5. Incident Reporting

a) Mandatory Reporting under IR(ME)R

Regulation 4 requires the Employer to provide a framework of procedures for medical exposures and to carry out investigations of incidents and appropriate reviews.

Regulation 4(5) requires Employers to “make an immediate preliminary investigation” of incidents and then “forthwith notify the appropriate authority” unless the Employer is certain that no exposure much greater than intended has occurred.

A detailed investigation and dose assessment is required and it is presumed that   notification to the appropriate authority will take place, unless there is early confirmation that there is no need (SI 2000 No 1059).

SCoR guidance

It is imperative that there are no undue delays in notifying the IR(ME)R appropriate authority (the IR(ME)R Inspector) of a reportable incident following the local preliminary investigation. This is obviously important in learning from errors but also in protecting the patient / public.

Notifiable IR(ME)R Incidents

Notifiable incidents under IR(ME)R are those where a dose “much greater than intended” has been delivered to an individual and should be reported to the appropriate authority. Under-doses are not notifiable but must still be locally investigated.

“Much greater than intended”

The current guidance as to what constitutes an exposure “much greater than intended“ under IR(ME)R is available from the Department of Health (2007) available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati... (based on Appendix 2 of the “Guidance Note PM77 (Third edition) Equipment used in connection with medical exposure (HSE, 2006)”  The HSE (2006) guidance details the doses which are likely to be “much greater than intended” for particular types of medical exposure.

Further guidance is awaited from the DH (by end of 2009) – SCoR has made a contribution to this forthcoming guidance.

Examples of incidents that require investigation:

1. patient ID error
2. wrong imaged anatomy / geographical miss of the target volume
3. human error resulting in incorrect exposure or repeated exposure
4. repeat of treatment planning x-ray procedures due to equipment failure or incorrect imaging protocols applied.
5. incorrect treatment dose given (greater or lower than intended)

The detailed local preliminary investigation of incidents required by the Regulations should be aimed at:

• finding out what happened
• where the failure actually lay (i.e. what was the initiating error)
• what action is required to minimise the chance of a similar failure?
• what actual dose was given to the patient in the incident and how did this compare with the intended dose?
• if the error was due to equipment malfunction, it is also reportable to the Health & Safety Executive (HSE)

  (DH, 2007)

Initial incident reports following a medical over-exposure due to human error must be kept for at least two years, detailed reports must be kept for 50 years (Regulation 4(5)).

The dose received by the patient due to any over-exposure incident must be recorded in the patient’s notes. It is good practice that the patient is also informed of the incident unless there is good reason for the patient not to be (which should be documented in the patient’s notes) – how the patient is informed is down to local procedure but the IR(ME)R practitioner and referrer should be involved.

IR(ME)R Inspectorate information

There are 4 separate IR(ME)R Inspectorates (the “appropriate authority” for the four UK home countries (contact details below). IR(ME)R inspections are undertaken either on:

• a pro-active basis (where inspections provide assurance of regulation compliance and guidance is given) or
• on a re-active basis (where evidence is gathered following an incident being reported - sometimes this may involve interviewing witnesses / duty-holders under caution).

i) IR(ME)R Incident notification to CQC (England only)

In England, the Healthcare Commission (HCC) was the independent inspection body for both the NHS and independent healthcare. From 1st April 2009, the HCC became the Care Quality Commission (CQC), the new independent regulator of all health and adult social care in England (a merger between the Mental Health Act Commission and the Commission for Social Care and Inspection).

The IRMER email address changed to IRMER@cqc.org.uk and this email should be used for any correspondence to the IRMER team.

For the foreseeable future, the IRMER incident webform will still be located on the Healthcare Commission website. A link to the webform that is on the Healthcare Commissions website is also to be provided from the new Care Quality Commission’s website - www.cqc.org.uk. In due course it is planned to relocate the webform to the CQC website for the radiology / radiotherapy community to access the incident reporting form to submit IRMER notifications.
Further information about the use of ionising radiation and the CQC is available from the following link: http://www.cqc.org.uk/guidanceforprofessionals/healthcare/allhealthcares... where there is information about how to report an IR(ME)R incident, their inspection programmes and the key findings of previous inspections.

Note
Information about reporting incidents is available on the CQC website at: http://www.cqc.org.uk/guidanceforprofessionals/healthcare/allhealthcares.... A link is there to the HSE for incidents that involve a medical exposure to a patient through equipment failure.

Notifications can be made directly to CQC by using their web-based notification form – available from: https://admin.webforms.cqc.org.uk/popup/survey.php?sid=944966036

An example of the normal sequence of events when a radiation incident (IR(ME)R) notification has been made to CQC (England)

• completion of web form (normally completed by a departmental head or RPA)
• upon receipt, CQC attaches a number automatically to the case
• CQC phones the person who completed the form as the CQC needs to know how the “internal report” is proceeding (ie more background information and if the department had instigated its own internal inspection etc) and when the “internal” report is going to be sent to CQC
• the decisions about whether an inspection is required or not is made by a group at CQC (physicists and others) and includes the CQC Lead IR(ME)R Inspector
• the decision is conveyed back to the hospital department in the form of a written letter which must go to the CEO as  Employer (and copied to the person who originally completed the web-form)
• if there is to be no inspection – the letter normally states something like “the department must abide by the recommendations within the internal report, continue to monitor protocols etc”
• the case is then closed.

Other points of note:

• 9 out of 10 cases will not have an inspection
• there is to be an annual inspection form (which is risk based)
• if there are a few notifications from the one department, CQC may obviously decide to inspect (even if they are seen to be fairly minor incidents).

The IR(ME)R Inspector (England) within CQC (previously HCC) had written the first report entitled: “Ionising Radiation (Medical Exposure) Regulations 2000. A report on regulation activity from 1 November 2006 to 31 December 2007”

The report highlights the nature of incidents where patients have been exposed to ionising radiation to a degree ‘much greater than intended’.  The total number of notifications HC received during the 14 -month period from 1 November 2006 to 31 December 2007 was 329. Report available at: http://www.cqc.org.uk/publications.cfm?fde_id=817

The CQC also publish individual reports from proactive visits on their website, see: http://www.cqc.org.uk/guidanceforprofessionals/healthcare/allhealthcares...

Review of the annual reports and site inspection reports is an excellent tool in improving radiation protection in clinical departments.

The IR(ME)R Inspectorate for England has a detailed annual inspection programme and also writes quarterly IR(ME)R reports for the radiology and oncology community and he is particularly keen to hear feedback from radiographers as to the usefulness of these reports.

To view the inspection programme and the reports, see: http://www.cqc.org.uk/guidanceforprofessionals/healthcare/allhealthcares...

ii) Other IR(ME)R Inspectorate details

Responsibility for the protection of patients undergoing medical exposure to ionising radiation has been devolved to the home countries. All notifications of incidents where patients have been exposed to ionising radiation to a degree ‘much greater than intended’ (IR(ME)R 2000) should be sent to the relevant IR(ME)R Inspectorates.

Wales

The enforcing authority for Wales for the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) is the Welsh Ministers. The Minister for Finance and Public Service Delivery and the Minister for Health and Social Services has agreed to the transfer of the IR(ME)R enforcement programme from Health Protection Division (HPD) of the National Assembly Wales (NAW) to Healthcare Inspectorate Wales (HIW) and agreed to transfer the IR(ME)R budget to HIW. 

For further information, see: http://wales.gov.uk/publications/accessinfo/drnewhomepage/healthdrs/Heal...

Dr Owen Crawley, the Welsh Chief Scientific Adviser in NAW still retains the current warrant but warrants are also issued to inspectors in HIW who will be taking on the responsibilities for reactive inspections in the near future.

HIW has the responsibility of being the “appropriate authority” for IR(ME)R inspectorate arrangements on a pro-active arrangement which are organised on a “risk” basis and which are formally reported back to the community and the public. Self-assessment tools that relate to the generic healthcare standards for Wales also include IR(ME)R information and are completed by local departments, see HIW IR(ME)R page at: http://www.hiw.org.uk/page.cfm?orgid=477&pid=35707 

The Welsh Chief Scientific Adviser retains professional oversight of IR(ME)R and NAW retains policy oversight and a meeting takes place annually with HIW to discuss IR(ME)R issues. Regular seminars are organised via the Chief Scientific Adviser’s office to disseminate information and learning – the latest had the theme of “patient safety in radiotherapy”. See http://wales.gov.uk/topics/health/professionals/scientific/ionising-radi...

Note
Incidents in Wales, which result in a patient receiving a radiation dose “much greater than intended”, must be reported to:

Dr O.Crawley
Chief Scientific Adviser

Department of Public Health and Health Professionals

Welsh Assembly Government
Cathays Park

Cardiff

CF10 3NQ

E-mail: CMO.webmaster@Wales.gsi.gov.uk

Information about what should be supplied to the inspectors following a detailed investigation of an IR(ME)R incident is available on the Welsh Government website at: http://wales.gov.uk/dphhp/publication/professionals/scientific/ionising-...

Scotland

The enforcing authority for Scotland for the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) is the Scottish Ministers. Dr Arthur M Johnston is the Warranted Inspector appointed by the Scottish Ministers and his contact details are:

St Andrew’s House
Regent Road
Edinburgh
EH1 3DG
Tel 0131 244 2779
Fax 0131 244 1030
http://www.scotland.gov.uk/Topics/Health

Northern Ireland

Incidents in Northern Ireland which have gone through a local preliminary investigation and which results in a patient receiving a radiation dose “much greater than intended”, must be reported to:

Deputy Chief Medical Officer
DHSSPS
Castle Buildings
Stormont
Belfast
Tel: 028 9052 0710
http://www.dhsspsni.gov.uk/index/hss.htm

The enforcement powers and responsibility for inspections under IR(ME)R will lie with the Regulation and Quality Improvement Authority (RQIA) from the end of summer 2009 – see http://www.rqia.org.uk/home/index.cfm .

b) Voluntary reporting

It is mandatory to report those incidents described under IR(ME)R to the appropriate authority. As discussed, the CQC and HIW share information via their respective websites on those incidents reported, and on their findings at pro-active inspections within the radiology community. The findings and the  reports provide valuable tools for improving radiation protection in radiology on a national scale. Much more could be learned if information about lower level incidents (ie those that are not notifiable) was to be shared.

Towards Safer Radiotherapy (2008) has a dedicated chapter on ‘Learning from errors’ in radiotherapy (Chapter 6). Much of the ethos of this document is transferable across the different modalities in radiology. This discusses the value of local and national learning from errors and near misses. It also proposes a voluntary national UK radiotherapy reporting, analysis and learning system, with the provision of feedback to the radiotherapy community.

i) National Patient Safety Agency
The National Patient Safety Agency (NPSA) has an established system of voluntary reporting of patient safety incidents and near misses called the National Reporting and Learning Service (NRLS). The NPSA have engaged expertise from the HPA to undertake analysis of radiotherapy incidents. The first analysis was reported on the NPSA website in its quarterly report in May 2008.
http://www.npsa.nhs.uk/nrls/patient-safety-incident-data/quarterly-data-...

The HPA now have a data sharing agreement with the NPSA to provide the expertise to undertake the analysis of data collected on radiation incidents on a regular basis. It is envisaged that these reports will be routinely published on the NPSA website as part of their quarterly reports. This will enable the national sharing of any lessons learnt from incidents and near misses.

The NPSA also issue “Safer Practice Notices” periodically – an example of such a Safer Practice Notice relating to a reported failure to act on radiological imaging reports is available for download at http://www.npsa.nhs.uk/nrls/alerts-and-directives/notices/radiological/

ii) In England - the Cancer Standards also have a requirement for systems to be in place for handling incidents etc. Further information is available at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati...

iii)  For further guidance, the staff of the HPA, Radiation Protection Division, Medical Exposures Department is able to give advice on all radiographic safety matters and have particular support for radiotherapy services, see: http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/122223671...

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