RADIATION PROTECTION PROGRAM OHIO NUCLEAR MEDICINE. A Template provided by:

Transcription

1 RADIATION PROTECTION PROGRAM OHIO NUCLEAR MEDICINE A Template provided by:

2 PROTOCOL Table of Contents Purpose 1 Policy Changes 2 Regulatory Agencies 3 Management 4 Radiation Safety Officer 5 Storage and Accountability of Radioactive Material 6 Radiation and Risks 7 Breastfeeding Recommendations 8 Report and Notification of a Dose To Embryo/Fetus or Nursing Child 9 Instructions Concerning Pregnant Worker 10 Maintaining Occupational Exposures ALARA 11 Occupational Exposure Limits 12 Dose to Members of the Public 13 Medical Event vs. Accidental Administration 14 Personnel Monitoring Program 15 Personnel Training Program 16 Radiation Monitoring Instruments 17 Dose Calibrator Testing 18 Sealed Sources 19 Rules for Safe Use of Radiopharmaceuticals 20 Package Order and Receipt Procedures 21 Procedures Opening/Returning Radioactive Packages 22 Radioactive Material Use 23 Area Survey Procedures 24 Area Wipes Test Procedures 25 Radioactive Spills 26 Waste Disposal 27 Prescribed Dose List 28 Air Concentration Control 29 Definitions

3 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 3701: 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.

4 1 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 required 1 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: Ohio Administrative Code 3701: Ohio Administrative Code 3701: Ohio Administrative Code 3701: License amendments are necessary for the following changes: Before receiving, preparing, or using byproduct 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 3701: (A) Before changing Radiation Safety Officers, except as provided in 3701: Before receiving byproduct 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 byproduct material is used only in accordance with either 3701: or 3701: Before changing the address(es) of use identified in the application or on the license Before revising procedures required by 3701: , 3701: , 3701: , and 3701: , as applicable, where such revisions reduce radiation safety

5 2 REGULATORY AGENCIES Ohio Administrative Code State agency that develops, inspects and enforces rules and regulations governing the possession, use and disposal of byproduct material, noted as 3701:1-38, regulates and terminates licenses for this purpose. Byproduct 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.) Ohio Administrative Code Chapter 3701:1-38 General Radiation Protection Standards for Sources of Radiation. Chapter 3701:1-58 Medical Use of Radioactive Materials. Sections of the Code of Federal Regulations (CFR) of importance: Part 21 Reporting of Defects and Noncompliance Reporting Substantial Safety Hazards Part 31 - General Domestic Licenses for Byproduct Material Small RIA and in vitro licenses Part 35 - Human Uses of Byproduct 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

6 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

7 3 MANAGEMENT Management as defined by the United State Regulatory Commission 3701: 1-58: 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 3701:1-13 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

8 4 RADIATION SAFETY OFFICER The Radiation Safety Officer (RSO) shall: AUTHORITY, DUTIES AND RESPONSIBILITIES 1. Have the authority to implement the Radiation Protection Program as referenced in 3701: 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 3701: 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 are terminated by the state such as: a. All records, reports, written policies and procedures required by regulatory agencies concerning radioactive material.

9 b. A copy of the regulations governing the possession, use and disposal of licensed material, such as the Ohio Administrative Code. 6. Periodically evaluate action levels for continued appropriateness to ensure compliance with 3701: and 3701: 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 3701: (D)(2). 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 3701: (D)(3). 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 3701: (D)(4) 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 3701: (F).

10 5 STORAGE AND ACCOUNTABILITY OF RADIOACTIVE MATERIAL This facility adheres to the Ohio Administrative Code regulations for securing licensed radioactive material. All radioactive material will be secured from unauthorized access or removal. Rooms / areas containing stored radioactive material will be actively secured. Stored radioactive material will be secured from unauthorized removal. Control and constant surveillance will be maintained over radioactive material not in storage, such as patient doses. We will maintain records of receipt, transfer, and disposal of licensed material, and we, or a designee, will conduct physical inventories at required frequencies to account for sealed sources as required.

11 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.

12 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 Products b 9 Medical Diagnostic X-rays 39 Nuclear Medicine 14 Total 53 Total about 360 mrem/ a Adapted from Table 8.1, NCRP 93 b Includes building material, television receivers, luminous watches, smoke detectors, etc. (from Table 5.1, NCRP 93) Each of us naturally contain ~9000 Bq (~0.25 Ci) 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

13 2. What are the NRC 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 NRC. 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 NRC 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.

14 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)

15 7. 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 Accidents a INDUSTRY TYPE Estimated Days of Life 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 <1 Non-Radiation Industrial Accidents (Nuclear Facilities) 58 Estimated Loss of Life Expectancy from Health Risks a HEALTH RISK Estimated Days of Life Expectancy Lost (Avg) Smoking 20 cigarettes/day 6 years Overweight by 15% 2 years Alcohol Consumption (U.S. avg.) 1 year All accidents combined 1 year Auto Accidents 207 days Home Accidents 74 days Drowning 24 days All natural hazards (earthquake, lightning, flood, etc.) 7 days Medical radiation 6 days Occupational Radiation Dose 300 mrem/yr. from age 18 to days 1000 mrem/yr. from age 18 to days a Adapted from Reference 4 8. What are the health risks from radiation exposure to the embryo/fetus? During certain stages of development, primarily the first trimester, the embryo/fetus is believed to be more sensitive to radiation damage than adults. In recognition of the

16 possibility of increased radiation sensitivity, and because the dose to the embryo/fetus is involuntary on the part of the embryo/fetus, a more restrictive dose limit has been established for the embryo/fetus of a declared pregnant worker. If an occupationally exposed woman declares her pregnancy in writing, she is subject to the more restrictive dose limit of 500 mrem for the total gestation period. No developmental effects caused by radiation have been observed in human groups at doses at or below the 5 rem occupational dose limit. At doses below this occupational dose limit, an increase in cancer has not been proven, but is presumed to exist even if it is too small to be measured. It is expected that radiation exposure before birth may be 2 or 3 times more likely to cause cancer over a person s lifetime than the same amount of radiation received as an adult. If this were true, there would be 1 radiation-induced cancer death in 200 people exposed in utero at the occupational dose limit of 5 rem. At the 0.5 rem (500 mrem) dose limit, there would be 1 radiation-induced cancer death per 2000 people. This would be in addition to the 400 cancer deaths from all causes that one would normally expect in a group of 2000 people. 9. Can a worker become sterile or impotent from normal occupational radiation exposure? No. Temporary or permanent sterility cannot be caused by radiation at the levels allowed under the NRC s occupational limits. Acute doses on the order of 10 rem to the testes can result in a measurable but temporary reduction in sperm count. Temporary sterility (suppression of ovulation) has been observed in women who have received acute doses of 150 rem. (1) Additional information is available in the United States Nuclear Regulatory Commission Regulatory Guide This and other informative articles are available to you for your review in the Nuclear Medicine Department.

17 7 Breastfeeding Recommendations Clinical procedures for breast-feeding should establish a process that assures that patients who are breastfeeding are identified and that breast-feeding patients receive proper written instruction. Appropriate guidelines must be available so that breastfeeding may be discontinued and whenever possible resumed as soon as safe for the breast-feeding child. The NRC s Table 3 Activities of Radiopharmaceuticals that Require Instructions and Records has been available for all accounts as a guide for providing recommended duration of interruption of breastfeeding times and listing activities of radiopharmaceuticals that require instructions and records when administered to patients who are breast-feeding. However, the NRC table has been criticized for being difficult to interpret. In this regard, MPC has provided an alternate table for the recommendation of breast-feeding interruption times adapted from the NRC Table 3 and Stabin and Brietz (J:Nucl Med 2000; 41: ). Please note: When no cessation is recommended, mothers should still restrict contact with the child to avoid unnecessary exposure to the child. Please contact your physicist if you have questions regarding this matter. It is a pleasure to be of service.

18 Radiopharmaceutical Recommended Breast Feeding Interruption Schedule Activity which Require Instruction Activity which Require Record Recommended Breast- Feeding Interruption Time I-131 NaI mci mci Complete cessation I-123 NaI 0.5 mci 3 mci Complete cessation I-123 OIH 4 mci 20 mci No cessation I-123 MIBG 2 mci 10 mci 48hr/10 mci 2 12hr/4 mci I-125 OIH 0.08 mci 0.4 mci No cessation I-131 OIH 0.30 mci 1.5 mci No cessation Tc-99m DTPA 30 mci 150 mci No cessation Tc-99m MAA 1.3 mci 6.5 mci 12.6 hr/4 mci Tc-99m Pertechnetate 3 mci 15 mci 24hr/30 mci 12hr/12 mci Tc-99m DISIDA 30 mci 150 mci No cessation Tc-99m 30 mci 170 mci No cessation Glucoheptonate Tc-99m HAM 10 mci 50 mci No cessation Tc-99m MIBI/Myoview 30 mci 150 mci 3hr/30 mci 1 6hr/60 mci 1 Tc-99m MDP 30 mci 150 mci No cessation Tc-99m PYP 25 mci 120 mci No cessation Tc-99m RBC In-Vivo 10 mci 50 mci 12hr/ 20 mci 2 Labeling Tc-99m RBC In-Vitro 30 mci 150 mci No cessation Labeling Tc-99m Sulfur Colloid 7 mci 35 mci 6hr/12 mci Tc-99m DTPA Aerosol 30 mci 150 mci No cessation Tc-99m MAG3 30 mci 150 mci No cessation Tc-99m WBC 4 mci 15 mci 48hr/5 mci 2 12hr/2 mci Ga-67 Citrate 0.04 mci 0.2 mci 1 month/4 mci 2 weeks/1.3 mci 1 week/0.2 mci Cr-51 EDTA 1.6 mci 8 mci No cessation In-111 WBC 0.2 mci 1 mci 1 week/0.5 mci Tl-201 Chloride 1 mci 5 mci 96hr/<3 mci 2 2 weeks/3 mci 1 Complete Cessation/>5 mci The duration of interruption of breast-feeding is selected to reduce the maximum dose to a newborn infant to leas than 1 millisievert (0.1 rem), although the regulatory limit is 5 millisieverts (0.5 rem). The actual doses that would be received by most infants would be far below 1 millisievert (0.1rem). Of course, the physician may use discretion in the recommendation, increasing or decreasing the duration of interruption. 1 Adapted from US Nuclear Regulatory Commission, NUREG-1556, Volume 9, Appendix U; Table U.3 and NUREG Stabin and Breitz. Journal of Nuclear Medicine 2000; 41: recommendation, increasing or decreasing the duration of interruption.

19 8 REPORT AND NOTIFICATION OF DOSE TO EMBRYO/FETUS OR NURSING CHILD A licensee must report any dose to an embryo/fetus that is >5 rem (0.05 Sv) dose equivalent that is a result of an administration of Radioactive Material to a pregnant individual, unless the dose was specifically approved, in advance, by the authorized user. A licensee must report any dose to a nursing child that is a result of an administration of Radioactive Material to a breast-feeding woman that is >5 rem (0.05 Sv) total effective dose equivalent or has resulted in unintended permanent functional damage to an organ or physiological system of the child, as determined by a physician. Notifications consist of telephoning the Ohio Department of Health ( ) no later than the next calendar day after discovery of the event. This is followed by a written report to the appropriate Ohio Department of Health office (3701: ) 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.

20 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.

21 8 INSTRUCTIONS CONCERNING PREGNANT WOMEN 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 will review radiation protection and the facilities 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 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 gave you instruction. References (1) U.S. Nuclear Regulatory Commission, 1996, INSTRUCTION CONCERNING RISKS FROM OCCUPATIONAL RADIATION EXPOSURE, Regulatory Guide 8.29, February (2) National Council on Radiation Protection and Measurements, IONIZING RADIATION EXPOSURE OF THE POPULATION OF THE UNITED STATES, NCRP Report No. 93, September (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.

22 (5) U.S. Nuclear Regulatory Commission, 1994, INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE, Regulatory Guide 8.13, October 1994 IV. Example 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.

23 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 the RIA laboratory and 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.

24 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 Radiation Safety Officer Date Date

25 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

26 10 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 improvement 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 byproduct 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.

27 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; active blood forming organs; or gonads. 2. Hands and forearms; feet and ankles. Skin of whole body. 3. Lens of the eye (3) The RSC/RSO will evaluate our facilities 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.

28 (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

29 (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.

30 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. Radiation Safety Officer Date: Administrator Date:

31 11 OCCUPUATIONAL EXPOSURE LIMITS ALARA Area Exposed NRC STATE Level 1 & Level II Values are in mrem per period of time Whole Body 5000/yr 5000/qtr 125/qtr 375/qtr (Deep Dose) Head and trunk, gonads, Blood forming organs Lens of Eye 15000/yr 5000/qtr 375/qtr 1125/qtr Extremities Skin 50000/yr 50000/qtr 1250/qtr 3750/qtr (Shallow Dose) Fetus 500/term As low as possible (Declared Pregnancy)

32 12 DOSE TO MEMBERS OF THE PUBLIC Dose Limits to Members of the Public Licensees shall conduct operations in accordance with 3701: 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 3701: 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 3701: Licensees must show compliance with the annual public dose limit by following 3701:

33 13 MEDICAL EVENT VS. ACCIDENTAL ADMINISTRATION The following form is to differentiate an accidental administration from a medical event. In the event of the injection of a patient with the wrong dosage, wrong patient or wrong isotope, you would complete the dosimetry worksheet and fax it to your physics consultant at MPC. A consultant will return to you a completed form of the dose received and what category it satisfies. Please file your completed worksheet with our completed effective dose form in your blue MPC binder under Fetal/Patient Dose Calculations. Medical event means the administration of: (2) 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 - (i) An administration of a wrong radioactive drug containing byproduct material: (ii) An administration of radioactive drug containing byproduct material by the wrong route of administration; (iii) An administration of a dose or dosage to the wrong individual or human research subject; (iv) An administration of a dose or dosage delivered by the wrong mode of treatment; (v) A leaking sealed source.

34 RADIOPHARMACEUTICAL DOSIMETRY CALCULATION WORKSHEET Date: : Institution: : Patient Name: : Patient Identification Number: : Patients Age: : Intended Radiopharmaceutical and Activity: : Intended Study: : Administered Radiopharmaceutical and Activity: : Route of Administration: : Modifying Factors: Abnormal Renal Function Abnormal Liver Function Occluded Bile Duct Thyroid Uptake : % Blocking Agents: Please fax this completed form for calculation to your MPC physics consultant at (734)

35 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 will be issued monthly. 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 Must 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. i. Keep away from heat ii. Keep away from water iii. 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 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. Only nuclear medicine technologists will be assigned ring dosimeters. All other radiation workers will wear whole body dosimeters only. 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.