RADIATION SAFETY MANUAL
FACILITY NAME
RADIATION PROTECTION PROGRAM
NUCLEAR MEDICINE
Implemented Date:____________________
Updated Date:________________________
A Template provided by
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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
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.
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.
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.
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.
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
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.
4 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
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.
j. Personnel training of those who work in or frequent areas of radioactive material use or storage.
5. 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:
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.
6. 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
7. 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
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).
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.
Average Annual Effective Dose Equivalent to Individuals in the U.S.a
Source Effective Dose Equivalent (mrem)
Natural Radon 200
Other than Radon 100
Total 300
Nuclear Fuel Cycle 0.05
Consumer Productsb 9
Medical
Diagnostic X-rays 39
Nuclear Medicine 14
Total 53
Total about 360 mrem/
aAdapted from Table 8.1, NCRP 93
bIncludes building material, television receivers, luminous watches, smoke detectors, etc. (from Table 5.1, NCRP 93)
Each of us naturally contain ~9000 Bq (~0.25 μCi) of activity. This results in the following 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:
• 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
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:
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.
4. 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.
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
Estimated Days of Life
INDUSTRY TYPE Expectancy Lost (Avg)
All Industry 60
Trade 27
Manufacturing 40
Service 27
Government 60
Transportation and Utilities 160
Agriculture 320
Construction 227
Mining and Quarrying 167
Radiation Dose of 5 rem/year for 50 years 250
Radiation Dose of 650 mrem/year for 30 years
(industry average) 20
Death from Accidental Radiation Exposure 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.
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.
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.
(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.
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.
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
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 - Care of patients following
treatment of thyroid carcinoma Nuclear Medicine
with I-131 diagnostic procedures
- Care of patients undergoing - Diagnostic x-ray
treatment with brachytherapy procedures
sources
Radiation Therapy - Handling of brachytherapy - External beam treatments
sources - Simulations
- P-32 Therapy
Nuclear Medicine - Treatment of thyroid - Preparation of
carcinoma with I-131 radiopharmaceuticals
- Injection of patients
- Imaging
- QA procedures
PET - Preparation of
radiopharmaceuticals
- Injection of patients
- Imaging
- QA procedures
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.
(3) The RSC/RSO will ensure that the users justify their procedures and that individual and collective doses will be ALARA.
b. 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.
c. 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; 125 375
active blood forming organs;
or gonads.
2. Hands and forearms; feet and 1250 3750
ankles. Skin of whole body.
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.
d. Program Review
(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.
e. 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.
f. 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.
(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.
g. 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.
Authorized Users
a. 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.
b. 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 in Order to Monitor Individual Occupational External Radiation Doses
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.
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.
12 OCCUPUATIONAL EXPOSURE LIMITS
(Values are in mrem per period of time)
ALARA
Area Exposed NAC STATE Level 1 Level II
Whole Body 5000/yr 1250/qtr 125/qtr 375/qtr
(Deep Dose)
Lens of Eye 15000/yr 1250/qtr 375/qtr 1125/qtr
Extremities Skin 50000/yr 18750/qtr 1250/qtr 3750/qtr
(Shallow Dose)
Fetus 500/term As low as possible
(Declared Pregnancy)
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.
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.
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.
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.
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: 734.662.9224
Indiana Fax: 317.581.1931
Wisconsin Fax: 734.662.9224
Utah Fax: 801.272.2952
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.
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.
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.
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.
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
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.
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 Tc-99m 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 Tc-99m 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%.
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 μCi
6. Date of the test
7. Name of individual performing the test
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 μCi) 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 μCi 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 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.
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.
10. The use of a dose calibrator to measure “unit dosages” of the following beta-emitters, 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.
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 !!
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.
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.
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.
Surface One Meter
WHITE I 10 mR/hr
Exclusive Use Only
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 (in mCi) value listed above = Major spill
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. This should include the following information:
a. Date, time and location of the spill
b. Who was involved
c. Radionuclide and activity
d. How the spill occurred
e. How the area was decontaminated
f. Include instruments used (i.e. GM survey meter, well counter)
g. Diagram of area
h. Survey results and wipe test results
i. Any follow up
j. How to prevent the recurrence
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. This should include the following information:
a. Date, time and location of the spill
b. Who was involved
c. Radionuclide and activity
d. How the spill occurred
e. How the area was decontaminated
f. Include instruments used (i.e. GM survey meter, well counter)
g. Diagram of area
h. Survey results and wipe test results
i. Any follow up
j. How to prevent the recurrence
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.
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 low-level 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.
|Radionuclide |Activity (mCi) |Radionuclide |Activity (mCi) |
|Ba-133 |8.1 |Mo-99 |2 |
|C-14 |8.1 | N-13 |1.6 |
|Co-57 |27 |Na-22 |1.4 |
|Cr-51 |81 |Ni-63 |81 |
|Cs-137 |1.6 |P-32 |1.4 |
|F-18 |1.6 |Pd-103 |110 |
|Ga-67 |8.1 |Sm-153 |1.6 |
|Ho-166 |1.1 |Sr-89 |1.6 |
|I-123 |8.1 |Sr-90 |0.81 |
|I-125 |8.1 |Tc99m |11 |
|I-131 |1.9 |Tl-201 |11 |
|In-111 |8.1 |Xe-133 |270(gas) |
|Lu-177 |1.9 |Y-90 |0.81 |
28 RECORD RETENTION
RECORD RETENTION REFERENCE
Area Surveys (daily and weekly) 3 years 35.70(h)
Area evacuation time calculations Duration of Use 35.205(d)
Brachytherapy patient care personnel instruction 3 years 35.410(b)
Brachytherapy patient room surveys 3 years 35.415(a)(4)
Brachytherapy patient survey at removal 3 years 35.404(b)
Brachytherapy source use records 3 years 35.406(d)
Brachytherapy surveys at implant 3 years 35.406(d)
Disposal (other) Indefinitely 20.401(c)(3)
Disposal by decay in storage 3 years 35.92(b)
Dose calibrator geometry Duration of dose calibrator 35.50(b)(4)
Dose calibrator Q.C. (lin., const., accur.) 3 years 35.50(e)
1-131 thyroid bioassay Indefinitely 35.315(a)(8)
Ministerial changes Until license renewed or terminated 35.31(b)
Misadministrations 5 years 35.33(4)(b)
Mo-99 assay 3 years 35.204(c)
Mobile nuclear medicine authorization letters 3 years past last service 35.29(b)
Mobile nuclear medicine surveys 3 years 35.80(f)
Patient care personnel instruction for 1-131
therapies 3 years 35.310(b)
Patient Dosage 3 years 35.53(c)
Personnel monitoring Indefinitely 20.2106(f)
Quality Management Program
Review 3 years 35.32(b)(3)
Recordable events 3 years 35.32(c)(3)
Record of administered dose (& written directive) 3 years 35.32(d)(2)
Radiation Safety Committee Minutes Duration of license 35.22(a)(5)
Radiopharmaceutical therapy room survey
at administration 3 years 35.315(a)(4)
Radiopharmaceutical therapy room survey
at release Undefined 35.315(a)(7)
Receipt 3 years from transfer or disposal 30.51(a)(1)
Sealed source handling instructions Duration of use 35.59(a)
Sealed source inventory 3 years 35.59(g)
Sealed source leak tests 3 years 35.59(d)
Sealed source storage area surveys 3 years 35.59(i)
Statement of authority and responsibilities
for RSC and RSO Duration of license 35.23(b)
Survey meter calibration 3 years 35.5 l(d)
Teletherapy dosimetry equipment
calibration, comparison, inter-comparison Duration of license 35.630(c)
Teletherapy five year inspection Duration of license 35.647(c)
Teletherapy monitor operational check 3 years 35.615(d)(4)
Teletherapy radiation surveys Duration of license 35.641 (c)
Teletherapy safety checks 3 years 35.636(c)
Teletherapy safety instruction 3 years 35.610(c)
Teletherapy spot-checks 3 years 35.634(f)
Teletherapy unit calibration Duration of use of source 35.632(g)
Transfer 3 years from transfer 30.51(a)(2)
Xenon trap check & ventilation studies Undefined 35.205(e)
These are the stated NRC required retention periods. Please be aware that other regulatory agencies may require longer retention periods.
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 radio-pharmaceutical. 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.
30 PEDIATRIC DOSAGE LIST
| |
| | | |
|Weight |Fraction of |
|kg |lb |adult dose |
|2 |4.4 |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. | |
| | | |
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
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.
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.
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 (μCi): 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.
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.
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: Hereditary changes produced by the absorption of ionizing radiation in the gonads.
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.
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 (ν) in hertz and Plank constant (h). The equation is E=hν.
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, x-ray, 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.
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.
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.
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.
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
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..
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.
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
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
____________________________ ________________________
33 WRITTEN DIRECTIVE PROGRAM – RADIOPHARMACEUTICAL SECTION
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: 131I as Sodium Iodide only in amounts greater than 30 μCi for either diagnostic or therapeutic uses.
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.
• 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.)
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
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.
35 RADIOPHARMACEUTICAL PROCEDURES REQUIRING A WRITTEN DIRECTIVE -- VERIFICATION OF PATIENT IDENTITY
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 (μCi) 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
1. Changed by-product material to radioactive material
2. Inserted #4 in Major Spill Procedure
3. Changed box to uCi symbol under Radioactive Material Use
4. Hyphenated Breast-feeding
5. Added Radiac wash and Survey meter to Spill kit
6. Added Prescribed Dose List protocol
7. 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. Added NARM info to NRC, under Regulatory Agencies
2. Under definitions changed Written Directive to 30 uCi
3. Under Prescribed Dose List, changed #2, should to must, #4, will to should, #7 added and/or authorized user.
4. Under Instructions Concerning Pregnant Worker, added RSO delegate into Part II and III, changed facilities to facility’s
5. Under ALARA changed facilities to facility’s in Part II
REVISIONS 8-21-07 (VERSION 3.0)
1. Added pediatric dose list #31
2. 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/cm2, to contamination in excess of 6600/300 cm2.
REVISION 10-13-08 (VERSION 4.5)
1. Changed Pediatric (#31) and Prescribed (#29) Dose List to Doseage
2. Combined Program audit (#1) and Annual Review form
3. Added Disclaimer to Purpose
4. Added F-18 to Major spills
5. Added Pediatric (#31) and Prescribed (#29) Dose List to WD Table of Contents
6. Deleted (i.e. 1000 dpm/per 100 cm2) in spills
7. Added Implemented date and Updated Date to cover page
8. Added statement to restricted or unrestricted areas for Wipe Test #25
9. Deleted security escort for 321 Package Order & Receipt Procedures
10. Removed Implemented and Revised Dates on all protocols
11. Added RPP Update page
REVISION 03/01/11 (VERSION 5.2)
1. Changed definition for medical event to NRC exact definition (#15)
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