Wis. Admin. Code Department of Health Services DHS 157.63 - Unsealed radioactive material - written directive not required
(1) USE OF
UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND EXCRETION STUDIES FOR
WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED. A licensee may use for uptake,
dilution or excretion studies any unsealed radioactive material, except in
quantities that require a written directive under s. DHS 157.61 (4), prepared
for medical use that meets any of the following requirements:
Note: Uptake, dilution and excretion studies determine the amount of radioactive material absorbed by a patient and the patient's ability to excrete the remainder of the radioactive material.
(a) Is obtained from any of the following:
1. A manufacturer or preparer licensed under
s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state
requirements.
2. A PET radioactive
drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other
agreement state requirements.
(b) Excluding production of PET
radionuclides, is prepared by any of the following:
1. An authorized nuclear
pharmacist.
2. A physician who is
an authorized user and who meets the requirements in sub. (5), or sub. (5) (c)
2. g. and s. DHS 157.64 (4).
3. An
individual under the supervision, as specified in s. DHS 157.61 (10), of the
authorized nuclear pharmacist in subd.1. or the physician in subd.
2.
(c) Is obtained from
an NRC or agreement state licensee for use in research under a radioactive drug
research committee-approved protocol or an investigational new drug protocol
accepted by the FDA.
(d) Is
prepared by the licensee for use in research under a radioactive drug research
committee-approved application or an investigational new drug protocol accepted
by the FDA.
Note: Information on radioactive drugs or investigational new drug protocols may be obtained from the following FDA website: http://www.fda.gov/Radiation-EmittingProducts/default.htm.
(2) USE OF UNSEALED
RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN
DIRECTIVE IS NOT REQUIRED. A licensee may use for imaging and localization
studies any unsealed radioactive material, except in quantities that require a
written directive under s. DHS 157.61 (4), prepared for medical use that meets
any of the following requirements:
(a) Is
obtained from any of the following:
1. A
manufacturer or preparer licensed under s. DHS 157.13 (4) (i), or equivalent
NRC or other agreement state requirements.
2. A PET radioactive drug producer licensed
under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state
requirements.
(b) Is
prepared by, excluding production of PET radionuclides, any of the following:
1. An authorized nuclear
pharmacist.
2. A physician who is
an authorized user and who meets the requirements in sub. (5), or s. DHS 157.64 (4) and sub. (5) (c) 2. g.
3. An
individual under the supervision, as specified in s. DHS 157.61 (3), of the
authorized nuclear pharmacist in subd.1., or the physician in subd.
2.
(c) Is obtained from a
NRC or agreement state licensee for use in research under a radioactive drug
research committee-approved protocol or an investigational new drug protocol
accepted by the FDA.
(d) Is
prepared by the licensee for use in research under a radioactive drug research
committee-approved application or an investigational new drug protocol accepted
by the FDA.
(3)
PERMISSIBLE RADIONUCLIDE CONTAMINANTS.
(a) A
licensee may not administer to humans a radioactive drug containing more than
the following:
1. 0.15 kilobecquerel of
molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of
molybdenum-99 per 1 millicurie of technetium 99m).
2. 0.02 kilobecquerel of strontium-82 per
megabecquerel of rubidium-82 chloride injection (0.02 microcurie of
strontium-82 per 1 millicurie of rubidium-82 chloride injection).
3. 0.2 kilobecquerel of strontium-85 per
megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85
per 1 millicurie of rubidium-82 chloride injection).
(b) A licensee that prepares radioactive
drugs from radionuclide generators shall do all the following:
1. If using a molybdenum-99/technetium-99m
generator for preparing a technetium-99m radiopharmaceutical, measure the
molybdenum-99 concentration in each eluate from a generator to demonstrate
compliance with par. (a).
2.
Measure the concentration of radionuclide contaminant in each eluate or
extract, as appropriate for other generator systems.
3. If using a strontium-82/rubidium-82
generator for preparing a rubidium-82 radiopharmaceutical shall, before the
first patient use of the day, measure the concentration of radionuclides
strontium-82 and strontium-85 to demonstrate compliance with par.
(a).
(c) A licensee that
must measure radionuclide contaminant concentration shall retain a record of
each measurement under s. DHS 157.71 (14).
(d) The licensee shall report any measurement
that exceeds the limits in par. (a) at the time of generator elution, in
accordance with s. DHS 157.72 (4).
(4) TRAINING FOR UPTAKE, DILUTION AND
EXCRETION STUDIES. Except as provided in s. DHS 157.61 (10), a licensee shall
require an authorized user of unsealed radioactive material 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. Complete 60 hours
of training and experience in basic radionuclide handling techniques and
radiation safety applicable to the medical use of unsealed radioactive material
for uptake, dilution, and excretion studies that includes the topics listed in
par. (c).
2. Pass an examination,
administered by diplomates of the specialty board, that assesses knowledge and
competence in radiation safety, radionuclide handling, and quality control.
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) Is an authorized user under sub. (5), s.
DHS 157.64 (4), or equivalent NRC or agreement state requirements.
(c) Has completed 60 hours of training and
experience, including a minimum of 8 hours of classroom and laboratory
training, in basic radionuclide handling techniques applicable to the medical
use of unsealed radioactive material for uptake, dilution and excretion studies
that includes all the following:
1. 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. Chemistry of radioactive material for
medical use.
e. Radiation
biology.
2. Work
experience, under the supervision of an authorized user who meets the
requirements in this subsection, sub. (4) or (5), s. DHS 157.61 (10) or 157.64 (4), or equivalent NRC or agreement state requirements, involving all the
following:
a. Ordering, receiving and
unpacking radioactive materials safely and performing the related radiation
surveys.
b. Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters.
c. Calculating, measuring and safely
preparing patient or human research subject dosages.
d. Using administrative controls to prevent a
medical event involving the use of unsealed radioactive material.
e. Using procedures to contain spilled
radioactive material safely and using proper decontamination
procedures.
f. Administering
dosages of radioactive drugs to patients or human research
subjects.
3. A written
attestation under sub. (6) (a).
(5) TRAINING FOR IMAGING AND LOCALIZATION
STUDIES. Except as provided in s. DHS 157.61 (10), a licensee shall require an
authorized user of unsealed radioactive material for the uses authorized under
sub. (2) to be a physician who meets any of the following requirements:
(a) Is certified by a medical special 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 both of the
following:
1. Complete 700 hours of training
and experience in basic radionuclide handling techniques and radiation safety
applicable to the medical use of unsealed radioactive material for imaging and
localization studies that includes the topics listed in par. (c) 1. and
2.
2. Pass an examination,
administered by diplomates of the specialty board, which assesses knowledge and
competence in radiation safety, radionuclide handling, and quality control.
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) Is an authorized user under s. DHS 157.64 (4) and meets the requirements in par. (c) 2. g., or equivalent NRC or
agreement state requirements.
(c)
Has completed 700 hours of training and experience, including a minimum of 80
hours of classroom and laboratory training, in basic radionuclide handling
techniques applicable to the medical use of unsealed radioactive material for
imaging and localization studies that includes, at a minimum, all the
following:
1. 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.
Chemistry of radioactive material for medical use.
e. Radiation biology.
2. Work experience, under the supervision of
an authorized user, who meets the requirements in this subsection, s. DHS 157.61 (10), or subd. 2. g. and s. DHS 157.64 (4), or equivalent NRC or
agreement state requirements. An authorized nuclear pharmacist who meets the
requirements in s. DHS 157.61 (9) or (10) may provide the supervised work
experience under subd. 2. g. Work experience must include all of the following:
a. Ordering, receiving and unpacking
radioactive materials safely and performing the related radiation
surveys.
b. Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters.
c. Calculating, measuring and safely
preparing patient or human research subject dosages.
d. Using administrative controls to prevent a
medical event involving the use of unsealed radioactive material.
e. Using procedures to safely contain spilled
radioactive material and using proper decontamination procedures.
f. Administering dosages of radioactive drugs
to patients or human research subjects.
g. Eluting generator systems appropriate for
preparation of radioactive drugs for imaging and localization studies,
measuring and testing the eluate for radionuclidic purity, and processing the
eluate with reagent kits to prepare labeled radioactive drugs.
Note: Eluting generator systems are a family of radioactive material devices used to extract useful radioactive materials by passing sterile fluid through a column of the parent material. The resulting mixture of fluid and radioactive material, known as the eluate, is used in the diagnostic procedures. These generators are used to produce Tc-99m, Ga-67 or Rb-82.
3. A
written attestation under sub. (6) (b).
(6) WRITTEN ATTESTATION.
(a)
Unsealed radioactive material for
uptake, dilution, and excretion studies for which a written directive is not
required. As required by sub. (4) (c) 3., the licensee shall require
an authorized user of unsealed radioactive material for the uses authorized
under sub. (1) to have obtained written attestation that the individual has
successfully completed the requirements of sub. (4) (c) and is able to
independently fulfill the radiation safety-related duties as an authorized user
for the medical uses authorized under sub. (1). The attestation must be
obtained from either of the following:
1. A
preceptor authorized user who meets the requirements of sub. (4) or (5), s. DHS 157.61 (10), s. DHS 157.64 (4), 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 sub. (4) or (5), s. DHS 157.61 (10), s. DHS 157.64 (4), 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. (4) (c).
(b)
Unsealed radioactive material for
imaging and localization studies for which a written directive is not
required. As required by sub. (5) (c) 3., the licensee shall require
an authorized user of unsealed radioactive material for uses under sub. (2) to
have written attestation that the individual has successfully completed the
requirements in sub. (5) (c) and is able to independently fulfill the radiation
safety-related duties as an authorized user for the medical uses authorized
under subs. (1) and (2). The attestation must be obtained from either of the
following:
1. A preceptor authorized user who
meets the requirements in sub. (5), s. DHS 157.61 (10), ss. DHS 157.64 (4) and 157.63 (5) (c) 2. g., 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 sub. (5), s. DHS 157.61 (10), ss.
DHS 157.64 (4) and 157.63 (5) (c) 2. g., 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. (5)
(c).
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.