MPC SAMPLE
FACILITY NAME
RADIATION PROTECTION PROGRAM
NUCLEAR MEDICINE
Implemented Date:______
Updated Date:______
A Template provided by
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)