Radiation Safety Manual

Transcription

1 Disclaimer This document must be regarded as an example only. It can be used as a guide for the creation of a manual only after careful consideration of the types of activities involving ionizing radiation hazards in your institution and the Philippine Government regulatory requirements. The document is written to comply with specific United States Regulations that may differ from those in the Philippines. This document describes a program for both in vitro research activities and research activities involving the intake of radioactive materials by human research subjects which are regulated much more strictly than simple laboratory use. This document does not include programs for the use of x-ray and other radiation producing machines. A manual is only one element of an effective radiation safety program. An effective program must also have adequate training procedures and a well supported management structure. The words Philippine Academy are generic and do not refer to any specific entity. Please feel free to contact us if you have any questions or comments. Radiation Safety Manual 2001 Administrator Chair, Radiation Safety Committee Radiation Safety Officer Prepared for PHILIPPINE ACADEMY by Edward A Christman, Ph.D., CHP Dr. Florence T. Cua-Christman

2 EMERGENCY PROCEDURES IN CASE OF FIRE, INJURY OR OTHER EMERGENCY WHERE RADIOACTIVITY MAY BE INVOLVED: 1. CALL xxx. State the nature of the emergency, the location and your name and the extension at which you can be reached. State that radioactive materials may be involved 2. QUALIFIED PERSONS SHOULD TREAT A SERIOUS INJURY OR FIRE WITHOUT REGARD TO THE POSSIBLE PRESENCE OF RADIOACTIVITY. HOWEVER, TAKE PRECAUTIONS TO PREVENT THE SPREAD OF ANY RADIOACTIVE CONTAMINATION THAT MAY BE PRESENT. 3. CALL THE RADIATION SAFETY OFFICER. (xxx) xxx-xxxx 4. For additional information see the emergency response procedures in the manual and the Philippine Academy emergency response procedures. Dr. Florence T. Cua-Christman i

3 Table of Contents EMERGENCY PROCEDURES IN CASE OF FIRE, INJURY OR OTHER EMERGENCY WHERE RADIOACTIVITY MAY BE INVOLVED:... i Table of Contents... ii Philippine Academy Radiation Safety Policy... 1 Introduction... 1 The PHILIPPINE ACADEMY Radiation Safety Program Structure... 2 The Professional Standards for the Program... 5 Annual Review and Audit of the Program... 5 Security of Radiation Sources... 6 Acquisition of a Radiation Source... 6 Authorization to Use a Radiation Source... 6 Security of Radiation Sources... 8 Standard operating procedures for the use of unsealed sources of radioactive materials (both medical and non-medical uses) Standard Procedures for Medical (Human Use) of Radioactive Materials The Quality Management Program for Therapeutic Administrations of Radioactive Materials Provision of Information to Patients at Release Response to Spills, Fire and Other Emergencies Standard operating procedures for sealed sources Education and Training Personal Radiation Dose Limits and Personal Monitoring Radiation Dose Limits Appendices The PHILIPPINE ACADEMY Radiation Safety Committee Appendix II Application to use Radioisotopes (Non-Human Use) PHILIPPINE ACADEMY Application to use Radioisotope(s) (non-human use) Experience Relevant to Use of Proposed Material Appendix III Application for Human Use of Radioactive Materials (Insert protocol blank form here) Appendix IV The PHILIPPINE ACADEMY Quality Management Program Appendix V The PHILIPPINE ACADEMY Patient Release Information Form Dr. Florence T. Cua-Christman ii

4 Appendix VI Declaration of Pregnancy Form Appendix VII Radioactive Material Receipt, Inventory and Disposal Forms Appendix VIII Laboratory Contamination Survey Form Appendix IX Survey Record for Sealed Sources of Radioactivity Appendix X Using Radioactive Materials in the Animal Care Facility Appendix XI PHILIPPINE ACADEMY Licenses to Possess and Use Radioactive Materials Appendix XII References and Information about Specific Radionuclides Frequently used vendors of radioactive materials and radiation safety Equipment APPENDIX XIII Records and Reports that must be kept Glossary INDEX Dr. Florence T. Cua-Christman iii

5 The Philippine Academy Radiation Safety Policy The use of all ionizing radiation sources in the PHILIPPINE ACADEMY must be such that radiation exposures to those using the sources and other PHILIPPINE ACADEMY employees, to patients, members of the public and to the environment are kept as low as reasonably achievable. The PHILIPPINE ACADEMY complies with all relevant governmental regulations and the current professional standards. Introduction The PHILIPPINE ACADEMY uses radioactive materials in two major activities, the diagnosis and treatment of patients ("human use") and as one of many tools in laboratory research activities ("non-human use"). Although there are similarities in the requirements and precautions for these different activities, there are also important differences. The ACADEMY Radiation Safety program covers both of these activities. It also has policies and procedures specific to each. Each individual using radioactive materials under any of the ACADEMY's regulatory licenses must be familiar with the policies of the Radiation Safety Program and comply with all of the relevant procedures. This manual reflects the differing nature and concerns of human use and non-human use of radioactive materials. Some sections refer to one of the activities, some cover both. It enunciates the policies of the Radiation Safety Program and contains information and materials to assist users in complying with them. This information includes: the application and procedure for the use of radioactive materials guidance for precautions that must be taken when using this sources procedures that are required for compliance to the governmental regulations procedures for the disposal of radioactive materials You should read this manual and become familiar with the sections that are relevant to your needs and activities. Keep it with your other administrative information. If you supervise others who use ionizing radiation sources, you must also make the manual available to them. If you have questions or concerns about the manual or the radiation safety program, please contact the Radiation Safety Officer or the Radiation Safety Committee Chair. The Philippine Academy Licenses and Permits The ACADEMY has obtained a "specific license of broad scope" (License No ; a copy is in Appendix X) from the US Nuclear Regulatory Commission (NRC) which permits the possession and use of a variety of by-product materials in both medical (human use) and non-medical applications. A similar license (No /00/008) has been obtained from the NJ Department of Environmental Protection (NJDEP) for 1

6 naturally occurring and accelerator produced radioactive isotopes, which are regulated by the State of New Jersey. Only materials that are listed on these licenses may be used in the ACADEMY. All uses must comply with the license conditions and regulations. The licenses may be amended to include new radionuclides but the process can result in substantial delays in the approval process. Use of these sources must comply with the relevant federal regulations including 10CFR Parts, 19, 20, 30, 35 and NJAC 7:28. Copies of the regulations are available in the Radiation Safety Office and the websites of the NRC ( and the NJ DEP ( ). Copies of these licenses are posted on bulletin boards in these locations: The hallway near the Clinic Office (1 st floor) The hallway in the radiolabeling facility (1 st floor) The Radiation Safety Office (1 st floor) The State of New Jersey regulations (NJAC 7:28) require that any device capable of producing ionizing radiation, for example x-ray machines or particle accelerators, be registered with the NJ Department of Environmental Protection (NJ DEP). The registrations are renewed annually and devices must be checked annually to insure that they do not result in radiation doses to the users and others. Inspectors from the NRC and the NJ DEP occasionally visit the ACADEMY to monitor compliance to the regulations, license and permit conditions. The ACADEMY may be subject to fines and citations if violations are observed Employees of the ACADEMY have the right to report a violation of NRC regulations or NJ DEP regulations to the respective agency and to request inspections. Any user who believes that a violation of the regulations or license conditions exists or has occurred in license activities with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the NRC or any NRC inspector (or to the NJ DEP or its inspectors). Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the user. Additional information about these rights is found on the notices posted at the employees entrance and outside the Radiation Safety Office. The PHILIPPINE ACADEMY Radiation Safety Program Structure The Radiation Safety program is designed to use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to ensure that all occupational exposures and doses to members of the public that are as low as is reasonably achievable (ALARA). It also ensures that the PHILIPPINE ACADEMY complies with the relevant governmental regulations and the current professional standards. The radiation safety program has four levels of responsibility: 2

7 The Individual User The Authorized Investigator The Radiation Safety Officer The Radiation Safety Committee Individual users Scientists, physicians, laboratory technicians, and other research, clinical and support personnel, engaged in activities involving the actual use of ionizing radiation sources, both radioactive materials and machine sources. These individuals must be trained adequately for the hazard they may encounter and adhere to the approved procedures for each of the sources. They must work under the supervision of an Authorized User. Visiting scientists, summer college and high school students and others working temporarily in the laboratory must also be adequately trained, obtain and use the appropriate dosimeters, and observe the precautions and procedures of the radiation safety program. Minors, those under 18 years old, may work in the laboratory but are subject to much lower permissible dose limits under the NRC and NJ DEP regulations. Users who are or may be pregnant may also work with the sources. If they declare the pregnancy to the RSO in writing, they are subjected to lower regulatory permissible dose limits. Authorized Users Authorized Users are typically, scientists and physicians with training and experience such that they are authorized by the Radiation Safety Committee to possess and use specific sources of radiation. Working with the RSO, Authorized Users must plan each use of the source such that the exposure to those involved is kept at acceptable levels and as low as possible. They must adequately train those involved and provide the equipment and materials required. They must ensure compliance with the Radiation Safety Program procedures. The Authorized User must ensure the security of the radioactive materials or machine sources at all times by restricting access to those who are adequately trained and informed. Specifically, the Authorized User must: Perform radiation surveys and contamination surveys in all authorized restricted areas often enough to demonstrate that these areas are free of unnecessary radiation fields and radioactive contamination. Surveys must be conducted at least monthly whenever radioactive material is in use. The appropriate units (e.g., Bq (µci) for radioactivity measurements, C Kg -1 hr -1 for radiation field intensity cgy (mrads) for absorbed dose must be used in the records of all surveys. The records must be maintained for the life of the license and are subject to inspection by the RSO and regulatory inspectors. Keep a current inventory of all radioactive materials for which he or she is responsible released down the drain. 3

8 Educate and train each user working under the Authorization at a level adequate for the hazards encountered. Train and closely supervise all visitors and others working temporarily in the laboratories, especially those under 18 years old. Enforce the policies and procedures of the Radiation Safety Program in the authorized restricted areas. The Radiation Safety Officer (RSO) The RSO has the responsibility for the implementation and management of the Radiation Safety Program, including the upkeep of all documentation and records necessary to demonstrate compliance to the ACADEMY policies and government regulations. A copy of the Memo delegating authority to the current RSO is in Appendix I. The RSO may delegate these activities to complete them efficiently, but retains the full responsibility for them. Typical activities include: Receiving, delivering and shipping from the ACADEMY all radioactive materials Maintaining an inventory of all sources Operating the ACADEMY radiolabeling suite Monitoring the use of these materials both in the radioisotope suite and in other areas Monitoring individual users by provision of dosimeters or bioassay when appropriate Providing instruction and training about the appropriate procedures and precautions for the use of the sources to individual users Providing training and education to maintenance, custodial, security staff members and other persons who may need to enter the restricted laboratories Providing general "awareness" information to secretarial, clerical and other staff members. Providing instructions to patients and their families Supervising and coordinating the disposal of radioactive waste Performing leak tests on all sealed sources Supervising the clean up of spills of radioactive materials Maintaining the necessary survey instrumentation and other equipment in proper operating condition and in calibration Acting as liaison with the NRC, NJ DEP and other regulatory agencies when radiation sources are involved Implementing program changes suggested as a result of the annual program audit and/or required by changes in the regulations or license conditions. The RSO also provides technical assistance to ensure that the uses of the radiation sources do not result in unwarranted and unnecessary exposure to radiation and to ensure compliance with program policies and procedures. The Radiation Safety Committee The Radiation Safety Committee recommends policies and procedures of the Radiation Safety program to senior management. The committee approves of all proposed uses of radiation sources, provides technical assistance to the Radiation Safety Officer (RSO) and 4

9 oversees the quality of the implementation of the program. The Committee reports to the Vice President of PHILIPPINE ACADEMY. The committee meets every three months but may meet more frequently if necessary to transact its business. The Committee Chair maintains minutes of each meeting for the life of the ACADEMY's licenses. Appointed by the Senior Management, the Committee is composed of experts in radiation protection, the Radiation Safety Officer, representatives of the user community and ACADEMY management representatives with responsibilities that affect the radiation safety program. The Chair of the Committee is the Director of Clinical Research Administration; the RSO is the Executive Secretary. The current membership of the committee is shown in Appendix I. The committee reviews all proposed uses of ionizing radiation to determine that they comply with the policies and procedures of the Radiation Safety Program and that all exposures to radiation are kept as low as reasonable achievable. No work with radioactive material can proceed without the prior approval of the committee or the Radiation Safety Officer, acting as its agent. The Committee may authorize the RSO to act as its agent in routine approval and review activities. However, it has the final responsibility for the implementation and management of the program. The Committee reviews all instances of alleged infractions of the policies and procedures with the RSO and the responsible management before submitting reports and recommendations to the senior management. It also adjudicates any differences arising between Authorized Users and the Radiation Safety Officer. The Professional Standards for the Program The standards of the following organizations are used as a basis for the PHILIPPINE ACADEMY program. Each organization maintains an Internet web site listing its activities and publications as well as links to additional interesting and useful web sites about radiation and radiation protection. National Council on Radiation Protection and Measurements (NCRP) American Association of Physicists in Medicine(AAPM) American Board of Radiology (ABR) International Committee on Radiation Protection (ICRP) International Atomic Energy Agency (IAEA) The Health Physics Society (HPS) Annual Review and Audit of the Program A federal regulation requires that a formal audit of the Radiation Safety Program be conducted at least once every twelve-month period. The Radiation Safety Manual is 5

10 reviewed and updated after the Audit is completed. The Committee Chair keeps copies of each Annual Audit report for the life of the licenses. Security of Radiation Sources A key tenet of the radiation safety program is to ensure that only authorized and properly trained individuals are permitted access to sources of radiation. Acquisition of a Radiation Source The Radiation Safety Committee, through its agent, the RSO, must approve the purchase, lease, donation, or other acquisition of any source of ionizing radiation. Contact the Radiation Safety Officer well before you acquire any source so that any adjustments to the ACADEMY's NRC license or regulatory permits can be made. For example, it takes about four weeks to add a radionuclide not already listed to the license. All purchased radioactive materials sources must use a purchase requisition signed by the RSO. The requisition must contain the name of and be signed by the Authorized User. Blanket and standing orders must have the prior approval of the RSO. All radioactive material sources, purchased or otherwise acquired, must be shipped to this address during normal business hours (7:00 a.m. to 5 p.m., M-F): Philippine Academy (address) Attention: Radiation Safety Officer (name) RSO Deliveries at other times must have the prior approval of the RSO. When the source is delivered, the RSO will check the shipment for possible contamination, review the accompanying shipping documentation for compliance to the regulations and initiate the internal inventory tracking documentation before releasing the shipment to the authorized user. Authorization to Use a Radiation Source Using these procedures will provide to the Radiation Safety Committee with the necessary information to evaluate the proposed use of the source(s) with minimum burden to both the Committee and prospective authorized user. Human (Medical) Use of radio-labeled pharmaceuticals and other chemical substances. A physician who has the appropriate training and experience in the use of the materials must supervise human administration of radioactive material. The specific requirements for the training and experience are delineated in the NRC regulations (10 CFR 35; Subpart J). Unless the administration is explicitly listed in 10 CFR 35, the Radiation Safety Committee must approve a complete proposed clinical protocol before any human use of radioactive materials. (See Appendix III for procedural details). 6

11 The proposal, which must include an approved Institutional Review Board (IRB) protocol, should be submitted to the Chair of the Radiation Safety Committee. The Radiation Safety Committee will consider the recommendations of its Human Use subcommittee and the RSO during its evaluation. (IRB). The protocols are reviewed for renewal annually. Unsealed Radioactive Materials (non-medical use). Complete the appropriate application (Appendix IV), with the assistance of the RSO if necessary, and send it to the RSO. The RSO will present the complete application to the Committee for review with recommendations. In some cases, when the activities involved are relatively uncomplicated, the RSO, acting as agent for the Committee may approve the proposal subject to a final review by the Committee. No work may begin until the Committee issues a formal approval. The authorizations are approved for a two-year period and can be renewed. The Committee must approve any significant changes in the approved activities before implementation. The authorizations are terminated if an Authorized User leaves employment with the ACADEMY or ends the use of radioactive materials. All sources of radioactivity, including radioactive waste must be transferred to the RSO or placed under the control of another active Authorization before an Authorization is ended. A final survey of all restricted areas controlled exclusively by the Authorization, showing the areas to be free of contamination by the authorized materials, must be submitted with a written request for termination. An Authorization can also be terminated by the Radiation Safety Committee for repeated failure to comply with the Policies and Procedures of the Radiation Safety Program by the Authorized User or one of the workers under the authorization. This termination may take place after a sequential chain of actions: 1. An informal verbal or written warning by the RSO or a designated person 2. A formal notice of violation issued by the RSO with copies to the Radiation Safety Committee and the Authorized Users immediate superior. 3. A formal hearing by the Radiation Safety Committee 4. A formal vote by the Committee on remedial action(s) The Radiation Safety Committee acts as the final adjudicator in all disputes about Radiation Safety in the ACADEMY. Sealed Radioactive Material Sources (e.g., an electron capture detector for a gas chromatograph or check sources, flood sources) The person responsible for the source must be an Authorized User. (See Appendix II for application form) The purchase requisition for the source or the device that contains it 7

12 must be signed by the RSO. A completed application must accompany the requisition. The RSO approves the acquisition and use of the source subject to the license conditions and the program procedures. The RSO must be notified when the source arrives so that an initial evaluation and leak check test can be performed before it is put into service. Security of Radiation Sources Access to all sources of ionizing radiation, unsealed and sealed radioactive materials and machine sources, must be restricted to those with adequate training and knowledge about the hazards of the source. They must be used only in areas restricted to approved persons. The acquisition, relocation or disposal of all sources must have the prior approval of the RSO. Radioactive materials sources, both unsealed and sealed, must be stored in locked areas when not in use. Access to the operating controls of radiation producing devices, usually restricted by a key, must be limited to approved persons. Sources must never be left unsecured and unattended. Each Authorized User must keep a current inventory listing all sources and the location of each. This inventory must be updated semi-annually. These inventory records must be kept for the life of the Authorization and submitted to the RSO before the Authorization is ended. The entry doors to each restricted area where unsealed radioactive materials sources may be used must be posted with the appropriate caution sign. These signs are supplied by the RSO upon approval of the application for radioactive material use. Refrigerators and other storage areas for radioactive materials must be labeled with caution signs. Containers for sealed radioactive material sources and machine sources must be labeled in accordance with the regulations. The RSO will supply the labels and guidance related to positioning them. 8

13 Standard operating procedures for the use of unsealed sources of radioactive materials (both medical and non-medical uses). Authorized Users must provide these procedures to all individual users and enforce compliance. In general, all chemical hygiene precautions and procedures must be followed and all laboratory workers must be familiar with the location and use of safety devices such as eye wash stations, drench hoses and safety showers. Protective Measures Do not eat, drink, smoke, chew gum or apply cosmetics in chemical laboratories. Do not store food or beverages in refrigerators or freezers that store chemicals, including radioactive materials. Wear disposable protective gloves made of material impervious to the chemicals used when handling radioactive materials. Replace torn or perforated gloves immediately, check for the presence of radioactive contamination before washing your hands prior to donning new gloves. Contact the RSO immediately if there is contamination. Do not wear gloves when leaving the lab, using the telephone or the computer keyboard or other similar activities. Wash your hands and exposed skin areas on forearms thoroughly before you begin other activities. Wear appropriate protective eyewear. Safety glasses are adequate for routine activities. Consider wearing goggles or a face shield for activities involving large volumes, extremely hazardous substances or substances such as powders or volatile liquids that can become airborne easily. Consult the RSO or your supervisor if you have any questions about the need to do so. Wear protective lab coats at all times in the laboratory. Store them in the lab. Clean or replace them routinely and when they are contaminated. Do not wear them outside of the laboratory. Be aware of the particular hazards (external and internal) of the radionuclides you use and the necessary precautions to reduce the risk from them. Operating Procedures Always work in areas clearly delineated for the use of radioactive materials. Use specially designated trays or cover bench surfaces with absorbent paper. Clean-up all spills immediately and monitor to assure that no contamination remains. Report all spills except those of a very minor nature to the Radiation Safety Officer. Records of all spills except very minor ones and cleanup actions must be kept for the life of the licenses. Label all containers of radioactive materials with a radioactive label containing your name, the isotope and chemical in the container, the activity, the CAS number and the date. 9

14 Label all equipment that may be contaminated. This may include chemical fume hoods, centrifuges, biosafety cabinets, laminar flow hoods and similar equipment. Pipetters, stirrers, peristaltic pumps and other small items must also be labeled. Use and store all materials that are relatively volatile in a properly operating chemical fume hood. Minimize the possibility of aerosolization of the radioactive materials by using the appropriate precautions and lab equipment such as centrifuges and vibrators. Never pipette by mouth. Transport containers of radioactive materials sealed and in an enclosed secondary container. Constantly monitor your activities for contamination. When you finished and have cleaned the area, monitor the area and equipment to assure that it is free of inadvertent contamination. Record the results on your survey log. Records of these surveys must be kept for the life of the Authorization and submitted to the RSO before the Authorization is ended. Dispose of radioactive waste according to the procedures provided. Never discard radioactive waste or containers with radiation labels in the normal trash. This includes the disposal of liquid scintillation vials. Records of all disposals must be maintained for the life of the Authorization and submitted to the RSO before the Authorization is ended. Decontaminate and check any device or equipment that may be contaminated before servicing or relocation from the restricted area. This eliminates the possibility that service personnel, moving personnel and other untrained persons will be contaminated. Install traps in any vacuum line that may be used with radioactive materials. This will prevent contamination of the vacuum system. The traps must be appropriate for the materials involved. These additional precautions should be taken if the radioisotopes emit highenergy betas (betas with kinetic energies greater than 70 KeV), positrons or gammas: Monitor your activities with a properly operating survey instrument such as a geiger counter. Keep the instrument on and close by. Continuously check for contamination as you work. Keep the radiation exposure to you and others in the area as low as possible by adding shielding materials to minimize the radiation levels. Use plastic or other low density (low Z) materials to shield strong beta sources to minimize the x-radiation produced 10

15 by bremsstrahlung interactions. Lead or some other high density material is more appropriate for gammas and x-rays. Minimize the source handling times, use shielding materials around the source containers and use tongs or other handling devices if necessary to minimize the radiation doses to the hands and fingers. ("Time, distance, shielding"). Store the radioactive materials in remote areas of the laboratory and add shielding to minimize the radiation fields in the vicinity of the storage area. Wear your personal dosimeter and extremity dosimeters whenever the sources are used. Administrative Procedures Plan your experiments so that the minimum activity of the radioactive material is required. This will reduce the hazard involved as well of the cost of purchasing and disposing of the material. Do not accept radioactive materials into the laboratory unless they have been approved and processed by the Radiation Safety Officer or a designated individual. Ship or transfer radioactive materials from the Technology ACADEMY only through the Radiation Safety Officer. Do not hand carry radioactive materials from the ACADEMY without the approval of the Radiation Safety Officer. Escort visitors to the laboratory at all times, providing information and instructions that will minimize the potential for unnecessary exposure to the radioactivity. Visitors include anyone not a trained individual user and may include maintenance, custodial, secretarial staff as well as friends and family. Evaluate the training and experience of temporary workers, such as summer students and visiting research scientists to assure that each person is qualified to be an individual user. They must be trained and supervised as individual users. The RSO or a designated representative will conduct a routine radiation safety survey of each restricted area, including a contamination check, at least every two months. The Authorized User must keep the areas under his or her supervision free of radioactive contamination and correct any deficiencies observed during these surveys. Records of these surveys and of any corrective actions are maintained by the RSO for the life of the license. Termination of a restricted or controlled area. An area can be reclassified as unrestricted only after the RSO has determined that all sources of radiation have been removed and there is no contamination remaining. The release of a restricted area 11

16 must be thoroughly documented; the records must be kept for the life of the license plus one year. Disposal of Radioactive Waste The disposal of radioactive waste materials is extremely expensive. Therefore, every effort must be made to minimize the volume of the waste. You should consider the disposal options, conferring with the RSO as necessary, as you plan your activities. Each Authorized User must maintain complete records of the radioactive waste material generated as part of the radioactive material inventory. The RSO coordinates the transfer of the waste material from a laboratory or the radiolabing laboratory to an on-site storage area where it is processed for disposal. The options for disposal: Decay in storage. Radioisotopes with half-lives of 120 days or less must be stored for a period of at least 10 life-halves. After that time, they may be released to the normal waste if the radioisotope is not detectable by an appropriate survey instrument. Disposal via the sanitary sewerage system. Water miscible liquids containing some radioisotopes may be released through the sanitary sewerage system under controlled conditions. The RSO coordinates this procedure. Authorized Users must keep complete records of all radioactive materials released down the drain. Disposal of certain Tritium and Carbon 14 labeled materials without regard to the radioactivity. Liquid scintillation cocktail solutions and animal tissues with activity concentrations less than µci/gm averaged over the bulk material may be discarded as if they contained no activity. Disposal by transfer to a qualified waste hauler. This is the most expensive option and is used only when the other options are not available. The RSO coordinates the transfer and maintains the records tracking the material to its ultimate fate. The material may be incinerated or placed in an engineered waste disposal site. 12

17 Standard Procedures for Medical (Human Use) of Radioactive Materials Follow all the relevant procedures in the SOP for use of radioactive materials. Complete documentation of all human administrations of radiolabeled substances must be maintained. 1. All Standard Nuclear Medicine precautions and procedures shall be followed 2. All radioactive materials must be transported in containers with shielding such that the radiation field at one meter from the container is not greater than 2.0 mr/hr 1 3. When there is a possibility that the patient will exhale, excrete, sweat or otherwise contaminate his surroundings, the administration should be performed in a private injection room that has a functioning toilet. The room must be restricted and posted with required "Caution -Radioactive Material" signs. 4. The surfaces of the room should be impervious to moisture and easily cleaned. Absorbent materials and protective coverings should be strategically located to minimize contamination and clean up hence to minimize the unnecessary radiation dose to the clinical staff. A properly labeled waste container for disposable utensils, surgical dressings, absorbent tissues, etc., must be provided, as well as plastic bags to hold reusable items. 5. Syringe shields shall be used unless it can be adequately demonstrated that their use will increase the hand dose of the administrator or adversely affect the health of the patient. The shield must be labeled properly unless the label on the syringe can be easily observed with the shield in placed. 6. After the patient has been given the radioactive material, measure the radiation exposure levels in the room and the adjacent areas with an ion chamber based survey instrument. Portable shielding should be placed around the patient so that the exposure rate does not exceed 2.0 mr/hr in any unrestricted area (outside the room) and so that radiation dose to the clinical staff attending to the patient is minimized. 7. Radioactive waste must be held for a minimum of ten half-lives and until the radioactivity decays to levels undetectable with a scintillation survey instrument. The room and reusable items must be cleaned or stored until the radioactivity is no longer detectable with the scintillation detector based survey instrument or equivalent instrument. 1 As measured by a properly calibrated ionization chamber survey instrument. 13

18 8. Excreta or vomitus collected from a patient for analysis must be held for decay in the radioactive waste storage room. However, a patient may excrete or vomit material containing radionuclides directly into the sanitary sewerage system. The Quality Management Program for Therapeutic Administrations of Radioactive Materials. The Quality Management Program, required by the NRC license, provides a high confidence that byproduct material will be administered as directed by the Authorized User. The details of the ACADEMY's program are given in Appendix IV. The program requires: 1. That prior to a therapeutic administration, a written directive (see below) is prepared. This must be done unless the patient's health would be jeopardized by the delay. Under that circumstance, an oral revision to an existing written directive may be given, if it is documented immediately in the patient's file and followed within 48 hours by a revised written directive. 2. That prior to each administration, the patient's identity is verified by more that one method as the individual named in the written directive. 3. That each administration is in accordance with the written directive 4. That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken. Written Directives. A written directive is an order for a specific patient, dated and signed by an Authorized user prior to the administration of a radiopharmaceutical. It must be written for every therapeutic administration and all administrations of 125 I or 131 I labeled sodium iodide greater than 30 microcuries. It must contain the name of the radiopharmaceutical, the dosage and the route of administration. (for 125 I or 131 I only the dosage is required). Each directive and a record of each administered dose must be kept at least three years after the date of administration. Oral changes to the directive by qualified persons due to patient related difficulties must be documented within 48 hours after the change is made. Misadministrations For all diagnostic and therapeutic radioactive materials (except 125 I and 131 I in quantities less than 1.11 MBq [30 microcuries]) a misadministration is declared if a patient receives an effective equivalent dose greater than 0.05 Sv (5 rem) or a dose equivalent to any organ greater than 0.5 Sv (50 rem) under any of these circumstances: The pharmaceutical is given to the wrong patient The wrong pharmaceutical is administered The pharmaceutical is administered by the wrong route 14

19 The administered dosage differs from the prescribed dosage; for therapeutic dosages, the difference is greater than 20%. For 125 I and 131 I, the administered dosage differs from the prescribed dosage by more than 20% and the difference is greater than 1.11 MBq [30 microcuries] A misadministration must be reported to the RSO immediately and the following actions must be taken: 1. The RSO must report the misadministration by telephone to the NRC Operations Center, no later than the next calendar day after it is discovered. 2. She or he must file a written report with NRC Region I Office (King of Prussia, PA) within 15 days after discovery. 3. The referring physician must be notified no later than 24 hours after the discovery. 4. After consultation with the referring physician or if the physician cannot be reached within 24 hours, the patient must be notified unless, based on medical judgment, such notification would be harmful. 5. If the patient is notified, a written report, either the report to the NRC or one referring to it, must be sent to the patient within 15 days after discovery. 6. NRC regulations require that a complete record of an misadministration must be kept for a minimum of five years after discovery. Recordable Events Although some discrepancies are considered not serious enough to report to the NRC,. they must be reported immediately to the RSO. The RSO must investigate each event, prepare a comprehensive report of the relevant facts and the corrective actions taken for review by the Radiation Safety Committee. The reports must be kept for at least three years. These "recordable" events are: An administration without a written directive when one is required An administration of 125 I or 131 I greater than 1.11 MBq [30 microcuries] that differs from the prescribed dosage by more than 10% and 0.56 MBq [15 microcuries] An administered therapeutic dosage other than 125 I or 131 I that differs by more than 10% from the prescribed dosage. Deviations from the Package Insert Requirements An Authorized user (Physician) may direct a specific departure from a manufacturer's instructions for a radiopharmaceutical preparation and use if there is a reasonable medical justification. However, the rationale for the departure and a detailed description of the changes made must be documented in writing as part of the written directive. If the patient's health requires it, the documentation may be done after the administration. Audits The Quality Management Program must be audited annually. The review must include evaluations of a representative sampling of patient administrations, all recorded events, 15

20 and all misadministrations. Records of each audit must be retained for at least three years. Provision of Information to Patients at Release The patient to be released must, by the ACADEMY license conditions, be provided with information about the radioactive material(s) within and about the precautions and procedures to use to minimize the radiation dose to members of the family and others. The extent of the information provided depends on the dose as well as the identity of the radiopharmaceutical. A copy of the information form that must be given to each patient is in Appendix V. 16

21 Response to Spills, Fire and Other Emergencies If material is volatile or can become airborne: 1. Warn other workers and evacuate the area immediately. Be careful not to spread the contamination 2. Contact the Radiation Safety Officer or Assistant RSO immediately and wait for their arrival 3. Post a notice prohibiting entry on each entry door; close and lock the doors. If there is a serious injury or illness involved: 4. Call the emergency response team immediately. Inform them that contamination by radioactive substances is possible. 5. If you are qualified to do so, treat the injury without regard to the radioactive contamination. However, try to minimize the spread of contamination as much as possible consistent with treatment. 6. If the spill is major. Such as a large volume of material or high activity [greater than < 1.8 x 10 7 Bq (0.5 mci)] or a radionuclide that emits gammas with energies greater than 100 kev. Warn others and leave the area immediately; prohibit access to the area. Contact the Radiation Safety Officer or Assistant RSO immediately Do not leave the area before the RSO arrives For other spills 7. Immediately wash off any material spilled or splashed on the skin with soap or mild detergent and warm water. Flush the material from the eyes with an eyewash. If it possible to do so, use a survey instrument to determine the amount of contamination before removing the radioactive material from the skin. Check for residual contamination. 8. Inform the RSO immediately of any personal contamination. 9. Avoid tracking the material away from the spill by checking the bottoms of shoes and clothing immediately. Immediately remove or clean any contaminated items. 10. Localize the spill and prevent it from spreading 11. Put on clean protective gloves, eye protection and if necessary a clean protective lab coat. 12. Right the container 13. Apply an appropriate absorbent on the spilled material 14. If the material is dry, carefully wet it with water or other suitable solvent Decontamination 15. For small spills, you are expected to perform the major work of the decontamination. Upon request, the RSO or his Assistant will survey the area for contamination and will also advise on the procedures and assist as necessary. 16. The contaminated absorbent, as well as any contaminated clothing, wipes, utensils or equipment must be discarded as radioactive waste. 17

22 17. The RSO will perform a final survey of the area to assure that it is free of contamination before normal work can resume. In the event of sudden electrical power outage 21. If you are working in a chemical fume hood, immediately cease all work and close the sash. 22. Cease all work with radioactive materials and close all containers. 23. If the material is considered volatile leave the laboratory and prevent access by others. 24. Notify the RSO immediately 18

23 Standard operating procedures for sealed sources Electron Capture Detectors Electron capture detector sources installed in Gas Chromatograph systems (GC's) must be tested for contamination every six months. The RSO or his designated representative normally does this. If the GC is relocated to another laboratory, notify the RSO. Notify the RSO before removing a EC detector from a GC for storage, servicing, disposal or return to vendor so that he can perform a contamination check. Notify the RSO immediately if the GC temperature control system malfunctions and causes the system to overheat. In the past, this malfunction has resulted in release of the radioactivity. EC detectors not in GC's must be stored in locked areas. The detector must be labeled with an appropriate caution label. Other sealed sources If the source contains a gamma or strong beta emitter (beta energies greater than 70 KeV), wear your personal dosimeter when using the source. Obtain and use a properly operating survey instrument such as a geiger counter or ionization chamber to monitor the radiation fields. Sources in use must be tested for contamination every six months. Source in storage must be tested every five years. Records of the surveys are kept by the RSO. They must be kept for the life of the license(s). Sources must be stored in a locked area and used only in a restricted area. If necessary, the source must be shielded so that the radiation level outside the storage area is as low as possible and in no case greater than 2.0 mr/hr. The storage area should be located in area remote from normal activities. 19

24 Education and Training For Individual and Authorized Users All users of ionizing radiation sources must demonstrate knowledge of the hazards involved and about the precautions and procedures required to minimize the risks from those hazards. They must also demonstrate the maturity required to adhere to those precautions and procedures. Authorized Users must have adequate experience using the sources or similar sources as well. Evaluation of the adequacy of the training and education for both the individual user and the Authorized user is made by the Radiation Safety Committee or the RSO as its agent, as part of the evaluation of an application to use a radiation source. Insufficient training or knowledge may be supplemented by the RSO, an outside source or by the Authorized User supervising the individual. The RSO may restrict the conditions under which the sources may be used until adequate experience and training is obtained. The Authorized User must arrange for adequate training for each visiting research scientist, part time lab worker and student worker before he or she begins work with radioactive materials. Workers younger than 18 years old must be given special attention because the maxmum permissible dose limits are considerably lower. Declared pregnant users should be given information about the risks to the embryo/fetus and special instructions to ensure that the potential for a radiation dose to the embryo/fetus is minimized and kept well below the permissible dose limits for the embryo/fetus. The RSO will provide a mandatory annual training seminar for all Individual and Authorized Users. These seminars will provide a review of the fundamental of radiation protection in addition to current information about the regulatory requirements and hazards involved. For Support Staff and Emergency Response Personnel Maintenance and custodial staff who service the areas containing radiation sources must be informed about the hazards that may exist in those areas and be trained to avoid the risk from those hazards. The RSO will provide the training for new employees before they begin work in those areas and annual refresher training for all support personnel. The Authorized User responsible for a restricted area must make sure that each maintenance person or custodian working in that area is aware of the hazards present and takes the appropriate precautions to avoid unnecessary risk. Similar precautions must be taken with emergency response personnel. 20

25 Emergency medical technicians, fire and security personnel and others who may enter the restricted areas in case of a serious injury, fire, or other emergency must also be informed about the hazards and precautions required to avoid unnecessary risk. Other PHILIPPINE ACADEMY Personnel Secretaries, clerical staff and other staff members who may not routinely enter laboratories and other restricted areas, should be instructed about the general hazards involved with the use of radioactive materials and about precautions to avoid risk from those hazards. Personal Radiation Dose Limits and Personal Monitoring Because risk from radiation seems to exist even at very low doses, PHILIPPINE ACADEMY requires that all employees keep all radiation exposures "as low as reasonably achievable". Personnel monitoring provides an additional check to ensure that this is done. Users of sources of penetrating radiation, gamma emitters, strong beta emitters (beta energies greater than 70 KeV), positron emitters, and radioisotopes that decay by electron capture, are required to wear personal dosimeters ("radiation badges") that monitor exposure to penetrating, external sources of radiation. The purpose of these dosimeters is to assess the effectiveness of the radiation safety procedures in use ("quality control"), that helps to the ensure the safety of the user and compliance with the regulatory dose limits. The dosimeters are issued after the RSO evaluates the individual potential for radiation exposure. The number of dosimeters issued and the frequency of processing them will depend on the anticipated radiation exposure for each individual. Dosimeters may be issued for the trunk of the entire body (whole body), certain areas of the body such as the eyes or gonads and extremities such as fingers, wrists or ankles. The RSO coordinates the exchange and processing of the dosimeters, and maintains the dose reports as required by the regulations. Federal and State regulations require that reports be provided to individual users annually upon request and be kept for at least the life of the license. Individual Users must wear the dosimeters at all times when they are working in restricted areas, store them in a safe place away from radiation sources when they are not worn and exchange them in a timely fashion at the request of the RSO or a designated representative. Since these dosimeters are to monitor only occupational exposures, they should never be taken home or removed from the ACADEMY. In addition, a user who undergoes a nuclear medicine procedure as a patient must notify the RSO prior to the procedure to receive instructions about the wearing of the dosimeter afterwards. The ACADEMY reserves the right to charge individual users a fee for lost or deliberately damaged badges. 21