FACILITY NAME
RADIATION PROTECTION PROGRAM
NUCLEAR MEDICINE
Implemented Date:____________________
Updated Date:________________________
A Template provided by
MPC SAMPLE
Table of Contents
Purpose/ Disclaimer
1
Program Audit/ Annual Review
2
Policy Changes
3
Regulatory Agencies
4
Management
5
Radiation Safety Officer
6
Radiation and Risks
7
Storage and Accountability of Radioactive Material
8.
Breastfeeding Recommendations
9
Report and Notification of a Dose To Embryo/Fetus or a Nursing Child
10
Instructions Concerning Pregnant Worker
11
Maintaining Occupational Exposures ALARA
12
Occupational Exposure Limits
13
Dose to Members of the Public
14
Personnel Monitoring Program
15
Medical Event vs. Accidental Administration
16
Personnel Training Program
17
Radiation Monitoring Instruments
18
Dose Calibrator Testing
19
Sealed Sources
20
Rules for Safe Use of Radiopharmaceuticals
21
Package Order and Receipt Procedures
22
Procedures Opening / Returning Radioactive Packages
23
Radioactive Material Use
24
Area Survey Procedures
25
Area Wipes Test Procedures
26
Radioactive Spills
27
Waste Disposal
28
Record Retention
29
Prescribed Dosage List
30
Pediatric Dosage List
Definitions
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Purpose
This manual was designed to meet several objectives:
1.
Serve as a template for the establishment of the required Radiation Protection
Program (RPP) as noted in NAC 459.321.
2.
Define units and terms that individuals working with radiation should be familiar
with.
3.
Put into perspective the hazards and risks associated with Ionizing Radiation.
4.
Outline the regulatory limits for radiation exposure to a radiation worker, the
general public and a fetus.
5.
Outline the rules and procedures for the safe use and handling of radioactive
materials.
6.
Provide a resource for information, which may be helpful to you in your daily
handling of radioactive materials.
Disclaimer:
This Radiation Protection Program manual reflects our radiation safety policies and
procedures that are a condition of our State license. However, some accreditation
agencies require commitment to policies and procedures which may be more
prescriptive than necessary to comply with State requirements. These policies and
procedures are not to be used for regulatory purposes.
For radiation safety issues and for compliance with State requirements please refer to
this Radiation Protection Program manual.
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1
PROGRAM AUDIT
AUDIT PROGRAM
The licensee must, at least annually, review the radiation protection program content
and implementation.
The licensee must maintain records of audits and other reviews of the radiation
protection program content and implementation.
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ANNUAL RADIATION PROTECTION PROGRAM REVIEW
The individuals listed below have reviewed and approved this document:
Radiation Safety Officer
Date
Management
Date
Supervising Nuclear Medicine Physician
Date
Physicist
Date
The following protocols and procedures are reviewed and approved at the date of
implementation and annually thereafter.
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2
POLICY CHANGES
Making Changes to the Radiation Protection Program
Purpose:
To outline the method for making changes to the radiation protection program, as well
as describing the documentation that is necessary.
Policy:
Changes may be made to the radiation protection program if the following conditions
are met:
 A license amendment is not required1
 Changes are in compliance with the regulations and license
 The revision has been reviewed and approved by licensee management and the
Radiation Safety Officer
 The individuals affected by the changes are instructed before implementation
Documentation of changes made to the radiation protection program must be retained
for a period of five years. Documentation shall include:
 A copy of the old procedure
 A copy of the new (revised) procedure
 The effective date of the change
 The signature of the licensee management that reviewed and approved the
change
References:
 Title 10 of the Code of Federal Regulations, Part 35.13
 Title 10 of the Code of Federal Regulations, Part 35.26
 Title 10 of the Code of Federal Regulations, Part 35.2026
1License







amendments are necessary for the following changes:
Before receiving, preparing, or using Radioactive Material for a type of use that is
not authorized on the licensee’s current license
Before permitting anyone to work as an authorized user, authorized nuclear
pharmacist, or authorized medical physicist, except someone meeting the
respective requirements specified in 10 CFR 35.13(b)
Before changing Radiation Safety Officers, except as provided in 10 CFR 35.24
Before receiving Radioactive Material in excess of the amount or in a different
form, or receiving a different radionuclide than is authorized on the license
Before adding to or changing the areas of use identified in the application or on
the license, except for areas of use where Radioactive Material is used only in
accordance with either 10 CFR 35.100 or 35.200
Before changing the address(es) of use identified in the application or on the
license
Before revising procedures required by 10 CFR 35.610, 35.642, 35.643, and
35.645, as applicable, where such revisions reduce radiation safety.
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3
REGULATORY AGENCIES
NUCLEAR REGULATORY COMMISSION (NRC) Federal agency that develops,
inspects and enforces rules and regulations governing the possession, use and
disposal of all Radioactive Material, to include those that are naturally occurring or
accelerator/cyclotron produced (NARM), due to the Energy Policy Act of 2005. NRC
has total control of receipt, use transfer and disposal of all naturally occurring or
accelerator/cyclotron produced (NARM) and issues, regulates and terminates licenses
for this purpose.
Radioactive Material is residual radioactive material from fission of Uranium in a reactor
i.e. (H-3, C-14, P-32, S-35, Co-60, Sr-89, Y-90, Mo-99, Tc-99m, I-131, Xe-133, Cs-137,
etc.)
Sections of the Nevada Administrative Code (NAC) of importance:
Part 19 - Notices, Instructions, and Reports to Workers; Inspections
Postings, inservice requirements, rights of workers, etc.
Part 20 - Standards for Protection Against Radiation
Radiation Protection Program (RPP), personnel exposure limits, exposure rate
limits for areas, posting of areas, surveys, package opening, waste disposal,
reportable events, etc.
Part 21 - Reporting of Defects and Noncompliance
Reporting Substantial Safety Hazards
Part 31 - General Domestic Licenses for Radioactive Material
Small RIA and in vitro licenses
Part 35 - Human Uses of Radioactive Material
Administrative requirements, Technical requirements, Unsealed use, Sealed
source use, Written directive program, Medical events, training and
experience requirements for authorized users, RSO, Nuclear Pharmacists,
Reports
Part 71 - Packaging / Transportation of Radioactive Materials
Package requirements, signs, survey / wipe test limits, vehicle signs, etc.
Part 170 - Application Fees
Part 171 - Annual Fees, Small Entity Status
DEPARTMENT OF TRANSPORTATION (DOT) Regulates transportation of radioactive
materials via Title 49, NRC adopts all DOT requirements, Hazardous Materials Training
FEDERAL AVAITION ADMINISTRATION (FAA) Regulates airborne transportation of
radioactive materials, Hazardous Materials Training
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FOOD AND DRUG ADMINISTRATION (FDA) review and approves all radioactive
drugs for routine or research use
ENVIRONMENTAL PROTECTION AGENCY (EPA) Regulates emissions of radioactive
material
STATE DEPARTMENT OF HEALTH OR BOARD OF HEALTH develops, inspects and
enforces rules and regulations governing the possession, use and disposal of naturally
occurring and accelerator produced material. State agencies can issue regulate and
terminate certificates and or licenses for this purpose.
NOTE – State governments can enter into agreements with the NRC to govern all uses
of radioactive materials within their borders, excluding federal instillations. These are
known as “Agreement States”. There are approximately 33 such states.
Agreement states “agree” to enforce NRC requirements at a minimum.
Examples:
Illinois, Ohio, Wisconsin
Accelerator / Cyclotron Produced Material – N-13, O-15, F-18, Co-57, Ga-67, Pd-103,
In-111, I-123, Tl-201
Naturally occurring - Ra-226
Machines which produce ionizing radiation- diagnostic x-ray, linear accelerators.
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MANAGEMENT
Management as defined by the United State Regulatory Commission 10 CRF Part 35:
“Management means the chief executive officer or other individual having the authority
to manage, direct, or administer the licensee’s activities, or those persons’ delegate or
delegates.”
Management shall approve in writing:
1.
Requests for a license application, renewal, or amendment before
submittal to the Commission.
2.
Any individual before allowing that individual to work as an authorized
user, authorized nuclear pharmacist authorized medical physicist.
3.
Radiation protection program changes that do not require a license
amendment and are permitted under 35.26
Management shall appoint a Radiation Safety Officer (RSO), who agrees in writing, to
be responsible for implementing the radiation protection program. The licensee through
the Radiation Safety Officer, shall ensure that radiation safety activities are being
performed in accordance with licensee approved procedures and regulatory
requirements.
Management must permit the RSO the following:
1.
Specific written notation of authority, duties and responsibilities.
2.
Sufficient authority, organizational freedom, time, resources and management
prerogative to:
a.
Identify radiation safety problems
b.
Initiate, recommend or provide corrective actions
c.
Stop unsafe operations
d.
Verify implementation of corrective actions
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5
RADIATION SAFETY OFFICER
AUTHORITY, DUTIES AND RESPONSIBILITIES
The Radiation Safety Officer (RSO) shall:
1.
Have the authority to implement the Radiation Protection Program as referenced
in NAC 459.321.
2.
Have the authority, organizational freedom, time, resources, and management
prerogative to:
a.
Identify radiation safety problems;
b.
Initiate, recommend or provide corrective actions,
c.
Stop unsafe operations; and,
d.
Verify implementation of corrective actions.
3.
Investigate deviations from the radiation safety practices approved by facility
management and/or the Radiation Safety Committee, if applicable.
4.
Collect in a centralized location, executive management approved procedures
that can include policy and technical issues which, would makeup the Radiation
Protection Program as follows:
a.
Authorization for the purchase of radioactive material.
b.
Receipt and opening of packages containing radioactive material.
c.
Storage of radioactive material.
d.
Inventory control of radioactive material.
e.
Safe use of radioactive material.
f.
Emergency procedures in the event of loss, theft, etc.
g.
Periodic radiation surveys and wipe tests
h.
Checks of radiation survey and other radiation safety instruments.
i.
Disposal of radioactive material.
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j.
5.
Personnel training of those who work in or frequent areas of radioactive
material use or storage.
Oversee a record system of the Radiation Protection Program per NAC
459.3645 to include at least the following:
Audits and other reviews of the Radiation Protection Program content and
implementation for a period of three (3) years after the record is made.
The provisions of the Radiation Protection Program until the license is terminated
by the State such as:
6.
7.
a.
All records, reports, written policies and procedures required by regulatory
agencies concerning radioactive material.
b.
A copy of the regulations governing the possession, use and disposal of
licensed material, such as the Nevada Administrative Code.
Periodically evaluate “action levels” for continued appropriateness to ensure
compliance with NAC459.337 and NAC 459.339.1 for the following:
a.
Personnel exposure investigation levels
b.
Area surveys, dose rates, wipe tests and contamination levels
c.
Bioassays, if necessary
d.
Radioactive effluent concentrations, if necessary
Review the following Radiation Protection Program records, if applicable:
a.
Sealed source inventories
b.
Sealed source leak tests
c.
Dose calibrator linearity tests
d.
Dose calibrator accuracy tests
e.
Dose calibrator geometrical variation tests
f.
Occupational radiation exposure reports
g.
Medical event documentation
h.
Spill / incident reports for cause and corrective action
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i.
Dose rate surveys and contamination wipe results
j.
Changes in the radiation safety program
8.
Ensure the use of reasonable practices and controls to strive to maintain doses
to workers and to the public are ALARA, in compliance with NAC 459.321(b).
9.
Review with facility management at least annually of the content of the Radiation
Protection Program and determine if the written program is being implemented in
compliance with NAC 459. 321(c).
10.
Ensure as a part of the ALARA effort that individual members of the public shall
not receive a Total Effective Dose Equivalent (TEDE) of more than 10 mrem (0.1
mSv) per year from airborne radioactive material releases as per NAC 459.321
as necessary.
11.
Be a member of the Radiation Safety Committee (RSC), if applicable, that will
oversee all uses of Radioactive Material permitted by the license as per 10 CFR
35.24(f).
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6
RADIATION AND ITS’ RISKS
Adapted from NRC Regulatory Guide 8.29
Radioactivity may be defined as a spontaneous process characteristic of atoms with
unstable nuclei in which the nucleus releases energy either as a particle with kinetic
energy (beta particle) or as electromagnetic energy (gamma rays).
Types of Radiation
Alpha Particles: Large particles consisting of two protons and two neutrons emitted
from the nucleus of certain radioactive atoms. They are unable to penetrate the skin,
but are very effective in damaging living cells if the radioactive materials are ingested
into the body. External radiation dosimetry badges cannot detect them.
Beta Particles: Electrons that are emitted from the nucleus of radioactive isotopes.
These particles are very small and only able to penetrate small thicknesses of tissue.
When these particles come into contact with high-density materials such as lead, they
tend to produce electromagnetic radiation (bremsstrahlung x-rays) of high energy. Pure
beta emitters of high energy are best shielded with low-density material such as plastic
or water to minimize the production of these penetrating x- rays.
Gamma Rays: These photons are identical to x-rays except that gamma rays are
emitted from the nucleus. The gamma ray photon can penetrate varying amounts of
tissue depending upon their energy.
They are the most energetic of the
electromagnetic radiation that also include visible light and microwaves. Gamma
radiation is shielded the best with high-density materials such as lead.
The following questions are intended to provide personnel information
concerning the risks associated with radiation.
1.
What are background radiation exposures?
The average person is constantly exposed to ionizing radiation from several sources.
Our environment and even the human body contain naturally occurring radioactive
materials. The following table summarizes the effective dose equivalent we receive
from background exposures.
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Average Annual Effective Dose Equivalent to Individuals in the U.S.a
Source
Effective Dose Equivalent (mrem)
Natural Radon
Other than Radon
Total
200
100
300
Nuclear Fuel Cycle
0.05
Consumer Productsb
9
Medical
Diagnostic X-rays
39
Nuclear Medicine
14
Total
53
Total
about 360 mrem/
a
Adapted from Table 8.1, NCRP 93
b
Includes building material, television receivers, luminous watches, smoke detectors, etc.
(from Table 5.1, NCRP 93)
disintegration rates to our selves from our selves:
~9000 disintegration’s / sec
1,100,000 disintegration's / 2 hours
770,000,000 disintegration's / day
2.
What are the Nevada State Health Division occupational dose limits?
For adults:
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
5 rem (5000 mrem) for the total effective dose equivalent (external and internal
whole body dose)
50 rem (50000 mrem) for the total organ dose equivalent (external and internal
dose to any organ other than the lens of the eye)
15 rem (15000 mrem) for the lens of the eye dose equivalent (external dose)
50 rem (50000 mrem) for the shallow dose equivalent (external dose to the skin
or to any extremity)
For minor workers:

all limits are 10 percent of the dose limits for adult workers
For protection of the embryo/fetus of a declared pregnant woman:

0.5 rem (500 mrem) during the entire pregnancy
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The 5 rem (5000 mrem) total effective dose equivalent is based on consideration of the
potential for delayed biological effects. This dose level provides a level of risk
considered acceptable by the Nevada State Health Divsion. The limits for individual
organs are below the dose levels at which early biological effects are observed in the
individual organs.
The dose limit for the embryo/fetus of a declared pregnant woman is based on a
consideration of the possibility of greater sensitivity to radiation of the embryo/fetus and
the involuntary nature of the exposure.
3.
What is meant by ALARA?
ALARA means “as low as reasonably achievable.” In addition to providing an upper
limit on an individual’s permissible radiation dose, the Nevada State Health Division
requires that its licensees establish radiation protection programs and procedures to
achieve occupational does as far below the limits as is reasonably achievable.
Three important factors, which help you practice this ALARA philosophy and keep your
radiation exposure low, are:
4.
a.
Time: The less time you spend near a source of radiation, the lower your
exposure. Therefore, you should work efficiently, but not hurriedly around
radioactive materials.
b.
Distance: The farther away you are from a source of radiation the less
exposure you will receive. As you double the distance, the exposure rate
decreases by a factor of four.
c.
Shielding: Interposing dense material between you and a radiation
source will reduce your exposure.
What is meant by health risk?
A risk is generally thought of as something that may endanger health. With radiation,
risk can be quantified in terms of the probability of a health effect per unit of dose
received.
When x-rays, gamma rays and ionizing particles interact with living materials such as
our bodies, they may deposit enough energy to cause biological damage. Radiation
can cause several different types of events such as the very small physical
displacement of molecules, changing a molecule to a different form, or ionization, which
is the removal of electrons from atoms and molecules. When the quantity of radiation
energy deposited in living tissue is high enough, biological damage can occur as a
result of chemical bonds being broken and cells being damaged or killed.
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5.
What are the possible health effects of exposure to radiation?
Very high (100’s of rem), short-term doses of radiation have been known to cause
prompt effects, such as vomiting and diarrhea, skin burns, cataracts and even death. It
is suspected that radiation exposure may be linked to the potential for genetic effects in
the children of exposed parents. Also, children who were exposed prior to birth have
shown an increased risk of mental retardation and other congenital malformations.
6.
What are the estimates of the risk of fatal cancer from radiation exposure?
We don’t exactly know what the chances are of getting cancer from a low-level radiation
dose, primarily because the few effects that may occur cannot be distinguished from
normally occurring cancers. However, we can make estimates based on extrapolation
from extensive knowledge from scientific research on high dose effects.
According to the BEIR V report approximately 20% of all workers will die from cancer
without any occupational radiation exposure. A lifetime cumulative radiation dose of
1000 mrem is estimated to increase the cancer incidence from 20% to 20.04%. A
lifetime dose of 10,000 mrem could raise the estimate to 20.4%(3)
How can we compare the risk of cancer from radiation to other kinds of health risks?
On way to make these comparisons is to compare the average number of days of life
expectancy lost because of the effects associated with each particular health risk. The
tables below summarize some of these risks.
Estimated Loss of Life Expectancy from Industrial Accidentsa
INDUSTRY TYPE
All Industry
Trade
Manufacturing
Service
Government
Transportation and Utilities
Agriculture
Construction
Mining and Quarrying
Radiation Dose of 5 rem/year for 50 years
Radiation Dose of 650 mrem/year for 30 years
(industry average)
Death from Accidental Radiation Exposure
Non-Radiation Industrial Accidents (Nuclear Facilities)
Estimated Days of Life
Expectancy Lost (Avg)
60
27
40
27
60
160
320
227
167
250
20
<1
58
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Estimated Loss of Life Expectancy from Health Risksa
HEALTH RISK
Smoking 20 cigarettes/day
Overweight by 15%
Alcohol Consumption (U.S. avg.)
All accidents combined
Auto Accidents
Home Accidents
Drowning
All natural hazards (earthquake, lightning, flood, etc.)
Medical radiation
Occupational Radiation Dose
300 mrem/yr. from age 18 to 65
1000 mrem/yr. from age 18 to 65
aAdapted from Reference 4
8.
Estimated Days of Life
Expectancy Lost (Avg)
6 years
2 years
1 year
1 year
207 days
74 days
24 days
7 days
6 days
15 days
51 days
What are the health risks from radiation exposure to the embryo/fetus?
During certain stages of development, primarily the first trimester, the embryo/fetus is
believed to be more sensitive to radiation damage than adults. In recognition of the
possibility of increased radiation sensitivity, and because the dose to the embryo/fetus
is involuntary on the part of the embryo/fetus, a more restrictive dose limit has been
established for the embryo/fetus of a declared pregnant worker. If an occupationally
exposed woman declares her pregnancy in writing, she is subject to the more restrictive
dose limit of 500 mrem for the total gestation period.
No developmental effects caused by radiation have been observed in human groups at
doses at or below the 5 rem occupational dose limit. At doses below this occupational
dose limit, an increase in cancer has not been proven, but is presumed to exist even if it
is too small to be measured. It is expected that radiation exposure before birth may be
2 or 3 times more likely to cause cancer over a person’s lifetime than the same amount
of radiation received as an adult. If this were true, there would be 1 radiation-induced
cancer death in 200 people exposed in utero at the occupational dose limit of 5 rem. At
the 0.5 rem (500 mrem) dose limit, there would be 1 radiation-induced cancer death per
2000 people. This would be in addition to the 400 cancer deaths from all causes that
one would normally expect in a group of 2000 people.
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9.
Can a worker become sterile or impotent from normal occupational
radiation exposure?
No. Temporary or permanent sterility cannot be caused by radiation at the levels
allowed under the Nevada State Health Division’s occupational limits. Acute doses on
the order of 10 rem to the testes can result in a measurable but temporary reduction in
sperm count. Temporary sterility (suppression of ovulation) has been observed in
women who have received acute doses of 150 rem. (1)
Additional information is available in the United States Nuclear Regulatory Commission
Regulatory Guide 8.29. This and other informative articles are available to you for your
review in the Nuclear Medicine Department.
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7
STORAGE AND ACCOUNTABILITY OF RADIOACTIVE MATERIAL
This facility adheres to the Nevada regulations for securing licensed radioactive
material. All radioactive material will be secured from unauthorized access or removal.
Rooms / areas containing stored radioactive material will be actively secured. Stored
radioactive material will be secured from unauthorized removal. Control and constant
surveillance will be maintained over radioactive material not in storage, such as patient
doses.
We will maintain records of receipt, transfer, and disposal of licensed material, and we,
or a designee, will conduct physical inventories at required frequencies to account for
sealed sources as required.
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8
Breast - Feeding Recommendations
Clinical procedures for breast-feeding should establish a process that assures that
patients who are breast-feeding are identified and that breast-feeding patients receive
proper written instruction. Appropriate guidelines must be available so that breastfeeding may be discontinued and whenever possible resumed as soon as safe for the
breast-feeding child. The NRC’s Table 3 “Activities of Radiopharmaceuticals that
Require Instructions and Records” has been available for all accounts as a guide for
providing recommended duration of interruption of breast-feeding times and listing
activities of radiopharmaceuticals that require instructions and records when
administered to patients who are breast-feeding. However, the NRC table has been
criticized for being difficult to interpret. In this regard, MPC has provided an alternate
table for the recommendation of breast-feeding interruption times adapted from the
NRC Table 3 and Stabin and Brietz (J:Nucl Med 2000; 41:863-873).
Please note: When no cessation is recommended, mothers should still restrict contact
with the child to avoid unnecessary exposure to the child.
Please contact your physicist if you have questions regarding this matter.
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Recommended Breast - Feeding Interruption Schedule
Radiopharmaceutical
Activity which
Require
Instruction
Activity which
Require Record
Recommended BreastFeeding Interruption Time
I-131 NaI
I-123 NaI
I-123 OIH
I-123 MIBG
0.0004 mCi
0.5 mCi
4 mCi
2 mCI
0.0002 mCi
3 mCi
20 mCi
10 mCi
I-125 OIH
I-131 OIH
Tc-99m DTPA
Tc-99m MAA
Tc-99m Pertechnetate
0.08 mCi
0.30 mCI
30 mCi
1.3 mCi
3 mCi
0.4 mCi
1.5 mCi
150 mCi
6.5 mCi
15 mCi
Tc-99m DISIDA
Tc-99m
Glucoheptonate
Tc-99m HAM
Tc-99m MIBI/Myoview
30 mCi
30 mCi
150 mCi
170 mCi
Complete cessation
Complete cessation
No cessation
48hr/10 mCi 2
12hr/4 mCi
No cessation
No cessation
No cessation
12.6 hr/4 mCi
24hr/30 mCi
12hr/12 mCi
No cessation
No cessation
10 mCi
30 mCi
50 mCi
150 mCi
Tc-99m MDP
Tc-99m PYP
Tc-99m RBC In-Vivo
Labeling
Tc-99m RBC In-Vitro
Labeling
Tc-99m Sulfur Colloid
Tc-99m DTPA Aerosol
Tc-99m MAG3
Tc-99m WBC
30 mCi
25 mCi
10 mCi
150 mCI
120 mCi
50 mCi
No cessation
3hr/30 mCi1
6hr/60 mCi1
No cessation
No cessation
12hr/ 20 mCi 2
30 mCi
150 mCi
No cessation
7 mCi
30 mCi
30 mCi
4 mCi
35 mCi
150 mCi
150 mCi
15 mCi
Ga-67 Citrate
0.04 mCi
0.2 mCi
6hr/12 mCi
No cessation
No cessation
48hr/5 mCi 2
12hr/2 mCi
1 month/4 mCi
2 weeks/1.3 mCi
1 week/0.2 mCi
Cr-51 EDTA
F-18
In-111 WBC
Tl-201 Chloride
1.6 mCi
8 mCi
0.2 mCi
1 mCi
1 mCi
5 mCi
No cessation
12 hr/10 mCi
1 week/0.5 mCi
96hr/<3 mCi 2
2 weeks/3 mCi 1
Complete Cessation/>5
mCi
The duration of interruption of breast-feeding is selected to reduce the maximum dose to a newborn infant to leas than 1
millisievert (0.1 rem), although the regulatory limit is 5 millisieverts (0.5 rem). The actual doses that would be received by
most infants would be far below 1 millisievert (0.1rem). Of course, the physician may use discretion in the
recommendation, increasing or decreasing the duration of interruption.
1.
Adapted from US Nuclear Regulatory Commission, NUREG-1556, Volume 9,
Appendix U; Table U.3 and NUREG-1492.
2.
Stabin and Breitz. Journal of Nuclear Medicine 2000; 41: 863-873
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Instructions to patients who are breast-feeding
I confirm that I am breast-feeding a child and that I will adhere to the waiting period
listed below. During this waiting period, I may express breast milk, but I will discard this
milk and will not feed it to a child.
I understand that a portion of the radioactive material which I have received can be
found in breast milk and that if I breast-feed during the delay time, my child will receive
an unnecessary radiation dose. If I have received I-131 and breast-feed, my child may
suffer thyroid damage.
Signature:
Date:
Radiopharmaceutical:
Administered Dose:
Time to wait before resuming breast-feeding:
Reference Recommended Breast - Feeding Interruption Schedule
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9
REPORT AND NOTIFICATION OF DOSE TO EMBRYO/FETUS OR NURSING
CHILD
A licensee must report any dose to an embryo/fetus that is >5 rem (0.05 Sv) dose
equivalent that is a result of an administration of Radioactive Material to a pregnant
individual, unless the dose was specifically approved, in advance, by the authorized
user.
A licensee must report any dose to a nursing child that is a result of an administration of
Radioactive Material to a breast-feeding woman that is >5 rem (0.05 Sv) total effective
dose equivalent or has resulted in unintended permanent functional damage to an
organ or physiological system of the child, as determined by a physician.
Notifications consist of telephoning the Nevada State Health Division no later than the
next calendar day after discovery of the event. This is followed by a written report to
the appropriate Regional Office within 15 days. The written report must include the
following items:
Licensee’s name
Name of the prescribing physician
Brief description of event
Why event occurred
Effect, if any, on embryo/fetus or nursing child
Actions taken, if any, to prevent occurrence
Certification that licensee notified pregnant individual or mother (or responsible
relative or guardian, and if not, why
The report must not contain any information that could lead to identification of the
individual or child.
The licensee must provide notification of the event to the referring physician and also
notify the pregnant individual or mother, no later than 24 hours after discovery of the
event, unless the referring physician personally informs the licensee either that he or
she will inform the mother or that based on medical judgment, telling the mother would
be harmful. The licensee is not required to notify the mother without first consulting
with the referring physician. If the referring physician or mother cannot be reached
within 24 hours, the licensee must make the appropriate notifications as soon as
possible thereafter (if necessary, notification may be made to a responsible relative or
guardian). The licensee may not delay any appropriate medical care for the
embryo/fetus or for the nursing child. If a verbal notification is made, the licensee must
inform the mother that a written description of the event can be obtained upon request.
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The licensee must also provide an annotated copy of the report to the referring
physician no later than 15 days after the discovery of the event, with the name of the
pregnant individual or the nursing child and his or her Social Security number or other
identification number.
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10
INSTRUCTIONS CONCERNING PREGNANT WORKER
I.
Sensitivity of Fetus to Radiation
A number of studies have suggested that the embryo/fetus may be more sensitive to
ionizing radiation than an adult, especially during the first three months of gestation.
The National Council on Radiation Protection and Measurements (NCRP) has
recommended (NCRP No. 53 & 91) that special precautions be taken to limit exposure
when an occupationally exposed woman could be pregnant. The maximum permissible
dose to the fetus from occupational exposure of the expectant mother should not
exceed: 500 mrem during the entire gestation period without substantial variation. This
is approximately one-tenth of the occupational dose limit.
II.
What to do if You Become Pregnant and are Exposed to Ionizing Radiation
in Your Work
When you learn you are pregnant, you may wish to but are not required to inform your
supervisor and Radiation Safety Officer. Once contacted, the Radiation Safety Officer
or a RSO delegate will review radiation protection and the facility’s policy regarding
pregnant radiation workers with you. This process is termed a declaration of your
pregnancy. There is no reason to become alarmed.
III.
If You Have Questions or Want Additional Information
The Nuclear Regulatory Guide 8.13 ("Instruction Concerning Prenatal Radiation
Exposures") will be made available to you for informational purposes, if you request.
The radiation safety officer or RSO delegate is available for discussion regarding levels
of exposure from sources of ionizing radiation in the work environment and the risks to
the developing embryo/fetus as a result of prenatal exposure. You will be asked to
acknowledge in writing that the radiation safety officer or RSO delegate gave you
instruction.
References:
(1)
U.S. Nuclear Regulatory Commission, 1996, INSTRUCTION CONCERNING
RISKS FROM OCCUPATIONAL RADIATION EXPOSURE, Regulatory Guide
8.29, February 1996.
(2)
National Council on Radiation Protection and Measurements, IONIZING
RADIATION EXPOSURE OF THE POPULATION OF THE UNITED STATES,
NCRP Report No. 93, September 1987.
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(3)
National Research Council, HEALTH EFFECTS OF EXPOSURE TO LOW
LEVELS OF IONIZING RDIATION, Report of the Committee on the Biological
Effects of Ionizing Radiation (BEIR V), National Academy Press, Washington,
D.C.
(4)
B.L. Cohen and I.S. Lee, CATALOG OF RISKS EXTENDED AND UPDATED,
Health Physics, Vol. 61, September 1991.
(5)
U.S. Nuclear Regulatory Commission, 1994, INSTRUCTION CONCERNING
PRENATAL RADIATION EXPOSURE, Regulatory Guide 8.13, October 1994
IV.
Facility Policy
A.
A facility can adopt a conservative policy of restricting the dose of ionizing
radiation to the fetus during the entire period of gestation to no more than 500
mrem during the entire gestation period without substantial variation
B.
If you work in an area where the anticipated dose is less than 500 mrem during
the entire gestation period without substantial variation, you are able to continue
to work in this area with no restrictions. Your work assignments will be under the
direction of your supervisor. However, the radiation safety officer may make
certain recommendations regarding your work assignments to further reduce the
dose to the fetus.
C.
If a situation is identified in which the anticipated dose to the fetus over the
gestation period would be more than 500 mrem, the following three alternatives
listed below are possible:
1.
You may be assigned to another area involving less exposure to ionizing
radiation.
2.
You may continue to work in the area with certain restrictions to limit
exposure of the fetus to less than 500 mrem (based on recommendations
made by the radiation safety officer). In nearly all cases, the work
environment will require slight modifications to ensure that the dose to the
fetus does not exceed 500 mrem during the entire gestation period
without substantial variation.
3.
You may, at your option and with the full awareness of a slight increased
risk for the unborn child, decide to continue working in this area. It is
likely, under these circumstances, that the fetus could receive a dose of
more than 500 mrem. If you choose this option, you must sign a
statement acknowledging your willingness to work in the area where the
dose to the fetus might exceed 500 mrem. You are not encouraged to
select this option.
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D.
If you are unwilling to accept the increased risk to your unborn child due to your
current level of radiation exposure, you may request reassignment to an area
involving less exposure to ionizing radiation. The facility should make a good
faith effort to accommodate your request in accordance with the general policy
for reassignments. If it is not possible or practicable to grant your request, after
a good faith effort has been made, then you may be laid-off or placed on a leave
of absence in accordance with the facilities general policies.
E.
Individuals who are pregnant are not prohibited from working in or frequenting
radiation areas. These individuals may also operate sources of ionizing radiation
(diagnostic x-ray equipment, cobalt-60 teletherapy units, and linear accelerators)
and handle radioactive materials such as those that are present in Nuclear
Medicine.
F.
During your pregnancy, you are expected to perform your assigned duties as a
radiation worker, unless certain restrictions are placed upon you by the radiation
safety officer.
G.
During your pregnancy, you are encouraged to monitor your radiation exposure
via the dosimeter readings, which are made available to radiation workers.
Contact the radiation safety officer if any unusual readings occur.
H.
As noted above your verbal and written “Declaration” of your pregnancy is
optional and once made it can be rescinded by you and you alone. If you
choose to rescind your declaration this facility is not required to restrict your fetal
exposure to 500 mrem, but you will return to the normal adult exposure limits.
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V.
Documentation
Section I
To:
Department Supervisor
Radiation Safety Officer
The purpose of this communication is to voluntarily inform you of my pregnancy. My
estimated date of conception is ____________________ (month/year).
Name: ____________________________________________
Employee Number: _______________________
Signed: _____________________________________________
Date: _____________________________
Section II
The Radiation Safety Officer or their delegate has reviewed the following topics with me
and /or I have read the following items. I understand the information provided. I realize
that if I have further questions I may contact the Radiation Safety Officer who may refer
me to a consulting radiological physicist for further information.
Exposure reduction through time, distance, and shielding
Radiation risks as they pertain to my job
My exposure history
NRC Regulatory Guide Instruction Concerning Prenatal Radiation Exposure
Employee
Date
________________________________
Radiation Safety Officer
___________________________
Date
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GENERAL GUIDELINES FOR THE PREGNANT WORKER
Occupation
Restrictions
Allowed Tasks
Diagnostic X-Ray
- No restrictions
- General radiography
- Portable radiography
- Fluoroscopy
- Special Procedures
Laboratory
- Iodination of proteins
- RIA
- In-vitro laboratory tests
Nursing
- Care of patients undergoing
treatment of thyroid carcinoma
with I-131
- Care of patients undergoing
treatment with brachytherapy
sources
- Care of patients following
Nuclear Medicine
diagnostic procedures
- Diagnostic x-ray
procedures
Radiation Therapy
- Handling of brachytherapy
sources
- P-32 Therapy
- External beam treatments
- Simulations
Nuclear Medicine
- Treatment of thyroid
carcinoma with I-131
- Preparation of
radiopharmaceuticals
- Injection of patients
- Imaging
- QA procedures
PET
- Preparation of
radiopharmaceuticals
- Injection of patients
- Imaging
- QA procedures
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11
MAINTAINING OCCUPATIONAL RADIATION EXPOSURES (ALARA)
Management Commitment
a.
We, the management of this medical facility, are committed to the program
described herein for keeping individual and collective doses as low as is
reasonably achievable (ALARA). In accord with this commitment, we hereby
describe an administrative organization for radiation safety and will develop the
necessary written policy, procedures, and instructions to foster the ALARA
concept within our facility. The organization will include a Radiation Safety
Officer (RSO) and Radiation Safety Committee (RSC), if required.
b.
We will perform a formal, at least annually, review of the radiation safety
program, including ALARA considerations. This will include reviews of operating
procedures and past dose records, inspections, etc., and consultations with the
radiation safety staff or outside consultants.
c.
Modifications to operating and maintenance procedures and to equipment and
facilities will be made if they will reduce exposures unless the cost, in our
judgment, is considered to be unjustified. We will be able to demonstrate, if
necessary, that improvements have been sought, that modifications have been
considered, and that they have been implemented when reasonable. If
modifications have been recommended but not implemented, we will be
prepared to describe the reasons for not implementing them.
d.
In addition to maintaining doses to individuals as far below the limits as is
reasonably achievable, the sum of the doses received by all exposed individuals
will also be maintained at the lowest practicable level. It would not be desirable,
for example, to hold the highest doses to individuals to some fraction of the
applicable limit if this involved exposing additional people and significantly
increasing the sum of radiation doses received by all involved individuals.
Radiation Safety Committee / Officer
a.
Review of Proposed Users and Uses
(1)
The RSC/RSO will thoroughly review the qualifications of each applicant
with respect to the types and quantities of materials and methods of use
for which application has been made to ensure that the applicant will be
able to take appropriate measures to maintain exposure ALARA.
Executive management will approve all users.
(2)
When considering a new use of Radioactive Material, the RSC/RSO will
review the efforts of the applicant to maintain exposures ALARA.
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(3)
b.
c.
The RSC/RSO will ensure that the users justify their procedures and that
individual and collective doses will be ALARA.
Delegation of Authority
(1)
The RSO will have the authority of enforcement of the ALARA concept.
(2)
The management will support the RSO and RSC when it is necessary for
the RSO to assert authority. If management or the RSC has overruled the
RSO, it will record the basis for its actions in the minutes of the quarterly
meeting.
Review of ALARA Program
(1)
The RSC/RSO will encourage all users to review current procedures and
develop new procedures as appropriate to implement the ALARA concept.
(2)
The RSC/RSO will perform a review of occupational radiation exposure
with particular attention to instances in which the investigational levels in
Table I are exceeded. The principal purpose of this review is to assess
trends in occupational exposure as an index of the ALARA program
quality and to decide if action is warranted when investigational levels are
exceeded.
TABLE I:
INVESTIGATIONAL LEVELS
Level I
Level II
Body Part Exposed
(mrems per calendar quarter)
________________________________________________________________
1.
Whole body; head and trunk;
active blood forming organs;
or gonads.
125
375
2.
Hands and forearms; feet and
ankles. Skin of whole body.
1250
3750
3.
Lens of the eye.
375
1125
(3)
The RSC/RSO will evaluate our facility’s overall efforts for maintaining
doses ALARA on an annual basis. This review will include the efforts of
the RSO, authorized users, and workers as well as those of management.
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d.
Program Review
e.
f.
(1)
At least annual review of Radiation Safety Program. The RSO will
perform an annual review of the radiation safety program for adherence
to ALARA concepts.
(2)
Quarterly review of Occupational Exposures. The RSO will review at least
quarterly the external radiation doses of authorized users and workers to
determine that their doses are ALARA in accordance with this program. A
summary report will be prepared for the RSC.
(3)
Quarterly review of Records of Radiation Surveys. The RSO will review
radiation surveys of unrestricted and restricted areas to determine that
dose rates and amounts of contamination were at ALARA levels during
the previous quarter. A summary report will be prepared for the
RSC/RSO.
Education Responsibilities for the ALARA Program
(1)
The RSO will schedule briefings and educational sessions to inform
workers of ALARA program efforts.
(2)
The RSC/RSO will ensure that authorized users, workers, and ancillary
personnel who may be exposed to radiation will be instructed in the
ALARA philosophy and informed that management, and the RSO are
committed to implementing the ALARA concept.
Cooperative Efforts for Development of ALARA Procedures
Radiation workers will be given opportunities to participate in formulating the
procedures that they will be required to followed.
g.
(1)
The RSO will be in close contact with all users and workers in order to
develop ALARA procedures for working with radioactive materials.
(2)
The RSO will establish procedures for receiving and evaluating the
suggestions of individual workers for improving health physics practices
and will encourage the use of those procedures.
Reviewing Instances of Deviation from Good ALARA Practices
The RSO will investigate all known instances of deviation from good ALARA practices
and, if possible, will determine the causes. When the cause is known, the RSO will
implement changes in the program to maintain doses ALARA.
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Authorized Users
a.
b.
New Methods of Use Involving Potential Radiation Doses
(1)
The authorized user will consult with the RSO during the planning stage
before using radioactive materials for new uses.
(2)
The authorized user will review each planned use of radioactive materials
to ensure that doses will be kept ALARA.
Authorized User's Responsibility to Supervised Individuals
(1)
The authorized user will explain the ALARA concept and the need to
maintain exposures ALARA to all supervised individuals.
(2)
The authorized user will ensure that supervised individuals who are
subject to occupational radiation exposure are trained and educated in
good health physics practices and in maintaining exposures ALARA.
Individuals Who Receive Occupational Radiation Doses
a.
Workers will be instructed in the ALARA concept and its relationship to work
procedures and work conditions.
b.
Workers will be instructed in recourses available if they feel that ALARA in not
being promoted on the job.
Establishment of Investigational Levels
Occupational External Radiation Doses
in
Order
to
Monitor
Individual
This facility hereby establishes investigational levels for occupational external radiation
doses which, when exceeded will initiate review or investigation by the RSO. The
investigational levels that we have adopted are listed in Table 1. These levels apply to
the exposure of individual workers.
The RSO will review form NRC-5, "Current Occupational External Radiation Exposures"
or an equivalent form (e.g., dosimeter processor's report) results of personnel
monitoring not less than once in any calendar quarter. The following actions will be
taken at the investigational levels as stated in Table 1:
a.
Personnel dose less than Investigational Level I.
Except when deemed appropriate by the RSO, no further action will be taken in
those cases where an individual's dose is less than Table 1 values for the
Investigational Level I.
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b.
Personnel dose equal to or greater than Investigational Level I but less than
Investigational Level II.
The RSO will review the dose of each individual whose quarterly dose equals or
exceeds Investigational Level I and will report the results to management and the
RSC following the quarter when the dose was recorded. If the dose does not
equal or exceed Investigational Level II, no action related specifically to the
exposure is required unless deemed appropriate by management.
The
management will, however, review each such dose in comparison with those of
others performing similar tasks as an index of ALARA program quality and will
record the review.
c.
Personnel dose equal to or greater than Investigational Level II.
The RSO will investigate in a timely manner the causes of all personnel doses
equaling or exceeding Investigational Level II and, if warranted, will take action.
A report of the investigation, any actions taken, and a copy of the individual's
NRC Form-5 or its equivalent will be presented to management following
completion of the investigation. The details of these reports will be filed by the
RSO and reported to the RSC.
d.
Re-establishment of investigational Levels to levels above those listed in Table
1.
In cases where a worker or group of workers' doses need to exceed an
investigational level, a new, higher investigational level may be established for
that individual or group on the basis that it is consistent with good ALARA
practices. Justification for new investigational levels will be documented by the
RSO.
Signature of Certifying Officer
I hereby certify that this institution has implemented the ALARA Program set
forth above.
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12
OCCUPUATIONAL EXPOSURE LIMITS
(Values are in mrem per period of time)
Area Exposed
Whole Body
(Deep Dose)
NAC
5000/yr
STATE
1250/qtr
ALARA
Level 1
Level II
125/qtr
375/qtr
Lens of Eye
15000/yr
1250/qtr
375/qtr
1125/qtr
Extremities Skin
(Shallow Dose)
50000/yr
18750/qtr
1250/qtr
3750/qtr
Fetus
(Declared Pregnancy)
500/term
As low as possible
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13
DOSE TO MEMBERS OF THE PUBLIC
Dose Limits to Members of the Public
Licensees shall conduct operations in accordance with NAC 459.335.
Members of the public include persons who are not radiation workers. This includes
workers who live, work or may be near locations where licensed material is used or
stored and employees whose assigned duties do not include the use of licensed
materials and who work in the vicinity where it is used or stored.
The dose to the public is controlled by ensuring that licensed material is used,
transported, and stored in such a way that members of the public will not receive >100
mrem (1mSv) in 1 year and that the dose in any unrestricted area is not >2 mrem (0.02
mSv) in any 1 hour. To properly control public dose, licensed material must be secured
to prevent unauthorized access or use by individuals coming into the area.
Compliance with Dose Limits for Individual Members of the Public
Licensees shall conduct operations in accordance with NAC 459.3355.
Licensees must make, as appropriate, surveys of radiation levels in unrestricted and
controlled areas to demonstrate compliance with dose limits for individual members of
the public in NAC 459.335.
Licensees must show compliance with the annual public dose limit by following NAC
459.3355.
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14
PERSONNEL MONITORING PROGRAM
1)
Remember this is the only device you have at your disposal to accurately monitor
your personnel exposure.
2)
Your personnel dosimeters may be issued monthly or quarterly.
3)
In order to appropriately monitor the absorbed radiation dose to your eyes, a
collar badge may be assigned specifically for this purpose. In order for it to
accurately reflect your dose it must be worn consistently at collar level and
outside any shielding, i.e. lead apron. Collar badges are required in Michigan for
fluoroscopic x-ray usage
Personnel dosimeters should be worn at collar level to approximate exposure to
the lens of eye.
Extremities TLD Chip (Ring) must be worn with the label facing radiation source.
4)
Treat your personnel dosimeters with care.



Keep away from heat
Keep away from water
Keep away from animals (They are bite size!)
5)
Personnel dosimeters issued by your facility are to be worn only at your facility.
6)
The RSO or delegate will promptly review all dosimeter reports to look for
workers or groups of workers whose reported exposures are unusual.
7)
All individuals for whom there is a reasonable probability of exceeding 10% of
the occupational dose equivalent limit of 5 rem/yr for the State or 25% of the
occupational dose equivalent limit of 1250 mrem/qtr for the state in the course of
their work will be issued a personnel dosimeter. The RSO and/or management
determines which individuals are required to be issued a personnel dosimeter.
8)
All individuals who are occupationally exposed to significant radiation levels on
an occasional basis, such as nurses caring for radiopharmaceutical therapy or
implant patients, will be issued a whole body personnel dosimeter when caring
for those patients.
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9)
Other individuals who are exposed to radiation on an occasional basis such as
security personnel who deliver packages, secretarial personnel who work in the
nuclear medicine clinic but do not work with patients, and nurses who
occasionally care for patients who have received diagnostic dosages will not
normally be issued personnel dosimeters.
10)
All personnel dosimeters will be changed on a specific time period. Personnel
dosimeters should be changed on a specific date either monthly or quarterly.
11)
We will use a NVLAP accredited dosimetry processor.
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15
MEDICAL EVENT VS. ACCIDENTAL ADMINISTRATION
All administrations of a radiopharmaceutical indicative of a medical event / accidental
administration will be investigated to determine which category it satisfies.
Medical event means the administration of:
A dose that differs from the prescribed dose or dose that would have resulted from the
prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50
mrem to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
The total dose or dosage delivered differs from the prescribed dose by +/- 20% or more
or falls outside the prescribed dosage range, or;
The fractionated dose delivered differs from the prescribed dose, for a single fraction,
by 50% or more.

A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem)
to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from
any of the following o An administration of a wrong radioactive drug containing byproduct
material;
o An administration of radioactive drug containing byproduct material by the
wrong route of administration;
o An administration of a dose or dosage to the wrong individual or human
research subject;
o An administration of a dose or dosage delivered by the wrong mode of
treatment; or
o A leaking sealed source.
The following dosimetry calculation worksheet can be used to differentiate an
accidental administration from a medical event. In the event of the administration of a
radiopharmaceutical dosage to a patient above or below 20%, the wrong dosage,
isotope, drug or an administration of a radiopharmaceutical to the wrong patient,
complete the dosimetry worksheet and fax it to your physics consultant at MPC. A
consultant will return to you a completed form of the effective dose received and what
category it satisfies.
Upon determination of the category of the event, medical events will be reported in
accordance with 10 CFR 35.3045. Accidental administrations will be handled internally
in accordance with hospital/clinic policy regarding administration of a wrong
pharmaceutical. The RSO should be notified for all events.
File the completed dosimetry worksheet with the completed effective dose form in your
blue MPC binder under Fetal / Patient Dose Calculations.
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RADIOPHARMACEUTICAL DOSIMETRY CALCULATION WORKSHEET
Date:
Institution:
Facility address:
Individual requesting information:
Contact Phone:
Report should be sent to:
Title:
Patient Name:
Patient Identification Number:
Patients Age:
Intended Radiopharmaceutical and Activity:
Intended Study:
Administered Radiopharmaceutical /Activity:
Route of Administration:
.
Modifying Factors:
Abnormal Renal Function
Yes / No
Abnormal Liver Function
Yes / No
Occluded Bile Duct
Yes / No
Thyroid Uptake
%
Blocking Agents:
Please complete this form and fax back to the appropriate office:
Michigan Fax:
Indiana Fax:
Wisconsin Fax:
Utah Fax:
734.662.9224
317.581.1931
734.662.9224
801.272.2952
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16
PERSONNEL TRAINING PROGRAM
All personnel who handle radioactive material, or are likely to receive 100 mrem
per quarter, and whose duties will require them to work in the vicinity of radioactive
materials will receive instruction. The list of topics covered, the date of the instruction,
and the names of those attending will be kept on hand for review. Format will be
lectures or selected exams or handouts or videotaped presentations or demonstrations
as directed by the Radiation Safety Officer and the Radiation Safety Committee.
Training Frequency
1.
Before assuming duties with, or in the vicinity of, radioactive materials.
2.
During annual refresher training.
3.
Whenever there is a significant change in duties, regulations, or in the
terms of the license.
Instruction Topics
1.
Applicable regulations and license conditions.
2.
Areas where radioactive material is used or stored.
3.
Potential hazards associated with radioactive material in each area where
the employees will work.
4.
Appropriate radiation safety procedures.
5.
The licensee's in-house work rules.
6.
Each individual's obligation to report unsafe conditions to the Radiation
Safety Officer.
7.
Appropriate response to emergencies or unsafe conditions.
8.
The worker's right to be informed of occupational radiation exposure and
bioassay results.
9.
Locations where the licensee has posted or made available notices,
copies of pertinent regulations, and copies of the license and license
conditions, as required by NAC 459.782.
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10.
Written Directive Program - all policies and procedures. (As Necessary)
11.
Radioactive Material Shipment Training
Instructions to Nursing Personnel Caring for Hospitalized Therapy Patients
Training shall be provided at least initially and annually and must include the following
topics:
1.
Subject control
2.
Visitor control
3.
Contamination control
4.
Waste control
5.
RSO notification in case of medical emergency or patient death
Records of this training must kept for three (3) years and include the topics covered,
date of instruction, name of attendees and name of instructor.
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17
RADIATION MONITORING INSTRUMENTS
CALIBRATION OF SURVEY INSTRUMENTS
All survey Instruments will be calibrated and checked in accordance with
manufacturer’s recommendations or national standards. Survey instruments will be
calibrated by:
1.
The manufacturer:
2.
Medical Physics Consultants: (NRC License # 21-20153-01)
3.
Any authorized user licensed to perform survey meter calibrations as a service.
4.
Records of survey instrument calibration must be kept for three (3) years and
contain:
a.
Model number
b.
Serial number
c.
Date of calibration
d.
Results of the calibration
e.
Name of the individual performing the calibration
PROCEDURE FOR THE USE OF A SURVEY METER
During your use and handling of radioactive materials you will be required to use a G-M
survey meter. The following is a list of steps that must be taken to ensure proper use of
the meter.
1.
Check the batteries. Turn the instrument to the "Battery Check" indicator and if
indicated, replace the batteries in unit and verify proper battery function.
2.
Check the high voltage supply to the meter, if applicable. Turn the instrument to
the "HV" indicator and determine whether the high voltage is within acceptable
range. If the high voltage supply is not within acceptable range, DO NOT USE
survey meter.
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3.
Verification of proper operation: Mobile service meters require a method of
verifying proper operation prior to the use of the meter. Turn meter to
appropriate scale and verify the check source reading is within 20% of the
dedicated check source value assigned on the date of calibration. If the check
source reading is not within 20% of the dedicated check source value:
a.
Verify meter is turned to proper scale.
b.
Verify that you are following instructions given on calibration sticker (cap
on or off?; side window opened or closed?)
c.
Adjust probe geometry to produce a reading, which is within 20% of the
dedicated check source value.
If steps a through c do not yield a reading within 20% of the dedicated check source
value, DO NOT USE survey meter. You must obtain a replacement meter. Contact
Medical Physics Consultants at (734) 662-3197.
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18
DOSE CALIBRATOR TESTING
Daily:
Test – runs through zeroing / background / voltage test
Constancy Testing -- includes measuring Cs-137 on Cs-137, Tc-99m and any
other commonly used isotopes.
Quarterly:
Linearity – Calicheck or decay method
Annually:
Accuracy – done as recommended by the manufacturer.
Upon Set-up or After Repair (prior to patient use)
Accuracy – as above
Linearity – as above
Geometry
CALIBRATION OF DOSE CALIBRATOR (will be done in accordance with
manufacturer’s specifications). Records will be maintained for three (3) years and
contain:
a.
Model number
b.
Serial number
c.
Date of calibration
d.
Results of the calibration
e.
Name of the individual performing the calibration
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Test
Frequency
Tolerance
Constancy
Daily prior to patient dose assays
+/- 10%
Linearity
Installation, after repair, and quarterly
+/- 10%
Accuracy
Installation, after repair, and annually
+/- 10%
Geometry
Installation and after repair
+/- 10%
CONSTANCY testing will be performed using a long-lived reference source (e.g.,
Cesium-137) with activity greater than 50 microcuries. Zero or record the background
reading on the appropriate setting. Assay the source for both the reference source
setting and the most commonly used radiopharmaceutical settings. Record the
readings and compare to the calculated values. The Radiation Safety Officer will be
notified and the unit will be repaired or replaced if the constancy error exceeds 10
percent.
LINEARITY testing will be performed using a Technetium-99m source having activity at
least as great as the maximum activity administered to patients. Testing will be
conducted with the decay or the leaded-sleeve method over the entire range of
administered activity.
Decay Method: Assay the source at approximately 0, 6, 24, 30, 48, etc. hours over
the entire range of use (between the highest activity administered to patients and
the lowest). Record the net activities, time and date. Using a measured activity for
reference which is closest to that which is commonly administered to patients,
calculate the expected readings and compare to the measured readings. The
Radiation Safety Officer must review and sign the test document. The Radiation
Safety Officer will be notified and the unit will be repaired or replaced or patient
dosage readings will be mathematically corrected if the linearity error exceeds 10
percent over the range of use.
Sleeve Method: The sleeves will be calibrated at the time of an initial reading of a
decay-method linearity test. Either the "Calicheck" or "Lineator" product will be used.
The testing procedure will be performed according to the manufacturer's
instructions. The Radiation Safety Officer must review and sign the test document.
The Radiation Safety Officer will be notified and the unit will be repaired or replaced
or patient dosage readings will be mathematically corrected if the linearity error
exceeds 10 percent over the range of use.
MPC SAMPLE
ACCURACY testing will be performed using Cesium-137 and Cobalt-57 or Barium-133
reference sources having NIST-traceable activities greater than 50 microcuries. The net
measured activities will be compared to the calculated activities based on radioactive
decay. The Radiation Safety Officer must review and sign the test document. The
Radiation Safety Officer will be notified and the unit will be repaired or replaced if the
accuracy error exceeds 10 percent.
GEOMETRY DEPENDENCE testing will be performed using a solution of Tc-99m
having an activity concentration of 1-10 mCi/ml for all syringes and vials used. If
generators and/or radiopharmaceutical kits are normally used, both of the following
tests will be performed:
1. Vial test: You will need 5.0 mCi of Tc-99m in a 10 cc glass vial with a
concentration of 5 mCi/mL and one vial of saline. Take the first reading of Tc99m without adding saline. Then add one mL of saline and take a reading.
Continue to add one mL of saline to the Tc-99m vial and take readings up to 8
mL (8 readings total). The activity in each should not vary by more than 10%.
2. Syringe test: You will need a syringe containing 2.0 mCi of Tc-99m in 0.5 mL
(concentration of 4 mCi/mL) and one vial of saline. Take the first reading of Tc99m without adding saline. Then add 0.5 mL saline and take a reading.
Continue to add approximately 0.5 mL of saline to the syringe. The activity in
each should not vary by more than 10%.
MPC SAMPLE
19
SEALED SOURCES
PHYSICAL INVENTORY
Records of the semi-annual sealed source inventory will be maintained for three (3)
years and contain:
1.
Model Number of each source
2.
Serial number if assigned
3.
Radionuclide identity
4.
Nominal Activity
5.
Location of each source
6.
Name of individual performing inventory
LEAK TESTS
Sealed sources will be leak tested on a semi-annual basis that is not to exceed 6
months. Medical Physics Consultants, Inc. (NRC License No. 21-20153-01), or anyone
licensed by the NRC can perform the leak testing.
Records of the sealed source leak test will be maintained for three (3) years and
contain:
1.
Model Number of each source
2.
Serial number if assigned
3.
Radionuclide identity
4.
Estimated Activity
5.
Results of the test, i.e. < 0.005 Ci
6.
Date of the test
7.
Name of individual performing the test
MPC SAMPLE
The measurement of the leak test sample is a quantitative analysis requiring that
instrumentation used to analyze the sample be capable of detecting 185 Bq (0.005 Ci)
of radioactivity on the sample. Leak test samples shall be collected at the most
accessible area where contamination would accumulate if the source were leaking.
Test results in excess of 0.005 Ci shall cause for the immediate removal of the source
from use and store, dispose or cause it to be repaired in accordance with Parts 20 and
30. A report must be filed within 5 days of the test with the NRC regional office and
copied to the NRC in Washington, D.C. in accordance with 35.3067.
The following sources are exempt from leak testing:
1.
Source half life <30 days
2.
Source contains Radioactive Material gas
3.
Source contains 100 Ci (3.7 MBq) or less of beta or gamma emitting
material
4.
Source contains 10 Ci (0.37 MBq) or less of alpha emitting material
5.
Seeds of Ir-192 in nylon ribbon
6.
Sources stored and not being used.
LOST SEALED SOURCES
Lost / stolen or missing sources > 1000 X Part 20 Appendix C. values must be reported
immediately to the RSO and the Nevada State Health Division via telephone and fax. A
written report must be filed within 30 days.
Lost / stolen or missing sources > 10 X Part 20 Appendix C. values must be reported to
the RSO and the Nevada State Health Division within 30 days.
MPC SAMPLE
20
RULES FOR THE SAFE USE OF RADIOPHARMACEUTICALS
1.
Laboratory coats or other suitable over garments will be worn in areas where
radioactive materials are used. These items should be buttoned for maximum
protection.
2.
Disposable gloves will be worn at all times when handling radioactive materials.
3.
All personnel working with radioactive materials will wear the appropriate
radiation detection badges, as determined by the Radiation Safety Officer
(RSO). These devices should be kept on site, in a low background area (i.e.
office or locker) while not worn during off duty hours.
4.
A finger TLD ring will be worn with label facing the radiation source during the
elution of 99Mo/99mTc generators; during the preparation, assay and
administration of radioactive materials; and while holding patients injected with
radiopharmaceuticals for image positioning purposes.
5.
Either after each procedure or before leaving the area (i.e. for lunch / home),
hands and clothing should be monitored for contamination in a low background
area with a thin window Geiger-Mueller (GM) survey meter.
6.
Appropriate syringe shields will be used for the routine preparation of
radiopharmaceutical kits and the administration of the same to patients, except
in those circumstances in which their use is contraindicated (i.e. recessed veins,
infants, etc.). In these exceptional cases, other protective methods will be
considered such as a remote delivery of the administered dose via a butterfly
setup.
7.
Shielded syringe carriers will be used in the transportation of all
radiopharmaceuticals from the compounding area to the injection area. Therapy
doses will be transported in appropriate shielded containers.
8.
Syringes, vials and/or unit dosages must be labeled at least with the
radiopharmaceutical name or abbreviation. Additionally syringe and/or vial
shields must be labeled unless the syringe / vial label is visible.
9.
Each “unit dosage” should be assayed in the dose calibrator before
administration. Decay corrected activity can also be determined from the unit
dose label.
MPC SAMPLE
10.
The use of a dose calibrator to measure “unit dosages” of the following betaemitters, P-32, Sr-89, Y-90, Sm-153 is not advised due to inherent detector
inaccuracies. Decay corrected activity can be determined from the unit dose
label.
11.
Any patient dosage other than a “unit dose” or a unit dose that is manipulated in
any way must be assayed in a dose calibrator.
12.
Radiopharmaceutical dosages must be within either the prescribed dosage
range or +/-20% of the prescribed dose, unless otherwise directed by an
authorized user prior to use.
13.
Upon assay or disposal, all unshielded radioactive vials should be handled with
forceps.
14.
When adding either radioactive or non-radioactive material to a vial, which
contains either radioactive or non-radioactive material, always withdraw an equal
amount of air to equalize pressure within the vial; thereby preventing inadvertent
spray of radioactive material.
15.
All radioactive waste or waste that is suspected to be radioactive will be so
confirmed by monitoring prior to disposal in designated, labeled and properly
shielded receptacles. For volume reduction purposes only waste that is
confirmed to be radioactive will be placed in these receptacles.
16.
Do not eat, drink, smoke or apply cosmetics in a radioactive material preparation,
usage, storage or waste areas or any restricted area as defined by the RSO.
17.
No food, drink or personal effects will be stored in radioactive material
preparation, usage, storage or waste area or any restricted area as defined by
the RSO.
18.
Never mouth pipette.
19.
All areas of radioactive material preparation, storage or dose administration
areas will be wipe tested for removable contamination and surveyed for
excessive exposure as described in the radiation protection program.
20.
Areas where radioactive materials requiring a written directive are routinely
prepared for use or administered will be surveyed for contamination at the end of
the normal workday with an appropriate survey instrument and the results
recorded. Initiate the facility decontamination procedure as appropriate.
21.
“Spills” or uncontained radioactive material must be controlled, decontaminated
to ALARA levels, wiped, surveyed and documented as described in the radiation
protection program. The use of shielding may be used as necessary.
MPC SAMPLE
22.
Radioactive materials and sealed sources / restricted areas will be either
secured or under the direct supervision of authorized personnel at all times to
prevent unauthorized removal or entry.
23.
Decrease TIME in and around radiation sources i.e., injected patients.
24.
Increase DISTANCE from radiation sources - Doubling the distance between
you and the source will lower your dose by a factor of ~4, tripling your distance
will reduce it by a factor of ~9.
25.
Increase SHIELDING between you and radiation source - We usually think of
lead at the mention of this dose reduction technique, however the bodies(soft
tissue) of others is a well- known attenuator of ionizing radiation !!
MPC SAMPLE
21
PACKAGE ORDER AND RECEIPT PROCEDURES
1.
The Radiation Safety Officer (RSO) or a designee must authorize each order for
radioactive materials and ensure that the requested materials and quantities are
authorized by the license for use by the requesting authorized user and that
possession limits are not exceeded.
2.
The RSO will establish and maintain a system for ordering and receiving
radioactive material. The system must contain the following information:
a.
Written records that identify the authorized user or department, isotope,
chemical form, activity, supplier will be made.
b.
The above records will be checked to confirm that material received was
ordered through proper channels.
3.
For deliveries during normal working hours, packages are received in the hot lab.
4.
If off duty deliveries are a necessity, the carrier will place the package within the
secured designated area and re-lock all doors opened to gain access.
5.
All packages containing radioactive material will be stored in a secured area to
prevent unauthorized access to these items.
MPC SAMPLE
22
PROCEDURE FOR OPENING/ RETURNING PACKAGES CONTAINING
RADIOACTIVE MATERIAL
1.
Put on gloves to prevent hand contamination.
2.
Visually inspect the package for any sign of damage (e.g., wet or crushed). If
damage is noted, stop and notify the RSO.
3.
Measure and record the exposure rate from the package at 1 meter and at the
package surface. If the rate is greater than 10 mR/hr, stop and immediately
notify the RSO, the final delivery carrier and by telephone and fax the regional
office of the NRC.
4.
Measure and record the exposure rate on the surface of the package in the
same orientation as the data taken in step 3 above. If greater than 200 mR/hr
stop the procedure and immediately notify the RSO, the final delivery carrier and
by telephone and fax the regional office of the NRC.
5.
Wipe 100 cm2 external surface area of the package in compliance with NAC
459.3585. Assay the wipe sample with a suitable instrument sufficient to detect
22,000 dpm to determine if there is any removable activity. If there is any
contamination in excess, immediately notify the RSO, the final delivery carrier
and by telephone and fax the regional office of the NRC.
DO NOT OPEN THE PACKAGE!!
6.
Follow the steps listed below when opening the package.
a.
Remove the packing slip.
b.
Open the outer package following the supplier's instructions, if available.
c.
Open the inner package and verify that the contents agree with the
packing slip.
d.
Check the integrity of the final source container. Look for broken seals or
vials, loss of liquid, condensation, or discoloration of the packing material.
e.
if anything unusual is noticed, stop and notify the RSO.
7.
Verify that the material received is the material ordered.
8.
Verify that the manufacturer receives the material being returned.
MPC SAMPLE
9.
Monitor the packing material and the empty packages for contamination with a
GM survey meter before discarding. If contaminated, treat as radioactive waste.
If not contaminated, deface all radiation labels before discarding.
10.
Record the receipt and all readings taken.
The diamond label used is determined by the exposure measurements noted below.
Make sure your package conforms to these exposure levels / label pairings.
WHITE I
YELLOW II
YELLOW III
YELLOW III
Exclusive Use Only
Surface
<0.5 mR/hr
0.5 - 50 mR/hr
50 - 200 mR/hr
200 - 1000 mR/hr
One Meter
Background
< 1 mR/hr
1 - 10 mR/hr
> 10 mR/hr
MPC SAMPLE
23
RADIOACTIVE MATERIAL USE
Unit Dose Records - are to be maintained for three (3) years and MUST contain a
notation of the following:
a.
Radiopharmaceutical
b.
Patient name and/or ID number
c.
Prescribed Dosage
d.
Determined Dosage or notation that the activity is <30 µCi (1.1 MBq)
e.
Date and time of the dosage determination
f.
Name of the individual who determined dosage
Multidose Vial Records - MUST contain a notation of the radioactive drug. It is
highly suggested that the following information be noted:
1.
2.
Technical Data
a.
Radionuclide
b.
Chemical form or abbreviation
c.
Date of preparation
d.
Date, time, and activity of initial assay
e.
Supplier of kit manufacturer
Administrative Data
a.
Date and time dosage was drawn
b.
Prescribed dosage
c.
Calculated inverse concentration (ml/mCi) at drawing time
d.
Calculated volume needed for prescribed dose
e.
Measured activity and associated time
f.
Patient name and ID number
g.
Method of disposal and date and associated time
MPC SAMPLE
h.
Name of person recording information
If radionuclide generators are used the following additional records will be maintained.
Molybdenum Concentration Records - Must be performed and calculated on the first
elution of each generator, prior to patient use. These records will be maintained for
three (3) years and MUST contain the following information:
a.
Date and time of measurement
b.
Ratio of the total Mo-99 microcuries per millicurie of Tc-99m and
documentation that the ratio is less than specified in 10 CFR 35.204 (a)
c.
Name of the person who made the record.
It is highly suggested that the following information be noted:
a.
Date the generator was received
b.
Measured Mo-99 activity in microcuries
c.
Product of the measured Mo-99 activity and the correction factor noted by
the molybdenum breakthrough pig manufacturer.
d.
Measured Tc-99m activity in millicuries
MPC SAMPLE
24
AREA SURVEY PROCEDURES
1.
All areas where radioactivity is handled, used, and prepared should (unless a
written directive is required and these areas will) be surveyed at the end of each
day of use for ambient radiation exposure rates.
2.
All areas where radioactive materials are stored should be surveyed weekly for
ambient radiation exposure rates.
3.
Surveys for ambient exposure rates will be performed with a radiation detection
survey instrument. For example, a Geiger-Mueller meter able to detect as low as
0.1 mR/h.
4.
All measurements will be made on the lowest scale, unless exposure rates
exceed this scale.
5.
Trigger level exposure rates will be determined for each area that is to be
surveyed.
6.
Survey results greater than the trigger levels will result in decontamination or
shielding procedures necessary to reduce the exposure or contamination levels
to background on repeat surveys. Any result that exceeds the trigger level
must be reported to the RSO.
7.
A record shall be kept of all survey results. These records will be retained for a
period of three (3) years. The record MUST include:
a.
Date of the survey
b.
Results of the survey
c.
Instrument used to make the survey
d.
Name of the person conducting the survey.
It is highly suggested that the following information be noted:
a.
Location surveyed
b.
Drawing of the area surveyed.
c.
Trigger levels keyed to the location on the drawing.
d.
Results keyed to the location on the drawing.
MPC SAMPLE
e.
8.
Corrective actions taken in case of contamination or excessive exposure
rates and reduced contamination levels after corrective action.
The RSO or their designate will review the survey results on a quarterly basis for
conformance to certain action levels.
MPC SAMPLE
25
SURVEY FOR REMOVABLE CONTAMINATION (WIPES TEST)
1.
All areas where radioactivity is handled, used, prepared, and stored should be
surveyed weekly for removable contamination.
2.
Wipe tests for removable contamination will consist of a series of wipes, which
will be assayed using a procedure sufficiently sensitive to detect the trigger levels
noted below.
3.
All values will be recorded in disintegration's per minute (dpm)/ per 100 cm 2.
4.
All wipe tests will be analyzed with a detector of sufficient sensitivity to detect the
trigger levels noted below, i.e., (well, uptake, camera).
5.
Trigger levels for removable contamination will be determined for each area
(restricted or unrestricted).
*MPC conservatively suggests that both restricted and unrestricted area
trigger levels be set to:
200 dpm/ per 100 cm2 for I-131, P-32
2000 dpm/ per 100 cm2 for all other radionuclides.
6.
Survey results greater than the trigger levels will result in decontamination to
reduce contamination levels below the trigger level on repeat surveys. As an
alternative the area affected may be covered to prevent the spread of
contamination until decay. Any result that exceeds the trigger level must be
reported to the RSO.
7.
A record shall be kept of all survey results. The record should include:
a.
Location, date, and type of equipment used.
b.
Initials of the person conducting the survey.
c.
Drawing of the area wipe tested.
d.
Trigger levels keyed to the location on the drawing.
e.
Results keyed to the location on the drawing.
f.
Corrective actions taken in case of contamination or excessive exposure
rates and reduced contamination levels after corrective action.
MPC SAMPLE
The method for determining the wipe test values in dpm's is as follows:
A
B
C
D
=
=
=
=
Calculated source activity of sample isotope in dpm
Measured source counts of sample isotope in cpm
Measured background counts in cpm
B - C (Net Counts in cpm)
Efficiency Factor = Calculated Activity in dpm (A)
Net Counts in cpm (D)
Wipe Sample-dpm = (Net Counts of Wipe Sample) x (Efficiency Factor)
9.
The RSO will be notified of all positive wipe test and ambient survey results.
MPC SAMPLE
26
RADIOACTIVE SPILLS
1.
Assemble a spill kit to be ready in case of a spill containing radioactive material.
This should be comprised of:










2.
Disposable gloves
Disposable shoe coverings and gowns
Absorbent paper/ Radiac Wash
Tape
Plastic bags
“Radioactive material” labeling tape
Marking pen
Wipes/ Survey Meter
“Spill Report” from MPC binder
Copy of “Emergency Spill Procedures”
Determine if the spill is a minor or major spill using the table below:
Radionuclide
P-32
Cr-51
Co-57
F-18
Y-90
Co-60
Ga-67
Sr-89
Millicurie
1
100
10
50
1
1
10
1
Radionuclide
Tc-99m
In-111
I-123
I-125
I-131
Sm-153
Tl-201
F-18
Millicurie
100
10
10
1
1
10
100
50
Activities < (in mCi) values listed above = Minor spill
Activities > (in mCi) value listed above = Major spill
MPC SAMPLE
Minor Spills
1.
NOTIFY: Notify persons nearby that a spill has occurred.
2.
PREVENT THE SPREAD: Cover the spill with absorbent paper.
3.
CLEAN UP: Put on disposal gloves. Absorbent paper and a cleaning solution
such as RADIAC WASH should be used for cleaning. Place all contaminated
absorbent paper and gloves in a plastic bag. Once the clean up is completed,
seal the bag and place it in radioactive material storage for decay.
4.
SURVEY: Survey the area with a low-range, GM survey meter. Check the area
around the spill, any exits from the area, hands, clothing, and shoes for
contamination.
5.
WIPE TEST: A wipe test for contamination should also be performed, specifically
in areas around and involving the spill to detect if it has spread via shoe contact
from others. If the results of the wipe test exceed the established trigger level,
repeat step #3.
6.
REPORT: Report the incident to the RSO who will supervise the cleanup of the
spill and complete the Radioactive Spill Report and the Radioactive Spill
Contamination Survey. The RSO may delegate the actual clean-up and survey
performance to a trained technologist. However, the RSO will retain the ultimate
responsibility to ensure that the Report and Survey are completed properly.
7.
DOCUMENT: A radioactive material spill report should be generated.
should include the following information:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Date, time and location of the spill
Who was involved
Radionuclide and activity
How the spill occurred
How the area was decontaminated
Include instruments used (i.e. GM survey meter, well counter)
Diagram of area
Survey results and wipe test results
Any follow up
How to prevent the recurrence
This
MPC SAMPLE
Major Spills
1.
CLEAR THE AREA: Notify all persons not involved in the spill to vacate the
room.
2.
PREVENT THE SPREAD: Cover the spill with absorbent paper, but do not
attempt to clean it up. Confine the movement of all personnel potentially
contaminated to prevent the spread.
3.
SHIELD THE SOURCE: This should be done only if it can be done without
further contamination or a significant increase in radiation exposure.
4.
CLOSE THE ROOM: Leave the room and lock the door(s) to prevent entry.
5.
NOTIFY: Notify the RSO immediately.
6.
PERSONNEL DECONTAMINATION: Decontaminate personnel by removing
contaminated clothing and flushing the contaminated skin with lukewarm water
and then washing with mild soap. If contamination remains, induce perspiration
by covering the area with plastic. Then wash the affected area again to remove
any contamination released by the perspiration.
7.
REPORT: Report the incident to the RSO who will supervise the cleanup of the
spill and complete the Radioactive Spill Report and the Radioactive Spill
Contamination Survey. The RSO may delegate the actual clean-up and survey
performance to a trained technologist. However, the RSO will retain the ultimate
responsibility to ensure that the Report and Survey are completed properly.
8.
DOCUMENT: A radioactive material spill report should be generated.
should include the following information:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Date, time and location of the spill
Who was involved
Radionuclide and activity
How the spill occurred
How the area was decontaminated
Include instruments used (i.e. GM survey meter, well counter)
Diagram of area
Survey results and wipe test results
Any follow up
How to prevent the recurrence
This
MPC SAMPLE
27
WASTE DISPOSAL
Liquids and Gases
Liquids may be disposed of by release to the sanitary sewer release to the atmosphere.
1.
Disposal to the sanitary sewer system will be made in accordance with NAC
459.320-459.374. A record will be kept of the following: date, radionuclide,
estimated activity released, and place where material was released.
2.
Permissible concentrations in effluents will be kept within the limits enumerated
in NAC 459.320-459.374. A record will be kept of the date, radionuclide,
estimated activity released, estimated concentration, and vent site at which the
material was released.
Decay in Storage
1.
Only material with a physical half-life of less than 120 days may be decayed in
storage at the facility.
2.
Each container will be tagged to include:
a.
the date sealed or set into storage
b.
the longest-lived isotope in the container
3.
Material will be decayed until its radioactivity cannot be distinguished from the
background radiation level.
4.
Prior to disposal as in-house waste, each container will be monitored as follows:
a.
Low-range GM survey meter will be checked for proper operation on the
most sensitive scale.
b.
Waste will be monitored in a low level area.
c.
Any shielding around the container will be removed.
d.
All surfaces of each individual container will be monitored.
e.
Only those containers, which cannot be distinguished from background
levels will be disposed of after all radioactive labels, have been defaced.
MPC SAMPLE
5.
Mo-99/Tc-99m generators will be held for at least 60 days before being
dismantled. When dismantling generators, a low-range GM survey meter will be
kept at the work area. The oldest generator will be dismantled first, working
forward chronological l. Each individual column will be held in contact with a lowlevel survey instrument in a low background (less than 0.05 mR/hr) area. The
generator date and disposal date will be logged in the disposal records.
Radiation labels will be removed or defaced on the generator shield. Generators
may also be returned to the manufacturer for disposal. Manufacturer's
instructions will be followed.
6.
Records of decay-in-storage disposal shall be maintained for three (3) years and
must contain the following information:
1.
Date of disposal will be recorded
2.
Survey instrument used
3.
Background radiation level
4.
Radiation level measured at the surface of the container
5.
The name of the individual that performed the survey
Unit Dose Waste
If a unit dose pharmacy is used, the materials supplied by them (e.g., syringes,
needles, etc.) may be returned to the unit dose pharmacy in the original shipping
container.
If combinations of radionuclides are shipped together in the same package, the
total activity for the package must not exceed the lowest activity limit noted below for
the radionuclides to be shipped.
MPC SAMPLE
Radionuclide
Ba-133
C-14
Co-57
Cr-51
Cs-137
F-18
Ga-67
Ho-166
I-123
I-125
I-131
In-111
Lu-177
Activity (mCi)
8.1
8.1
27
81
1.6
1.6
8.1
1.1
8.1
8.1
1.9
8.1
1.9
Radionuclide
Mo-99
N-13
Na-22
Ni-63
P-32
Pd-103
Sm-153
Sr-89
Sr-90
Tc99m
Tl-201
Xe-133
Y-90
Activity (mCi)
2
1.6
1.4
81
1.4
110
1.6
1.6
0.81
11
11
270(gas)
0.81
MPC SAMPLE
28
RECORD RETENTION
RECORD
RETENTION
Area Surveys (daily and weekly)
Area evacuation time calculations
Brachytherapy patient care personnel instruction
Brachytherapy patient room surveys
Brachytherapy patient survey at removal
Brachytherapy source use records
Brachytherapy surveys at implant
Disposal (other)
Disposal by decay in storage
Dose calibrator geometry
Dose calibrator Q.C. (lin., const., accur.)
1-131 thyroid bioassay
Ministerial changes
Misadministrations
Mo-99 assay
Mobile nuclear medicine authorization letters
Mobile nuclear medicine surveys
Patient care personnel instruction for 1-131
therapies
Patient Dosage
Personnel monitoring
Quality Management Program
Review
Recordable events
Record of administered dose (& written directive)
Radiation Safety Committee Minutes
Radiopharmaceutical therapy room survey
at administration
Radiopharmaceutical therapy room survey
at release
Receipt
Sealed source handling instructions
Sealed source inventory
Sealed source leak tests
Sealed source storage area surveys
Statement of authority and responsibilities
for RSC and RSO
Survey meter calibration
Teletherapy dosimetry equipment
calibration, comparison, inter-comparison
Teletherapy five year inspection
Teletherapy monitor operational check
Teletherapy radiation surveys
Teletherapy safety checks
Teletherapy safety instruction
Teletherapy spot-checks
Teletherapy unit calibration
Transfer
Xenon trap check & ventilation studies
REFERENCE
3 years
Duration of Use
3 years
3 years
3 years
3 years
3 years
Indefinitely
3 years
Duration of dose calibrator
3 years
Indefinitely
Until license renewed or terminated
5 years
3 years
3 years past last service
3 years
35.70(h)
35.205(d)
35.410(b)
35.415(a)(4)
35.404(b)
35.406(d)
35.406(d)
20.401(c)(3)
35.92(b)
35.50(b)(4)
35.50(e)
35.315(a)(8)
35.31(b)
35.33(4)(b)
35.204(c)
35.29(b)
35.80(f)
3 years
3 years
Indefinitely
35.310(b)
35.53(c)
20.2106(f)
3 years
3 years
3 years
Duration of license
35.32(b)(3)
35.32(c)(3)
35.32(d)(2)
35.22(a)(5)
3 years
35.315(a)(4)
Undefined
3 years from transfer or disposal
Duration of use
3 years
3 years
3 years
35.315(a)(7)
30.51(a)(1)
35.59(a)
35.59(g)
35.59(d)
35.59(i)
Duration of license
3 years
35.23(b)
35.5 l(d)
Duration of license
Duration of license
3 years
Duration of license
3 years
3 years
3 years
Duration of use of source
3 years from transfer
Undefined
35.630(c)
35.647(c)
35.615(d)(4)
35.641 (c)
35.636(c)
35.610(c)
35.634(f)
35.632(g)
30.51(a)(2)
35.205(e)
These are the stated NRC required retention periods. Please be aware that other
regulatory agencies may require longer retention periods.
MPC SAMPLE
29
PRESCRIBED DOSAGE LIST
Date Implemented:
Date Revised: __________
1. A list of all patients’ procedures and their prescribed dosages should be listed and
typed on facility letterhead.
2. The prescribed dosage must be documented either as a dosage range or a
prescribed dosage ±20%.
3. The document must include the correct isotope and chemical form of the radiopharmaceutical. For example: Tc-99 m MDP, I-123 Sodium Iodide, Ga-67 Citrate.
4. This list should be posted conspicuously in the Hot Lab preferably near the dose
drawing station.
5. The document should also include methods for calculating pediatric dosages if
pediatric studies are performed.
6. Whenever new patient procedures are performed the list will be updated to reflect
this.
7. This document must be signed by the RSO and/or an authorized user.
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30
PEDIATRIC DOSAGE LIST
Weight
kg
lb
2
4.4
Fraction of
adult dose
0.09
3
6.6
0.12
4
8.8
0.14
6
13.2
0.19
8
17.6
0.23
10
22.0
0.27
15
33.0
0.30
20
44.0
0.48
25
55.0
0.55
30
66.0
0.62
35
77.0
0.69
40
88.0
0.75
45
99.0
0.81
50
110.0
0.87
55
121.0
0.91
65
143.0
1.00
*Data taken from CRC Manual of Nuclear Medicine
Procedures, 4th
Edition.
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PROGRAM UPDATES
Radiation Protection Program Manual implemented on: __________
Radiation Protection Program Manual updated on:
__________
The current version of the Radiation Protection Manual supersedes the previous
version.
Please note the following:
Changes may be made to the radiation protection program if the following conditions
are met:
 A license amendment is not required1
 Changes are in compliance with the regulations and license
 The revision has been reviewed and approved by licensee management and the
Radiation Safety Officer
 The individuals affected by the changes are instructed before implementation
Documentation of changes made to the radiation protection program must be retained
for a period of five years. Documentation shall include:
 A copy of the old procedure
 A copy of the new (revised) procedure
 The effective date of the change
 The signature of the licensee management that reviewed and approved the
change
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DEFINITIONS
Absorption: The process by which radiation imparts some or all of its energy to any
material through which it passes.
Authorized User: A physician, dentist, or podiatrist who is identified as an authorized
user on an NRC or Agreement State license that authorizes the medical use of
Radioactive Material material or meets the criteria of Part 35.
Activity: The number of nuclear transformations occurring in a given quantity of
material per unit time at a given time. Activity has the unit of (second)-1. (See
Becquerel and Curie.)
Annihilation (Electron): An interaction between a positive and a negative electron in
which they both disappear; their energy, including rest energy, is converted into
electromagnetic radiation (called annihilation radiation).
Atom: Smallest particle of the element which is capable of entering into a chemical
reaction.
Atomic Mass: The mass of a neutral atom of a nuclide, usually expressed in the terms
of "atomic mass units". The "atomic mass unit" is one-twelfth the mass of one neutral
atom of carbon-12; equivalent to 1.6604 X 10-24 gm. (Symbol: u.)
Atomic Number: The number of protons in the nucleus of an atom. (Symbol: Z)
Background Radiation: Ionizing radiation arising from radioactive material other than
that directly under consideration.. Background radiation due to cosmic rays and natural
radiation is always present. There may also be background radiation due to the
presence of radioactive substances in other parts of the building, in the building
material, etc.
Becquerel (Bq): The special name for the unit of activity which equals one nuclear
transformation per second. (See Curie also)
Note that:
1 Ci = 3.7 x 1010 Bq, and
1 Bq=2.7 x 10-11 Ci
Beta Particle: Charged particle emitted from the nucleus of an atom; having a mass
and charge equal in magnitude to that of an electron.
Bremsstrahlung: Secondary photon radiation produced by deceleration of charged
particles passing through matter.
Calibration: Determination of variation from standard, or accuracy, of a measuring
instrument to ascertain necessary correction factors.
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Carrier Free: An adjective applied to one or more radioactive isotopes of an element
that are essentially undiluted with stable isotope carrier.
Carrier: A quantity of non-radioactive or non-labeled material of the same chemical
composition as its corresponding radioactive or non-labeled counterpart. When mixed
with the corresponding radioactive labeled mixture, the carrier permits chemical (and
some physical) manipulation of the mixture with less label or radioactivity loss than
would be true for an undiluted label or radioactivity.
Chamber, Ionization: An instrument designed to measure a quantity of ionizing
radiation in terms of the charge of electricity associated with ions produced within a
defined volume.
Chemical Atomic Weight: The weighted mean of the masses of the neutral atoms of
an element expressed in atomic mass units.
Contamination, Radioactive: Deposition of radioactive material in any place where it
is not desired, and in particular in any place where its presence may be harmful. The
harm may be in invalidating an experiment or a procedure, or in being a source of
unnecessary exposure to personnel.
Controlled Area: A defined area in which the occupational exposure of personnel (to
radiation) is under the supervision of the Radiation Safety Officer.
Count (Radiation Measurement): The external indication of a device designed to
enumerate ionizing events. It may refer to a single directed event or be a total number
of registered events in a given period of time. The term is often erroneously used to
designate a disintegration, ionizing event, or voltage pulse.
Spurious Count: In a radiation counting device, a count caused by any agent
other than radiation.
Counter, Gas Flow: A device in which an appropriate atmosphere is maintained in the
counter tube by allowing a suitable gas to flow through the sensitive volume.
Counter, Geiger Mueller: Highly sensitive, gas-filled radiation measuring device. It
operates at voltages sufficiently high to produce avalanche ionization and the pulse
produced is independent of the number of ions formed in the gas by the primary
ionizing particle.
Counter, Proportional: Gas-filled radiation detection device. It operates at voltages
sufficiently high to produce avalanche ionization and the pulse produced is proportional
to the number of ions formed on the gas by the primary ionizing particle.
Counter, Scintillation: The combination of Fluor (scintillator), photomultiplier tube,
and the associated circuits for counting light emissions produced in the Fluor.
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Committed dose equivalent (CDE, HT,50): The dose equivalent to organs or tissues
of reference (T) that will be received from an intake of radioactive material by an
individual during the 50 year period following the intake.
Committed effective dose equivalent (CEDE, HE,50): The sum of the products of the
weighting factors to each of the body organs or tissues that are irradiated and the
committed dose equivalent to these organs or tissues.
Cosmic Rays: High-energy particulate and electromagnetic radiation which originate
outside the earth's atmosphere.
Curie (Ci): The special unit of activity. One curie equals exactly 3.700 x 1010 nuclear
transformations per second. Several fractions of the curie are in common usage.
Millicurie (mCi): One-thousands of a curie (3.7 x 107 disintegration's per second).
Microcurie (Ci): One-millionth of a curie (3.7 x 104 disintegration's per second)
Picocurie (pCi): One-millionth of a microcurie (3.7 x 10-2 disintegration's per second)
Daughter: Synonym for decay product.
Decay, Radioactive: Disintegration of the nucleus of an unstable nuclide by
spontaneous emission of charged particles and/or photons.
Decay product:
A nuclide resulting from the radioactive transformation of a
radionuclide, formed either directly or as the result of successive transformations in a
radioactive series. Some decay products are radioactive, others are stable.
Declared pregnant woman: A woman who has voluntarily informed her employer, in
writing, of her pregnancy and the estimated date of conception.
Decontamination Factor: The ratio of the amount of undesired radioactive material
initially present to the amount remaining after a suitable processing step has been
completed. Decontamination factors may refer to the reduction of some particular type
of radiation, or in the gross measurable radioactivity.
Deep dose equivalent (Hd, DDE): The external whole body exposure at a tissue depth
of 1 cm.
Detector, Radiation: Any device for converting radiant energy to a form more suitable
for observation. Any instrument used to determine the presence, and sometimes the
amount, of radiation.
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Disintegration, Nuclear: A spontaneous nuclear transformation characterized the
emission of energy and/or mass from the nucleus. When large numbers of nuclei are
involved, the process is characterized by a definite half-life.
Dose, Absorbed: The mean energy imparted to matter by ionizing radiation per unit
mass of irradiated material at the point of interest. The irradiated material is usually
specified, e.g., absorbed dose in water, absorbed dose in lead, etc. The unit of
absorbed dose is J(Kg-1). The special name for the unit of absorbed dose is the gray
(Gy) where
1Gy=1 J(Kg-1)
The special unit for the absorbed dose is the rad where
1 rad=100 erg(g-1)=0.01 Gy
Dose Equivalent (HT): The product of the absorbed dose in tissue and various
modifying factors. The dose equivalent is used in radiation protection as an indication
of the biological effect that will be produced in an irradiated tissue. The unit of dose
equivalent is J(Kg-1). The special name for the unit of dose equivalent is the sievert
(Sv):
1 Sv=1 J(Kg-1)
The special unit of dose equivalent is the rem:
1 rem=0.01 Sv
Dose Rate, Absorbed: Absorbed dose delivered per unit time.
Dose Ratemeter: Any instrument, which measures radiation dose rate.
Dosimeter: Instrument to detect and measure accumulated radiation exposure. In
common usage, a pencil-sized ionization chamber with a self-reading electrometer,
used for personnel monitoring.
Effective dose equivalent (HE): The sum of the products of the dose equivalent to the
organ or tissue (HT) and the weighting factors (wT) applicable to each of the body
organs or tissues that are irradiated.
Efficiency (Counters): A measure of the probability that a count will be recorded when
radiation is incident on a detector. Usage varies considerably so it is well to ascertain
which factor (window transmissions, sensitive volume, energy dependence, etc) are
included in the given case.
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Electron: A stable elementary particle having an electronic charge equal to +/- 1.60210
x 10-19 Coulomb, and a rest mass equal to 9.1091 x 10 -31 Kg.
Secondary Electron: An electron ejected from an atom, molecule, or surface as a
result of an interaction with a charged particle or photon.
Valence Electron: Electron, which is gained, lost, or shared in a chemical reaction.
Electron Volt (eV): A unit of energy equivalent to the energy gained by an electron in
passing through a potential difference of one Volt. (1 eV=1.6 x 10 -12 erg). Larger
multiple units of electron volt are frequently used: keV for thousand or kilo electron
volts; MeV for million or mega electron volts.
Electroscope: Instrument for detecting the presence of electric charges by the
deflection of charged bodies.
Element: A category of atoms all of the same atomic number.
Exposure:
(1) Being in the same place at the same time as something, as in "exposure to
neutrons" for example.
(2) A measure of the ionization produced in air by photons. More specifically, it is
the sum of the electrical charges in all ions of one sign produced in air when all
electrons liberated by photons in a volume element of air are completely stopped
in the volume element, divided by the mass of the air in the volume element.
The unit of exposure is the C(Kg-1). The special unit of exposure is the
roentgen(R):
1R=2.58 X 10-4C(Kg-1)(exactly).
Eye dose equivalent: The external exposure of the lens of the eye. It is taken as the
dose equivalent at a tissue depth of 0.3 centimeters.
Film Badge: A packet of photographic film used for the approximate measurement of
radiation exposure for personnel monitoring purposes. The badge may contain two or
more films of differing sensitivity, and it may contain filters that shield parts of the film
from certain types of radiation. Light stimuable phosphors (LSP) may be also used.
Gamma Ray: Very penetrating electromagnetic radiation of nuclear origin. Similar
properties to x-ray (see X-ray)
Genetic Effect of Radiation:
ionizing radiation in the gonads.
Hereditary changes produced by the absorption of
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Generator (Cow): A device in which a daughter radionuclide is eluted from an ion
exchange column containing a parent radionuclide that is long-lived compared to the
daughter.
Half-Life, Biological: The time required for the body to eliminate one-half of an
administered dosage of any substance by regular processes of elimination.
Approximately the same for both stable and radioactive isotopes of a particular
element.
Half-Life, Effective: Time required for a radioactive element in the body to be
diminished 50% as a result of the combined action of radioactive decay and biological
elimination.
Effective half life=
Biological half-life X Radioactive half-life
Biological half-life + Radioactive half-life
Half-life, Radioactive: Time required for a radioactive substance to lose 50% of its
activity by radioactive decay. Each radionuclide had a unique half-life. (also known as
Physical Half-Life.)
Half Value Layer: (Half thickness): The thickness of any specified material necessary
to reduce the intensity of an x-ray or gamma ray beam to one-half its original value.
Health Physics: A term in common use for that branch of radiological science dealing
with the protection of personnel from harmful effects of ionizing radiation.
Health, Radiological: The art and science of protecting human beings from injury by
radiation, and promoting better health through beneficial applications of radiation.
Inverse Square Law: The intensity of radiation at any distance from a point source
varies inversely as the square of that distance. For example: If the radiation exposure
is 100 R/hr at 1 inch from a source, the exposure will be 0.01 R/hr at 100 inches.
Ion: Atomic particle, atom, or chemical radical bearing an electrical charge, either
negative or positive.
Ionization: The process by which a neutral atom or molecule acquires either a positive
or a negative charge.
Ionization Chamber: An instrument designed to measure the quantity of ionizing
radiation in terms of the charge of electricity associated with ions produced within a
defined volume.
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Ionizing Radiation: (See Radiation.)
Isotopes: Nuclides having the same number of protons in their nuclei, and hence the
same atomic number, but differing in the number of neutrons, and therefore in the mass
number. Almost identical chemical properties exist between isotopes of a particular
element.
Stable Isotope: A non-radioactive isotope of an element.
Kilo Electron Volt(keV): One thousand electron volts, 103eV.
Labeled Compound: A compound consisting, in part, of labeled molecules. By
observations of radioactivity or isotopic composition, this compound or its fragments
may be followed through physical, chemical, or biological processes.
Medical Event: An error in the delivery of the prescribed dose (radiation from a sealed
source) or dosage (radiopharmaceutical) that exceeds the acceptable range of error
and, therefore, is reportable to the regulatory agency. (See Written Directive Program)
Millirem (m rem): One thousandth (1/1000) of a rem. (See Rem)
Milliroentgen(mR): A multiple of the roentgen equal to one one-thousandth (1/1000th)
of a roentgen. (See Roentgen)
Monitoring, Radiological: Periodic or continuous determination of the amount of
ionizing radiation or radioactive contamination present in an occupied region as a safety
measure for purposes of health protection.
Area Monitoring: Routine monitoring of the level of radiation or radioactive
contamination of any particular area, building, room, or equipment.
Personnel Monitoring: Monitoring any part of an individual, his breath, excretion,
or any part of his clothing for radioactive contamination. (See Radiological Survey.)
Nuclide: A species of atom characterized by the constitution of its nucleus. The
nuclear constitution is specified by the number of protons (Z), number of neutrons (N),
and energy content; or alternatively, by the atomic number (Z), mass number A =
(N+Z), and atomic mass. To be regarded as a distinct nuclide, the atom must be
capable of existing for a measurable time. Thus, nuclear isomers are separate
nuclides, whereas promptly decaying excited nuclear states and unstable intermediates
in nuclear reactions are not so considered.
Photon: A quantity of electromagnetic energy (E) whose energy in joules is the product
of its frequency () in hertz and Plank constant (h). The equation is E=h.
MPC SAMPLE
Quality Factor: (QF): The linear-energy-transfer-dependent factor by which absorbed
doses are multiplied to obtain (for radiation protection purposes) a quantity that
expresses, on a common scale for all ionizing radiation, the effectiveness of the
absorbed dose.
Rad: The unit of absorbed dose equal to 0.01 J/kg in any medium. (See Absorbed
Dose.)(Written: rad.)
Radiation: (1)The emission and propagation of energy through space or through a
material medium in the form of waves; for instance, the emission and propagation of
electromagnetic waves, of sound and elastic waves. (2)The energy propagated through
space or through a material medium as waves, for example energy in the form of
electromagnetic waves or of elastic waves. The term radiation or radiant energy, when
unqualified, usually refers to electromagnetic radiation. Such radiation commonly is
classified, according to frequency, as Hertz Ian, infrared, visible (light), ultra-violet, xray, and gamma ray. (See Photon.) (3)By extension, corpuscular emissions, such as
alpha and beta radiation, or rays of mixed or unknown type, as cosmic radiation.
Annihilation Radiation: Photons produced when an electron and a positron unite
and cease to exist. The annihilation of a positron-electron pair results in the
production of two photons, each of 0.511 MeV energy.
Background Radiation: Radiation arising from radioactive material other than the
one directly under consideration. Background radiation due to cosmic rays and
natural radioactivity is always present. There may also be background radiation due
to the presence of radioactive substances in other parts of the building, in the
building material itself, etc.
Characteristic (Discrete) Radiation: Radiation originating from an atom after
removal of an electron or excitation of the nucleus. The wavelength of the emitted
radiation is specific, depending only on the nuclide and particular energy levels
involved.
External Radiation: Radiation from a source outside the body-the radiation must
penetrate the skin.
Internal Radiation: Radiation from a source within the body (as a result of
deposition of radionuclides in body tissues.)
Ionizing Radiation: Any electromagnetic or particulate radiation capable of
producing ions, directly or indirectly, in its passage through matter.
MPC SAMPLE
Radiological Survey: Evaluation of the radiation hazards incident to the production,
use or existence of radioactive materials or other sources of radiation under a specific
set of conditions. Such evaluation customarily includes a physical survey of the
disposition of materials and equipment, measurements or estimates of the levels of
radiation that may be involved, and a sufficient knowledge of processes using or
affecting these materials to predict hazards resulting from expected or possible
changes in material or equipment.
Radioactivity: The property of certain nuclides spontaneously emitting particles or
gamma radiation or of emitting x radiation following orbital electron capture or of
undergoing spontaneous fission.
Natural Radioactivity: The property of radioactivity exhibited by more than fifty
naturally occurring radionuclides.
Radiotoxicity: Term referring to the potential of an isotope to cause damage to living
tissue by absorption of energy from the disintegration of the radioactive material
introduced into the body.
Rem: The special unit of dose equivalent. The dose equivalent in rems is numerically
equal to the absorbed dose in rads multiplied by the quality factor, distribution factor,
and any other necessary factor. (See Dose Equivalent.)
Relative Biological Effectiveness (RBE): The RBE is a factor used to compare the
biological effectiveness of absorbed radiation doses (i.e., rads) due to different types of
ionizing radiation; more specifically, it is the experimentally determined ratio of an
absorbed dose of a reference radiation required to produce an identical biological effect
in a particular experimental organism or tissue. NOTE: This term should not be used in
radiation protection. (See Quality Factor.)
Resolving Time, Counter: The minimum time interval between two distinct events
which will permit both to be counted. It may refer to an electronic circuit, to a
mechanical indicating device, or to a counter tube.
Roentgen (R): The special unit of exposure, One roentgen equals 2.58 X 10 -4 coulomb
per kilogram of air. (See Exposure.)
Scintillation Counter: A counter in which light flashes produced by a scintillator by
ionizing radiation are converted into electrical pulses by a photomultiplier tube.
Self-absorption: Absorption of radiation (emitted by radioactive atoms) by the material
in which the atoms are located; in particular, the absorption of radiation within a sample
being assayed.
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Shallow dose equivalent (HS, SDE): The external exposure of the skin or an
extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeters
averaged over an area of 1 square centimeter.
Shielding Material: Any material which is used to absorb radiation and thus effectively
reduce the intensity of radiation, and in some cases eliminate it. Lead, concrete,
aluminum, water, and plastic are examples of commonly used shielding material.
Smear: (Smear or Swipe Test): A procedure in which swab, e.g., a circle of filter
paper, is rubbed on a surface and its radioactivity measured to determine if the surface
is contaminated with loose radioactive material.
Specific Activity: Total radioactivity of a given nuclide per gram of a compound,
element, or radioactive nuclide.
Standard, Radioactive: A sample of radioactive material, usually with a long half life,
in which the number and type of radioactive atoms at a definite time is known. It may
be used as a radiation source for calibrating radiation measurement equipment.
Tracer, Isotopic: The isotope or non natural mixture of isotopes of an element which
may be incorporated into a sample to make possible observation of the course of that
element, alone or in combination, through a chemical, biological, or physical process.
The observations may be made by measurement of radioactivity or isotopic abundance.
Thermoluminescent Dosimeter (TLD): A dosimeter made of certain crystalline
material which is capable of both storing a fraction of absorbed ionizing radiation and
releasing this energy in the form of visible photons when heated. The amount of light
released can be used as a measure of radiation exposure to these crystals.
Total Effective Dose Equivalent (TEDE): The sum of the deep dose equivalent (for
external exposures) and the committed effective dose equivalent (for internal
exposures).
Written Directive: A written order, dated and signed from an authorized user before
the administration of Radioactive Material or radiation from Radioactive Material to a
specific patient.
1. For any administration of quantities greater than 30 uCi of NaI-131, it must state
the name of the patient and prescribed dosage.
2. For a therapeutic administration of any radiopharmaceutical other than NaI-131,
it must state the name of the patient, radioactive drug, dosage, and route of
administration.
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3. For gamma stereotactic radiosurgery, it must state the name of the patient, total
dose, treatment site, target coordinates/treatment/each anatomically distinct
treatment site.
4. For teletherapy, it must state the total dose, dose per fraction, number of
fractions, and treatment site.
5. For high-dose rate remote afterloading brachytherapy, it must state the
radionuclide, the treatment site, dose per fraction, number of fractions and total
dose.
6. For all other brachytherapy including low, medium and pulsed
a. Prior to implementation, it must state the treatment site, radionuclide and
dose, and….
b. After implementation but prior to completion of the procedure, it must state
the radionuclide, the treatment site, number of sources and total strength and
exposure time ( or equivalently, the total dose).
X-rays: Penetrating electromagnetic radiation having wavelengths shorter than those
of visible light. They are usually produced by bombarding a metallic target with fast
electrons in a high vacuum. In nuclear reactions it is customary to refer to photons
originating in the nucleus as gamma rays, and those originating in the extra-nuclear part
of the atom as x-rays. These rays are sometime called roentgen rays after their
discoverer, W.C. Roentgen.
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Table of Contents
Purpose
1
Program Audit
2
Policy Changes
3
Regulatory Agencies
4
Management
5
Radiation Safety Officer
6
Radiation and Risks
7
Storage and Accountability of Radioactive Material
8.
Breastfeeding Recommendations
9
Report and Notification of a Dose To Embryo/Fetus or a Nursing Child
10
Instructions Concerning Pregnant Worker
11
Maintaining Occupational Exposures ALARA
12
Occupational Exposure Limits
13
Dose to Members of the Public
14
Personnel Monitoring Program
15
Medical Event vs. Accidental Administration
16
Personnel Training Program
17
Radiation Monitoring Instruments
18
Dose Calibrator Testing
19
Sealed Sources
20
Rules for Safe Use of Radiopharmaceuticals
21
Package Order and Receipt Procedures
22
Procedures Opening / Returning Radioactive Packages
23
Radioactive Material Use
24
Area Survey Procedures
25
Area Wipes Test Procedures
26
Radioactive Spills
27
Waste Disposal
28
Record Retention
29
Prescribed Dosege List
30
Pediatric Doseage List
31
Xenon Monitoring / Air Concentration Control
32
Authorized Users Therapy
33
Written Directive Program
34
Written Directive Assurance
35
Written Directive Verification
Definitions
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31
XENON MONITORING / AIR CONCENTRATION CONTROL
TRAP EFFLUENT MONITORING
Spent gas will be collected in a shielded trap. We will follow the procedures listed
below for monitoring the trap effluent.
1.
The trap effluent will be collected from the exhaust of the trapping system upon
initial use of each trap and once each month in which the system is used.
2.
The trap effluent from one patient study will be collected in a plastic bag.
3.
The activity in the bag will be monitored by holding the bag against a camera
which has been adjusted to detect Xe-133 and comparing its counts per minutes
(cpm) to background cpm.
4.
A record will be kept of the date, background cpm, and bag cpm.
5.
An action level will be established based on the background cpm or a multiple of
background. Significant increases in the bag cpm above normal, indicate that
the trap is breaking down and will be replaced.
6.
If a xenalert system is available, the manufacturer's instructions will be followed
for monitoring the trap effluent.
7.
Manufacturer's directions will be followed for replacing the trap.
8.
All rooms in which radioactive Xenon-133 gas studies are performed will be
maintained at negative pressure.
9.
All rooms in which radioactive Xenon-133 gas studies are performed should be
maintained at negative pressure and performed at 6 month intervals..
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ACCIDENTAL RELEASE OF XENON-133 - EMERGENCY PROCEDURES
1.
Notify persons in the room that a spill (release) has occurred.
2.
All persons should vacate the room at once.
3.
Notify the RSO immediately.
4.
Prevent entry into the room until the calculated evacuation time has occurred.
The evacuation time is calculated as follows:
Evacuation Time (T) = (-V/Q) ln(CV/A)
A = The highest activity of gas in a single container, (mCi).
S = Measured airflow supply from each vent in the room,(ml/min).
Q = The total room air exhaust determined by measuring in
(ml/min) the airflow to each exhaust vent in the room.
C = The derived air concentration (DAC) for restricted areas for
Xe-133 = 1x10-4 mCi/ml OR Allowable Effluent Concentration in
air for Xe-133 is 5 x10-7 mCi/ml.
V = The volume of the room (ml).
WORKER DOSE FROM AEROSOLS
We will collect spent aerosol in a single use shielded trap and therefore no effluent
monitoring is needed.
PUBLIC DOSE FROM AIRBORNE EFFLUENT
We will not directly vent spent aerosols and gases to the atmosphere and, therefore, no
effluent estimation is necessary.
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32
AUTHORIZED USERS THERAPY
The names listed below are authorized users on our State of Nevada Radioactive
Materials License, which allows for the possession, use and disposal of radioactive
material requiring a written directive.
Authorized Users Materials 35.300, 35.400
Physician Signature
____________________________
________________________
____________________________
________________________
____________________________
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MPC SAMPLE
WRITTEN DIRECTIVE PROGRAM – RADIOPHARMACEUTICAL SECTION
33
Please note the following about your Written Directive Program:

Reconfigured from previous Quality Management Program on 10/24/03 as required
by the U.S. Nuclear Regulatory Commission (NRC) 10 CFR 35.40 and 35.41.
Impacts the usage of:
as Sodium Iodide only in amounts greater than 30 Ci
for either diagnostic or therapeutic uses.
131I
Any radiopharmaceutical used for therapeutic purposes
such as 32P, 89S, 90Y, 153Sm, etc.

A “Written Directive” (prescription) is required to be issued to the Nuclear Medicine
technical staff from an authorized user (Nuclear Medicine Physician) as listed on
your License prior to the initiation of the procedure.

The Written Directive for Iodine-131 must contain the following in a clear manner:
1. Patient Name
2. Activity to be administered
3. Signature of Authorized User and Date

The Written Directive for all other radiopharmaceuticals must contain the following in
a clear manner:
1. Patient Name
2. The Radioactive Drug
3. Activity to be administered
4. The route of administration
5. Signature of Authorized User and Date


If any of the above information is unclear or missing STOP and seek clarification.

The patient must be positively identified prior to administration.
Written procedures must exist and be implemented for assurance that the written
directive is followed and patient identification is made at a minimum.
MPC SAMPLE
 MEDICAL EVENT has been defined as follows and must be reported to the State of
Nevada Health Division within the next calendar day with a written report to follow in
15 days. Except in the case of patient intervention.
1.
The radiation dose (mrem) delivered DIFFERS from the radiation dose that
would have resulted from the prescribed dosage (mCi) by more than:
5 rem (0.05 Sv) Effective Dose Equivalent (EDE) – Whole Body
50 rem (0.5 Sv) to an organ or tissue or
50 rem (0.5 Sv) Shallow Dose Equivalent (SDE) – Skin
AND
The total dosage (mCi) delivered differs from the prescribed dose by +/- 20% or more
or
The total dosage (mCi) delivered falls out of the prescribed dosage range.
2.
A radiation dose exceeds 5 rem (0.05 Sv) Effective Dose Equivalent (EDE) – Whole Body
50 rem (0.5 Sv) to an organ or tissue or
50 rem (0.5 Sv) Shallow Dose Equivalent (SDE) – Skin
from any of the following:
Wrong Radioactive Drug
Wrong Route of Administration
Wrong Individual
Delivered by Wrong Mode of Treatment
Leaking Source
3.
A radiation dose (mrem) to the skin or an organ or tissue other than the
treatment site exceeds 50 rem (0.5 Sv) to an organ or tissue
AND
Exceeds 50% or more of the radiation dose expected from the administration as noted
in the written directive.
(This excludes permanent implants, seeds that were implanted correctly and migrated
outside the treatment area.)
MPC SAMPLE
34
RADIOPHARMACEUTICAL PROCEDURES REQUIRING A WRITTEN
DIRECTIVE -- ASSURANCE WRITTEN DIRECTIVE FOLLOWED
PURPOSE: To insure that the intent of the written directive was followed as required by
10 CFR 35.41.
SCOPE: Issuance of a written directive must be followed by confirmation that the
explicit prescriptive directions of the written directive such as radiopharmaceutical,
activity and route of administration were in agreement.
POLICY: The radiopharmaceutical, administered dose and route of administration must
be verified by the individual administering the radiopharmaceutical for agreement with
the written directive. Determine and record the activity of the radiopharmaceutical
dosage or radiation dose before medical use. This can be done by dose calibrator
assay or mathematical calculation.
Each final container (i.e., syringe) must be properly labeled to identify the
radiopharmaceutical and activity.
Written directives will contain the prescribed route of administration.
The sole responsibility for assurance that the patient was properly identified and the
prescriptive instructions of the written directive were followed rests with the individual
(Nuclear Medicine Technologist or physician authorized user) responsible for the direct
administration of the radiopharmaceutical to the patient.
Verification must be established for:

Patient identification by at least one of the following methods:

Patient called by name

Patient spells their name

Patient states their Date of Birth

Patient states their Social Security Number

Patient provides positive (picture) identification

In-patient identification verified by wrist band
MPC SAMPLE

Route of administration by comparison to the written directive.

Radiopharmaceutical and the dosage measurement noted on the final
container label must be compared to the prescribed dosage on the written
directive.
If any part of the written directive or patient identification process is unclear or not
understood, do not proceed until you receive guidance to rectify any questions or
concerns.
After the administration, the authorized user or qualified individual under the supervision
of the authorized user, must record the administered dose, the date and their signature
or initials in an auditable form, such as on the written directive itself.
MPC SAMPLE
35
RADIOPHARMACEUTICAL PROCEDURES REQUIRING
DIRECTIVE -- VERIFICATION OF PATIENT IDENTITY
A
WRITTEN
PURPOSE: To provide a clear method of patient identification as directed by 10
CFR.35.41.
SCOPE:
Verification of patient identity is a crucial facet in the prevention of medical
events of radiopharmaceuticals such as:

Sodium Iodide - 131 or in amounts greater than thirty (30) microcuries
(Ci) for diagnostic or therapeutic purposes.

Any radiopharmaceutical therapy, i.e.,
32P, 89Sr, 153Sm, 90Y,
etc.
POLICY:
Each patient shall be properly identified prior to the administration of any
radiopharmaceutical as noted in the scope of this policy.
The individual (Nuclear Medicine Technologist or physician authorized user)
responsible for the direct administration of the radiopharmaceutical to the patient is
solely responsible for securing the identity of the patient.
Each patient under this policy shall be identified by at least one of the following
methods:

Patient called by name

Patient spells their name

Patient states their Date of Birth

Patient states their Social Security Number

Patient provides positive (picture) identification

In-patient identification verified by wristband
If the information obtained does not correspond to the information on the written
directive, the radiopharmaceutical shall not be administered until conclusive evidence is
obtained that this agent/procedure is intended for the patient in question.
200 dpm/ per 100 cm2 for I-131, P-32
2000 dpm/ per 100 cm2 for all other radionuclides.
REVISIONS 3-2-07
MPC SAMPLE
1.
2.
3.
4.
5.
6.
7.
Changed by-product material to radioactive material
Inserted #4 in Major Spill Procedure
Changed box to uCi symbol under Radioactive Material Use
Hyphenated Breast-feeding
Added Radiac wash and Survey meter to Spill kit
Added Prescribed Dose List protocol
Added Air Concentration protocol
REVISIONS 3-2-07
1.
Added "6 month intervals" to Air Concentration Control, #9
REVISIONS 7-31-07 (VERSION 2.5)
1.
2.
3.
4.
5.
Added NARM info to NRC, under Regulatory Agencies
Under definitions changed Written Directive to 30 uCi
Under Prescribed Dose List, changed #2, should to must, #4, will to should, #7
added and/or authorized user.
Under Instructions Concerning Pregnant Worker, added RSO delegate into Part
II and III, changed facilities to facility’s
Under ALARA changed facilities to facility’s in Part II
REVISIONS 8-21-07 (VERSION 3.0)
1.
2.
Added pediatric dose list #31
Added disclaimer (under purpose)
REVISIONS 10-08-07 (VERSION 3.5)
1.
Removed RSO and Management signatures from pages and replaced with a
signed cover sheet.
REVISIONS 01-21-08 (VERSION 4.0)
1.
Changed under receipt of packages (#22) contamination in excess of 6600/cm 2,
to contamination in excess of 6600/300 cm 2.
MPC SAMPLE
REVISION 10-13-08 (VERSION 4.5)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Changed Pediatric (#31) and Prescribed (#29) Dose List to Doseage
Combined Program audit (#1) and Annual Review form
Added Disclaimer to Purpose
Added F-18 to Major spills
Added Pediatric (#31) and Prescribed (#29) Dose List to WD Table of
Contents
Deleted (i.e. 1000 dpm/per 100 cm2) in spills
Added Implemented date and Updated Date to cover page
Added statement to restricted or unrestricted areas for Wipe Test #25
Deleted security escort for 321 Package Order & Receipt Procedures
Removed Implemented and Revised Dates on all protocols
Added RPP Update page
REVISION 03/01/11 (VERSION 5.2)
1. Changed definition for medical event to NRC exact definition (#15)