Select Committee on Health Written Evidence


Memorandum by the Royal College of Radiologists (PS 12)

PATIENT SAFETY

  1.  The Royal College of Radiologists (RCR) has approximately 7,600 members and Fellows worldwide representing the disciplines of clinical oncology and clinical radiology. All members and Fellows of the College are registered medical or dental practitioners. The role of the College is to advance the science and practice of radiology and oncology, further public education and promote study and research through setting professional standards of practice.

  2.  This College is unique in that its specialties are regulated under criminal law in reference to staff and patient safety as part of IR(ME)R—Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006, which came under the responsibility of the Healthcare Commission on 1 November 2006. They published a report on their first 14 months of enforcing the regulations in March 2008[93]. This report can be found at the following weblink:

http://www.healthcarecommission.org.uk/_db/_documents/IRMER_14month_report.pdf

  3.  This response outlines the main risks to patient safety and the actions that could be taken to reduce harm in the College's specialty areas of clinical oncology and clinical radiology.

4.  CLINICAL ONCOLOGY

  This section outlines the main risks to patient safety from radiotherapy. It also suggests actions to minimise the risks.

4.1  Radiotherapy

  Radiotherapy is a highly complex, multi-step process that requires the input of many different staff groups in the planning and delivery of the treatment. Though errors are rare, when they do occur the consequences can be significant for the patient.

4.1.1  Towards Safer Radiotherapy

  Radiotherapy is generally safe; however, in any system errors are inevitable. By understanding why they occur, processes can be put in place to minimise their frequency and maximise detection before harm can be done. Earlier this year, the RCR, along with the Society and College of Radiographers (SCOR), Institute of Physics and Engineering in Medicine (IPEM), National Patient Safety Agency (NPSA) and British Institute of Radiology (BIR), published a report entitled Towards Safer Radiotherapy[94] which can be found at the following link: https://www.rcr.ac.uk/docs/oncology/pdf/Towards_saferRT_final.pdf

  The report provides a template list of possible radiotherapy errors (page 22) and outlines the contributory factors that are of particular importance in radiotherapy incidents. These include:

    —  Lack of training, competence or experience

    —  Fatigue and stress

    —  Poor design and documentation of procedures

    —  Over-reliance on automated procedures

    —  Poor communication and lack of teamworking

    —  Hierarchical departmental structure leading to a reluctance of junior members of the team to question senior staff

    —  Inadequate staffing and skills levels

    —  Poor working environment

    —  Changes in process.

  The report contains 37 recommendations which suggest ways of ensuring patient safety through improvements in:

    —  Departmental culture, resources and structure

    —  Working practices

    —  Safety management

    —  Patient and staff involvement

    —  Change management

    —  Quality assurance systems

    —  Recommendations for national implementation.

  A full summary of the recommendations can be found on pages 58-60 of the report.

4.1.2  Chief Medical Officer Reports

  Sir Liam Donaldson, Chief Medical Officer (CMO) for England, wrote the Foreword for Towards Safer Radiotherapy. In his last two Annual Reports[95],[96] he has also addressed the problem of radiotherapy safety. He highlighted three frequent causes of error:

    —  Unsafe transfer of data

    —  Lack of training in new technology

    —  Lack of an agreed process to pick up an error once it has occurred.

4.1.3  In vivo dosimetry radiation checks

  One of the CMO's recommendations for action in his 2006 Annual Report[97] was the routine use of in-vivo dosimetry radiation (IVD) checks. IVD is the direct measurement of individual patient dose. At present it is offered in about a third of UK radiotherapy centres. It is compulsory in some European countries.

  The RCR has actively supported the introduction of in vivo dosimetry through a joint statement with SCOR, IPEM and BIR entitled Implementing in vivo dosimetry[98] (http://www.rcr.ac.uk/docs/oncology/pdf/Invivo_joint.pdf). This recommends a phased introduction of in vivo dosimetry into forward plans for radiotherapy which cancer networks should be developing in response to the Cancer Reform Strategy. The capital and revenue implications and the cost of the impact on linear accelerator throughput and its potential effect on waiting times have recently been discussed in the British Journal of Radiology[99],[100] ,[101]).

4.1.4  Reporting and learning

  The need to improve patient safety in radiotherapy by learning from near misses, errors and incidents was raised in a commentary in the British Journal of Radiology in May 2007[102]. This emphasized the need to develop an open national reporting system for radiotherapy incidents, with effective processes in place for the analysis of reports and feedback of what has been learnt. A multidisciplinary group has since been set up, including representatives from the Healthcare Commission, National Patient Safety Agency and the Health Protection Agency and chaired by the RCR's Dean of the Faculty of Clinical Oncology, to address these issues. Unfortunately, because serious incidents are investigated under criminal law it is unusual for the full facts to come into the public domain: a retrospective analysis of incidents reported to the Department of Health (2000-6) is only now being undertaken by the National Confidential Enquiry into Patient Outcome and Death (NCEPOD). The publication by the Scottish Executive of the report into a recent case in Glasgow was exceptional[103] and has lead to widespread changes in practice.

  The Royal College of Radiologists would welcome the Health Committee's help in changing the culture of secrecy[104] so that lessons can be learnt more effectively from serious radiotherapy incidents as well as from near misses (which have no legal overlay).

5.  CLINICAL RADIOLOGY

  The specialty of clinical radiology encompasses both diagnostic and interventional radiology services. Although some areas of risk are common to all aspects of radiology, there are some which are specific to interventional radiology and these will be considered separately in section six.

5.1  Failure to achieve timely reporting and communication of imaging results

  High standards of patient care can only be achieved through timely reporting and communication of results. Across the UK, large numbers of radiographic images obtained for medical purposes never receive an expert interpretation and in many other instances, reporting is delayed. This poses a serious risk to patient safety. This is primarily due to a shortage of clinical radiologists.

  The RCR's document Standards for the Reporting and Interpretation of Imaging Investigations [105] recommends:

    —  Effective and timely communication of imaging reports.

    —  A reliable mechanism in place whereby the referring doctor can discuss the imaging findings in complex cases with the radiologist.

5.2  Lack of availability of appropriate imaging for emergency admissions and trauma

  The NCEPOD report on Emergency Admissions[106] published in 2007 recommended that hospitals which admit patients as an emergency must have access to both conventional radiology and CT scanning 24 hours a day, with immediate reporting. However, it found that 15.1% of Emergency Assessment Units in England, Wales and Northern Ireland that admitted patients as an emergency did not have access to CT scans 24 hours a day.

  The NCEPOD report on the severely injured patient, Trauma: Who Cares?[107], published in November 2007 states that CT scanning will have an increasing role in the investigation and management of trauma patients and therefore timely access to CT scanning, and reporting, is essential.

  The RCR recommends:

    —  Plain films, CT and ultrasound are required 24/7 in all acute hospitals, with timely reporting.

    —  MRI should be provided on an on call basis.

    —  CT scanners and angiographic facilities should be readily accessible from trauma resuscitation rooms. Transfer of seriously ill patients poses a hazard to them and emergency departments should therefore be modernised to incorporate comprehensive, modern radiological facilities.

5.3  Reporting errors

  Issuing of incorrect reports is a significant risk to patient safety. This will never be wholly avoidable but can be reduced by attention to several factors including:

    —  The availability of accurate and comprehensive clinical information at the time of reporting

    —  The availability of previous imaging studies for comparison

    —  The ability to enter into a dialogue with the requesting clinician in cases of doubt or difficulty

    —  The ability to access expert second opinions when required

    —  Many factors affecting the reporting environment including pressure of workload on the reporter.

  In addition the RCR believes that there must be a change of culture to allow continuous learning and discussion of mistakes. The RCR has encouraged the discussion of and learning from errors and incorrect reports in departmental discrepancy meetings as part of the development of a "no-blame" culture[108].

5.4  Risks associated with Teleradiology

  Teleradiology involves the reporting of radiographic images at a place remote from the site of their acquisition. This has many advantages in an emergency context and its introduction does help to reduce delays in the production of reports. However, in order to ensure patient safety and standards of care, it is important that the teleradiologist:

    —  Has access to full clinical information, previous images and results of other investigations such as blood tests

    —  Is available for electronic consultation with the referring clinician

    —  Is subject to the same UK medical regulation as all other medical disciplines.

  The first two conditions are very hard to achieve and it has been noted that for this reason a report issued by a teleradiologist can never reach the highest quality standards[109].

  It will be noted that plurality of provision in imaging providers and the lack of a fully integrated imaging service significantly increases the risk that the standards required to achieve the highest quality of image reporting will not be achieved.

5.5  Reports issued but not acted upon

  The National Patient Safety Agency's Safer Practice Notice 16[110] was published in 2007 following the receipt of 22 reports where the failure to follow up radiological imaging reports led to patient safety incidents, most of which involved fatalities or significant long-term harm. It included recommendations for action by the referrer, the radiology department and the individual reporting the study, and medical and nursing directors.

  Following this, the RCR produced the document: Standards for the communication of critical, urgent and unexpected significant radiological findings[111] in June 2008. This states that:

    —  Every department should define and develop policies for the communication of critical, urgent and unexpected significant findings as outlined by Safer Practice notice 16[112]. This will not replace the essential requirement for each referrer to be responsible for reading the result of every investigation they generate but should be aimed at providing a safety net for the highlighting of significant findings.

    —  The processes involved should be auditable, transparent and represent a clear trust policy.

    —  Trusts should provide the appropriate IT support and resource to achieve compliance with the safer practice notice.

5.6  Inappropriate imaging

  As mentioned above, radiologists (and others) have a statutory responsibility to minimise exposure of the population to the harmful affects of ionizing radiation.

  The RCR recommends:

    —  Use and adoption of the RCR referral guidelines Making the best use of clinical radiology services, 6th edition (2007)[113] http://www.rcr.ac.uk/content.aspx?PageID=995

    —  Implementation of the recommendations made by the Committee on Medical Aspects of Radiation in the Environment (COMARE) on the impact of personally initiated X-ray CT scanning for health assessment of asymptomatic individuals[114].

5.7  Adverse reactions to intravascular contrast media.

  Contrast agents—substances injected to enhance the quality of some radiographic images—carry a small risk of adverse reaction.

  The RCR recommends that:

    —  Facilities for the treatment of acute adverse reactions should be readily available[115].

    —  Resuscitation facilities should be available in all CT rooms.

6.  INTERVENTIONAL RADIOLOGY

  This section outlines the main risks to patients in interventional radiology and suggests actions to reduce the risk.

6.1  Patients who would benefit from minimally invasive interventional radiology procedures are subjected to major surgery instead

  Across a wide range of conditions, from major haemorrhage to uterine fibroids, patients who would benefit from minimally invasive "pinhole" techniques are being treated with major surgery under general anaesthesia because of a shortage of interventional radiologists and underdevelopment of interventional radiology services.

  The relatively recent development of Interventional Radiology (IR) has huge potential to increase patient safety and to conserve financial resources by replacing much conventional surgery with minimally invasive techniques. The RCR is in the process of publishing standards for the delivery of 24 hour interventional radiology but there are only a small number of hospital Trusts that can offer a full range of interventional procedures and very few that can offer a 24/7 service to emergency patients.

  The Healthcare Commission's investigation into ten maternal deaths at Northwick Park Hospital[116] highlighted the risks to patient safety of failure to provide an Interventional Radiology service and recognised the shortage of suitably trained interventional radiologists. One of the national recommendations arising from the investigation was the provision of an emergency interventional radiology service that is responsive to patients' needs wherever and whenever they arise.

  There are two main reasons for the underdevelopment of IR services:

    —  a shortage of interventional radiologists

    —  the current funding mechanisms for radiology.

  6.1.2  Interventional radiology has always been funded from radiology department budgets which are also required to support a comprehensive diagnostic imaging service. Given fixed resources, radiology departments have often been limited in their ability to develop interventional services to their full potential. Patients have therefore continued to be treated by traditional surgical techniques, albeit at higher risk and greater cost.

  This is not the case in countries where market forces influence health spending. In the USA, Australasia and many European countries, interventional radiology is a major source of income for hospitals. The introduction of Payment by Results (PBR) in 2002 was seen by radiologists and finance departments as a way of solving this financial problem and ensuring that patients could receive the best available treatment. However to date the Department of Health has been unable to link activity to a coding structure that has assigned realistic costs and at the time of writing this response there is no immediate prospect of unbundling interventional radiology activity. This is currently stifling the development of IR services and resulting in a great many patients receiving sub-optimal therapy.

  The RCR recommends:

    —  The identification of interventional radiology as a distinct service required to provide a 24/7 service in all acute hospitals.

    —  That the need for such a service should be given the same priority in acute Trusts as the need for an acute general surgical service.

    —  That IR should be funded in the same way as surgical services.

6.2  Patient identification errors

  Many risks in IR are similar to those of surgery: wrong patient, wrong leg etc. Adequate investment by hospital trusts in systems and staff is needed to ensure that such errors do not occur. The Royal College of Radiologists has issued Guidelines on Nursing Care in Interventional Radiology[117] but these have not been widely implemented.

6.3  Sedation

  A major advantage of interventional procedures over competing techniques is the avoidance of general anaesthesia with its attendant risks. However, the sedative agents used in IR all carry some risk and their use requires an appropriate level of monitoring care and support.

  This would be best addressed by the establishment of a body of specially trained ancillary staff, especially radiographers and nurses. These would form the equivalent of the staff trained to work in operating theatres. This would best be addressed jointly between the RCR, the Royal College of Nursing (RCN) and the Society and College of Radiographers (SCOR). A salary structure for such staff would be necessary to ensure adequate recruitment[118].

  The RCR recommends:

    —  Establishing a DH working party with participation from the RCR, SCOR and the RCN to review the requirements for appropriate training of nurses and radiographers in supporting IR procedures.

6.4  Introduction of new procedures

  Guidelines on the introduction of new procedures and techniques must be followed to the letter and The Royal College of Radiologists has worked hard to provide such guidelines and to encourage national registries and databases to monitor results There are currently 9 National Registries active (go to www.bsir.org)[119].

  The RCR recommends:

    —  That the National Institute for Health and Clinical Excellence (NICE) recognises the need to develop guidelines for imaging guided procedures that incorporate the requirement of core training in interventional radiology.

  Interventional radiology can treat many patients more safely and at lower cost than traditional surgery. We would encourage the Health Committee to recommend an in-depth review of the provision of these services with a view to establishing how the current obstacles to their provision can be replaced with appropriate incentives.

Professor Andy Adam

President

The Royal College of Radiologists

September 2008








93   Healthcare Commission. Ionising Radiation (Medical Exposure) Regulations 2000. A report on regulation activity from 1 November 2006 to 31 December 2007. London: Commission for Healthcare Audit and Inspection, 2008. Back

94   The Royal College of Radiologists, Society and College of Radiographers, Institute of Physics and Engineering in Medicine, National Patient Safety Agency, British Institute of Radiology. Towards Safer Radiotherapy. London: The Royal College of Radiologists, 2008. Back

95   Sir Liam Donaldson. On the state of public health: Annual report of the Chief Medical Officer 2006. London: Department of Health, 2007. Back

96   Sir Liam Donaldson. On the state of public health: Annual report of the Chief medial Officer 2007. London: Department of Health, 2008. Back

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98   The Royal College of Radiologists, Society and College of Radiographers, Institute of Physics and Engineering in Medicine, British Institute of Radiology. Implementing in vivo dosimetry. London: The Royal College of Radiologists, 2008. Back

99   Munro AJ. Hidden danger, obvious opportunity: error and risk in the management of cancer. (Commentary) Br J Radiol 2007; 80: 955-966. Back

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101   Williams MV, McKenzie A. Can we afford not to implement in vivo dosimetry? Br J Radiol 2008; 81: 681-4. Back

102   Williams MV. Improving patient safety in radiotherapy by learning from near misses, incidents and errors. (Commentary) Br J Radiol 2007; 80: 297-301. Back

103   Scottish Executive. Unintended overexposure of patient Lisa Norris during radiotherapy treatment at the Beatson Oncology Centre, Glasgow in January 2006. Report of the investigation by the Inspector appointed by Scottish Ministers for the Ionising Radiation (Medical Exposures) Regulations 2000. http://www.scotland.gov.uk/Resource/Doc/153082/0041158.pdf (last accessed 12.9.08) Back

104   Williams MV. Culture of secrecy must be tackled. BMJ 2007; 334: 381. Back

105   The Royal College of Radiologists. Standards for the reporting and interpretation of imaging investigations. London: The Royal College of Radiologists, 2006. Back

106   National Confidential Enquiry into Patient Outcome and Death. Emergency Admissions: A journey in the right direction? 2007 Back

107   National Confidential Enquiry into Patient Outcome and Death. Trauma: who cares? 2007 Back

108   The Royal College of Radiologists. Standards for the Radiology Discrepancy Meetings. London: The Royal College of Radiologists, 2007. Back

109   Boland GW. Teleradiolgy coming of age: winners and losers. Am J Roentgenol 2008; 190: 1161-1162. Back

110   National Patient Safety Agency. Safer practice notice 16. Early identification of failure to act on radiological imaging reports. London: NPSA, 2007. Back

111   The Royal College of Radiologists. Standards for the communication of critical, urgent and unexpected significant radiological findings. London: The Royal College of Radiologists, 2008. Back

112   National Patient Safety Agency. Safer practice notice 16. Early identification of failure to act on radiological imaging reports. London: NPSA, 2007. Back

113   The Royal College of Radiologists. Making the best use of clinical radiology services: referral guidelines. London: The Royal College of Radiologists, 2007 Back

114   Committee of Medical Aspects of Radiation in the Environment (COMARE). Twelfth Report. The impact of personally initiated X-ray computed tomography scanning for the health assessment of asymptomatic individuals. Health Protection Agency, 2007. Back

115   The Royal College of Radiologists. Standards for Iodinated Intravascular Contrast Agent Administration to Adult Patients. London: The Royal College of Radiologists, 2005. Back

116   Healthcare Commission. Investigation into 10 maternal deaths at, or following delivery at, Northwick Park Hospital, North West London Hospitals NHS Trust, between April 2002 and April 2005. London: Commission for Healthcare Audit and Inspection, 2006. Back

117   The Royal College of Radiologists and The Royal College of Nursing. Guidelines for Nursing Care in Interventional Radiology. London: The Royal College of Radiologists, 2006. Back

118   The Royal College of Radiologists and The Royal College of Nursing. Guidelines for Nursing Care in Interventional Radiology. London: The Royal College of Radiologists, 2006. Back

119   The Royal College of Radiologists. Advice from The Royal College of Radiologists concerning training for Carotid Artery Stenting (CAS). London: The Royal College of Radiologists, 2006 Back


 
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