Last Revision of this Section on: July 24 th, 2007 Page 1 of 1 Title & Revision History Radiation Safety Manual of the Montreal Neurological Institute & Hospital Draft: July 2007 Revision History of Radiation Safety Manual (RSM) (All revisions listed below have been approved by the Radiation Safety Committee of the MNH/I) Version No.: Issue Date: 1 May, 1999 J.M.Lupien, RSO, RVH First version 2 September 1st, 2007 E. Meyer, RSO, MNH/I First revision since inception of CNSC Radiation Safety Manual of the MNI/H Submitted by: Comments: Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24th, 2007 Page 1 of 1 Distribution List Distribution List for Radiation Safety Manual (RSM) Name of Recipient: Title or Position: Dr. M. Diksic Chairman, RS Committee, MNH/I Version No.: 2 Distribution Date: Recipient’s Signature (or confirmation of reception) *: September 1st, 2007 All Lab. Directors * this information to be kept in RSO’s copy Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 17 th, 2006 Page 1 of 1 Foreword Foreword This document is the second version of the Radiation Safety Manual (RSM) of the Montreal Neurological Institute and Hospital. The policies and procedures described herein reflect the Regulations of the Canadian Nuclear Safety Commission (CNSC), which replaced the Atomic Energy Control Board (AECB) on May 31 st, 2000. The website of the CNSC is: www.nuclearsafety.gc.ca Parts of the first version (May 1999) of this document had been adapted from radiation safety manuals available from other institutions such as the Royal Victoria Hospital, McGill University (www.mcgill.ca/ehs) and the University of California. The present revision of the manual has been approved by the members of the Radiation Safety Committee of the MNI/H. We are grateful for financial assistance given towards this manual by the Director of the MNI and by the Associate Director General of the MUHC. We would like to thank Ms. Belinda Preziosi for help with the preparation of the manuscript. The Radiation Safety Committee hopes that this manual will help maintain high standards in radiation safety at the Montreal Neurological Institute and Hospital. The manual is accessible on the internet from the MNI homepage at the following address: www.mni.mcgill.ca. Mirko Diksic, PhD Chairman, Radiation Safety Committee MNI & MNH/MUHC Summer, 2006 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 17th, 2006 Page 1 of 1 Relevant Sections It is essential for personnel handling radioactive materials or radiation emitting equipment to read the following sections of the Radiation Safety Manual: 1. Technologists, Radiologists, Medical and Nursing Personnel: Chapters 1-11, 13, 14 2. Laboratory Technologists and Researchers: Chapters 1-7, 10, 11, 13, 14 Cyclotron Personnel shall read Chapter 12 as well 3. Administrative assistants, Security, Receiving and Maintenance Personnel: Chapters 1-3, 5, 6, 13 4. Nuclear Medicine Technologists: Chapters 1-7, 10-13 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2nd, 2007 Page 1 of 3 Table of Contents Table of Contents 1. Purpose of the Manual 2. Organization and Responsibilities 2.1 Radiation Safety Committee (RSC) 2.2 Radiation Safety Officer (RSO) 2.3 Responsible Radiation User (RRU) 2.4 Departmental Radiation Supervisor (DRS) 2.5 Individual "Radiation Workers" 3. Effective Dose Limits 3.1 Nuclear Energy Workers 3.2 Pregnant Nuclear Energy Workers 3.3 General Public 4. Licensing and Authorization 4.1 CNSC License 4.2 MNI/MNH Internal Permits 5. Purchase, Reception, Storage and Transfer of Radioactive Material 5.1 Purchase of Radioisotopes 5.2 Reception of Radioactive Material 5.3 Storage of Radioactive Material 5.4 Transfer of Radioactive Material and Devices 6. Radiation Monitoring 6.1 General Principles 6.2 Area and Procedure Monitoring 6.3 Personnel Monitoring 6.4 Monitoring of Internal Radioactivity 6.5 Medical Surveillance 7. Collection and Disposal of Radioactive Waste 7.1 General Principles 7.2 Collection and Storage of Radioactive Waste in the Laboratory 7.3 Disposal of Radioactive Waste from the Central Collection Area 7.4 Disposal of Irregular Radioactive Waste 8. Safety Guidelines for Diagnostic Radiology 8.1 General Recommendations 8.2 Recommendations for Operation of Radiographic Units 8.3 Recommendations for Operation of Fluoroscopic Units 8.4 Recommendations for Operation of Mobile Units 8.5 Recommendations for Special Radiological Procedures Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2nd, 2007 Page 2 of 3 Table of Contents 9. Procedures for Minimizing Dose to Patients 9.1 Guidelines for the Prescription of Diagnostic X-Ray Examinations 9.2 Guidelines for Radiography in Pregnant Women 9.3 Recommendations for Reducing Gonadal Dose to the Patient 9.4 Guidelines for Carrying Out X-Ray Examinations 10. Use of Unsealed Radioisotopes 10.1 General Principles 10.2 Classification of Laboratories 10.3 Handling of Unsealed Radioisotopes in Laboratories 10.4 Handling of Radioisotopes in the Department of Nuclear Medicine 11. Radiation Safety in the Wards 11.1 Use of Mobile X-ray Units in Wards 11.2 In-Patient Undergoing Treatment with Unsealed Radioisotopes 12. Procedures for the MNI/MNH Medical Cyclotron Facility 12.1 Introduction 12.2 Description of Cyclotron Facility 12.3 Radiation Monitoring in the Cyclotron Facility 12.4 Safety Interlock and Warning System 12.5 Laboratory Safety Instructions 12.6 Personal Responsibilities 12.7 Records 12.8 Radiation Safety Check List 12.9 Procedures for Handling of Irradiated Targets 12.10 References 13. Radiation Accidents and Emergency Procedures 13.1 General Principles 13.2 Accidents Involving External Exposure Only 13.3 Contamination by Radioactive Material 13.4 Fires Involving Radioactive Material 13.5 Loss or Theft of Radioactive Material or Radiation Devices 14. Education and Training of Personnel 15. Appendices (* hardcopy or scanned version only) 1. Radiation Measurement Units – Système International (SI) 2. Radiotoxicity and Half Life of Selected Radionuclides 3. Request Form to Use New Radiochemical 4. Radiation Safety Declaration Forms a) RSM Declaration b) TLD Monitor Application c) Radiation Training Form 5. Pregnancy Declaration Form 6. Internal Permit Application Form Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2nd, 2007 Page 3 of 3 Table of Contents 7. 8. 9. 10. 11. 12. 13. MNI/MNH Internal Radioisotope User Permit Radioisotope Inventory Sheet Minor Spill Incident Form MNI/H Contamination Control Protocol How to Convert CPM to Bq/cm2 Internal Inspection Checklist Request for Decommissioning of Radioisotope Laboratory 14. CNSC a) b)* c)* d) e)* f)* g)* h)* i)* k)* l)* m)* 15. 16. 17. 18. 19. 20. Posters and Publications: Physical Characteristics for Commonly used Radionuclides Proper Care and Use of Personal Dosimeters (INFO-0742) Receiving Radioactive Packages (INFO-0744) Dose Limits for Pregnant Workers: Rationale for the Limits in the Radiation Protection Regulations (INFO-0700) Use of Unsealed Nuclear Substances Poster “Basic Level” (INFO-0728-1) Use of Unsealed Nuclear Substances Poster “Intermediate Level” (INFO-0728-2) Use of Unsealed Nuclear Substances Poster “High Level” (INFO-0728-3) Use of Unsealed Nuclear Substances Poster “Nuclear Medicine” (INFO-0728-4) Radioisotope Safety: Spill Procedures (INFO-0743) Radioisotope Safety Information Poster - Iodine – 131 (INFO 0546-1) Radioisotope Safety Information Poster - Iodine – 125 (INFO 0546-2) Radioisotope Safety Data Sheet - Phosphorus – 32 (from Website: http://www.nuclearsafety.gc.ca/eng/publications/) Exemption Quantities (EQ) for some Radioactive Nuclear Substances Annual Limits on Intake (ALI) for some Radioactive Nuclear Substances (Area Classification) Weekly Contamination Survey Log PET Investigators Radiation Safety Information microPET Investigators Radiation Safety Information and Radioisotope Transfer Protocol Regulatory Quantities for some Radionuclides Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: March 13 th, 2005 Page 1 of 1 Acronyms and Abbreviations List of Acronyms ALARA ALI AECB AQ BIC CNSC CRP CTCR DRS ED EDE EHS EPD EQ ERT FDG HMPAO LSV MNH MNH/I MNI MPD MUHC NDS NEW PET REB RF RG RPB RPR RRU RSC RSM RSO RTS RVH SI SPECT SR TLD TDG WHO WMF As Low As Reasonably Achievable Annual Limit on Intake Atomic Energy Control Board (became the CNSC in 2000) Animal Quarters Brain Imaging Center Canadian Nuclear Safety Commission Commission on Radiological Protection Canadian Transport Commission Regulations Departmental Radiation Supervisor Effective Dose Effective Dose Equivalent Environmental Hygiene and Safety Office Electronic Personal Dosimeter Exemption Quantity Emergency Response Team Fluoro-Deoxy-Glucose Hexa-Methyl-Propylene-Amine-Oxime Liquid Scintillation Vial Montreal Neurological Hospital Montreal Neurological Hospital & Institute Montreal Neurological Institute Maximum Permissible Dose McGill University Health Center National Dosimetry Service Nuclear Energy Worker Positron Emission Tomography Research Ethics Board Radio Frequency Regulatory Guide Radiation Protection Bureau Radiation Protection Regulations Responsible Radiation User Radiation Safety Committee Radiation Safety Manual Radiation Safety Officer Radioisotope Tracking System Royal Victoria Hospital (MUHC) Système International Single Photon Emission Computed Tomography Safety Report Thermo-Luminescent Dosimeter Transport of Dangerous Goods World Health Organization Waste Management Facility Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 17 th, 2006 Page 1 of 1 Attention ATTENTION IN CASE OF A RADIATION ACCIDENT AND/OR A RADIOACTIVE CONTAMINATION (if you think you cannot handle the situation) 1 Call ????? and say “Radiation Accident” or “Radiation Spill” 2 A “Code Brown” will then be issued, mobilizing the Emergency Response Team (ERT). 3 The ERT will contact the RSO (ext. 8927 or pager No. 4063069) and both will proceed to the accident site. 4 Wait for ERT and RSO for further directions. 5 The ERT, with the help of the RSO, will initiate decontamination and survey of the area. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 17 th, 2006 Page 1 of 1 Useful Telephone Numbers Useful Telephone Numbers: MNH/I Dr. Ernst Meyer, Radiation Safety Officer, MNH/I: Office 398-8927 Home 525-0220 Pager 406-3069 RVH Locating 8888-53333 Dr. Mirko Diksic, Chairman, Radiation Safety Committee, MNH/I: Office 398-8526 Home 697-9489 _____________________________________________________________________________________________ McGILL Mr. Joseph Vincelli, McGill Environmental Safety Office: Office 398-1538 MUHC MUHC Radiation Safety Service: Office Radiation Safety Manual of the MNI/H (514) 934-1934 ext. 43866 Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 17 th, 2006 Page 1 of 1 1. Purpose of the Manual 1. Purpose of the Manual This manual constitutes a handbook of procedures for the safe handling and application of sources of ionizing radiation. The rules, recommendations and information included in the manual have been approved by the Radiation Safety Committee as the basis of radiation safety at the Montreal Neurological Institute and Hospital. The overall intention of these rules and recommendations is as follows: a) protection of staff, patients and the general public from the hazards associated with the use of ionizing radiation sources of all kinds. b) compliance with federal, provincial and local laws, regulations and licensing requirements related to such sources. In other words: The guiding principle throughout this manual is the ALARA Principle which demands that the doses received by workers and members of the public be kept As Low As Reasonably Achievable, social and economic factors taken into account (see CNSC Regulatory Guide G-129). Adherence by this Institution to the ALARA Principle is demonstrated by the following elements: 1) a solid commitment from the management of the MNH/I towards radiation safety (i.e., awarding of a budget for radiation safety, appointment of a RSO and a RSC and a continuing interest in their activities, delegation of a representative from the administration to the RSC, continuing interest and support for upgrading radiation safety, purchasing and renewal of equipment); 2) the provision of resources (see under 1), organization and support of training sessions (i.e., the MNH/I assumes the cost of employee training sessions organized by McGill), establishment of “action levels” (see chapter 6), continuing efforts to further reduce radiation doses to employees and to the environment, documentation of radiation safety-related procedures, data and events; 3) operational reviews of dose records, frequency of incidents (contamination control), review and introduction of new technology for improved radiation protection (e.g., the purchase of modern electronic direct reading personal dosimeters or EPDs). We believe that there is ample evidence to be found throughout the present Radiation Safety Manual indicating that radiation safety at the MNH/I is managed in the spirit of the above statements. Notes: -Throughout this manual “shall” is used to designate features or actions which are essential, while “should” is used to designate features or actions which are recommended. -This manual will be amended and supplemented from time to time in the light of changes in regulations, knowledge, equipment, organization or legal requirements. - All quantities in this manual, unless otherwise stated, are given in the Système International (SI) units. The table in Appendix 1 gives conversion factors between the old and the SI units. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 18th, 2006 Page 1 of 6 2. Organization and Responsibilities 2. Organization and Responsibilities The licensee of our current CNSC licenses is the Montreal Neurological Hospital & Institute. The management of the MNH/I is thoroughly committed to radiation safety as demonstrated by its assumption of the following responsibilities: 1) 2) 3) 4) Provision of a radiation safety budget Appointment of a radiation safety officer (RSO) Provision of physical resources (space) for the radiation safety program Requesting operational reviews from time to time The organizational basis of radiation safety at the Montreal Neurological Institute and Hospital is as follows: a) A Radiation Safety Committee initially appointed on the advice of the Director of the Montreal Neurological Institute and the Associate Executive Director of the MNH/MUHC. b) A Radiation Safety Officer who reports to and works under the general directives of the Radiation Safety Committee. c) Responsible Radiation Users, who are persons officially designated, for licensing and other purposes, as the individuals responsible for the procurement and use of specified radiation sources. d) Departmental Radiation Supervisors who, in co-operation with Heads of Departments and Directors of Laboratories and with the Radiation Safety Officer, ensure compliance with the relevant radiation safety requirements within a defined geographical or departmental area. e) Individual members of laboratories or departmental staff who have the responsibility of using radiation sources in such a way that they do not endanger themselves or other people. 2.1 Radiation Safety Committee (RSC) 2.1.1 Membership of the RSC The membership of the RSC is chosen such that all major radiation user groups at the MNH/I are represented. These include in-vitro and animal research laboratories, radiochemistry cyclotron operations, PET research and nuclear medicine operations. Furthermore, in addition to the RSO, representatives from the administration, radiology, security, McGill University radiation safety and MUHC radiation safety are included as well. At present, the RSC consists of 13 voting members. The quorum for meetings therefore is 7 members. The RSC has access to an administrative assistant who organizes the meeting dates, takes minutes and distributes them to the members of the RSC as well as to the Director of the MNI, the Associate Executive Director of the MNH/MUHC as well as to the CNSC. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 18th, 2006 Page 2 of 6 2. Organization and Responsibilities 2.1.2 Terms of Reference of the RSC a) To review at least four times a year, and whenever necessary, the matters and problems arising from the use of ionizing radiation in the Montreal Neurological Institute and Hospital in diagnosis, therapy and research, with a view to ensuring satisfactory standards of safety for patients, staff and the general public. b) To ensure that radiation equipment, sources, handling and shielding procedures and safety standards satisfy such legal requirements and/or recommendations as may be issued from time to time by national, provincial and municipal regulatory authorities. c) To review and to approve, or disapprove, the use of radioisotopes and radio-pharmaceuticals in the Institute and Hospital for both human and non-human applications, from the standpoint of radiation safety; to authorize the acquisition of these materials through the license holder; where necessary, to apply additional conditions to such use, other than those stated in the relevant license; and to suspend such use where appropriate, irrespective of the source of the original authorization. d) To review and to approve, or disapprove, requests for the acquisition, installation and housing of equipment capable of producing ionizing radiation, from the standpoint of radiation safety. e) To review arrangements for the disposal of radioactive waste, including unused radioisotopes and radio-pharmaceuticals, to ensure adequate protection of the staff and the environment. f) To ensure that an adequate system of radiation monitoring is implemented, in all departments in which ionizing radiation is employed, in collaboration with the appropriate national and/or provincial health authorities. g) To ensure that adequate records are maintained of all matters pertaining to radiation hazards and radiation doses received by Institute and Hospital personnel and, where applicable, patients and other persons; and to ensure that cases of over-exposure or unwarranted hazard are investigated and that remedial action is taken. h) To ensure that Institute and Hospital personnel are properly instructed in matters of radiation hazards and radiation safety. i) To ensure that plans are prepared and suitable equipment made available to deal with accidents and emergencies involving an actual or potential radiation hazard. Such emergencies include incidents occurring within or outside the Institute and Hospital which result in the arrival at the Institute or Hospital of persons who are contaminated with radioactive materials and/or have received excessive doses of radiation. ??? j) To prepare, and to revise from time to time, a "Radiation Safety Manual" which incorporates the rules, recommendations, instructions, data and other information required for the implementation of these Terms of Reference. k) To supervise and direct the activities of the Radiation Safety Officer in implementing the various measures laid down in these Terms of Reference. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 18th, 2006 Page 3 of 6 2. Organization and Responsibilities l) 2.2 To report to the Director of the MNI and to the Associate Executive Director of the MNH/MUHC as well as to the Canadian Nuclear Safety Commission whenever a situation arises, involving an actual or potential radiation hazard, such that the effective control of the hazard lies outside the authority vested in the Radiation Safety Committee and/or the Radiation Safety Officer. Radiation Safety Officer (RSO) The RSO is responsible for implementing the Terms of Reference of the Committee set out in 2.1.2 above. In particular, the duties of the RSO shall include: 2.2.1 Assessment of the status of radiation safety measures undertaken in all rooms, laboratories, wards and other locations where radiation sources (including patients containing radioactive sources) are housed and/or used. 2.2.2 Providing or organizing such services as may be required for radiation safety and for compliance with federal, provincial and local laws and recommendations, where these services cannot be provided internally by individual departments or laboratories. Examples of these services are: a) Instruction and training of employees in the safe handling of radiation sources. b) Calibration, certification and maintenance of radiation monitoring equipment. c) Carrying out radiation surveys, including environmental surveys, personnel monitoring (additional to that provided by the national monitoring service) and surveys relating to particular equipment or procedures. d) Survey of the collection and disposal of radioactive waste. e) Planning for, and supervision of, emergency procedures and special decontamination operations. f) Maintenance of records relating to all aspects of radiation safety, including personnel exposure records, radiation survey records and licensing documents. g) Participation in the planning of new installations or procedures involving radiation sources. h) Co-operation with federal, provincial and local authorities in all matters relating to radiation safety. 2.2.3 Reporting to the Radiation Safety Committee regularly and whenever any unusual or emergency situation arises or has recently been dealt with. In particular, the RSO shall perform internal inspections (see “Internal Inspection Checklist” in Appendix 12) of all radioisotope facilities that operate under a CNSC license issued to the MNH/I and present the results of such inspections to the RSC. 2.3 Responsible Radiation User (RRU) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 18th, 2006 Page 4 of 6 2. Organization and Responsibilities A Responsible Radiation User, sometimes also called Permit Holder, is a person who is officially designated, for licensing or other purposes, as the individual responsible for the procurement and use of specified radiation sources. A Responsible Radiation User is normally the director of a department, division or laboratory. As such, he is ultimately responsible for providing adequate facilities, equipment, supervision and instruction needed by his staff to enable radiation sources to be handled safely and in compliance with the requirements of this manual. Frequently, the day-to-day responsibilities for some of these matters are delegated to a Departmental Radiation Supervisor (DRS) (e.g., chief technician, see 2.4 below). Whether the responsibility is exercised directly or is delegated, the list of duties related to radiation safety is as given in 2.4 below. 2.3.1 Internal Permit Application Responsible Radiation Users performing in-vitro and animal laboratory studies that are covered by a Consolidated License issued by the CNSC to the MNH/I must obtain an internal permit (see Appendix 7). The application form (see Appendix 6) requires information such as: - name and position of Responsible Radiation User name and position of Departmental Radiation Supervisor names of radiation badge users list of radioisotopes to be used and means and areas of storage radioisotope reception procedures intended use list of sealed radioisotopes in use, with their respective activities (per manipulation; per year) available radiation monitoring equipment waste disposal procedure proof of radiation safety training for staff, willingness to attend RS course (see also paragraph 4.2 of Chapter 4: Licensing and Authorization) 2.4 Departmental Radiation Supervisor (DRS) The Departmental Radiation Supervisor (DRS) is a person who works full-time in a given area, laboratory or other circumscribed location, such that he/she is able to provide day-to-day supervision of the work of employees in matters of radiation safety. The DRS derives his/her authority from the Head of the Department, Director of the Laboratory or other Responsible Radiation User as defined in 2.3. In particular, the DRS is responsible for: a) Maintaining (in co-operation with the RSO) an up-to-date list of rooms in which radiation sources are installed, stored, handled, used or applied. b) Maintaining a day-to-day inventory of radiation sources in the form of radiation-emitting equipment and/or radioactive sources (open or sealed) received, used or disposed of (relative to each project). The MNI/MNH radioisotope inventory form is given in Appendix 8. As of March 22nd, 2004, the MNI/H has subscribed to the Radioisotope Tracking System (RTS), a computerized method of keeping track of the amount and location of a radioactive substance Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 18th, 2006 Page 5 of 6 2. Organization and Responsibilities from its acquisition to disposal. This program is administered by the McIntyre Waste Management Program of McGill University. The RTS inventory established by each radiation user together with the radioactive waste pick-up date information kept by the RSO may be used to replace the inventory form given in Appendix 8. c) Ensuring that all persons handling radiation sources receive adequate instruction in the safety aspects of such handling. For that purpose, the DRS will direct new radiation users (fellows, postdocs, technicians, students) to the RSO who will assure that these individuals will attend the appropriate training sessions (see Chapter 14: Education and Training of Personnel for more information on this topic). d) Allowing only authorized persons to enter areas that are specified as restricted for reasons of radiation safety. e) Ensuring that personnel wear assigned radiation monitors throughout the working day and that such monitors: i) ii) 2.5 are not left in close proximity to radiation sources when not being worn; and are handed in promptly at the end of each monitoring period or before the user commences a period of prolonged absence. f) Posting warning labels and signs as required by current laws and safety codes. g) Establishing, and ensuring observation of, appropriate working procedures (in co-operation with the RSO) to guarantee compliance with applicable laws and safety codes. h) Ensuring that radioactive waste is disposed of in strict accordance with Section 7 of this manual. i) Notifying the RSO when any female Nuclear Energy Worker under his/her supervision, or any such worker about to come under his/her supervision, is known to be pregnant (see Appendix 5 and Appendix 14 (d). j) Supplying the RSO with all the information needed for licensing purposes and/or issuing of the internal permit. k) Ensuring that, when required, personnel make themselves available for bioassay procedures such as thyroid monitoring and that adequate records of the results of such procedures are maintained. l) Monitoring the work area for radioactive contamination by means of a wipe test at least weekly and recording the results in a log book. Individual "Radiation Workers" (RW) An individual RW, for the purpose of this manual, is an individual that handles radioactive substances under the direction of a DRS or, by extension, of a RRU as defined earlier in this chapter. RSC of the MNH/I requests that every RW abides by the rules set out in paragraphs a) to c) below: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 18th, 2006 Page 6 of 6 2. Organization and Responsibilities a) Every individual RW who acquires, installs, stores, handles or applies radiation sources is responsible for working in such a way that he/she does not endanger either himself/herself or his/her colleagues and that he/she complies with the procedures and rules laid down by the Departmental Radiation Supervisor and/or listed in the applicable sections of this manual. b) An RW is responsible for any radiation monitor (e.g., TLD monitor) assigned to him/her and must carry it on his/her person throughout the working day. He/she must not lend or assign his/her personal monitor to anyone else, nor leave the monitor outside working hours in such a location that it could be exposed to radiation. c) An RW must read and understand the relevant sections of this manual and other regulatory documents applicable to his/her type of work. (The sections concerned will be assigned by the Responsible Radiation User, in consultation with the RSO. See also the page Relevant Sections at the beginning of this manual). The appropriate declaration form (Appendix 4a) must be signed and returned to the RSO. To this end the worker may request a copy of this manual and a copy of the relevant Safety Code (edited by the CNSC or Quebec provincial authorities) for his/her personal use, if he/she so desires. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 19 th, 2006 Page 1 of 2 3. Effective Dose Limits 3. Effective Dose Limits The Canadian Nuclear Safety Commission (CNSC), formerly the Atomic Energy Control Board (AECB), under the Nuclear Safety and Control Act and Regulations requires that the licensee ensure that the effective dose (due to exposure to radioactive substances or equipment regulated by the CNSC) of a person described in column I during the corresponding period in column II does not exceed the corresponding effective dose in column III of the following table: column I column II column III person period effective dose (ED) in mSv item 1 Nuclear Energy Worker, including one year dosimetry period a pregnant nuclear energy worker five-year dosimetry period 50 100 2 pregnant Nuclear Energy Worker the balance of pregnancy 4 3 any other person (general public) 1 calendar year 1 Nuclear Energy Worker: A person who is required, in the course of the person’s business or occupation in connection with a nuclear facility, to perform duties in such circumstances that there is a reasonable probability that the person may receive a dose of radiation that is greater than the prescribed limit for the general public. One year dosimetry period : a period of one calendar year beginning on January 1, and every period of one calendar year thereafter. Five year dosimetry period: a period of five calendar years beginning on January 1, and every period of five calendar years thereafter. Balance of pregnancy: period of time from the moment the licensee is informed in writing of the pregnancy, until the end of pregnancy. The following segments (1) and (2) are excerpts adapted from the Radiation Protection Regulations (paragraph 11) issued on May 31st, 2000 by the Canadian Nuclear Safety Commission: Obligations of Pregnant Nuclear Energy Workers: (1) Every nuclear energy worker who becomes aware that she is pregnant shall immediately inform the licensee in writing. (2) On being informed by a nuclear energy worker that she is pregnant, the licensee shall, in order to comply with the legal limits shown in the preceding table, make any accommodation that will not occasion costs or business inconvenience constituting undue hardship to the licensee. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 19 th, 2006 Page 2 of 2 3. Effective Dose Limits 3.1 Nuclear Energy Workers The doses listed are maximum permissible doses or MPD (also referred to as dose limits). They are in no sense "dose allotments" which can and should be used up. On the contrary, the guiding principle of all radiation work is: the dose should be as low as is reasonably achievable, economic and social factors being taken into account. This is called the "ALARA" principle and is central to all radiation safety. Any Nuclear Energy Worker whose dose exceeds his personal action level (see paragraph 6.3 for specific action levels, ALs) is subject to investigation by the Radiation Safety Officer. 3.1.1 Both external and internal radiation may contribute to the dose received by an individual. External radiation arises from radiation sources, including x-ray machines and radioisotope sources, which are external to the body. Internal exposure occurs when radioactive material is ingested, swallowed, inhaled, or otherwise enters the body and is deposited in body tissue. Internal contamination is particularly hazardous for radioactive materials that have long half-lives and are deposited in bone or lung (e.g., radium-226, strontium-90), but all internal radiation carries some risk and should be avoided. For this reason, stringent precautions are needed in laboratories where unsealed (liquid and gaseous) radioisotopes are handled. 3.2 Pregnant Nuclear Energy Workers The dose limits include special provisions for female nuclear energy workers of reproductive age: 3.3 a) the annual maximum permissible dose must be evenly distributed throughout the year; b) if pregnancy is diagnosed, the worker's duties must be such that the dose to the abdomen, after the licensee has been informed of the pregnancy, shall not exceed a total of 4mSv for the remaining period of the pregnancy accumulated at the rate of no more than 0.6mSv per two weeks. 1 General Public The dose limit for non-Nuclear Energy Workers and members of the public is 1mSv in one calendar year. As stressed in paragraph 3.1, the ALARA principle applies, and every effort must be made to reduce the actual doses received by non-Nuclear Energy Workers to as low a level as possible. This applies to any situation in the hospital in which non-Nuclear Energy Workers or members of public, including patients, may be exposed to radiation from devices or substances regulated by the CNSC or to radioactive contamination, in circumstances such that the individual concerned derives no personal benefit from the exposure. 1 AECB (CNSC) report INFO-0700, Dose Limits for Pregnant Workers: Rationale for the Limits in the Radiation Protection Regulations (Appendix 14d). Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 20th, 2006 Page 1 of 3 4. Licensing and Authorization 4. Licensing and Authorization 4.1 CNSC License 4.1.1 The Canadian Nuclear Safety Commission (CNSC) licenses the possession and use of radiation sources in Canadian hospitals and research institutions. Licensed activities include the following categories: a) Unsealed radioisotopes and radio-pharmaceuticals used for diagnosis or therapy on human subjects, whether in a Department of Nuclear Medicine or elsewhere. b) Unsealed radioisotopes used for investigations and research not involving human subjects (in-vitro or animal laboratory studies). c) Unsealed radioisotopes used for investigations and research involving human subjects (human research studies such as positron emission tomography investigations on human volunteers). d) Sealed radioisotopes used in therapy, including sources intended for implantation (brachytherapy) and sources housed in teletherapy (e.g. cobalt) units. e) Sealed radioisotopes permanently housed in instruments and equipment. This category includes sealed isotopic sources provided for instrument calibration, for diagnostic purposes (e.g. bone mineralization scanners) and for neutron activation analysis. f) Particle accelerators that are capable of giving rise to high-energy ionizing particles, either as the useful product (e.g. a beam of high energy electrons) or as a by-product (e.g. stray neutrons). In practice this means that all medical accelerators (linear accelerators, betatrons, cyclotrons) are licensable. g) Processing and shipping of radioisotopes produced by a particle accelerator (e.g., production and transfer or sale of 18F-FDG produced by a medical cyclotron). 4.1.2 The list in 4.1.1 excludes all radiographic and fluoroscopic equipment in the Diagnostic X-ray Department (at present under the jurisdiction of the “Laboratoire de Santé Publique du Québec). 4.1.3 All radioisotope users in category b) above (in-vitro or animal laboratory studies) at present are covered under a single collective or Consolidated License issued to the Montreal Neurological Hospital and Institute. Each Responsible Radiation User in this category is then issued an Internal Radioisotope User Permit (see section 4.2). 4.1.4 The application of radiation sources of any kind (external or internal) to human volunteers for research, or for other purposes not directly linked to the welfare of the individuals concerned, is subject to further restrictions. Investigations of this nature fall under the jurisdiction of the Biologics and Genetic Therapies Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 20th, 2006 Page 2 of 3 4. Licensing and Authorization Directorate of Health Canada (see letter, dated October 22, 2003, to Dr. Jean-Paul Soucy, PET Unit Coordinator, MNI), the role of the Radiation Safety Committee being to advise the REB on the radiation dosimetry aspects of the proposal. Also, the guidelines issued by the World Health Organization in 1973 provide a suitable basis for decision-making in these areas of research. An applicant for a license for the use of radiation sources in human subjects has to satisfy the following conditions, as required by the CNSC: a) he/she is a qualified and registered Nuclear Medicine specialist of the province of Quebec; b) he/she is qualified and experienced in the handling of radioisotopes and radiation sources; c) the quantities of radioisotopes to be purchased, stored and handled at any one time do not exceed the safe limits for the type of laboratory and facilities available; d) the procedure (protocol) and administered radioactivity per subject (human volunteer) are approved by the Research Ethics Board (REB); e) adequate instrumentation for measurement and monitoring of radiation is available. Information on all of these points is asked for on the license application form (CNSC Regulatory Guide C-292). Other specific information is required for each of the licensing categories listed above, particularly for category 4.1.1.f (particle accelerators). The Radiation Safety Officer of the MNH/I, in consultation with the applicant, will assure the complete and timely processing and/or renewal of any specific license application to be submitted to the CNSC. 4.2 MNI/MNH Internal Permits As already mentioned above, all users of radioisotopes under category b) (in-vitro or animal laboratory studies) are covered by a Consolidated License issued to the MNH/I by the CNSC. However, each Responsible Radiation User must hold a current “Internal Radioisotope User Permit” issued by the RSO on behalf of the Radiation Safety Committee. This permit is valid at the very most for a period not exceeding the validity duration of the Consolidated License. It contains specified conditions of approval, compliance with which is mandatory. Failure to comply may result in the cancellation of the permit and may even jeopardize the MNH/I’s Consolidated License. 4.2.1 Procedure for Obtaining Internal Permits To apply for an Internal Permit, the RRU has to complete the "Internal Permit Application Form", a sample of which is given in Appendix 6. This form has to be completed in full and returned to the RSO. (Notice that this form includes a clause on radiation safety training!). The application is then reviewed by the Radiation Safety Committee (if the next Radiation Safety Committee Meeting is some time away, the chairman of this committee together with the RSO may temporarily approve a permit application) and detailed conditions of approval are formulated. A copy of the approved “Internal Radioisotope User Permit” is then sent to the applicant, and another copy is retained by the RSO. An example of the “Internal Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 20th, 2006 Page 3 of 3 4. Licensing and Authorization Radioisotope User Permit”, which has to be posted at the location(s) specified on the permit, is shown in Appendix 7. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on Sept. 19 th, 2006 Page 1 of 4 5. Purchase, Reception, Storage and Transfer of Radioactive Material 5. Purchase, Reception, Storage and Transfer of Radioactive Material 5.1 Purchase of Radioisotopes 5.1.1 All purchases of radioactive materials must be approved by a Responsible Radiation User (RRU) who is the holder of an MNI/MNH internal permit, which in turn is issued in accordance with a valid CNSC license. All purchases of radioactive materials must be signed by the RSO prior to processing. The RSO’s office signs the purchase orders only if the following conditions are met: (1) RESULTS of the most recent routine (weekly) wipe test are included with the order (the RSO may ask to see further wipe tests to verify full compliance with contamination control requirements). (2) If areas of contamination are apparent from these wipe tests, a second wipe test has been performed AFTER SUCCESSFUL CLEANUP and the results of both wipe tests, BEFORE and AFTER cleanup, are included with the order. The RSO’s office maintains a record of all radioactive materials purchased at the MNI/MNH. 5.1.2 The Montreal Neurological Institute and Hospital has a standardized system for the purchase, reception and distribution of radioisotopes. 5.1.3 The activity of each type of radioisotope that can be purchased, stored and used by the individual Responsible Radiation User is limited by the possession limit indicated on the internal permit and, for the institution as a whole, by the maximum quantities (possession limits) specified on the CNSC license. 5.1.4 Up-to-date individual inventories have to be maintained by each RRU with detailed data about each incoming shipment and its partial or total use in the laboratory and its disposal. The inventories have to be presented for inspection by the RSO/CNSC or other competent authority. A copy of the recommended form of a radioisotope inventory is included as Appendix 8. Since the implantation at the MNH/I of the Radioisotope Tracking System (RTS) by the McGill Waste Management Facility on March 22nd, 2004, the computer record generated by this comprehensive program is acceptable as a substitute for the Inventory Sheet shown in Appendix 8. 5.2 Reception of Radioactive Material Each package containing radioactive material bears at least two RADIOACTIVE warning labels which display the required information about the contents and activity of the package. Packages are classified according to the dose-equivalent rate at the surface and at a distance of 1 meter from the surface. Category I: Category II: Category III: Less than 5µSv/hr on the surface. Less than 500μSv/hr on the surface and a transport index of 1.0. Less than 2mSv/hr on the surface and a transport index of less than 10. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on Sept. 19 th, 2006 Page 2 of 4 5. Purchase, Reception, Storage and Transfer of Radioactive Material The transport index (TI) is the maximum radiation level in μSv (microsieverts) per hour measured at 1 meter from the surface of a package, divided by 10. The TI is also equal to the radiation level measured in mrem/h at 1m, or, for most practical purposes, equal to the radiation field measured in mR/h at 1m from the surface of the parcel. Detailed information is given in the CNSC poster Guidelines for Handling Packages Containing Nuclear Substances (INFO-0744) which is included as Appendix 14c in this manual. Packages are usually delivered to stores, unless special arrangements are made between the supplier and a particular laboratory in exceptional cases. Stores have outlined a specific area which is reserved for the reception of radioactive packages. Packages are briefly examined for damage and eventual leakage by stores personnel. If the package shows obvious damage, then the addressee should be called immediately and the RSO should be contacted as well. If the damage is beyond control (severe leakage), the Radiation Emergency Number (?????) should be called. The RSO will then automatically be alerted and called to provide assistance. If no damage to the package is detected, stores personnel will deliver it to the addressee as quickly as possible (delivery hours are from 8am to 3:30pm). 5.2.1 Only the holder of an internal permit or the person designated by the holder himself/herself may receive an incoming radioactive shipment that is delivered to his/her laboratory. 5.2.2 The RRU of a given laboratory should designate: i) a room or area as the reception point and ii) a suitable person, or persons, authorized to accept delivery of packages containing radioactive materials. 5.2.3 Incoming packages containing radioactive material have to be examined for leakage, damage and contamination by the RRU or another qualified individual designated by the latter. 5.2.4. Under no circumstances should it be possible for radioactive materials to be delivered and left unattended, without the knowledge of an authorized person. 5.2.5 The MNH/I Receiving (Stores) Department personnel and Security personnel are instructed to call the RSO when radioactive material of unknown destination within the MNH/I arrives. ??? 5.2.6 If any delivery is made during holidays or off-duty hours, only MNH/I Security personnel can accept it. The on-duty Security Officer has a key to the appropriate storage room (central waste storage facility in the basement, room #045) and is instructed to leave incoming radioactive packages there under lock and key. The Responsible Radiation User should then be informed as soon as possible. 5.3 Storage of Radioactive Material 5.3.1 All radioactive material (activity > 1EQ) must be kept in appropriately shielded containers that carry a label indicating the name of the radionuclide (e.g., 32P), its activity (e.g., 50MBq) and date of the assay (determination) of the activity (e.g., May 20 th, 2003). The label has to have the exact appearance (color and wording) of the symbol shown in Fig. 5.3.1a below. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on Sept. 19 th, 2006 Page 3 of 4 5. Purchase, Reception, Storage and Transfer of Radioactive Material 5.3.2 All containers with radioactive material must be stored in a safe area, compartment or facility, which must be lockable. (Freezers located in hallways, if permitted by the Fire Marshal, that contain radioactive materials must be lockable). The storage area has to be identified with the proper radiation warning sign shown in Fig. 5.3.1a (symbol and writing - “RAYONNEMENT – DANGER – RADIATION” - in black or magenta on a yellow background) if: a) more than 100 exemption quantities (see Appendix 15 for a list of exemption quantities) of a radioactive substance are stored in the area, or b) there is a reasonable probability that a person in the area will be exposed to an effective dose rate greater than 25µSv/hr (2.5mR/hr). 5.3.3 The storage location or facility must have sufficient shielding to reduce the radiation level to no more than 25µSv/hr (2.5mR/hr) in areas accessible to Nuclear Energy Workers only, and to a level not exceeding 2.5µSv/hr (0.25mR/hr) in areas accessible to other persons. 5.3.4 It is strictly forbidden to store or to consume any kind of food or beverage in an area where radioactive material is used or stored. 5.3.5 Gaseous radioactive materials must be kept in a designated fume-hood provided with adequate ventilation. Figure 5.3.1a: Official Radiation Warning Signs Figure 5.3.1b: Unofficial Radiation Warning Sign Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on Sept. 19 th, 2006 Page 4 of 4 5. Purchase, Reception, Storage and Transfer of Radioactive Material 5.4 Transfer of Radioactive Material and Devices 5.4.1 The following instructions have to be observed when transferring radioactive material or radiation devices (i.e., a piece of equipment that permanently incorporates a radioactive substance) to recipients elsewhere in Canada: a) b) c) d) 5.4.2 It is the sender’s responsibility to make sure that the recipient has a valid CNSC license to accept the shipment. Valid leak test results have to be sent to the recipient of sealed sources. Transfer records including date of transfer, the recipient’s license #, name and address, make, model, serial # and name of nuclear substance or source as well as its activity with date of assay have to be maintained. Only certified radiation devices may be transferred to other users within Canada. At the MNH/I, in addition to the above regulations, the following instruction has to be adhered to: The RSO has to be informed of any intent by a responsible radiation user to transfer a radioactive source (or device) to a third party at least one month prior to the planned shipping date, and then again at least 24hours before the actual time the shipment is scheduled to leave the MNH/I. Nonobservance of this obligation may lead to a temporary suspension of the sender’s internal license. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 24 th, 2006 Page 1 of 5 6. Radiation Monitoring 6. Radiation Monitoring 6.1 General Principles Monitoring of dose, dose-rate and internal contamination is an essential component of any program of radiation safety. Such monitoring takes four forms: a) Area monitoring, i.e., measurement of radiation dose or dose rate at various points in a laboratory, room or department where sources are stored, handled and applied. b) Procedure monitoring, i.e., measurement of radiation dose or dose rate received by specific individuals and/or at specific locations, during particular procedures involving radiation sources. c) Personnel monitoring, i.e., measurement of the total dose received by individual workers (mandatory for Nuclear Energy Workers) over a period of time. d) Monitoring of internal radioactivity to determine the level of gamma-emitting radioisotopes ingested by workers. In addition, medical surveillance is an adjunct to radiation monitoring, especially where over-exposure is known or suspected. Another type of monitoring is concerned with radioactive contamination of laboratory surfaces, equipment and personnel. These procedures are considered in Chapter 10. 6.2 Area and Procedure Monitoring The responsibility for these types of monitoring rests with the Radiation Safety Officer. It is his/her duty to carry out, either directly or by delegation, whatever surveys and measurements are needed to ensure that room and equipment shielding are adequate to ensure a proper standard of radiation safety. Responsible Radiation Users, heads of departments, departmental radiation supervisors and individual Nuclear Energy Workers have the duty to collaborate with the RSO in this task and, in particular, to draw the RSO's attention to any situation or procedure that warrants special investigation. In addition, Responsible Radiation Users and/or heads of departments and departmental radiation supervisors have the responsibility of carrying out whatever recommendations are made as a result of such investigations. 6.3 Personnel Monitoring Nuclear Energy Workers are subject to routine, continuous monitoring of the radiation dose received from external sources by means of a Thermoluminescent Dosimeter (TLD) badge. TLDs are the official dosimeters for dose measurements for external beta and gamma radiation and must be worn by Nuclear Energy Workers. Radiation exposure monitoring with TLDs may be performed on any individual handling radioactive substances or devices, or working in the vicinity of sources of radiation, in mutual agreement between the worker and the RSO. The dosimeter service at the MNH/I is provided by the National Dosimeter Service (NDS) of the Radiation Protection Bureau (RPB) of Health Canada, which Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 24 th, 2006 Page 2 of 5 6. Radiation Monitoring is a service of the Federal Ministry of Health and Welfare. The RPB is a provider of dosimetry services recognized by the CNSC. Depending on the service requested by the various radiation users, TLDs are provided periodically by the RPB at intervals of ½, 1 or 3 months. The distribution within the Hospital and the Institute is undertaken by the RSO and/or his/her assistant. The TLD service for Radiology at the MNH/MUHC is handled by the manager of this department via the MUHC. He also sends a copy of the exposure reports to the RSO. Exposed TLDs are read and records maintained by the RPB as well as by the RSO. Exposure reports are examined by the RSO and any unusually high doses are subject to investigation by the RSO. Formal action levels (ALs) have been established for NEWs working at the Medical Cyclotron Facility and in the PETSuite (Nuclear Medicine) of the MNH/I. The informal internal action level for all other radiation users is background level, for on very rare occasions only do their doses exceed background levels). What is a radiation badge? The radiation badge (TLD) consists of two square elements which are made of lithium fluoride (LiF) mounted on a removable metal insert. The TLD element with the very thin aluminized Mylar light shield detects beta radiation. This element measures the shallow equivalent dose, or the surface or skin dose. The other element is covered by a layer of aluminum, a radiation attenuator, whose thickness is equivalent to 1cm of tissue. This element measures the equivalent dose at a depth of 1cm or more in tissue, usually called the body dose (H10). A reading of the skin dose (H07) is obtained with the same TLD. Lithium fluoride is a thermoluminescent compound. When a thermoluminescent material is exposed to ionizing radiation, some electrons freed by ionization get enough energy to move through the crystal lattice. Some of the free electrons get trapped in imperfections in the crystal lattice where they remain until subjected to high temperatures. Upon heating, the trapped electrons are evicted and promptly undergo recombination, releasing their surplus energy in the form of light. The light emitted is measured with photo-tubes. The amount of light emitted is proportional to the number of trapped electrons, which in turn is proportional to the dose received by the individual wearing the TLD. Wearing a radiation badge does not protect the wearer from radiation - it is merely a means of monitoring the radiation each individual is exposed to. See Appendix 14b (Proper Care and Use of Personal Dosimeters) for more details on the proper use of TLDs. Remember and practice the three rules for radiation safety in the workplace: 1) minimize exposure time 2) maximize the distance from the radiation source (remember: the radiation intensity drops as the inverse square of the distance between the source and the worker) 3) use adequate shielding to keep your exposure levels low Who needs a TLD radiation badge? TLDs have an important inherent limitation in that they are insensitive to weak beta radiation such as that from H-3, C-14 and S-35. Personnel who work in labs which use only these isotopes do not need dosimeters. They might, however, be subject to other forms of radiation monitoring (see paragraph 6.4 on bioassays). Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 24 th, 2006 Page 3 of 5 6. Radiation Monitoring A TLD radiation badge is appropriate if: 1) you use radioisotopes other than H-3, C-14 and S-35 in your work 2) you work with more than 50MBq (~ 1.5mCi) of P-32; in this case you also need an extremity (finger) ring TLD monitor as required by CNSC regulations (remember to wear the ring monitor such that the TLD crystal faces the palm of the hand where the handled radioisotope is closest ). your work-space is located in close proximity to an area where substantial amounts (> 370 MBq ) of radioisotopes (other than H-3, C-14 and S-35) are regularly being used. you are pregnant and have chosen to continue working in an environment where you may be exposed to radiation. 3) 4) A TLD monitor may be obtained from the RSO upon completion of the “TLD Monitor Application” form (see Appendix 4b). 6.3.1 6.3.2 The individual Worker or Nuclear Energy Worker is responsible for: a) taking good care of the monitor at all times (the RPB charges $75.00 for a lost or damaged TLD) b) wearing the monitor at work whenever there is a possibility of exposure to radioactivity. The monitor is best worn at chest height. When a lead apron or protective clothing is worn, the monitor should be carried under the apron, since its job is to record the radiation reaching the body, not the radiation reaching the apron c) guarding the monitor as a personal monitor, issued to a named individual. Under no circumstances may a monitor be loaned to another person or otherwise used to record doses received by more than one individual d) taking care that the monitor does not accidentally drop onto the floor or onto any place (e.g., a radiographic table) where it might accidentally become exposed to a direct radiation beam e) taking care that the monitor is not accidentally splashed or otherwise contaminated by a radioactive solution f) taking care that, outside working hours, the monitor is left in a safe place which is well away from any radiation source and from any source of intense heat, including a radiator. (See Appendix 14b for information about proper use and care of personal dosimeters) Personnel monitoring of the type described in the previous two sections is a satisfactory general indicator of whole-body dose due to external X or gamma-radiation. However, the externally worn TLD has some important limitations: a) it does not record the additional dose received by the hands, limbs or face in some procedures. b) it does not record exposure arising from ingestion or inhalation of radioactive materials. c) it does not record doses due to low-energy beta rays such as those from tritium, carbon-14 and sulphur-35. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 24 th, 2006 Page 4 of 5 6. Radiation Monitoring d) it does not record doses due to neutrons. However, special neutron monitors are available from the RBP upon request. (The decision to monitor neutron doses should be made by the RSO in consultation with the departmental radiation supervisor). 6.4 Monitoring of Internal Radioactivity requires the setting up of special sensitive equipment for external counting of gamma radiation from radioisotopes deposited in the body. As an example the routine measurement of radio-iodine uptake in the thyroid is carried out by using a calibrated thyroid rate meter capable of detecting at least 1kBq of I-125 or I-131 (license condition 2600). Calibration phantoms to verify the sensitivity of the rate meter are available from the RPB. Workers in this category should be monitored as stipulated in the license conditions on bioassays (e.g. license conditions 2046-7, 2600-1 and 2601-4 for thyroid monitoring). 6.4.1 Who should be bio-assayed? 2) A bioassay program is required for radiation users who work with significant amounts of volatile radioiodine in a soluble, inorganic form or in organic form which can be metabolized in the body to produce iodide. Activity levels above which bioassay for iodine-125 and iodine-131 (see Appendices 14k and 14l for further safety information) is required within 5 days following exposure (CNSC license condition 2046-7): Type of operation or event Activity handled (or involved) at a single time Processes carried out in open room >5MBq (135 Ci) Processes carried out in fume hood >50MBq (1.350mCi) Processes carried out in a glove box >500MBq (13.5mCi) Any CNSC-approved containment Any CNSC-approved quantity Involvement in spill >5MBq External contamination on body Any activity (135 Ci) Pregnant workers should not be allowed to handle volatile radio-iodine. 2) see CNSC documents C-58, C-201 and R-58 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: January 24 th, 2006 Page 5 of 5 6. Radiation Monitoring 6.5 Medical Surveillance 6.5.1 A Nuclear Energy Worker whose dose in the preceding 12-month period, as evidenced by personnel exposure records, exceeds 50mSv must undergo a medical examination. This is also required in case of accidental over-exposure (real or suspected) of radiation or non-radiation staff or members of the public. Where the over-exposure is severe, i.e., 200mSv or more, a cytogenetic examination is required. (Recommendations by the RSC). 6.5.2 The CSST (Commission de Santé et Sécurité au Travail) has the authority to require the temporary suspension of an employee from work involving the possibility of radiation exposure and the transfer of the employee to other duties. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 1 st, 2006 Page 1 of 3 7. Collection and Disposal of Radioactive Waste 7. Collection and Disposal of Radioactive Waste 7.1 General Principles The use of radio-nuclides or radio-pharmaceuticals usually gives rise to radioactive waste which has to be disposed of in an authorized and safe manner. The waste may include residual amounts of the original radio-nuclides, generators of short-lived radio-nuclides, disposable containers (vials, etc.), radioactive samples, contaminated solids and radioactive animals. The method of disposal depends on the nature and activity of the waste, in particular on whether the waste is solid or liquid, is chemically toxic, and contains sufficient radioactivity to render it a potential hazard. With the transition from the AECB to the CNSC in June 2000, the rules on radioactive waste disposal also have changed. For example, the Scheduled Quantity approach is no longer valid. 7.2 Collection and Storage of Radioactive Waste in the Laboratory The collection and storage of radioactive waste in the laboratories and/or collection center of the MNH/I (metal cage in room B045) must be carried out according to the principles of radiation safety. As of March, 2004, the MNH/I has adopted McGill’s computerized Radio-Isotope Tracking System (RTS) which is administered by the Waste Management Facility (call ext. 5066 for information). Strict adherence to the rules governing this system is required by all radioisotope users. 7.2.1 In each laboratory, an area must be designated for the temporary storage of waste, preferably well out of the usual traffic. Use proper radiation warning signs to outline this area (depending on the activity, the regular sign, Fig. 5.3.1a, or the unofficial black sign on white background, Fig. 5.3.1b, may be used). 7.2.2 Laboratories are provided with labeled solid and liquid waste containers from the McGill Waste Management Facility (call your RSO or ext. 5066 if supply is short). The empty containers are available from the central radioactive disposal area in the basement (room B045). The key to this room has to be signed out from the security front desk on the first floor. 7.2.3 Storage of radioactive waste must conform to the guidelines stated in 5.3.3. (Adequate shielding must be used.) 7.2.4 Radioactive liquids must be placed in white plastic containers (1 or 4 liter). Radioactive solids must be placed in the cardboard boxes (dry solid waste) or white plastic containers (if only small amounts of waste present, but do not mix solid and liquid waste). Note: In order to save money and valuable public waste storage space, the McGill WMF will store radioactive waste according to half-life and will let decay the short-lived radio-isotopes until they are no longer considered a radiation hazard and may be disposed of via regular garbage. The radio-isotopes falling in this category are: P-32, P-33, S-35 and I-125. In order to assist the McGill WMF in this effort, it is essential that you use separate containers for each of these four radioisotopes. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 1 st, 2006 Page 2 of 3 7. Collection and Disposal of Radioactive Waste Do not mix containers and tag them properly. Remember, one container, one isotope! The adoption of McGill’s computerized Radio-Isotope Tracking System (RTS) facilitates this process. 7.2.5 Spill trays or absorbent material must be placed under each waste container in the labs. 7.2.6 Liquid scintillation vials (well capped!), whether bio-degradable or not, go into large metal drums (kept in the central storage area) with the abbreviation “LSV” written on the lid. The inventory attached to the lid of the barrel has to be filled in (disposal date, radionuclide and approximate activity). Users of liquid scintillation counting are urged to use water-miscible bio-degradable scintillation fluids unless there is a good reason for not doing so. 7.2.7 Identification labels on each container, listing the activity and radionuclide contained within, as well as the name of the Responsible Radiation User and the date the activity was measured, have to be completed in full. In particular, the RTS number (generated by the RTS program) has to be written onto each waste container. 7.2.8 Only properly identified containers will be picked up. The RTS number of each container brought to the central collection area has to be transcribed into the log book placed on the LSV barrel. (The driver collecting the waste will use this log book to indicate which containers had been collected on which date). 7.2.9 Pointed materials should be put in containers (sharps) identified with a yellow label. As soon as the containers become full, they should be delivered to the central collection area located in the basement of the MNI, room B045. and disposed of following RTS rules. Keys to the radioactive waste storage room B045 are available upon signing a book, at the front desk (security, main floor) 24 hours a day, 7 days a week. 7.2.10 Do not overfill containers in order to avoid spills that might occur during handling and transfer of waste containers. Make sure you remove all radiation warning signs from waste items of any kind. 7.3 Disposal of Radioactive Waste from the Central Collection Area 7.3.1 Disposal of Regular Solid, Liquid or Gaseous Radioactive Waste Since the coming into effect of the new Nuclear Safety and Control Regulations in June 2000, the RSC has decided that, at the MNH/I, all radioactive waste shall be disposed of via the McGill Waste Management Facility (phone: 398-5066), which also supplies the containers. No radioactive waste shall be disposed of via regular garbage, sewer or ventilation systems, except for: 1) 2) 3) rinsing water from the final washing of radioactive utensils after initial cleaning residual minor fumes from the storage of volatile radioactive material in fume hoods limited quantities of short-lived radioactive gases from the medical cyclotron facility (see Safety Report for Cyclotron Facility) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 1 st, 2006 Page 3 of 3 7. Collection and Disposal of Radioactive Waste 4) regulatory quantities of radioactive waste as specified in the CNSC license. Before applying the provisions made in the individual CNSC licenses for the use of the public garbage, sewer and atmospheric routes for disposal of radioactive waste, the RSO should be consulted, since the lawful application of these provisions requires the knowledge and observation of additional data with regard to the quantities of radioactive waste generated at the MNH/I. 7.3.2 Disposal of Animal Carcasses Radioactive animal carcasses are also picked up by the McGill Waste Management Facility. Laboratory workers who want to get rid of a radioactive animal carcass must insert the carcass into two (2) plastic bags with an identification tag attached, displaying the name of the Responsible Radiation User (lab director), the isotope used and its activity, and the date when the animal was killed. The carcass is then brought to the freezer of the Animal Quarters, located on the eighth floor of the Penfield Wing of the MNH/I. The carcass will be stored there along with bio-hazardous waste and non-radioactive carcasses until they are picked up. The Animal Quarters have controlled access, but workers of the facility will provide access to the freezer from 8h30 to 16h30. 7.3.3 The identification tag provided by the McGill Waste Management Facility, if used alone, specifies the waste as Class I under the Canadian Transport Commission Regulations (i.e., Category I). Therefore, the Responsible Radiation User must ensure that the dose rate at the surface of each container leaving the laboratory is less than 5µSv/hr. If this condition is not met, then Category II or Category III labels must be attached to the container. See section 5.2. 7.4 Disposal of Irregular Radioactive Waste On rare occasions, you might have to get rid of a piece of equipment that had served for radiation-related purposes (e.g., a centrifuge, a target box from the cyclotron etc.) and therefore might be radioactive. In this case, contact your RSO. It will be absolutely essential to remove all radiation warning signs from the piece of equipment should it be decided that the item may be discarded as a non-radioactive object (regular garbage, scrap yard etc.). This also applies to empty shipping containers that served to send the various radioactive substances to your laboratory. It is essential that you remove all radiation warning labels from such containers once they no longer contain any radioactive material. Non-compliance with this directive will correctly be criticized by CNSC inspectors as “frivolous“ use of radiation warning signs. Non-contaminated (wipe tested!) empty lead containers may be placed in the container labeled “ lead pigs” put in the waste storage cage from time to time (room B045); or arrangements may be made with the supplier who might take the containers back for recycling. Remember, lead cannot be disposed of via regular garbage! Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 1 of 3 8. Safety Guidelines for Diagnostic Radiology 8. Safety Guidelines for Diagnostic Radiology The guidelines in this section are based on Safety Code 20 A, prepared by the Radiation Protection Bureau of the Federal Ministry of Health and Welfare, and a draft version of the “Guide Normatif en Radioprotection Hospitalière (Radiologie Diagnostique)” of the Quebec Ministry of Health and Social Services. 8.1 General Recommendations 8.1.1 X-ray equipment must be operated only by properly trained individuals. 8.1.2 An x-ray room must not be used simultaneously for more than one radiological investigation. 8.1.3 All personnel must take full advantage of the protective devices available. 8.1.4 No person whose presence is not essential for the investigation may be in an x-ray room when an exposure is carried out. 8.1.5 Personnel must at all times keep as far away from the useful beam as is practicable. Exposure of personnel to the useful beam must never be allowed unless the beam is adequately attenuated by the patient and by protective clothing or screens. 8.1.6 Operators should remain inside the control booth or behind protective screens when making an x-ray exposure. If, for special reasons, this is impractical, protective clothing must be worn. 8.1.7 When there is a need to support children or weak patients, holding devices should be used. If parents, escorts or other personnel are called to assist, they must be provided with protective aprons and gloves and be positioned so as to avoid the useful beam and to minimize exposure to scattered radiation. No one person should regularly perform these duties. 8.1.8 All entrance doors to an x-ray room, including patient cubicle and preparation room doors, should be kept closed and secured while a patient is in the room. 8.1.9 An x-ray tube housing must not be held by hand during operation. 8.1.10 X-ray machines which are energized and ready to produce radiation must not be left unattended. 8.2 Recommendations for Operation of Radiographic Units 8.2.1 The x-ray exposure should, as a general rule, be controlled from the control panel located inside the control booth or behind a shielded wall. For techniques requiring the operator to control the exposure while at the side of the patient, appropriate protective clothing must be worn. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 2 of 3 8. Safety Guidelines for Diagnostic Radiology 8.2.2 The operator must have a clear view of the patient during every exposure and be able to communicate with the patient and/or attendants without leaving the control booth. 8.2.3 Film cassettes must never be held by hand during an exposure. 8.3 Recommendations for Operation of Fluoroscopic Units 8.3.1 All persons required to be in the room during a fluoroscopic procedure should wear protective aprons. Lead shields or curtains mounted on the fluoroscopic unit must not be considered a sufficient substitute for protective clothing. 8.3.2 Protective gauntlets should be worn by the radiologist during every fluoroscopic examination. During fluoroscopy, palpation with the hand should be kept to a minimum. 8.3.3 During fluoroscopy and spot film operation, associated personnel required to be at the side of the patient must wear appropriate protective clothing. 8.3.4 All fluoroscopic examinations should be carried out as rapidly as possible and with minimum dose-rate and x-ray field size compatible with the diagnostic requirements. 8.4 Recommendations for Operation of Mobile Units 8.4.1 Mobile units shall be used only if the condition of the patient is such as to make it inadvisable for the examination to be carried out with a permanent unit in the main x-ray department. 8.4.2 During operation, the primary beam should be directed away from other occupied areas if at all possible, and every effort must be made to ensure that the beam does not irradiate any other person in the vicinity of the patient. 8.4.3 The operator must stand at least 3 meters from the x-ray tube and out of the direct beam. 8.4.4 The operator should wear a leaded apron when exposures are made. 8.4.5 In a capacitor discharge unit (if still in use), a residual charge is left in the capacitors after an x-ray exposure has been made. This charge can give rise to a "dark current" and result in x-ray emission even though the exposure switch is not activated. The residual charge must therefore be fully discharged before the unit is left unattended. 8.5 Recommendations for Special Radiological Procedures 8.5.1 In these procedures, the radiologist and other personnel in the vicinity of the patient can be subjected to appreciable scattered radiation from the patient when the x-ray beam is on. The radiologist and other personnel should wear protective glasses and clothing and remain as far away from the patient as practical. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 3 of 3 8. Safety Guidelines for Diagnostic Radiology The protective devices (e.g., shield panels, leaded drapes, extended collimator cones, etc.) provided with the x-ray equipment should be used whenever they do not interfere unduly with the diagnostic procedure. The smallest x-ray field consistent with the procedure should be used. When possible, pulsed fluoroscopy should be used. 8.5.2 Angiography: Angiography is potentially one of the main sources of exposure to personnel in diagnostic radiology, since it requires the presence of many personnel close to the patient and involves fluoroscopy for extended periods of time and multiple radiographic exposures. For such procedures, all personnel must be aware of the radiation hazards involved and make every effort to adhere to the recommendations below: a) Full use must be made of the protective devices provided with x-ray equipment (e.g., shielded panels, leaded drapes, bucky slot covers, etc.). b) All personnel must wear protective clothing and personal dosimeters, which might include head and hand (finger ring type) dosimeters. Protective glasses should also be worn. c) All personnel who are not required to be immediately adjacent to the patient when the radiation beam is activated must stand back as far as possible and, if at all possible, behind a protective shield. d) When possible, pulsed fluoroscopy should be used. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 1 of 5 9. Procedures for Minimizing Dose to Patients 9. Procedures for Minimizing Dose to Patients The following recommendations for the protection of the patient are directed toward the physician, the radiologist, and the operator. They provide guidelines for the elimination of unnecessary radiological procedures and for minimizing exposure of patients to radiation when a radiological examination is indicated. 9.1 Guidelines for the Prescription of Diagnostic X-Ray Examinations The medical practitioner is in a unique position to reduce unnecessary radiation exposure to the patient by eliminating examinations that are not clinically justified. The practitioner can achieve this by adhering, as far as possible, to the following recommendations: 9.1.1 The prescription of an x-ray examination of the patient should be based only on a clinical evaluation of the patient and should be for the purpose of obtaining diagnostic information or carrying out specialized interventional procedures. 9.1.2 Routine or screening procedures, such as for pre-employment examinations, tuberculosis or mass mammographic screening etc., in which there is no prior clinical evaluation of the patient, should not be prescribed. 9.1.3 The practitioner shall determine whether there have been any previous x-ray examinations that would make a further examination unnecessary, or would allow the ordering of an abbreviated examination. The previous radiographs should be examined along with a clinical evaluation of the patient. 9.1.4 When a patient is transferred from one physician or hospital to another, any relevant radiographs should accompany the patient and should be reviewed by the consulting physician. 9.1.5 When prescribing a radiological examination, the physician should specify precisely the clinical indications and information required. 9.1.6 The number of radiographic views required in an examination should be kept to the minimum consistent with the clinical objectives of the examination. 9.1.7 In prescribing an x-ray examination of a pregnant or possibly pregnant woman, full consideration should be taken of the consequences of fetal exposure. (See section 9.2) 9.1.8 If the radiograph contains the required information, repeat exposures should not be prescribed simply because a radiograph may not be of the "best" diagnostic quality. 9.1.9 Specialized studies should be undertaken only by, or in close collaboration with, a qualified radiologist. 9.1.10 Staff must not operate x-ray equipment, or be responsible for the use of such equipment, unless qualified to do so (i.e., physicians or members of the ORTQ). Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 2 of 5 9. Procedures for Minimizing Dose to Patients 9.1.11 Radiographs must be monitored routinely to ensure that they satisfy diagnostic requirements with minimal patient exposure. 9.1.12 A patient's imaging record should include details of all x-ray examinations carried out (e.g., kV & mAs) 9.2 Guidelines for Radiography in Pregnant Women The following recommendations apply to x-ray examinations involving pregnant or potentially pregnant women. 9.2.1 Only essential investigations should be undertaken in the case of a pregnant or suspected pregnant woman. 9.2.2 Elective radiography of the abdominal and pelvic area in a pregnant woman must be avoided. ("Elective" is taken to mean an examination of the abdomen and pelvis that does not contribute to the diagnosis or treatment of a female patient in relation to her immediate illness.) 9.2.3 When radiography of the pelvic area or abdomen is required, the exposure must be kept to the absolute minimum necessary and full use must be made of gonadal and other protective shielding if the clinical objectives of the examination will not be compromised. 9.2.4 If a radiographic examination of the fetus is required the prone position should be used. This has the effect of shielding the fetus from the softer x-rays and hence reducing the fetal dose. 9.2.5 Radiography should not be used for the determination of abnormal presentations of the fetus or for placental localizations. Other techniques such as ultrasonography are better suited for this purpose and are less hazardous. 9.2.6 Radiography of the chest, extremities, etc., of a pregnant woman, for valid clinical reasons, should only be carried out using a well-collimated x-ray beam and with proper regard for shielding of the abdominal area. 9.3 Recommendations for Reducing Gonadal Dose to the Patient Radiologists and technologists must pay special attention to four factors that are important for reducing gonadal dose to the patient. 9.3.1 Correct collimation of the x-ray beam. It is insufficient merely to limit the beam to the size of the image receptor: care should be taken to further restrict the beam to the region of the patient's body that is of diagnostic interest. Irradiation of any part of the body outside that region contributes nothing to the examination and increases the dose to the body and to the gonads. 9.3.2 Gonadal shields. Appropriate use of specific-area gonadal shielding is strongly advised when: a) the gonads of necessity lie within, or are in close proximity to, the primary x-ray beam; b) the patient has reproductive potential; and Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 3 of 5 9. Procedures for Minimizing Dose to Patients c) clinical objectives will not be compromised. 9.3.3 Appropriate selection of technique factors. An appropriate selection of tube voltage, current and filtration, is particularly important for diagnostic procedures in which the gonads lie within or near the primary x-ray beam. For example, in fluoroscopy, use of higher tube voltage and filtration and lower tube current will almost always reduce the gonadal dose. 9.3.4 Sensitivity of imaging systems. The gonadal dose is inversely proportional to the sensitivity of the imaging system. Thus, doubling the sensitivity halves the gonadal dose; conversely, halving the sensitivity doubles the gonadal dose. It is therefore very important to maintain the sensitivity of the imaging system at its optimum value and to be alert for any significant deterioration. In this sense, semi-dark adaptation for image-intensified fluoroscopy is important. 9.4 Guidelines for Carrying Out X-Ray Examinations The recommendations that follow are intended to provide guidance to the operator and radiologist in exercising their responsibility towards reduction of patient exposure. 9.4.1 General Recommendations a) The operator must not perform any examination which has not been prescribed by the physician responsible for the patient. b) The exposure of the patient must be kept to the lowest practicable value, consistent with clinical objectives and without loss of essential diagnostic information. To achieve this, techniques appropriate to the equipment available should be used. c) Particular care, consistent with recommendations of Section 9.2, must be taken when radiological examinations of pregnant or potentially pregnant women are carried out. d) The x-ray beam must be collimated so as to restrict it as far as practicable to the area of diagnostic interest. e) The x-ray beam size must be limited to the size of the image receptor or smaller. f) The x-ray beam should not be directed towards the gonads unless it is absolutely essential, in which case gonadal shielding is strongly advised. g) Shielding should be used where appropriate and practicable to limit the exposure of body tissues. It is particularly important that a special effort be made to protect the blood-forming organs, gonads and thyroids of children. h) The target-to-skin distance should be as large as possible, consistent with good radiographic technique. i) For young children, special devices should be employed to restrict movement. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 4 of 5 9. Procedures for Minimizing Dose to Patients j) 9.4.2 Full details of the radiological procedures carried out should be noted on the patient's imaging records. Recommendations for Radiographic Procedures a) The edges of the x-ray beam should be seen on all x-ray films to ensure that no more than the desired area has been irradiated. The film size used should be as small as possible, consistent with the diagnostic objectives of the examination. b) Screen-type film should not be used for non-screen techniques because it is less sensitive to direct x-radiation than non-screen film. c) The fastest film or intensifying screen-film combination, consistent with diagnostically acceptable results, should be used. When highest definition is not required a high-speed film-screen combination should be used. X-ray intensifying screens made from rare earth phosphors should be used where appropriate. d) To ensure that patient exposure is kept to a minimum consistent with image quality, full advantage should be taken of a combination of techniques such as: - use of an anti-scatter grid between the patient and the image receptor. - use of the optimum focus-to-film distance appropriate to the examination. - use of the highest kilovoltage that produces films of good quality. - use of automatic exposure control devices designed to keep all exposures and repeat exposures to a minimum. e) The radiographer should see the films after processing in order to verify that the techniques being used are producing diagnostic quality films and that the x-ray equipment is functioning correctly. f) Before taking a long series of films, it is particularly important to avoid the need for retakes by taking and processing a preliminary film in order to verify the correctness of the machine settings. 9.4.3 Recommendations for Fluoroscopic Procedures a) In view of the relatively high exposure that results from fluoroscopy, such procedures should not be carried out when an equivalent result can be obtained from radiography. Fluoroscopy must not be used as a substitute for radiography. b) Fluoroscopy must only be carried out by, or under the immediate supervision of, a radiologist or physician properly trained in fluoroscopic procedures. c) A fluoroscopic procedure should be carried out as rapidly as possible with the smallest practical x-ray field size. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 2 nd, 2006 Page 5 of 5 9. Procedures for Minimizing Dose to Patients d) The exposure rate used in fluoroscopy should be as low as possible and must not exceed 5 Roentgens per minute at the position where the central axis of the x-ray beam enters the patient. e) The ambient light level in the fluoroscopic room should be set as low as possible. f) Image intensification must be used in order to reduce patient exposure. Image intensifiers can significantly reduce both exposure rate and exposure time. However, the operator must monitor the x-ray tube current and voltage on equipment with automatic brightness control, since both can rise to high values without the knowledge of the operator, particularly if the gain of the intensifier is decreased. g) Television monitoring should be used in conjunction with the image intensifier. h) Mobile fluoroscopic equipment should be used only for examinations where it is impractical to transfer patients to a permanent fluoroscopic installation. i) Whenever possible, pulsed fluoroscopy should be used in order to reduce the dose to the patient and the operator. 9.4.4 Recommendation for Special Procedures a) Significant exposure to the patient's eyes can result from neurological radiography, such as carotid angiography. An eye shield, therefore, should be used in projections where it does not interfere with the diagnostic information sought. b) During angiography, significant exposure of the patient's thyroid gland can occur. Appropriate shielding should be used whenever possible. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 3 rd, 2006 Page 1 of 4 10. Use of Unsealed Radioisotopes 10. Use of Unsealed Radioisotopes 10.1 General Principles 10.1.1 The internal permit holder shall ensure that only persons who are properly trained in work with radioactive materials and informed of the hazards involved are allowed to handle radioisotopes. Any other individual who handles radioactive material shall do so only temporarily (until her/his training is completed), and under the supervision of a trained person. 10.1.2 A copy of the relevant Internal Permit shall be prominently displayed on the permit holder's premises in each location where radioactive substances are handled or stored, while the consolidated license from the CNSC is kept by the RSO. 10.1.3 A copy of the proper CNSC poster with the subtitle “Use of Unsealed Nuclear Substances” shall be prominently displayed in each laboratory where radioisotopes are used. This poster has to correspond to the level of radioactivity being used in the area of the laboratory under consideration. The Classification of Areas is specified in the corresponding CNSC license and reads as follows: Each area where more than one exemption quantity (EQ) is used at a single time shall be classified as: a) basic-level if the quantity does not exceed 5 ALI b) intermediate-level if the quantity used does not exceed 50 ALI c) high-level if the quantity does not exceed 500 ALI d) containment-level if the quantity exceeds 500 ALI e) special purpose area, e.g. Nuclear Medicine The Annual Limit on Intake (ALI) is a quantity that has to do with the radiation dose from ingestion or inhalation of a specific radioisotope and its relation to accepted radiation dose limits. More on the ALI may be found in ICRP Publication 61, where a table of ALI values for the majority of radio-isotopes is given. A summary of ALI and EQ values for the most frequently used radio-isotopes is also given in Appendix C to CNSC License Application Guide C-237 as well as in Appendices 15, 16 and 20 of this manual. 10.2 Classification of Laboratories 10.2.1 Based on the above classification, in laboratories falling into the basic-level category, the “Basic Level” poster (INFO-0728-1) shall be shown. For areas in the intermediate-level category, the “Intermediate Level” poster (INFO-0728-2) applies and for high-level areas, the “High Level” poster (INFO-0728-3). Finally, a room is classified as “Nuclear Medicine” for the use of unsealed nuclear substances where diagnostic or therapeutic nuclear medicine procedures are performed. In these rooms, the “Nuclear Medicine” poster (INFO-0728-4) has to be displayed. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 3 rd, 2006 Page 2 of 4 10. Use of Unsealed Radioisotopes Copies of the four posters mentioned above are included as Appendices 14e, 14f , 14g and 14h of this manual. 10.2.2 Any laboratory or area in which unsealed radioisotopes are stored, handled, or used shall be equipped in accordance with the AECB Regulatory Document R-52, Rev. 1 (June, 1991). This code, entitled "Design guide for Basic and Intermediate level Radioisotope Laboratories", details the facilities (including surface finishes, bench tops, fume hoods, air movement, floors, sinks and drains) required in laboratories designated as "Basic level", "Intermediate level" or "High level". Copies of this code are available through the RSO. (N.B: A well functioning fume hood should have an air flow with a face velocity of 80 to 100 linear feet per minute with a sash opening of 30cm). 10.2.3 Most laboratories used for tracer investigations are of the "basic level" type (i.e., essentially a good chemistry laboratory), but upgrading of such laboratories to "intermediate level" is required wherever the activity of open sources handled at any one time exceeds 5ALIs (example: a user might avoid upgrading a lab by ordering several vials containing less than 5ALIs each). 10.2.4 The maximum activity of an unsealed radioactive material that may be used in a laboratory of a given classification depends on its ALI, which is linked to the "radio-toxicity" of the radioisotope concerned and the type of procedure undertaken. Appendix 2 gives the radio-toxicity classification of various radioisotopes. 10.3 Handling of Unsealed Radioisotopes in Laboratories 10.3.1 In any laboratory where both radioactive and non-radioactive work is carried out, a separate area must be set aside and clearly designated as the "radioactive area". (Do not use the official yellow and black, or yellow and magenta, radiation warning labels for outlining this area; rather use another type of warning label, e.g., an “unofficial” black on white background radiation warning sign). 10.3.2 Smoking, eating, drinking and storage of food or drink are prohibited in any area used for storage, handling or use of radioactive material. 10.3.3 Pipetting of radioactive solutions must not be carried out by mouth. 10.3.4 Procedures involving radioactive materials should be carried out in trays or on benches lined with disposable absorbent material. Secondary containments should be used for all radioactive liquids. 10.3.5 Procedures that might produce airborne contamination (e.g. iodination with I-125 etc.) should be carried out in a fume hood. In any case, some method of containment should be adopted. 10.3.6 Procedures involving dry radioactive powdered materials should be carried out in a glove box. 10.3.7 Laboratories must be kept locked when not in use. (Freezers that are kept in the hallways, if permitted by the Fire Marshall, must be locked at all times). 10.3.8 Protective gloves and clothing must be worn at all times. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 3 rd, 2006 Page 3 of 4 10. Use of Unsealed Radioisotopes 10.3.9 10.3.10 After handling unsealed radioactive materials, and before leaving the laboratory, the operator must wash his/her hands. Equipment, tools and utensils used for work with radioactive materials should not be used for other purposes and should be surveyed for contamination prior to removal from the laboratory. 10.3.11 Wipe tests must be performed on surfaces and equipment that may become contaminated with radioactive material. These tests must be done weekly and also after each significant work-load. Records of these tests must be properly documented and filed in a log-book. In particular, areas that read three times background level have to be decontaminated and wipe-tested again ! (See Appendices 10, 11 and 17 for contamination –related topics). The following exception has been granted by the CNSC: Wipe tests are not required when working only with the following short-lived (PET) radioisotopes: C-11, N-13, O-15 and F-18. All other license conditions however apply! 10.3.12 Before any radioisotope facility is decommissioned, a radiation survey shall be performed and appropriate actions shall be taken to decontaminate any areas where the count rate is above background. At the same time, the form “Request for Decommissioning Radioisotope Laboratory” (see Appendix 13 for a copy of the form) has to be completed by the RRU and sent to the RSO. 10.3.13 Animals used in experiments involving radioactive material shall be housed in a separate enclosure and all waste, including carcasses, shall be treated as radioactive (see section 7.3.2). 10.3.14 Investigators working in the microPET laboratory and their associates or assistants - performing research studies in the microPET-Suite but not handling radioactive substances themselves - shall, in compliance with CNSC regulations, read and sign, in the presence of an authorized individual, the “microPET Investigators Radiation Safety Information Sheet “ (see Appendix 19). 10.3.15 Investigators working in the microPET laboratory and their associates or assistants shall make sure that the positron emitting radiopharmaceutical used in the experiment is transferred from the cyclotron radiochemistry facility of the MNH/I to the microPET laboratory by an authorized individual following the protocol described in the abovementioned information sheet (see Appendix 19). 10.4 Handling of Radioisotopes in the Department of Nuclear Medicine PET procedures are carried out with radio-nuclides such as: 15O (T1/2=124s), 13N (T1/2=10 min), 11C (T1/2= 20 min), and 18F (T1/2=110 min). These radio-nuclides are positron emitters and are produced by the medical cyclotron located in the basement of the MNH/I. Some of the PET tracers such as the radioactive gases 15O -CO or 15O-CO2 produced at the radiochemistry laboratory in the cyclotron facility are sent directly to the PET unit by means of a system of stainless steel tubes, so that the exposure to personnel is minimal, and the gases are utilized for imaging (inhalation studies) without delay . Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 3 rd, 2006 Page 4 of 4 10. Use of Unsealed Radioisotopes Some non-volatile compounds are also produced at the cyclotron facility. These ready-to-inject compounds, such as 18F-FDG, are shipped to the PET scanning suite via a pneumatic system. In addition to the precautions recommended in section 10.3, staff undertaking radioisotope procedures directly involving patients in the Positron Emission Tomography (PET) Unit, or elsewhere, are required to adhere to the practices outlined below. 10.4.1 Syringes or needles used for injection of radioactive material should be kept separate from those used for non-radioactive work. 10.4.2 Used syringes or needles containing residues of radioactive material should be separated from other radioactive waste. 10.4.3 Disposable gloves should be worn during preparation and during injection of radioactive material. 10.4.4 Procedures involving a radioactive gas must be carried out in such a way that no diffusion of the radioactivity into the immediate environment is possible; and these gases are dispersed into the outside environment according to the procedure described in Section 7.3. 10.4.5 PET researchers and their associates or assistants, performing PET research studies in the PET-Suite without handling radioactive substances themselves, shall, in compliance with CNSC regulations, read and sign, in the presence of an authorized individual, the “PET Investigators Radiation Safety Information Sheet“ (see Appendix 18). Remember that: lab coats must be worn at all times when working with radioactive materials; - eating and drinking is prohibited in the scanning room; - TLDs must be worn when there is possibility of exposure; - a contamination meter in good working order must be readily available in case of spills and to verify contamination; - the ALARA principle must be applied here as well. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 3rd, 2006 Page 1 of 2 11. Radiation Safety in the Wards 11. Radiation Safety in the Wards Sources of ionizing radiation may be encountered in a hospital ward in the following circumstances: 11.1 a) A mobile x-ray unit may be used in a ward for diagnostic investigation of a patient. b) An in-patient may undergo a diagnostic investigation with an unsealed radioisotope in the PET Unit (or Department of Nuclear Medicine) and be transported back to the ward. c) An in-patient may undergo an investigation using radioisotopes in certain other locations in the hospital (e.g. administration of 99mTc-HMPAO to patients in the epilepsy clinic for subsequent ictal SPECT scanning). d) An in-patient may undergo a treatment which requires the administration of an unsealed radioisotope such as the injection of P-32 in the patient's room. (N.B.: such procedures are not currently performed at the MNH/I). Use of Mobile X-ray Units in Wards The safety aspects of the use of mobile x-ray units have already been covered in chapter 8, particularly in section 8.4. It must be stressed that, when a radiographic examination is carried out in the ward, the operator must take every precaution to ensure that other patients and personnel are not irradiated by the direct beam and are sufficiently far from the patient under investigation (more than 1 meter) to reduce the dose from scattered radiation to a low level. If necessary, portable screens or lead-rubber aprons arranged as screens should be used to protect the other patients. 11.2 In-Patient Undergoing Treatment with Unsealed Radioisotopes (N.B.: this section is included for the sake of completeness only, as such procedures are not currently performed at the MNH/I). 11.2.1 Occasionally, P-32 is used for treatment, the activity being about 166.5MBq (4.5mCi). Injections might be done at the MUHC (RVH), but patients may return to the MNH/I for further evaluations, etc. 11.2.2 In-patients being treated with unsealed radioisotopes must be housed in a single-bedded room. Any patient who receives a dose exceeding 1.11GBq (30mCi) will perforce be an in-patient. 11.2.3 Before the administration of a radioactive dose, the responsible staff must ensure that the floor of the patient's bathroom and the toilet seat are covered with absorbent material. 11.2.4 The patient should be instructed to flush the toilet several times after every use. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 3rd, 2006 Page 2 of 2 11. Radiation Safety in the Wards 11.2.5 Visits to patients undergoing treatment with unsealed sources should be restricted. In particular, visits by young and/or pregnant persons should be severely curtailed. Direct contact between visitors and patients should be avoided and visitors should be instructed to remain as far as possible from the patient. The Responsible Radiation User and/or RSO will give more detailed instructions according to the individual patient and dose. 11.2.6 When surgery has to be performed on a patient who has recently received unsealed radioisotopes for therapeutic purposes, the Responsible Radiation User, in consultation with the RSO, must assess the degree of hazard arising from the activity remaining in the patient's body and advise the surgeon and operating room staff if any special precautions need to be taken. 11.2.7 A patient can only be discharged after consultation with the RSO who will ascertain that regulatory radiation dose rate limits are respected. 11.2.8 After discharge of the patient, the RSO must monitor the room and its contents before freeing the room for future use. Further instructions will be given to the ward staff by the RSO. 11.2.9 If a patient should die soon after receiving unsealed radioisotopes for therapeutic purposes, the Responsible Radiation User must be notified. He/she will then, in conjunction with the RSO, notify the pathologist and all other staff concerned of the possible existence of a hazard and of the precautionary procedures to be followed. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 1 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility 12. Procedures for the MNI/MNH Medical Cyclotron Facility 12.1 Introduction The MNI/H Medical Cyclotron produces radioactive nuclides for use in medical and biological research and nuclear medicine procedures by bombarding target materials with accelerated protons and deuterons. The nuclides so produced are transferred to the radiochemistry laboratory or "hot lab" for processing. Because of the nature of the operations, radiation as well as non-radiation hazards exist. Depending upon the particle energy and the material irradiated, high fluxes of secondary neutrons and gamma radiation may be produced. Residual radioactivity may be induced in the cyclotron structure and components and in the structural materials surrounding the cyclotron. The radioactive nuclides created by the irradiation of target materials and transferred to the hot lab may also emit significant amounts of radiation. During the handling and processing of irradiated target materials, radioactive gases or particulates may escape into the atmosphere. In addition to these radiological health hazards, non-radiation hazards such as mechanical, electrical, toxic chemical, fire and explosion hazards exist. The purpose of these safety procedures is to ensure maximum safety to all personnel in and around the Medical Cyclotron Facility. They are intended to establish and maintain correct methods of operational safety and to familiarize personnel with the potential hazards. The procedures reflect the policies and recommendations of the MNI/H Radiation Safety Committee and conform to the Regulations and Requirements of the Government of Quebec and the Canadian Nuclear Safety Commission. The procedures and instructions that are unique to the activities and operations in the facility are covered in detail in this chapter. General safety practices pertaining to the initiation and maintenance of records, radioactive material labeling, waste disposal, and non-radiation hazards are discussed only briefly. 12.2 Description of Cyclotron Facility The Cyclone 18/9, designed by IBA (Ion Beam Applications, Belgium, at the time of acquisition marketed through Siemens Medical Systems), is a negative ion machine that produces protons of 18MeV and deuterons of 9MeV at maximum beam currents of approximately 100µA and 40µA respectively. There are two radially mounted ion sources, one for each particle. Acceleration is achieved by using a magnet and RF system. It has eight external beam ports with dedicated chemistry targets. Beam may be extracted at two diametrically opposed ports simultaneously (same type of particle at both ports) which allows a very efficient operation of the facility with one port, for instance, supplying radioisotopes for PET imaging and the other one being used for radiochemistry research. The Cyclotron Radiochemistry Facility is part of the McConnell Brain Imaging Center (BIC) of the MNI. It produces selected positron emitting radioisotopes for medical research and diagnosis. By means of positron emission tomography (PET), the in-vivo investigation of (cerebral) physiological processes in humans is feasible. Cyclotron operation is highly automated, which means reduced operator intervention in the vault and, therefore, reduced radiation exposure to personnel. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 2 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility The following four positron emitting radioisotopes are produced by the Cyclone 18/9 and used for the labeling of a variety of compounds: Isotope Physical half-life (T1/2) in minutes 11 C 20 13 N 10 15 2 O 18 F 110 The above radioisotopes are used to label a variety of compounds which serve to study such quantities as cerebral blood volume, cerebral blood flow, cerebral glucose and oxygen metabolism, protein synthesis rates, cerebral enzyme activities, cognitive activities, neuro-receptor occupancies and many more. These investigations are performed on normal subjects as well as on patients. The Cyclotron Radiochemistry Facility is located at the following address: Cyclotron Radiochemistry Facility Montreal Neurological Institute 3801 University Street Montreal, P.Q., H3A 2B4, CANADA The facility occupies an area of approximately 500 m2 in total with 120 m2 being used for the cyclotron and associated equipment (control room, power supply room, transformer room) and the remainder for the chemical and radio-chemical laboratories, offices, a washroom and emergency shower, and storage area. Except for a cyclotron secondary cooling circuit remote water chiller located on the roof, the facility is wholly contained within the basement of a single building. Services are drawn from neighboring buildings. The facility places no restrictions on the development of neighboring areas. The buildings and land surrounding the facility are all owned and administered by McGill University. 12.2.1 Area Designation The cyclotron facility comprises several distinct areas. These are: 1) the vault where the cyclotron is located, 2) the Hot Lab where large quantities (Curies) of radioactive material are transformed into the various PET radiopharmaceuticals mainly using automated synthesis units and hot cells, 3) the clean room where the ready-to-inject products are prepared, 4) the quality control room for the final products, 5) radiochemistry labs for research activities, 6) chemistry labs (no radioactivity), 7) the cyclotron control room and 8) the power supply room. The cyclotron vault is a zone of "no access" (exclusion area) during accelerator operation. There are, however, two potentially high radiation areas, namely the maze entrance and the Hot Lab. duct. Both areas are marked with radioactive warning signs, and personnel avoid these areas during accelerator operation. All other areas are shielded sufficiently so that no physical access Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 3 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility control is necessary while the accelerator is operating. However, because of the nature of the work involved, the entire cyclotron facility, with the exception of the offices, is designated a limited access area. The clean room is designated a high radiation area whereas the hot lab is an intermediate level facility. The two entrances to the Facility are locked whenever operational personnel are not present in the facility. Access to the facility at other times is through the main entrance only which is kept locked at all times (ring a bell to ask for access). 12.3 Radiation Monitoring in the Cyclotron Facility 12.3.1 Radiation Surveys The purpose of radiation monitoring is to verify the existence of safe operating levels. Radiation surveys are necessary to establish these levels. Initial, or reference, surveys are performed whenever new target materials or configurations are used. They consist of the measurement of leakage radiation through vault walls while the accelerator beam is on. In this case, neutron radiation is monitored as well. Special surveys may be conducted whenever radiation hazards are suspected. Routine surveys are also performed with the beam turned off to establish reference radiation levels. These surveys involve the measurement of residual beta-gamma radioactivity in the cyclotron vault, contamination in the vault, Hot Lab and radio assay areas with the cyclotron shut off. Surveys of contamination and exposure levels in the radioactive material storage room are also performed. 12.3.2 Access Control and Personnel Monitoring The cyclotron facility is a limited access area with the exception of the offices. The cyclotron vault, the clean room and parts of the Hot Lab are high radiation areas. Access to the facility is through the main entrance (MP024) and through Room MP012 (for authorized personnel only). All entrances are locked whenever operational personnel are not in the facility. Keys to the Facility are controlled. Routine TLD badge service (body and extremity) is provided for all personnel permanently assigned to the facility. Some workers are also given electronic personal dosimeters (EPDs) with continuous digital readout and audible alarm capabilities. Visitors and temporary personnel are assigned TLD badges according to their degree of access to radiation areas. All personnel areas are controlled in accordance with the MNI/H Regulations. Occasional visitors must be accompanied by an escort who is a member of the cyclotron unit. 12.3.3 Area Monitoring (gamma radiation) Continuous monitoring of the gamma dose rate at several locations in the cyclotron facility is performed by a Remote Area Monitoring System. This system consists of three multi-range ion-chamber monitors with associated controls. These ion-chambers are permanently wall-mounted and are located inside the vault, in the Hot Lab, and on the duct leading to the roof. 12.3.4 Exhaust Air Monitoring Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 4 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility The exhaust air from the vault and from the fume hoods in the Hot Lab is monitored with an Eberline Model RMS II Continuous Air Monitor. This monitor provides continuous measurement of beta-gamma activities of air-borne particulate and gaseous components in the exhaust duct of the ventilation system. 12.3.5 Portable Survey Instruments In addition to the above radiation detection systems, the following survey instruments are available: One Berthold LB 1210B Contamination Meter One Victoreen Model 190 “Frisker” One Victoreen Thyac IV Model 290-SI Survey Meter One Victoreen 488A-511 Neutron Monitor One Siemens Mk2.2 Electronic Personal Dosimeter (EPD) One Siemens Mk2.3 Electronic Personal Dosimeter (EPD) 12.4 Safety Interlock and Warning Systems The purpose of the safety interlock and a warning system is to ensure that no person is in the vault at any time when the cyclotron is producing hazardous levels of ionizing radiation. The system is "fail-safe", i.e., if the safety procedures are followed, generation of a beam of accelerated particles is possible only when the entrance door is closed. Details on the functioning of this safety interlock are described in the cyclotron Safety Report which is on file with the CNSC. 12.4.1 Cyclotron Vault Entry and Clearance Sequence The vault-ready interlock system requires that the cyclotron operator actually enter each bay in the vault and manually reset the interlock system. This operation ensures that the operator himself/herself makes a personal examination of both bays for clearance of personnel before proceeding with beam generation. Furthermore, after cocking the second of the two vault-ready switches, the operator must leave the vault and close the safety door to the vault within the time allotted (30 seconds), or the "ready" condition of the interlock system reverts back to the "stand-by" condition, and the entire procedure must be repeated. The interlock is fail-safe in that the machine is immediately shut down if any one of the interlock switches is interrupted. Details on the operation are described in the cyclotron Safety Report. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 July 24 th, 2007 Last Revision of this Section on: Page 5 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility 12.5 Laboratory Safety Instructions 12.5.1 General Safety Practices Hazards of a general nature include fire and explosion, falls, accidents during lifting and handling of heavy equipment, electrical shock and toxic material release and dispersion. All of these topics are covered in detail in a number of regulations and publications, some of which are contained in the references at the end of this manual. The RSO, under the direction of the Director of the cyclotron facility, is responsible for the general cyclotron operational safety. He will ensure that all personnel are thoroughly familiar with the safety procedures and that all operations are conducted safely. All experiments, irradiations and processing operations will be reviewed and evaluated with regard to potential non-radiation hazards. Any operation which is considered to be unsafe will be discontinued immediately and will not be resumed until corrected and approved. Special attention has to be given to electrical hazards because of the existence of high voltage in the accelerator and its power supplies. Standard operating procedures and precautions, which are observed by all personnel, include the following: 12.5.2 1. Never perform a new servicing operation or manipulation alone for the first time. 2. Always use grounding hooks to discharge capacitors. 3. Always have grounding hooks across high-voltage sources while working on the equipment. 4. Never by-pass interlock circuits in the protective interlock system unless absolutely essential. If a by-pass is necessary, then a large sign indicating the by-pass condition must be displayed on the equipment and on the operating console. General Facility Safety 1. All personnel are required to wear TLD badges or dosimeters where required by CNSC and/or MNI/H Regulations. 2. Eating, drinking, smoking or application of cosmetics is not permitted in the laboratory areas and the cyclotron vault. 3. No food or drink storage is permitted in the radiation areas (only allowed in control room). 4. Protective clothing should be worn in all areas where the handling of radioactive materials may result in contamination. 5. Radioactive materials with substantial radiation levels should be handled with tongs and transferred and stored in approved shielded containers. 6. All radioactive materials and their containers have to be labeled in accordance with Section 5.3 of the MNI/H Radiation Safety Manual. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 6 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility 12.5.3 12.5.4 7. Transfer and control of all radioactive materials should be under the direction of the RSO or a qualified user. 8. Personnel entering exclusion areas should be instructed of the hazards and safety and emergency procedures. 9. All radioactive waste should be deposited in designated containers only and should be packaged and disposed of in accordance with Section 7 of the MNI/H Radiation Safety Manual. 10. Decontamination operations should be performed under the direction of the RSO or his qualified alternate. 11. All personnel exposed to radioactive contamination must monitor their hands, feet and clothing before leaving the contaminated area. If contamination is found, decontamination procedures must be followed before leaving the area. 12. Two cyclotron laboratory staff members should be present when the cyclotron is operated or radioisotopes are processed in the Hot Lab. Vault Safety 1. Each day at the start-up of the cyclotron, an operational check should be made of interlocks, fixed monitors and warning devices. 2. Before the cyclotron vault is secured and an irradiation begun, the target system and/or experimental arrangements should be inspected for conformity with approved safety practices, and the vault cleared of all personnel. 3. Entry into the cyclotron vault should not be permitted without the approval of the cyclotron operator. 4. Vault areas to be occupied for extended periods by personnel should be monitored with portable survey instruments prior to entry. Hot Lab Safety 1. No radioactive materials are to be washed down the floor or sink drains in the Hot Lab. 2. All materials must be packaged, labeled and monitored in accordance with approved procedures before transfer from the Hot Lab. 3. All personnel in the clean room or the Hot Lab during radioisotope processing operations must monitor their hands and feet before leaving the facility. If contamination is found, decontamination procedures must be followed. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 July 24 th, 2007 Last Revision of this Section on: Page 7 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility 12.5.5 Emergency Procedures The purpose of this plan is to provide step-by-step procedures to be followed in the event of an emergencysituation. The goal of any emergency procedure is to prevent injury if none has occurred yet in an accident and to prevent further injury if some has already occurred. Furthermore, every effort must be made to confine and control any radioactivity that may be released as a result of an accident. Safety procedures have been established in the laboratory, which are designed to reduce the possibility of an accident to a minimum; however, it is recognized that even with the most efficient safety program the possibility of an emergency situation still exists. In the Medical Cyclotron Laboratory such emergencies may arise as a result of operational accidents, natural disasters (earthquakes, floods) or civil disturbances such as riots, sabotage, vandalism. The responsibility for the safety program rests with the Director of the Medical Cyclotron Facility, Dr. M. Diksic. In the event of an emergency at least one of the following persons is to be notified. Priority of notification begins at the top of the list. NAME: MNI/H PHONE HOME PHONE 398-8526 398-8527 398-8927 398-8527 697-9489 455-1162 525-0220 669-7263 Dr. M. Diksic Mr. D. Jolly Dr. E. Meyer (RSO) Ms. M. Kovacevic All persons listed above are trained in radiation safety practices and are authorized to direct/or perform decontamination operations. Cyclotron personnel should be familiar with the locations of the fire extinguishers, telephones, alarm box and electrical breaker panels as well as with the evacuation routes to be taken in an emergency. The cyclotron is located inside a vault consisting of concrete walls 1m thick. In addition to the cyclotron, there is a variety of electronic equipment and vacuum systems. The step-by-step procedure to be followed in the event of one or more of the above emergencies is outlined below: 1. Turn off, disconnect or otherwise disable all equipment involved. NOTE In the event of an electric shock situation, where the individual, or individuals, are still in contact with the power source and it cannot be shut off, remove the source or the victim (s) using an insulating material such as dry wood, a cloth or a newspapers. 2. Evacuate the area using the hallway exits. 3. Close all doors to isolate any fires. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 8 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility 4. Notify the MNI/MNH Emergency Response Team (?????). For fires, use the alarm box in the hallway and phone ?????. Give the operator the name and location of the building, room number, fire box number and the nature and extent of the fire, and personnel injuries. 5. Use available fire equipment to extinguish fires. 6. Administer first aid to injured personnel. 7. Notify at least one of the persons on the notification list above. 8. Notify hospital maintenance of the emergency, describing the accident and the extent of any damage, and inform them of any persons who may have been subjected to radioactive contamination. 9. Secure the area, sealing off openings if flooding or gas leaks are present. In the event of a fire, wait until the fire has been completely extinguished and fire department personnel have declared the area safe to enter with regard to fire safety. 10. If radioactivity is involved, check all personnel, including fire and rescue personnel, for contamination. If contamination is found, follow the personnel decontamination procedures. 11. Transfer injured contaminated persons to the special contaminated personnel handling facility located in the Emergency Room of the Royal Victoria Hospital (MUHC). 12. Record as much of the following information as possible: a. Time and place of accident. b. Names of persons involved. c. Radiation monitor readings and instrument settings, if applicable. d. Description of accident in as much detail as possible, with the probable cause and the action taken. NOTE If radioactive materials are involved, every person who might have been in the area at the time of the accident, or following it, is considered contaminated until a personnel radiation survey has been performed by one of the individuals on the notification list. Those involved in the accident or its control must remain in the immediate vicinity until decontamination has been performed. Do not enter the accident area until an authorized survey and decontamination procedure has been performed and the area has been declared safe by one of the individuals on the notification list above. N.B.: In the case of a malfunction of the pneumatic tube system used to transfer radioactive samples from the cyclotron facility to the PET-suite, i.e., if a transport container should get stuck underway, the container should be pulled back to the start position by means of a vacuum generator. If this attempt fails, radiation levels in the vicinity of the transport duct Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 July 24 th, 2007 Last Revision of this Section on: Page 9 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility will be monitored and personnel working in its vicinity (analysis room WB205) relocated temporarily if needed (e.g. if radiation field larger than 25μSv/hr (2.5mR/hr). In the case of an emergency entry into the vault, unplug the mains power supply of the Eberline monitoring unit in the Control Room (remember: under normal circumstances, the vault cannot be entered until the vault Eberline monitor reading is below a preset safe radiation level). In the event of an earthquake, the following action is to be taken in addition to the above procedure: 1. After the earthquake has passed, remain in the vicinity for notification form the MNI/H emergency units or other competent authority. 2. Check the area for fires, floods, gas leaks and other damage and take appropriate action to eliminate or control the hazard. 3. Initiate the step-by-step emergency procedure above. 4. Prepare for possible aftershocks. Secure all rolling equipment or objects that may fall. DO NOT: a. b. 12.5.6 Smoke or light a flame. Make unnecessary telephone calls. Decontamination The RSO should be notified of all human contamination. Emergency personnel decontamination materials are located on shelves above the sinks in the shop area and in the Hot Lab. Radiation survey meters are located in the quality control room and in the storage cabinet next to the control room. Decontamination of equipment, furniture and building surfaces should be performed only by a qualified person, an individual who has been trained and/or approved by the RSO. Contaminated areas should be isolated, secured and warning signs posted until decontamination can be performed. Whenever possible, personnel decontamination should be performed by a qualified person. However, since prompt removal of the contamination is of the utmost importance to reduce the potential hazard, if a qualified person is not readily available, other persons are permitted to perform decontamination following the procedures outlined in this section. All operating personnel should receive instruction on the use of the portable radiation survey instruments in the facility. a) Contamination Measurement of an Area Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 July 24 th, 2007 Last Revision of this Section on: Page 10 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility b) 1. Perform preliminary working check of the instrument outside and away from the contaminated area. 2. Ensure that the instrument selected for the measurement is sensitive to the radiation to be measured and is in operating condition. 3. Measure background before and periodically during the survey. 4. When measuring alpha or beta radiation, keep the survey meter shield open and hold the detector window as close to the surface as possible without touching it. 5. Close the shield when measuring gamma radiation. 6. Pass the detector window slowly and carefully over the entire surface. When the meter indicates a radiation level above background, stop and wait for the maximum deflection. 7. If the radiation level exceeds the maximum meter reading, switch to the next highest scale. 8. As soon as reasonably possible, record contamination data in a log-book, including location, radiation level and time of measurement. Emergency Personnel Decontamination Procedure 1. On completion of a quick contamination survey, remove all contaminated clothing, including shoes, and place together in a small area to avoid spreading the contamination. 2. Proceed to the nearest sink, and wash all contaminated areas thoroughly with the soap and solutions provided. Be sure to scrub all parts of the hands, under the nails, and across the knuckles with a surgical scrub brush. 3. Dry with paper towels and place the used towels in a radioactive waste container. 4. Check all areas of the body with a survey meter and repeat the washing operation until the radiation level reaches background, or until successive washings fail to lower the level significantly. Do not abrade the skin. 5. Blow nose, using absorbent paper tissue, and save the tissues for assay of radioactivity. Do not attempt to wash out the nasal passages until medical assistance is available. 12.6 Personal Responsibilities 12.6.1 Director of the Medical Cyclotron Facility All activities that are conducted in the Medical Cyclotron Facility are under the direction and supervision of the Director of the Medical Cyclotron Facility. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 11 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility No irradiation, beam experiment or radiochemical processing operation may be conducted without his approval. He is responsible for ensuring that all procedures are performed in compliance with MNI/H safety practice. 12.6.2 Chief Cyclotron Operator The chief cyclotron operator is directly responsible to the Director of the Medical Cyclotron Facility and through him to the Director of the MNI. All radiochemical operations, including target preparation and processing and handling of the irradiated target, are under the direction of the Director of the Medical Cyclotron. He is responsible for the activities of all individuals involved in these operations and, with their assistance, he ensures compliance with all regulations and safety procedures. Whenever new radio chemical or target handling operations are considered, the operator should consult with the Director of the Medical Cyclotron and the Radiation Safety Officer. He must ensure that all persons working in the Hot Lab are thoroughly familiar with regulations and safety procedures. 12.7 Records Regulations governing the procedures for initiating and maintaining radiation records and reports are set forth elsewhere in this manual. These Regulations should be followed and, in addition, other records pertinent to the activities of the Medical Cyclotron Facility should be maintained. 12.7.1 Personal Dosimeter and Access Log Individual TLD badge records are routinely maintained by the chief cyclotron operator and posted at the main entrance to the facility. Additionally, the RSO’s office keeps a copy of all exposure reports. All visitors and transient operational personnel are required to sign in. If personnel dosimeters are required, the relevant information will be entered into the record. Also, the RSO has to file a report to the CNSC within 21 days of noticing that the action level of a worker has been reached. 12.7.2 Radiation Survey Record This record contains detailed information regarding routine and special surveys as well as safety inspections. Cyclotron equipment maintenance operations, details of unusual incidents and operational conditions etc. are maintained separately. 12.7.3 Radioactive Material Accountability Record Information and records regarding radioactive material inventories, transfer and waste disposal are maintained in this record. Copies of current valid radioisotope applications from persons and agencies requesting radioisotopes are maintained as a part of the record (e.g., nuclear medicine license of MGH/MUHC). 12.7.4 Radiation Instrument Maintenance and Calibration Record Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 12 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility This record contains the maintenance and calibration information and dates for all radiation survey instruments, gamma area monitors, and direct reading personnel dosimeters (pocket dosimeters). The RSO keeps a record of the compulsory yearly calibrations of all radiation survey meters. 12.7.5 Cyclotron Operational Log This log contains the operational data of the cyclotron, including pertinent instrument settings, nature of experiment or irradiation, irradiation periods and names of responsible individuals. It is usually maintained by the chief cyclotron operator. 12.8 Radiation Safety Check List 12.8.1 Cyclotron Safety Tests Consolidated Cyclotron Safety Tests Based on suggestions by Dr. S. Jovanovich, CNSC, and discussions with Mr. Dean Jolly, Chief Cyclotron Operator. Approved by the CNSC on May 5, 2006. New: Every 6 months, 1/2 day will be requested to perform six-monthly and yearly cyclotron- related safety tests listed below. Every day: (new) Morning inspection, 5min or less: at the start-up of the cyclotron, an operational check is made of such indispensable safety features as: 1. 2. 3. 4. 5. “last person out of vault” (i.e., green button in vault) “emergency cyclotron shut-off operations”(i.e., red button in vault) “audible warning devices” (i.e., vault bell) “vault door interlock mechanism” (sliding maze door) “operational state of interlocked radiation level survey instruments” (Eberline monitors) - We have modified the “IBA Cyclone 18/9 Daily Log Sheet “accordingly (see Appendix 1). There are 5 check boxes to be filled in daily by the operator. -The testing of points 1 to 4 is achieved in a single step by making sure that the vault bell rings. If either of the buttons or the door interlock is malfunctioning, the door bell will not ring (see circuit diagram). -The vault and hot lab fixed Eberline monitors are checked visually by making sure that they are reading a non-zero radiation level as soon as the beam is turned on. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 13 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility Every week: (new: no more weekly routine tests) Every 1 month: (new) As suggested by Dr. Jovanovich, the 3 fixed radiation monitors (Eberline) will be tested in turn, one monitor every month, as to their capability to halt cyclotron operation by approaching a gamma radiation source to the monitor and making sure that the cyclotron magnet power supply is shut off by this manoeuvre. Every 6 months: (new) 15 Monitoring of external cyclotron component activation around target areas (at 1 foot from targets, at areas where personnel might occasionally perform interventions). O-line leak check on radioactive gas steel tubing system to prevent escape of 15O-gases into the environment. Every 12 months: (as before) Calibration of the three fixed radiation monitors (vault, hot lab and exhaust stack) using a procedure approved by the CNSC. Whenever required or feasible: (new) Thorough radiation surveys (gamma and neutrons, see recent survey by Bubble Tech Inc.) shall be performed following modification of target constellations and after major structural and/or functional changes to the cyclotron equipment or its immediate surroundings (shielding, new adjacent facilities) in order to confirm regulatory and safe operating radiation levels. Radiation monitoring of internal cyclotron components (magnet poles, etc.) whenever the cyclotron has to be opened for servicing or repair purposes. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: July 24 th, 2007 Page 14 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility 12.8.2 Interlock and Warning Systems 1. 2. 3. 12.8.3 SCRAM Button Tests Vault Buzzer Check Interlock Switches Functional Check Radiation Monitors Gamma Area Monitoring System (fixed “Eberline” area monitors) a. Calibration b. Check source reading c. Background reading 1. 12.9 Procedures for Handling of Irradiated Targets 12.9.1 Liquid Targets The liquid target chambers are capable of retaining up to 10 cc of liquid. In general, a one-eighth-inch diameter teflon tube is connected between the solution withdrawal port of the target chamber and a container inside the shielded hot box. Extraction of the irradiated solution is accomplished either by developing a negative pressure at the end of the system inside the hot box and allowing the solution to pass into the container, or by passing a pressurized stream of dry air through the target chamber, thus forcing the solution through the teflon tube and into the container. This latter method permits the flushing out of the system after withdrawal of the irradiated solution. When the irradiated solution has been completely withdrawn, the tube is closed off inside the hot box and the solution container placed in a lead container before removal from the hot box for further processing or transfer to authorized users. 12.9.2 Foils Foils may break or develop pin-holes during bombardment. Because of the high dose involved, these must be replaced only the following day. _____________________________________________________________________________ In case of an accidental puncture of target or vacuum chamber foils, the following steps are to be taken: 1. 2. 3. 4. Enter vault as soon as vault access radiation interlock allows the door to be entered. Close all target gas supply valves. Leave vault and close door. Wait 24h to let radioactivity decay (typically over night) and perform repair the next day only. N.B.: In case of a target foil puncture, the radioactive material produced in the target box will leak into the helium target cooling system which is a closed circuit. If the vacuum foil only is punctured, all radioactive material remains in the target box. If both the target and the vacuum foil are punctured, some radioactive material will be retained in the oil of the vacuum pumps and the rest will be vented to the exhaust system of the facility. Therefore, in the case of any foil puncture, no radioactive material will be leaked into the vault. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 July 24 th, 2007 Last Revision of this Section on: Page 15 of 15 12. Procedures for the MNI/H Medical Cyclotron Facility It should also be remembered that the vault is under negative pressure with respect to the rest of the facility such that, in the unlikely event that some activity should leak into the vault, this activity would not spread to the other locations of the facility. _____________________________________________________________________________ 12.9.3 Gas Targets Gaseous targets are irradiated while under positive pressure in cylindrical target chambers. Stainless steel or copper tubing connects the target chamber to a valve station inside one of the fume hoods where collection and treatment of the irradiated gas takes place. Following irradiation, gas is collected either in a holding tank or appropriate solution. Solution traps are also located downstream from the collection system together with terminal holding tanks to ensure that no gas escapes into the surrounding atmosphere until it has sufficiently decayed. In addition, the fume hood is under negative pressure and vented so that no gas escapes into the lab. All solutions are assayed for radioactivity before disposal or removal from the laboratory. Both the laboratory and the fume hood are monitored with a gas monitor. 12.10 References 1. Blatz, Hanson: Radiation Hygiene Handbook, McGraw-Hill, 1959. 2. National Bureau of Standards: Radiological Safety in the Design and Operation of Particle Accelerators (U.S.) Handbook, No. 107, June, 1970. 3. United States Atomic Energy Commission, Division of Operational Safety: Electrical Safety Guide for Research, Safety and Fire Protection Technical Bulletin 13, December 1967. 4. United States Atomic Energy Commission, National Accelerator Safety Committee: Safety Guidelines for High Energy Accelerator Facilities, TID 23992, 1967. 5. United States Department of Health, Education, and Welfare: Particle Accelerator Safety Manual Handbook, MORP 68-12, October, 1968. 6. University of California at Los Angeles, Office of Environmental Health and Safety: UCLA Radiation Safety Handbook, 1964. 7. State of California Department of Public Health, California Radiation Control Regulations, Title 17, California Administrative Code, Chapter 5, Subchapter 4. 8. Federal Register, Standards for Protection Against Radiation, Title 10, Chapter 1, Part 20. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2 nd, 2007 Page 1 of 4 13. Radiation Accidents and Emergency Procedures 13. Radiation Accidents and Emergency Procedures 13.1 General Principles A radiation accident is any unplanned incident or occurrence, which results, or may result, in exposure of human beings to either external or internal irradiation. Such an incident can occur in one of two basic ways, the responses to which are different: 1. External exposure without contamination: this may result from a failure or breakdown of a radiation generator such as an x-ray unit or an accelerator such as a cyclotron, or from a departure from the procedures designed to ensure safe working conditions with such machines. 2. Contamination: as a consequence of the spreading or dispersal of unsealed radioisotopes, which may lead to internal or external exposure, or both. 3. If you have been involved in a radiation accident or an emergency situation involving radiation,, you must report this event to your superior as well as to the RSO as soon as possible. The RSO will immediately file the necessary reports to the appropriate instances. Reporting periods: immediate and 21days follow-up (check: General Nuclear Safety and Control Regulations items 29, 30 & 31. Action level reached: 21days Transm. Source servicing location change or cessation: 7days notice Gammacell: 7d before transfer or export and within 48hrs after receipt of a transfer or import. Labs.: new location (more than 90d): 7d notification upon start and also after decommissioning. 13.2 Accidents Involving External Exposure Only Accidental exposure of the whole or part of the body to a direct radiation beam, or an unplanned exposure of the body to high activity sealed sources is unlikely but not impossible. Anybody who knows or suspects that he/she has been exposed to a direct radiation beam or unshielded source must immediately report the fact, with as much detail as possible, to the RSO, who will: a) Take immediate precautions to avoid the possibility of exposure to others (turn off the beam, shield the source, cordon off the area, etc.). b) Arrange for the exposed person to receive a medical examination, including a full blood examination. c) Arrange for a cytogenetic examination if the exposure is likely to be above 200mSv. d) Investigate the accident with a view to assessing the dose received by the individual and the cause of the accident. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2 nd, 2007 Page 2 of 4 13. Radiation Accidents and Emergency Procedures e) Collect the individual’s radiation monitor (if worn) and send it to the Radiation Protection Bureau immediately. f) Remove or re-shield the source of radiation, if necessary with the help of provincial or federal radiation safety authorities. g) Write a detailed report about the accident for submission to the RSC, the CNSC and other pertinent authorities. h) In the case of a malfunction of the pneumatic tube system used to transfer radioactive samples from the cyclotron facility to the PET-suite, i.e., if a transport container should get stuck underway, the container should be pulled back to the start position by means of a vacuum generator. If this attempt fails, radiation levels in the vicinity of the transport duct will be monitored and personnel working in its vicinity (analysis room WB205) relocated temporarily if needed (e.g. if radiation field larger than 25μSv/hr (2.5mR/hr). 13.3 Contamination by Radioactive Material 13.3.1 “Minor spills” of a radioisotope (less than 100 EQ), without contamination of personnel (i.e., spills of a few drops of radioactivity in a very well defined location, such that you think you can handle the situation): 13.3.2 a) define activity, nature and spread of contamination; (INFORM) b) isolate contamination area; (CONTAIN) c) clean up with appropriate liquid and disposable absorbent material. Prevent spreading of the contamination. Avoid contact with contaminated area (use disposable gloves); (DECONTAMINATE) d) repeat the clean-up procedure with repeated wipe tests until an acceptable level of contamination is obtained as per license condition 2642-2 (see Appendix 11). e) keep a sample log of the accident on file using the Minor Spill Incident Form a copy of which has to be sent to the RSO. (A copy of a Minor Spill Incident Form is given in Appendix 9). “Major spill” involving significant quantities of a radioisotope (more than 100 EQ) spilled in a random uncontrollable fashion and/or contamination of personnel and/or release of volatile material (i.e., a spill such that you think you cannot handle the situation): (see also section “Attention” at the beginning of this manual) a) Call ????? and say “Radiation Accident” or “Radiation Spill”. b) A “Code Brown” will then be issued over the intercom, mobilizing the Emergency Response Team (ERT). Radiation Safety Manual of the MNI/H (Steve: ???) Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2 nd, 2007 Page 3 of 4 13. Radiation Accidents and Emergency Procedures c) The ERT will contact the RSO (ext. 8927, or pager No. 406-3069) and both the ERT and the RSO will proceed to the accident site. d) Wait for the ERT and the RSO to arrive on accident site to receive further directions. e) The ERT, with the help of the RSO, will initiate decontamination and survey of the area. The RSO will write a detailed report about the accident for submission to the CNSC and the RSC. See also Appendix 14i on “Spill Procedures”. 13.3.3 Decontamination Procedures The contaminated area must be defined and isolated. The RSO should investigate the nature and extent of the contamination. In case of minor spills involving low toxicity material, the decontamination procedures might involve the use of a simple cleaning substance (count-off and hand cleaner) only. All decontaminating material (gloves, pails, etc.) should be stored or disposed of in the same way as other radioactive waste. To test the success of the decontamination, wipe-tests should be applied in the following manner: With a square of absorbent paper, wetted with an appropriate solvent, a 100cm2 surface must be wiped clean and the resulting activity analyzed by an appropriate scintillation or gamma counter. Cleaning and monitoring should be continued until readings indicate no further decrease of contamination. At this point, the residual activity has to be assessed and, if not within regulatory limits (see Appendix 11), further decontamination measures have to be taken such as removing the wax on the floor etc. In case of a major spill, protective clothing must be worn during the decontamination process. Where isotopes of short half-lives are involved, it may be sufficient to decommission the lab temporarily and lock it up or keep the contaminated area covered with lead or plastic sheets taped to the contaminated surface for the necessary decay period. Appropriate warning signs and barriers must be posted and warning given to other personnel and housekeeping staff. 13.3.4 Contaminated patients who need medical attention: a) Isolate the patient to protect the environment against the further spread of contaminating radioactive material. Usual surgical isolation techniques should be applied. b) Notify the RSO, who has the necessary instruments and knowledge to determine the amount and toxicity of the contamination and would also take care of the decontaminating procedures. In case the RSO cannot be reached immediately, contact the Emergency Response Team (ERT) at ?????. c) Unless very grave injuries make delays impossible, allow the radiation control personnel to decontaminate the patient and surrounding area. d) If the patient is seriously injured, give emergency lifesaving assistance immediately. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: August 2 nd, 2007 Page 4 of 4 13. Radiation Accidents and Emergency Procedures 13.4 e) When external contamination is complicated by a wound, care must be taken NOT to crosscontaminate surrounding surfaces from the wound and vice versa. The wound and surrounding surfaces should be cleaned separately and sealed off when clean. When crushed dirty tissue is involved, early preliminary wet débridement following wound irrigation may be indicated. Further débridement and more definitive therapy can await sophisticated measurement and health physics consultant guidance. f) Do NOT use lead aprons or thick rubber gloves, which give protection only against diagnostic xrays and are of no use against radioisotope contamination. This heavy and cumbersome equipment will only hinder your movements, cause more contamination and diminish your ability to deal with the patient. g) Handle contaminated patient and wound as one would during a surgical procedure, i.e., use gown, gloves, cap, mask, etc. h) When external contamination is involved, save all clothing and bedding from ambulance, blood, urine, stool, vomitus, personal effects of the patient and your own surgical protective clothing for the radiation control personnel to deal with. Disposable plastic bags should be used for this purpose, with tags attached to show date and content. i) The RSO will forward a report of the incident to the CNSC as per license agreement. Fires Involving Radioactive Material The procedures to be followed in the event of a fire are well defined at the hospital and they have to be carried out in all instances. It is imperative to give precise information to the fire-fighting units about the location and extent of any additional radiation hazard. Once the fire is dealt with, the RSO must monitor the whole area to detect any possible contamination. Only after a careful survey should the area be declared open to access. The RSO will draw up a report summarizing the event and promptly forward it to the CNSC. In Case of an Emergency Which Can Result in Fatalities, Radiation Hazard Must Be Considered Only if the Exposure that Anyone Could Reasonably Receive Is in Excess of the Relevant Annual Dose Limit. 13.5 Loss or Theft of Radioactive Material or Radiation Devices If a worker notices that radioactive material or a radiation device has been either stolen or lost, he shall inform his supervisor immediately and contact the RSO. The RSO will immediately file a preliminary report to the CNSC and then investigate the incident, trying to trace the lost or stolen item. The investigation will also include a review of the working and security procedures in place at the site or laboratory of the incident and finding means to improve them. The results of this investigation will be summarized in a detailed report and sent to the CNSC within 21 days of the incident. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 6 th, 2006 Page 1 of 2 14. Education and Training of Personnel 14. Education and Training of Personnel The purpose of a radiation safety program in any institution is to ensure that procedures involving the handling and use of radiation sources are carried out with minimum hazard to all concerned. To this end, the Radiation Safety Committee, the RSO, Responsible Radiation Users and Radiation Supervisors need to establish and maintain close contact with all personnel who work with or near radiation sources. The “human element” is the key factor in the application of all safety rules and regulations. Each department or laboratory, each group or type of personnel and each application or use of radiation sources is associated with specific hazards which require specific safety procedures. Safety implies understanding the working procedures in each area and adjusting or modifying these procedures in order to minimize the hazards. As an example, all nuclear medicine technologists at the MNH/I are certified professionals, and the Medical Cyclotron Radiochemistry Facility personnel all have experience, some over 10 years, in working with high levels of radioactivity and, to various degrees, have undergone training offered by the manufacturer of the cyclotron. As a rule, any individual who is going to be involved with the handling of radioactive substances or devices at the MNH/I has to register with the RSO. At the time of registration, the applicant agrees (see form in Appendix 4c) to attend the next available Radiation Safety Course offered by the Environmental Hygiene and Safety Office (EHS) of McGill University. If the next available Radiation Safety Course offered by the EHS is some time away (these courses are given approximately every 2 to 3 months), the applicant has, before working independently with radiation, to take a test (quiz), prepared by the RSO, that consists of 30 basic questions related to radiation matters. A passing mark of 80% is required. Individuals with previous pertinent experience in radiation work, as documented by a written statement from another institution, may be required to only take the exam (rather than the 1-day course) that is associated with the McGill Radiation Safety Course. Furthermore, the RSO meets with the individual laboratory personnel for formal and informal discussions on radiation issues whenever required. In addition, each employee involved in radiation work must be provided access to a copy of the Radiation Safety Manual and sign a form (see Appendix 4a) confirming that she/he has read the sections which are “required reading” for her/his job category (see list at end of this chapter). Refresher courses covering all aspects of radiation safety plus information on regulations are being developed in collaboration with the Environmental Hygiene and Safety Office, McGill University. This teaching module will be accessible over the internet to all radiation users and will provide documented updated training for all individuals dealing with radiation. All procedures at the MNH/I are subject to review and re-evaluation. Procedural changes and the introduction of new techniques create a need for continuing education of existing personnel as well as for training of new personnel. New employees usually receive on-the-job training and supervision, followed by periodic retraining and further education. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last Revision of this Section on: February 6 th, 2006 Page 2 of 2 14. Education and Training of Personnel In order to ensure that all persons handling radiation sources receive adequate instruction in the safety aspects of such handling, the DRS will direct new radiation users (fellows, post-docs, technicians, students) to the RSO who will assure that these individuals will attend the appropriate training sessions. The employee is expected to study the assigned documents (e.g. the RSM) and must be given adequate opportunity to discuss and query the material concerned with the Responsible Radiation User, the RSO or other members of the safety organization in order to obtain further information or clarification. Once this process is completed, the employee must sign the Declaration Forms (Appendices 4a and 4c), which are then sent to the RSO for safe-keeping. Notice also that individuals associated with studies where radioisotopes are being used, who do not, however, handle the radioisotopes themselves (for example PET or microPET investigators), have to undergo a “minimal training” by reading and signing the appropriate radiation safety information sheet (Appendices 18 and 19). At least one member of the Animal Care Facility has to be fully certified as a radiation user, i.e., has attended the Radiation Safety Course offered by the EHS of McGill University and will attend future refresher courses. The sections of the Radiation Safety Manual (RSM) which apply to different groups of personnel at the MNH/I are as follows: 1. Technologists, Radiologists, Medical and Nursing Personnel: Chapters 1-11, 13, 14 2. Laboratory Technologists and Researchers: Chapters 1-7, 10, 11, 13, 14 Cyclotron Personnel shall read Chapter 12 as well 3. Secretaries, Security, Receiving and Maintenance Personnel: Chapters 1-3, 5, 6, 13 4. Nuclear Medicine Technologists: Chapters 1-7, 10-13 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Date of last change to RSM: Page: 1 of 1 12/02/2016 15. Appendices Appendices to the Radiation Safety Manual of the Montreal Neurological Institute & Hospital Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 20th, 2006 Appendix 1 Appendix 11) Systme International (Si) Units The rad (rad) is replaced by the gray (Gy) 1 kilorad (krad) = 10 grays (Gy) 1 rad (rad) = 10 milligrays (mGy) 1 millirad (mrad) = 10 micrograys (μGy) 1 microrad (μrad) = 10 nanograys (nGy) 1 gray (Gy) = 100 rad (rad) 1 milligray (mGy) = 100 millirad (mrad) 1 microgray (μGy) = 100 microrad (μrad) 1 nanogray (nGy) = 100 nanorad (nrad) The rem (rem) is replaced by the sievert (Sv) 1 kilorem (krem) = 10 sieverts (Sv) 1 rem (rem) = 10 millisieverts (mSv) 1 millirem (mrem) = 10 microsieverts (μSv) 1 microrem (μrem) = 10 nanosieverts (nSv) 1 sievert (Sv) = 100 rem (rem) 1 millisievert (mSv) = 100 millirem (mrem) 1 microsievert (μSv) = 100 microrem (μrem) 1 nanosievert (nSv) = 100 nanorem (nrem) The curie (Ci) is replaced by the becquerel (Bq) *) 1 kilocurie (kCi) = 37 terabecquerels (TBq) 1 curie (Ci) = 37 gigabecquerels (GBq) 1 millicurie (mCi) = 37 megabecquerels (MBq) 1 microcurie (μCi) = 37 kilobecquerels (kBq) 1 nanocurie (nCi) = 37 becquerels (Bq) 1 terabecquerel (TBq) = 27 curies (Ci) 1 gigabecquerel (GBq) = 27 millicuries (mCi) 1 megabecquerel (MBq) = 27 microcuries (μCi) 1 kilobecquerel (kBq) = 27 nanocuries (nCi) 1 becquerel (Bq) = 27 picocuries (pCi) *) 1 Bq = 1 disintegration / second = 1 1) From: AECB Publication R-52, Revision 1 Radiation Safety Manual of the MNI/H s-1 Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 20th, 2006 Appendix 2 Appendix 2 Radiotoxicity and Half-Life of Selected Radionuclides Very High Radiotoxicity Moderate Radiotoxicity Radium-223 (223Ra) 11.7 days Carbon-14 (14C ) 5730 years Radium-226 (226Ra) 1620 years Fluorine-18 (18F) 111 minutes Radium-228 (228Ra) 6.7 years Phosphorous-32 (32P) 14.3 days Sulphur-35 (35S) 87.4 days High Radiotoxicity Sodium-22 (22Na) 2.61 years Chromium-51 (51Cr) 27.8 days Calcium-45 (45Ca) 165 days Iron-52 (52Fe) 8.3 hours Cobalt-56 (56Co) 77 days Krypton-85m (85Krm) 4.4 hours Cobalt-60 (60Co) 5.3 years Krypton-87 (87Kr) 76 minutes Strontium-90 (90Sr) 28 years Molybdenum-99 (99Mo) 66 hours Iodine-131 (131I) 8 days Iodine-135 (135I) 6.7 hours Cesium-137 (137Cs) 30 years Rubidium-86 (86Rb) 18.6 days Europium-152 (152Eu) 9.2 hours Low Radiotoxicity Hydrogen-3 (3H) 12.3 years Oxygen-15 (15O) 2 minutes Xenon-131m (131Xem) 12 days Technetium-99m (99Tcm) 6 hours Xenon-135 (135Xe) 5.3 days Iodine-125 (125I) 60 days Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 3 Appendix 3 Request to Use New Radio-Chemical Montreal Neurological Hospital and Institute Date: _________________ Laboratory Director: ___________________ Internal Permit No.:_________________ 1) Name of Radio-Chemical: _______________________Open:_____ Sealed: ______ 2) Chemical Form: ______________________________________________________ 3) Radioactivity Manipulated per Experiment (MBq or mCi):______________________ 4) Frequency of Experiments: _____________________________________________ 5) Maximum Estimated Activity Requested per Year (MBq or mCi):_________________ 6) Major Use of the New Radio-Pharmaceutical (short description of planned experiment): For more Information Call the RSO at Local: 8927 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 4a Appendix 4a Declaration by Employees Handling Radioactive Materials and Radiation - Emitting Devices The purchase and use of radioisotopes and of radiation-emitting devices at the Montreal Neurological Institute and Hospital are governed by the license(s) issued to the Institute and Hospital by the Canadian Nuclear Safety Commission (CNSC). It is an implicit condition of these licenses that every person handling radioisotopes or radiation-emitting devices shall read and understand the relevant sections of the MNI/MNH Radiation Safety Manual. Declaration Name of Employee: __________________________________________________________________ Department or Laboratory: _____________________________________________________________ Responsible Rad. User (RRU) or Supervisor: _________________________ (Int. Permit #: __________) I hereby declare that I have read those sections of the MNI/MNH Radiation Safety Manual that are relevant to my work (as listed below) and that I understand the meaning and implications of these sections. I further declare that, before signing my name, I have been given adequate opportunity to discuss and clarify the contents of the Radiation Safety Manual and other documents listed below with my supervisor and/or other authorized person(s) in the field of radiation safety. Relevant sections: 1. Technologists, Radiologists, Nursing and Medical Personnel: 1-11, 13, 14 2. Laboratory Technologists and Researchers: 1-7, 10, 11, 13, 14 Cyclotron Personnel shall read chapter 12 as well. 3. Secretaries, Security, Receiving and Maintenance Personnel: 1-3, 5, 6, 13 4. Nuclear Medicine Technologists: 1-7, 10-13 N.B.: If I-125 or I-131are used, CNSC regulatory document R-58, available from the RSO, must also be consulted. Signature of Employee: _______________________________ Date: ___________________________ Signature of RRU or Supervisor: _________________________ Date: ___________________________ This form must be filed by the RRU of the laboratory or by the departmental supervisor concerned, and a copy sent to the Radiation Safety Officer at the MNH/I. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 4b Appendix 4b Application for Radiation Monitor (A) Personal Information / Information personnelle Family name / Nom de famille; First Name / Prénom: Sex / Sexe: (circle, cercler) M F Yes No Date of birth / Date de naissance: Place of birth / Lieu de naissance: Social insurance number / No.d’assurance sociale: Previous badge ? / Moniteur précédent ? (B) Work-related Information / Information concernant le travail Department / Département: Room Number / Numéro de la salle: Internal Permit # / Numéro de permis interne: Work telephone number / No. de téléphone au travail : Duration of stay / Durée de séjour: Job classification / Classification d’emploi: (C) Signatures Signature Date Applicant / Demandeur: RRU or Supervisor / Superviseur: Radiation Safety Officer / Agent de Radioprotection: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 4c Appendix 4c Radiation Worker Registration Form To be filled out and returned to the Radiation Safety Office (room WB-211) by all new personnel/ staff/ students who plan to use radioactive materials. New users may also be asked to pass a test (power point presentation quiz) for assessment of their knowledge of basic rules for working with radioisotopes. Questions on the test will be based upon information provided in the “Radiation Safety Manual” as well as the “Primer for New Users”. Personal Information: Name: Lab. Phone #: Supervisor: Department: Start date: Room #: Previous Radiation Safety Training: Have you ever worked with radioactive materials? If yes, specify radioisotopes handled : Yes No Radioisotopes: Place: Year: Have you had any formal radiation safety training? Yes No Yes No If yes, specify the following: Place: Year: As a part of this training, did you receive a certificate? If yes, please provide a copy of the certificate to the RSO’s office. Declaration by Worker I, ________________________, agree to attend the next available Radiation Safety Training Course, offered by McGill University. I also agree to take the exam associated with this course (exam fee to be paid by the MNI). In the interim, I acknowledge that I have read, understood, and will comply with, the policies outlined in the Radiation Safety Manual of the Montreal Neurological Institute and Hospital. Signature: __________________________________________ Date: ________________ RSO: ___________________________________________Date: _______________ Training may be waived if you are able to demonstrate that you have received appropriate training at another institution. Training waived: Yes / No Radiation Safety Manual of the MNI/H RSO’s Signature: __________________________ Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 5 Appendix 5 Declaration of Pregnancy by Nuclear Energy Workers In accordance with the Canadian Nuclear Safety Commission Radiation Protection Regulations (paragraph 11), June, 2000: I hereby inform my employer that I am pregnant. Name of Employee: __________________________________________ Phone: ___________________ Stage of Pregnancy (months): ___________________________________________________________ Signature of Employee: _______________________________________ Date: ____________________ Name of Head of Laboratory or Department: ________________________________________________ Signature of Head of Laboratory or Department: ___________________________ Date:_____________ Pregnancy Monitoring The Radiation Protection Bureau (Health Canada) offers a Pregnancy Radiation Monitoring Service for pregnant workers handling radioactive substances or devices and for any other Nuclear Energy Workers. If you decide to make use of this service, your radiation exposure will be reported every two weeks as opposed to every three months for the remaining duration of your pregnancy. Do you wish to be on the semi-monthly service for pregnant workers? Yes No Signature of Employee: ___________________________________ Date: ____________________ This form must be filed with the records kept by the head of the laboratory or department, and a copy sent to the RSO. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 Appendix 6 Internal Permit Application Form (Updated: March, 2005) Montreal Neurological Institute and Hospital 3801 University Street Montreal, Quebec H3A 2B4 (Please type or print legibly) NAME OF APPLICANT: _______________________________________ Office Use Only Internal Permit Number: CNSC Radioisotope License Number: Expiry Date: This form must be filled out by all MNI/MNH researchers who propose to use radioisotopes in their laboratories. Completed forms must be returned to the RSO (room WB 211, ext. 8927). Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 Internal Permit Application Form 1. PERSONNEL (A) RESPONSIBLE RADIATION USER INFORMATION Name: Position: Location (Room #): Office LAB Telephone Number: LAB Office Home E-mail Address: (B) DEPARTMENTAL RADIATION SUPERVISOR INFORMATION Name: Position: Location: Office LAB Telephone Number: Office LAB Home Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 (C) PERSONNEL INVOLVED (use additional sheets if necessary.) Category I: Category II: Those directly working with radioactive material(s) Those having regular access to a room containing radioactive material(s) NAME CATEGORY (I or II) POSITION ROOM NUMBER 2. Locations (A) LOCATION(S) WHERE RADIOISOTOPES WILL BE PROCESSED OR USED: Room #: (B) RADIOISOTOPE STORAGE INFORMATION FOR THE NEXT TWO (2) YEARS: Radioisotope (C) Maximum Activity Storage Location IF STORAGE CONTAINER IS A REFRIGERATOR, IS IT ALSO USED FOR STORAGE OF NONRADIOACTIVE MATERIAL? Yes Radiation Safety Manual of the MNI/H No Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 (D) IF LAB SPACE IS SHARED BETWEEN MORE THAN ONE GROUP, A SIGNED STATEMENT OF CONSENT (see Appendix) MUST BE PROVIDED WITH THE APPLICATION. 3. Radioisotopes (A) UNSEALED SOURCES Will unsealed radioisotopes be used for: Use type: Yes No Yes No In-vivo administration to patients? In-vivo administration to healthy volunteers? In-vivo administration to animals? In-vitro clinical or research? (B) SEALED SOURCES PLEASE ATTACH STATEMENT OF INTENDED USE ON SEPARATE SHEET Will sealed radioisotopes be used for: Use Type: External and/or internal irradiation of patients? (If yes, attach/send copy of appropriate Institute/Hospital Ethics Report) External and/or internal irradiation of animals? (If yes, attach/send copy of appropriate Institute/Hospital Ethics Report) In vitro irradiation? Other purposes, e.g., instrument calibration etc.? (C ) List all unsealed radioisotopes to be used and/or all sealed radioisotopes to be used or possessed in the next 2 years. (Use additional sheets if necessary). Activities should be expressed in S.I. units (Becquerels). Consult table at the end of this application form for conversion from Curies to Becquerels. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 Maximum activities to be used: Radioisotope Chemical form 1 year In single delivery Handled at one time 4. Monitoring and Disposal (A) Please include make and type of any monitoring equipment for the weekly monitoring of contamination of benches, floors, equipment, personnel, and information on the twice yearly leak tests of sealed sources. Instrument (B) Please indicate the model and location of the liquid scintillation counter which will be used for monitoring surface contamination and weekly wipe tests: Instrument Model (C) Make/ Model Location (Room #) WASTE DISPOSAL: If waste is not collected by the McGill Waste Management Program using RTS, please describe your method of disposal. (See section 7 of the Radiation Safety Manual). McGill (RTS):_________________________________________________________________ Other (give details): ___________________________________________________________ Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 5. Radiation Safety Training The applicant agrees to comply with radiation safety training requirements in effect at the MNH/I as specified in the Radiation Safety Manual and modified as needed from time to time by the Radiation Safety Committee of the MNH/I. Signature of Responsible Radiation User : Date : Office Use Checked by: Radiation Safety Committee Approval Date: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 Quick Reference Table The following table gives the conversion factors from the old units to the Système International (SI) units. The curie (Ci) is replaced by the Becquerel (Bq) 1 Ci = 37 Giga-Bq (GBq) 1Bq=27 pico-Ci (pCi) Radiation Safety Manual of the MNI/H Curies Becquerels 1 µCi 37 kBq 5 µCi 185 kBq 10 µCi 370 kBq 30 µCi 1.11 MBq 100 µCi 3.7 MBq 0.5 mCi 18.5 MBq 1 mCi 37 MBq 5 mCi 185 MBq 10 mCi 370 MBq Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 6 Appendix (to App. 6) To be filled out and signed by all users of an area designated as shared or common space which will be used to store or use radioactive materials. STATEMENT OF CONSENT I / We, the undersigned, have been informed by: ___________________________ that the following area(s):_______________________________________________ will be used to store, or work with, radioisotopes. We hereby state that we have no objection to radioisotopes being manipulated in the above area(s). Name Radiation Safety Manual of the MNI/H Signature Date Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 7 Appendix 7 Internal Radioisotope User Permit (example) Issued by: The Radiation Safety Committee of the Montreal Neurological Institute and Hospital Authorized by the Canadian Nuclear Safety Commission CNSC Radioisotope License Number: 01187-2-08.0 (and all revisions thereof) 1. Radioisotope User Permit Number Classification Date of Issue Revision Date Expiry Date : : : : : MNI_001 (Revision No. x) BASIC (e.g.) May 1, 2003 March 20, 2004 April 30, 2008 2. Name of Principal Investigator : USER, Xyz 3. Department : Neuro-Something 4. Location(s) approved by this permit : WB010, 945, etc. 5. Radioisotopes approved by this permit : See non-shaded cells in table below. Note: The permit holder needs written authorization by the CNSC for projects requiring more than 10,000 exemption quantities (E. Q.) of a radioactive substance. 3H approved for use of: 10'000 exemption quantities (E. Q) your possession limit is: 14C 35S 32P 45 Ca 51Cr 10 TBq or 270 Ci 100 MBq or 2.7 mCi 10 GBq or 270 mCi 10 GBq or 270 mCi 1 GBq or 27mCi 81 MBq or 2.2 mCi 18.5 MBq or 0.5 mCi 370 MBq or 10 mCi 125I 6. Personal Dosimeters Required 7. Method of Disposal: All radioactive waste (solid and liquid) must be disposed of in compliance with the Radioactivity Tracking System (RTS) requirements set out by the McIntyre Waste Management Program (McGill) using their containers that have to be brought to the central waste storage cage in the basement of the MNH/I (room 045 B). Radiation Safety Manual of the MNI/H : YES Version No.: 2 September 1st, 2007 Appendix 7 8. Last revision of this Appendix on: February 28th, 2006 Special Conditions: Gloves and lab coats mandatory. Weekly wipe tests required in areas where radioisotopes are used. Ring badges required for staff using > 50 MBq of 32 P. Monitoring of all work surfaces where 32P is used at the end of the work day. Radio-iodinations: Must be carried out in a working fume hood. Schedule thyroid monitoring. Use of proper survey equipment during radio-iodine manipulations. The Radiation Safety Officer, MNH/I: ___________________________ (E. Meyer, RSO, ext. 8927) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 8 Appendix 8 Radioisotope Inventory Sheet (1 vial per sheet) Location Source Shipment Lab: Isotope: Supplier: Supervisor: Product: Batch/Lot number: Contact person: Activity: Received: Volume: Reference date: Date User Procedure Activity used Activity in stock Waste Form L O S A G B A = = = = = = = Aqueous Liquid Organic Solvent Solid Absorbent Material Glass/Sharps Biohazard /infectious Animal Carcass Waste Form Disposal Method Amount of Activity in waste Disposal Method 1 . 2 3 4 5 6 = = = = = = = Send to waste storage (use McIntyre RTS System) Municipal Garbage Municipal Sewer (sink) Incinerator Return to supplier Transfer to another lab Check with RSO NB. : Since the introduction of the McGill (McIntyre Waste Management Program) Radioactivity Tracking System (RTS) in March of 2004, the computer printout of the RTS summary is an acceptable replacement for the above Inventory Sheet. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 9 Appendix 9 Minor Spill Incident Form (Maintain a copy for your records and send another copy to the RSO (Room WB 211) For spills involving a few drops only of an isotope and no personnel contamination, such that you feel comfortable to be able to handle the situation to the best of your knowledge (i.e., a spill of less than ~ 100 EQ). Minor Spill Incident Report Date Location of Spill RadioNuclide Radiation Safety Manual of the MNI/H Monitor Readings Activity Before After Incident/ Cleanup Details Technician Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 10 Appendix 10 MNI/H Contamination Control Protocol (Updated: April 26th, 2002) This document outlines and updates the protocol which all users of open sources of radioactivity MUST follow in order to comply with the license condition entitled “Contamination Criteria” (see e.g. condition 15 in CNSC license 01187-2- 08.3, LABORATORY STUDIES). 1. Person-in-charge: While there is no restriction on who performs the contamination or wipe test, it is important to have one person in the lab/group that is ultimately in-charge of the process. This ensures continuity in the maintenance of records in the lab. It is also essential that the person performing the wipe test be fully aware of the protocol and rules outlined in this document. 2. What constitutes a contamination? The criteria for non-fixed contamination have been modified in the process of the transformation of the AECB into a new entity called CNSC (Canadian Nuclear Safety Commission) which officially came into existence on May 31st, 2000. The new criteria fall into three groups, each group representing a Class of radio-nuclides. The classification of radio-nuclides is given in the Table attached to the present document. Essentially, the radio-nuclides in Class A are the most “harmful” ones while those in Class C are the least “harmful”. Note: All the open source radionuclides presently being purchased under the above license belong to Class C (the only radionuclides listed on the license that belong to Class B are I-131, F-18, Ga-68, Kr-85 and Fe-55, but, except for the PET tracer F-18, these are only sporadically being used, if at all). The new contamination criteria are summarized below : Type of area all areas, rooms or enclosures where unsealed radioisotopes are used or stored all other areas CNSC limits for non-fixed contamination Class A 3 Bq/cm2 Class B 30 Bq/cm2 Class C 300 Bq/cm2 Class A 0.3 Bq/cm2 Class B 3 Bq/cm2 Class C 30 Bq/cm2 Assuming an instrument efficiency of 50%, a wipe efficiency of 10% and a wiped area of 100 cm 2, this translates into a cpm-value of 90,000 and 9,000 for radioactive and “clean” areas, respectively, for Class Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 10 C radionuclides. These values are considerably higher than the previously acceptable limits (action levels) at this Institute. The Radiation Safety Committee and the MNI/H Radiation Safety Office are committed to keeping radiation levels ALARA (as low as reasonably achievable). Therefore, the acceptable limits for contamination for practical purposes (action levels) are set, as before, at considerably lower values than those derived from the new CNSC contamination criteria: Areas where detected counts are more than 3 times the background level will be considered contaminated and cleanup will be required. 3. Background wipe: The background wipe is an unused or blank wipe which is treated the same way as a regular wipe. In other words, take a clean swipe, place it in a vial, add the scintillation cocktail and count. 4. If a routine wipe test indicates the presence of contamination at a specific location: a. Clean up the area. b. Perform additional wipe tests on the contaminated area after cleanup is completed and document the results (including the LSC printout) in the wipe test book as proof that the contaminated area was cleaned up appropriately. 5. Frequency of wipe testing: Frequency of radioisotope use Wipe testing requirement once a week or more at least weekly less than once a week upon completion of manipulation involving radioisotope use, or at the end of the work week during which the isotope was used. The Weekly Contamination Survey Log (see Appendix 17) must be filled out in either case. If no radioisotopes were used in a particular week, this must be indicated on the log. 6. Record Keeping: Weekly wipe test results must be maintained in a clearly marked separate folder. A complete contamination survey record consists of the following: a. A labeled lab-layout diagram; b. A table with the counts recorded at the locations indicated on the layout; c. A copy of the printout obtained from the liquid scintillation counter d. A weekly entry in the Contamination Survey Log. 7. Records: Wipe test / inventory records must be kept in the lab for three years. a. b. Prior to disposing of any records related to the use of radioisotopes, permission must be obtained from the CNSC. If you have records dating back more than 3 years and wish to discard them, call the MNI/H radiation safety office at 8927. Records (wipe test as well as inventory) must be kept in the laboratory and available for inspection at any time. The Radiation Safety Officer MNI/H Radiation Safety Office, Room WB211 Phone: 398-8927 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 10 Table (to Appendix 10) Classification of Radio-Nuclides The most commonly licensed radionuclides have been grouped into Class A, Class B and Class C, based upon their radiological properties. Class Class A Class B Class C Radio-Nuclide All alpha emitters and their daughter isotopes. Na-22 N-24 Co-60 Ir-192 Sb-124 Ta-182 Zn-65 As-74 Au-198 Br-82 Co-58 F-18 Fe-59 Ga-67 Gd-153 Hg-203 I-131 In-111 In-114m Nb-95 Rb-84 Rb-86 Sc-46 Se-75 Sm-153 Sn-113 Sn-123 Sr-85 Sr-90 Au-195m C-14 Ca-45 Cd-109 Ce-144 Cl-36 Co-57 Cr-51 H-3 I-123 I-125 Ni-63 P-32 P-33 Re-186 Re-188 Ru-103 S-35 Sr-89 Tc-99 Tc-99m Tl-201 Y-90 Yb-169 When using more than one radio-nuclide in a room, the radio-nuclide with the lowest (most restrictive) contamination limit must be used to determine the limit (Class A, Class B or Class C) that applies to the room. If a radio-nuclide is not listed in the table, contact your CNSC licensing officer at 1-888-2292672. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 11 Appendix 11 Converting Liquid Scintillation Counter (LSC) Readings to New CNSC Regulatory Criteria for Radioactive Contamination - or How to convert CPM measurements to Bq/cm2 MNI/H Radiation Safety Office (Updated: April 29th, 2002) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 11 Converting LSC Readings to New CNSC Regulatory Criteria for Radioactive Contamination - or How to convert CPM measurements to Bq/cm2 INTRODUCTION Removable contamination is typically monitored with wipes assayed in a liquid scintillation counter (LSC) and reported in cpm (counts per minute). As a rule, surfaces with cpm readings of more than three times the background are presently considered as contaminated at our Institute. The CNSC requires that contamination be reported in terms of Becquerels/cm2 (Bq/cm2). The new CNSC criteria for non-fixed or removable radioactive contamination (see for instance condition 15 of Lab. License 01187-2-08.3) are as follows: Table 1 Type of Area All areas, rooms or enclosures where unsealed radioisotope are used or stored. All other areas CNSC limits for non-fixed contamination Class A 3 Bq/cm2 Class B 30 Bq/cm2 Class C 300 Bq/cm2 Class A 0.3 Bq/cm2 Class B 3 Bq/cm2 Class C 30 Bq/cm2 N.B : The CNSC has « replaced » the AECB as of May 31, 2000, and a number of regulations have changed in the process of this transition. Please refer to the preceding document (Appendix 10) entitled “MNI/H Contamination Control Protocol” for more details on the changes regarding the contamination criteria. The present document will guide you through the steps involved in converting cpm readings to Bq/cm2 as in the past, but taking into account the new CNSC contamination criteria. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 11 AREA CLASSIFICATION As an example, for Class C Radionuclides (most of the radionuclides on your license fall into this category), the limit of 300 Bq/cm 2 applies only to those areas which are exclusively reserved for radioisotope use. Areas where radioisotopes are used only occasionally should be treated as nonradioactive areas, and the stricter limit of 30 Bq/cm 2 should be used. Background Information The following equation is given in AECB document INFO-0545 to convert cpm to Bq/cm 2 : Arem [Bq/cm2] = N (cpm) / [Efficiency x 60(sec/min) x Area(cm2) x F] where: Arem N Area Efficiency F 60 (1) is the removable activity in Bq/cm 2 is the net count rate in counts per minute and equals: (total count rate - background count rate), both in cpm = Ntotal - Nbackground is the area wiped (not to exceed 100 cm2) is the efficiency of the LSC for the radioisotope in question is the collection factor for the wipe that takes into account the fact that only a small amount of removable activity is collected on a wipe. This factor is taken as: 0.01 (1%) for dry wipe 0.1 (10%) for wet wipe sec/min conversion factor In order to use equation (1), the efficiency of the LSC for all isotopes which will be assayed in it must be known. The efficiencies of LSCs vary and depend upon the energy of the radiation emitted (or in other words, on the radioisotope). Typical efficiencies of a LSC (Rackbeta 1219) are given in the Table below: Isotope Efficiency (as per instruction manual) 3H 60 % 14C 95 % 32P 99 % 35S 95 % The problem with using these efficiency figures for contamination control type of measurements are: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 11 Last revision of this Appendix on: February 28th, 2006 (1) The number of counts detected can vary considerably with the quality of the sample. For instance, a swipe from a dirty area would typically yield counts lower than that from an identical swipe collected from an area which is clean because the dirt dispersed in the scintillation cocktail would not allow all the light to pass through it. (2) The counting efficiency of LSCs depends upon the radioisotope (specifically on the energy of the or emission). Therefore, when several radioisotopes are used in a specific working area, how should one account for different efficiencies? (3) Counting efficiency measurements given in the instrument manuals are made under very specific and controlled conditions. The bottom line is that the use of counting efficiencies of LSCs for cpm to Bq/cm 2 conversion in wipe test measurements is imprecise. It can lead to considerable errors in the estimation of the actual contamination. To minimize the confusion and to eliminate the guesswork associated with this type of conversion, we at the MNI/H radiation safety office have decided to adopt a universal efficiency factor of 50% for all radioisotopes and all liquid scintillation counters. By doing this, we will be overestimating the contamination in some cases, but the error will always be on the side of caution, so that there will be no risk of overlooking any contamination whatsoever. Method ASSUMING the wiped area is 100 cm2, and your instrument (LSC) gives results in CPM, Table A contains the necessary information to determine the presence of unacceptable levels of contamination by answering the following questions: First: Determine what class the radioisotope you are wipe-testing for belongs to by consulting Appendix 3. If you have been using radioisotopes that belong to more than one class, use the row in Table A that shows the lower CPM values. Example: You have used P-32 (Class C) and I-131 (Class B) during the same experiment on the same bench. In this case, you have to use the row belonging to Class B in order to determine whether contamination levels are within CNSC limits. The remaining steps are as before: 1. Area TYPE: Is the area wiped classified as an area where radioisotopes are used? a. YES USE Column (3) b. NO USE Column (4) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 11 2. Swipe TYPE: Did you wipe the area with a wet wipe? a. YES USE Column labeled (A) b. NO USE Column labeled (B) 3. What is the net count rate for your sample IN CPM? Sample count rate (CPM) = total count rate from sample (CPM) - background count rate (CPM) = Ntotal - Nbackground N.B.: The background count, Nbackground , is obtained by using a blank wipe and assaying it the same way as a regular wipe. In other words, take a clean swipe, place it in a vial, add the scintillation cocktail and “count” it. 4. Is the net count rate in CPM of your sample greater than the count rate given in the table? a. b. YES NO Contamination exists, cleanup is required. See box below. No contamination. Cleanup may still be required. See box below. REMEMBER: TABLE A MAY ONLY BE USED IF ALL OF THE FOLLOWING CONDITIONS ARE SATISFIED: (A) (B) THE WIPED AREA MEASURES ~100 cm2. (It is not necessary to wipe a 10 x 10 cm2 square area. Swipes covering an irregular area roughly 100 cm2 in extent are acceptable). THE LSC GIVES RESULTS IN CPM. The numbers in Table A were obtained by performing a “back-calculation” and estimating the net counts per minute, N, using equation (1). How Do these New Regulations Affect You? Routine contamination monitoring is done to ensure safe working conditions for all personnel. Having explicit limits (Table A) for different working areas eliminates guesswork from the process of contamination control so that one standard method is used for all labs at any institution. A copy of Table A must be kept in your wipe test folder. At the MNI/H, a copy of the most recent wipe test is required before radioactive materials are approved for purchase by the radiation safety office. Please notice the importance of assessing compliance with contamination criteria in the light of the following 3 important determinants: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 11 (a) (b) (c) The type of swipe (wet or dry). The classification of the area (whether used for radioisotope work or not). Areas where radioisotopes are used should be clearly indicated on the swipe test results. Remember there are areas which are used only for work involving radioisotopes and nothing else. Identify these areas either on the lab layout diagram itself or on the table used to report the count rates in different areas. All other areas including “safe” work benches, desks etc. fall under the stricter contamination criteria (column 4 The type (Class) of radioisotopes that have been used. WHAT CONSTITUTES CONTAMINATION? The Radiation Safety Committee and the MNI/H radiation safety office are committed to keeping radiation levels ALARA (as low as reasonably achievable). Therefore, the acceptable limits for contamination in effect at the MNI/H have been set at a much lower level than those prescribed by the CNSC contamination criteria (Table 1). Rule: Areas where detected total counts are more than 3 times the background level will be considered as contaminated and a clean-up will be required. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 11 Table A CPM - to - Bq /cm2 Conversion Rules for all Liquid Scintillation Counters at the MNI/H (1) (2) (3) (4) Radio- Efficiency Net Counts in CPM indicating Isotope (%) the presence of contamination in areas where radioactivity is used (A) (B) Wet Wipe Dry Wipe Net Counts in CPM indicating the presence of contamination in areas where radioactivity is NOT used (A) Wet Wipe (B) Dry Wipe Class C 50 90,000 9,000 9,000 900 Class B 50 9,000 900 900 90 Class A 50 900 90 90 9 THE INFORMATION GIVEN IN COLUMNS (3) and (4) OF TABLE A MAY BE USED ONLY IF ALL OF THE FOLLOWING CONDITIONS ARE SATISFIED: (A) THE WIPED AREA MEASURES 100 CM 2. (It is not necessary to wipe a 10 x 10 cm2 square area. Swipes covering an irregular area roughly 100 cm2 in extent are acceptable). (B) THE LSC GIVES RESULTS IN CPM. Only valid for those areas reserved exclusively for work involving radioisotopes. For all other areas, the data in column (4) apply. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 12 Appendix 12 Internal Inspection Checklist (Last update: July 25th, 2004) Lab Director: ________________________ Lab Room Numbers: _______________________ Survey Performed with: __________________________________ Phone: _______________ CHECKLIST O.K. NOT O.K. COMMENTS N/A general lab conditions number of occupants lab lockable fume hoods, air flow int. permit posted safety rules posted no food & drink in lab chair & bench covers lab-coats & gloves TLD badge worn if req. r.i. inventory updated working area labeled r.i. labeled & locked disposal area labeled warning signs posted radiation log book etc. meter: cal., battery O.K. Rad. Saf. Man. available wipe tests updated eye wash(test) / shower rad. safety education sealed sources used Overall Rating A (excellent) B (acceptable) C (can improve) D (fail) Lab Representative: _____________________________________Date:_________________ Radiation Safety Officer: __________________________________Date:_________________ Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 13 Appendix 13 Request for Decommissioning of Radioisotope Laboratory This form must be filled out by the Primary Investigator / Lab Director when a lab licensed for radioisotope use is either vacated or use of radioactive materials is stopped. The CNSC requires that a record of inventory disposition as well as the final wipe test results be forwarded to the Radiation Safety Office. RADIOISOTOPE USER PERMIT INFORMATION: Internal Permit Number: Primary Investigator / Lab Director: Department: Room number of lab to be decommissioned: This is to certify that I do not intend to continue the use of radioisotope in the above mentioned room. INVENTORY INFORMATION: (check all applicable) I have no radioactive material currently at this location. All radioactive material obtained on the permit has been disposed of as per guidelines. All radioisotope inventory stored at the above location has been transferred to Room: ______________ which is licensed for the use/storage of radioisotope. All radioisotope inventory stored in the above location has been transferred to the lab of _____________________________________ who holds a valid MNI/H internal license. The location of this lab is:__________________ All radiation warning signs and labels have been removed. Other(specify): SIGNATURES: Primary Investigator: Date: RSO: Date: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14a Appendix 14a (From: Radiation Safety Officer’s Handbook) Physical Characteristics for Commonly Used Radionuclides Major Radiation Energies a, b or c in MeV (abundance in %) Radionuclide HalfLife Beta 3 H 12.3 y R h-1 mCi-1 at 1 cmab Gamma 0.018 (100) + 0.97(100) Specific Gamma-Ray Constant Shielding Data mGy h-1 MBq-1 at 1 cm Half-Value Layer in Pb (mm) a, c Maximum Range of Beta Particles in Water (mm)d Tenth Value Layer in Pb (mm)d - - - - - 0.007 0.511(200) 5.91 1.6 4 - - 11 20.3 m 14 5730 y 0.16 - - - - - 0.3 13 10.0 m + 1.20(100) 0.511(200) 5.91 1.6 4 - - 15 2.0 m + .74(100) 0.511(200) 5.91 1.6 4 - - 18 1.8 h + 0.65(97) 0.511(194) 5.73 1.5 4 - - 22 2.6 y + .546(90)d 1.275(100)d 12 3.2 10 37 (2.0)d 24 15.0 h 1.4(100) 1.369(100) 18.4 4.96 15 59 6.4 32 14.3 d 1.7(100) - - - - - 8.2 33 25.4 d 0.249(100) - - - - - 0.7 35 88.0 d 0.17 (100) - - - - - 0.33 0.709(98) - - - - - 2.8 C C N O F Na Na P P S 36 CI 301000 y 45 165 d 0.25(100) - - - - - 0.7 47 4.56 d 0.67(82) 1.98(18) 0.490(5) 0.815(5) 1.398(74) 5.7 1.541 - - 9.7 51 27.8 d - 0.320(9) 0.164 0.04 2 7 - Ca Ca Cr Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14a Appendix 14a (continued) Major Radiation Energies a, b or c in MeV (abundance in %) Radionuclide HalfLife Beta 55 Fe 59 Fe Gamma mGy h-1 MBq-1 at 1 cm Half-Value Layer in Pb (mm) a, c Maximum Range of Beta Particles in Water (mm)d Tenth Value Layer in Pb (mm)d - 0.0059(23) - - - - - - 0.27(46) 0.46(53) 1.56(0.3) 0.19(2.4) 1.1(43) 6.19 1.7 11 44 - 0.09(15) 0.93(40) 0.185(24) 0.296(22) 0.388(7) 0.95 0.26 0.7 - - 0.511(176) 5.37 1.45 4 - - 0.93 0.25 0.3 ~0.7 - 78 h 68 1.13 h Ga R h-1 mCi-1 at 1 cmab Shielding Data 2.7 7 67 Ga Specific Gamma-Ray Constant + 1.90(87) 57 267 d - 0.014(9) 0.122(87) 60 5.26 y 0.31(99 +) 0.173(100) 13.2 3.568 12 40 - 83 100.1 y 0.066 - - - - - - 0.511(38) 1.16 0.31 4 - - 1.150(49) 2.7 0.73 10 42 - 2 0.541 2 5.1 Co Co Ni 64 12.9 h 65 245 d Cu Zn 0.057(39) + 0.64(19) 1.1 0.33(2) 120 d 0.08-0.25 e 0.121(16) 0.136(57) 0.265(60) 0.280(25) 0.401(13) 192 74.2 d - - - - - - - 198 2.7 d 0.97(99) 0.412(96) 2.34 0.632 0.3 - - 203 47 d 0.214(100) 0.279(82) 1.33 0.359 - - - - 0.135(2.6) 0.167(10) x-rays 0.068 - 0.08(95) 0.44 - 0.2 0.9 - 75 Se Ir Au Hg 201 Ti 73 h Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14a Appendix 14a (continued) Explanation of Subscripts a Padikal TN & Fivozinsky SP, Medical Physics Data Book, National Bureau of Standards (1982) b ICRP Publication 25: The Handling, Storage, Use and Disposal of Unsealed Radionuclides in Hospitals and Medical Research Establishments (1971) c Gordon K, Shields R and Kovarov El :Manual on Radiation Protection in Hospitals and General Practice: Volume 4 Unsealed Sources, jointly sponsored by IAEA / ILO / WHO / PAHO / CEC d Institute of Physical Sciences in Medicine Report 63: Radiation Protection in Nuclear Medicine and Pathology (1991) e To describe the clearance of inhaled radioactive materials from the lung, materials are classified as D, W or Y which refer to their retention in the pulmonary region. This classification applies to a range of half-times for D of less than 10 days, for W from 10 to 100 days and for Y greater than 100 days. In the interest of simplicity when creating the above table, the most restrictive inhalation ALI was selected. The same strategy was applied for different values of ingestion ALIs in ICRP 61. Note that besides applying a lower annual dose limit, ICRP-61 uses a new system of tissue weighting factors. Please refer back to the original ICRP publications (see f and g below) for more detailed information. f ICRP Publication 30: Limits for Intakes of Radionuclides by Workers, Part 1 (1979), Part 2 (1980) and Part 3 (1981) g ICRP Publication 61: Annual Limits on Intake of Radionuclides by Workers Based on the 1990 Recommendations (1991) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14b Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14c Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d Appendix 14 (d) INFO-O700 (E) DOSE LIMITS FOR PREGNANT WORKERS RATIONALE FOR THE LIMITS IN THE RADIATION PROTECTION REGULATIONS by Radiation and Environmental Protection Division Atomic Energy Control Board Ottawa, Ontario January 1999 Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14d Last revision of this Appendix on: February 27th, 2006 Dose Limits for Pregnant Workers--Rationale for the Limits in the Radiation Protection Regulations Published by the Atomic Energy Control Board AECB Catalogue number INFO-O700 (E) @ Minister of Public Work and Government Services Canada 1999 Extracts from this document may be reproduced for individual use without permission provided the source is fully acknowledged. However, reproduction in whole or in part for purposes of resale or redistribution requires prior written permission from the Atomic Energy Control Board. This publication is distributed free of charge upon request. For additional copies, or for further information about the AECB, please write or call: Communications Division Atomic Energy Control Board P.O. Box 1046, Station B Ottawa, Ontario KIP 5S9 Telephone: (613) 995-5894 or 1-800-668-5284 Fax.: (613) 992-2915 E-mail: info@atomcon.gc.ca Web site: www.gc.ca/aecb Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d Table of Contents SUMMARY HISTORICAL BACKGROUND OTHER INFORMATION ON RISK TO THE EMBRYO AND FOETUS TABLE 1: Estimates of the effects of low doses of radiation on the human embryo and foetus TABLE 2: Comparison of risks to the foetus during pregnancy TABLE 3: Risk of childhood cancer per 10 000 exposed from 4 mSv of radiation dose to embryo and foetus, from other publications REFERENCES Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14d Last revision of this Appendix on: February 27th, 2006 SUMMARY When a nuclear energy worker (NEW *) becomes pregnant, she is required by the new Radiation Protection Regulations to declare her pregnancy to the licensee associated with her workplace. The licensee may not be her employer (she may work for a contractor), but it is the licensee who is obliged by the regulations to inform all NEWs of the health risks due to radiation, including the particular risks to the foetus, and it is the licensee who must be notified in writing of the pregnancy. The licensee is required by the same regulations to ensure that the woman's dose does not exceed the more restrictive limit for pregnant NEWs, i.e., 4mSv effective dose to the abdomen or an intake of 0.2 ALl. This combination of limits on external and internal radiation is intended to limit the effective dose to the foetus to 4mSv during the remainder of the pregnancy following declaration. The limit is lower than the regular NEW limits of 50mSv in a single year and 100 mSv in five years because of the greater sensitivity of the embryo and foetus to radiation. This document discusses the AECB' s rationale for proposing the 4mSv dose limit for pregnant workers in the new Radiation Protection Regulations. This dose limit is higher than the limit of 2mSv which was recommended by the ICRP in its Publication of 60 and proposed by the AECB in its Consultative Document C-122 (1991). The reasons for proposing a dose limit of 4mSv are based mainly on an assessment of the risks of detriment to the embryo and foetus. They can be enumerated as follows: i) fundamentally, 4mSv is a low dose, and measuring it with precision is difficult; ii) the risk to the embryo and the foetus associated with a dose of 4mSv to the mother is very small; iii) the risk to the embryo and the foetus from a dose of 4mSv is certainly very small when compared to the risks from other sources; iv) during consultations leading to the adoption of the new limit, workers affected by it indicated to the AECB that the risk implications were acceptable; v) adoption of the ICRP 60's recommended limit of 2mSv could lead to discrimination against women, because some employers might conclude that the only effective method of compliance with the very low dose limit would be to remove a pregnant worker from work with radiation, or not hire women at all. *) [NEW: Nuclear energy worker is defined in the Nuclear Safety and Control Act as a person who is required, in the course of the person's business or occupation in connection with a nuclear substance or nuclear facility, to perform duties in such Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14d Last revision of this Appendix on: February 27th, 2006 circumstances that there is a reasonable possibility that the person may receive a dose of radiation that is greater than the prescribed limit for the general public.] HISTORICAL BACKGROUND i) Publication C-122: Proposed Amendments to the Atomic Energy Control Regulations for Reduced Radiation Dose Limits Based on the 1991 Recommendations of the ICRP. The Consultative Document C-122 was published in July 1991, announcing the AECB's intention to incorporate the ICRP 60 recommendation into the regulations. A dose limit of 2mSv to the surface of the abdomen and an intake of 0.05 AU were proposed for pregnant workers. The ICRP had stated that protection of the foetus should be "broadly comparable" to that of the general public. However, in ICRP 60 it was not clear whether the external dose limit was to be in addition to the internal limit. The AECB has interpreted the recommended dose limit of 2 mSv as a combination of a 1mSv limit for external radiation and a 1 mSv limit for the effect of intakes of radioactive material by the mother during her pregnancy. A dose limit of 2 mSv during pregnancy was interpreted by the AECB as "broadly comparable" to the annual 1 mSv dose limit for the public. ii) Public consultations on C-122 During the public consultations of C-122, the proposed 2mSv dose limit was criticized by some interested parties as being unnecessarily low. The critics noted that doses at this level, especially those from the internal component, would be difficult to measure and compliance would be difficult to demonstrate. It was feared by workers who submitted comments that some employers might conclude that the only effective method of compliance with the dose limit of 2mSv would be to remove a pregnant worker from work with radiation. If other work were not available, this could result in a lay-off, and eventually might lead to discrimination against the hiring of women for some types of radiation work. iii) Public meetings and the technical presentations on the risk to the embryo and foetus from prenatal exposure The AECB felt that it was necessary to give those radiation workers who were most likely to be affected an opportunity to present their views directly to AECB staff. Therefore, a series of eight public meetings was held in seven cities across Canada, and at a mine site, to obtain further comments. The main objective of these meetings, attended by a total of 338 people, was to discuss the proposed limit of 2mSv with the female workers and to include them in the decision making process. During the meetings, an AECB consultant (Dr. D. Myers) presented the risks to the embryo and foetus from 2mSv as well as the risk from natural causes. A report entitled Comments on ICRP 60 Rationale for Dose Limits for the Pregnant Worker (INFO-0421) was used for this purpose. It indicated that a dose of 2 mSv to the embryo and foetus would carry a risk of 1:10,000 for childhood cancer. For fatal cancer in later life, 2mSv to the embryo and Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14d Last revision of this Appendix on: February 27th, 2006 foetus carries a risk of 3:10,000. These risks were compared to the risks which the foetus faces from natural causes, which are much higher. Table 1 shows the comparison of the risks from 10mSv, 4mSv and 2mSv with the natural occurrence of fatal and non-fatal cancers. Table 2 Women who work in the uranium mining industry receive some exposure from inhaled radon progeny. Calculations based on the latest ICRP lung model (LUDEP) show that since most of the inhaled radioactive material is deposited in the mother's lung, the dose to the foetus is about 1/1000 of the lung dose. Therefore, the normal occupational limit for radon progeny affords adequate protection for the foetus. The meeting participants were presented with data from the National Dose Registry (NDR) for doses received by pregnant workers. Since 198 contains a list of a number of natural risks to a foetus. Because choosing a dose limit is mainly a risk-based decision, it is important to note that the quantitative risk estimates for very small doses have many uncertainties. Therefore, the numbers presented in Table 1 should not be interpreted as exact figures but as approximate values. 6, 300 to 400 pregnant workers have been monitored for external radiation doses each year. The maximum dose to any individual, recorded for the remainder of the pregnancy following declaration, varied from 1.3mSv to 2mSv. The dose limit at the time was 10mSv to the abdomen of the worker. The NDR data for the category of nuclear medicine technologist (not those who are pregnant) indicate that 50% of these workers receive less than 2mSv per year, and only 5% receive more than 5mSv per year. These doses are well below the occupational limits and should not be a source of concern to the majority of workers in this field. Female workers in other sectors of the nuclear industry may receive higher average doses but it is expected that in most of these cases the licensee would be able to transfer them to jobs with lower doses if they became pregnant. The NDR data cited above do not include any contribution from internal contamination. Information that is available at present suggests that this does not make a major contribution to total dose in most cases. The participants at the meetings were of the general opinion that slightly higher risks, i.e., about double that from 2mSv, would be acceptable when compared to the risks to the foetus from natural causes. Following the technical presentations, a majority of the workers* who would be most affected by the proposed limit suggested a dose limit of4 or 5mSv during pregnancy; a value between the previous limit of 10mSv and the ICRP's recommendation of 2mSv. (* One group of workers did not support the higher limit. This group was subject to general labor code regulations in their province which were seen as more advantageous to workers who became pregnant.) Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d OTHER INFORMATION ON RISK TO THE EMBRYO AND FOETUS Table 3 summarizes additional information obtained from other publications on the effects of radiation exposure to the embryo and foetus. BEIR V, 1990: For childhood cancer, the risk estimate quoted in ICRP 60 is 2.8 x 10-5 per mSv (or 1:10000 for 4mSv). The same data were analyzed earlier by Gilman et at. (1989) showing a risk estimate of 13 x 10-5 per mSv (or 5:10,000 for 4mSv). UNSCEAR 1994: UNSCEAR concluded that studies of uterine exposure gave a wide range of risk estimates from relatively high to essentially undetectable risk, including (possibly) none at all. It was stated in the report that there was no biological reason to assume that the embryo or foetus is radiation resistant, but the exact quantification of effects was subject to much uncertainty. Based on the more recent analysis of the Oxford survey of childhood cancer, risk for mortality of all childhood cancers is about 5 x 10-5 per mSv. This value corresponds to a mortality risk of 2: 10 000 for 4mSv prenatal exposure. NCRP 1994: A Commentary by the NCRP entitled Considerations Regarding the Unintended Radiation Exposure of the Embryo, Foetus or Nursing Child, May 1994, which is the most recent NCRP publication on the subject, includes a section on radiation risks which reviews information from other NCRP publications. For childhood cancer induction following prenatal exposure, the Commentary concludes that the risk is numerically about the same as for the irradiation of young children, i.e., 10 x 10-5 per mSv (or 4: 10000 for 4mSv). For heritable effects, i.e., effects in the foetal genetic material that will be expressed in foetus' descendants, the risk is given as 10-5 per mSv. This figure is derived from animal experiments and no human study has shown such risks. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d TABLE 1: Estimates of the effects of low doses of radiation on the human embryo and foetus Risk for foetus following 10mSv exposure over the 8 months of pregnancy (per 10,000) Risk for the foetus following 4mSv exposure over the 8 months of pregnancy (per 10,000) Childhood cancers 5* 2 1 200 Life-time cancers 15 6 3 2500 Health detriment Risk for the foetus following 2mSv exposure over the 8 months of pregnancy (per 10,000) Spontaneous incidence per 10,000 live births Source: Modified from Myers O.K. Comments on ICRP 60: Rationale for Dose Limits for the Pregnant Worker (INFO-0421), June 1992. * This risk estimate is derived from a risk coefficient = 5 x 10-2 per Sv (95% Cl, 0.8 x 10-2 -9.5 x 10-2 per Sv) from Mole R.H. (1990). Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d TABLE 2: Comparison of risks to the foetus during pregnancy Pregnancy Outcome (Effect) Risk of Occurrence (% of foetus exposed to risk factor that develop the effect) Maternal German Measles Defects of heart, lens of the eye, skeletal muscle, inner ear, teeth 67% Maternal cigarette smoking Low birth weight 20% Maternal alcohol consumption: 2 drinks/day Low birth weight 10% Signs of foetal alcohol syndrome (growth deficiency, brain dysfunction, characteristic facial signs) 10% Risk Factor 2-4 drinks/day 4 drinks/day chronically alcoholic Maternal age: <20 years 35-39 yrs. Living at high altitude: 5000 ft. Unknown Unknown Genetic Down’s syndrome (mental and physical growth retardation) Low birth weight 20% 50% 0.04% 1.5% 10% Developmental anomaly 2-4% Intrauterine growth retardation 2-3% ABO haemolytic disease 1% Chromosomal abnormalities Unknown 0.5% (natural incidence) Major malformation rate at Unknown 2.75% delivery Malformation and genetic Unknown 6-10% diseases at 1-2 yrs. Of age Spontaneous abortion during Unknown 30-50% pregnancy Childhood leukaemia deaths 0.03% Embryo or foetal irradiation: before age 12 10 mSv Deaths from other childhood 0.03% cancers before age 10 Source: Medical Effects of Ionizing Radiation, Mettler, F.A. and Moseley, R.D.; Grune and Stratton Inc. 1985. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d TABLE 3: Risk of childhood cancer per 10 000 exposed from 4 mSv of radiation dose to embryo and foetus, from other publications Health detriment Gilman et al. (1989) BEIR V (1990) UNSCEAR (1994) NCRP (1994) 5* 1** 2@ 4# Childhood cancers The risk estimates in the table are derived from the following risk coefficients: * Risk estimate = 13 x 10-2 per Sv (95% CI, 8.4 x 10-2 -19.2 x 10-2 per Sv) ** Risk estimate = 2.8 x 10-2 per Sv (upper bound risk estimate) @ Risk estimate = 5 x 10-2 per Sv (95% CI, 0.8 x 10-2 -9.5 x 10-2 per Sv) (from Mole R.H. et al. 1990) # Risk estimate = 10 x 10--2 per Sv Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14d REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. Consideration regarding the unintended radiation exposure of the embryo foetus or nursing child (1994). NCRP Commentary No.9, National Council on Radiation Protection and Measurements, Bethesda, Maryland. Gilman E.A., Kneale, G.W., Knox, E.G. et al. (1989) Recent estimates of the risk of childhood cancer following the irradiation of the foetus in: Low Dose Radiation Biological Basis of Assessment (K.F. Baverstock and J. W. Stather eds), Taylor and Francis, London. Health Effects of Exposure to Low Levels of Ionizing Radiation (1990). Committee on the Biological Effects of Ionizing Radiations. National Research Council, National Academy Press, Washington D.C. International Commission on Radiological Protection, ICRP Publication 60 (1991), Pergamon Press. Mettler, F.A. and Moseley, R.D.: Medical Effects of Ionizing Radiation, Grune & Stratton Inc., 1985. Mole, R.H.: Fetal dosimetry by UNSCEAR and risk coefficients for childhood cancer following diagnostic radiology in pregnancy (1990). J. Radiol. Prot. 10, pp. 199-203. Mole, R.H.: Childhood cancer after prenatal exposure to diagnostic x-ray examinations in Britain (1990). Brit. J. Cancer 62, pp. 152-168. Sources and Effects of Ionizing radiation. United Nations Scientific Committee on the Effects of Atomic Radiation. 1994 Report to the General Assembly. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14e Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14f Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14g Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14h Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14i Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14k Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Appendix 14l Radiation Safety Manual of the MNI/H Last revision of this Appendix on: February 27th, 2006 Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14m Appendix (14m) Canadian Nuclear Safety Commission Radiation Safety Data Sheet This data sheet presents information on radioisotopes only. For information on chemical compounds incorporating this radionuclide, see the relevant Material Safety Data Sheet. Part 1 - RADIOACTIVE MATERIAL IDENTIFICATION Chemical Symbol: P Common Names: Phosphorus Atomic Weight: 32 Atomic Number: 15 Part 2 – RADIATION CHARACTERISTICS Physical Half-Life: 14.3 days CNSC Exemption Quantity (in Bq): 10 kBq A CNSC license is not required if the amount of radioactive nuclides possessed is less than one Exemption Quantity. Average Energy (MeV)** Maximum Energy (MeV)*** Dose Rate at 1m (mSv/h) / (GBq) Recommended Shielding Neutrons - - - - Gamma & X-rays - - - - Beta* 0.6947 1.710 9.17 1 cm Plexiglas Alpha - - - - Principal Emissions * Where beta radiation is present, Bremsstrahlung radiation will be produced. Shielding may therefore be required. ** *** Average energy of most abundant emission. Maximum of most abundant emission. Progeny Radiation Safety Manual of the MNI/H n/a Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 14m Part 3 – DETECTION AND MEASUREMENT Method of Detection: Geiger-Mueller detector, gamma survey meters with sodium iodide crystal detectors Dosimetry: External: TLD (whole body & skin ______ Internal: Whole body __X__ Thorax ____ Extremity ________ Neutron _________ Urine analysis ___X____ Other (specify) ____ Part 4 - PREVENTIVE MEASURES Chromic acid and its salts have a corrosive action on the skin and mucous membranes. Sodium phosphate is a mild irritant. Phosphocol and Sodium Phosphate (P-32) solutions may emit radioactive fumes containing P-32 when heated to decomposition. Recommended protective clothing: Disposable plastic, latex, or rubber gloves. Lab coat. Safety glasses. Keep handling time to minimum. Use syringe shields (aluminum or lead foil) and tongs to avoid direct skin contact. When possible work behind a Plexiglas screen. Finger dosimeters should be worn if using quantities greater than a few tens of MBq (~a mCi). Vial should be encased in Lucite. Always use the principles of time, distance and shielding to minimize dose. Consult CNSC license for requirements concerning engineering controls, protective equipment, and special storage requirements. Part 5 - ANNUAL LIMIT ON INTAKE Ingestion Inhalation Compound Type All compounds All compounds Annual Limit on Intake (MBq) 8 8 EMERGENCY PROCEDURES Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 14m Last revision of this Appendix on: February 27th, 2006 The following is a guide for first responders. The following actions, including remediation, should be carried out by qualified individuals. In cases where life threatening injury has resulted, first treat the injury, second deal with personal decontamination. Personal Decontamination Techniques Wash well with soap and water and monitor skin Do Not abrade skin, only blot dry Decontamination of clothing and surfaces are covered under operating and emergency procedures Spill and Leak Control Alert everyone in the area Confine the problem or emergency (includes the use of absorbent material) Clear area Summon Aid Emergency Protective Equipment, Minimum Requirements Gloves Footwear Covers Safety Glasses Outer layer or easily removed protective clothing Suitable respirator selected Revision number: 0 Radiation Safety Manual of the MNI/H Date of revision: 5 April 2004 Version No.: 2 September 1st, 2007 Last revision of this Appendix on: Feb ruary 27th, 2006 Appendix 15 Appendix 15 Exemption Quantities (EQ) for Radioactive Nuclear Substances appearing on CNSC licenses issued to the Montreal Neurological Institute (Last update: November 22, 2005) From: Schedule in Nuclear Substances and Radiation Devices Regulations (May 31, 2000) and Appendix C to License Application Guide C-237, and e-mail message from CNSC (Cu-64, I-124). Useful Multiples of Exemption Quantities (EQs) in Bq (mCi) Radioisotope 1 EQ 100 EQs 10'000 EQs C-11 0.1 MBq 2.7 µCi 10 MBq 270 µC i 1 GBq 27mCi C-14 100 MBq 2.7mCi 10 GBq 270mCi 1TBq 27Ci O-15 1 MBq 27 µCi 100 MBq 2.7mCi 10 GBq 270mCi Ca-45 1 MBq 27 µCi 100 MBq 2.7mCi 10 GBq 270mCi Cr-51 1 MBq 27 µCi 100 MBq 2.7mCi 10 GBq 270mCi F-18 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi - - Fe-55 - - - - Cu-64 0.1 MBq 2.7 µCi 10 MBq 270 µC i 1 GBq 27mCi Ga-68 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi H-3 1 GBq 27mCi 100 GBq 2.7Ci 10 TBq 270Ci I-124 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi I-125 1 MBq 27 µCi 100 MBq 2.7mCi 10 GBq 270mCi I-131 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi P-32 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi P-33 1 MBq 27 µCi 100 MBq 2.7mCi 10 GBq 270mCi S-35 100 MBq 2.7mCi 10 GBq 270mCi 1TBq 27Ci Tc-99m 10 MBq 0.27mCi 1 GBq 27mCi 100 GBq 2.7Ci Ge-68 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi Cs-137 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi Na-22 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi Ra-226 10 kBq 0.27µCi 1 MBq 27µCi 100 MBq 2.7mCi Eu-152 - - - Co-57 0.1 MBq Radiation Safety Manual of the MNI/H 2.7µCi 10 MBq 270 µC - - 1 GBq 27mCi Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 16 Appendix 16 Area Classification Requirement as per CNSC License Application Guide C-237, Appendix C For labs where more than one Exemption Quantity of an unsealed nuclear substance is used at a single time. ALI stands for Annual Limit on Intake (ingestion if not otherwise specified; see also e-mails from CNSC) (Last update: February 27th, 2006) Radioisotope Activity Limits in Bq (mCi) Basic- Level Interm.-Level High-Level Cont.- Level (Act. < 5 ALI)* (Act. < 50 ALI)* (Act. < 500 ALI)* (Act. > 500 ALI)* C-11 30 GBq 810mCi 300 GBq 8.1Ci 3 TBq 81Ci 3 TBq 81Ci C-14 170 MBq 4.5mCi 1.7 GBq 45mCi 17 GBq 450mCi 17 GBq 450mCi O-15water*) 0.107 TBq 2.9Ci 1.07TBq 29Ci 10.7 TBq 290Ci 10.7TBq 290Ci Ca-45 30 MBq 0.8mCi 300 MBq 8mCi 3 GBq 80mCi 3 GBq 80mCi Cr-51 2.65GBq 70mCi 26.5GBq 700mCi 265GBq 7Ci 265GBq 7Ci F-18 2.00 GBq 55mCi 20 GBq 550mCi 200 GBq 5.5Ci 200 GBq 5.5Ci Fe-55 500 MBq 14mCi 5 GBq 140mCi 50 GBq 1.4Ci 50 GBq 1.4Ci Cu-64 500 MBq 13.5mCi 5 GBq 135mCi 50 GBq 1.35Ci 50 GBq 1.35Ci Ga-68 1 GBq 27mCi 10 GBq 270mCi 100 GBq 2.7Ci 100 GBq 2.7Ci H-3 5 GBq 140mCi 50 GBq 1.4Ci 500 GBq 14Ci 500 GBq 14Ci I-124 7.5 MBq 0.2mCi 75 MBq 2mCi 750 MBq 20mCi 750 MBq 20mCi I-125 5 MBq 0.13mCi 50 MBq 1.4mCi 500 MBq 14mCi 500 MBq 14mCi I-131 5 MBq 0.13mCi 50 MBq 1.4mCi 500 MBq 14mCi 500 MBq 14mCi P-32 40 MBq 1.1mCi 400 MBq 11mCi 4 GBq 110mCi 4 GBq 110mCi P-33 400 MBq 11mCi 4 GBq 110mCi 40 GBq 1.1Ci 40 GBq 1.1Ci S-35 130 MBq 3.5mCi 1.3 GBq 35mCi 13 GBq 350mCi 13 GBq 350mCi Tc-99m 4.5 GBq 125mCi 45 GBq 1.25Ci 450 GBq 12.5Ci 450 GBq 12.5Ci Ge-68 350 MBq 10mCi 3.5 GBq 100mCi 35 GBq 1Ci 35 GBq 1Ci Cs-137 5 MBq 0.13mCi 50 MBq 1.4mCi 500 MBq 14mCi 500 MBq 14mCi Na-22 30 MBq 0.8mCi 300 MBq 8mCi 3 GBq 80mCi 3 GBq 80mCi N.B.: License condition 2108-2 states: Except for the Basic-Level classification, the licensee shall not use unsealed nuclear substances in these rooms, areas or enclosures without written approval from the CNSC. *) value for intravenous O-15 water administration Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 17 Appendix 17 Weekly Contamination Survey Log PERMIT HOLDER: YEAR: LAB. RADIATION SUPERVISOR: LAB. LOCATION: WEEK NO. ISOTOPE USE NO ISOTOPE USE INITIALS WEEK NO. 1 27 2 28 3 29 4 30 5 31 6 32 7 33 8 34 9 35 10 36 11 37 12 38 13 39 14 40 15 41 16 42 17 43 18 44 19 45 20 46 21 47 22 48 23 49 24 50 25 51 26 52 Radiation Safety Manual of the MNI/H ISOTOPE USE NO ISOTOPE USE INITIALS Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 18 Appendix 18 PET Investigators Radiation Safety Information (last revised: February 28th, 2006) This form lists some simple rules and instructions on how to avoid unnecessary exposure to radiation and is intended for investigators and associates who carry out research projects that require their presence in the PET-Suite, but who do not handle radioactive substances themselves. Radiation Safety Rules To be read by the PET Investigator in the presence of the RSO or an authorized delegate. Please read carefully the following basic Radiation Safety items and other Item Check item No. information which you should know to keep radiation exposure to yourself when read and understood. and to your co-workers as low as reasonably achievable (ALARA). I have read and understood the warning signs and posters displayed in 1 the PET-Suite. I am not handling any radioactive substance or withdrawing blood 2 samples in the PET-Suite. 3 I am wearing my radiation monitor (TLD) and a lab. coat. 4 I am not eating, drinking or applying any make-up while in the PET-Suite. 5 I will wash my hands upon leaving the PET-Suite. 6 7 The radiation levels in the PET-Suite are highest around the subject being scanned and close to the pneumatic system port and dose calibrator. Also, I will not enter the scanning room while the transmission scan is in progress. Three ways to reduce radiation exposure to my body are summarized in the principle of: Time, Distance and Shielding. N.B.: I understand that non-compliance with the above rules may lead to the suspension of our human PET research license issued by the CNSC. PERSONAL INFORMATION Name of PET investigator/associate: Phone at work: SIGNATURES PET investigator/associate: Date: RSO or authorized delegate: Date: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Appendix 19 Last revision of this Appendix on: February 28th, 2006 Appendix 19 microPET Investigators Radiation Safety Information (last revised: February 28th, 2006) This form lists some simple rules and instructions on how to avoid unnecessary exposure to radiation and is intended for investigators and associates who carry out research projects that require their presence in the microPET-Suite (rooms 694 and 694A), but who do not handle radioactive substances themselves. Radiation Safety Rules To be read by the microPET Investigator in the presence of the RSO or an authorized delegate. Please read carefully the following basic Radiation Safety items and other Item Check item No. information which you should know to keep radiation exposure to yourself when read and understood. and to your co-workers as low as reasonably achievable (ALARA). I have read and understood the warning signs and posters displayed in 1 the microPET-Suite. I am not handling any radioactive substance or withdrawing blood 2 samples in the microPET-Suite. 3 I am wearing my radiation monitor (TLD) and a lab. coat. 4 I am not eating, drinking or applying any make-up in the microPET-Suite. 5 I will wash my hands upon leaving the microPET-Suite. 6 7 The radiation levels in the microPET-Suite are highest around the object being scanned, close to open or sealed radiation sources or the calibration sources in room 694A. Three ways to reduce radiation exposure to my body are summarized in the principle of: Time, Distance and Shielding. N.B.: I understand that non-compliance with the above rules may lead to the suspension of our consolidated labs license issued by the CNSC. PERSONAL INFORMATION Name of investigator/associate: Phone at work: SIGNATURES Investigator/associate: Date: RSO or authorized delegate: Date: Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 28th, 2006 Appendix 19 Radioisotope Transfer Protocol from Cyclotron to Cone Lab (691, 693, 694) or Animal Care Facility (8th floor) This protocol concerns radio-pharmaceuticals labeled with the following positron emitting tracers: C-11 O-15 F-18 (T1/2 ~ 20 min) (T1/2 ~ 2 min) (T1/2 ~ 110 min) 1 EQ = 2.7 µCi 1 EQ = 27 µCi 1 EQ = 0.27 µCi 1 Always wear TLD radiation badge. 2 Use designated trolley and lead container. 3 Never transport more than 15mCi (370 MBq). 4 Properly label vial containing the radioactive substance (tracer, pick-up). 5 6 (EQ is “Exemption Quantity”) hem.. Form, activity, date of Fill in licence transfer form (cyclotron license to labs license 01187-2-08.2 with Internal Permit MNI_035_694 issued to Dr. Jean-Paul Soucy) The route for transport is: Cyclotron unit, sub-basement (by carpenters shop), elevator (93 or 94) from sub-basement to 6th (Cone Lab) or 8th floor (Animal Care Facility). (Only if elevators 93 and 94 are out of order should the route through the PET-Suite to the first (main) floor and elevators 67 or 68 (X-ray) be used. 7 Never use a crowded elevator (e.g., more than half a dozen passengers). 8 If elevator breaks down, ask passengers to stand along one wall and keep trolley on opposite wall (in this way, the radiation exposure to all passengers is well within acceptable limits). 9 Upon arrival in microPET room, deposit radioactive substance with its inner container in designated storage area in room 694A. 10 Keep an inventory in the microPET lab of radioactivity received and used. N.B: The transport unit (Pb container and trolley) is designed such that the radiation field at the circumference of the trolley is less than 25 micro-R/hr (0.25 micro-Sv/hr). This together with an occupancy factor of 1/16th for the corridors and elevators used for the transfer results in an additional radiation exposure for the public on the premises as well as for the operator of less than 1/10th of the 1mSv/y limit for the general public. Radiation Safety Manual of the MNI/H Version No.: 2 September 1st, 2007 Last revision of this Appendix on: February 27th, 2006 Appendix 20 Appendix 20 Regulatory quantities for some typical radio-nuclides From: License Application Guide C-237 (Nuclear Medicine and Human Research) Radionuclide EQ [MBq] ALI estim. (ingestion) [MBq / year] Intermediate Level [MBq] Basic Level [MBq] Wipes Controlled Area [Bq / cm2] High Level [MBq] Wipes Public Area [Bq / cm2] Waste Disposal Pub. Pub. Air Garb. Sewer [kBq [MBq / [MBq / / m3] kg] yr] 3 Br-82 0.1 37 185 1850 18’500 30 C-14 100 34 170 1700 17’000 300 30 3.7 10’000 - Co-57 0.1 95 475 4750 47’500 300 30 0.37 1000 - Co-58 0.1 27 135 1350 13’500 30 3 0.37 100 - Co-60 0.1 6 30 300 3000 3 0.3 0.01 0.1 - Cr-51 1 530 2650 26’500 265’000 300 30 3.7 100 - F-18 0.01 400 2000 20’000 200’000 30 3 0.01 - - Fe-59 0.1 10 50 500 5000 30 3 0.01 1 - Ga-67 1 100 500 5000 50’000 30 3 0.037 - 1000 1000 5000 50’000 500’000 300 30 37 100 1 Mio. 37 I-123 10 95 475 4750 47’500 300 30 3.7 1000 3 I-125 1 1 5 50 500 300 30 0.03 I-131 0.01 1 5 50 500 30 3 0.037 1'000’0 100 00 0.037 10 In-111 0.1 70 350 3500 35’000 30 3 0.037 100 - Na-22 0.01 6 30 300 3000 3 0.3 0.01 0.1 - P-32 0.01 8 40 400 4000 300 30 0.37 1 - P-33 1 80 400 4000 40’000 300 30 1 10 - Ra-226 0.01 0.07 0.35 3.5 35 3 0.3 0.01 1 - S-35 100 26 130 1300 13’000 300 30 0.37 1000 - Sb-127 0.01 8 40 400 4000 3 0.3 0.37 - - Sr-85 0.1 36 180 1800 18’000 30 3 0.37 Tc-99m 10 900 4500 45´000 450’000 300 30 3.7 1000 - Tl-201 1 210 1050 10’500 105’000 300 30 0.037 100 - 100 GBq - - - - 300 30 1 - 3.7 H-3 Xe-133 Radiation Safety Manual of the MNI/H .175 10 .175 Version No.: 2 September 1st, 2007