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| Vanderbilt University Online Radiation Safety Policies &
Procedures Manual |
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Table of Contents |
Appendix A: Acceptable Training and Experience for Medical Uses of
Radioactive Material
A. Training requirements for physician to use or supervise the use of
radioactive materials listed in Groups I, II, and III
The authorized user of a radiopharmaceutical, generator, or reagent kit must
be a physician who:
- Is certified in:
- Nuclear Medicine by the American Board of Nuclear Medicine;
- Diagnostic Radiology or Radiology by the American Board of Radiology;
- Diagnostic Radiology or Radiology by the American Osteopathic Board of
Radiology;
- Nuclear Medicine by the Royal College of Physicians and Surgeons of
Canada; or
- American Osteopathic Board of Nuclear Medicine in nuclear medicine; or
- (I) Has completed 700 hours of training and experience in basic
radionuclide handling techniques applicable to the medical use of unsealed
byproduct material for imaging and localization studies. The training and
experience must include, at a minimum,--
- Classroom and laboratory training in the following areas--
- Radiation physics and instrumentation;
- Radiation protection;
- Mathematics pertaining to the use and measurement of radioactivity
- Chemistry of byproduct material for medical use;
- Radiation biology; and
- Work experience, under the supervision of an authorized user, who meets
the requirements in 10 CFR 35.290, 35.390, or, before October 24, 2005,
10 CFR 35.920, or equivalent Agreement State requirements, involving--
- Ordering, receiving, and unpacking radioactive materials safely and
performing the related radiation surveys;
- Calibrating instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
- Calculating, measuring, and safely preparing patient or human research
subject dosages;
- Using administrative controls to prevent a medical event involving the
use of unsealed byproduct material;
- Using procedures to safely contain spilled radioactive material and
using proper decontamination procedures;
- Administering dosages of radioactive drugs to patients or human
research subjects; and
- Eluting generator systems appropriate for preparation of radioactive
drugs for imaging and localization studies, measuring and testing the
eluate for radionuclidic purity, and processing the eluate with reagent
kits to prepare labeled radioactive drugs; and
(II) Has obtained written certification, signed by a preceptor authorized
user who meets the requirements in 10 CFR 35.290, 35.390, or, before
October 24, 2005, 35.920, or equivalent Agreement State requirements, that
the individual has satisfactorily completed the requirements in paragraph
(c)(1) of this section and has achieved a level of competency sufficient to
function independently as an authorized user for the medical uses authorized
under 10 CFR 35.100 and 35.200; or
- Is an authorized user under 10 CFR 35.390, or, before October 24,
2005, 35.920, or equivalent Agreement State requirements; or
- The requirements specified in 2 may be satisfied concurrently in a three
month training program if all three areas are integrated into the program;
or
- Has successfully completed a six-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 paragraph (2) of this section; or
- A physician that the Radiation Safety Committee (RSC) recognizes as
having equivalent training and experience. Examples of documentation that
the RSC will consider in its evaluation is documentation that the applicant
has substantial previous experience at another institution or is listed as
an Authorized User on a license issued by the Nuclear Regulatory Commission
(NRC) for the types of procedures requested.
B. Training requirements for physician who wishes to be authorized for
only one or two diagnostic procedures:
- Group I (uptake, dilution, and excretion studies): The authorized user of
a radiopharmaceutical in uptake, dilution, and excretion studies must be a
physician who:
- Has had classroom and laboratory training in basic radioisotope handling
techniques applicable to the use of prepared radiopharmaceuticals, and
supervised clinical experience as follows:
- 40 hours of classroom and laboratory training that includes:
- Radiation physics and instrumentation;
- Radiation protection;
- Mathematics pertaining to the use and measurement of radioactivity;
- Radiation biology; and
- Radiopharmaceutical chemistry; and
- 20 hours of supervised clinical experience under the supervision of an
authorized user and that includes:
- Examining patients or human research subjects and reviewing their case
histories to determine their suitability for radioisotope diagnosis,
limitations, or contraindications;
- Selecting the suitable radiopharmaceuticals and calculating and measuring the
dosages;
- Administering dosages to patients or human research subjects and using
syringe radiation shields;
- Collaborating with the authorized user in the interpretation of radioisotope
test results; and
- Patient or human research subject follow up; or
- A physician that the Radiation Safety Committee (RSC) recognizes as having
equivalent training and experience. Examples of documentation that the RSC will
consider in its evaluation is documentation that the applicant has substantial
previous experience at another institution or is listed as an Authorized User on
a license issued by the Nuclear Regulatory Commission (NRC) or agreement state
for the types of procedures requested.
- Group II (imaging and localization studies) or Group III (Generators and
reagent kits)
- A physician should qualify under requirements of A(1), A(2) and A(4); or
- Be a physician that the Radiation Safety Committee (RSC) recognizes as having
equivalent training and experience. Examples of documentation that the RSC will
consider in its evaluation is documentation that the applicant has substantial
previous experience at another institution or is listed as an Authorized User on
a license issued by the Nuclear Regulatory Commission (NRC) or agreement state
for the types of procedures requested.
C. Training requirements for a physician who wishes to be authorized for only
one or two diagnostic procedures to use or supervise the use of sealed sources
of radioactive material
The authorized user of a sealed source in a device for bone mineral analysis
which contains Iodine-125, Americium-241, or Gadolinium-153 must be a physician,
dentist, or podiatrist who:
- Is certified in:
- Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology
by the American Board of Radiology;
- Nuclear medicine by the American Board of Nuclear Medicine;
- Diagnostic radiology or radiology by the American Osteopathic Board of
Radiology; or
- Nuclear medicine by the Royal College of Physicians and Surgeons of Canada;
or
- Has had 8 hours of classroom and laboratory training in basic radioisotope
handling techniques specifically applicable to the use of the device that
includes:
- Radiation physics, mathematics pertaining to the use and measurement of
radioactivity, and instrumentation;
- Radiation biology;
- Radiation protection; and
- Training in the use of the device for the uses requested.
D. Training requirements for physician who wish to perform therapy procedures
involving radiopharmaceuticals (Group IV and V)
The authorized user of a radiopharmaceutical for therapy procedures must be a
physician who:
- Is certified by:
- The American Board of Nuclear Medicine;
- The American Board of Radiology in radiology, therapeutic radiology, or
radiation oncology;
- Nuclear medicine by the Royal College of Physicians and Surgeons of Canada;
or
- The American Osteopathic Board of Radiology after 1984; or
- Has had classroom and laboratory training in basic radioisotope handling
techniques applicable to the use of therapeutic radiopharmaceuticals, and
supervised clinical experience as follows:
- 80 hours of classroom and laboratory training that includes:
- Radiation physics and instrumentation (approx. 25 hours);
- Radiation protection (approx. 25 hours);
- Mathematics pertaining to the use and measurement of radioactivity
(approx. 10 hours); and
- Radiation biology (approx. 20 hours); and
- Clinical experience for specific Group IV therapy procedures:
- Iodine-131 for treatment of hyperthyroidism and/or cardiac conditions:
Clinical experience in the diagnosis of thyroid function and active
participation in treatment of ten (10) patients.
- Phosphorus-32 for treatment of polycythemia vera, leukemia and/or bone
metastases: Active participation in the treatment of three (3) patients with any
combination of these three conditions.
- Colloidal phosphorus-32 intracavitary treatment: Active participation in
the treatment of three (3) patients.
- Clinical experience for specific Group V therapy procedures:
- Iodine-131 for treatment of thyroid carcinoma: Clinical experience in
diagnosis of thyroid function, personal participation in the treatment of ten
(10) patients with hyperthyroidism and/or cardiac dysfunction, and active
participation in treatment of three (3) patients with thyroid carcinoma.
- Colloidal gold-198 for intracavitary treatment: Active participation in
treatment of three (3) patients.
- Is a physician that the RSC recognizes as having equivalent training and
experience. Examples of documentation that the RSC will consider in its
evaluation is documentation that the applicant has substantial previous
experience at another institution or is listed as an Authorized User on a
license issued by the Nuclear Regulatory Commission (NRC) or agreement state for
the types of procedures requested.
E. Training requirements for therapy procedures involving sealed sources
The authorized user of a brachytherapy source listed in Group VI for therapy
must be a physician who:
- Is certified in:
- Radiology, therapeutic radiology, or radiation oncology by the American Board
of Radiology;
- Radiation oncology by the American Osteopathic Board of Radiology;
- Radiology, with specialization in radiotherapy, as a British "Fellow of the
Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
- Therapeutic radiology by the Canadian Royal College of Physicians and
Surgeons; or
- Is in the active practice of therapeutic radiology, has had classroom and
laboratory training in radioisotope handling techniques applicable to the
therapeutic use of brachytherapy sources, supervised work experience, and
supervised clinical experience as follows:
- 200 hours of classroom and laboratory training that includes:
- Radiation physics and instrumentation (approx. 110 hours);
- Radiation protection (approx. 40 hours);
- Mathematics pertaining to the use and measurement of radioactivity
(approx. 25 hours); and
- Radiation biology (approx. 25 hours);
- 500 hours of supervised work experience under the supervision of an
authorized user at a medical institution that includes:
- Ordering, receiving, and unpacking radioactive materials safely and
performing the related radiation surveys;
- Checking survey meters for proper operation;
- Preparing, implanting, and removing sealed sources;
- Maintaining running inventories of material on hand;
- Using administrative controls to prevent the misadministration of byproduct
material; and
- Using emergency procedures to control byproduct material; and
- Three (3) years of supervised clinical experience that includes one (1) year
in a formal 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 two years of clinical experience in therapeutic radiology under
the supervision of an authorized user at a medical institution that includes:
- Examining individuals and reviewing their case histories to determine their
suitability for brachytherapy treatment, and any limitations or
contraindications;
- Selecting the proper brachytherapy sources and dose and method of
administration;
- Calculating the dose; and
- Post-administration follow up and review of case histories in collaboration
with the authorized user.
F. Training for physicians wishing to use Strontium-90 Ophthalmic Eye
applicators only.
The authorized user of only a strontium-90 ophthalmic eye applicator for therapy
must be a physician who:
- Is certified by the American Board of Radiology in radiology or therapeutic
radiology; or
- The authorized user of only strontium-90 for ophthalmic radiotherapy must be
a physician who is in the active practice of therapeutic radiology or
ophthalmology, and has had classroom and laboratory training in basic
radioisotope handling techniques applicable to the use of strontium-90 for
ophthalmic radiotherapy, and a period of supervised clinical training in
ophthalmic radiotherapy as follows:
- 24 hours of classroom and laboratory training that includes:
- Radiation physics and instrumentation; (6 hours)
- Radiation protection; (6 hours)
- Mathematics pertaining to the use and measurement of radioactivity; and (4
hours)
- Radiation biology; (8 hours)
- Supervised clinical training in ophthalmic radiotherapy under the supervision
of an authorized user at a medical institution that includes the use of
strontium-90 for the ophthalmic treatment of five individuals that includes:
- Examination of each individual to be treated;
- Calculation of the dose to be administered;
- Administration of the dose; and
- Follow up and review of each individual's case history.
G. Training requirements for therapy procedures involving accelerators
The authorized user of a medical accelerator used for therapy must be a
physician who:
- Is certified in:
- Radiology, therapeutic radiology, or radiation oncology by the American Board
of Radiology;
- Radiation oncology by the American Osteopathic Board of Radiology;
- Radiology, with specialization in radiotherapy, as a British "Fellow of the
Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
- Therapeutic radiology by the Canadian Royal College of Physicians and
Surgeons; or
- Is in the active practice of therapeutic radiology, and has had classroom and
laboratory training in basic medical accelerator techniques applicable to the
use of a medical accelerator in therapy, supervised work experience, and
supervised clinical experience as follows:
- 200 hours of classroom and laboratory training that includes:
- Radiation physics and instrumentation;
- Radiation protection;
- Mathematics pertaining to the use and measurement of radioactivity; and
- Radiation biology;
- 500 hours of supervised work experience under the supervision of an
authorized user at a medical institution that includes:
- Review of the full calibration measurements and periodic spot checks;
- Preparing treatment plans and calculating treatment times;
- Using administrative controls to prevent misadministrations;
- Implementing emergency procedures to be followed in the event of the
abnormal operation of a medical accelerator unit; and
- Checking and using survey meters; and
- Three years of supervised clinical experience that includes one year in a
formal 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
two years of clinical experience in therapeutic radiology under the supervision
of an authorized user at a medical institution that includes:
- Examining individuals and reviewing their case histories to determine their
suitability for medical accelerator treatment, and any limitations or
contraindications;
- Selecting the proper dose and how it is to be administered;
- Calculating the doses and collaborating with the authorized user in the
review of patients' or human research subjects' progress and consideration of
the need to modify originally prescribed doses as warranted by patients' or
human research subjects' reaction to radiation; and
- Post-administration follow up and review of case histories.
H. Training for an authorized nuclear pharmacist
The authorized nuclear pharmacist must be a pharmacist who:
- Has current board certification as a nuclear pharmacist by the Board of
Pharmaceutical Specialties, or
- Has completed 700 hours in a structured educational program consisting of
both:
- Didactic training in the following areas:
- Radiation physics and instrumentation;
- Radiation protection;
- Mathematics pertaining to the use and measurement of radioactivity;
- Chemistry of byproduct material for medical use; and
- Radiation biology; and
- Supervised experience in a nuclear pharmacy involving the following:
- Shipping, receiving, and performing related radiation surveys;
- Using and performing checks for proper operation of dose calibrators, survey
meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;
- Calculating, assaying, and safely preparing dosages for patients or human
research subjects;
- Using administrative controls to avoid mistakes in the administration of
byproduct material;
- Using procedures to prevent or minimize contamination and using proper
decontamination procedures; and
- Has obtained written certification, signed by a preceptor authorized nuclear
pharmacist, that the above training has been satisfactorily completed and that
the individual has achieved a level of competency sufficient to independently
operate a nuclear pharmacy; or
- A pharmacist who has completed a structured educational program as specified
above before December 2, 1994, and who is working in a nuclear pharmacy would
qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist
need not comply with the requirements on preceptor statement and recentness of
training to qualify as an authorized nuclear pharmacist.
I. Training requirements for physicians to use or supervise the use
of radioactive materials for nuclear cardiology
The authorized user for nuclear cardiology must be a physician who:
- Is certified by the Certification Board of Nuclear Cardiology; or
- Must submit evidence of at least 40 hours of didactic training in
applicable radiation principles, and clinical experience under a preceptor
physician that documents at least 100 total cases of the various nuclear
cardiology studies. To be named as an authorized user for lymphoscintigraphy,
the physician must submit evidence of 24 hours of applicable didactic
training and 10 clinical cases under a preceptor physician. The statements
of clinical experience must be signed by the preceptor physician.
J. Recentness of training.
The training and experience specified in this section must have been obtained
within the 7 years preceding the date of application or the individual must have
had related continuing education and experience since the required training and
experience was completed.
K. Groups of medical uses of radioactive material.
- Group I. Use of prepared radiopharmaceuticals for certain diagnostic studies
involving measurements of uptake, dilution and excretion. This group does not
include uses involving imaging and tumor localization.
- Iodine-123 as sodium iodide;
- Iodine-125 as sodium iodide, iodinated human serum albumin, oleic acid or sodiumiothalamate;
- Iodine-131 as sodium iodide, iodinated human serum albumin, labeled rose bengal, triolein, or sodium iodohippurate;
- Cobalt-57 as labeled cyanocobalamin;
- Cobalt-58 as labeled cyanocobalamin;
- Cobalt-60 as labeled cyanocobalamin;
- Chromium-51 as sodium chromate or labeled human serum albumin;
- Potassium-42 as chloride;
- Sodium-24 as chloride;
- Iron-59 as citrate;
- Technetium-99m as pertechnetate; and
- Any radioactive material in a radiopharmaceutical and for a diagnostic use
involving measurements of uptake, dilution or excretion for which a "Notice of
Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the
U.S. Food and Drug Administration (FDA).
- Group II. Use of prepared radiopharmaceuticals for diagnostic imaging and
localization studies.
- Iodine-131 as sodium iodide, iodinated human serum albumin, macro-aggregated
iodinated human serum albumin, colloidal (micro-aggregated) iodinated human
serum albumin, rose bengal or sodium iodohippurate;
- Iodine-125 as sodium iodide or fibrinogen;
- Iodine-123 as sodium iodide;
- Chromium-51 as human serum albumin;
- Fluorine-18 in solution;
- Gallium-67 as citrate;
- Gold-198 in colloidal form;
- Mercury-197 as chlormerodrin;
- Mercury-203 as chlormerodrin;
- Selenium-75 as selenomethionine;
- Strontium-85 as nitrate;
- Strontium-87m as chloride;
- Technetium-99m as pertechnetate, sulfur colloid, or macro-aggregated human
serum albumin;
- Thallium-201 as chloride;
- Ytterbium-169 as pentatate sodium;
- Indium-113m as chloride;
- Any radiopharmaceutical prepared from a reagent kit listed in (c)3; and
- Any radioactive material in a radiopharmaceutical and for a diagnostic use
involving imaging or localizing for which a "Notice of Claimed Investigational
Exemption for a New Drug" (IND) has been accepted by the U.S. Food and Drug
Administration (FDA).
- Group III. Use of generators and reagent kits for the preparation and use of
radiopharmaceuticals for certain diagnostic studies.
- Molybdenum-99/technetium-99m generators for the elution of technetium-99m as pertechnetate;
- Technetium-99m as pertechnetate for use with reagent kits for preparation and
use of radiopharmaceuticals containing technetium-99m as provided in (c)3 and
(c)5;
- Reagent kits for preparation of technetium-99m labeled:
- Sulfur colloid;
- Pentatate sodium;
- Etidronate sodium;
- Human serum albumin;
- Human serum albumin microspheres;
- Polyphosphates;
- Macroaggregated human serum albumin;
- Medronate sodium;
- Stannous pyrophosphate;
- Gluceptate sodium;
- Oxidronate sodium;
- Disofenin;
- Succimer.
- In-113/indium-113m generators for the elution of indium-113m as chloride;
and
- Any generator or reagent kit for preparation and diagnostic use of a
radiopharmaceutical for which generator or reagent kit a "Notice of Claimed
Investigational Exemption for a New Drug" (IND) has been accepted by the U.S.
Food and Drug Administration (FDA).
- Group IV. Use of prepared radiopharmaceuticals for certain therapeutic uses
that do not normally require hospitalization for purposes of radiation safety:
- Iodine-131 as iodide for treatment of hyperthroidism and cardiac dysfunction;
- Phosphorus-32 as soluble phosphate for treatment of polycythemia vera,
leukemia and bone metastases;
- Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of
malignant effusions;
- Any therapeutic material in a radiopharmaceutical for a therapeutic use not
normally requiring hospitalization for purposes of radiation safety for which a
"Notice of Claimed Investigational Exemption for a New Drug" (IND) has been
accepted by the U.S. Food and Drug Administration (FDA).
- Group V. Use of prepared radiopharmaceuticals for certain therapeutic uses
that normally require hospitalization for purposes of radiation safety:
a. Gold-198 as colloid for intracavitary treatment of malignant effusions;
b. Iodine-131 as iodide for treatment of thyroid carcinoma;
c. Any radioactive material in a radiopharmaceutical and for a therapeutic use
normally requiring hospitalization for radiation safety reasons for which a
"Notice of Claimed Investigational Exemption for a New Drug" (IND) has been
accepted by the U.S. Food and Drug Administration (FDA).
- Group VI. Use of sealed sources and devices containing radioactive material
for certain medical uses:
- Americium-241 as a sealed source in a device for bone mineral analysis;
- Cesium-137 encased in needles and applicator cells for topical, interstitial,
and intracavitary treatment of cancer;
- Cobalt-60 encased in needles and applicator cells for topical, interstitial,
and intracavitary treatment of cancer;
- Gold-198 as seeds for interstitial treatment of cancer;
- Iodine-125 as a sealed source in a device for bone mineral analysis;
- Iridium-192 as seeds encased in a nylon ribbon for interstitial treatment of
cancer;
- Strontium-90 sealed in an applicator for treatment of superficial eye
condition;
- Radon-222 as seeds for interstitial treatment of cancer;
- Radium-226 encased in needles, applicator cells, and plaques for topical,
interstitial and intracavitary treatment of cancer; and
- Iodine-125 as seeds for interstitial treatment of cancer