Rapid Responses to:

EDITORIALS:
Liam Donaldson
Reducing harm from radiotherapy
BMJ 2007; 334: 272 [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Safety issues caused by lack of government leadership
Richard Evans   (14 February 2007)
[Read Rapid Response] Human error is,indeed, inevitable
Jonathan J Nicoll, Paul Barker   (14 February 2007)
[Read Rapid Response] Radiotherapy Service Delivery is a national rather than local issue, and should be funded centrally
Bruce Sizer, Philip Murray, Alan Lamont   (14 February 2007)
[Read Rapid Response] Reducing Harm from Radiotherapy
Michael V Williams   (15 February 2007)
[Read Rapid Response] Adequate in-vivo dosimetry would prevent most accidental exposures
Katharine Tylko, Mitzi Blennerhassett   (20 February 2007)
[Read Rapid Response] Advanced 3-dimensional dosimtery could be the answer?
Mark Godber, G. P. Liney, J. W. Goodby   (21 February 2007)

Safety issues caused by lack of government leadership 14 February 2007
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Richard Evans,
Chief Executive Officer
Society & College of Radiographers, 207 Providence Square

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Re: Safety issues caused by lack of government leadership

Radiographers throughout the UK will have been pleased to read Sir Liam Donaldson’s editorial on safety in radiotherapy. The Society and College of Radiographers supports the need for appropriate training and to put safety at the core of therapy delivery. The dedication and hard work of staff involved in radiotherapy masks the inescapable fact that we have a service in crisis featuring unacceptably long waiting times.

Sir Liam states: "An organisational culture that promotes safety has distinct and consistent characteristics. These include effective organisational leadership, well designed systems and processes of care,and competent health staff. Such characteristics are vital for ensuring the safety of patients."

If the government committed to appropriate investment, radiographers and other members of the front-line multidisciplinary radiotherapy team could deliver all of Sir Liam's wishes. The reality is that we have outdated equipment, lack of sufficient workforce to implement new technologies, under-investment in post graduate training opportunities, and an inequitable service that varies from county-to-county across the UK. Radiographers are delivering the best service they possibly can under enormous pressure.

The reality of the argument Sir Liam presents, and which he fails to acknowledge, is that in the incidents he cites errors were due to two primary causes. In Leeds, the issue was inadequate staffing levels resulting in a chaotic working environment, a scenario ripe for errors. In Glasgow and North Staffordshire, the issue was ineffective management of the introduction of new technology. The latter two incidents can be attributed to a failure to consider the implications of change and how they might impact on all staff groups.

Radiographers and other radiotherapy staff demonstrate daily their commitment to patient safety and excellence in standards of care. The government’s stated pledge to develop world-class cancer services in the UK has, in the past, offered some hope that staff commitment would be supported by adequate leadership and resource. The work of the Department of Health National Radiotherapy Advisory Group was a beacon of hope but this has all but been extinguished because the group's report is not likely to be published until the end of this year. Meanwhile, the pressures on an already overstretched service continue to grow.

It is time for the government to go further than lip service to improving radiotherapy provision. Service improvements and, ultimately, the safety systems we all want to see in place are being prevented by indecision and a leadership vacuum from the centre.

Competing interests: None declared

Human error is,indeed, inevitable 14 February 2007
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Jonathan J Nicoll,
Consultant Clinical Oncologist
Cumberland Infirmary CA2 7HY,
Paul Barker

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Re: Human error is,indeed, inevitable

Professor Donaldson states in his article that "..human error is inevitable.." and the half page devoted to corrections in the current issue would appear to support this. Unfortunately Professor Donaldson's own article appears itself to contain an error in relation to the 2006 overexposure incident at the Beatson Oncology Centre. He states that "..it was not realised that a manual calculation needed to be applied.." when , in fact, the error was that a manual calculation was applied which shouldn't have been . This is made clear in the Scottish Executive's report on the incident. A small difference, perhaps, but the sort of small error which may have large consequences.

Competing interests: None declared

Radiotherapy Service Delivery is a national rather than local issue, and should be funded centrally 14 February 2007
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Bruce Sizer,
Consultant in Clinical Oncology
Essex County Hospital, Colchester CO3 3HY,
Philip Murray, Alan Lamont

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Re: Radiotherapy Service Delivery is a national rather than local issue, and should be funded centrally

The commissioned, but not externally peer – reviewed, editorial by Donaldson (1) might have been more fairly summarised in the new redesigned BMJ ‘The Week in Quotes’ section as “Millions of radiation treatments delivered safely, thousands of cancer patients cured, but errors occur occasionally”.

Whilst any mistake in treatment planning is keenly felt by those involved, Donaldson does a considerable disservice to the work of the multidisciplinary members of radiotherapy departments, including radiographers and physicists, and misleads the more general readership of the BMJ, in implying that these errors are not being actively addressed.

Furthermore, whilst no one would disagree with the three challenges which he identifies, two of the them, namely “to prevent harm to patients” and “to put safety at the core of healthcare delivery” are hardly specific to radiotherapy.

Unlike Donaldson, we do not believe that “analysing information from all major radiotherapy incidents worldwide” is likely to be worthwhile and certainly the resources required to do this would be better spent on funding those ‘common causes’ already identified by work done in the UK, one of which is adequate staffing.

Following the tragic incident at the Beatson Oncology Centre, Glasgow, every department in the UK was asked to evaluate their service in the light of the report (2). Fourteen separate action points were identified by our team, the first and most significant of which is chronic understaffing in the treatment planning section. We noted that even though processes are robust, most of the checking procedures are manual, and rely on staff working efficiently at a reasonable work rate; indeed we compare unfavourably with the Beatson in terms of staff (especially Physicists) / Linear Accelerators / patient ratios. This also correlates with our Cancer Services Peer Review Report (2006) which highlighted understaffing ‘in all areas’. This is likely to be the case elsewhere.

There are, undoubtedly, process flaws, but they lie less in the processes and standard operating procedures staff use in radiation treatment, and more in the processes involved to secure the funding to redress deficiencies. Most departments in the UK are DGH - based, and any bids for service improvements are considered in direct competition against other services, in an atmosphere of 2 week cancer waits, and other ‘must do’ performance targets (some of which have associated financial incentives).

No one would disagree that this is a clinical governance issue, but whilst the ultimate accountability for clinical governance sits with provider organisations, the performance management sits with commissioners. However, in the 12 months since our last submission for increased resources in radiotherapy was made, we have become part of a new Cancer Network, the 5 main PCTs whose patients we treated no longer exist, and nor does the SHA. To whom, therefore, should we be putting forward our business cases ? And what are their funding decisions likely to be in these financially – challenged times ?

Glasgow is a wake up call, not only for individual departments but for the NHS as a whole : this is a national issue not a local one. The continuing cancer reform strategy recently outlined by the National Cancer Director should recognise this and allocate central funding to improve radiotherapy service provision.

References 1 Donaldson L. Reducing harm from radiotherapy. BMJ 2007;334:272 2. ‘Unintended overexposure of patient Lisa Norris during radiotherapy treatment at the Beatson Oncology Centre, Glasgow in January 2006’. Report of an Investigation for IR(ME)R.

Competing interests: None declared

Reducing Harm from Radiotherapy 15 February 2007
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Michael V Williams,
Dean
Faculty of Clinical Oncology, The Royal College of Radiologists, 38, Portland Place, London W1B 1JQ

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Re: Reducing Harm from Radiotherapy

The Royal College of Radiologists welcomes the Chief Medical Officer’s editorial on reducing harm from radiotherapy. He highlights the fact that 4.25 million doses of radiotherapy are administered across the UK for cancer treatment each year (1). In the five years to April 2006 only 211 incidents of a dose greater than intended were reported under the IR(ME)R regulations (2). Many of these were correctable by adjusting subsequent treatment. Patient injury is a rare event; this is as it should be for a non-emergency treatment given routinely to patients with an established diagnosis.

Previous work on radiotherapy incidents occurring worldwide has led to the conclusion that departments should have a quality assurance system and also a programme of in vivo dosimetry (3, 4). United Kingdom departments are compliant with these two measures and routinely review near misses, incidents and errors. This provides a secure basis for continuous improvement.

The World Health Organisation aims to determine whether a set of standardised safety interventions can be developed to reduce the risk of harm to patients. The fine detail of working practices is critical: the enquiry into the Leeds incident showed that although staff followed checking procedures, interruptions and the pressures of overwork lead to a state of automaticity which made the procedure valueless and led to patient injury (5).

The WHO will also ask whether lessons from radiotherapy errors can be quickly acted upon and translated into international learning with resultant safer health care. This is the equivalent of the “orange wire test” whereby a safety incident results in a rapid world-wide response as in aviation [6]. Achieving this objective will depend on developing an open reporting culture which is presently lacking in England. Incidents identified within individual departments are reported within quality assurance systems and are reviewed on a regular basis. In addition the reports are forwarded to the National Patient Safety Agency (NPSA) through Trust risk management systems. Unfortunately, there has been no feedback or learning from the data which have been collected.

In June 2006 The Royal College of Radiologists set up a multidisciplinary working party to identify measures to prevent and mitigate errors in radiotherapy. One of the main obstacles to this work is the culture of secrecy surrounding radiotherapy incidents. Quality improvement experts have said that every system is perfectly designed to produce the results that it delivers. The system for reporting radiotherapy incidents in the UK is dysfunctional: the results of enquiries are secret; there is no dissemination of learning; errors are repeated; and public confidence is corroded (1). Most of the incidents reported under the IR(ME) regulations remain confidential and can only be identified under the Freedom of Information Act (2). The full report of the inquiry into the Leeds incident has still not been published despite the fact that it contains a number of recommendations for practice nationally. Open publication, as in the Glasgow incident, is the exception but should be the rule. This could be facilitated by establishing a web site to host anonymised reports of enquiries. At the very least, a confidential system to disseminate learning on the NCEPOD model should be established. This would involve collaboration between the National Patient Safety Agency, the Health Protection Agency and the Healthcare Commission. Change in the UK is essential if we are to improve our learning from errors. The Royal College of Radiologists welcomes support of the Chief Medical Officer in taking further steps to improve the safety of radiotherapy.

1. Donaldson L. Reducing harm from radiotherapy. BMJ 2007;334:272

2. Sunday Times. Over 200 hurt or killed by botched radiation. 30th April 2006

3. IAEA Report. International Atomic Energy Agency. Lesson learned from accidental exposures in radiotherapy. Safety reports series number 17, Vienna, International Atomic Energy Agency, 2000.

4. ICRP Report. International Commission on Radiological Protection. Prevention of accidental exposures to patients undergoing radiation therapy. ICRP publication 86. Ed. J Valentin. Elsevier Science Limited, Oxford, 2001

5. Toft B, Mascie-Taylor H. Involuntary automaticity: a work system induced risk to safe healthcare. Health Serv Manage Res 2005; 18: 211-216. http://www.who.int/patientsafety/information_centre/Automaticity_Patient_Safety_Summit.pdf

6. Donaldson L. When will health care pass the orange-wire test? Lancet 2004; 364: 1567-8.

Competing interests: None declared

Adequate in-vivo dosimetry would prevent most accidental exposures 20 February 2007
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Katharine Tylko,
Former radiotherapy patient
Bath BA2 3AB,
Mitzi Blennerhassett

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Re: Adequate in-vivo dosimetry would prevent most accidental exposures

As two former patients campaigning for ring-fenced government funds for radiotherapy safety we are delighted that the Chief Medical Officer's editorial has prompted an open debate, and that the Royal College of Radiologists is vigorously promoting an open incident-reporting culture. (1)

The truth about seriously compromised NHS radiotherapy safety can no longer be successfully buried by individual Hospital Trusts.

We were treated by highly trained and dedicated radiotherapy professionals working according to strict quality assurance protocols but under immense pressure to move on to save the next life. Due to chronic understaffing and under-resourcing, both of us experienced delays in starting radiotherapy. For one, treatment ran smoothly, according to plan with a review by a clinical oncologist twice a week. The other experienced frequent breakdown of ailing linear accelerators, total confusion about who was monitoring side-effects and no appointment with a clinical oncologist during treatment. Definitely a 'scenario ripe for errors', which in fact resulted in two 'near misses'.

Sir Liam states, "Organisations need to have robust mechanisms for detecting errors quickly to ensure that patients are not harmed."

He mentions the WHO World Alliance for Patient Safety's new radiotherapy safety project which asks "whether a set of standardised safety interventions (...) can be developed to reduce harm to patients." (2)

In a rapid response, Michael Williams of the Royal College of Radiologists provides an excellent quick-win solution by referring to the International Commission on Radiological Protection's report 'Prevention of accidental exposures to patients undergoing radiation therapy'. This report states plainly: "Adequate in-vivo dosimetry will prevent most accidental exposures." (3). In-vivo dosimetry (IVD) would indeed have prevented all three high-profile accidents to which Sir Liam refers.

As concerned patients, we regard IVD as a vital safety-net, particularly necessary in the over-stressed and increasingly complex NHS radiotherapy service. IVD is a means of checking radiation doses from individual beams given to patients on or around their first treatment fraction. This can be done cheaply and quickly with radiation detectors called diodes which are placed on a patient's skin in the radiation beam and then 'read out' after the beams have been given. The patient is protected from dose errors being repeated in subsequent fractions. IVD is an objective check at the output stage. It is able to weed out errors that may have crept in due to mis-communciations between the many different staff involved in producing and delivering a treatment plan.

The International Atomic Energy Agency considers in-vivo dosimetry to be "an essential part of the quality assurance programme of the radiotherapy department."(4) Although standard in parts of Europe, routine IVD is not yet mandatory in NHS radiotherapy departments, despite years of campaigning by eminent UK physicists, clinical oncologists and radiographers. Ironically, every single NHS radiotherapy centre possesses the technology to perform IVD ... but the vast majority only use it in special cases, e.g. total body irradiation, or where a treatment plan has been altered. We argue that every patient is a 'special case' and should be protected with this common-sense procedure. Unfortunately, the three incidents that Sir Liam describes were judged not to be special cases.

Given the dangerously overstretched NHS radiotherapy service, surely it is prudent to use all safety nets available rather than shut them away in boxes? It would be tragic if the government took as long thinking about making IVD routinely mandatory as happened with the mandatory use of seat-belts in cars.

We urge the DH to ring-fence funding for mandatory, routine IVD in all NHS radiotherapy centres NOW!"

Katharine Tylko,

Mitzi Blennerhassett

References

(1) Williams M. Rapid Response to Reducing harm from radiotherapy BMJ 2007; 334:272

(2) www.who.int/patientsafety/activities/technical/radiotherapy/en/print.html

(3) ICRP publication 86, ed. J.Valentin. Elsevier Science Limited, Oxford, 2001

(4) www-naweb.iaea.org/nahu/dmrp See E2.40.14 Development of procedures for in vivo dosimetry in radiotherapy

Competing interests: None declared

Advanced 3-dimensional dosimtery could be the answer? 21 February 2007
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Mark Godber,
Research Fellow
University of York, Chemistry Department, YO10 5DD,
G. P. Liney, J. W. Goodby

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Re: Advanced 3-dimensional dosimtery could be the answer?

There is a definite need to improve patient safety in radiotherapy treatments, and if possible, tie this in with improved treatments and cure rates. As more advanced radiotherapy treatments are available, conventional methods of dose verification (ionisation chambers, films) are no longer practical for use with highly conformal delivery methods.

A true 3-dimensional (3-D) dosimeter, with excellent dose and spatial accuracy can give the consultant and more importantly the patient full peace of mind in the treatment they are giving/receiving. The beauty of such a dosimeter is that it can be used as a ‘phantom patient’ and therefore any radiotherapy plan can be validated prior to the real patient receiving any radiotherapy treatment. The dosimeter can image the complete patient plan, unlike ionisation chambers and diodes, not only accurately measuring dose but also spatial resolution.

As well as providing true 3-D patient quality assurance (QA) it is possible to use the dosimeter as a training and commissioning tool, allowing new users to learn effectively and new methods to be properly assessed before being implemented.

Such a dosimeter is being developed at the University of York, in collaboration with the University of Hull and Hull and East Yorkshire NHS Trust. The dosimeter is being trialled at some of the leading UK radiotherapy centres and will hopefully be available commercially in the near future, offering a cheap, quick and reliable method of full radiotherapy plan validation.

Competing interests: A company, Imagel Ltd, has been set up to try and commercialise the technology described. The company is a spin-out from University of York, University of Hull and Hull and East Yorkshire NHS Trust.