Three primary groups participate in the radiation safety program (RSProgram) and have varying degrees of management responsibility. They are the Radiation Safety Committee, Radiation Safety Office, and Approved Users/RGE Supervisors. A management tool integral to the success of the RSProgram, with respect to RAM, is the Radiation Safety (Yellow) Binder maintained by each Principal Investigator (PI) in their primary laboratories. Many of the RSProgram records and references as they relate to the day-to-day activities of PIs in research laboratories are maintained in a radiation safety binder. The participatory groups and binder are addressed below.

Radiation Safety Committee

The Radiation Safety Committee (RSC) is appointed by and reports to the President of Miami University. At minimum, membership of the RSC shall consist of:

1. The Senior Vice President for Finance and Business Services or a designated representative.
2. A representative for academic departments that operate RGEs.
3. Representatives from each of the academic departments deemed major users of RAM.
4. A representative from the Office for the Advancement of Scholarship and Teaching.
5. A representative from the Office of Purchasing
6. The Radiation Safety Officer (RSO).

Business brought before the RSC including the authorization of Approved Users and approval of proposals for RAM use require a quorum. A quorum is defined as the RSC Chair, RSO, the technical committee member representing the department from where the proposal originated, and any other committee member whose field of expertise may be necessary to address pertinent safety matters. Minutes of all RSC meetings shall be recorded and distributed to RSC members and to the University Secretary (upon RSC approval). The RSC has dispensed with the reading of the minutes and are automatically approved two weeks after distribution of the draft. Meetings shall be held as often as necessary to conduct business (e.g., quarterly).

The RSC addresses RGEs and RAM used in research and teaching endeavors. The functions of the RSC include:

1. Approving local regulations pertaining to the operation of RGEs and use of RAM at Miami University. Local regulations are rules and procedures more stringent than ODH regulations and are addressed in this manual.
2. Reviewing periodic activities of the RSProgram to ensure the adequacy of the current management control system to include:
   • RSOffice records.
   • Routine reports from the RSO.
   • Results of laboratory/user inspections.
   • Material use protocols.
   • Procedure addressing the procurement, inventory, and transfer of RAM.
   • Possession limits.
   • Monitoring results.
   • Disposal activities.
3. Granting Approved User status, approving use proposals, and approving facilities prior to installation of controlled areas.
4. Reviewing training and testing criteria for each worker classification.
5. Considering methods for maintaining records of committee proceedings and safety evaluations of proposed users, protocol, and facilities.
6. Reviewing the RSManual as necessary to ensure proper program management, education of persons working with RAM, and good health physics practices.
7. Specifying and approving permissible revisions to the ODH material license application without notification to the regulatory agency. These revisions include:
   • Rule changes dictated by ODH.
   • Changes in internal management forms.
   • Members of the RSC except those specifically listed on the material license.
   • Specific dates.
   • Changes in contractors for bioassay, waste disposal, dosimetry, or for the servicing or calibrating equipment.
   • Changes in percentage of total waste disposed by disposal method.
   • References to specific equipment.
8. Reviewing and approving RAM training courses for staff and students.
9. Administering the RSProgram through the RSO.

Radiation Safety Office

The RSOffice provides a variety of administrative and technical services designed to achieve compliance with the ODH Materials License agreement and with rules and procedures established by the RSC. The RSOffice is a function of the Environmental Health and Safety Offices (EHSO), and is staffed by the RSO and trained professional staff responsible for RSProgram management.

The RSO acts on decisions made by the RSC and has the authority to immediately stop a procedure involving RAM or an RGE if, in the opinion of the RSO, it is unsafe to continue. The RSO shall direct the RSOffice in the following activities:

1. Determine compliance with the ODH materials license, RSC rules and procedures, and the conditions of use proposals specified by the RSC.
2. Monitor all activities involving RAM including routine monitoring and special surveys of all areas in which RAM is used.
3. Provide radiation safety consultation to personnel at all levels of responsibility.
4. Supervise the receipt, survey, and release of RAM packages arriving and the packaging and shipping of all RAM leaving Miami University.
5. Supervise the distribution of personnel monitoring equipment and determine the need for bioassays. Monitor personnel exposure and bioassay records. Notify individuals and their supervisors of unusual exposures and recommend appropriate remedial action.
6. Conduct and/or supervise training programs that present RSProgram procedures for the use of RAM.
7. Supervise and coordinate the radioactive waste disposal program.
8. Monitor the storage of RAM not currently in use.
9. Perform or arrange for leak tests on sealed sources.
10. Schedule the calibration of radiation survey instruments.
11. Maintain an inventory of all radioisotopes and ensure that individual and total quantities are in accordance with amounts authorized by the current materials license.
12. Terminate any activity found to be a threat to health or property.
13. Supervise significant decontamination and recovery operations.
14. Supervise maintenance of radiation safety program records in accordance with the current regulatory requirements.

Approved User/RGE Supervisor

Approved User status is granted by the RSC based on training and experience. It carries responsibilities that include procurement, storage, and use of RAM and other sources of ionizing radiation in their research. Approved Users are expected to provide the day-to-day supervision of students and staff under their direction and radiation safety training (RSTraining) specific to their research. A Principal Investigator (PI) is a faculty member with Approved User status who has one or more radioisotope use proposals approved by the RSC. PIs are held accountable for managing the RSProgram as it relates to their research and for maintaining records in the radiation safety binder.

RGE Supervisor status is granted by the RSC based on training and experience. RGE Supervisors are expected to provide the day-to-day direct supervision of students and staff under their direction and RSTraining specific to their research.

The Radiation Safety Manual

The Radiation Safety Manual (RSManual) documents the Radiation Safety Program in accordance with Ohio Administrative Code (OAC) 3701:1-38-11 and the Quality Assurance Program in compliance with OAC 3701:1-66-04 (Radiation-Generating Equipment Requirements and Quality Assurance Standards) and OAC 3701:1-68-02 (industrial Radiation-Generating Equipment). It includes policies and procedures established by the RSC for the comprehensive implementation of the radioactive materials license and Ohio Department of Health rules. All persons who use radioactive materials or radiation-producing devices (Radiation-Generating Equipment; RGE) must be familiar with the contents of this manual applicable to them and strictly observe its provisions. The Radiation Safety Officer maintains current copies of the radioactive materials licenses and registrations and Ohio rules. These documents are available at the Radiation Safety Office (58 Hughes Hall, 529-2812). Ohio rules (3701:1-38, 66, 68) are also available at the ODH web site.

Failure to follow safety regulations and the provisions of this manual can jeopardize the authority of the University to use radioactive material and radiation-producing devices and could result in considerable negative impact on teaching and research programs, including possible loss of research funding. Violators of these regulations are therefore subject to penalties such as suspension or withdrawal of user status by the RSC. In addition, users should be aware that careless or willful violation of Radiation Safety regulations can also subject the perpetrator to civil or criminal prosecution by government agencies.

A Safe Environment Depends On You

Each user of radioactive material or radiation-generating equipment as well as any member of the university community, is encouraged to promptly report any actual or suspected infraction of these policies to a laboratory supervisor or the Radiation Safety Officer. Timely action can prevent a minor violation from escalating to a major incident. The Ohio Department of Health "Notice to Employee" signs are posted in each use area. These forms contain the Ohio Department of Health phone number to call if you feel university personnel disregard your genuine safety concerns.

As Low As Reasonably Achievable (ALARA) Philosophy

Whereas radiation safety is a shared responsibility, individuals approved to operate RGEs and use RAM at Miami University are held accountable for their actions and for failure to comply with established rules and procedures through the radiation safety program. Practices and techniques that reduce potential and expected radiation exposures to levels As Low As Reasonably Achievable (ALARA) OAC 3701:1-38-01(15) are expected and include: minimizing duration of exposure, establishing a reasonable distance from a source, and provision of shielding; control of personnel access into and around a controlled area; proper ventilation; use of trays or plastic-backed absorbent liners; and the use of gloves, lab coats, and eye protection. ALARA action levels are listed below. Exceeding these values constitutes an occurrence that will be evaluated by the Radiation Safety Officer and reported to the Radiation Safety Committee.

Whole body (deep dose) dosimeter results: 100 mrem/quarter
Skin (shallow) dose results: 100 mrem/quarter
Extremity dosimeter results: 500 mrem/quarter
Declared Pregnant Woman: 50 mrem/quarter
Minor (less than 18 years of age): 50 mrem/quarter
Any personal contamination with radioactivity.
Any suspected intake of radioactivity.
Any radioactive contamination to an unrestricted area.
Any radioactive contamination in a restricted area that prevents use of the lab.

Radiation Safety (Yellow) Binders

Radiation safety binders (referred to as Yellow Binders) are maintained in primary use laboratories where RAM is used. They are an important management tool that links PI activities with RSProgram management. A Yellow Binder is provided to each PI and must be kept in the primary use laboratory in a location where it may be located without obstruction (on a desktop or in an open bookshelf, not in a drawer or cabinet). Each Yellow Binder contains information and records regarding the users, isotopes, and monitoring conducted in the primary and secondary laboratories. Each binder contains:

1. Radiation Emergency Procedures (Inside Front Pocket). This information is a reprint of the Emergency Procedures section in this manual for easy access in the event of a release or fire involving radiation. It is provided on laminated card stock for protection and easy decontamination.
2. Isotope Use Records - When radioisotopes are released to a PI by the RSOffice, an Isotope Use Record (IUR) used for inventory control accompanies the package. Upon receipt, the PI places the IUR in the Yellow Binder. It is used by the PI and the RSOffice for inventory control and inspection purposes.
3. Wipe Tests - A floor plan diagram of rooms where RAM is used and the Controlled Area Wipe Testing Record is maintained for compliance and inspection purposes. Note that although printouts of liquid scintillation counter results must be kept on file for three years, the RSOffice may request that any printouts stored in the Yellow Binder for more than a 90-day period be removed by the PI for archiving. (See Radiation Monitoring, Wipe Testing for Removable Contamination).
4. Approved Protocol – Copies of all proposals approved for use in the laboratory by the RSC are available for reference and review. Originals are maintained by the RSOffice.
5. Certifications - Applications/Certifications of individuals who work with RAM in the laboratory must be readily available for verification. Certifications are mailed to the PI for placement in the Yellow Binder. Anyone who handles RAM in any manner or is in a controlled area but does not have a certification on file must be identified to the RSOffice immediately. Their actions could place Miami University in violation of our material license agreement.
6. Inspection Reports - The RSOffice suggests that PIs file their Inspection Reports in the Yellow Binder.
7. Radiation Safety Updates - Periodic updates used to disseminate changes made to the RSManual as well as information relative to federal, state, and local regulations that complement the RSManual. The PI is responsible for ensuring that his/her staff and students review each RSUpdate before posting it in the Yellow Binder.
8. Miscellaneous - Reserved for future use. May be used to file isotope manufacturer quotes, isotope reference sheets, etc.
9. Miami University Radiation Safety Manual.

Actions In Response To Non-Compliance

Compliance is defined as meeting or exceeding current mandates of ODH, agreements made as part of our material license application and subsequent amendments, and local regulations established by the RSC. Although non-compliant conditions or acts do not always result in a written violation from the ODH, they reflect the RSC’s ability to maintain effective management control through the RSProgram at Miami University. It is important to note that the procurement and use of RGEs and RAM are not a right but a privilege granted by the regulatory agencies. The non-compliant conditions or acts of a single user can jeopardize our entire program through monetary penalties, restrictions imposed by ODH, or a revocation of our equipment registration and/or material license. Therefore, accountability within the RSProgram is imperative to protect that privilege for everyone.

Non-compliance is typically reported to the PI in writing via a quarterly inspection report with a copy to the appropriate RSC departmental representative. Inspections involving RAM are conducted quarterly and RGE inspections are conducted semi-annually or as required. A summary of each inspection is provided to the RSC and a verbal report made at each RSC meeting. If necessary, items of non-compliance are discussed for clarification.

Actions taken by the RSC in response to non-compliance should be interpreted as a demonstration of management control of the RSProgram and as an effort to maintain accountability among the users. Non-compliance with inspection report items 1, 2, 4, 5, and 9 are in direct violation of ODH regulations and shall result in the following actions if they occur within a period defined by two or more consecutive inspections or within an academic year, whichever is most restrictive:

1. 1st Occurrence - The inspection report will serve as written notification to the PI and respective RSC departmental representative. No further action will be taken.
2. 2nd Occurrence - A memo from the RSC Chair addressing the repeat violation and the corrective action required of the PI shall be issued. If no response is received from the PI by the specified date, the violation will be elevated to a 3rd occurrence violation.
3. 3rd Occurrence - Termination of all protocol and possible RSC expropriation of RAM. Use restrictions and/or reporting assignments may be placed on RGE operators.

Notifications of violations at all levels of occurrence may be contested in writing to the Chair of the RSC by a PI. The RSC will review the details of the alleged violation and the written appeal. Prior conditions and acts of non-compliance will be taken into consideration. If the violation is deemed valid, the violation will stand but may be downgraded to a local violation (LV, a violation of Miami University regulations that are more stringent than ODH regulations). Alleged violations successfully contested will be removed from the record and a response written to the PI.

The remaining items on the inspection report and other regulatory issues (e.g., personal dosimeter exchange, survey meter calibration, protocol updates) demonstrate management control while assisting users and the RSC in their compliance efforts. Non-compliance with those items/practices and other safety and health issues (e.g., food and drink in laboratories) shall be handled on a case-by-case basis. Repeat occurrences and patterns of non-compliance may be interpreted by ODH as a breakdown in management control and, therefore, may result in actions described above.

User Definitions

Approved User

Approved User status may be granted to faculty, students at the graduate level or above, or unclassified staff who have met the minimum training and experience requirements established by the RSC. Requirements for Approved User status are:

1. A baccalaureate degree in the physical or biological sciences or in a discipline where radiological health is addressed.
2. Training in RSProgram practices and procedures with at least 40 hours of experience in radiation physics and instrumentation, radiation protection, related mathematics, and radiation biology. The types and forms of RAM used in the past will be compared with the expected research at Miami University when determining status approval.
3. Completion of Miami University’s Radiation Worker Training Course and a passing grade of at least 80 percent on the written test.
4. Approval of the RSC.

Other Approved User responsibilities may include:

1. The day-to-day supervision of Radiation Workers under their direction and direct supervision of any guest faculty, student, staff, or visitor not recognized by the RSProgram who enters a room where RAM is used or stored.
2. Providing performance-based and other RSTraining specific to their research.
3. Providing direct supervision to a Radiation Worker until confidence in his or her abilities and understanding of applicable rules and procedures have been achieved.
4. Maintaining records, logs, and other documentation as required by the RSProgram.

Principal Investigator

Only a faculty member with Approved User status may become a PI—an individual having one or more approved protocol granted by the RSC. the PI status carries with it an increased level of accountability including direct responsibility for aspects of RSProgram management as it relates to the approved protocol (e.g., recordkeeping, wipe testing, inventory, security, quarterly inspection requirements).

Radiation Worker

A Radiation Worker is any person engaged in activities related to research and development that involves the procurement, handling, use, or disposal of RAM. A Radiation Worker must:

1. Complete the Miami University Radiation Worker Training Course and achieve a passing grade of at least 80 percent on the written test.
2. Work under the supervision of an Approved User.
3. Receive performance-based training conducted by an Approved User. Individuals are encouraged to document that training as it can be used toward Approved User status.

Short-term Radiation User

An individual expecting to work at Miami University for one academic year or less and whose activities in controlled areas will be limited in scope may seek status as a Short-Term Radiation User. User certification may be extended beyond one year as determined by the Radiation Safety Officer and the Principal Investigator. Short-term Radiation Users shall:

1. Complete an abbreviated Radiation Safety Course and achieve a passing grade of at least 80 percent on the written test.
2. Receive performance-based training conducted by an Approved User. Individuals are encouraged to document this training as it can be used toward Approved User status.
3. Work under the supervision of an Approved User.

The Short-Term Radiation User status does not lead to Radiation Worker or Approved User status. While Short-term Radiation Users may perform experiments involving RAM in a research environment, responsibilities for radiation monitoring, maintenance of recordkeeping, and ordering RAM shall not be delegated to those individuals.

Student Radiation User

A student in a controlled academic laboratory (classroom) environment that may handle microcurie quantities of RAM under the direct supervision of an Approved User is considered a Student Radiation User. The purpose of this status is to permit instruction and demonstration of safe RAM handling techniques with limited handson opportunities for the student. Radiation safety training will be provided by the Approved User(s) associated with the course.

Ancillary Staff

Ancillary Staff are employees or contractors of Miami University who do not handle or use RAM but have the potential for exposure given the nature of their support function. Ancillary Staff shall be provided a level of training necessary to gain an understanding of the possible radiation hazards associated with their respective job functions and to safely perform their assigned duties.

User Responsibilities - General

All persons engaged in activities involving RAM are responsible for the safe use of materials in their possession. At minimum and when applicable, every user must:

1. Keep exposures as low as reasonably achievable (ALARA).
2. Wear the prescribed monitoring equipment (i.e., personal dosimeters) in controlled and radiation areas.
3. Survey hands, shoes, and body for radioactivity and remove all loose contamination before leaving a controlled area.
4. Utilize all appropriate protective measures to include:
   • At a minimum, wearing easily removable protective clothing–a lab coat is most common. Do not wear protective clothing outside the laboratory. Note that street clothes are not considered protective clothing.
   • At a minimum, wearing disposable gloves. Remove gloves before leaving a controlled area. Always presume the gloves being worn are contaminated unless you have demonstrated otherwise.
   • At a minimum, wearing eye protection appropriate for the hazard (e.g., a splash hazard requires chemical splash goggles).
   • Using protective shields and other physical barriers whenever possible.
   • Using mechanical devices to reduce distance and exposure (e.g., tongs).
   • Using mechanical pipetting devices. Never pipette by mouth.
   • Using a laboratory hood or certified biological safety cabinet that has been commissioned for use of radioactive materials if an inhalation hazard exists.
   • Using the minimum quantity of radioactivity relative to the objectives of the protocol.
5. Prohibit smoking, eating, drinking, and applying cosmetics in laboratories. Laboratory space includes any office areas, work desks, or work stations within a room listed on an approved protocol.
6. Prohibit the use of refrigerators/freezers in laboratories for the storage of food and drinks intended for human consumption.
7. Maintain good personal hygiene. This includes:
   • Keeping fingernails short and clean.
   • Avoiding all work with RAM if there is a break in the skin below the elbow.
   • Wash hands and arms thoroughly before handling any object which goes to the mouth, nose, or eyes.
8. Monitor the controlled areas for contamination at least once each day RAM is used. A record of these surveys and results should be maintained. Removable contamination must be reduced to less than 200 counts per minute (cpm) above background. A contaminated area greater than 2000 cpm should be decontaminated immediately and the RSO notified.
9. Practice good housekeeping.
   • Keep controlled areas as separated from non-radioactive work areas as possible.
   • Work areas should be free from equipment and materials not required for the immediate procedure.
   • Store and transport RAM in a manner that prevents breakage and spillage (e.g., tube holders in a tray) while ensuring adequate shielding.
   • Use plastic-backed absorbent paper in a tray or pan to contain a potential spill.
10. Isolate and label equipment used in conjunction with RAM. This equipment shall not be used for other work nor shall it leave a controlled area until it has been demonstrated to be free of contamination.
11. Request RSOffice supervision of any emergency repair involving equipment that is contaminated or contains RAM. At no time shall servicing personnel be permitted to work on equipment in controlled areas without the supervision of an Approved User.
12. Immediately report any incident of inhalation, ingestion, or injury involving RAM to the PI and to the RSO. An individual shall cooperate in any and all attempts to evaluate an exposure and shall carry out prescribed corrective measures.
13. Prevent the spread of contamination to other areas in the event of a release and carry out decontamination procedures.
14. Comply with RSOffice requests for body burden measurements. This may involve a whole body counter or urine samples for radioassays.

Approved User Responsibilities

Approved Users are accountable for the actions of users under their supervision and for:

1. Adequate planning. Before RAM can be procured, an Approved User must determine the types and amount of radiation or RAM to be used in a well-defined procedure. An evaluation shall be conducted by questionnaire, experimental plan, and written protocol review and submitted to the RSOffice for RSC approval (see Evaluation of Proposed Uses and Facilities). A rehearsal, or “dry run” is recommended and may be required to identify any unexpected circumstances before a procedure is actually performed with radiation. The RSO is available for consultation in the preparation of the proposal.
2. Training. Approved Users must instruct all users under their supervision in safe techniques and the application of approved radiation safety practices.
3. Requesting the addition and/or deletion of personal dosimeters for users under their supervision through the RSOffice.
4. Requesting RAM waste drums through the RSOffice.
5. Furnishing the RSOffice with current information regarding individuals in their areas.
6. Contacting the RSOffice whenever changes in operational procedures, new techniques, and facility alterations are anticipated. Approval by the RSC may be required prior to implementation.
7. Contacting the RSOffice prior to an extended absence from the laboratory. This may require appointing another Approved User or PI to assume responsibility for laboratory management or temporarily deactivating experimental protocols.
8. Complying with the rules, procedures, and regulations governing the use of RAM as established by Miami University, ODH, other applicable governmental agencies having jurisdiction.
9. Following the procedures for the procurement of RAM by purchase or transfer (see Procurement).
10. Posting areas where RAM is stored or used or where radiation areas exist.
11. Recording the use and disposal of RAM.
12. Consigning solid radioactive waste to the RSOffice for disposal.
13. Restricting the use of a RAM to RSC-approved users.
14. Keeping quantities of stored RAM to a minimum and in controlled areas.
15. Maintaining adequate records as required by the RSC.
16. Complying with the procedures for employee resignation or termination.
17. Shipping all RAM through the RSOffice.
18. Promptly returning personnel monitoring devices to the RSOffice.

Training is in accordance with Ohio regulation (reference OAC 3701:1-38-10) and at a level based on past training, experience with the use of RAM, and the type of work to be performed. In order to effectively train individuals having a wide range of education and experience, courses and awareness programs are structured accordingly. Emphasis is placed on performance-based training for persons supervised by Approved Users. Ancillary staff shall be provided a level of training necessary for them to gain an understanding of the possible radiation hazards associated with their respective job functions and to safely perform their assigned tasks.

Radiation Worker Training

Anyone planning to use RAM at Miami University must successfully complete the Web-based Radiation Basics modules and attend the 2-hour Radioactive Materials Class offered by the RSOffice once each month. Following successful completion of these courses individuals will be granted the status of Radiation Worker. Radiation Worker Training is the only course that will lead to an Approved User status.

Web-based Radiation Basics modules

This course is designed to provide a basic understanding of radiation through completion of the following six computer training modules:

• Radiation Properties
• Background Radiation
• Biological Effects
• Regulations
• External & Internal Dose Limits
• Radiation Monitoring

Radioactive Materials Class

This course addresses the details of RSProgram management and the control of RAM at Miami University. User definitions and responsibilities, procurement procedures, recordkeeping, radiation surveys, emergencies, and waste management will be presented. A multiple choice/short answer take-home test will be distributed at the end of the course and requires a passing grade of 80 percent or better. If tests are not returned within ten days of distribution, the student may be required to attend Radioactive Materials Class the following month and a new test completed.

Student Radiation User Training

Students will receive specific practical instruction and education in radiation safety as part of approved academic course work. All aspects of instructional training, material handling through disposal, monitoring for contamination, and recordkeeping will be the responsibility of the Principal Investigator under an experimental plan approved by the RSC. This user category does not lead to a Radiation Worker or Approved User status.

Radiation Safety Awareness

Persons working in laboratories and other areas where RAM are located are encouraged to attend this one-hour awareness program designed to provide attendees with an appreciation for radiation safety. This program does not lead to a Radiation Worker or Approved User status.

Continuing Education

The RSO communicates regulatory changes that have not been incorporated in the RSManual through e-mail notifications to the PI’s. In addition, the RSO also meets with each PI once a year to perform a half-hour of continuing education. The training includes a review of the main elements of the radiation safety program as well as any changes that have occurred during the previous year. It is the responsibility of the PI to inform all users under his/her supervision of this information and place it in the “Radiation Safety Updates” section of the RSManual.

Performance-Based Training

Training that provides instruction or develops a person’s proficiency using a task-based approach and objectives written with an action verb is commonly defined as performance based training. Students prove competency to an Approved User by the actual performance of defined objectives. Performance-based training is commonly practiced in the laboratory environment; however, it is typically offered informally and without documentation by Approved Users. Although not required, the RSOffice encourages documentation of performance-based training to enhance an individual’s records.

General Use Procedures

The following procedures address use requirements expressed by regulation and are applicable to all aspects of licensed RAM at Miami University.

Proper Marking of Work Areas and Equipment

1. A "RADIOACTIVE MATERIAL USED IN THIS ROOM" sign placed at the entrance of rooms where one or more specific areas within the room are labeled and used as controlled areas.
2. A "CAUTION RADIOACTIVE MATERIAL" sign or equivalent label tape shall be conspicuously placed in controlled areas where RAM is being stored or used.
3. Containers in which materials are transported or stored shall bear a durable, clearly visible label having the radiation caution symbol and the words "CAUTION RADIOACTIVE MATERIAL" or equivalent label tape. This labeling shall reflect the isotope and activity in the container, the date of assay, and the Isotope Use Record (IUR) number for reference to the corresponding form.
4. Controlled areas and locations around RGEs and RAM may be defined as radiation areas—locations where radiation levels could expose individuals to 5 millirems at 30 cm in any one hour or a dose in excess of 100 millirems in any five consecutive days from any surface through which radiation penetrates. Radiation areas shall be posted with a "CAUTION RADIATION AREA" sign.
5. Disposal sinks shall be demarcated with RAM label tape and a sign posted designating the sink is suitable for the disposal of radioactive isotopes.
6. All equipment contaminated with RAM shall be marked with radiation signs, decals, tape, or by other conspicuous means. Labeling is not required for laboratory containers such as beakers, flasks, or test tubes used in laboratory procedures if those containers are in the controlled area or in the possession of trained personnel at all times and if those items are decontaminated immediately following the procedure.
7. Signs and labels referred to in this part, with the exception of RAM label tape, are available through the RSOffice. All signage posted by the RSOffice must not be removed except under the direction of the RSO.

Shielding of Sources

Radiation sources shall be shielded in such a manner that the radiation levels in any unrestricted area will not expose individuals more than 2 millirem in any one hour. Figures 1 and 2 provide the penetration ability of beta and gamma radiation through various shielding materials, respectively.

Beta Radiation

Beta radiation can penetrate through the following shielding materials:

1. Air (easiest to penetrate)
2. Water
3. Plastic
4. Concrete
5. Glass
6. Aluminum
7. Iron
8. Lead
9. Copper (hardest to penetrate)

Gamma Radiation

Gamma radiation can penetrate through the following shielding materials:

1. Water (easiest to penetrate)
2. Concrete
3. Steel
4. Lead (hardest to penetrate)

Aerosols, Dusts, and Gaseous Products

1. Procedures that generate airborne contamination such as aerosols, dust, or gaseous products shall be conducted in a functioning laboratory hood, certified biosafety cabinet, or other ventilation device approved by the RSOffice.
2. Incorporate traps into the experimental plan to ensure environmental releases will be as low as possible. All releases from such systems shall not exceed the maximum permissible concentration as defined in OAC 3701:1-38-12 Appendix C.
3. Radioactive gases or materials with gaseous radioactive daughters must be stored in gas-tight containers and stored in areas having adequate ventilation.
4. The performance of laboratory hoods and biosafety cabinets used for radionuclide work should be certified at least annually.

Sealed Sources

1. Procurement of sealed radioactive sources must be made through the RSOffice. An amendment to our ODH Material License may be required prior to procurement of the source.
2. The RSOffice, in cooperation with individual users, shall establish strict accountability procedures when sources are contained within portable units.
3. Sealed sources shall be leak tested by the RSOffice upon receipt and quarterly thereafter. Sealed sources placed in storage within three months after receipt do not require leak testing until it is removed from storage.

Radioactive Material in Gas Chromatography Equipment

1. Radioactive foils used in gas chromatography cells must be procured through the RSOffice. An amendment to our Materials License may be required prior to ordering of the source.
2. Each cell containing a radioactive foil shall be labeled or tagged with
   
   1. Signage bearing the radiation caution symbol and the words "CAUTION RADIOACTIVE MATERIAL"
   2. The identity and activity of the RAM.
3. The radioactive foil shall not be removed from its cell.
4. The following notice shall appear in a conspicuous location on the outside of each gas chromatography unit:
   • "This equipment contains a radioactive source and is registered with the Radiation Safety Office at Miami University. Removing the source or transferring the equipment must be approved by the Radiation Safety Officer prior to removal or transfer".
5. Radioactive cells in gas chromatographic equipment shall be vented via an approved exhaust system or approved trap to avoid possible exposure of personnel and contamination of the work area.
6. Radioactive cells are sealed sources and shall be leak tested by RSOffice personnel prior to initial use and quarterly thereafter.

Work Surfaces

All work surfaces including bench tops, laboratory hoods, and biosafety cabinets should be constructed of non-porous material and designed to contain spills and with decontamination in mind (e.g., one piece stainless steel with coved corners and edges) in the event of an unexpected release. Cover work surfaces with plastic-backed absorbent paper or equivalent for easier clean-up. It is recommended that storage areas and surfaces adjacent to set-ups and sinks be covered as well. The use of stainless steel or plastic trays, uncracked glass plates, or other impervious containment is encouraged. Always assume plastic-backed absorbent paper, trays, plates, etc. are contaminated. Frequent monitoring or replacement will prevent the spread of radioactive contamination.

Equipment Removal and Repair

1. Once used in a RAM procedure, equipment shall not be used for other work or be released from a controlled area until it has been demonstrated to be free of contamination by using monitoring procedures outlined in this manual.
2. Equipment to be repaired by the Central Instrumentation Laboratory, Physical Facilities Department, or by commercial service contractors shall be monitored for contamination as outlined in this manual and shall not be released by the Approved User for service until it has been demonstrated to be free of contamination. If it becomes necessary to make emergency repairs on contaminated equipment, the work will be supervised by the RSOffice to ensure that all necessary safeguards are taken. It is the responsibility of the Approved User to request this supervision from the RSOffice.

Application for Use of Radioactive Materials

Application must be made through the RSOffice to the RSC prior to any procurement or use of RAM. An Application and Certification for Radiation Worker/Approved User Status form must be acquired from the RSOffice, 58 Hughes Hall. The form provides the following information:

• Part A – Applicant Data. Information that includes Banner ID number and date of birth is required for the issuance of personal radiation dosimetry devices. It is the responsibility of the applicant to identify the Approved User will be working under so a certification document can be mailed. However, if an Approved User is unknown or undecided at the time of application, that information must be left blank.
• Part B - Applicant signature certifying receipt and understanding of course content.
• Part C - RSOffice approval and Approved User status information.

Evaluation of Proposed Uses and Facilities

A written proposal for experiments using RAM shall be submitted to the RSOffice for RSC approval prior to any procurement or use of RAM. A peer review process provides the PI with input from experienced researchers and support staff. The process is important in maintaining RSC management control of activities involving licensed RAM.

Laboratories and other rooms must be commissioned (evaluated and approved) prior to the use or storage of RAM. An evaluation of facilities is conducted by the RSOffice and is based on the activity and form of isotopes to be used and the experiments to be performed. Consideration is given to shielding, containment, area controls, remote handling equipment, and monitoring instruments as they relate to the proposed use. The RSC approves facilities based on a recommendation by the RSO.

Laboratories and other rooms should be released for unrestricted use if the use or storage of RAM is being discontinued in those areas. Released for unrestricted use demonstrates that a room is free of contamination and removes the room from further consideration in the RSProgram.

Proposal for Radioisotope Use

The Proposal for Radioisotope Use at Miami University form provides the RSC information required to conduct a peer review. The original form must be signed by the PI. The proposal (typically referred to as the "protocol") must be submitted to the RSOffice for distribution and subsequent review by the RSC. The proposal will be dated upon receipt and it will be assigned a unique protocol number. Approved Users are encouraged to consult with the RSO during proposal development. A quorum of the RSC may grant tentative approval until reviewed and final approval is sought at the next RSC meeting. Approved protocol will be maintained by the RSOffice with a copy filed in the PI’s Yellow Binder. The proposal consists of:

• Part A - Questionnaire. Applicant information, clarifications about facilities and monitoring, and RSTraining course information.
• Part B - Experimental Plan.
  • Radioactive Material. Isotopes and their chemical form, maximum activities per purchase, and maximum monthly usage must be determined and listed. Note that the activities approved by the RSC may affect procurement. The RSOffice will deny an order if it exceeds maximum activities reflected on an approved protocol.
  • Surveys/Monitoring. The frequency of wipe testing is based on material license agreements, PI preference, and RSC determinations in special circumstances. Minimum frequency of wipe testing is 30 days when one millicurie or less of any RAM is used or disposed of in a 30 day period. If more than one millicuries are used or disposed of in a 7 day period, conduct wipe tests for that period. If isotopes are used that cannot be monitored with a survey meter (e.g., ³H, ¹⁴C, ³⁵S, ⁴⁵Ca), wipe tests are recommended after each use to detect contamination.
    Whole body and ring dosimeters shall be issued by the RSOffice whenever the risk of exposure in one year is ten percent of established limits for an adult or declared pregnant woman (see Table 3). Dosimeters may be issued for lower risks of exposure at the request of the Approved User.
  • Waste Disposal. An estimate of the percentage of radioactive waste streams for each isotope complements management control and helps determine waste drum requirements. Current disposal options include aqueous waste disposal via the sanitary sewer system, storage for decay, and incineration. (See Radioactive Material Waste Management).
• Part C - Written Protocol. Details of the proposal must be described in a typed document not to exceed three pages and should be written to convince the RSC that the PI will be using RAM safely and in accordance with applicable regulations. The written protocol should include an introduction to and purpose of the research, a step by step process that involve isotopes (expressed in microcuries), rooms/locations that specific processes occur, storage practices, and disposal activities. Safety procedures and equipment must be addressed and protocol must reflect consideration of the ALARA philosophy.

Procurement

Orders of all regulated RAM shall be placed through and approved by the RSOffice. A PI must initiate an order; however, Procurement authorization may be granted to any Radiation Worker on the PI’s research team. The PI must provide the RSOffice with the name of each person authorized to order on his/her behalf.

Each isotope ordered must agree with maximum activities stated in the RSC-approved protocol on file which will be verified by the RSOffice prior to placing an order. Information necessary to place an order includes: the isotope, its chemical form, and amount; manufacturer and catalog number; purchase order number; and RSC-approved protocol number. That information shall be entered onto an Isotope Order and Receipt Form by the RSOffice for inventory control and recordkeeping purposes. Orders shall be submitted to the RSOffice by one of the following procedures:

1. Miami University Requisition - Requisitions for RAM procurement must be initiated by the PI and forwarded to the RSOffice for approval prior to submission to Purchasing. (NOTE: The Manager of Academic Procurement will only honor requisitions or limited purchase orders (LPOs) for RAM that have been approved by the RSOffice)
2. Telephone Orders - Orders can be made through the RSOffice by telephone. As a necessary measure of control, only the PI or member of his/her research team on the procurement authorization list may place an order.

Splitting Orders Between Principal Investigators

A cost savings can sometimes be realized when multiple units of RAM are ordered or a volume is split between two or more PIs. While that is an acceptable practice, only one PI can place the order. Therefore, a split shall be approached as a transfer of material. The process must be approved by the RSOffice prior to placing the order (see Transfer of Material). Coordination by the RSOffice is necessary to maintain inventory control of RAM.

Receipt and Distribution of Packages

All radioisotope packages shall be delivered directly to the RSOffice by common carrier for inspection and processing during normal business hours. Although highly unusual, special circumstances that would necessitate delivery of a package at another time shall be coordinated by the RSOffice. The integrity of the package and its contents shall be verified and control of the RAM shall be maintained by the RSOffice until released to the PI or member of his/her research team on the procurement authorization list.

The RSOffice shall conduct the following receipt and distribution procedures:

1. The RSOffice shall monitor the package for radiation and radioactive contamination upon receipt. The wipe testing procedure requires opening of the package. The PI or a member of his/her research team on the procurement authorization list is notified that the package is ready for pick-up. An Isotope Use Record will be provided with the package.
   • Until it has been demonstrated that the package is free of removable contamination, gloves shall be worn when handling a package.
   • Packages are inspected for signs of leakage and damage.
   • Contents shall be compared with the packing slip.
   • Package surfaces shall be surveyed as appropriate to ensure that external radiation and contamination limits are not exceeded pursuant to current regulations.
   • Wipe testing shall be conducted to determine removable contamination on the exterior and interior of the package and on the exterior of the pig or packaging containing the RAM.
   • Results of package monitoring are maintained by the RSOffice.
2. The PI or a member of his/her research team on the procurement authorization list is notified that the package is ready for pick-up. An Isotope Use Record will be provided with the package.
3. Contaminated shipping containers and packaging materials shall not be disposed as regular trash; however, all RAM packages are surveyed and wipe tested prior to release by the RSOffice and have been demonstrated to be free of removable contamination. Upon receipt of a RAM package, the research group must: If a contaminated package is suspected, immediately isolate the package and contact the RSOffice.
   • Immediately remove the shipping pig that contains the RAM (by end of business day) from the shipping container.
   • Remove all dry ice and dispose accordingly.
   • Remove or deface all labels and language referencing radioactive material. Only then may the container and packaging material be discarded as regular trash.
     If RAM is not removed and the container is used for storage beyond the pick-up date, the container and packing materials are presumed contaminated. Wipe testing must then be conducted by the PI prior to disposal to demonstrate that the package is not contaminated.
4. If a contaminated package is suspected, immediately isolate the package and contact the RSOffice.

Isotope Use Record

An Isotope Use Record (IUR) is an inventory and tracking document that will accompany each radioisotope package distributed by the RSOffice. The responsibility for the maintenance and correctness of each IUR issued lies with the PI. Inventory of that material is maintained by the RSOffice. An IUR might not be issued if RAM 1) is used only for its radiation attributes, 2) is not to be removed from its original container, and 3) volume will not change.

The IUR is designed to track the amount of isotope that is in use, in storage, decayed, disposed via the sanitary sewer (via an approved hot sink), discharged as gases to the air, and has been placed in a radioactive waste drum for eventual pick up and disposal by the RSOffice. Each IUR will reflect a unique isotope number and general information identifying the PI and isotope ordered. All transactions must be recorded in microcuries. Indelible ink must be used.

The following is a brief explanation of how the IUR is used.

1. Date - Identifies each IUR transaction.
2. A blank that may be used for noting discharged gases to air, container volume, or for calculation.
3. Decayed - Calculated decay of material currently in use and in storage only. Do not decay any isotope that has been disposed via the hot sink or placed in a radioactive waste drum; however, decay should be calculated and recorded at that time, if applicable. Decay must be calculated and recorded at least monthly or every half-life, whichever is longer. The sum of the column provides the total isotope decayed.
4. In Use - Activity of isotope that has been removed from the original container and is currently in process or is being held for eventual hot sink disposal or placement in a radioactive waste drum. Accumulating and storing radioactive waste in a small bag or jar (e.g., in a laboratory hood) with the intent of placing the waste in a radioactive waste drum or disposing it down the drain when a waste container is full is an efficient and acceptable practice; however, waste accumulating (e.g., in a hood) is not yet disposed and must be calculated as isotope In Use for inventory control purposes. Only the last transaction should reflect current isotope In Use.
5. Unused - Activity of unused isotope in the original container. Only the last transaction reflects current isotope In Storage.
6. Sewer - Activity of aqueous waste isotope disposed via the hot sink. Accumulated and stored waste prior to hot sink disposal is considered isotope In Use (see In Use above). The sum of the column provides the total isotope disposed via the hot sink.
7. Drum - Activity of solid waste placed in a radioactive waste drum. Accumulated and stored waste prior to placement in a drum is considered isotope In Use (see In Use above). The sum of the column provides the total isotope placed in a drum.

The accuracy of RAM inventory is a dynamic process and is primarily dependent upon the PI’s timely maintenance of the IUR. Furthermore, the RSProgram database is most accurate when the PI promptly completes and returns the IUR to the RSOffice when all RAM has been depleted, disposed, or placed in a radioactive waste drum.

Transfer of Material

A materials transfer is defined as the conveyance of RAM to a person or organization authorized by a regulatory agency to receive said material. Any materials transfer shall be approved by and coordinated through the RSOffice prior to its implementation. The splitting of isotope orders as described above under Procurement shall be considered a materials transfer.

Security and Control of Radioactive Material

A controlled area is identified for storage, use, and disposal of RAM and may include bench tops, laboratory hoods, refrigerators/freezers, and cold rooms. Access to those areas is not restricted except by security and control measures practiced by RAM users. A wide variety of people not certified as Radiation Workers have access to laboratories and to controlled areas—delivery persons, technical staff, colleagues, friends, and family. Responsibilities for security and control of RAM lay primarily with the PIs who use them. Although the RSProgram requires the use of an IUR for inventory purposes that can assist in the control process, physically securing RAM in the laboratory and controlling access to it can only be achieved by the user.

Three levels of security and control have been established and will deter unauthorized persons from accessing RAM at Miami University:

• Lock the door - Locking the door to the laboratory limits access to the room to those individuals having a key. It is understood that others have key access (e.g., department personnel, maintenance); therefore, locking the door is considered the lowest level of security and control.
• Lock the refrigerator/freezer or utilize a lock-box - A good line of defense against unauthorized access is keeping RAM in a locked refrigerator/freezer. If refrigerator/freezer access must be provided to others in a laboratory, the use of a durable lock-box that can be stored in the refrigerator/freezer is acceptable.
• Line-of-site view of RAM - The best method of security and control is having a clear view of the laboratory, your RAM, and who is entering and leaving the area.

The above steps do not address deliberate acts by persons familiar to you. Contact the RSO and University Police if you suspect theft or contamination of a suspicious nature. Be proactive. Approach and challenge anyone you do not know who enters your laboratory or contact University Police for assistance.

Monitoring for radiation involves surveying and wipe testing of rooms where RAM is used or stored, surveying radiation areas, and personal dosimetry. The timely maintenance, calibration, and turn-around of associated equipment and dosimetry helps minimize the potential spread of removable contamination and radiation exposures. Surveys and wipe testing shall be conducted by the PI. Semi-annual surveys and wipe testing, monthly and quarterly personal dosimetry, and annual calibrations shall be conducted/coordinated by the RSOffice.

Surveying for Radiation

Surveying areas for radiation can identify the need for additional shielding of sources or can locate areas that require decontamination. Surveys shall be conducted at a minimum frequency identified in Part B of the applicable RSC-approved protocol. Note that monitoring with a survey meter does not take the place of wipe testing.

1. Each PI approved to use applicable isotopes (e.g., P³², P³³, I¹²⁵) shall purchase and maintain a portable or semi-portable survey meter approved by the RSO (see Monitoring Equipment and Devices).
2. Care should be taken to prevent the contamination of the survey meter. Always presume contamination. Avoid placing the meter in any controlled area or using the meter with gloved hands. Covering the probe window with a low density plastic wrap that can be easily removed and disposed will protect it against unexpected contact with contaminated surfaces.
3. Surveys shall be conducted using generally accepted practices. At minimum, the survey meter probe window should be held about one inch from the surface being monitored and a 2 seconds per foot traverse used.

Survey Meter Operations Check

Prior to each daily use, a survey meter must be checked against a radiation source for verification of operation.

1. Check battery level. Follow manufacturer’s instructions for this check and, if necessary, for replacing the battery.
2. Locate the calibration label on the meter and determine the check source level in mrem/hr or cpm. If no calibration label is present, contact the RSOffice.
3. Set the function switch of the meter to read the expected level. If unsure, begin at a higher multiplication setting to avoid pegging the needle.
4. Hold the probe window up to the check source attached to the meter and measure the radiation level.
5. If the level is not within 20 percent of the expected measurement, the survey meter should not be used. Contact the RSOffice.

Wipe Testing for Removable Contamination

Wipe testing surfaces demonstrates radiation control, provides evidence of good laboratory technique and, provides the RSOffice an opportunity to review housekeeping practices. Wipe tests shall be conducted at the minimum frequency identified in Part B of the applicable RSC-approved protocol and should be conducted as often as necessary to verify that controlled areas are within acceptable limits of removable contamination.

While background levels are desirable, ALARA levels have been established at 200 net counts per minute (~210-350 dpm, depending on machine counting efficiencies). Contamination above 200 counts per minute (cpm) requires decontamination and a follow-up wipe test to demonstrate that the desired levels have been achieved. If contamination is 2000 cpm or greater, follow procedures as above and inform the RSOffice the following business day. Areas where contamination cannot be reduced to below 200 cpm must be demarcated and the RSOffice contacted the following business day.

Wipe testing procedures are as follows:

1. Develop a floor plan diagram of your room and identify wipe testing locations (e.g., bench tops, fume hoods, refrigerators/freezers, hot sinks). Include the floor where RAM is used and one location where you would not expect contamination (e.g., keyboard, telephone, door knob). Minimum locations will be established in concert with the RSO when establishing or modifying RAM use in a laboratory. Attach to back of wipe test tab separator.
2. Swab or wipe a representative 100 cm2 area where RAM is used.
3. Prepare an unwiped swab as a control. Count the blank to determine background radioactivity.
4. Count the sample for gross counts per minute using a liquid scintillation counter or, if applicable, dry gamma counting methods. For greater accuracy, counting windows may be set for the energy level of the radioisotopes used in the laboratory. Only biodegradable liquid scintillation cocktail may be used.
5. Record the wipe test results in gross counts per minute on the Controlled Area Wipe Testing Record located behind the Wipe Test tab in the Yellow Binder.

Determining Wipe Test Frequency

Determine the expected level of activity in a given month. If the total expected cumulative activity is less than or equal to 1 millicurie, conduct wipe testing at least every 30 days. If the total expected cumulative activity used is greater than 1 millicurie in a given 7 day period, conduct wipe testing at least every 7 days. If any procedure involves 5 millicuries or more, conduct wipe testing daily until the procedure is complete. Wipe test frequencies approved in Part B of the PI’s RSC-approved protocol that are more restrictive take precedence. For example, if the protocol reflects a 7-day wipe test schedule and the total expected cumulative activity used is less than 1 millicurie, the PI must wipe test and record the results at least every 7 days (see Table 1).

* Although a typical survey meter used at Miami University will not effectively monitor ¹⁴C or ³⁵S sources, some level dose rate may be measured verifying the presence of a radiation hazard.

Using the Controlled Area Wipe Testing Records

1. Record the wipe test results for locations that correspond with the floor plan diagram in gross cpm. A background activity must be included. (Note: Although it not necessary to store machine counter printouts in the yellow binder, they must be made available for inspection upon request. Verify that the date and locations on the machine counter printout correspond with the Controlled Area Wipe Testing Record, print the primary room location and machine counting efficiency on the printout, and file it. Those printouts must be kept by the PI for three years after the record has been made and be available for review upon request.)
2. If gross cpm are above 200 for any given location, take steps to reduce the removable contamination and conduct a follow-up wipe test in that location. Record the former and latter results to demonstrate effort to reduce the contamination. Only those locations exceeding 200 cpm need retesting.
3. If RAM is not handled, used, or disposed in a given wipe test period or in specific locations as referenced on the form, “NEP” may be entered across the results section or in the specific location(s) cell in lieu of wipe testing, unless otherwise instructed by the RSC. Should the PI not anticipate using RAM for an extended period (i.e. several months) NEP may be entered into the wipe test record in advance. Should RAM use re-start during this period the PI can strike a line through NEP and continue wipe testing. Any handling of RAM can result in some level of contamination requiring wipe testing. The abbreviation NEP, or “No Experiments Performed,” refers to no actions involving RAM.

Note: The Controlled Area Wipe Testing Record is designed to provide the information necessary to calculate wipe test results in gross cpm to dpm. Locate the machine counting efficiency on each scintillation counter. Contact the RSOffice if assistance is needed.

Personal Monitoring Program

In accordance with the ALARA philosophy, personal dosimeters shall be issued by the RSOffice whenever the risk of exposure in a year is 10 percent of established limits for an adult or declared pregnant woman (see Table 2). However, dosimeters are generally recommended and may be issued at the request of the Approved User. Other methods of monitoring radiation exposures shall be instituted by the RSO as required. Personal dosimeters will be processed by a contract service on a monthly or quarterly basis depending on the dosimeter type.

¹ - For information on specific tissues not listed, contact the RSO.
² - ALARA levels are established at 10% of the allowable limits unless otherwise noted. 

1. Total Effective Dose Equivalent. The Total Effective Dose Equivalent (TEDE) limit is 5,000 mrem per year for adult persons using radiation sources. The TEDE is the sum of the deep-dose equivalent (DDE) for external exposure and the committed effective dose equivalent (CEDE) for internal exposure.
2. Committed Dose Equivalent. The Committed Dose Equivalent (CDE) limit to any individual organ or tissue must not exceed 50,000 mrem in any year.
3. Eye Dose Equivalent. The dose equivalent limit to the lens of the eye is limited to 15,000 mrem per year.
4. Skin or Extremity Dose Equivalent. The shallow-dose equivalent (SDE) limit to the skin or extremity is 50,000 mrem per year.
5. Declared Pregnant Woman. A pregnant woman is subject to exposure limits listed in (a)-(d) above unless she declares her pregnancy. A "declared pregnant woman" voluntarily informs her Authorized User and the Radiation Safety Officer, in writing, of her pregnancy and the estimated date of conception. The declaration will be kept confidential. The dose to the fetus (from both internal and external sources) is then legally limited to 500 mrem equally distributed over the term of the pregnancy (i.e., 50 mrem/month). In the interest of ALARA, the Radiation Safety Committee has set the action level for exposure review for declared pregnant women at 50 mrem/quarter. Women are not required to declare their pregnancy; however, the lower dose action level only applies to declared pregnant women. The woman may revoke the declaration anytime she chooses. Documented medical proof is not required.

In addition to the above:

1. Individuals who are exposed to ionizing radiation below the ALARA levels on a regular basis may be issued a personal whole-body dosimeter.
2. Individuals who handle quantities of RAM greater that 5 mCi on a regular basis may be issued a finger (ring) dosimeter.
3. Personal whole body dosimeters must be worn exterior to any garment worn, located between the neck and waist, and generally between the person and the source. Finger dosimeters must be worn under a protective glove on the hand that is primarily used to handle or remain in the vicinity of a radiation source.
4. The RSO will promptly review all exposure reports to identify individuals whose exposure is unexpectedly high or low. This procedure only applies to the dosimetry of record and does not apply to backup dosimeter types (e.g., pocket ionization chambers).
5. Other individuals who are potentially exposed to radiation on an occasional basis such as emergency response personnel, Physical Facilities Department staff, or departmental support staff will not normally be issued personal dosimeters.

Bioassays

Current and anticipated usage quantities do not require bioassays. Should usage requirements change significantly, appropriate monitoring based on nuclide, quantity, and types of use will be initiated. In the event of incidental exposure, appropriate biosampling will be accomplished through the University of Cincinnati, Department of Nuclear Medicine, Cincinnati, Ohio.

Monitoring Equipment and Devices

Survey meters are most often used for monitoring beta and gamma radiation. A survey meter is a Geiger-Mueller (G-M) counter and probe connected to a count rate meter with a scale reading in R/hr, mrem/hr, or cpm. Each survey meter must be calibrated annually in coordination with the RSOffice. The cost of battery replacement between annual calibrations and any repairs of the survey meter are the responsibility of the PI.

Liquid scintillation counting involves dissolving a sample directly into a solvent media cocktail and counting low energy beta particles that scintillate as they pass through the cocktail. Counts may be calculated to disintegrations based on background radiation and equipment efficiency. Equipment efficiencies are calculated annually by the RSOffice and posted on each unit. The efficiencies are necessary to calculate disintegrations from net counts.

Thermoluminescent dosimeters (TLDs) and film badges are personal monitoring devices that may be provided monthly or quarterly by the RSOffice. Personal dosimetry may be required when a person is working with or in the vicinity of:

• Beta emitters whose maximum energy is greater than 1 MeV.
• Gamma emitters.
• Neutron sources or neutron-generating devices.
• X-ray generating equipment.

Personal dosimeters are not required by regulation where it has been established by the RSO that exposures cannot exceed 25 percent of the maximum permissible dose. This determination will be based upon the intensity and energy of the radioisotopes used as well as techniques used in and the working conditions of a controlled area. As noted, the conservative approach at Miami University results in the issuance of personal dosimetry more often than required by regulatory requirements.

Minor Spills of Liquids or Solids (typically <100 μCi)

1. Notify persons in the area that a spill has occurred.
2. Prevent the spread of contamination by covering the spill with absorbent material (e.g., paper towels). Wear the appropriate personal protective equipment.
3. Clean up the spill using absorbent paper. Carefully fold the absorbent paper with the clean side out and place in a plastic bag for transfer to the appropriate radioactive waste drum. Place disposable gloves and any other contaminated disposable material in the bag.
4. Monitor the area as appropriate (survey meter or wipe testing). Check the area around the spill. Check your hands, clothing, and shoes for contamination.
5. The PI shall follow up on the cleanup of the spill and submit a report addressing spill clean-up efforts and monitoring results to the RSO within 7 days of the incident.

Major Spills of Liquids or Solids (typically ≥100 μCi)

1. Evacuate if spill is of a volatile material.
2. For non-volatile materials all persons not involved in the spill should vacate the room.
3. Prevent the spread of contamination by covering the spill with absorbent material (e.g., paper towels). Survey all personnel who may have been contaminated and immediately remove contaminated shoes or clothing.
4. Shield the source only if it can be done without further contamination or a significant increase in radiation exposure.
5. Exit and secure the room.
6. Inform the PI and the departmental RSC representative as listed on page i of this manual. Contact the RSO. Outside normal business hours, call University Police at 911 to notify the RSO.
7. Unless you are confident in approaching the clean-up of the contamination at hand, prohibit entry into the room. RSOffice personnel will have authority over the scene when they arrive.
8. Decontamination of the facility will begin at the perimeter of the spill and proceed toward the center, or higher area of contamination. An appropriate level of personal protective equipment shall be worn. Surface decontamination will be accomplished using soap and water or other response materials appropriate for the chemistry of the spill. Work shall be slow and deliberate with a continuous survey of radiation levels.
9. The PI (or RSO if present) shall supervise the cleanup of the spill. The PI shall complete a report addressing spill clean-up efforts and monitoring results to the RSO within 7 days of the incident.

Fires Involving Radiation

1. Pull the fire alarm. Contact University Police at 911 of a fire situation involving a radioactive material at your location and follow building evacuation procedures. University Police will contact the fire department and the RSO.
2. If the fire is confined and you have received training in the operation of the fire extinguisher, attempt to put the fire out. If the fire is not manageable, evacuate the building and await University Police and the fire department. It is extremely important to the safety of the emergency responders that they be informed of the radiation and/or chemical hazards involved in the fire.

Decontamination

Skin

It is important to follow procedures 1 through 6 in the order they are presented. You should also take care not to abrade or scratch the skin. Avoid spreading contamination, protect uncontaminated areas with tape or plastic, and discontinue any step when less than 5 percent of the surveyed contamination is removed. It is recommended that a skin lotion be applied after decontamination of skin. All materials contaminated during cleanup shall be treated as radioactive waste.

1. Immediately wash wounds with copious amounts of water. Spread the edges of the wound to permit flushing action by the water. Protect the wound with waterproof bandage.
2. Gently brush or wipe loose particles from the skin and into a bag or sink. Survey the contaminated area of the skin.
3. Rinse the area with water and survey the contaminated area of the skin.
4. Wash with a mild soap and warm water building a thick lather. A soft brush may be used on the skin. Wash fingernails and callused areas of the skin with a stiffer brush. Survey the contaminated area of the skin.
5. Scrub with a 1:1 mixture of commercial laundry detergent and cornmeal or use an acceptable skin decontamination foam. Survey the contaminated area of the skin.
6. If contamination remains, induce perspiration by covering the area with plastic. Then wash the affected area again to remove any contamination that was released by the perspiration.

Ingestion by swallowing

If the material is not a corrosive, immediately induce vomiting and have the victim drink large amounts of water. Excretion analysis and/or a bioassay may be required to determine the amount of body burden.

Surface and Equipment

1. Clothing - If levels permit, wash the clothes as usual. Wash water must be below maximum permissible level for sewer disposal. If levels do not permit washing, dispose as radioactive-contaminated waste.
2. Glassware and laboratory tools - Wash in soap or detergent and water. Monitor wash water and hot sink.
3. Walls, Floors, and Benches - Wash with soap or detergent and water. Detergents should first be tested on surfaces.

General Animal Care Instructions

1. All work must be conducted in accordance with regulations as described in the RSManual.
2. Animals must be housed in the Animal Care Facility located and in accordance with IACUC standards.
3. Animals, cages, and used bedding used in conjunction with RAM must be segregated from non-radioactive animals, cages, and bedding.
4. Animals, cages, and used bedding used in conjunction with RAM shall be presumed contaminated. At minimum, gloves, eye protection, and protective clothing shall be worn whenever animals or cages are handled or bedding is changed.
5. Bedding used in conjunction with RAM must be collected in a manner determined by the RSO and incorporated into the written protocol for approval by the RSC.
6. Prior to releasing cages to the Animal Care Facility for cleaning, the PI shall perform a wipe test, record the results in the Yellow Binder, and report the results to the Laboratory Animal Resources Director. Counts above 200 net cpm shall be reported to the RSO prior to cage cleaning. Wipe testing of cage washers after the cleaning process may be necessary.
7. Cages must be constructed of a material easily decontaminated and approved by the Laboratory Animal Resources Director.
8. This section, Animal Studies, shall be posted in all rooms used in conjunction with RAM.

Handling Radioactive Animals, Cages, and Bedding

1. Injections of RAM in animals shall be performed by or under the supervision of a PI in a controlled area.
2. If volatile RAM is used, work shall be performed in a functioning laboratory hood or certified biocabinet that is mechanically exhausted to the building exterior.
3. Cages used in conjunction with RAM shall be clearly posted with a “CAUTION RADIOACTIVE MATERIAL” sign or equivalent label tape and with the following information:
   • Name and form of the radioisotope.
   • Amount and activity of the radioisotope injected into each animal.
   • Date of the injection(s).
   • Name and telephone numbers (work and home) of the PI.
4. The PI is responsible for correct labeling, posting of signs, and the posting of the animal care instructions as stated above.

Waste Disposal

1. Animal excreta must be treated as radioactive waste.
2. Radioactive carcasses and dissected parts must be wrapped in absorbent paper, sealed in a watertight bag or container, double-bagged, clearly labeled as radioactive material (see Packaging Instructions), and include the following information:
   • Name and form of the radioisotope.
   • Activity of the radioisotope at time of packaging.
   • Name and telephone number of the PI.
3. Package animals in double plastic bags using as small a volume as possible. Teeth, bones, claws and other sharp edges must not puncture the plastic bags. Waste shall be appropriately labeled, frozen, and stored by the PI until disposal by the RSOffice.
4. When possible, radioactive carcasses shall be blended (liquefied) using a blender or garbage disposal and disposed via the sanitary sewer system at an approved hot sink.

Radioactive Material Waste Management

All forms of RAM waste (aqueous, solid, contaminated product) shall be disposed by one of five methods: decay in storage, sanitary sewer system, release to the atmosphere, contracted licensed broker. Activity and volume limitations are established by federal and state regulatory agencies and by our material license agreement.

General Collection and Storage

1. Segregate RAM waste from non-radioactive waste. Keep volumes/quantities of waste to a minimum.
2. Avoid unnecessary accumulation of RAM waste. Decontaminate containers and noncombustible items to background levels for disposal via non-radioactive waste streams.
3. Secure and control RAM waste as it remains a licensed material and must not be stored in unsecured areas.
4. Clearly identify and segregate RAM waste by isotope and from other work in the area.
5. Maintain RAM waste records. Waste records are subject to inspection by the RSOffice staff and the RSC and will remain a principal item of inspection by regulatory agencies.
6. Account for all RAM received. Proper waste handling is dependent on waste segregation and adherence to the packaging procedures described below. Handle and dispose of all radioactive waste in accordance with established procedures.

Radioactive Waste Drum System

Radioactive waste drums are color-coded to designate segregated waste streams. Waste drums are light weight and are delivered ready to use including a plastic double liner with absorbent material to provide appropriate containment for residual fluids that might leak from the waste. The fiber drums and the plastic bags that contain the waste do not provide significant shielding from radiation. Additional shielding may be required depending on the storage location of the drums and the isotope the drums hold for disposal.

Radioactive waste drums are used for decay in storage, incineration, and contracted licensed broker methods of disposal. Drums are delivered to and collected from approved areas through the RSOffice and at the request of a PI.

Color-Coded Drums

Drums are color-coded orange and yellow for easy identification in the laboratories and in storage at the Hazardous Residuals Facility. Each drum is issued a unique ID number for tracking purposes. Yellow drums are used for radioactive-contaminated solid waste containing 3H, 14C, or other isotopes with a half-life of greater than 120 days. The contents of yellow drums will be disposed by incineration through a contracted licensed broker. Orange drums are used for radioactive-contaminated solid waste containing 32P, 33P, 35S, 125I, or other isotopes having a half-life of 120 days or less. the contents of orange drums will be disposed by using decay in storage methods.

Packaging Instructions

General

Place solid waste in sturdy 1-2 gallon-sized clear plastic bags tightly sealed with a twist tie or fashion a bundle and tape the waste in absorbent paper about the size of an American football (i.e., a size that can be easily handled with one hand). Instructions for using the type of RAM waste drum issued are provided with each drum.

The following are general restrictions when packaging a RAM waste drum:

• No loose waste. All waste must be sealed in smaller bundles or bags for handling and placed inside the double-lined drum.
• No chemical waste. Flammable and non-flammable solvents (including alcohols), corrosives, and toxic compounds are strictly prohibited. Contact the Environmental Health and Safety Offices for the disposal of chemical waste.
• No Sharps. Pointed and sharp objects that include pipettes, blades, needles, capillary tubes, microscope slides, and broken glass are strictly prohibited. Decontaminate contaminated glass and metals to background levels and dispose via non-radioactive waste streams.
• Do not overfill a drum. The drum lid must fit securely and completely on the drum. Drums that are overfilled cannot be stacked for storage and the PI will repack the drum before it is removed from the assigned room.

Orange

Remove or deface all labels referencing radiation and radioactive material. Waste in an orange drum is destined for a sanitary landfill. Removing labels, rolling labels up into a ball, or marking out all radiation symbols and the words “RADIOACTIVE MATERIALS”, or similar wording with a black indelible marker are acceptable. Orange drums are stored in the Hazardous Residuals Facility for a period determined by multiplying the half-life of the isotope in the drum by ten (i.e., at least ten half-lives). After a period of at least ten half-lives, the waste is surveyed to verify it is free of contamination and disposed via sanitary landfill.

Yellow

Waste in yellow drums is disposed via incineration through a licensed waste broker. No glass, metal, or other non-combustible materials are permitted to be discarded in the yellow waste drums.

Drum Log

Packaged waste that is placed in a drum shall recorded on a Radioactive Waste Drum Log. When a drum is issued, it is given a unique ID number reflected on the log sheet . The following information shall be recorded legibly on the log and in indelible black ink:

1. Date the bag or bundle was placed in the drum.
2. Brief description of the waste (e.g., paper, gloves, pipette tips).
3. Activity of the bag or bundle. Record the activity in microcuries. DO NOT use the phrase “trace amounts” or mathematical symbols such as approximation (~), less than (<), or greater than (>). A mass balance of inventory must be maintained and the users are in the best position to determine an estimate to the nearest microcurie.
4. Initials of the individual making the entry.

Drum Pickup and Delivery

Radioactive waste drums are transported by the Environmental Health and Safety Offices. However, the PI must contact the RSOffice to request an empty drum and to request pick-up of a full drum. Before the drum is removed from the area, it will be inspected to verify the following information:

1. Log entries are complete and legible.
2. Proper segregation (only one isotope per drum).
3. Waste has been packaged as described above.
4. All radiation labels have been removed or defaced from materials with a half-life of less than 120 days placed in the drum.

Radioactive waste drums inconsistent with the procedures described in this section shall be corrected by the PI prior to pick-up of full drums.

Sanitary Sewer (Hot Sink) Disposal

Radioactive water-soluble liquids shall be disposed via approved hot sinks and in amounts not to exceed the recommended permissible quantities indicated in Table 3. Exceedances may be permissible on a case-by-case base with prior approval from the RSO.

When disposing small quantities of radioactive water-soluble liquids, carefully pour the liquid directly into the drain so not to pour or splash it onto the gasket between the drain and the sink. Avoid pouring liquid onto the gasket. Decontaminating the gasket is extremely difficult and not always successful. Follow the waste with copious amounts of tap water until monitoring of the drain indicates background levels of radiation.

Large volumes of diluted aqueous waste, such as a tub of contaminated wash water from glassware, should be carefully poured into the sink to avoid splashing and followed with copious amounts of tap water. The sink, surrounding work surfaces, and the immediate area of the floor should be thoroughly washed, rinsed, and monitored for radiation.

Hot sinks are often found contaminated to some degree. Decontamination must be performed as necessary to achieve ALARA levels.

Decay

Storage in Decay waste shall be stored for at least ten half-lives until it has decayed to background radiation levels and below 0.1 microcuries. A survey of the waste will be performed to demonstrate background levels. The contents will be inspected to ensure that all radioactive labeling has been removed. The waste will then be discarded as nonradioactive waste via regular trash. The date of disposal, background radiation, dose rate of waste, model and serial number of the survey meter used, and the name or initials of the responsible person shall be recorded on the Radioactive Waste Drum Log.

Other Waste

De Minimus

De minimus radioactive waste is limited to ³H and ¹⁴C in liquid form with an activity of less than 0.05 μCi/mL. Under the supervision of the RSO, de minimus waste may be disposed without regard to its radioactivity.

Impervious materials (e.g. glassware, solid waste) may be disposed in regular trash if:

1. The material has a background activity as determined with a portable survey meter.
2. Wipe testing of the material surface reveals less than twice the background count for an alpha or beta emitter.

Animals

Package animals in double plastic bags using as small a volume as possible. Teeth, bones, claws and other sharp edges must not puncture the plastic bags. Waste shall be appropriately labeled, frozen, and stored by the user until disposal by the RSOffice. When possible, radioactive carcasses shall be blended (liquified) and disposed via the sanitary sewer system at an approved hot sink. (See Waste Disposal).

¹ Contact the RSOffice for permissible activities of isotopes not listed.

Activities of Radioactive material disposed via the sanitary sewer are consistently well below the allowable monthly average concentration as defined in 10 CFR 20, Table 3. The following equation is used to determine activities of radioactive material that may be disposed via the sanitary sewer by a Principal Investigator in any given month (reference 10 CFR 20.2003(a)(4):

~MPA_I = (DD_I × MAR) ÷ (12 months × PI_T)

Where:

MPA_I = Maximum permissible activity of isotope that may be disposed via the sanitary sewer system in μCi/Month.

DD_I = Ratio of total isotope disposed. ³H = 1; ¹⁴C = 1; All other isotopes = activity of isotope sink disposed ÷ sum of all other isotopes sink disposed. 

MAR = Maximum annual releases per isotope category. ³H = 5 curies. ¹⁴C = 1 curie, and all other isotopes combined = 1 curie.

PI_T = Number of Principal Investigators typically using isotope I in a given year.

I/DD_I/PI_T/MAC(FY2001): H³/1/5/1 E-2; C¹⁴/1/5/3E-4; P³²/.99/10/9E-5; P³³/.99/10/9E-5; P³³/.1/1/8E-4; S³⁵/.1/1/1E-3; Ca⁴⁵/.1/1/2E-4; I¹²⁵/.2/2/2E-5

The policies and procedures of the Radiation Safety Manual apply to the use of radiation generating equipment governed by Chapters 3701:1-38, 3701:1-66, and 3701:1-68 of the Ohio Administrative Code (OAC). All radiation-generating equipment, whether active or in storage, must be registered with Ohio Bureau of Radiation Protection. Radiation-generating equipment (also known as radiation-producing devices) consist of a wide variety of diagnostic and analytical x-ray units. This manual provides general guidance for safety and usage. Required operating procedures for each device give more detailed information and procedures relevant to safety and regulatory compliance. The provisions of the Radiation Safety Manual and the operating procedures for each device constitute the Quality Assurance Program required by OAC 3701:1-66-04 and OAC 3701:1-68-02.

Radiation Generating Equipment (RGE)

Table 4 contains the current list of RGEs and their RGE Supervisor.

X-ray Diffraction

X-ray diffraction machines are designed for and regulated as analytical devices. The mode of operation for x-ray diffraction involves a primary beam from an x-ray tube emerging through a collimator, striking a sample, and measured by a detector. This radiation chain is fully contained in a shielded, fail-safe cabinet sometimes referred to as cabinet radiography. The diffraction of x-radiation from sets of planes within a crystalline sample, typically a single-crystal on the order of 100 microns in size (single-crystal diffractometry) or a powdered sample (powder diffractometry), provides an examination of the macroscopic structure of materials by nondestructive methods.

The primary beam in x-ray diffractometry is highly-collimated. In conjunction with the shielded and interlocking cabinet, x-ray diffraction machines are inherently safe and, therefore, do not present a radiation hazard when properly operated. However, Approved Operators may be instructed to wear personal monitoring.

X-ray Fluorescence (XRF)

X-ray Fluorescence is the emission of characteristic “secondary” (or fluorescent) Xrays from a material that has been excited by being bombarded with high-energy X-rays or gamma rays. The technology is widely used for elemental and chemical analysis, particularly in the investigation of metals for research in geochemistry. Approved Operators using portable handheld XRF units are required to wear ring dosimetry when operating these devices without the portable test stand.

Dual-energy X-ray absorptiometry (DXA)

DXA machines are used to measure bone mineral density. Two X-ray beams, with different energy levels, are aimed at the patient’s bones. When soft tissue absorption is subtracted out, the bone mineral density can be determined from the absorption of each beam by bone. Duel-energy X-ray absorptiometry is the most widely used and most thoroughly studied bone density measurement technology. Approved Operators are required to wear personal monitoring.

Current list as of 12/12/2023

RGE Supervisor

One or more RGE Supervisors shall be named for each RGE listed on Miami’s registration with the Ohio Bureau of Radiation Protection. The RGE Supervisor administratively oversees and coordinates radiation-generating equipment operations and maintenance to ensure appropriate and safe usage. Additionally, the RGE Supervisor serves as a conduit for communications between the Radiation Safety Officer (and the Radiation Safety Committee) and the RGE Operators in matters concerning the radiation-generating equipment operation and safety.

RGE Supervisor Qualifications

The Chair of the department housing the radiation-generating equipment nominates the prospective RGE Supervisor for approval by the University Radiation Safety Committee. The primary RGE Supervisor must be a permanent faculty member (teaching or research) who has sufficient knowledge, experience, and administrative authority to reasonably assure safety, training, oversight, and control of the radiation-generating equipment. Additional RGE supervisors for a given instrument must meet these criteria but need not be faculty.

RGE Supervisor Responsibilities

The RGE Supervisor is responsible for the day-to-day direct supervision of RGE Operator-in-Training under their direction. They provide performance-based and other RSTraining specific to the RGE being used until confidence in the RGE Operator-in-Training abilities and understanding of applicable rules and procedures to use the equipment independently have been achieved. Additional RGE Supervisor Responsibilities include:

• Develop operating procedures for the RGE that satisfy the requirements from OAC 3701:1-66 (for Radiation Generating Equipment) and OAC 3701:1-68 (for Industrial Radiation Generating Equipment). The Radiation Safety Manual and Operating Procedures must be accessible to radiation-generating equipment operators at all times.
• Operating procedures must contain site-specific instructions, as well as manufacturer’s instructions. Review the operating procedures periodically to ensure they are current. Communicate to RGE Operators any change in operating status of the device or required operating procedures.
• Establish and administer controls limiting access to each device to approved operators, as well as scheduling the use of radiation-generating equipment.
• Develop and maintain a use log for each radiation-generating equipment.
• Develop training programs for operators and any individual likely to receive a radiation exposure rate of 0.1 mrem/hr, not to exceed 100 mrem in a calendar year from the RGE. Training will include general radiation safety training offered by the RSOffice.
• Sign off on the adequacy of training and experience for RGE Operators in Training for institutional accountability and quality assurance.
• Arrange for appropriate maintenance of each device and schedule housekeeping services for the facility. A record of maintenance is required.
• Arrange with the Radiation Safety Officer for periodic surveys of the safety features of each device, including the quality assurance check of the warning lights and interlock systems for each piece of radiation-generating equipment. Record results in users’ log. Keep the Radiation Safety Officer informed of any changes that would affect the radiation output or safety aspects of any device.
• Inform the Radiation Safety Officer prior to the acquisition of additional or upgraded equipment or removal from service of old equipment to ensure that registrations with the Ohio Bureau of Radiation Protection are kept current.
• Immediately inform the Radiation Safety Officer and Department Chair of any situation resulting in or that could have resulted in personal injury.
• Inform the Radiation Safety Officer and RGE Operators of any significant modifications to existing equipment, facility alterations, or construction near the facility that may affect personnel safety or the adequacy of shielding.
• Complete EHS Web-based Radiation Basics modules.
• Name an interim RGE Supervisor in the event of sabbatical leave or any other situation when the RGE Supervisor is on an extended leave away from the university. The Radiation Safety Officer must be informed prior to such leave.

RGE Operator

Faculty, staff, or students that have met the minimum training and experience requirements set forth by the RGE manufacturer and the department operating the equipment and have been trained and authorized by the RGE Supervisor to use specific RGEs independently.

RGE Operator Responsibilities

RGE Operators are accountable for the proper use and safe operation of RGE(s) and for:

• Operate only radiation-generating equipment for which approval has been granted.
• Adhere to the safety rules and regulations as promulgated in this manual, RGE Operating Procedures, and any communications from the Radiation Safety Committee.
• Operate the radiation-generating equipment in such a way as to keep radiation exposures As Low As Reasonably Achievable (ALARA).
• Ensure that the radiation-generating equipment is left with power "off" after use with equipment. Remove key, if possible, or lockout/tag out equipment. Make sure the door to the facility secured against unauthorized use.
• Inform the Radiation Safety Officer and the RGE Supervisor immediately of any safety-related incident that has or could have resulted in personal injury, even if it occurs after normal working hours.
• Ensure that facility logbook entries are recorded for routine use and for "notable" events; e.g., malfunctions and repairs, unusual operating conditions.
• Report any malfunctions or unusual operating conditions to the responsible RGE Supervisor.
• Complete EHS Web-based Radiation Basics modules.
• Note: An RGE Operator does not have the authority to train others on the use of an RGE.

RGE Operator-in-Training Responsibilities

Faculty, staff, or students unfamiliar with RGEs and who are receiving instruction and hands-on training will be considered RGE Operator-in-Training. An RGE Operator-in-Training must work under the direct supervision of an RGE Supervisor. Table 4 reflects the RGE Supervisors relative to the RGE under their authority at Miami University.

At a minimum, an RGE Operator-in-Training must:

• If applicable, read NRC Regulatory Guide 8.13, Instruction Concerning Prenatal Radiation Exposure. The guide provides information to women who become pregnant to help them make an informed decision regarding their choice to formally declare their pregnancy in accordance with regulations.
• The Operator-in-Training must successfully complete Miami’s Web-based Radiation Basics modules. The RGE Supervisor is responsible for contacting the RSOffice to verify this training has been completed.
• Participate in performance-based training. An Operator-in-Training must receive instructions for use and a demonstration of the safe use of the device. The Operator-in- Training must then become familiar with the operation of the device and demonstrate a competent degree of familiarity in the presence of an RGE Supervisor.
• Operate the device under the direct supervision of the RGE Supervisor until a level of competence is achieved and RGE Operator status is granted.

Medical Operators

A Medical Operator is a departmentally affiliated member of the university who uses radiation-generating equipment under the direction of an RGE Supervisor approved for clinical or research use on human subjects. All use of radiation-generating equipment on live humans MUST have an approved Institutional Review Board Use Authorization when using equipment for research purposes. A Medical Operator must hold either a Radiographers or an X-ray Machine Operators license issued by the Ohio Department of Health to operate an x-ray unit used to expose humans to the primary beam. The Medical Operator is responsible for the safety of the patient, compliance with the RGE operating procedures, and acting in a safe manner. The RGE Supervisor must apply to the Radiation Safety Committee to add a person to his/her radiation-generating equipment. Approval of Medical Operator status is granted by the Radiation Safety Committee based on completion of licensure and fulfillment of training on Operating Procedures specific to the medical RGE. Subject to review by the Radiation Safety Committee, the Radiation Safety Officer may approve persons who are clearly qualified.

Medical Operator in Training

The RGE Supervisor must:

• Submit the prospective operator's prior training and experience to the Radiation Safety Officer.
• Ensure the individual has a Radiographers or a General X-ray Machine Operators license.
• Provide and document training to each new operator on the topics addressed in the Operating Procedures. Complete EHS Web-based Radiation Basics modules.
• Provide direct (observed) supervision for each operation until the RGE Supervisor is confident that the prospective operator complies with the Operating Procedures and can work independently. The period of supervision depends on the prospective operator’s performance and previous experience with similar devices.

Medical Operator Responsibilities

• Operate only radiation-generating equipment for which approval has been granted. Maintain licensure in accordance with OAC 3701-72. Notify the RGE Supervisor if the operator’s license has expired or has been taken away for any reason.
• Adhere to the safety rules and regulations as promulgated in this manual, RGE Operating Procedures, and any communications from the Radiation Safety Committee.
• Wear issued radiation dosimeters when radiation-generating equipment is operating.
• Operate radiation-generating equipment in such a way as to keep radiation exposures for all personnel, including the patient, As Low As Reasonably Achievable (ALARA).
• Ensure that radiation-generating equipment is secured against unauthorized use. Remove any keys or use lockout/tag-out procedures to ensure the equipment is tamperproof. Ensure all entry doors are locked.
• Inform the Radiation Safety Officer and the RGE Supervisor immediately of any safety-related incident that has or could have resulted in personal injury, even if it occurs after normal working hours.
• Inform the RGE Supervisor and Radiation Safety Officer if any certified components fail. Certified components must be replaced by certified components.
• Report any malfunctions or unusual operating conditions to the responsible RGE Supervisor.

Student Operator

There may be instances when a student will take a semester course with the opportunity to use radiation-generating equipment in the laboratory. Student users are considered “training-under-observation” and thus will never become independent operators without additional, in-depth tutelage or permission of the Radiation Safety Officer. Student operators must complete the general Web-based Radiation Basics modules, as well as machine-specific training. Student Operators must follow the same guidelines as RGE Operators, listed above.

Ancillary Staff

Ancillary Staff are employees or contractors of Miami University who do not operate RGEs but have the potential for exposure given the nature of their support function. Ancillary Staff shall be provided a level of training necessary to gain an understanding of the possible radiation hazards associated with their respective job functions and to safely perform their assigned duties.

Acquisition of Radiation-Generating Equipment

The purchase or receipt of radiation generating equipment shall be coordinated with the Radiation Safety Officer during the initial planning stages to ensure that the facility is adequately shielded and the device can be properly registered with the Ohio Bureau of Radiation Protection. Installed radiation-generating equipment may not be operated, other than for controlled, preliminary, installation tests, until all safety interlocks and warning devices are fully operational, administrative requirements have been met, and acceptance tests have been performed by the Radiation Safety Officer or other qualified person approved by the Radiation Safety Committee.

Locations of Use

Each location having radiation-generating equipment must be registered by the Radiation Safety Officer with the Ohio Bureau of Radiation Protection. The operation of each radiation-generating equipment is contingent upon verification of the adequacy of shielding, interlocks, warning devices, ventilation equipment, and personnel protection equipment by the Radiation Safety Officer. Inform the Radiation Safety Officer well in advance should it become necessary or desirous to change the location or dispose of radiation-generating equipment, whether it is operational or not.

Protective Measures From Exposure

Time, Distance, and Shielding

Use of the principles of time, distance, and shielding can significantly reduce personal exposure to levels that are as low as reasonably achievable (ALARA). Practical applications include using lead aprons for fluoroscopy and standing clear of primary radiation beams and radiation areas.

• Time - Radiation exposure can be decreased by reducing the amount of time people spend working in radiation fields.
• Distance - X ray intensity decreases inversely with the square of the distance (1/d²) when the source is small compared to the distance. For instance, if you double your distance from a radiation source, you reduce your exposure by (1/4) one-fourth. The radiation intensity decreases more slowly for large radiation-generating equipment or planar sources.
• Shielding - Attenuating material placed in the radiation path can effectively reduce external dose. The thickness of shielding needed is determined by the type and energy of radiation, type of shielding material, distance from the source, time spent in the work area, and acceptable level of dose reduction. The adequacy of the shielding is evaluated by the Radiation Safety Officer and verified using a survey meter. The exposure rate to the user should be reduced to 1 mrem/hr or less for long procedures. The exposure rate in any unrestricted area must not exceed 2 mrem/hr. Dose to members of the public must be restricted to less than 100 mrem/year. In the interest of ALARA the exposure rate in any unrestricted area should be consistent with background. Information on the attenuating characteristics of shielding materials can be obtained from the Radiation Safety Officer.

Inform the Radiation Safety Officer if facility changes (e.g., structural changes, moving radiation-generating equipment, increasing operating voltage range, construction around the facility) are contemplated or in progress so that the potential impact on shielding can be evaluated.

RGE Operating Procedures

The Radiation Safety Manual does not address specific concerns for each unit of radiationgenerating equipment. As an extension of the Radiation Safety Manual, Operating Procedures provide guidance to radiation-generating equipment operators on facility procedures and safety requirements. The RGE Supervisor promulgates the Operating procedures. The procedures should be reviewed periodically by the Radiation Safety Officer and RGE Supervisor for possible updating or changes. Operating procedures must be present in the facility and accessible to all approved operators.

Because each radiation-generating equipment has distinctly different levels of concern, the operating procedures must address safety items that are specific to the RGE. Any special precautions to enhance safety (e.g., access control, emergency response, usage) should be clearly communicated. The procedures should contain the following information, as applicable or if augmented from the conditions of this manual:

• a brief description of the facility design and purpose.
• any limits to operations.
• training requirements.
• responsible parties and responsibilities.
• security.
• use log.
• safety interlocks and warning devices.
• good safety practices.
• dosimetry requirements.
• radiation detectors available for use.
• general safety concerns (e.g., electrical, noxious gases, lifting).
• maintenance, repairs, system alterations, lock out/tag out procedures.
• emergency procedures.
• checklists for start-up, operation, shutdown, testing interlocks and warning devices.

General Precautions When Using Radiation-Generating Equipment

Never expose fingers, hands, or any other body part to the primary beam. No person may be intentionally exposed to the primary beam, except a patient who has a physician’s order or Institutional Review Board approval. This restriction applies to training, demonstrations, and any other non-medical diagnostic purpose. Other general precautions include:

• Never disengage a safety interlock or warning device or operate a unit if one of these systems malfunctions.
• Use time, distance, and shielding to minimize your exposure.
• Properly wear dosimetry, if issued, whenever the radiation-generating equipment may be energized.
• Record radiation-generating equipment usage and maintenance in a facility logbook, according to operating procedures.
• Never operate equipment for which you have not been trained by an RGE Supervisor.
• Never alter, repair, or perform maintenance on radiation-generating equipment component(s) without authorization and approval from the RGE Supervisor.

Use Log

A record of radiation-generating equipment usage must be maintained to document routine operations and unusual events. The presence of visitors, students, or trainees must be recorded. This record should be retained indefinitely.

• Routine Entries. Routine entries (depending on the type of unit) may include date, operator, operating parameters (e.g., kVp, mA), duration of exposure, or any other relevant information.
• Testing of Interlocks. Whenever system interlocks or warning devices are tested, the result of that test must be logged.
• Maintenance or Repairs. A record of maintenance and repairs should also be maintained. If the unit is inoperable or unsafe to operate, the record should indicate the status and what measures were taken to prevent operation.
• Unusual Events. Unusual events may include irregular sounds, presence of fumes, vapors, or smoke, malfunction of components, or suspected injury to an individual.

Testing of Safety Devices

Routine Testing

The proper function of safety interlocks, visible and audible warning devices, emergency interrupt devices, radiation level monitors and key-lock or security shutoff switches will be verified at least:

• during each scheduled inspection with the RSOffice.
• prior to use after maintenance, repairs, or alteration that may affect safety device operation.

A record of the verification, observations and description of any repairs found necessary will be entered in the facility's use log.

Safety Device Failure

Any time a safety device fails to operate properly, all operations with the RGE must be immediately terminated. Implement lock out/tag out procedures (if applicable). Post a "DO NOT USE" sign on the console and make an entry in the Use Log regarding the failure. The RGE Supervisor must be notified. The Radiation Safety Officer must be notified if anyone has or may have received an unplanned radiation greater than the ALARA levels. Once the problem is corrected, the safety devices will be tested again and results logged. The RGE Supervisor is the only person who can remove the “DO NOT USE” sign when the safety devices are shown to be operational.

Safety Device BY-PASS

No safety or warning device may be defeated or by-passed during routine operation. Jumpers, interlock plugs, or other devices that may defeat safety or warning systems will be conspicuously tagged and a notice of its installation posted (e.g., a "DO NOT USE" sign, implement the university lock out/tag out procedures) at the control panel of the radiation generating equipment. An entry in the Use Log must be made stating which safety device(s) has been over-ridden and for what purpose. After service or repair has been completed, the safety and warning equipment will be tested to verify proper operation. A log entry will be made stating that the RGE is fully operational and safety devices have been tested. Only the RGE Supervisor may remove a "DO NOT USE" sign.

Maintenance and Repairs

The RGE Supervisor must authorize all repairs, maintenance, and facility alterations. Any change that may affect personal safety or radiation exposure, facility design, or shielding must be submitted to the Radiation Safety Officer for evaluation and to the Radiation Safety Committee for approval.

Manufacturer representatives, contracted maintenance and repair specialists may only make maintenance and repairs, or persons approved by the RGE Supervisor who have the training and experience to make repairs safely. The RGE Supervisor must approve the procedures for maintenance and repairs. Implement "lock out/tag out" procedures, if applicable. A "DO NOT USE" sign must be posted on the unit's console and a log entry made to record the respective repairs. When the unit is operational and the safety interlocks are tested, a log entry is made. Only the RGE Supervisor may remove the "DO NOT USE" sign when the facility is fully operational.

Security

Radiation producing devices will be secured against tampering and unauthorized operation. The controls of the device will be inaccessible, locked, disconnected or otherwise disabled, or positively secured when not under the physical supervision of an approved operator.

In special circumstances, equipment may be operated while unattended; so long as positive security against unauthorized entrance to radiation areas and the operating controls are maintained. Conditions for unattended operation should be clearly stated in the operating manual. Two requirements for unattended operation are:

1. the entryway must be locked and safeguarded against unauthorized entry.
2. a notice must be posted at the entryway informing departmental and emergency personnel of necessary precautions and actions in case of an emergency.

Posting/Labeling Warning Signs

Warning signs and labels heighten the awareness of persons who may enter the lab and alert them of possible or eminent dangerous conditions. They provide a constant reminder for operators, custodians, and maintenance personnel to exercise caution and responsible action.

Posting at Lab Entryways

• Radiation Area. A warning sign bearing the radiation symbol and "Caution Radiation Area" will be conspicuously posted at the entrance to an accessible area where a person could receive 5 millirem (0.05 mSv) in one hour at 30 cm from the radiation source or its shielding.
• High Radiation Area. A warning sign bearing the radiation symbol and "Caution High Radiation Area" will be conspicuously posted at the entrance to any accessible area where a person could receive 100 millirem (1mSv) in one hour at 30 cm from the radiation source or its shielding.
• Notice to Employees. Ohio Department of Health form 4786.32 Notice to Employees, must be visibly posted in or near laboratories where radiation-generating equipment is located.
• Damaged Signs. The Facility Coordinator will notify the Radiation Safety Officer for replacement if any posted form is found defaced, altered, or removed.

Warning On Control Panel

The control panel of a radiation generating equipment will be labeled with the notice, "Caution: This machine produces radiation when energized." or similar words appropriate for the radiation-generating equipment.

Radiation-Generating Equipment Evaluations

The Radiation Safety Officer surveys each radiation-producing device soon after installation to ensure compliance with Ohio Bureau of Radiation Protection rules. The survey will evaluate administrative and engineering controls, such as interlocks, warning devices, operating and emergency procedures, security, and shielding. Radiation exposure levels in areas that may be occupied during operation are also recorded. Each RGE will be re-evaluated either semi-annually or as required. Surveys will also be conducted when significant modifications are made to the facility or near the facility that may affect the integrity of shielding. The RGE Supervisor must notify the Radiation Safety Officer when such changes are expected or suspected.

The survey results are reported to the RGE Supervisor who will ensure corrective actions are made. If the facility is considered unsafe to operate, the RGE Supervisor will ensure that the facility is closed and positive measures are taken to prevent operation until repairs rectify the problem.

The Ohio Bureau of Environmental Health and Radiation Protection (BEHRP) will inspect each operational unit periodically. For most radiation-generating equipment this period is every three years.

Emergency Response

Any unusual event that may injure an individual or damage the radiation-generating equipment or the facility must be handled immediately to prevent the situation from becoming worse. Some potential emergency situations include electrical shock, accidental radiation exposure, fire in the facility or elsewhere in the building, detection of fumes, unusual sounds, water leaks, and smoke.

Situations involving severe or life-threatening injuries can vary significantly. The outcome of an emergency depends largely on the actions taken by the persons present. The following list of actions prescribes general guidance for emergency response. Key to any reaction is for the responder to act calmly and rationally. The operating procedures for each RGE may address specific actions expected of operators in the event of an actual emergency. The event should be recorded in detail in the Use Log or by memorandum to the RGE Supervisor and Radiation Safety Officer as soon as possible after the situation is under control.

1. Shut down the radiation-generating equipment.
2. If personal radiation exposure is suspected, avoid changing the operating parameters. This information may be necessary to reconstruct exposure conditions.
3. IMMEDIATELY NOTIFY the RGE Supervisor and Radiation Safety Officer. The RGE Supervisor will immediately notify the Department Chair.
4. For immediate assistance for serious injuries contact Public Safety by dialing 529-2222 or 911.
5. Ensure the unit cannot be used until the problem is resolved by removing facility keys. Post a sign, "DO NOT USE" on the console, if circumstances permit. Only the RGE Supervisor can remove a “DO NOT USE” sign. Disconnect the system from the electrical power, if safely feasible.

Sale or Transfer

Prior to release of any RGE device, documentation must be provided to Miami University demonstrating acceptance or approval by the governmental regulatory authority administering radiation protection rules for buyer/transferee to receive, possess, or use the device being sold/transferred. Documentation may include, but not be limited to: copy of license or registration from governmental regulatory authority; copy of relevant regulatory code, rules, or regulation addressing exemption to receive, possess, or use the RGE device being sold/transferred; other governmental regulatory document reflecting allowance or approval to receive, possess, or use the RGE device being sold/transferred. The buyer/transferee must certify in writing that the RGE device and the supplies used in connection with that device will not be installed or placed in operation until all requirements of the buyer's/transferee’s governmental authority have been satisfied.

Disposal

X-ray tubes must be removed from the RGE device and disposed through the RSOffice. Documentation of the disposal will be prepared and submitted as required by regulation. the equipment housing the x-ray tube may be disposed through normal methods after the tube has been removed and disposed through the RSOffice.