UCSF RADIATION SAFETY MANUAL

Transcription

1 UCSF RADIATION SAFETY MANUAL The enclosed Radiation Safety Manual outlines the regulations and procedures governing the use of radioisotopes under the University of California, San Francisco (UCSF) Type A Broad Scope Radioactive Materials License (Broad License). This document was submitted to the State of California, Radiologic Health Branch as part of the license renewal application and therefore it continues to be the legal document governing the use of radioactive material at UCSF. (IT ALSO SUPERSEDES ALL PREVIOUS COMMITMENTS, DOCUMENTS AND PROCEDURES.) Any future changes in this document will be approved by the Radiation Safety Committee (RSC), and/or the State of California, as appropriate, prior to implementation. You will receive updated copies from the Radiation Safety Officer (RSO) when such changes have been made. Approved: December 1996 Revised: May 2016

2 UCSF RADIATION SAFETY MANUAL Approvals Original signature on file with EH&S Brian Smith, JD, MBA Associate Vice Chancellor, Research Infrastructure and Operations Original signature on file with EH&S Robert Eaton, MS, CIH, CSP, REHS,CHMM Director, Environment, Health and Safety Original signature on file with EH&S Bonnie Joe, MD, PhD Chair, Radiation Safety Committee Original signature on file with EH&S James Cook, MD Radiation Safety Officer, EH&S Radiation Safety Manual Revised: May 2016 pg. 2

3 Table of Contents CHAPTER 1: INTRODUCTION... 5 A. THE NEED FOR RADIATION SOURCES AT UCSF... 5 B. THE UCSF AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY... 5 C. THE PURPOSE OF THIS MANUAL... 6 D. REQUESTS FOR EXEMPTION... 6 CHAPTER 2: THE UCSF CAMPUS LICENSE... 7 A. APPLICABLE REGULATIONS... 7 B. LICENSING REQUIREMENTS AND REGULATIONS... 8 CHAPTER 3: GOALS AND RESPONSIBILITIES... 9 A. GOALS... 9 B. RESPONSIBILITIES: THE ROLES OF INVOLVED PERSONS CHAPTER 4: APPLICATION FOR RADIOACTIVE MATERIALS USE AUTHORIZATION A. APPLICATION FOR APPROVAL BY THE RADIATION SAFETY COMMITTEE (RSC). 18 B. INSTRUCTION OF PERSONNEL CHAPTER 5: RECEIPT AND USE OF RADIOACTIVE MATERIALS A. FACILITIES AND HANDLING B. PROCUREMENT C. GENERAL SAFETY PRECAUTIONS D. USERS AND LOCATIONS E. ADMINISTRATION OF RADIOISOTOPES TO ANIMALS F. RADIOACTIVE WASTE DISPOSAL G. INSTRUMENTATION H. RADIATION MONITORING I. RECORD KEEPING J. REPORTING OF ACCIDENTS/INCIDENTS CHAPTER 6: EMERGENCIES A. NOTIFICATION OF THE RADIATION SAFETY OFFICE B. NOTICE TO LICENSING AGENCIES C. MANAGEMENT OF RADIATION INCIDENTS D. PERSONNEL CONTAMINATION E. TEMPORARY SUSPENSION OF RADIATION WORK Radiation Safety Manual Revised: May 2016 pg. 3

4 F. EMERGENCY TELEPHONE NUMBERS G. INJURY AND CONTAMINATION H. DEALING WITH MINOR SPILLS AND ACCIDENTS APPENDIX A. FACILITIES AND HOOD CLASSIFICATION B. INTERNAL INSPECTION AND REVIEW C. RECORD KEEPING D. BIOASSAYS E. BASIC SHIELDING NEEDS AND METHODS F. INSTRUMENTATION AND SEALED SOURCES G. LIMITS OF RADIATION IN CONTROLLED AND UNCONTROLLED AREAS H. PREGNANT PERSONNEL POLICY (10 CFR ) I. U.S. NUCLEAR REGULATORY COMMISSION, REG GUIDE J. FORMS K. GLOSSARY Radiation Safety Manual Revised: May 2016 pg. 4

5 CHAPTER 1: INTRODUCTION A. THE NEED FOR RADIATION SOURCES AT UCSF Radiation sources are useful tools in clinical applications, as well as biomedical investigations. On a health sciences campus, such as the University of California, San Francisco (UCSF), important research often depends upon the use of radiation sources or radioactive materials. Such research includes studies of basic cellular mechanisms, disease processes from the molecular to the whole organism level, genetic processes, and interactions of radiation with biological entities. At an even more immediate level, the routine diagnosis and treatment of diseases often depend upon the use of ionizing radiation. Thus, this extremely useful tool needs to be incorporated into campus activities in such a manner that maximum benefit is achieved while potential hazard is reduced to the minimum achievable level. B. THE UCSF AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY 1. INTRODUCTION The setting and execution of guidelines for radiation protection are based upon an underlying philosophy in which two factors are of prime importance. First is the assumption that there is no radiation dose so small that it does not involve some degree of risk. The second major factor to consider is that radiation, like many other developments of modern life, confers great benefit upon both the individual and the society in spite of its small risk to health. Consideration of the extent of these benefits makes a certain degree of risk acceptable. Thus, a balance must be struck in each contemplated radiation usage, in which the benefit to be gained is weighed against the anticipated risk. If the benefit outweighs the risk, the radiation is utilized so that its maximum benefit will be realized while individual exposure will be reduced to the minimum consistent with deriving these benefits. The overall protection philosophy, then, is to maximize the advantages from the use of radiation while minimizing exposure by eliminating whenever possible all unnecessary exposure to radiation. Radiation Safety Manual Revised: May 2016 pg. 5

6 2. AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) Occupational exposure includes all the dose equivalents and intakes incurred by a worker during periods of work but excludes medical and natural radiation, unless the latter is enhanced as a result of a particular working environment. The arrangements for restricting occupational exposure should be applied to the source of radiation and to the designed features of the work place so that the use of Personal Protective Equipment should, in general, be regarded as supplemental to these more fundamental provisions. Access to controlled areas should be restricted and subject to local operating instructions. External exposure may be restricted by the use of shielding, distance and limitation of time. Contamination by radioactive material may be avoided by attention to safety precautions and good work habits, which should ensure substantial reduction in occupational exposure. The State of California has set occupational exposure limits which should not be exceeded under normal operational conditions. Even though current occupational exposure limits provide a very low risk of injury, it is prudent to maintain exposure to radiation below these limits. The objective is thus to reduce exposure by means of good radiation protection planning, as well as by management commitment to policies that foster vigilance against departure from good, prudent practices. This is the concept of As Low As is Reasonably Achievable (ALARA) occupational exposure to radiation. This is only possible if each individual user of radioactive materials joins the Management s efforts in implementation of these concepts. C. THE PURPOSE OF THIS MANUAL The purpose of this manual is to assist University research personnel in using ionizing radiation in accordance with the current standards of good practice, the provisions of the University license, and the laws of the State of California. The manual is designed primarily for laboratory personnel. There is a Radiation Protection Handbook covering clinical uses of ionizing radiation. D. REQUESTS FOR EXEMPTION Requests for exemption from procedures discussed in this manual must be submitted in writing to the Radiation Safety Committee (RSC). The RSC will forward its recommendation to the Director of Environment, Health & Safety (EH&S), or the Assistant Vice Chancellor, Research as appropriate for consideration. Radiation Safety Manual Revised: May 2016 pg. 6

7 CHAPTER 2: THE UCSF CAMPUS LICENSE The following State of California and Federal requirements are applicable to the use of radioactive material at the University of California, San Francisco (UCSF). A. APPLICABLE REGULATIONS 1. CAL/OSHA 8 CCR 3203(a)(1) Effective July 1, 1991, every employer shall inaugurate and maintain an accident prevention program which shall include, but not be limited to a training program designed to instruct employees in general safety work practices and specific instructions with respect to hazards unique to the employee's job assignment. 2. CALIFORNIA DEPARTMENT OF PUBLIC HEALTH, RADIOLOGICAL HEALTH BRANCH Title 17, Public Heath, provides applicable regulations regarding radiation, radiation technology, and nuclear medicine. 17 CCR incorporates by reference the federal regulations specified in Title 10, Code of Federal Regulations (CFR), Part 20, Standards for Radiation Protection Against Radiation. 17 CCR incorporates by reference the federal regulations specified in Title 10, Code of Federal Regulations (CFR), Part 35. Medical Use of Radioisotopes. 17 CCR requires that each user shall inform individuals working in or frequenting any portion of a controlled area as to the presence of sources of radiation; instruct such individuals in safety problems associated therewith and in precautions or procedures to minimize radiation exposure; and instruct such individuals in the provisions of department regulations and licenses applicable for the protection of personnel. L.C.43, incorporating applicable portions of 10 CFR Part 37, Physical Protection of Category 1 and 2 quantities of radioactive materials Radiation Safety Manual Revised: May 2016 pg. 7

8 B. LICENSING REQUIREMENTS AND REGULATIONS 1. UNIVERSITY LICENSE UCSF has a Type A Broad Scope Radioactive Materials License (Broad License) issued by the California Department of Public Health, Radiologic Health Branch. Copies of the license are available for inspection at EH&S. The license describes the campus possession limits for each radioisotope, the authorized addresses, and provides for internal authorization procedures. Any requests for amendments to the campus Radioactive Materials License must be approved by the Radiation Safety Committee (RSC) and communicated to the State of California by Environment, Health & Safety (EH&S). 2. MEDICAL CENTER REGULATIONS Authorization by the RSC is required before any individual may bring into, or remove radioisotopes in any form from the Medical Center. All uses of radioisotopes involving humans must have prior approval of the RSC, the Radioactive Drug Research Committee (RDRC) (if applicable), and the Committee on Human Research (CHR)(research only). Radiation Safety Manual Revised: May 2016 pg. 8

9 CHAPTER 3: GOALS AND RESPONSIBILITIES A. GOALS 1. OBJECTIVES OF THE RADIATION SAFETY PROGRAM As a health sciences campus, the University of California, San Francisco (UCSF) has extensive teaching, research and clinical facilities in which sources of ionizing radiation are used. The goal of the campus Radiation Safety Program is to provide adequate protective measures against exposure to these sources for patients, visitors, students, faculty and staff on campus, and for the community at large. These measures are required by the UCSF Radioactive Material License. Responsibility for maintaining this license is delegated appropriately within the campus. 2. TYPE A BROAD SCOPE RADIOACTIVE MATERIAL LICENSE (BROAD LICENSE) - THE PRIVILEGE OF INTERNAL REVIEW The State of California Department of Public Health, Radiologic Health Branch has the responsibility of evaluating each proposed use of radioactive materials within its jurisdiction. The State of California Department of Public Health could accomplish this by requiring a direct, individual application for each proposed use of radiation. Instead, it has delegated the responsibility of reviewing such uses on this campus to UCSF, through the issuance of a Type A Broad Scope Radioactive Material License (Broad License). It is through the campus Radiation Safety Program that this internal, delegated responsibility is implemented. To obtain a Type A Broad Scope Radioactive Material License, UCSF has had to demonstrate: a. Considerable experience with a large and varied radioisotope program. b. A well-developed health physics group capable of evaluating and dealing with radiation safety problems. c. Detailed procedures for evaluating proposed uses of radioactive materials and for maintaining surveillance over approved users. d. Establishment of a program to assure technical review of individual users and their procedures and facilities before approval. The internal review program must be coupled with an internal inspection program to ensure that all health and safety requirements are being met. These licensing and Radiation Safety Manual Revised: May 2016 pg. 9

10 inspection functions are coordinated through EH&S. These operations are recorded to demonstrate compliance with the State of California Department of Public Health statewide programs. B. RESPONSIBILITIES: THE ROLES OF INVOLVED PERSONS The rules and procedures set forth in the Radiation Safety Manual have one single, straightforward purpose -- to protect UCSF patients, students, and employees against unnecessary and potentially harmful radiation exposure. 1. RADIATION SAFETY COMMITTEE (RSC) UCSF is authorized to procure and use radioactive materials in specified areas, including satellite programs, under a Broad License issued by the State of California Department of Public Health. This license is contingent upon the existence of a Radiation Safety Committee (RSC) and a Radiation Safety Officer (RSO). a. Responsibility The UCSF RSC is appointed by the Executive Vice Chancellor for Research, in accordance with the conditions of the license. This committee will: i. Establish policies and regulations governing the use of ionizing radiation at UCSF. ii. iii. iv. Consider technical and safety related aspects of the use of ionizing radiation within the jurisdiction of UCSF. Advise the Chancellor on all matters related to radiation safety, and recommend such policies and procedures as it may deem appropriate to protect the safety of users, patients, students, employees and the public. Promulgate a Radiation Safety Program that satisfies the conditions of the UCSF License. v. Committee meetings are scheduled to review the present Radiation Safety Program and to consider radiation safety problems. b. Organization of the RSC The RSC shall consist of a minimum of six members including at least one physician from the Department of Nuclear Medicine, one from the Department of Radiation Oncology, one from the Department of Radiology, one person from the Radiation Safety Manual Revised: May 2016 pg. 10

11 research community, and one person representing the UCSF administration. The RSO is a member of the committee. Activities of the RSC are directed by its Chair who shall be a member of the Academic Senate. The Chair shall convene the RSC at least quarterly and at other times at the call of the Chair. A quorum shall consist of a majority of the members and the RSO (or a designated alternate in the RSO s absence). The Chair of the RSC may appoint subcommittees to examine and approve or disapprove of Radiation Use Authorization (RUA) applications and renewals, and such other duties, as directed by the Chair of the RSC and authorized in the license. c. Functions and Activities of the RSC i. Review the safety-related aspects of the use of all sources of ionizing radiation, including radiation producing machines and equipment. When humans are to receive radiation in research, the RSC will forward a copy of its review to the Committee on Human Research (CHR). ii. iii. iv. Assure that any Principal Investigator (PI) using radioactive materials is qualified by training and experience, has the facilities to handle the materials safely, and proposes a plan that is safe to all concerned Establish guidelines for and advise on the content of the UCSF Radiation Safety Program. All new users must participate in a campus training program for the use of radioactive materials. The extent of which will be determined by the RSO. All exemptions must be approved by the RSC/RSO. Assure observance of safety standards established by the Nuclear Regulatory Commission, State of California Department of Public Health, Federal and State Department of Transportation, National Council on Radiation Protection and Measurements, and other duly recognized regulatory and standard-setting bodies. v. Provide oversight of the campus Radiation Safety Program implemented by the RSO, including annually reviewing the operation of the Radiation Safety Office in receiving, auditing the use, and disposing of radioactive material at locations specified in the license. vi. Review infractions of use and safety rules referred by the RSO and responsible clinical or laboratory directors. Review investigations of accidents and incidents and prepare reports, when deemed necessary. Radiation Safety Manual Revised: May 2016 pg. 11

12 vii. viii. ix. Recommend policy on patient and research activities that use ionizing radiation. Request technical advice from the RSO on matters regarding radiation safety. Receive, review, and act on applications (requiring RSC approval) for the use of radioactive sources used by UCSF personnel. This includes the use of radioactive materials in human subjects THE RADIATION SAFETY COMMITTEE AND THE RADIATION SAFETY OFFICER ARE AUTHORIZED BY THE CHANCELLOR TO LIMIT OR REVOKE AN INDIVIDUAL'S AUTHORITY TO USE RADIOACTIVE MATERIAL OR SOURCES OF IONIZING RADIATION IF SUCH USE PRESENTS A HAZARD TO INDIVIDUALS OR VIOLATES HEALTH AND SAFETY CODES. 2. RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC) a. Responsibility The purpose of the Radioactive Drug Research Committee (RDRC) is to guarantee subjects who take part in research protocols the greatest degree of both radiological and pharmacological safety. Before approving such studies, it is this Committee s responsibility to determine the intrinsic value of the research with a risk versus benefit analysis. The RDRC is defined by Federal law, and its membership must be approved by the Food and Drug Administration (FDA, 21 CFR, Part 361). The RDRC is independent of the RSC and its services are available to all users of radioactive material and Department Chairs. It shall complement the RSC activities already existing within the hospitals and medical research facilities. b. Organization The RDRC Chair shall be a member of the RSC. The RDRC members shall be appointed by the Assistant Vice Chancellor, Research. The RDRC shall consist of at least five members and include the RSO as a member who advises the committee and implements its decisions. The activities of the RDRC are directed by its Chair. To conduct business, a quorum (including the RSO, or his designated alternate) is necessary. Meetings Radiation Safety Manual Revised: May 2016 pg. 12

13 of the RDRC shall be called by the Chair not less than four times a year, or on petition of any member of the RDRC. c. Approvals Research involving radioactive drugs must be approved by the RDRC when they are administered to human subjects in a study intended to: i. Obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a drug. ii. Obtain basic information regarding human physiology, pathophysiology, or biochemistry. The RDRC regulations, from the Food and Drug Administration, require review of study design and appropriateness of the research protocol; they also impose limits on radiation absorbed doses and the amount of the drug administered. The RDRC grants final approval to a study that falls under its purview after approval of the CHR and the RSC has been received. 3. ENVIRONMENT, HEALTH AND SAFETY (EH&S) a. Organization Environment, Health and Safety (EH&S) conducts the Radiation Safety Program. This program includes surveillance of all users of radioisotopes, radiationproducing machines and equipment; monitoring of exposure levels, and investigation of incidents. EH&S provides consultation, training in radiation safety, and radiation safety services. These services conform to the standards set forth in this Manual, the license conditions, State of California Regulations, Nuclear Regulatory Commission 10 CFR regulations, National Council on Radiation Protection Guidelines, as well as other standards as set by the RSC. The Director of EH&S is responsible for informing the Chancellor of matters related to radiation safety. The RSO is responsible for the operation of the Radiation Safety Program and for assuring that the use of ionizing radiation is in conformance with UCSF policies and applicable government regulations. The RSO is also responsible for referring to the RSC matters requiring its review and approval. b. Functions of the Radiation Safety Program Radiation Safety Manual Revised: May 2016 pg. 13

14 i. General surveillance of all health physics activities, including both personnel and environmental monitoring. ii. iii. iv. Provide consulting services to personnel at all levels of responsibility on all aspects of radiation protection. Receive and inspect all radioisotopes that come to UCSF, and consult on all packages of radioisotopes shipped from UCSF. Monitor all machines capable of producing ionizing radiation. Evaluate the output of these machines on an annual basis or as requested. v. Distribute and process personnel monitoring equipment. Keep records of internal and external personnel exposure. Notify individuals and their Laboratory Supervisor of exposures approaching or exceeding the maximum permissible levels and recommending appropriate remedial action. vi. vii. viii. ix. Instruct personnel in proper procedures for the use of radioactive materials and conduct refresher classes. Supervise and coordinate the waste disposal program, including the keeping of waste storage and disposal records. Perform leak tests on all sealed sources greater than 100 μci. Maintain a periodic inventory of all radioactive materials at UCSF. x. Supervise decontamination of any contaminations; investigate accidents. xi. xii. xiii. Maintain a continuous program of environmental radiation hazard evaluation and hazard elimination. Review all radiation use authorization applications and renewals. Conduct the laboratory audit program designed to evaluate the conformance of the users with the safety requirements. 4. INDIVIDUAL USERS Authorized laboratory workers handling radioactive materials are immediately responsible for their own safety and the safety of those around them. These responsibilities include: Radiation Safety Manual Revised: May 2016 pg. 14

15 a. Keep exposure to radiation as low as reasonably achievable, and specifically below the maximum permissible dose as listed in the following table: OCCUPATIONAL DOSE Whole body Lens of eyes Extremities or skin Any individual organ or tissue Declared pregnant worker dose to fetus (over gestation period) ANNUAL DOSE LIMIT 50 msv (5 rem) 150 msv (15 rem) 500 msv (50 rem) 500 msv (50 rem) 5 msv (0.5 rem) GENERAL PUBLIC 1 msv (0.1 rem) Dose in any unrestricted area cannot exceed 2 mrem in any hour or 100 mrem in a year b. Maintain a laboratory environment free from airborne radioactive contamination. This is done through the maintenance and use of engineering controls such as fume hoods. c. When issued, wear the prescribed monitoring equipment, such as dosimetry badges and ring badges, when working with radioactive materials. d. Survey hands and body for radioactivity with a rate meter with a thin end-window or pancake probe (exception: 125 I, use rate meter with a scintillation probe) and remove all loose contamination before leaving the laboratory for any reason. 5. PRINCIPAL INVESTIGATORS (PI) Principal Investigators (PI) are responsible for ensuring that the laboratory environment of the individual users is kept safe. Further responsibilities are as follows: a. Adequate planning is required before an experiment is conducted. The Laboratory Supervisor shall determine the types and amounts of radiation or radioactive material necessary for the procedure. This will provide an indication of the necessary protection. Before the procedure is conducted, it should be rehearsed to preclude any unexpected circumstances. In any situation where there may be a radiation hazard, the Departmental Safety Advisor (DSA) shall be consulted prior to conducting the experiment. b. Instruct their employees in the safe use of radionuclides used in their procedures, including appropriate use of Personal Protective Equipment (PPE). All untrained personnel are required to read and to be tested on the Radiation Safety Training Manual that is available online in the laboratory; additional copies may be Radiation Safety Manual Revised: May 2016 pg. 15

16 obtained from EH&S. In addition, all authorized principal investigators, or their delegated alternative, must provide practical instruction in all aspects of radiation safety that are detailed in this manual. c. Inform the DSA when the individuals or activities under your RUA are changing. This includes new individuals, changing laboratory locations or termination of activity on the campus. d. Follow correct procedures for the procurement of radioactive materials by purchase or transfer. e. Post areas where radionuclides are kept or used, or where radiation fields may exist. f. Record the receipt, transfer, use, and disposal of radioactive material used in your area. This includes sealed sources. The PI must be prepared to submit a quarterly inventory upon request. g. Properly prepare all radioactive waste material for pickup by EH&S for disposal. h. Minimize the stock of stored radioisotopes within the laboratory area. i. When terminating an RUA, the PI must either transfer to an authorized user or return to EH&S all radioactive materials, including waste, assigned to him/her under the authorization. All dosimetry badges for staff must also be returned at this time. A final laboratory survey must be performed by the PI to ensure that the area is free of contamination. An exit survey will be conducted by the DSA before releasing the laboratory for general use. 6. DEPARTMENT CHAIRS Department Chairs have the following responsibilities. All may be delegated to a departmental safety representative: a. Assure that the applicant and all personnel listed on an application have training that will be commensurate with the proposed project. b. Assure that the project design and monitoring methods, as well as the resources available, meet the UCSF safety standards. c. Correct work errors and conditions that may result in personal injury. In departments with electrical sources of ionizing radiation, the Department Chair may appoint a person or subcommittee to see that all practical efforts to reduce Radiation Safety Manual Revised: May 2016 pg. 16

17 radiation exposure have been performed. This should be done prior to purchase, installation, and use of equipment. The person or subcommittee should cooperate with the RSO to: i. Establish guidelines for qualifications of users of radiation sources. ii. iii. Assure departmental compliance with UCSF radiation policies. Review incident investigations. 7. CHANCELLOR Under the terms of the Broad License, from the State of California Department of Health Services to the Regents, the Chancellor has the ultimate responsibility for the safe handling of radiation on the UCSF campus. Acting for the Assistant Vice Chancellor, Research, administers the UCSF Radiation Safety Program through the RSC, the RDRC, and EH&S. The Chancellor certifies that UCSF will implement the As Low As is Reasonably Achievable (ALARA) Program set forth in this manual. Radiation Safety Manual Revised: May 2016 pg. 17

18 CHAPTER 4: APPLICATION FOR RADIOACTIVE MATERIALS USE AUTHORIZATION A. APPLICATION FOR APPROVAL BY THE RADIATION SAFETY COMMITTEE (RSC) The review process is designed to ensure the safe handling and use of radioisotopes and other radiation sources. Applications are reviewed on their merit as well as for their impact on the campus. 1. SUBMISSION PROCEDURES RIO (Research Information Online) Application Submit to EH&S Departmental Safety Advisor (DSA) Review RSO/RSC Approval Summary sheet to Radiation Safety Program and Principal Investigator (PI) a. Basic Research Authorization (Non-Human) Each Principal Investigator (PI) must apply for a Radiation Use Authorization (RUA) before using radioisotopes at the University off California, San Francisco (UCSF). The PI can access the online RUA application by using the RIO program located in MyAccess or the UCSF EH&S website. The RIO program provides step by step instructions for creating all RUAs, human or non-human. Entry to the RIO program requires a username and password. Contact the department DSA or RSO for more information on creating a new RUA application. The Radiation Safety Program will review the proposed project and facilities which normally includes an interview with the applicant and a visit to the proposed use locations to evaluate the factors outlined below: i. The training and experience of all personnel who will be involved in the project. PIs must have some trainingg or practical experiencee in the following Radiation Safety Manual Revised: Mayy 2016 pg. 18

19 areas: characteristics of ionizing radiation, radiation dose quantities, radiation detection instrumentation, and the biological hazards of exposure to the types and forms of radiation to be used. All personnel involved in the project must be familiar with the UCSF radiation safety requirements. The PI is responsible for initial indoctrination and training of all persons working under his/her authorization. The DSA will assist if needed. ii. iii. iv. The radioisotopes (quantities, and chemical and physical forms of each of the radioisotopes) to be used will be reviewed. A brief description of lab procedures to be utilized. The adequacy of all locations for the proposed use with respect to: (See Appendix A for Criteria) Storage facilities. Hoods, glove boxes, and other special equipment. Housing and maintenance of experiment animals, if applicable. Impact of radiation use on surrounding areas. Housekeeping and hygiene. v. Radiation Control and Personnel Protection Inventory records (receipts, use, transfer, and disposal of radioisotopes). Waste disposal procedures. Monitoring methods, frequency and record keeping. Survey instrumentation, calibration procedures and records. Contamination control procedures. Shielding and/or remote handling techniques. Provisions for controlling releases to the environment. Personnel dosimetry and bioassay requirements. vi. Area posting and security Proper posting of work areas. Security measures to prevent unauthorized removal of radioisotopes. b. Human Use Authorizations Projects involving human subjects must have the overall approval of the Committee for Human Research Committee (CHR) and the Radiation Safety Radiation Safety Manual Revised: May 2016 pg. 19

20 Committee (RSC). For some research projects, the approval of the Radioactive Drug Research Committee (RDRC) is also required. Requirements for human use are much more restrictive than those not involving human subjects. Human Use Authorizations are renewable when approved by the DSA, RSO, RSC, and/or RDRC. This authorization may be revoked at any time. The review and approval process is similar to that of Basic Research Authorization. Whenever humans are to be exposed to radiation in a research context, the Radiation Exposure to Subjects form must be completed and submitted to the RSC and/or RDRC, in addition to a Radioisotope Use Authorization, if necessary. The CHR requires approval from the RSC on studies involving radiation exposure to human subjects before giving its final approval. c. Classroom Use of Radioisotopes Application shall be submitted to the Radiation Safety Program at least four (4) weeks prior to the commencement of the class. The following supplemental information will be required: i. Laboratory instructor (if other than applicant) in charge, and years of training and experience in the use of radioisotopes. ii. iii. iv. Names and years of experience of laboratory or teaching assistants involved in the course. Number of laboratory sections. Number of students per laboratory assistant. v. Number, type, and calibration data of monitoring instruments available in the laboratory. vi. vii. viii. Health and safety instructions for students. Extent to which students will be handling radioisotopes. Safety measures and emergency procedures. As a condition of approval, the RSC will require special safety measures, equipment and procedures. Radiation Safety Manual Revised: May 2016 pg. 20

21 The application will be reviewed by the RSO and will be submitted to the RSC for final approval. A copy of the approved application will be returned to the applicant with the conditions of approval. Allow approximately three weeks for processing of the RSC application. Radioisotopes may not be ordered before satisfying the conditions of the approval. Violation of this requirement may result in denial or revocation of the authorization. 2. CRITERIA FOR APPROVAL OF RADIOISOTOPE USE AUTHORIZATION (RUA) APPLICATIONS BY THE RADIATION SAFETY COMMITTEE (RSC) a. A completed RUA application submitted in RIO (Research Information Online). b. Each user included in the RUA must have current radiation safety training, and be trained by the PI in safe handling practices for the isotopes specified. c. Information must be complete and include necessary supplements. d. A Radiation Safety Office report on the facility, competency of PIs, and handling procedures must be satisfactory. e. Experimental design, technique, and safety must be adequate. f. Laboratory staff dosimetry history and compliance record during the previous interval must be acceptable. 3. TERMINATION OF USE OF RADIOISOTOPES An authorized user found to be willfully or negligently violating any of the UCSF or State of California regulations regarding the safe use of ionizing radiation may have his RUA revoked. Any radioactive materials in his possession may be removed for storage or disposal. RUAs will ordinarily be terminated upon: a. Completion of the research project. Upon completion of work with radioisotopes or cessation of the use of an approved facility, the DSA must be notified. This will be followed by final monitoring, clearance, and proper disposal of the remaining radioisotopes by the PI. An exit inspection should then be performed by the DSA before the PI leaves UCSF. b. Expiration of the authorization without renewal. Radiation Safety Manual Revised: May 2016 pg. 21

22 4. INACTIVATION OF AN RUA If there is no radioactive work currently, but there may be in the future, then a PI may opt to Inactivate their RUA. This allows them to reactivate via an expedited process, instead of submitting a new RUA. An RUA can be inactivated if there is no radioisotope inventory or waste, surveys and wipe tests confirm there is no contamination, and radiation signage has been taken down. Contact your DSA to initiate inactivation or to reactivate an RUA. 5. EXTENDED CAMPUS LEAVE BY A PRINCIPAL INVESTIGATOR (PI) Upon an extended leave from campus, the PI shall appoint an "alternate," who will be responsible for laboratory activities and ensure that the laboratory complies with all of the UCSF radiation safety requirements. This appointment must be reviewed by the RSO and submitted to the RSC for approval. 6. MODIFICATIONS TO THE RADIATION USE AUTHORIZATION (RUA) All changes to the RUA must be approved by the RSC/RSO. To modify an existing RUA, submit a modification in RIO and include an explanation of the changes in the Mod Justifications section. a. Personnel To add or delete a new user to the RUA, note the user change in the Mod Justifications section. For new users, radiation safety training must be current before the modification can be approved. If new users require dosimetry, submit a Dosimetry Request Form. For deleted users who were receiving dosimetry, contact dosimetry.coordinator@ucsf.edu to discontinue dosimetry. b. Use Area To add a new use area, note the room to be added in the Mod Justifications section and upload a map of the room in the documents section. After a site visit the RSP staff will issue the appropriate approvals. To delete a use area, note the room to be removed in the Mod Justifications section. Remove all radioactive materials from the room, survey and decontaminate if necessary. The DSA will conduct a site visit and spot check for contamination prior to approving the request. c. Changes in Possession Limits Radiation Safety Manual Revised: May 2016 pg. 22

23 Changes in possession limits of existing approved radionuclides must be listed in the Mod Justifications section. Minor changes (few mci) will be approved by the Radiation Safety Program. Addition of substantial quantities (10's of mci) will be sent to RSC for review and approval. d. Addition of New Radionuclides Addition of new radionuclides must be listed in the Mod Justifications section. Addition of low mci quantities of radionuclides with similar hazards to those already permitted (e.g., 35S for 14C users) may be approved by the Radiation Safety Program. All other requests will be forwarded to the RSC for review and approval. B. INSTRUCTION OF PERSONNEL 1. TRAINING REQUIREMENTS All persons using radioisotopes at UCSF must have radiation safety training documented in the UC Learning Management system and/or RIO. Specific training experience may be requested by the RSC/RSO. All exemptions must be approved by the RSC/RSO. 2. RETRAINING OF PERSONNEL In order to maintain a working knowledge of safety, all staff will be required to undergo radiation safety retraining at least once every two years. This schedule may be revised if the RSO believes that the skills of an individual warrant such a revision. 3. RESOURCES AVAILABLE Copies of rules, regulations, and standards and the UCSF license to procure and use radioactive materials are available in the EH&S Radiation Safety Program for review by employees and staff. A copy of the UCSF Radiation Safety Manual must be maintained in the office of each department that uses sources of ionizing radiation, or be readily available online. It must be available for review by all employees. It is highly recommended that these manuals be available in all laboratories using radioactive materials. Personal copies of the manual are available from the DSA. In addition, the Radiation Safety Program has a wide range of books, publications and audio-visual materials which are available to users. Please contact your DSA for further information. Radiation Safety Manual Revised: May 2016 pg. 23

24 CHAPTER 5: RECEIPT AND USE OF RADIOACTIVE MATERIALS A. FACILITIES AND HANDLING 1. POSTING AND LABELING a. Posting of an Area i. Areas in which radioactive materials are used shall be conspicuously posted with a sign or signs displaying the conventional three bladed symbol in magenta or purple on a yellow background. The sign shall bear the following words: CAUTION (OR DANGER) RADIOACTIVE MATERIAL ii. Areas in which the radiation exposure to individuals is at such levels that an individual could receive in any one hour a dose to the whole body in excess of 5 millirem, at 30 centimeters from the source shall have a conspicuously posted sign bearing the following words: CAUTION RADIATION AREA iii. Areas in which the radiation exposure to individuals is at such levels that an individual could receive in any one hour a dose to the whole body in excess of 100 millirem shall have a conspicuously posted sign bearing the following words: CAUTION (OR DANGER) HIGH RADIATION AREA When a High Radiation Area has been detected, the Radiation Safety Officer (RSO) must be notified immediately. The area must also be posted for advice on safe working procedures or engineering controls. b. Exceptions from Posting i. Hospital rooms or hospital areas should be posted when there is a patient present containing therapeutic levels of radioactive material. No diagnostic imaging rooms will be posted. These areas are not required to be posted if personnel, who will take the necessary precautions to prevent exposure of any individual to radiation in excess of the established limits, are in attendance. Radiation Safety Manual Revised: May 2016 pg. 24

25 ii. iii. Rooms or other areas containing radioactive materials for periods of less than 8 hours are not required to be posted with a CAUTION RADIOACTIVE MATERIAL sign - provided the materials are constantly attended by an individual who shall take necessary precautions to prevent the exposure of any individual to radiation or radioactive materials in excess of established limits. Equipment rooms used for measurement of the activity of samples with quantities which are exempted under 10 CFR 20 Appendix C will not be posted. c. Labeling of Containers i. Each container in which radioactive material is transported, stored, or used shall bear a label with the caution symbol and the words: CAUTION RADIOACTIVE MATERIAL ii. Whenever a container is removed from the working area or when containers are used for storage it must be labeled. The labels shall also state the types and quantities of radioactive materials in the containers and the date of the measurement of the quantities. d. Other Posting The University of California, San Francisco (UCSF) Type A Broad Scope Radioactive Materials License (Broad License) conditions and State of California Regulations require that specific informational materials be conspicuously posted in areas where radioactive materials are stored or used. These are available on the UCSF EH&S website, Radiation Safety section, and include the following: i. Summary of UCSF Campus Radiation Safety Procedure Guide which includes information regarding the following: Procurement of Radioactive Materials Authorized Applicant Responsibility General Safety Precautions Administration to Animals Waste Disposal Emergency Procedures ii. RH-2364, Notice to Employees This form is to be posted. The form will indicate the location of the license. Radiation Safety Manual Revised: May 2016 pg. 25

26 2. STORAGE/SECURITY Radioactive materials stored on the campus shall be secured against unauthorized removal. The security methods are determined by the Principal Investigator (PI) with approval of the RSO. This depends upon specific laboratory conditions. An inventory log (containing the date, radioisotope, manufacturer's lot number, and amount) must be kept for all radioisotopes stored. Log corrections must be updated through a routine physical inventory of storage items. The RSO/ Radiation Safety Committee (RSC) will determine the frequency of updates. 3. TRANSFER a. Within the University Transfer of radioactive material from one department, laboratory, or project to another within UCSF requires a TRANSFER OF RADIOACTIVE MATERIAL FORM, which must be completed for each transfer. (This form may be obtained at the Radiation Safety Program by calling , and is also available online on the UCSF EH&S website, Radiation Safety section). Adherence to these procedures is crucial for compliance with the requirements of the Broad License granted to UCSF. No radioactive materials may be transferred from one PI to another unless the recipient has a valid RUA number for the radioisotope and quantity to be transferred. The container and means of transportation must be adequate to ensure safety during transfer. When a vehicle is involved in the transfer, specific approval of the packaging (in accordance with Department of Transportation (DOT)) is necessary from the Radiation Safety Program prior to the transfer. All transfers of radioactive material must be documented in the files of the PI who transferred the material, the recipient of the radioisotope, and the Radiation Safety Program. b. Off-Campus (Non-UCSF Facilities) Radioisotopes purchased under the UCSF license may not be used for research projects at locations not specified in the license. Radioisotopes transferred off campus must be transferred in accordance with procedures described below. i. Radioactive material may not be transferred off campus unless the recipient is authorized by a specific license issued by an Agreement State or the U.S. Nuclear Regulatory Commission. Radiation Safety Manual Revised: May 2016 pg. 26

27 ii. iii. iv. A completed TRANSFER OF RADIOACTIVE MATERIAL FORM must accompany each transfer. All Radioactive material must be packaged according to the DOT specifications, if shipped domestically. International shipments must comply with applicable international regulations (International Air Transport Association (IATA), International Civil Aviation Organization (ICAO)). The transfer must be approved in advance of shipment by the RSO of the receiving institution. v. UCSF shall assume no responsibility for possession, use, storage, or radiation safety after the radioisotope transfer. vi. vii. In the event UCSF personnel are actively participating in the project, the RSO must be able to assure or verify that the RSP provided by the other licensee meets standards acceptable to UCSF. Before the package is sealed, it shall be brought to the Radiation Safety Receiving Laboratory for a wipe test. The Radiation Safety Program will provide necessary assistance for safe shipment of radioactive packages. Arrangements may be made by the PI transferring the radioactive material to have the common carrier pick-up of the package at the Radiation Safety Receiving Laboratory or to have the EH&S transport the material. B. PROCUREMENT 1. PURCHASING Radioactive materials may only be purchased or brought to UCSF by individuals having a valid Radioactive Use Authorization (RUA). All radioisotope orders must be initiated by the Purchasing Department. When an individual orders radioisotopes, the following procurement information must be provided to the vendor: PI. Researcher responsible for the order. PI RUA number. Telephone and room number of laboratory. The amount of any single vial order may not exceed the licensed maximum single vial purchase limit and the total quantity must be less than the laboratory's maximum possession limit. Vendors wishing a copy of the UCSF license should contact EH&S. Radiation Safety Manual Revised: May 2016 pg. 27

28 a. Special Purchase Order For a single order, submit a Purchase Requisition with the procurement information b. Miscellaneous Blanket Purchase Order This type of blanket purchase order does not name a specific vendor. The PI is responsible for verifying that purchase amounts do not exceed the RUA authorization. Orders received at the Radiation Safety Receiving Laboratory in excess of the RUA authorization will not be released to the PI. Provide the necessary procurement information on a Purchase Requisition including the expiration date and a "not-to-exceed" dollar amount for the blanket period. c. Specific Blanket Purchase Order This blanket order is issued to a specific vendor for specific items to be delivered on a regular basis or as needed by the user. 2. RECEIVING All incoming radioisotopes are delivered to the areas designated as approved Radioisotope Receiving Laboratories. NOTE: VENDORS ARE INFORMED OF THE APPROVED RECEIVING LOCATION BY RADIATION SAFETY. VENDORS WILL REFUSE DELIVERY TO UNAUTHORIZED LOCATIONS. Shipments are checked for damage, external or internal contamination as necessary, and appropriate authorization for the amount and type of radioisotope. All radioactive material orders that exceed the PI's authorized amount, type, or form will be held for review. After review these may be released if it is verified that the possession limits have been increased (e.g., RUA amendment) or inventory on hand reduced (e.g., waste disposal). These shipments may also be disposed of as radioactive waste or returned to the vendor, as appropriate. The PI and the RSO will be notified of contaminated shipments. Contaminated shipments will not be released unless the PI accepts responsibility for the contamination. If the levels of contamination are greater than 3 times background, the RSO will be notified and the Radiation Safety Program will take necessary actions as required by UCSF procedures and applicable regulations. Radiation Safety Manual Revised: May 2016 pg. 28

29 Upon completion of the package surveillance, the Radiation Safety Program will deliver the package to the laboratory address on the invoice. If shipping papers from the vendor do not contain the proper documentation (i.e., PI, RUA number, laboratory address, and phone number) additional time will be needed for the Receiving Technicians to identify the proper recipient. The PI or appropriately trained representative will sign for receipt. EH&S WILL NOT BE RESPONSIBLE FOR SPOILAGE OF SUCH PACKAGES. C. GENERAL SAFETY PRECAUTIONS Safety is achieved when careful procedures are followed in the laboratory. The safety of each operation or manipulation must be considered separately and in relation to the overall experiment design. Periodic self-evaluation of the facility or procedures is suggested for all users of ionizing radiation. The following precautions should be followed regardless of the amount or type of radioisotope involved: 1. Wear protective clothing whenever contamination is possible. Do not wear such clothing outside of the laboratory area unless the clothing has been monitored appropriately. 2. Use mechanical devices whenever their aid will assist in reducing exposure. 3. Use protective barriers and other shields whenever possible. 4. Use pipette-filling devices. NEVER PIPETTE RADIOACTIVE SOLUTIONS BY MOUTH. 5. Do not smoke, drink or eat in radionuclide laboratories. Eating may be permitted in a specified area of an office or laboratory that has been approved by the DSA. 6. Maintain good personal hygiene. 7. Use good laboratory work practices. 8. Wash hands and arms thoroughly before handling any object which goes to the mouth, nose or eyes. 9. Check the immediate areas, (e.g., hoods, benches) in which radioactive materials are being used, at least once daily for contamination. A record of routine surveys must be maintained at the frequency established in the RUA. The survey results Radiation Safety Manual Revised: May 2016 pg. 29