ARSAC Flashcards
(26 cards)
What does ARSAC stand for?
Administration of
Radioactive
Substances
Advisory
Committee
What is ARSAC?
A committee of experts (nuclear medicine clinicians, medical physicists, radiopharmacists) who provide expert advice and guidance to licensing authorities on the practical usage of radioactive materials for clinical use.
Why does ARSAC exist?
Because, under BSSD and IRMER17, it is a requirement to have a lisence for the deliberate administration of radioactive substances to persons for the purpose of medical diagnosis, treatment, or research.
Who requires an ARSAC liscence?
Employers and practitioners who are administering radioactive substances for a specific purpose at any medical radiological installation.
True or False: employers require a different Employer ARSAC license for each radiological installation that administers radionuclides.
True
Licenses are required for any administration of a radioactive substance that results in an effective dose of greater than _ ___.
1 µSv
How long are Employer ARSAC licenses valid for?
5 years
What needs to be included in applications for an Employer ARSAC license?
- Names and addresses of: the medical radiological installation, the employer, the accountable representative of the employer, the medical director, practitioners, MPE
- Details of staff training
- Equipment and facilities available to the employer
- Procedures for which authorisation is sought and for which purpose
- Local DRLs
- Summary of governance arrangements for IRMER
True or False: practitioners require an ARSAC license for every site they work at.
FALSE
They only require 1 license
How long are Practitioner ARSAC licenses valid for?
5 years
Who can be granted a Practitioner ARSAC license?
A pracitioner who is clinically responsible for the justification of administrations of radioactive substances. They must be medically trained practitioners (consultant grade) and provide evidence of their theoretical and practical training.
What is a Particular Patient License (PPL)?
A license that can be granted in cases of urgent medical need to employers and practitioners who already hold a valid ARSAC license. After applying, ARSAC puts the practitioner in contact with a fellow pracitioner that has experience of the procedure to provide guidance.
Under what circumstances will ARSAC deny a PPL?
- For research purposes
- For multiple administrations of the same type
- For a novel administration that hasn’t been previously authorised
What is the difference between an ammendment and a notification?
Ammendments are required when there is a change to or addition of procedures, whereas notifications are changes to the content that don’t impact the procedures.
When are ARSAC license ammendments required?
- For the addition of a procedure
- For a change in purpose of a procedure
- To request authorisation for an administered activity above a DRL
When are ARSAC license notifications required?
- For a change in contact details
- For a change if a practitioners radiological installation
- For a change in named person
Who is responsible for holding a valid ARSAC license?
The employer and the practitioner
In order to renew their license, practitioners must continue to demonstrate _________ and ___.
Competence
CPE (continuous professional education)
How are research trials approved by ARSAC?
Each invidividual trial requires ARSAC approval.
How are different procedures separated into ARSAC licensing categories?
They are divided into imaging and non-imaging, then further divided by pathology/physiology. It is assumed a clinician will be equally competent in all procedures within the dame functional group.
For each procedure, there is a given ________ _______ _____ (___) and an _________ _____ in order for clinicians to justify the procedure.
Diagnostic reference level (DRL)
Estimated dose
What are the ARSAC notes for guidance on children?
- Ensure the most appropriate investigation is chosen
- Ensure the dose is justifiable
- Consider sending the child to a dedicated centre
- Schedule more time for the appointment
- Fully inform the child and parent/guardian
- Lover the administered activity
- Consider sedation
What are the ARSAC notes for guidance on pregnancy?
- Only complete the prcedure if justifiable
- Follow employer procedures on establishing pregnancy
- If pregnancy cannot be ruled out check if menstrual period is overdue
What are the ARSAC notes for guidance on conception?
- Most diagnostic procedures require no advice for delaying conception
- For certain therapeutic procedures, conception should be delayed
