4.1 – Radiation Safety Program

In compliance with the regulations of the Pennsylvania Department of Environ­mental Protection (PaDEP); the U.S. Nuclear Regulatory Commission (NRC); the U.S. Environmental Protec­tion Agency (EPA); and the recommen­da­tions of the International Commission on Radiolog­ical Protection (ICRP), and the National Council on Radiation Protection and Measure­ments (NCRP), the Environmental Health and Radiation Safety Department (EHRS) has a program for the safe-use of radioactive materials and radiation-producing devices.

The Radiation Safety Program and policies are specified in the following sections of this handbook:

• Radiation Safety Program 4.1
• Radiation Safety Officer 4.2
• Radiation Protection Committee 4.3
• Radioactive Material Authorizations 4.4
• Radiation Dosimetry 4.5
• ALARA 4.6
• Radioactive Materials Procurement 4.7
• Radiation Safety Audits/Inspections 4.8
• Policy for Pregnant Radiation Workers 4.9
• Caution Signs and Labels 4.10
• Radioactive Sealed Sources 4.11
• Surveys and Monitoring 4.12
• Radiation Worker Registry 4.13
• Radiation Exposure Limits 4.14
• Radiation Emergencies 4.15
• Facility and Equipment Requirement 4.16
• Visitors to Radioactive Materials Laboratories 4.17
• Radiation Safety Training 3.4

4.2 -- Radiation Safety Officer

The Radiation Safety Officer (RSO) is responsible for implementation of the radiation safety program at Temple University. In that capacity, the RSO ensures that all activities involving radioactive materials; x-ray producing machines; and equipment capable of producing ionizing and non-ionizing electromagnetic radiation are performed in accordance with approved policies and regulatory require­ments. The RSO is authorized to stop an operation if, in the RSO's judgment, that operation is in violation of Temple University policies. Further­more, the RSO may require specific actions to assure compliance with Temple University policies and Federal and State regulations.

Responsibilities of the Radiation Safety Officer:

• General surveillance of all radiation safety activities, including investigations of over­exposures, accidents, spills, losses, thefts, unauthorized receipts, uses, trans­fers, dis­posals, misadministration, and other deviations from approved radiation safety practices and implementa­tion of corrective actions
• Developing and implementing an audit program to verify compliance by the users with regulatory requirements and Temple University’s policies
• Developing and implementing radiation safety training programs for workers
• Developing and implementing a personnel monitoring program for workers, including the need for bioassays, review of personnel exposure records, and developing corrective actions for exposures approaching the regulatory limits
• Performing a preliminary review of all proposed uses of radioactive material and making appropriate recommendations to the RSC for final approval or disapproval
• Performing an initial review of requests for new authorizations/procedures and making appropriate recommendations to the RSC for final approval or disapproval
• Reviewing and approving requests for ministerial changes in the use of radioactive material
• Controlling the procurement of radioactive material, including the authorization to purchase radioactive material
• Establishing and implementing procedures for receiving and opening packages of radioactive material
• Packaging, labeling, surveying, etc., of all shipments of byproduct material
• Performing leak tests and inventories of sealed sources
• Evaluating relevant equipment, physical facilities, operational techniques and procedures, and assigning personnel to perform those tasks
• Managing the radioactive waste program, including collection, storage, and disposal of radioactive waste
• Monitoring the written Quality Management Program (QMP)
• Performing or directing decontamination activities
• Preparing an annual report on the radiation safety program for a review by the Radiation Safety Committee and management
• Participating in the activities of the Medical Radiation Subcommittee (MRC), Institutional Review Board (IRB) and Radioactive Drug Research Committee (RDRC) as an active and voting member of these committees
• Maintaining records required by the regulations

4.3 -- Radiation Safety Committee

Temple University management has established the Radiation Safety Committee (RSC) in accordance with regulatory requirements, to oversee the conduct of activities authorized by regulatory agencies.

Temple University management appoints members and nominates the chairperson of the RSC. The composition of the RSC is in accordance with regulatory requirements.

The RSC discharges its responsibilities through the Radiation Safety Officer (RSO). The duties and responsibilities of the RSC are as follows:

• Assisting the Management in the management of the radiation safety program
• Ensuring with the assistance of the RSO, that the radiation safety program receives the appropriate level of support and resources
• Ensuring that all radioactive materials and radiation-producing equipment are used in compliance with all regulatory requirements and institutional policies and procedures
• Ensuring that the use of radioactive material and radiation-producing equipment is consistent with the ALARA philosophy and institutional program
• Reviewing the training and experience of proposed authorized users, radiation safety officer, teletherapy and medical physicists, to assure that they meet regulatory requirements, and assess whether qualifications are sufficient to enable the individuals to perform their duties safely
• Reviewing and approving or disapproving, with the advice and consent of the RSO and the representative of management, all radiation safety procedures and changes in the radiation safety program
• Establishing the investigational levels for individual occupational radiation exposures
• Identifying radiation safety program problems and providing solutions
• Reviewing all requests for authorization to use radioactive material on the basis of need, safety and the ALARA philosophy. Approve or disapprove of the requests with the concurrence of the RSO
• Periodically review the RSO’s summary report of the occupational radiation exposures of personnel, paying particular attention to individuals or groups of workers whose occupational exposures appear excessive.
• Reviewing annually, with the assistance of the RSO, the radiation safety program
• Recommending remedial action to correct any deficiencies identified in the radiation safety program audits

4.4 -- Radioactive Material Authorizations

Radioactive material is authorized for use in clinical procedures as well as in research. The Radiation Safety Committee (RSC) must review and approve authorized users in both disciplines. The RSC has established the following criteria that an individual must meet before approval as an authorized user of radioactive material or certain radiation producing equipment:

Criteria for Use in Clinical Procedures (Physicians)

• The user must meet the applicable qualification and training requirements specified in 10 CFR 35.

Criteria for Use in Non-Human Research

• The user must be a faculty member
• The user must have prior experience or adequate training in using the requested radioactive material
• The user must provide evidence of procedures or facility design that will ensure that security of radioactive materials is maintained
• The user must provide a description of the type of use and/or actual experimental procedures
• The user must possess or have access to adequate facilities and equipment, including survey instruments, for the type of material and use that is being requested. These facilities must be adequate to ensure safety of workers as well as members of the public

Criteria for Use in Research Involving Humans

• The user should be a physician and an authorized user
• Research must be approved by the Temple University Institutional Review Board (IRB)
• Research must be approved by the Radiation Safety Committee (RSC),
• The Radioactive Drug Research Committee (RDRC) reviews and approves all research studies that involve the administration of radioactive drugs to humans. The RDRC only approves research studies that are intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of radioactive labeled drugs or regarding human physiology, pathophysiology, or biochemistry as required by the United States Food and Drug Administration (FDA). Once RDRC approval is obtained satisfying FDA requirements, the committee submits the approval to the RSC to obtain authorization to carry out the project under Temple University’s specific radioactive material licenses. Approval of the RDRC, the RSC and the IRB are required prior to initiation of any research on humans that call for the administration of radioactive drugs.
• The Medical Radiation Subcommittee (MRC) of the Temple University Radiation Safety Committee (RSC) serves as an advisory body to the RSC concerning the use of ionizing and non-ionizing radiation in or on humans.

Criteria Used by the RSC to Approve Changes to Procedures

• The change must be in accordance with current applicable radiation safety requirements
• The change must not decrease the effectiveness of radiation safety
• The change must be consistent with ALARA philosophy

4.5 -- Radiation Dosimetry

A well-functioning dosimetry program is essential for a safe operation and for compli­ance with applicable Federal and Pennsylvania regulations. A large number of employees and students at Temple University are not exposed to ionizing radiation and are not radiation workers. Such individuals are not included in the personnel-monitoring program. Those who qualify for inclusion in the monitoring program are:

• Adults who are likely to receive an annual total effective dose equivalent (TEDE) of 500 mrem (5 mSv)
• Minors who are likely to receive an annual total effective dose equivalent (TEDE) of 50 mrem (0.5 mSv)
• Declared pregnant women who are likely to receive a TEDE of 50 mrem (0.5 mSv) during gestation as specified in the Environmental Health and Safety (EHRS) policy 4.9

Types of Dosimeters:

• External dosimeters (whole body) are used to measure deep dose equivalent expressed in units of rem or Sievert (Sv).
• Special external dosimeters such as ring, wrist, ankle, eye, or abdomen dosimeters are used in cases where external exposure to hands or other specific areas are likely to exceed the exposure level as specified by the Radiation Safety Committee (RSC), or in cases where the specific body areas warrant separate attention.
• Direct reading external dosimeters are used for short-term exposure at high radiation areas.

Whole body and ring badges are provided to individuals who may use more than 2 mCi of beta emitting isotopes of energy exceeding 1 MeV. Individuals who use more than 1 mCi of low energy gamma emitting isotopes (<100 keV), or more than 100 uCi of high energy gamma emitting isotopes (>100 keV) are also provided with whole body monitors. Individuals who handle large quantities of gamma and beta emitting isotopes (Nuclear Medicine Technologists, Radiation Oncologists, etc.) are provided with whole body as well as ring badges.

Internal Monitoring:

The Environmental Health and Safety Department (EHRS) performs two types of bioassays to monitor potential ingestion, inhalation or absorption of radioactivity into the body. These tests are analysis of urine specimens and in-vivo thyroid counting. Normally an individual is requested for such bioassays only if he/she conducts certain types of experiments or procedures with volatile radionuclides. Radiation workers are required to participate in the bioassay program subsequent to performance of specific procedures as listed in the table below:

EHRS performs two types of bioassays to monitor potential ingestion, inhalation or absorption of radioactivity into the body. These tests are analysis of urine specimens and in-vivo thyroid counting. Normally an individual is requested for such bioassays only if he/she conducts certain types of experiments or procedures with volatile radionuclides. Radiation workers are required to participate in the bioassay program subsequent to performance of specific procedures as listed in the table below:

• Bioassays for other radionuclides in volatile form are outlined in specific radiation safety protocols if it is anticipated that a potential intake in excess of 10% of the Annual Limit of Intake (ALI) for that radionuclide may occur.
• Bioassay, if needed, should be performed within 3 days of the use of I-131 and within 1 week of the use of I-125.
• Bioassay, if needed, should be performed within 3 weeks of the use of tritium. Bioassay for intake of tritium is performed by radioanalysis of the urine sample.

Exposure Reports:

Records of the doses received by all individuals for whom monitoring is required are maintained by the EHRS. All individuals who are badged receive their respective exposure reports annually. Exposure report is available at EHRS for individuals who wish to review their exposure. The EHRS reviews exposure reports and all high or unusual exposures are investigated and a report is provided to the RSC along with the result(s) of the investigation (Policy No. 4.3). The Radiation Safety Department will perform a written investigation when an individual’s total effective dose equivalent exceeds the ALARA trigger level (Policy 4.6).

Enforcement of External Dosimetry Program:

External dosimeters will be provided to individuals who are included in the dosimetry program on a frequency determined by the Radiation Safety Officer (RSO) and RSC. All monitored individuals in this group are required to promptly return the dosimeters. Individuals who are late in returning their dosimeters may be fined and repeated non-compliance will be referred to the RSC for further disciplinary action.

Enforcement of Internal Dosimetry Program:

The method and the frequency of bioassay depend upon the nature, including the physical and biological half-life, of the radioactive material. Authorized users are required to participate in the bioassay program subsequent to performance of specific procedures. Failure to have the appropriate bioassay performed within the specific time frame stated in this section constitutes a violation of radiation safety requirements, and could lead to revocation of authorization to use radioactive materials. The RSO will determine the frequency of bioassays not otherwise specified.

4.6 -- ALARA

• Radiation exposure (individual radiation exposure as well as collective dose equiva­lent) must be kept as low as reasonably achievable. This so called “ALARA” principle has been introduced into regulations of the U.S. Nuclear Regulatory Commission and the Pennsylvania Department of Environmental Protection, and has been adopted by Temple University. This policy provides specific guidance and data on Temple University’s approach to the implementation of the ALARA principle.
• Exposure Reports: The Radiation Safety Department reviews exposures on a regular basis. Subsequently, high or unusual exposures are reported to the Radiation Safety Co­mmittee. Written investigations by the RSD are performed when an individual's total effective radiation dose equivalent in one year exceeds trigger levels listed below:

*Critical organs are protected by leaded garments the formula to calculate the Total Effective Dose Equivalent (TEDE) is:TEDE= 0.3 badge wore outside lead apron, NCRP 122

**Critical organs are protected by leaded garments the formula to calculate the Total Effective Dose Equivalent (TEDE) is: NCRP report 168, the Effective dose equivalent (EDE) for the fluoroscopy guided interventionists be calculated with the formula EDE= collar badge reading / 5.6

4.7 -- Radioactive Materials Procurement

• The acquisition of radioactive materials by purchase, transfer, or as a gift, requires prior approval of the Radiation Safety Officer (RSO). Unless otherwise approved by the Radiation Safety Committee, all radioactive materials destined for Temple University are received by the Environmental Health and Radiation Safety Department (EHRS). All arriving radioactive materials are evaluated for contamination, and the necessary information is entered into a campus-wide inventory database.
• Procurement of Radioactive Material
• All radioactive material other than that required by the Nuclear Medicine Department is ordered through EHRS. Users are required to obtain authorization from the EHRS prior to ordering radioactive material. EHRS authorizes procurement of the material after verifying that the user is authorized to receive the material, and that the requested amount plus that already in the user’s possession does not exceed the user’s possession limit.
• All radioactive material other than that required by the Nuclear Medicine Department is received by EHRS. The EHRS staff opens the packages after performing the required radiological surveys. The contents are verified by comparing the order and the packing slip that accompanies the package. The material, the amount, and the name of the user are recorded in the computerized material inventory maintained by the EHRS. Each package is assigned an inventory identification number before it is delivered to the intended user by the EHRS. Each individual user is required to maintain a running inventory of the material in their possession.
• Transfer of Radioactive Material from Temple University to Other Recipients
• Transfer of radioactive material to another user outside of Temple University is not allowed without prior approval of the EHRS. The user must submit the amount and the name of the material along with the name of RSO of the receiving institution. Authorization for the transfer is granted after verification by the EHRS that the intended receiver is authorized to possess the material that is being transferred. The material being transferred must be delivered to the EHRS for packaging. The EHRS staff prepares the package for shipment in accordance with the regulatory requirements. The package is shipped by the EHRS to the intended institution and the inventory record is updated accordingly.
• Transfer of Radioactive Materials between Authorized Users
• An authorized user may transfer radioactive material in his/her possession to another user provided such a transfer is approved by the EHRS. Approval for transfer is granted by the EHRS after verifying that the recipient is authorized to possess the material and additional material does not exceed his/her possession limit. The inventory records maintained by EHRS are updated accordingly.

4.8 -- Radiation Safety Audits/Inspections

A program of periodic audits of the use of radioactive materials and radiation-producing equipment by users is implemented by the Environmental Health and Radiation Safety Department (EHRS) to ensure that activities are being conducted in a safe manner and in accordance with regulatory requirements. The audits review the adequacy of facilities for the type of use, training and competency of workers, supervision by authorized users, availability of survey instruments, security of radioactive material, minimization of personnel exposure to radiation, safety equipment, and the required record keeping. All approved areas of use are included in these periodic audits.

• A written report of the audit is prepared by the EHRS. The authorized user is informed if any deficiencies are noted. The Radiation Safety Officer (RSO) issues a notice of violation to the authorized user if a violation of regulatory requirements or license conditions is identified and the RSO determines that the violation has safety significance. The authorized user is required to respond in writing to the written notice. The results of the audit are presented to the Radiation Safety Committee (RSC) during one of its scheduled meetings. Details of significant safety violations are discussed by the RSC. The RSC and the RSO have the authority to limit authorized user’s use of radioactive material or in extreme cases suspend the use of radioactive material if the violation persists or are not addressed adequately.
• The audit program is continuously reviewed by the RSO and RSC for efficiency and effectiveness in ensuring a safe working environment, and may be updated to improve on these qualities.
• Special Audits: These are designated for the resolution of any complaints, allegations, incidents, or as a follow-up of previous non-compliance issues identified during routine auditing. These inspections will be conducted at the discretion of the director of EHRS or as requested by the safety committees.

4.9 -- Policy for Pregnant Radiation Workers

The National Council on Radiation Protection and Measurements (NCRP) has recommended limits for radiation exposure to an embryo/fetus. The Nuclear Regulatory Commission (NRC) and Department of Environmental Protection of the State of Pennsylvania (PA) have set limits for radiation exposure to the embryo/fetus of a declared pregnant woman. The NRC and PA require that the dose to an embryo/fetus during the entire pregnancy, from occupational exposure of a declared pregnant woman, must not exceed 500 mrem (5 mSV). Efforts must be made to assure that this dose is distributed uniformly over the entire period of pregnancy.

DECLARED PREGNANT WOMEN

A pregnant employee is highly encouraged to voluntarily inform her employer, in writing, of her pregnancy and the estimated date of conception. Further, such an employee is encouraged to visit the Radiation Safety Department and receive information regarding concerns she may have about radiation exposure during pregnancy. Such an employee may discuss her concerns with the Health Physicist.

Upon submission of a completed “Declaration of Pregnancy” form (available at the Radiation Safety Department, 3307 N. Broad Street, # B 49), the Radiation Safety Department will:

• Evaluate the exposure history of the individual and her coworkers;
• Provide information concerning risk and precautions;
• Evaluate the working environment with respect to radiation exposure;
• Make recommendations for reducing radiation exposure;

Monitor monthly radiation exposure with respect to the NRC and PA limits

4.10 -- Caution Signs and Labels

• It is important to alert personnel of the presence of radioactive materials, radiation-producing machines, and potential radiation hazards. This is accomplished, in part, by posting and labeling areas with appropriate caution signs.
• Posting areas or rooms where radioactive materials are used or stored:
• Areas or rooms where radioactive materials are used and/or stored are required to be posted with a CAUTION, RADIOACTIVE MATERIAL sign.
• Labeling containers of radioactive materials:
• Containers of radioactive materials exceeding the quantities or concentrations given in the following table must be labeled with a CAUTION, RADIOACTIVE MATERIAL label. The label must also indicate the radionuclide(s), activity, assay date, and/or other information (e.g., radiation level) to permit appropriate precautions to minimize radiation exposure.
• Containers of radioactive materials less than the quantities or concentrations given in the following table must be conspicuously labeled to identify the container as a vessel containing radioactive material.

• Note: For labeling requirements of other radionuclides, contact the Environmental Health and Safety Department (EHS).
• Posting “Radiation Areas”:
• Any area where radiation levels exceed 5 mrem/hr at 30 centimeters from the radiation source shall be posted with a CAUTION, RADIATION AREA sign.
• Posting “High Radiation Areas”:
• Any area where radiation levels exceed 100 mrem/hr at 30 centimeters from the radiation source shall be posted with a CAUTION, HIGH RADIATION AREA sign.
• Posting “Very High Radiation Areas”:
• Any area which is accessible to an individual with radiation levels exceeding 500rads at 1m from the radiation source shall be posted with a GRAVE DANGER, VERY HIGH RADIATION AREA sign.
• Posting areas where airborne radioactivity are present:
• Areas which have airborne radioactivity in excess of the derived air concentrations specified in the NRC regulations shall be posted with a CAUTION, AIRBORNE RADIOACTIVITY AREA sign.
• Nuclear medicine rooms where radioactive gases or aerosols are administered shall be posted with the amount of time for the concentration of radioactive material after an accidental release to be reduced to less than the derived air concentration. Appropriate safety measures to be followed after a release shall be posted.
• Posting brachytherapy and radiopharmaceutical therapy patient rooms:
• The door to the patient's room shall be posted with a RADIOACTIVE MATERIALS sign.
• Labelling radiation-producing machines:
• Radiation-producing machines, including electron microscopes, must be labelled CAUTION - RADIATION, THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED. The label should be on the control panel or near any switch which energizes the unit. Analytical x-ray machines must have a CAUTION - HIGH INTENSITY X-RAY BEAM warning sign or label on the source housing, and an illuminated, fail-safe warning light with the words X-RAY ON which is on when the x-ray tube is energized.
• The EHS maintains a supply of caution signs and labels for posting areas and rooms. Note that most caution labels and signs have specific color and design requirements; therefore, custom or hand-made signs need to conform to these requirements.

4.11 -- Radioactive Sealed Sources

Any radioactive material encased in a capsule designed to prevent leakage or escape of the radioactive material is defined as a sealed source. It is imperative that all radioactive sources sealed or encapsulated are properly accounted for and are periodically checked for leakage.

Registration of Sources: All sources of radioactive material sealed or encapsulated, regardless of the activity, must be registered with the Environmental Health and Safety Department (EHRS). This requirement applies to sources such as low activity check sources, or sources which are incorporated into machines or devices.

Leak Testing of Sealed Sources: All sealed sources containing 100 mCi or more of beta or gamma emitting radionuclides or 10 mCi or more of alpha-emitting material in any form other than gas will be tested for leakage and contamination by the EHRS, at intervals not to exceed six months. Exceptions are as follows:

• sources containing exclusively hydrogen-3
• sources containing radionuclides with a half-life of less than 30 days
• Iridium-192 seeds in nylon ribbon
• sealed sources that are in storage

Stored Sealed Sources: Sealed sources not in use and identified as stored will be leak tested before any use or transfer. Stored sources will be leak tested every ten years.

Inventory Control: A physical inventory of all sealed sources will be conducted semi-annually by EHRS. The inventory consists of the model; serial number, if any; location (room, building) of the source; and initials of the individual conducting the inventory.

4.12 -- Surveys and Monitoring

Radiation surveys are performed to identify and quantify radiation exposure situations, and to provide the basis for remedial actions to reduce exposure to as low as reasonably achievable (ALARA). Release of radioactivity to the environment also needs to be controlled and monitored to ensure compliance with regulatory requirements. Control of contamination is through the effective use of protective coverings of work surfaces, containment of radioactivity during processes, personal protective clothing, and careful attention to avoid spills. A primary element of such a program is monitoring for contamination by appropriate surveys.

The instruments used in these surveys must be suited to the measurement of the type, energy, and source of radiation. A survey using an instrument such as a Geiger-Mueller counter is acceptable as long as it is sensitive enough to detect the nuclides used. A survey instrument equipped with a low energy sodium iodide crystal should be used for detecting iodine 125. For low energy beta emitters such as H-3, C-14, S-35 or P-33, contamination surveys should be conducted using swipes (or smear wipes), which are counted using a liquid scintillation counter. An appropriate and effective filtering system should be in place while using volatile radioactive material, such as iodine 125.

Because of the nature of the use of radioactive material, and different regulatory requirements governing such uses, the radiological survey program at Temple University is divided into two categories: clinical and research.

Contamination Levels: Areas which show removable contamination in excess of 200 dpm should be decontaminated and resurveyed until removable contamination is below 200 dpm/100 cm². The Environmental Health and Safety Department (EHRS) should be notified immediately if decontamination does not reduce the contamination levels below 200 dpm/100 cm², if the contamination is on the floor, if a person is found contaminated, or if the contamination is fixed to a surface.

The activity in dpm is determined by dividing the net counts per minute (gross counts - background) by the detection efficiency of the instrument being used.

Survey Requirements for Clinical Facilities

Nuclear Medicine

• All areas where radiopharmaceuticals are routinely prepared for use, or administered, shall be surveyed each day for ambient exposure rates. The Radiation Safety Officer (RSO) shall be notified if the trigger level is exceeded.
• All areas where radiopharmaceuticals or radiopharmaceutical waste is stored shall be surveyed once each week with a survey instrument. The RSO shall be notified if the trigger level is exceeded.
• Records of these surveys must be kept for a minimum of three years.

Radiation Oncology

• A survey of the dose rates shall be performed promptly after sources are implanted in a patient.
• A survey shall be performed with a radiation detection survey instrument to confirm that all sources have been removed immediately after removing the last temporary implant source from a patient.
• Dose rates shall be measured in all areas where brachytherapy sources are stored.
• Records of these surveys must be kept for a minimum of three years.

Survey Requirements for Research Facilities

Users are required to perform appropriate surveys at the end of each day that radioactive materials are used. These surveys are meant to detect any contamination in areas of use or contamination of equipment. If any contamination is detected during these surveys, the users are required to decontaminate the area before leaving the area. If a complete decontamination cannot be accomplished, the user must cover the contaminated area or the equipment and mark it with caution labels to prevent spread of contamination to other areas and inform the EHRS immediately.

Each authorized user is required to perform periodic contamination surveys of those areas where radioactive materials are stored and/or used. Any area found to be contaminated must be decontaminated as soon as practical. Periodic surveys should include surveys for detection and removable contamination. The authorized user must maintain records of these periodic surveys. The EHRS reviews these records during its periodic audit of the laboratories.

The frequency of these surveys depends upon the amount, type and frequency of use. Therefore, a classification of laboratories where radionuclides are used is necessary to determine how frequently they should be surveyed. Three levels of survey frequencies are designated based on the nature of the radionuclide, its activity, and its use. The concept relies upon the principle that certain radionuclides are more hazardous than others, and thus require more frequent monitoring. Furthermore, each application is associated with certain risks, so the nature of operation dictates the frequency of monitoring. Table 3 is developed based on these principles and specifies the frequencies of monitoring in various laboratories.

TABLE 1. CLASSIFICATION OF RADIONUCLIDES

ACCORDING TO RELATIVE RADIOTOXICITY

GROUP I

GROUP II

GROUP III

GROUP IV

TABLE 2. HANDLING FACTORS

Operation Handling Factor

HF(0.1)^a 0.1

HF(1)^b 1

HF(10)^c 10

a. HF(0.1) consists of infrequent operations or those requiring uCi quantities of radionuclides.

b. Routine laboratory procedures requiring mCi quantities of radionu­clides.

c. Operations requiring complex procedures or those involving volatile radionuclides.

Examples:

Operation Activity

HF(0.1) storage

HF(0.1) sample counting

HF(0.1) radioimmuno­assay

HF(1) uptake studies

HF(1) metabolic studies

HF(10) radioiodinations

HF(10) ³H exchange labeling

TABLE 3.

FREQUENCY OF MONITORING FOR

CERTAIN RADIO­NUC­LIDES BASED ON

THEIR ADJUSTED QU­AN­TI­TY IN mCi-eq

Monthly Weekly Daily

Group I <0.01 0.01 to 1 >1

Group II <1.0 1.0 to 10 >10

Group III <10.0 10 to 100 >100

Group IV <100.0 100 to 1000 >1000

Radiation Exposure Survey

A proper type of survey instrument such as an ionization chamber or Geiger-Mueller (GM) counter with milliRoentgens per hour (mR/hr) display should be chosen to monitor exposure from a gamma or X-ray emitter source. The EHRS periodically calibrates the GM instruments used in research laboratories to measure radiation exposure.

4.13 -- Radiation Worker Registry

• Federal and Pennsylvania regulations require that those who work with radioactive materials or x-ray producing machines are provided training, and are monitored for potential radiation exposure. In order to assure that the requirements of these regulations are met, the Environmental Health and Safety Department maintains a Radiation Worker Registry. This registry includes, but is not limited to, those who are addressed by the Radiation Dosimetry Program.
• Radiation Worker Registration Forms must also include the signature of the authorized user or x-ray supervisor.

4.14 -- Radiation Exposure Limits

• The radiation exposure limits at Temple University are:

• *For duration of pregnancy
• The whole body dose is the sum of external and internal radiation doses. This is known as the total effective dose equivalent. The contribution from internal radiation doses is the product of the total dose* that an organ will receive from an intake and organ-specific weighting factors.
• A total effective dose equivalent limit of 100 millirem per year applies for individual members of the public.
• *For long-lived and long retained radionuclides a 50 year summation of the internal dose is assigned to the individual in the year that the uptake occurred.

4.15 -- Radiation Emergencies

• Potential Releases of Radioactive Materials to Unrestricted Areas

The Environmental Health and Safety Department (EHRS) must be notified immediately if an emergency occurs during the use of radioactive materials that could result in a release of material to unrestricted areas of buildings, or a release of radioactive materials to the environment. Such an event requires collection of certain data to determine the potential impact of the release on employees, members of the public and property. The nuclide(s) involved, along with the activities, should be known and communicated to the EHRS. Also, the nature of the event which could have led to the release should be described (i.e. containment failure, hood failure, etc.), along with the time and duration of the event.

• Minor Spills of Liquids and Solids

The following procedure must be followed for a minor spill of radioactive material:

• Place absorbent material over the spill to keep it from spreading
• Notify others in the area, and limit access to the spill area
• Monitor yourself and others for contamination and decontaminate immediately if you find any contamination
• Survey the suspected area to determine the boundary of the contaminated area and label with "Caution Radioactive Material" tape
• Gather cleaning supplies such as moistened paper towels and scouring powder or any detergent
• Do not ask housekeeping staff to assist in the cleanup or to lend you their equipment
• Wear protective clothing, i.e., lab coat and gloves (and shoe covers if necessary) while decontaminating the spill area
• Minimize the volume of water used to decontaminate
• Begin cleaning at the edges of the spill and work towards the center (lowest to highest level of contamination)
• Dispose of all cleanup materials as radioactive waste
• Re-survey yourself for contamination, including the bottom of shoes, to prevent spread of contamination
• Smear the area to ensure that removable contamination is below the level stated in your laboratory survey form provided by the EHRS
• Document spill cleanup on the laboratory survey form provided by the EHRS
• Cooperate with the Radiation Safety Officer (RSO) and/or the EHRS’s staff in investigation of root and cause. If requested provide bioassay samples
• Follow the instructions of the RSO and/or the EHRS’s staff in the decontamination techniques, surveys and documentation

• Major Spills of Liquids and Solids

The following procedure must be followed for a major spill of radioactive material:

• Clear the area. If appropriate, survey all persons not involved in the spill and vacate the room
• Prevent the spread of contamination by covering the spill with absorbent paper (paper should be dampened, if solids are spilled), but do not attempt to clean it up
• To prevent the spread of contamination, limit the movement of all personnel who may be contaminated
• Shield the source only if it can be done without further contamination or significant increase in radiation exposure
• Close the room and lock or otherwise secure the area to prevent entry. Post the room with a sign to warn anyone trying to enter that a spill of radioactive material has occurred
• Notify the EHRS immediately
• Survey all personnel who could possibly have been contaminated. Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water and then washing with a mild soap
• Allow no one to return to work in the area unless approved by the EHRS
• Cooperate with the RSO and/or the EHRS’s staff in investigation of root and cause. If requested provide bioassay samples
• Follow the instructions of the RSO and/or the EHRS’s staff in the decontamination techniques, surveys and documentation
• Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases
• Notify all personnel to vacate the room immediately
• Shut down ventilation system, if possible, unless it is determined that the room ventilation system needs to be used to clear the air for access purposes
• Vacate the room. Seal the area, if possible
• Notify the EHRS immediately
• Ensure that all access doors to the area are closed and posted with radiation warning signs, or post guards (trained) at all access doors to prevent accidental opening of the doors or entry to the area
• Survey all persons who could have possibly been contaminated. Decontaminate as directed by the EHRS
• Promptly report suspected inhalations and ingestion of radioactive material to the RSO
• Decontaminate the area only when advised and/or supervised by the EHRS
• Allow no one to return to work in the area unless approved by the EHRS
• Cooperate with the RSO and/or the EHRS’s staff in investigation of root and cause. If requested provide bioassay samples
• Follow the instructions of the RSO and/or the EHRS’s staff in the decontamination techniques, surveys and documentation
• Contaminated Lab Coat, Clothing or Shoes

Remove the contaminated item(s) and check the skin underneath for contamination. Place the item(s) in a plastic bag and label it with "Caution Radioactive Material" tape. Contact the EHRS for assistance and instructions

• Dose Assessment

If it is reasonable and does not hinder decontamination procedure, it is recommended that radiation worker record the following data:

• Survey meter reading, type of meter, and distance between the survey probe and original reading of skin surface (if a survey meter was used to detect the contamination)
• Radionuclide and chemical compound involved
• Approximate amount of radioactivity involved
• Location on your body where the contamination occurred
• Dimensions of the area contaminated, i.e., square centimeters
• Length of time the radioactive material was on your skin or in your eye
• Emergency Response and Management

Any unexpected event or accident situation that occurs during the transport, storage or use of radioactive materials constitutes a potential emergency. The EHRS must be notified immediately when such an event results in contamination of work areas or personnel, or if significant quantities of radioactive materials are released into the environment. Specific emergency procedures must be followed in such circumstances. It may also be required to notify the Temple University Police Department and the University Fire Marshal’s Office depending upon the nature of emergency.

The EHRS is ready to provide emergency assistance any time of the day and any day of the week. You may call the EHRS if you need assistance and information regarding management and/or use of radioactive materials and radiation producing equipment. For concerns about security or fire safety, you should call extension 1-1234 and state the nature of your concern and the specific assistance you seek.

Follow the following guidelines to obtain emergency help:

• During business hours (8:00am to 5:00pm on weekdays), contact the EHRS at (215) 707-2520, or call the page operator at (215) 707-4545 and ask the operator to page a representative of the EHRS.
• During other hours and on weekends and holidays, call the page operator at (215) 707-4545 and ask the operator to page a representative of the EHRS and if needed, the Fire Marshal’s Office.
• University Security may also be contacted at 1-1234.
• Fires

The following procedure should be followed in case of fire:

• Sound the building fire alarm.
• Call extension 1-1234 and state the nature of the problem and location
• If possible, and if trained to do so, attempt to put out the fire by approved methods (e.g., fire extinguisher) and only if other fire hazards or radiation hazards are not present
• Notify all persons present to vacate the area and immediately call the EHRS
• Once the fire is out, isolate the area to prevent the spread of possible contamination
• Survey all persons involved in combating the fire for possible contamination
• Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water, then washing with a mild soap
• In consultation with the EHRS, determine a plan of decontamination and the types of protective devices and survey equipment that will be necessary to decontaminate the area
• Allow no one to return to work in the area unless approved by the RSO
• Cooperate with the RSO, Fire Marshal’s Office, and/or the EHRS’s staff in the investigation of root and causes. Provide bioassay samples if requested.
• Follow the instructions of the RSO and/or the EHRS’s staff in the decontamination techniques, surveys and documentation
• Explosions/Fires, or Major Emergencies

The following steps must be taken for fire, explosion or any other such incident in the work area:

• Sound the building fire alarm.
• Notify all persons in the area to leave immediately
• Call extension 1-1234 and state the nature of the problem and location
• Notify the RSO
• Upon arrival of firefighters, inform them where radioactive materials are stored or where radioisotopes were being used; inform them of the present location of the radioactive materials and the best possible entrance route to the radiation area, as well as any precautions to avoid exposure or risk of creating radioactive contamination by use of high pressure water, etc.
• Cooperate with the RSO, Fire Marshal’s Office, and/or the EHRS’s staff in the investigation of root and cause. Provide bioassay samples if requested.
• Allow no one to return to work in the area unless approved by the RSO
• Follow the instructions of the RSO and/or the EHRS’s staff in the decontamination techniques, surveys and documentation
• Injury with Personnel Contamination

In the event of a serious injury (heavy bleeding, heart attack, etc.), seek medical assistance immediately. Notify your supervisor and the EHRS. For a minor injury (e.g., puncture wound, suspected inhalation or ingestion of radioactive material, skin contamination, etc.), first attempt to decontaminate yourself before seeking medical assistance. Notify your supervisor and the EHRS.

• Contamination Only

Skin contamination is always a possibility when working with radioactive materials and can result in significant radiation dose if not removed. It is important to detect skin contamination and decontaminate as quickly as possible. The dose to the skin from contamination must be assessed for inclusion in the individual's dosimetry record and to ensure adherence to applicable regulatory dose limits.

• Emergency Surgery of Patients Who Have Received Therapeutic Amounts of Radionuclides

If authorized users or other personnel involved in the surgical procedure are likely to receive exposures exceeding the dose of 500 mrem, the following procedure is followed:

• If emergency surgery is performed within the first 24 hours following the administration of I-131 sodium iodide, fluids (e.g., blood, urine, etc.), should be carefully removed and contained in a closed system
• The surgeon and the personnel involved in the surgical procedures will wear protective gear for the protection of the eyes from possible splashing of foreign materials, as well as from beta radiation
• The RSO will direct personnel in methods to keep doses ALARA during surgical procedures
• If an injury occurs during surgery that results in a cut or tear in the glove used, the individual involved will be monitored to determine if radioactive material was introduced into the wound.
• Autopsy of Patients Who Have Received Therapeutic Amounts of Radionuclides

If authorized users or other personnel involved in the surgical procedure are likely to receive exposures exceeding the dose of 500 mrem, the following procedures are followed:

• Upon the death of the therapy patient, the AU in charge and the RSO will be notified immediately
• An autopsy will be performed only after consultation and permission from the RSO
• Protective eye wear will be worn by the pathologist and assistants for protection from possible splashing of foreign materials and exposure from beta radiation
• If an entire block of tissue containing the radionuclide can be removed during autopsy, this will be done first. The remainder of the autopsy can then proceed as usual.
• The RSO will evaluate the radiation hazard(s), direct personnel in safety and protection, and suggest suitable procedures in order to keep doses ALARA during the autopsy
• When possible, separate organs will be promptly removed from the body, and detailed dissection will be carried out a safe distance away from the body
• After selected small samples have been removed, the radioactive tissues that are retained will promptly be either placed in appropriately shielded vessels for storage or disposed of according to procedures deemed appropriate by the RSO and in accordance with the regulations
• If an injury occurs during the autopsy which results in a cut or tear in the glove, the individual will be monitored to determine if radioactive material was introduced into the wound.
• Emergency Procedures for Teletherapy Units Containing Sealed Sources – Emergency Procedures for Beam Control Failure or Malfunction

If the light signals or beam-on indicates that the beam control mechanism has failed to terminate the exposure at the end of the pre-set time (e.g., if the red light stays on and the green light is off, or if both the red and green lights stay on for more than a few seconds), the source may still be in the exposed position. The following steps are to be taken promptly:

• Open the door to the treatment room
• Instruct an ambulatory patient to leave the room
• If the patient is not ambulatory, enter the treatment room but avoid exposure to the direct beam. Pull the treatment table as far away from the direct beam as possible. Transfer the patient to a stretcher and remove the patient from the room
• Close the door and secure the area by locking the door to the treatment room or posting a guard at the entrance
• Turn off the main switch at the control panel
• Notify the AU and RSO promptly
• Conspicuously post a sign in the area to warn others of the problem

4.16 -- Facilities and Equipment

Facilities and Equipment

Laboratories are classified based on:

• Type of radionuclide (beta, gamma, alpha, etc.)
• Quantity utilized
• Characteristics of radioactive compound (volatility, toxicity, physical form)
• Processes that will take place in the lab (evaporation, grinding, etc.)

The Radiation Safety Committee and the Radiation Safety Officer (RSO) will evaluate each laboratory in which radioactive materials are requested for use with regard to the following:

Type of Radionuclide

• Survey Instruments

All laboratories must have access to survey and analytical counting instruments appropriate for the type of radionuclides and use.

• Shielding

All laboratories must be equipped with the appropriate shielding materials for the type and quantity of radioactive material in use.

• Quantity of Radionuclide(s) in Use

Laboratories that use more than 1 mCi of low energy gamma (E<100 keV), or more than 100 uCi of high energy gamma (E>100 keV) radioisotopes should have:

• Lead or other high-density materials for bench use and storage
• Remote handling tools, such as forceps, tongs, or extension handles
• Laboratories that use more than 2 mCi of beta emitting isotopes of energy exceeding 1 MeV should have:
• Low atomic number materials such as high-density plastics for bench use and storage
• Remote handling tools, such as forceps, tongs, or extension handles
• Lockable Storage Equipment

All laboratories where radioactive materials are possessed in quantities that could result in the NRC Level III violation for failure to secure these materials from unauthorized access, should have lockable storage equipment.

Characteristics of Radioactive Compound

• Volatile and/or Gaseous Compounds
• Laboratories where iodination procedures are performed should have chemical-type fume hoods equipped with sampling systems to monitor effluent release
• Laboratories containing stock materials for, and waste materials from iodination procedures should have chemical-type fume hoods equipped with sampling systems that provide for continuous monitoring of effluent release

Fine Particulate Solid Materials

Laboratories should have:

• Chemical-type fume hood and/or
• Glove box, or similar equipment

Processes

• All laboratories where evaporation or any other process that may release radioactive gases or vapors, should have chemical-type fume hood.
• All laboratories where grinding or any other process where radioactive particulates or aerosols may be generated, should have chemical-type fume hood, and/or glove box or similar equipment

General Requirements

Each laboratory authorized to use radioactive material should have:

• Drip trays and/or absorbent paper for contamination control
• Appropriate means to respond to emergency and decontamination activities
• Labeled containers for collection of radioactive waste materials

Authorized Users are instructed to notify the Environmental Health and Safety Department (EHS) prior to initiation of significant modifications to areas where radioactive materials are approved for use and/or storage. The RSO or designee will evaluate the proposed modifications for compliance with the criteria listed in this section.

Unless specifically authorized by the RSO, radioactive waste may not be disposed into the sanitary sewer. Special waste containers provided by the EHS are to be used for the disposal of liquid radioactive waste. The EHS will collect full liquid waste containers upon request. All pertinent information requested on the waste tag must be completed for the waste to be removed. The EHS may dispose of the waste by sewer disposal, solidification and transfer to a disposal site, or by decay.

4.17 -- Visitors to Radioactive Material Laboratories

The Temple University Radiation Safety Committee has implemented the following safety policy regarding entering laboratories designated for radioactive material use and/or storage:

• Any individual who has not received radiation safety training commensurate with the potential radiological hazard present and is not under the direct and constant supervision of the Authorized User is prohibited from entering laboratories designated for radioactive material usage and/or storage.
• Minors (persons under the age of 18 years old) are also prohibited from entering radioactive material usage and/or storage laboratories unless special arrangements including training provided by the Radiation Safety Department, are made with the Radiation Safety Officer and/or the Radiation Safety Committee prior to entry.

*For long-lived and long retained radionuclides a 50 year summation of the internal dose is assigned to the individual in the year that the uptake occurred.