The professional and moral responsibility of all healthcare professionals and organisations in the UK, as regards patient safety, has increased since the publication of the second Francis report.1
For some bodies there were already, or are now, statutory duties. The College has no such duties. Furthermore, Royal colleges were not specifically tasked with action in this regard by Francis. However, his report said that all healthcare professionals share responsibility for the failings the inquiry disclosed and that the issues raised should be addressed on a personal and organisational basis. The report advocated a fundamental change in culture to ensure that patients are put first in everything that is done and every effort should be made to protect them from harm in future.
In the College’s response to the Francis report we said: ‘We will produce a policy clarifying the process for when serious patient safety concerns are raised and when this will trigger a reference to a regulatory body.’ This statement sets out the College’s policy.
Statutory and formal position
There is no clear statutory/legal duty imposed on the College (any medical Royal college), as an organisation, to take action in response to concerns. The College is, however, involved with training quality assurance systems through the postgraduate deaneries (and in England through the local education and training boards) and the General Medical Council (GMC).
In the light of the Francis report, the College acknowledges that while it does not have a statutory duty to disclose information to a regulator, its moral and professional responsibilities mean that in certain circumstances, it may be appropriate to do so. Regulators have already asked the College to disclose information for certain purposes and this policy is designed to govern how we will respond to such requests.
The College has agreed the following principles to underpin procedures and actions in regard to becoming aware of (potential) serious patient safety concerns:
- The College should appropriately balance its moral and professional responsibilities in the post-Francis era with its role as a membership body.
- The College is not, and does not intend to become recognised as, a regulatory body.
- Other than the quality assurance of training procedures, the College will deal with concerns in a reactive rather than a proactive manner. The College will not investigate any matters unless it is specifically invited and agrees to do so. Currently, the only established way in which that arises is through a service review.
- The College does not investigate or assess the individual performance of clinical oncologists or clinical radiologists in the workplace.
- Nothing in these principles is intended to affect in any way the duties of a doctor as prescribed from time to time by the GMC. Those duties bear upon College Officers and others working with the College as they do for any doctor; that is, in their individual capacity rather than in any College organisational role that they might fulfil.
- The College cannot ‘un-know’ any concerns it of which it becomes aware. This would be contrary to the principles set out in the Francis report which have been accepted by the College.
- Fellows and members should not be relieved of their individual and/or organisational responsibilities to take action in response to concerns locally.
Formal routes through which the College can become aware of concerns
The College has three ‘formal’ routes through which it can become aware of issues with potential to give rise to concerns about patient safety:
- Management of quality assurance (QA) of training in clinical radiology and clinical oncology
- Service reviews in clinical radiology and clinical oncology
- Imaging Services Accreditation Scheme (ISAS)
There are various unstructured or informal routes through which the College can become aware of patient safety concerns; for example, through conversations with Fellows and members who are seeking information, advice or guidance, through equivalence processes or through approaches made by patients, carers or family members.
The role of the College as a membership body is important in this process and Fellows and members need the opportunity to discuss their concerns informally with someone such as a College Officer. However, the clear expectation of bodies, such as colleges, to act on information post-Francis means that there may have to be limits on what can be permitted to remain informal and unrecorded. The College is also clear: it will not support the transfer of responsibility to act from the individual or local healthcare organisation to the College.
In order to fulfil its duties, the College has put in place procedures to record concerns in an appropriate way. The purpose of this is twofold:
- To provide an enduring body of knowledge, given that elected Officers who have oversight of these areas of activity serve for short terms, usually three years
- To avoid a situation where there is an accumulating body of knowledge from different sources about an organisation or individual(s) which together might give rise to concern.
The record is very closely controlled and can only be accessed by a limited number of authorised individuals in the College at any one time. It is, however, reviewed at a high level on a regular basis to ensure that any areas of serious concern are not being overlooked.
Apart from the formal routes indicated above, it is very rare for the College to take any action in regard to this information. For the most part, the College will give advice and guidance on how a matter should be handled locally or through another organisation.
Disclosure to a regulator
The College will only respond to a request for information from a regulator; invariably this will be in respect of one or more of the three formal routes identified in this statement. In making such a disclosure, the College will notify the regulator of the formal matter but not give any details. There are, however, pre-existing procedures in regard to College Service reviews:
- In the document College review of radiology services, fourth edition: ‘Alongside the reporting of recommendations, the RCR has a duty to raise serious safety concerns of immediate risks to the service to the Trust commissioning the review. If necessary, the RCR will refer the appropriate information immediately to the relevant regulatory body. This could mean an escalation of the concerns to the GMC or, as appropriate to the location of the service, to the Care Quality Commission, Healthcare Improvement Scotland, Healthcare Inspectorate Wales, or the Regulation and Quality Improvement Authority’. (page 17)2
- Para 5.4.1 of the Guide to the process for service reviews conducted by the Service Review Committee (February 2014), which only relates to service reviews in clinical radiology departments, states that: ‘A follow-up letter will be sent by the Chairman of the Service Review Committee (SRC) six months after the review to ascertain progress following the review. The team leader may seek an informal follow-up visit to assess progress’.3
- Para 7.1 of the Process for reviews in oncology services states: ‘A follow-up letter will be sent to the chief executive of the trust by the designated Clinical Oncology Officer six months after the review to ascertain progress following the review (Appendices 15 and 16), and a response will be required at chief executive level’.4
Exceptionally, outside those areas, it is possible that the College could disclose a concern about patient safety to a regulator where there have been a number of references or a single reference of such seriousness that disclosure is considered necessary. However, before so doing, the College would strongly encourage those who had reported the matter to resolve it locally or through other mechanisms. Only where the College felt that action was not being taken effectively or in a sufficiently timely manner would a disclosure be made to a regulator.
Inevitably, with these processes being new, there will be a need to review them periodically in the light of experience. However, the College is very clear that it needs to remain a supportive organisation for its Fellows and members while also balancing its role and responsibilities in the post-Francis era.
Approved by Clinical Oncology Faculty Board: 26 June 2014
Approved by Clinical Radiology Faculty Board: 27 June 2014
The Mid Staffordshire NHS Foundation Trust Public Enquiry. Chaired by Robert Francis QC. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery Office, 2014.
The Royal College of Radiologists. College review of radiology services, Fourth edition. London: The Royal College of Radiologists, 2014.
The Royal College of Radiologists. A guide to the process for service reviews conducted by the Service Review Committee. London: The Royal College of Radiologists, 2014.
The Royal College of Radiologists. Process for reviews in oncology services. London: The Royal College of Radiologists, 2012.