Date: Jan 4, 2008 Version: 2A Page: 1 of 6 1. PURPOSE/SCOPE: This SOP outlines safety procedures to be followed when working with radioactivity. These procedures include, but are not limited to, methods for the safe handling of radioactivity and its administration to animals for imaging purposes. 2. RESPONSIBILITIES: 1. Personnel approved to handle radioactive materials (personnel who have completed the UM Radiation Safety Service Orientation Course) are responsible for execution of these procedures. 2. Personnel handling radioactivity must undergo Refresher Training at the beginning of each calendar year. Documentation of refresher training will be filed in the Laboratory Radiation Safety Records Binder (located in Room D231). The Authorized User for Radioactive Materials is responsible for ensuring that all personnel training records are up to date. 3. The Authorized User is responsible for development, review and implementation of this program. 3. PROCEDURES: A. Access to Rooms D230 and D231 1. In general, access to Rooms D230 and D231 will be restricted to CMI personnel who are approved to handle radioactive materials (i.e. those who have prior RSS training). 2. Only personnel approved to handle radioactive materials will be permitted in Room D230 when conducting experiments involving radioactivity. A sign (RED SIGN) that indicates these entry restrictions will be posted at the entrance doorway to Room D230 whenever radioactivity is in use (see sign postings under Section B). 1
Date: Jan 4, 2008 Version: 2A Page: 2 of 6 3. Tours of the radiochemistry facilities by visitors must be scheduled in advance with the Authorized User. Visitors will only be permitted to enter Room D230 when escorted by CMI personnel who have had RSS training. Visitor entry to Room D230 will only be permitted under the following conditions: a) radioactivity is not being used AND b) the room has undergone a radioactivity contamination survey. A sign (Green Sign) to indicate that these conditions have been met will be posted at the entrance to Room D230. Visitors will be required to wear shoe covers (booties) prior to entry and survey themselves for radioactivity contamination prior to leaving the lab. 4. Due to the constant presence of high background radiation levels in Room D231 (Radiosynthesis Laboratory) and the potential for spread of radioactive contamination from these areas, visitors and individuals who do not have radiation badges will not be permitted access to this room. B. Room Sign Postings and PPE Requirements 1. A Sign posting (RED SIGN) indicating restricted access will be posted on the doorway of Room D230 when radioactivity is being used. The sign will have the following information: a) Radiation Hazard/Radioactive Material in Use b) Access is restricted to personnel with RSS training c) Personnel in Room must wear specific PPE for radioactivity handling 2. PPE to be worn when handling radioactivity include the following: disposable lab coat (blue coat), gloves, booties, safety glasses and radiation dosimeters (RSS personal dosimeter and finger rings). Personnel performing radioligand injections will also wear sleeve protectors. Additional PPE requirements when working with animals such as the use of bonnets and face masks are listed in the SOP titled Procedure for Imaging Rodents with ABSL-2 Level Pathogens. 3. A sign (GREEN SIGN) will be posted on the doorway of Room D230 a) when radioactivity is not being used AND b) the room has undergone a radioactivity contamination survey. NOTE: All personnel in Rooms D230 and D231 will need to have SHOE COVERS on at all times. 2
Date: Jan 4, 2008 Version: 2A Page: 3 of 6 C. Personnel Surveys for Contamination 1. Personnel will perform a whole body survey for contamination prior to exiting Room D230 into the hallway. Surveys will be conducted using one of the following survey meters: a) Ludlum Model 44-3 survey meter with Low Energy scintillator probe for I-125 radioisotopes b) Ludlum Model 3 survey meter with Model 44-9 GM pancake probe for Tc-99m, In-111 or PET radioisotopes. 2. Following survey, lab coats that are free of contamination will be placed on the coat rack located inside Room D230. Coats that are contaminated will be disposed in the radioactive solid waste container. Under no circumstances should either blue labcoats or booties from these labs be worn in the hallways. 3. Used booties will be placed in the waste booties container inside the doorway. These will be surveyed at the end of the day and disposed in the solid radioactive waste container or in regular trash, as appropriate. D. Radioactive Waste Disposal 1. There are two waste segregation categories for the radioisotopes that we use: Category D (I-125) Category E (F-18, Tc-99m, In-111, I-123 and I-124) 2. All solid, liquid, sharps and pathological radioactive wastes will be segregated accordingly into either of the above two categories. Mixing of radioactive waste categories is not permitted. 3. The regular trash containers in Room D230 will either be moved to Room D232 (Clean Room) or sealed with plastic during radioactivity use to avoid inadvertent disposal of radioactive wastes in regular trash. Regular trash will be surveyed prior to placement in the hallway for pickup by the custodian. 4. All solid wastes (e.g. gloves, Kim Wipe tissues, sleeve protectors, etc.) generated when radioactivity is being used in the room will be disposed in the solid radioactive waste container. Unbroken glass vials can be disposed as solid waste and should not contain more than 0.5 ml of residual liquid. 3
Date: Jan 4, 2008 Version: 2A Page: 4 of 6 5. All sharps (e.g. syringes, broken glass) will be disposed in the Radioactive Sharps one gallon plastic pail. Syringes should not contain more than 0.5 ml of residual liquid. 6. Radioactive wastes will be packaged and manifested at least once every 3 months for pickup by RSS/OSEH personnel. 7. Wipe tests will be conducted on the external surfaces of waste containers to confirm that they are free of radioactive contamination. Wipe test count data will be attached to the waste shipment manifest form. E. Injection of Radioligands 1. Radioligand doses for injection will be dispensed in Room D231 and the syringe will be transported to Room D230 in a lead syringe pig. 2. Injection of radioligands to animals will be conducted at a dedicated lab bench in Room D230. The perimeter of the bench will be marked off with yellow tape and radioactive signs. 3. The lab bench, anesthetizing chamber and floor area opposite the bench will be lined with new disposable absorbent blue pads prior to radioligand administration. 4. Two individuals will be involved in radioligand injection: one person will inject the animal and a second person will be available for assistance such as in operation of the anesthesia machine. 5. Precautions will be taken to avoid external radioactive contamination of the animal with radioactivity during injection. Following injection, the injection area (e.g. tail area) will be wiped off with alcohol swipes to remove any surface contamination. After injection, the complete syringe assembly is disposed in the Radioactive Sharps container. Gloves, sleeve protectors, blue pads, etc. will be discarded in the radioactive solid waste drum. 6. Both individuals will then survey themselves with the appropriate survey meter for the radioisotope in use. The Lab bench used for radioligand injection and floor areas around the bench will also be surveyed. 4
Date: Jan 4, 2008 Version: 2A Page: 5 of 6 7. Cages containing animals with radioactivity will be shielded behind lead bricks between imaging sessions. F. Animal Handling and Care 1. The animal bed and inner flat surface of the scanner will be lined with new adsorbent blue pads prior to each imaging session. The anesthetized animal will be transported to and from the animal imaging bed in a covered Plexiglass box. 2. Animals injected with I-125 will be placed in separate cages (cages owned by the CMI group). These cages will be marked with a radioactive sticker sign and have a Red Cage Card containing the following information: radioisotope, amount of radioactivity, date of injection, etc. Animals will be quarantined in Room D271 in these cages and attended to by CMI personnel until euthanization. A sign will be posted on the doorway of Room D271 indicating a) Radiation Hazard and b) Access limited to CMI personnel ONLY. After euthanization, animal carcasses, tissues, bedding/waste, etc., will be disposed as Pathological Radioactive Wastes in RSS-supplied yellow plastic bags and stored in the freezer in Room D230 for pickup by RSS personnel. The cages will be decontaminated by wiping with Radiacwash solution and stored in the ventilated cabinet beneath the radioiodination hood in Room D231. The completed Red Cage Cards will be returned to the ULAM office at the end of the study. 3. Animals injected with short-lived radioisotopes (F-18, Tc-99m) will be returned to their original ULAM cages. The cages will be marked with a radioactive sticker sign and have a Red Cage Card containing the following information: radioisotope, amount of radioactivity, date of injection, etc. Animals will be quarantined in Room D271 and monitored daily by CMI personnel until they reach background levels of radioactivity. At this point, animals will be transferred to a new cage and returned to Room D265 where they will be attended to by ULAM personnel. Animal carcasses, tissues, bedding/waste, etc., will be disposed as Pathological Radioactive Wastes in RSS-supplied yellow plastic bags and stored in the freezer in Room D230 for pickup by RSS personnel. The completed Red Cage Cards will be returned to the ULAM office at the end of the study. 5
Date: Jan 4, 2008 Version: 2A Page: 6 of 6 G. Post Experiment Contamination Surveys 1. Wipe test contamination assays will be performed in lab areas used for radioactive work at the completion of each days imaging experiment. 2. Wipe test smears will be assayed using the Beckmann Gamma-Counter located in Room D230. Decontamination procedures and repeat wipe tests will be conducted for areas that show contamination > (3x background levels of activity). 3. Monthly wipe tests will also be performed for all lab areas designated for the use of radioactivity. 4. Maps indicating areas to be surveyed are located in the Laboratory Radiation Safety Records Binder. H. Documentation and Recordkeeping 1. Doses of radioactivity (μci or mci) administered to animals and disposed as waste (including carcass radioactivity) will be recorded in the Radionuclide Receipt, Utilization and Disposal Record form. 2. Per RSS requirements, the above documents, wipe test data records (including Gamma Counter printouts) and copies of shipping manifests will be filed in the Laboratory Radiation Safety Records Binder for inspection by RSS or NRC personnel. 6