Dieblemorad open course material: Steps in nuclear medicine safety

Section

• Introduction

  

  
  

  WELCOME!

  • It's great that you have decided to take the first step in your journey to develop your and other participants’ skills in Hot Lab.

    This course is part of the project funded by EU. The project contains Base line measurement and filming (done in 2018) - Course - Post-measurement and filming (done in 2019)

    
    

    Aims: The purpose of this course is to improve your hot lab competencies.
    

    Instruction: There will be different type of learning tasks and activities. In every subject  there are videos related to  Hotlab work and after videos there is a discussion forum. Open the discussion forum and see detailed instructions for the learning task.

    Language: All the materials of the course are in English. In addition, the overall communication in the course and discussion fora is done in English to make sure everybody can understand each other. However, if you want, you can contact your local instructor in your own mother language.

    Time management and course schedule: The course is spread out through a time-frame of eight weeks, and the estimated number of working hours needed for completing this course is roughly 2 h per week. However, it may and will vary depending on the person and the week in question.

    In this eight-week course, there are altogether eight topics to be covered. We will open the new topic once a week. At the end, there is one week reserved for feedback and concluding the course. From the name of the topic you can see which of three universities is responsible from the certain part.

    Local instructors:

    • Belgium: Gwen De Mol and Harrie Mol
    • Slovenia: Tina Starc and Sebastijan Rep
    • Finland: Marja Jaronen (technical issues), Tiina Säilä and Tiina Taatila

    
    

    Our DIGMA area is organized chronologically following this structure:

  • Course schedule Page
  • News Forum
  • General Discussion for all, remember to order this site Forum
• 

  Open allClose all

  

• 1 Entering and Exiting the Hot Lab (SLO)

  • Instruction:

    • Read the information below
    • Watch the videos
    • Discuss the topics

  • Recommended reading for entering the hot lab:

    • page 17 at  https://www.eanm.org/content-eanm/uploads/2016/11/tech_radiopharmacy.pdf
    • https://humanhealth.iaea.org/HHW/Radiopharmacy/VirRad/Entering_the_Hot_Lab/index.html

    Recommended reading for exiting the hot lab: 
    

    • https://humanhealth.iaea.org/HHW/Radiopharmacy/VirRad/Exiting_the_Hot_Lab/index.html
  • IAEA Human Health Campus:

    The preparation of radiopharmaceuticals in a hospital radiopharmacy requires special attention and special precautions.
    

    As a result, a radiopharmacy is a restricted area to which public and patients do not have access. The authorized personnel must have received special training in the handling of unsealed radioactive sources and in the preparation of sterile and pyrogen-free pharmaceuticals for two reasons, patient and personnel safety.
    

    Most radiopharmaceuticals are solutions intended for intravenous injection and therefore must be sterile in order to ensure the safety of patients. The personnel who prepares the radiopharmaceutical therefore must use only sterile equipment and sterile licensed starting materials and adhere to strict aseptic working techniques.

    Radiopharmaceuticals contain radioactive material and the manipulation of radioactivity is subject to several rules, in order to ensure the safety of the personnel working with the radioactive materials.

  • Before entering the hot lab, the radiopharmacist/technician will enter a changing room in order to:

    • leave behind all unnecessary or prohibited materials before entering the hot lab (for example, bag, coat, food, drinks, cigarettes)
    • put on a special lab coat, mouth mask and hat
    • put on special shoes or overshoes
    • put on a personal dosimeter and if possible also one or two ring dosimeters.
    • put on gloves (this can also be done in the hot lab)

    
    

    (Based on IAEA Human Health Campus)

  • Please have a look at the films about entering and exiting the hot lab and compare the content of the films with your daily practice and references. 

    • Note, that all the films are not the ideal ones
    • Try to solve, which one is the nearest to good practice
    • Justify your opinion in discussion forums below
      

    Try to solve which of those are the nearest in good practice

  • Entering the Hot Lab (Tampere) URL
  • Entering the Hot Lab (Belgium) URL
  • Entering the Hot Lab (Slovenia) URL
  • Discussion about entering the Hot Lab Forum
  • Exiting the Hot Lab (Tampere) URL
  • Exiting the Hot Lab (Belgium) URL
  • Exiting the Hot Lab (Slovenia) URL
  • Discussion about exiting the Hot Lab Forum
  
• 2 Preparation of the LAF Cabinet (Odisee)

  • Preparation of the workspace

    The guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals describe personnel should appropriately apply aseptic techniques throughout the handling of radiopharmaceuticals for injection, including the radiolabeling of kits.
    

    For sterile radiopharmaceuticals, the working area where products are prepared should comply with appropriate environmental requirements. This implies the use of special clothing, sterile gloves, sterile vials, sterile syringes, sterile needles and sterile diluents, and that the work is done in a well-planned and expedient way. This may be achieved by the provision of a workstation with a laminar flow of HEPA-filtered Grade A air or a total containment workstation. The workstations should be in an environment conforming to at least Grade D. This can also be ascertained by surrounding the laminar flow workstation by a curtain of filtered Grade A air. The aseptic workstation should be sanitised at appropriate intervals. (EANM radiopharmacy Committee, 2007) 

    Continue reading by clicking the heading below!

    
    

  • Preparation of the workspace Page
  • Preparation of the workspace, LAF cabinet (Belgium), good practice URL
  • Assignment 1: Critical evaluation of daily practice Forum
  • Assignment 2: Implementation of the correct method to prepare your workspace Forum
  
• 3 Quality Control of the Dose Calibrator (Odisee)

  • This weeks program goes out the technical Quality control of the dose calibrator

    All medical equipment needs to be monitored to verify that the instrument performs according to its specifications.

    For this purpose, there are three types of tests:

    • Acceptance tests

    • Reference tests

    • Routine tests

    The acceptance test assures the user that the instrument can safely put into practice.

    Reference tests are performed on a regular basis and each time important maintenance is carried out on the equipment.

    The acceptance and Reference tests are generally performed by medical physicists. For several of these tests special equipment is needed.

    The routine tests are simple procedures that have to be performed on a short regular basis (daily, weekly, monthly). These tests have to be performed by ‘appropiately qualified and trained staff’ (EANM).  Detailed local operating procedures should be written for this routine work. All test results must be recorded and monitored for variations and appropriate actions taken when changes are observed.

    The QC tests are an important part of the routine work, and sufficient equipment time and staff time must be allocated for routine QC (EANM).
    

    The Dose calibrator

    In this lesson we perform a set of routine tests for the dose calibrator. As is stated above for every department local procedures should be written by a medical physicist. The test we perform here can therefore differ a bit from the test in your daily routine. To detect the differences between the protocol of this exercise and the ones used in your daily routine is part of the training process.

    Most modern dose calibrators have built in automatic quality control software. This helps to minimize the work of handling the results and it guarantees that the tests are performed every time the same.
    We are going to perform a daily and a monthly test in a manual way, which gives you some insight on the purpose of the test.

    
    

  • Practical work Page
  • Assignment 1: Procedure daily QC Page
  • Logbook File
  • Discussion assignment 1 Forum
  • Assignment 2: Monthly QC Page
  • Discussion assignment 2 Forum
  
• 4 Unwrapping / Eluting the Generator (Tampere)

  • Instruction:

    • Read the information below
    • Watch the videos
    • Discuss the topic

  • Good Distribution Practice of medicinal products for human use Page
  • Eluting the Generator
    

    The procedures for elution are designed to provide a sterile, pyrogen free product suitable for human injection or for elaboration into other radiopharmaceutical preparations.
    

  • Procedure for elution Page
  • Please have a look at the films about unwrapping and eluting the generator and compare the content of the films with your daily practice and references. 

    • Note, that all the films are not the ideal ones
    • Try to solve, which one is the nearest to good practice
    • Justify your opinion in discussion forum below

    
    
  • Wrapping the expired generator, Tampere URL
  • Unwrapping the Generator (Tampere) URL
  • Unwrapping and eluting the generator (Belgium) URL
  • Preparing the Generator (Slovenia) URL
  • Eluting the Generator (Slovenia) URL
  • Eluting the Generator (Tampere) URL

    
    
    
  • Discussion about Unwrapping and Eluting the Generator Forum
  
• 5 Labeling the RF (Odisee)

  • This week we will pay special attention to the actual preparation of the radiopharmaceutical kits.

    The guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals describe that the procedure for kit labelling differs for each radiopharmaceutical. The package insert gives detailed information about the procedure of kit labelling. Manufacturer instructions are based on the experience acquired for the particular kit. The package insert is approved by national authorities. Each package insert should be read carefully and followed.  Any deviation has to be validated and approved (EANM radiopharmacy Committee, 2007).

    However the differences in procedures for each radiopharmaceutical, there are some general safety aspects which must be taken into account. These safety aspects cover the two most important aspects in the hotlab: sterility (working under aseptic conditions) and radioprotection!

    The guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals describe both aspects.
    

  • ASSIGNMENT 1: Summary and discussion Page
  • Discussion area 1 Forum
  • Besides the previous described guidelines, the International Atomic Energy Agency developed a Virtual Course in Radiopharmacy which was part of the VirRAD project.

    The VirRAD project was established in 2002 with funding from the IST 2001 work program on Education and Training which was directed to support improvement in the process of learning through the use of ICT, focusing in particular on the trend towards greater individual control and responsibility for training (IAEA Human Health Campus, 2010-2016).

    This course, for example, describes the basic radiopharmaceutical preparation step by step, which makes it more practical and easy to introduce in your own daily practice. 

    The checklists below are developed based on this IAEA virtual course in Radiopharmacy.

  • Checklist 1. The LAF preparation and selecting of the appropriate materials for the labeling procedure File
  • Checklist 2. The labeling procedure File
  • 
    

    Below you can find more information about the key items related to radioprotection AND working under aseptic conditions mentioned in the checklists.  Please read these before moving further to assignment 2.

  • Summary of key items related to radioprotection File
  • Summary of key items related to working under aseptic conditions File
  • ASSIGNMENT 2: Critical evaluation of different labeling procedures Page
  • Video 1: RF Labeling (Tampere) URL
  • Video 2. RF Labelling (Slovenia) URL
  • Video 3. RF Labelling (Odisee) URL

    
    
    
  • Discussion, Critical evaluation of different labeling procedures Forum
  
• 6 Quality Control of the RF (SLO)

  • Instruction:

    • Read the information below
    • Watch the videos
    • Discuss the topic

  • Radiochemical purity tests of the radiopharmaceuticals should be performed on the first of each batch before patient administration.
    

    Read more about Radiochemical purity (RCP) and other tests from the links below.
    

  • Radiochemical purity Page
  • QC of the Radiopharmaceuticals File
  • QC RF part 1 (Slovenia) URL
  • QC RF part 2 (Slovenia) URL

    
    
    
  • Discussion, Critical evaluation of QC of the RF Forum
  
• 7 RF Dose Dispensing and Injecting the RF (SLO)

  • Instruction:

    • Read the information below
    • Watch the videos
    • Discuss the topic

  • Dispensing Radiopharmaceuticals File
  • Administration of RF File
  • The syringe has to be labelled with relevant information to ensure that the correct radiopharmaceutical with the correct activity will be administered to the correct patient, usually:

    • patient details
    • the name of the radiopharmaceutical
    • the measured activity
    • the date
    • the time
    • the time of injection
      
      

    
    

  • RF Dose Dispensing (Tampere) URL
  • RF Dose Dispensing (Odisee) URL
  • RF Dose Dispensing (Slovenia) URL
  • Injecting the RF (Tampere) URL
  • Injecting the RF 1 (Slovenia) URL
  • Injecting the RF 2 (Slovenia) URL
  • Assignment: RF Dose Dispensing and Injecting the RF Forum
  
• 8 Cleaning of LAF Cabinet and the End of the Day (Tampere)

  • Instruction:

    • Read the information below
      
    • Watch the videos
    • Discuss the topic

  • Clearing the working area Page
  • Decontamination / cleaning the working area Page
  • Video1. Cleaning and decontamination (Belgium)
    

  • Video 2. Radiation monitoring, alpha emitting isotopes (Tampere)
    

  • Video3. Decontamination bag (Tampere)
    

  • Video 4. Clearing the LAF Cabinet (Tampere)
    

  • Video 5. Cleaning of the LAF cabinet in the end of the day (Tampere)
    

  • Video 6. Radiation monitoring in the end of the day (Tampere)
    

  
• References and additional readings

  Are you excited to read more? Below are the references to all sources that were consulted for the development of this course

  
  

  • EANM The Radiopharmacy Techologist guide (2008) File
  • Good Distribution Practice of medicinal products for human use File
  • GOOD RADIOPHARMACY PRACTICE AND REGULATION File
  • Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals (2010) File
  • Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective (2014) File
  • Guidelines to Optimize Extremity Monitoring and to Reduce Skin Doses in Nuclear Medicine. Results of the ORAMED Project File
  • IAEA Operational guidance on Hospital Radiopharmacy File
  • Quality Control of Compounded Radiopharmaceuticals (2012) File
  • Radiation Protection and Dose Optimisation A Technologist’s Guide (2016) File
  • Radiochemical_Purity_Testing_of_Radiopharmaceuticals_2015 File
  • Routine quality control recommendations for nuclear medicine instrumentation File
  • Oramed Training material URL
  • The IAEA Human Health Campus material URL
  
• Feedback and conclusion

  The feedback form is closed!
  

  
  

  • Discussion about the issues related to end of the day Forum
  • Conclusion (discussion area) Forum