Interaction with Competent Authorities

Question 1

What is the HSEs graded approach to regulation?

Answer 1

Three tiers of practices with different levels of hazard/risk which require either (from lowest to highest risk):
- Notification: Under 1000 kg artificial or naturally occurring (e.g. radon) radionuclide. Depends on specific concentration/quantity levels.
- Registration: Radiation generators (e.g. x-ray devices), 1000 kg or over artificial or naturally occurring (e.g. radon) radionuclide. Depends on specific concentration/quantity levels. OR below 1000 kg with with higher concentration /quantity levels.
- Consent. See consent practices flashcard.

Question 2

How is notification, registration and consent undertaken?

Answer 2

• Online system with a series of questions which determine whether notification, registration or consent is required. Ideally this should be completed by a an executive representative employee of the organisation who is familiar with the practice(s).
• No evidence is required for notification and registration.
• Full radiation safety assessment and inspection required for consent.
• Confirmation of registration and consent will be provided.

Question 3

What kind of things must be confirmed before registration of a practice?

Answer 3

• Number of different types of equipment.
• Risk assessment and identification of foreseeable accidents.
• Measurement/estimation of exposure.
• Restriction of exposure.
• Contingency plans.
• Consultation with RPA.
• Radiation safety training.
• Controlled and supervised area designation.
• Local rules and appointment of RPS.

Question 4

What types of practices relevant to the medical sector require consent?

Answer 4

• Administration of radioactive substances for medical purposes.
• Deliberate addition of radioactive substances to products.
• Operation of an accelerator (e.g. radiotherapy linac).
• Long-term storage or disposal of radioactive waste.
• Discharge of significant amounts of radioactive effluent.

Question 5

What does the radiation safety assessment as part of the consent process involve?

Answer 5

• Online questions/templates to complete.
• General details (e.g. contact details, RPA details, rough employee numbers).
• Summary of work.
• Summary of management arrangements.
• Details of equipment (e.g. energies etc.) or RAM (including frequency of administration/discharge).
• Other sources of exposure (e.g. work in different areas, radon risk assessment etc.).
• Dose rate details (e.g. for controlled areas, routine and accident situations, staff and public etc.).
• Engineering controls in place (including sketch map).
• Maintenance and test schedules.
• Results of critical examinations.
• Radiation monitoring regime.
• Personal dosimetry details.
• Classification of staff.
• Radiation protection training details.
• Contingency plans for potential accident situations.
• Local rules.

Question 6

Aside from notification of practice, when else may notification to the HSE be required under IRR17?

Answer 6

• Suspected overexposure.
• Dose assessment following accidents.
• Loss, theft or release of certain quantities of RAM.

Question 7

What does REPPIR cover and when may notification to HSE be required in connection with REPPIR?

Answer 7

• Radiation Emergency & Preparedness & Public Information Regulations. Relates to potential exposure to the public due to some form of major accident.
• Notification may be required for operators/carriers holding of RAM above threshold levels.
• Hazard identification and risk evaluation (HIRE) required.

Question 8

What does RIDDOR cover and when may notification to HSE be required in connection with RIDDOR?

Answer 8

• Reporting of Injuries Diseases and Dangerous Occurrences Regulations.
• Notification may be required for radiation related dangerous occurrences (e.g. malfunction of radiation generator).
• Typically associated with industrial radiography etc.

Question 9

What is a permit to work and when may one be required in medical applications?

Answer 9

Additional control/management over conditions in which work will be done in relation to high-risk activities e.g. technicians working on a linac treatment head.

Question 10

What is required in the case of an overexposure to staff or the public, as per IRR17 Regulation 26?

Answer 10

• An immediate investigation must be undertaken to determine the likelihood of an overexposure, determine the circumstances and the cause and to assess the dose received.
• The employer must notify; the individual, the HSE, the approved doctor and any other relevant employers.
• An investigation report must be made and a copy provided to those above. The report should be kept for at least 30 years.
• The employee’s dose record should be updated.

Question 11

What would the investigation after a suspected overexposure consider?

Answer 11

• Work routine of individual and colleagues.
• Radiation monitor/alarm readings.
• Details of any known incidents.
• Recent assessed/estimated doses compared to colleagues.
• Radiation survey results.
• Adherence to, or deficiencies in, local rules.
• Training, information, instruction and competence.
• Other possible explanations (e.g. individuals treatment as a patient, exposure in security x-ray scanner).
• Reconstruction of events.

Question 12

What would an overexposure investigation report include?

Answer 12

• How the exposure was received.
• Evidence to support any conclusion that a dose was not genuine.
• Implications for individual concerned (e.g. need for classification).
• Action already taken.
• Further actions required (e.g. procedural changes, training updates, additional monitoring etc.).

Question 13

What is an accidental exposure? What is an unintended exposure? What do SAUE notifications depend on?

Answer 13

• Accidental: An individual has received an exposure in error when no exposure of any kind was intended
• Unintended: An individual has received an exposure that was significantly greater or different to that intended (e.g. due to dose, modality, technique, anatomy, equipment/ancillary equipment malfunction etc.).
• SAUE notifications are age dependent. For accidental exposures they depend on the exposure level. For unintended exposures, the intended dose is also taken into account.

Question 14

When is SAUE notification not required for fetal exposures or repeat exposures?

Answer 14

• Fetal: Where no procedural error has occurred.
• Repeat exposure: e.g. due to technical repeats or movement. Would still be required in the case of procedural, human, systematic or equipment errors.

Question 15

How do SAUE notification criteria differ for interventional/cardiology compared to other modalities?

Answer 15

• Based on procedural failure and observable deterministic effects.
• Or no procedural failure but results in unintended or unpredicted observable deterministic effects.

Question 16

When may a SAUE underexposure be notified?

Answer 16

Radiotherapy treatments.

Question 17

What do the SAUE notification codes M, E, V and C correspond to?

Answer 17

• M: More than one individual exposed within the same incident or theme.
• E: Equipment fault exposure.
• V: Voluntary notification.
• C: Clinically significant event.

Question 18

What should an investigation after a SAUE consider/what would the report include?

Answer 18

• Establishing what happened.
• Establishing the cause of the incident (e.g. equipment malfunction).
• Any similar incidents or trends.
• Whether the local duty of candour has been met.
• Whether local incident handling procedures have been applied.
• Learning from the investigation.
• Determining and implementing remedial action.
• Estimate doses and risks to those involved in the incident.

Question 19

Who might be involved in a SAUE incident investigation?

Answer 19

• Person in charge of department where incident took place.
• Operator during the incident.
• Service engineer who examined the equipment.
• Person responsible for equipment QA.
• MPE.
• RPS.

Question 20

What timescales are involved with SAUE notification?

Answer 20

• Preliminary investigation ASAP.
• CQC notification, if required, no later than 2 weeks.
• Detailed investigation report, if required, no later than 12 weeks.

Question 21

What types of inspections may be undertaken by competent authorities?

Answer 21

• To obtain/maintain consent.
• Proactive: Random selection (no specific issues).
• Reactive: Targeted after an incident, for example.
• Follow up: Checking up after previous issue has been identified.

Question 22

Who/what may an inspector want to see generally during an inspection?

Answer 22

• Management e.g. senior trust officer, head of department, chair of RPC etc.
• Staff: RPS, RPA/MPE, individual staff, support staff etc.
• The radiation safety policy (details will normally be checked against the radiation safety policy).
• Other related documentation.

Question 23

What specific documentation may a HSE inspector want to see?

Answer 23

• Radiation safety policy.
• Risk assessments.
• Local rules.
• Personal monitoring results.
• Environmental monitoring results.
• Critical examinations.
• RPS and staff training records.
• Minutes of meetings.
• RPA advice/audit reports.
• Accounts of recent incidents.

Question 24

What specific documentation may a CQC inspector want to see?

Answer 24

• Radiation safety policy.
• IR(ME)R procedures.
• Clinical audit evidence.
• Patient doses/DRLs.
• Comforter and carer doses.
• Equipment QA and servicing.
• Duty holder training records.
• Minutes of meetings.
• MPE advice.
• Account of recent incidents.

Question 25

What may an inspector do after an inspection?

Answer 25

• Everything fine (very rare).
• Verbal indication of minor issues to be addressed.
• Notice of non-conformance.
• Improvement notice with time limit for re-inspection.
• Prohibition notice (rare in medical sector).
• Prosecution.

Question 26

A classified interventional radiologist gets a dose of 5 mSv recorded on their whole body badge in one month. What are your initial thoughts regarding investigation and action?

Answer 26

This is a very large dose - it would correspond to a projected annual dose of 60 mSv. It is likely it may not be ‘real’. However, an investigation would be required to ascertain this. This would include checking:
- Details of any factors that could have contributed to the high dose (e.g. incidents, high workload).
- Previous monitoring results.
- Details of the radiation work undertaken by the individual.
- PPE use including dosimeter wearing and storage.
- Training records/details.

Question 27

Patient received chest/abdo/pelvis CT scan. They are subsequently referred for a thorax CT scan by a referrer who doesn’t notice the thorax was included on the previous scan. Is this notifiable?

Answer 27

• This is an unintended exposure as an exposure was intended but the exposure is different to the intended dose due to the additional CT thorax scan.
• Typical CT chest/abdo/pelvis effective dose = 19 mSv [Updated estimates of typical effective doses for common CT examinations in the UK following the 2011 national review].
• Typical CT thorax effective dose = 8 mSv (taken as CT chest from https://www.gov.uk/government/publications/medical-radiation-patient-doses/patient-dose-information-guidance).
• Therefore, this would not be notifiable under notification code 2.4. The intended dose is > 10 mSv but the unintended dose is not >= 2.5 x more than intended.