physicians and Surgeons of Canada in nuclear medicine, or
American Osteopathic Board of Nuclear Medicine in nuclear medicine.
b. For uses authorized under s.
DHS 157.64 (1), a physician who was certified on or before October 24, 2005, by the
American Board of Nuclear Medicine, the American Board of Radiology in
radiology, therapeutic radiology, or radiation oncology, the Royal College of
Physicians and Surgeons of Canada in nuclear medicine, or the American
Osteopathic Board of Radiology after 1984.
c. For uses authorized under s.
DHS 157.65 (1) or
157.67 (1), a physician who was certified on or before October 24, 2005,
by the American Board of Radiology in radiology, therapeutic radiology or
radiation oncology, the American Osteopathic Board of Radiology in radiation
oncology, or the Canadian Royal College of Physicians and Surgeons in
therapeutic radiology, or as a British "Fellow of the Faculty of Radiology" or
"Fellow of the Royal College of Radiology" in radiology, with specialization in
radiotherapy.
d. For uses
authorized under s.
DHS 157.66 (1), a physician who was certified on or before
October 24, 2005, by the American Board of Radiology, in radiology, diagnostic
radiology, therapeutic radiology, or radiation oncology, the American Board of
Nuclear Medicine in nuclear medicine, the American Osteopathic Board of
Radiology in diagnostic radiology or radiology, or the Royal College of
Physicians and Surgeons of Canada in nuclear medicine.
3. Physicians, dentists, or podiatrists who
used only accelerator-produced radioactive materials, discrete sources of
radium-226, or both, for medical uses performed at a government agency or
federally recognized Indian Tribe before November 30, 2007, or at all other
locations of use before August 8, 2009, or an earlier date as noticed by the
department, are exempt from the training requirements of ss.
DHS 157.63 to
157.67 when performing the same medical uses. A physician, dentist, or
podiatrist, who used only accelerator-produced radioactive materials, discrete
sources of radium-226, or both, for medical uses at the locations and time
period identified in this paragraph, qualifies as an authorized user for those
materials and uses performed before these dates, for the purposes of this
chapter.
(d) Individuals
who are not required to comply with the training requirements as described in
this section may serve as preceptors for, and supervisors of, applicants
seeking authorization on department licenses for the same uses for which these
individuals are authorized.
(11) RECENTNESS OF TRAINING. The training and
experience specified in this section and ss.
DHS 157.63 to
157.67 shall have
been completed within 7 years preceding the date of license application. If the
training and experience specified in this section and ss.
DHS 157.63 to
157.67
have not been completed within 7 years preceding the date of license
application, additional related continuing education and experience shall be
required.
(12) WRITTEN ATTESTATION.
(a)
Radiation safety officer or
associate radiation safety officer. As required by sub. (7) (b) 3.,
the licensee shall ensure that an individual fulfilling the responsibilities of
the radiation safety officer or associate radiation safety officer has obtained
written attestation, signed by a preceptor radiation safety officer or
associate radiation safety officer who has experience with the radiation safety
aspects of similar types of use of byproduct material for which the individual
is seeking approval as a radiation safety officer or an associate radiation
safety officer. The written attestation must state that the individual has
successfully completed the requirements in sub. (7) (b), has training in the
radiation safety, regulatory issues, and emergency procedures for the types of
use for which a licensee seeks approval and is able to independently fulfill
the radiation safety-related duties as a radiation safety officer or as an
associate radiation safety officer for a medical use license.
(b)
Authorized medical
physicist. As required by sub. (8) (b) 2., the licensee shall ensure
that the individual has obtained written attestation that the individual has
successfully completed the requirements in sub. (8) (b) 1., has training for
the type of use for which authorization is sought that includes hands-on device
operation, safety procedures, clinical use, and the operation of a treatment
planning system, and is able to independently fulfill the radiation
safety-related duties as an authorized medical physicist for each type of
therapeutic medical unit for which the individual is requesting authorized
medical physicist status. The written attestation shall be signed by a
preceptor authorized medical physicist who meets the requirements in sub. (8)
or (10), or equivalent NRC or agreement state requirements, for an authorized
medical physicist for each type of therapeutic medical unit for which the
individual is requesting authorized medical physicist status.
(c)
Authorized nuclear
pharmacist. As required by sub. (9) (b) 3., the licensee shall ensure
that the individual has obtained written attestation, signed by a preceptor
authorized nuclear pharmacist, 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 nuclear
pharmacist.
Notes
Wis. Admin. Code Department of Health Services
DHS 157.61
CR 01-108: cr.
Register July 2002 No. 559, eff. - see Note at the start of the chapter; CR
06-021: am. (1) (g), r. and recr. (7) to (10), cr. (12) Register October 2006
No. 610, eff. 11-1-06; CR 09-062: am. (10) (a) and (12) (b), renum. (10) (b) to
be (10) (c), cr. (10) (b) Register April 2010 No. 652, eff. 5-1-10.
Amended by,
CR 16-078: am. (7) (a) 2. b., (8) (a) 1. b., (10) (a), (c), cr. (10) (d)
Register
January 2018 No. 745, eff.
2/1/2018
Amended by, CR 22-015: am. (1) (b),
(c), (4) (a) 1., r. and recr. (4) (b), am. (5) (b) 3., 4., cr. (5) (b) 5., 6.,
am. (7) (intro.), (a) (intro.), (b) 2. (intro.), cr. (7) (b) 3., am. (7) (c)
1., 2., cr. (7) (c) 3., r. and recr. (8), am. (9) (intro.), (a) (intro.), 1.,
cr. (9) (b) 3., r. and recr. (10), am. (12) Register June 2023 No. 810, eff.
7-1-23; correction in (5) (b) 4., 5., (7) (intro.), (8) (a) 2. b., (10) (a) 1.
to 3., (b), (c) 2. a., c., 3. made under s. 35.17, Stats.,
Register
June 2023 No. 810, eff. 7/1/2023