Standard Operating Procedure Nuclear Medicine Imaging ... · PC-SOP-IM-004-v01 PC-SOP-004-v01...

PC-SOP-IM-004-v01

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Standard Operating Procedure

Nuclear Medicine Imaging

Safety Procedures at PERFORM

PC- SOP-IM-004-v01

Revision History

Version Reason for Revision Date

01 New SOP June/16/2013

Summary The content of this standard operating procedure (SOP) is to maintain compliances with safe practice, during research procedures in the Nuclear Medicine Imaging area of the PERFORM Centre, as radioisotopes and ionizing radiation emitting equipment presents known safety hazards.

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Table of Content

1. DEFINITION OF TERMS -------------------------------------------------------- 3

2. INTRODUCTION ---------------------------------------------------------------- 4

2.1 BACKGROUND ---------------------------------------------------------------------- 4 2.2 PURPOSE ----------------------------------------------------------------------------- 4 2.3 SCOPE -------------------------------------------------------------------------------- 4 2.4 RESPONSIBILITY ---------------------------------------------------------------------- 4 2.5 RELEVANT DOCUMENTS ------------------------------------------------------------ 5

3. PROCEDURE ---------------------------------------------------------------------- 6

3.1 GENERAL RULES --------------------------------------------------------------------- 6 3.2 RESTRICTED ACCESS AREA --------------------------------------------------------- 8 3.3 NUCLEAR MEDICINE TECHNOLOGIST --------------------------------------------- 8 3.4 TRAINING ---------------------------------------------------------------------------- 8 3.5 INFECTION CONTROL -------------------------------------------------------------- 8 3.6 EMERGENCY PROCEDURES --------------------------------------------------------- 9 3.7 INCIDENTAL FINDINGS ------------------------------------------------------------- 9

APPENDIX I --------------------------------------------------------------------------- 10

APPENDIX II -------------------------------------------------------------------------- 12

RESTRICTED AREA FLOOR PLANS --------------------------------------------- 12

APPENDIX 1II ------------------------------------------------------------------------ 14

PERFORM CENTER NUCLEAR MEDICINE TRAINING FORM ------------ 15

APPENDIX 1V ------------------------------------------------------------------------ 16

APPENDIX V -------------------------------------------------------------------------- 23

RADIATION CONTAMINATION MONITORING RECORD ------------- 24

APPENDIX VI ------------------------------------------------------------------------- 25

INCIDENT REPORT FORM ------------------------------------------------------- 25

APPENDIX V1I ----------------------------------------------------------------------- 26

SOP TRAINING RECORD FORM ------------------------------------------------ 26

PC-SOP-IM-004-v01


1. Definition of Terms ALARA As Low As Reasonably Achievable

Alconox Alconox is a concentrated, anionic detergent, designed for laboratory applications

Benchkote An absorbent, impermeable material designed to protect laboratory surfaces against hazardous spills

Background Ionizing radiation that the general population is exposed to, including natural and artificial sources

Bq One Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second

CAMRT A national certifying body for nuclear medicine professionals

CAO Chief Administration Officer

CPS Counts per second

Dosimeter A device for measuring the quantity of ionizing radiation to which a person has been exposed

EH&S Environmental Health and Safety

Hot Lab A room for working with high-activity radioactive compounds

Hot Spot A contaminated area with increased radioactivity

Incidental Findings (IFs)

IFs are unexpected discoveries or observations of the potential clinical significance detected during the course of a study/activity that are outside the scope, or unrelated to the purpose or variables of the study/activity

MBq 1 MBq = 1.000.000 Bq

MI Medical Imaging

mSv The SI unit of ionizing radiation effective dose.

Nuclear Medicine Nuclear medicine is a medical specialty involving the application of radioactive substances in the diagnosis and treatment of disease

PERFORM The PERFORM Center at Concordia University

PET-CT Positron Emission Tomography - Computed Tomography

Radiation Energy released in the form of particle or electromagnetic waves

Radiopharmaceutical A radioactive drug used for diagnostic or therapeutic purposes

Radioisotope A version of a chemical element that has an unstable nucleus and emits radiation during its decay to a stable form

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RSCO Research Compliance and Safety Officer

RSO Radiation Safety Officer

SI Units The International System of Units

Sparkleen A detergent that Removes proteins, fats, oils, media, wax pencil marks, dried blood and other organic-inorganic deposits.

SPECT-CT Single-photon emission computed tomography - Computed Tomography

Tomography A method of producing a three-dimensional image of the internal structures of a solid object

User Any trained person that is using instruments/equipment at the PERFORM Center

Wipe Tests A test for radioactive contamination in which the suspected surface or area is wiped with a filter paper (or other material)

2. Introduction 2.1 Background

All users of radioactive isotopes are required to follow specific rules and regulations in order to promote the security and safe use of radioactive materials in research nuclear medicine.

2.2 Purpose

The objective of the current SOP is to outline the minimum requirements and general rules to be adhered to in nuclear medicine suites.

2.3 Scope

This SOP applies to all PERFORM users working with radionuclides, or anyone on university premises potentially exposed to radiation, including but not limited to PERFORM researchers, staff, University auxiliary staff, students, research participants and authorized visitors.

2.4 Responsibility

2.4.1 Users All users are responsible for;

2.4.1.1 Following all applicable safety rules and practices 2.4.1.2 Reporting all potential hazards, unsafe conditions or safety issues to

the medical imaging manager, designate or RSO. 2.4.1.3 Using and wearing personal protective equipment 2.4.1.4 Attending all training courses as directed by EH&S and the research

compliance safety officer at PERFORM.

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2.4.2 Medical Imaging Manager

The medical imaging manager has overall responsibility for safety and general training of all users. Working with the RSO, the medical imaging manager will ensure that all users of the MI Suite have completed the proper training to be able to conduct activities in a safe manner.

2.4.3 Principal investigator/Project lead

The principal investigator/project lead is responsible for ensuring their team members, and all users in their protocols /projects and activity have completed the proper training to be able to conduct activities in a safe manner (i.e., read and sign off all required SOPs and PODs and any additional operational manuals, as well as demonstrate adequate abilities to use the equipment).

2.4.4 PERFORM Research Compliance Safety Officer (RCSO)

The research compliance safety officer ensures that all users follow the regulations as per CNSC for all nuclear medicine studies. As per University regulations, the RCSO will maintain a list of all the users who are authorized to access MI suite. Any spills/emergencies or incidents will need to be reported to the RSCO, and principal investigator/ project lead. The principal investigator/project lead is responsible for ensuring their team members and all users in their protocols /projects and activity have completed the proper training to be able to conduct activities in a safe manner. 2.4.5 Chief administrative officer (CAO)

The PERFORM Centre CAO is responsible for ensuring that a safety program is in place, and that reviews are conducted regularly to ensure compliance with Concordia University regulatory requirements.

2.5 Relevant Documents

• VPS-40 Environmental Health and Safety Policy • VPS-48 Hazardous material spill response policy • VPS-46 Radiation Safety Policy • PC-SOP-GA-007-v01 General Access to PERFORM Centre • PC-SOP-GA-009-v01 Emergency Response Procedures at the PERFORM • PC-SOP-GA-011-v01 Incidental Findings

Note: This SOP defers to Concordia policies at all times

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3. Procedure The following must be adhered to when working in nuclear medicine suites.

3.1 General Rules

All users are responsible for:

3.1.1 All members of staff, researchers, and students have a legal responsibility to protect themselves and their colleagues from radiation hazards arising from their work.

3.1.2 All radiation exposures to members of staff, researchers, students, and visitors must be kept as low as reasonably achievable or participle (ALARA).

3.1.3 Radionuclides must be handled only by authorized members of staff, researchers, and students who have received training in radiation safety.

3.1.4 Visitors and research participants entering radionuclide laboratories must be accompanied by authorized member of staff.

3.1.5 Eating, drinking, smoking and all application of cosmetics are forbidden in laboratories at all times.

3.1.6 Protective clothing must be worn when manipulating radionuclides.

• Laboratory coat (fastened at the front) or a surgical gown.

• Disposable gloves.

3.1.7 Protective clothing is to be removed at the end of the procedure. Before commencing work, cuts and hand breaks in the skin on hands should be covered with adhesive plasters.

3.1.8 Personal contamination monitoring of the hands must be performed on leaving the Hot Lab.

3.1.9 Contamination monitoring MUST be performed for background, work surface, floor area, disposal sink, and equipment before and after work (Appendix V).

3.1.10 Personal contamination monitoring of the body must be performed following a contamination incident. Results of monitoring must be

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recorded on the sheet provided for this purpose. If contamination is detected decontamination procedures are to be followed.

3.1.11 Personal monitors (Dosimeter) issued to staff, researchers, and students must be worn. A personal monitor provided to measure the dose to the trunk should be worn at shoulder or wrist level. Extremity monitors, if provided must be worn on finger. Care is to be taken to prevent personal monitors becoming wet or damaged, or inadvertently sent to the laundry.

3.1.12 When manipulating unsealed radionuclides a suitable contamination monitor must be at hand and regularly used to check for personal and laboratory contamination. Particular attention is to be given to the hands, clothing, bench surfaces and floor around the work area. The thyroid must be monitored 24 hours after any procedures involving manipulation of an unsealed radioiodine source having an activity greater than 1MBq or when intake of radioactive iodine is suspected. The result must be recorded in writing. Any sealed sources should be treated as unsealed sources unless satisfactorily wipe tested.

3.1.13 Contamination monitoring of surfaces and apparatus must be performed before and after any procedure involving unsealed radioactive materials. The result of monitoring must be recorded. The only exception to this rule may be applied when the undue delay in performing a thorough contamination monitoring check would adversely affect a research participant’s investigation. In this circumstance only, an operator may leave without monitoring for contamination provided that arrangements are made with Hot Lab staff to monitor for them immediately after the manipulation. If Hot Lab staff are not available the operator must perform the contamination monitoring.

3.1.14 Radioactive material must at all times be clearly identified with radioactive material hazard warning tape, and marked with details of the radionuclide, date, approximate activity, and name of member of staff or group responsible for it.

3.1.15 Users must utilize the radioactive materials tracking database on the Hot Lab computer.

3.1.16 Work with radioactive material must be carried out over a containment tray lined with absorbent wipes laid over plastic-backed absorbent paper (e.g. Benchkote).

3.1.17 All accidents (including spills) involving radioactivity must be reported to the medical imaging manager or designate.

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3.1.18 Radioactive materials, when not in use must always be stored in a secure location, taking special care to minimize the possibility of accidental contamination during storage. In particular, radioactive material stored in fridge is to be double-contained and separated from non-active materials.

3.1.19 Laboratories in which radioactive materials are used or stored must be locked when unoccupied.

3.2 Restricted Access Area

Certain areas such as the SPECT-CT, PET-CT, and the tracer preparation laboratory (Hot Lab) in the Imaging Suite will be inaccessible in the absence of a technologist or Nuclear Energy Worker as per university, provincial or federal regulations. Any access to such area will need to be approved by the access approver or PERFORM’s radiation safety officer on a daily basis. The Medical Imaging Department is identified as ristricted area to which access is restricted to authorized Persons only. Those authorized to work within restricted area must have completed appropriate safety training and must comply with all approved SOPs.

3.3 Nuclear Medicine technologist

3.3.1 All nuclear medicine technologists will be trained as evidenced by signed

documentation and will be accredited by federal/provincial associations for nuclear medicine technologists (CMRT).

3.3.2 The nuclear medicine technologist must be certain all female participants are not pregnant before radiopharmaceutical injection.

3.3.3 The nuclear medicine technologist must be present at all times and will verbally monitor the participant throughout the procedure.

3.3.4 The nuclear medicine technologist has the authority to stop procedures when they are deemed to be unsafe.

3.4 Training

All research personnel must have completed all the required safety training. Only trained individuals should operate devices and monitoring equipment in the radiation environments (Appendix III).

3.5 Infection Control

3.5.1 The scanning room table and any other surfaces that have come in

contact with the research participants must be cleaned and the linens

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changed before placing another research participant on the scanning table.

3.5.2 Gloves must be removed and disposed of properly before touching common areas such as scanner key board, log books, light switches, counter surface and other objects.

3.5.3 Surfaces touched with gloves must be cleaned properly before leaving the area.

3.5.4 All biohazard material must be disposed according to PERFORM SOP-GA-002-v01 Handling of Biological Materials.

3.6 Emergency Procedures

See Appendix (IV)

3.7 Incidental Findings

Incidental findings (IFs) are unexpected discoveries or observations of the potential clinical significance detected during the course of a study/activity that are outside the scope, or unrelated to the purpose or variables of the study/activity (see PC-SOP-GA- 011-v0).


APPENDIX I Personal Dosimeters


Personal Digital Dosimeter

http://www.google.ca/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&docid=BfmGsQqwJrCuSM&tbnid=_HQp8L7Pbm8EJM:&ved=0CAUQjRw&url=http://web.princeton.edu/sites/ehs/dosimeter/dosimetryinfo.htm&ei=3d6LUbfvAYfnqwGxkYDoCQ&bvm=bv.46340616,d.aWc&psig=AFQjCNFgJUKuCgLuyTzVBbHtXlSpRsMi0w&ust=1368207345779563

http://www.einstein.yu.edu/administration/environmental-health-safety/radiation-safety/film-badge.aspx

http://www.atnuke.com/nuclear/INSTRUMENTATION/Lud/m25.htm


APPENDIX II

Restricted Area Floor Plans


PCS1: Highlighted areas in yellow are restricted access for Distinction staff, contractors and facilities personnel who may only enter upon authorization. The highlighted area in pink requires that contractors and facilities personnel get prior approval from the athletic therapy manager before entering the area to do work so as not to disturb student labs or patients in the athletic therapy clinic.


Appendix 1II

PERFORM Center Nuclear Medicine Training Form


PERFORM Center Nuclear Medicine Training Form Radiation

Safety Wipe Testing Radioactive

Waste Disposal TDG

Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Name: Signature:


Appendix 1V Emergency Procedures


Nuclear Medicine Emergency Procedures

• An individual or research participants who becomes ill or injured must be removed from nuclear medicine hot lab or scanning room by the researcher or operator.

• If emergency response is required, call Security (extension 3717) and follow procedures.

If emergency does not involve radiation contamination the security department shall:

1. Answer emergency telephones and other calls for assistance. 2. Arrive on the site of emergency with appropriate first aid equipment to

assess the situation and, if necessary, administer the first aid. 3. The Security department shall: Contact the appropriate health and safety,

facility or municipal emergency response personnel. 4. The Security department: shall arrange for appropriate transportation to

a medical facility as required. 5. Keep records of all such calls received and the steps taken by entering in

a log book. 6. The incident report form must be completed (see Appendix IV). 7. Notify EH&S within 24 hours or, in case of a serious medical situation, as

soon as possible.

If emergency involves one of the following:

1. A spills of radioactive material outside of the radioactive work area. 2. Personal contamination (including clothing). 3. Known or suspected internal contamination (inhalation, ingestion,

injection). 4. Known or suspected external exposure where person(s) may have

received dose in excess of 3 mSv. 5. Widespread contamination in the laboratory. 6. Loss or theft of any quantity of nuclear substance (radioactive material). 7. A release of a quantity of radioactive nuclear substance into the

environment not authorized by Licensed activity. 8. An attempted or actual breach of security or sabotage at the site of the

licensed activity.


9. A serious illness or injury incurred or possibly incurred as a result of the licensed activity.

10. The death of any person at a nuclear facility as a result of licensed activity.

The following steps must be taken:

1. Notify all occupants in the area about the spill, if contaminate is volatile evacuate the area immediately.

2. Secure the area and keep all individuals from entering. 3. Ensure prompt first aid treatment is administered for injured personnel. 4. Remove all contaminated clothing and place in a plastic bag. 5. Attempts must be made to remove all external contamination as soon as

possible. Flush the area for a minimum of 15 minutes, if contamination is splashed in the eyes, mouth, or on skin.

6. Report the spill to Manager, Security and RSO immediately. 7. Contain large volumes of non-volatile liquid spills to prevent further

spreading. 8. Ensure proper personal protective equipment is being worn. 9. Remain in the area to provide information and assistance in the clean-up. 10. Ensure that all spilled and contaminated materials are properly packaged

for disposal and are treated as hazardous wastes. 11. Ensure that all other items used in the clean-up process are

decontaminated.

Managing Personal Contamination Immediate actions should be taken if you know or suspect that you may have radioactive contamination on your clothing or skin. Prompt actions will minimize your exposure and will prevent further contamination. The primary concern regarding contamination on the clothing or skin is the increased probability of intake and resultant internal radiation exposure. Remember, radioactivity can enter the body by way of inhalation, ingestion, absorption, or through breaks in the skin. Contaminated Wounds

Minor wounds (puncture, scrape, and cut) while working with radioactive materials require IMMEDIATE actions to limit any possible internal radiation exposure. Since minor wounds typically involve the hands, the following guideline is written for this situation.


1. Remove your gloves; turn them inside out, and DO NOT dispose. 2. Save the gloves and the object that caused the wound for monitoring and isotope identification. Information obtained from these items may help determine whether an internal exposure is likely. 3. Allow the wound to bleed and flush it gently with clean water for approximately FIVE minutes. This will remove any radioactivity present in the wound and may prevent its absorption into the body. 4. Bandage or cover the wound, and seek medical attention if required.

NOTE: For serious injuries or illnesses, always seek prompt medical attention first. Treatment and safety of the seriously injured person(s) ALWAYS takes precedence over radioactive contamination control.

Emergency Services will only treat decontaminated individuals Contaminated Clothing

1. Put on a clean pair of gloves to carefully remove all contaminated 2. clothing in such a way as to prevent further contaminations especially to

the skin. Remove clothing inside out to contain the contamination. 3. Seal the contaminated clothing in a plastic bag. Write the following

information on the bag: Name, telephone number of the owner of the clothing, and the radioisotopes involved.

4. After removal of contaminated clothing, carefully monitor all exposed skin areas. Monitor your hands. Follow the guidelines below if skin contamination is detected.

5. Contact RSO, for cleaning of contaminated clothing. The clothing will most likely be stored until the radioactivity has decayed, if the

6. clothing cannot be cleaned and the isotopes involved are short-lived.

Personal Contamination Radioactive contamination should be removed from the skin as soon as possible to reduce radiation exposure. Contamination deposited directly on the skin can cause intense irradiation of the skin as well as substantially increasing the risk for intake into the body.

1. Use mild hand soap or other appropriate solution for use on the skin. Some decontamination solutions and cleansers contain harsh chemicals and are not intended for use on the skin.


2. Water used for skin decontamination should be lukewarm in temperature. Water that is too hot or too cold will increase the blood flow to the area and increase the absorption of the contamination. 3. Gently wash or scrub the affected skin areas for about 2 to 3 minutes. pay special attention to the fingernails if the hands are contaminated. 4. Rinse with clean water and gently pat dry. Re-monitor the area with a contamination monitor. 5. Repeat this procedure as necessary, RUB DO NOT SCRUB.

NOTE: Gloves should be worn to prevent the spread of radioactive contamination to the hands during decontamination operations.

6. Work from the center of your body out (if your forearm is contaminated wash from the elbow towards the hand, hold your arm such that the water runs off your arm into the sink, not onto the floor or your body. 7. Monitor affected skin areas after every decontamination; attempt to determine effectiveness. 8. Stop cleaning immediately if contamination cannot be removed, or if the skin becomes irritated. 9. Rinse your eyes in an eyewash station for at least 15 minutes to flush foreign material out.

10. Rinse your mouth with water, but DO NOT swallow. 11. Blow your nose and keep the tissue, it will be analyzed for radioactive contamination. The nose filters approximately 50% of particulate matter. 12. Have someone absorb surface liquids, and liquids in the outer ear, lean to the side which has the liquid in it. Do not stick anything in your ear.

Decontamination of Equipment and Areas Tools, equipment, and work areas must be free of radioactive contamination whenever possible. All users are responsible for conducting surveys and promptly decontaminating all items and surfaces, if required.

1. Always wear protective clothing during decontamination operations. minimum requirements include wearing a lab coat and two pairs of gloves (triple gloving is highly recommended). 2. There are several products commercially available for decontamination. Alternatively, two tablespoons of Alconox or Sparkleen can be dissolved in water to make a paste.


3. Methods used in decontamination include washing, scrubbing, abrasion, and corrosive methods. Always start with washing before progressing to more difficult decontamination methods.

DO NOT use methods such as grinding, sanding, scraping or chipping contaminated surfaces without the specific direction of RSO.

5. Complex items should be disassembled as much as possible to allow sufficient cleaning of inner surfaces which may be contaminated. Do not disassemble if such action will jeopardize the operational integrity of the item or equipment, Use disposable materials, such as paper towels.

6. Minimize the spread of contamination during decontamination operations. Avoid wiping a highly contaminated cleaning towel over a less contaminated surface. Generally, the best technique is to start at the edge of a contaminated area and work toward the area of highest contamination. The exception to this, however, would be to clean highly contaminated areas first if those areas were creating unacceptably high radiation exposure levels.

7. Frequently monitor surfaces during decontamination with either portable survey instruments or swipe tests to determine the effectiveness of the procedures being used. Continue decontamination as necessary.

8. Conduct SWIPE TESTS to confirm that there is no removable contamination.

9. Items and surfaces which cannot be successfully decontaminated must be identified and controlled as radioactive material. Such areas may also require shielding.

10. Ensure that all radioactive waste generated during decontamination is properly collected and disposed of into radioactive solid and liquid waste containers.

11. Once decontamination procedures are complete, remove gloves and wash hands thoroughly. Monitor hands, body, lab coat, clothing, etc., for radioactive contamination.


Any incident causing injury to an individual or research participant must be reported to the Manager of Imaging Services, Research Compliance Safety Officer, and as well as Environmental Health and Safety. In case of an accident or injury when the PI is not present, the technologist or responsible user must report to PI: If an accident or injury occurs that is not related to the nuclear medicine study, then the technologist or responsible user on site is responsible and should report to the Manager of Imaging Services and to EH&S as per normal procedure by filling out an incident report (Appendix VI).

http://ehs.concordia.ca/incident/incident report.php

http://ehs.concordia.ca/incident/incident%20report.php


Appendix V

Radiation Contamination Monitoring Record


Radiation Contamination Monitoring Record Contamination monitoring with an appropriate monitor must be performed before and after each work activity involving radioactive open-source materials. This will hopefully confirm that the previous user of the area has not left any contamination, and check that your work activity has not contaminated the area. Monitoring should include:

1- Work surfaces 2- Floor area near the work area 3- Disposal sink 4- All equipment used

Record Counts Per Second (CPS) for the following areas, before and after work. Note: readings ≥ 2 x background represent contaminated areas. Date Name Monitor Type

& Serial No. Area Before starting

work After work completed

Comments / Action Taken

Background Work Surface Floor Area

Disposal Sink Equipment









Note: Any hot spot must be identified on the form and CPS recorded before and after decontamination. Contamination left by a previous worker should be reported to the Radiation Safety Officer.


APPENDIX VI

Incident Report Form Can be completed and submitted at:

http://ehs.concordia.ca/incident/incident_report.php

http://ehs.concordia.ca/incident/incident_report.php


APPENDIX V1I

SOP Training Record Form SOP Title


Nuclear Medicine Imaging Safety Procedures at PERFORM SOP Code

Ownership Document type Area SOP Number Version

PC SOP IM 004 01 Training Record

Full Name

Institution

Contact (email or phone number)

I certify that I have read and understood the SOP and have concluded an orientation with the appropriate PERFORM employee member. Signature

Sign here (trainee) Date

PERFORM Compliance Officer Date

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