IR(ME)R Flashcards
Exposure to which groups of people is covered by IR(ME)R?
- Patients.
- Carers and comforters.
- Asymptomatic individuals or those undergoing non-medical imaging (e.g. for screening or research).
Who is required to hold a license and why under IR(ME)R?
- Employer: At each installation where the administration of radioactive substances will take for a specified purpose (e.g. diagnosis, treatment or research).
- Practitioner: To administer radioactive substances for a specified purpose.
How is the ‘employer’ defined in IR(ME)R?
Any person who carries out or engages others to carry out exposures or practical aspects.
What procedures, protocols and QA programmes must be established by the employer, as per IR(ME)R?
- Management arrangements (radiation safety policy) and day-to-day working (employer’s procedures).
- Ensuring staff are adequately trained and undertake CPD.
- Protocols in place for every type of standard radiological practice.
- Referral guidelines.
- QA programmes for written procedures and protocols.
- Local DRLs and regular review.
- Dose constraints for researchers and carers and comforters.
What is clinical audit?
The evaluation of clinical outcomes and of clinical practice against standards (e.g. the evaluation of imaging within a healthcare pathway and its benefits in relation to the overall outcome).
What procedures must the employer’s procedures outline?
- Patient identification.
- Identification of duty holders.
- Pregnancy/breastfeeding checks.
- QA (documentation and equipment).
- Assessment of patient dose/administered activity.
- Use and review of DRLs.
- Research exposures.
- Information and instruction to patients.
- Informing patients of risks prior to an exposure.
- Evaluating images.
- Ensuring control of accidental and unintended dose.
- Informing stakeholders of clinically significant events.
- Performing non-medical imaging exposures.
- Establishing dose constraints for comforters and carers.
Which duty holder takes overall responsibility for patient identification and how do they identify patients?
- Operator.
- Ask non-leading questions.
- An advocate or interpreter may be required.
What information should be provided to a patient prior to an exposure?
Adequate information relating to the risks and benefits associated with the radiation dose from their exposure. The amount of information and method of conveying the information should be commensurate with the associated risk.
What is an accidental exposure? What is an unintended exposure? What must the employer do in the case of a ‘significant accidental or unintended exposure (SAUE)’?
- Accidental: Exposure to an individual where no exposure of any kind was intended.
- Unintended: Exposure to an individual that is significantly different to what was intended (e.g. due to dosage, modality, anatomy, timing of exposure, equipment/ancillary equipment malfunction etc).
- The employer must investigate the incident and report it to the appropriate enforcing authority (e.g. the CQC).
What is the difference between a clinically significant accidental or unintended exposure (CSAUE) and a significant accidental or unintended exposure (SAUE)? What additional procedures are required?
- Regulations do not define CSAUEs. However, guidance recommends that an AUE is clinically significant when moderate harm is caused triggering the duty of candour.
- The referrer, practitioner and individual exposed must be informed of a CSAUE.
What is the criteria for notification of a significant accidental exposure in England?
3 mSv effective dose or above for an adult/1 mSv effective dose or above for a child.
What do the categories and criteria for notification of significant unintended exposures for diagnostic examinations typically depend on? How do the criteria for notification differ for interventional/cardiology?
- Exposure categories depend on the intended dose. Criteria for notification depends on a threshold of exposure, above which, notification is required.
- For interventional/cardiology, notification is required when there is observable deterministic effects and/or procedural failings.
What do the criteria for notification of significant radiotherapy planning/verification scan exposures typically depend on?
The number of repeat scans required.
What are the criteria for notification of a significant foetal exposure?
Where there is an unintended foetal exposure AND the resultant foetal dose is 10 mGy or more.
What do the complimentary SAUE notification codes cover?
- M: More than one individual exposed within the same incident/theme.
- E: Equipment fault exposure (may also need to notify MHRA in this case).
- V: Voluntary notification.
- C: Clinically significant event.
