Select Committee on Health Written Evidence

Memorandum by Brian Capstick (PS 17)



  1.  There is a need to focus the National Reporting and Learning System (NRLS) on the more serious untoward incidents, with a view to identifying the correctable causes of them and then making changes in the healthcare system that will deliver a more consistent standard of care.

  2.  The correctable causes of serious incidents comprise shortcomings in a relatively small number of processes, such as supervision, that have already been identified and should be hard coded into the classification systems of the NRLS and local incident reporting systems. Serious incidents could then be screened for the presence of these process failures so that the evidence accumulating in the NRLS and local systems could then point the way to feasible changes in the healthcare system. The relevant processes could then be continuously validated, monitored and, if necessary, adjusted at local and national level.

  3.  A major strength of the recommended approach is that the existing framework of standards could provide a mechanism for ensuring that appropriate process changes take place. Periodic inspections against the standards would then provide a means of audit and feedback. The NHS would then have a joined-up system of patient safety management that would yield many times the benefit of the existing arrangements at little extra cost.

  4.  Recommendations for action by the government include:-

    (a)  policy should aim to achieve a consistent standard of care that can be relied upon not to cause serious harm to patients

    (b)  determined action should be taken to improve maternity care in such a way as to reduce the number of children born with birth-related cerebral palsy.

    (c)  messages should move away from the emphasis on clinical error and towards the improvement of processes that would assist clinicians in their work

    (d)  public and staff should be reassured that most NHS care is good care

    (e)  the NRLS should focus on the more serious incidents

    (f)  there should be a list of, say, a dozen or so sentinel events that all Trusts should record, including maternal death and intrapartum-related hypoxic injury

    (g)  serious incidents should be screened for the more common correctable causes of these events, which should be hard-coded into the NRLS.

    (h)  an improved taxonomy is required for the NRLS and policymakers should ensure that it is developed in conjunction with local incident reporting systems, in particular the Datix Common Classification System.

    (i)  the NHS should learn from private providers in the measurement and analysis of indicators and outcomes to improve patient safety.


  5.  My experience of patient safety began in the early 1980s when I founded a law firm which defended NHS hospitals against about 10% of the clinical negligence claims brought in England at that time. I became concerned about the number of incidents that gave rise to serious injury, especially in maternity care, and began to investigate the causes of them. In 1986, I founded a software company, Datix, that now supplies incident reporting software to healthcare providers serving a population of about sixty million people. This includes most of the NHS Trusts in the United Kingdom, large parts of Canada and, soon, the Military Health System in the USA. I have researched several aspects of patient safety and published the results in the peer-reviewed, academic press.

  6.  I declare interests as a non-executive director of Datix Ltd and of the NHS Litigation Authority.

1.  What are the risks to patient safety?

  7.  The risk to patient safety is of lapses in the standard of care that are liable to cause injury. A high proportion of the risks that cause serious injury come from a fairly small area that can be defined and improved. In the majority of cases, the injury is not caused directly by the doctor in the form of wrong site surgery, retained foreign objects and so on, but is caused by the disease after an avoidable failure to recognize or act on the severity of the patient's condition. Some of the process failures that are apt to cause serious injury are identified in Paras 15-16.

To what extent are the risks to patient safety avoidable?

  8.  Risks to patient safety can be reduced but probably not eliminated. Lapses in the standard of care occur as the result of human error and weak systems for the delivery of care. "Pure" human error that is not compounded by any discernible system error is difficult to reduce other than by training, except in the case of serial offenders who should be removed from the front line. However, there are a number of processes whose shortcomings create enlarged spaces for human error. Supervision is an example of such a process which is familiar to most people. A proportion of the risks to patient safety may be reduced by the improvement of these processes.

  9.  The potentially correctable causes of patient safety incidents have been narrowed down to a list of usual suspects and patient safety policy should move quickly towards validating, assessing and rectifying them. They include the processes referred to in Paras 15-16 below and in the article that accompanies this paper.

The definition of avoidable risk

  10.  A risk is avoidable if it can be mitigated or removed by delivering a standard of care that is acceptable to the community at large. The aim should be to provide a consistent standard of care that seldom or never fails in such a way as to cause serious injury.

Public perceptions

  11.  The extent of the patient safety problem is that the NPSA receives reports of about 25,000 serious patient safety incidents a year. The NHS Litigation Authority receives about 5,000 clinical negligence claims a year, of which about half cannot be successfully defended. Most claims in excess of one million pounds are brought by or on behalf of children with birth-related cerebral palsy and prompt action should be taken to end this state of affairs, each of which represents a tragedy for the family concerned.

  12.  While these are sizeable numbers, they do not amount to a pandemic of poor treatment except, possibly, in the case of maternity care and the public, including those who work in the Service, should be reassured that the NHS continues to provide a preponderance of good care and conscientious clinical practice. Scare stories which over-emphasize the scale of the problem undermine morale and are not helpful in winning the support of clinicians.

  13.  The task of eliminating process failures that are apt to have serious consequences should be driven by NHS leaders with the support of the public and NHS staff.

What is the role of human error?

  14.  In 2006 I carried out a study to assess the extent to which human error was responsible for the incidents serious enough to give rise to litigation claims and found that human error was the proximate cause of 97% of them. This is not surprising when one considers that, on the whole, healthcare is delivered by human beings and it is their errors which compromise the safety of patients. However, there are numerous systems whose shortcomings create enlarged spaces for human error and there was evidence of such system shortcomings in 50% of the cases in our study.

Systems failures

  15.  The focus of patient safety should be on improving weaknesses in the processes which are apt to cause serious harm to patients when they fail. In an article published in 2004 which accompanies this submission,[131] I identified about two dozen processes which are apt to cause serious injury to patients when they fail. Other commentators such as Professor Vincent and Professor Arulkumaran have since produced comparable lists and there seems to be a broad consensus about where the problems are thought to lie.

  16.  For the purpose of illustration, the relevant process failures include:-

    —  delays in making a primary diagnosis of a relatively small number of conditions or in recognizing the severity of the patient's condition generally

    —  the omission to act on adverse results

    —  the lack of an adequate management plan for high risk cases that have been identified

    —  the omission to allocate known high-risk cases to a reliable pathway or person

    —  allowing or encouraging clinicians to work outside or beyond their skill set;

    —  the unavailability of skilled supervision, guidelines or protocols;

    —  shortcomings in clinical leadership

    —  shortcomings in the recruitment or induction processes and

    —  deficiencies in educating the patient to deal with his or her own condition.

  17.  It is possible incorporate such a list in an incident reporting system and so produce a powerful analytical tool. Datix has largely completed this work (the "Datix matrix") and recommends using it in the manner described below.

2.   Incident reporting

  18.  The NPSA deserves recognition for the success in IT terms of the National Reporting and Learning System, the NRLS. It has succeeded where so many other healthcare-related IT projects have disappointed. The NRLS provides a reliable means of collecting data locally and relaying it to a central system that spans the entire NHS. However, the NRLS has historically achieved more in the direction of Reporting than it has in Learning and it is now time to redress the balance.

Whether adequate assessment is undertaken and acted upon

  19.  The NRLS would benefit from a more comprehensive classification system. In particular, the taxonomy needs to identify and codify the causes of serious adverse clinical events in such a way that the data accumulating in the NRLS point the way to feasible improvements in the healthcare system. These "correctable causes" are likely to be the process failures referred to in Paras 15-17 and should not just be broad descriptions of general factors such as "communication" or "training". The lack of a classification system that functions in this way has made it difficult for greater learning to be gleaned from the NRLS.

  20.  Amongst the possible sources for a revised classification system are the WHO's International Classification for Patient Safety (ICPS), the "Common Formats" being produced by a federal agency of the United States government, the Agency for Healthcare Research and Quality or AHRQ, the Datix Common Classification System or CCS and the NRLS itself.

  21.  The Datix CCS is probably the most widely used of these alternatives at this time and is probably also the most comprehensive, although it is mapped back to the NRLS. The CCS is currently being revised under the aegis of Project Linnaeus ( ) to take into account some elements of the WHO's and the AHRQ's taxonomies. Linnaeus combines the existing CCS with contributions from many eminent people and sources. Apart from Datix itself, the main participants in Linnaeus are from Scandinavia, the USA and Canada. The NPSA has been invited to participate but has not yet responded at the time of writing in mid September 2008.

  22.  Linnaeus is aimed at producing a classification system designed to be embedded in a computer software program and is expected to produce the world's most comprehensive and usable classification system for adverse events in healthcare. Policymakers should ensure that there is a process to ensure that the NRLS and the Datix taxonomies develop in conjunction with each other. Otherwise, there will be a wasteful duplication of effort in creating two systems and then of mapping the NRLS and the CCS to each other.

A focus on the more serious events

  23.  In addition to the development of its classification system, the NRLS should begin to focus on the 25,000 or so more serious untoward incidents or SUIs that occur each year. In the past, the NRLS has functioned as a system to notify the NPSA of large numbers of patient safety incidents with a relatively light amount of data about each one. The next step might be to retain a notification system for the less serious events while collecting a greater amount of data on the more serious incidents. The additional data that needs to be collected in relation to the more serious events includes a consistent set of data about their causes coded in a way that could be aggregated for large numbers of cases. The causes that need to be codified include the correctable causes referred to in Paras 15 and 16.

  24.  Another element of the taxonomy which would benefit from development and, following a process of consultation, endorsement by the NPSA would be a defined list of SUIs or "sentinel" events. A list of sentinel events is to be preferred to a formula that will be interpreted differently from one region to another and should include deaths resulting from the wrong route for the administration of medication, wrong-site surgery, maternal death and moderate or severe intrapartum-related hypoxic injury.

  25.  The intrapartum-related hypoxic injury group is important because about half the surviving infants will show signs of neurological impairment, including cerebral palsy in about one sixth of cases. Besides being an ongoing tragedy for the family, the cerebral palsy group is the source of most clinical negligence claims above one million pounds against the NHS. Intrapartum-related hypoxic injury is evidenced by stillbirths, early neonatal deaths and the syndrome of moderate or severe HIE (hypoxic ischaemic encephalopathy) in newborns. The incidence of stillbirth and early neonatal death is about 8 per thousand births and of moderate or severe HIE about 1.5 per 1,000.

  26.  When sentinel events or SUIs occur, they should be the subject of a consistent analysis aimed at screening for a defined list of contributory factors. A consistent list of pre-defined causal factors is already embedded in the CCS. If causal factors were consistently recorded, the data could then be aggregated for large numbers of cases in such a way as to reveal the frequency of the various factors which, in turn, would point the way to the possible nature and impact of the measures required to mitigate them. Conversely, if little effort is made to standardize the classification of causes, it is more difficult and perhaps impossible to discern common themes in large numbers of cases and correspondingly difficult to learn lessons from a database of adverse events.

  27.  In common with several other experts in this field, I would suggest a review of the benefits of root cause analysis (RCA) as it is currently applied in the NHS. One fundamental problem is that RCA does not provide sufficient consistency in the identification of causes for them to be automatically processed in a database. Another problem is that it is too time-consuming an approach to apply consistently well to large numbers of cases. Policymakers should consider a move away from large-scale RCA and towards the application of a simple screening test as described here.

Impact of the changing public-private mix in provision

  28.  Choose and Book and the Extended Choice Network have increased the importance of the role of private providers in the NHS. To qualify for inclusion in the Extended Choice Network, private providers must meet certain standards in risk management and patient safety. To assist with compliance, a number of large private providers have used Datix software to evidence improvements in care brought about by learning from patient safety incidents.

  29.  Some of the larger private providers use the data they collect in Datix on clinical and patient safety indicators and variances from care pathways to measure the quality of outcomes by hospital, procedure and clinician. Lessons learned from the analysis of this data have a tangible impact on improving clinical outcomes, one of the areas targeted by Lord Darzi in High Quality Care for All. The measurement and analysis of indicators and outcomes to improve patient safety are processes where the NHS could learn from the work done by private providers.

Whether past spending on patient safety has been sufficient

  30.  Past spending by definition has been enough to get us to the point where we are. Future spending should focus on enhancing the benefits of the existing infrastructure and should try to avoid the proliferation of too many initiatives. There is a need for improved leadership in patient safety and a greater sense of direction, but these may not be supplied by more money. Once policy has been settled, it is essential that Trusts are given adequate resources to ensure that patient safety is properly implemented.

Effectiveness of national bodies

  31.  The inquiry invites comments on the current effectiveness of national bodies. It seems to me that the NPSA under its current management team is likely to be effective in delivering the benefits expected of the NRLS, provided government policy is aimed in the right direction.

  32.  The NHS Litigation Authority seems to me to have done a good job since its inception. It defends claims against the NHS professionally and expeditiously and has developed useful and well-regarded risk management standards. More recently, is has begun to initiate various programmes to learn lessons about patient safety from the claims experience.

  33.  Other health service bodies are aware of the importance of patient safety but would benefit from guidance about what an effective patient safety programme entails.

  34.  Education for health professionals should include modules in patient safety management, emphasizing the process failures that have been identified as most frequently implicated in serious incidents. The RCOG already does this.

3.   Next steps

  35.  The emphasis should be on delivering a consistent standard of care that seldom, if ever, fails in such a way as to cause serious injury to patients. Evidence of benefit for this or that method would have to be a matter of comparing Trusts with good records with those with bad records. However, the process improvements advocated here are those that any organization of a comparable size should carry out as a matter of course.

  36.  Best practice is for clinicians to determine. The only comment that might be appropriate to make here is to point out that best practice is not necessarily in the domain of patient safety. Patient safety is about ensuring the delivery of a consistent quality of care that can be relied upon not to fall below an acceptable standard. It is not hard to see how the aim of delivering a consistent standard of care could become a popular national policy that the public has a right to expect.

  37.  The inquiry invites comments about how to ensure that learning is implemented. A major strength of the recommended approach is that there is an existing framework of standards that could be used to ensure that effective processes are devised, implemented and audited.

  38.  As a minimum, serious untoward incidents or sentinel events should be measured and assessed for the presence of correctable causes, as set out above. Data relating to the number, type and causes of events on the sentinel list should be published.

  39.  The main incentive for improving patient safety should be to create a consistent standard of care that does not let the patient down. NHS staff, patients and the taxpayer have a right to expect policymakers, management and clinicians to pursue this aim without further incentive. This is what most of them are motivated to do and, if given the right leadership, will do without the imposition of targets or intrusive supervision. In an increasingly competitive world, there are also commercial benefits to be gained by a provider that can supply a reliable standard of care. In our experience, private providers of healthcare are very conscious of this.

September 2008


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