Select Committee on Health Written Evidence


Memorandum by the Medical Protection Society (MPS) (PS 09)

PATIENT SAFETY

EXECUTIVE SUMMARY

  The underlying cause of the majority of adverse incidents in medicine is either systems failure, or a combination of systems failure and individual error. Only a minority of adverse incidents are solely caused by individual failure or poor clinical judgment. Our experience is that a significant proportion of adverse incidents are avoidable.

  Changes to the organisation and delivery of primary care services have brought new patient safety risks. An example can be seen in current out-of-hours (OOH) services. MPS is the largest indemnifier of OOH providers, and a review of complaints relating to OOH services indicated that wrong or delay in diagnosis was the most common cause of dissatisfaction with OOH services.

  The wide variety of commissioners and suppliers of OOH services means that it is difficult to apply common standards. Primary care organisations should ensure that the OOH services they commission are underpinned by robust corporate and clinical governance systems. We suggest that all OOH providers should be required to undertake regular independent risk assessments and implement comprehensive training and induction programmes. We would like to see more research carried out into the root cause of complaints relating to OOH care.

  Elsewhere in primary care, it is our view that there are barriers to incident reporting and learning lessons. Fifty-six per cent of practices involved in Clinical Risk Self-Assessments carried out by MPS had no formal system for reporting adverse incidents or near misses.

  There are practical and operational barriers to incident reporting. For example, there is no national minimum standard for significant event audits or incident reporting. Until recently, the method for incident reporting (the NRLS eForm) was heavily geared towards secondary care. Many general practices simply do not know what to report or to whom. This is compounded by the arbitrary use of different terminology to describe "adverse incidents". Incident reporting in primary care must be improved through a simple and consistent framework across primary care.

  These practical barriers are compounded by cultural barriers to reporting adverse incidents that centre around the very real fear that disclosing an adverse incident will lead to disciplinary or regulatory sanction and multiple jeopardy. It is our view that unjustified and/or mishandled disciplinary action against medical practitioners by trusts has significantly contributed to the culture of blame in the NHS, which is not conducive to improving patient safety. We are seriously concerned that proposed changes in the regulatory system, particularly "recorded concerns", will undermine the principle of open disclosure about adverse incidents and adversely affect patient safety.

  There are many bodies both within and outside the NHS that have an important role to play in improving patient safety and disseminating good practice. The NPSA clearly has a key role to play and we recognise that it faces a difficult task within a complex environment. We would like to see greater level of engagement by the NPSA with general practice, which currently only accounts for 0.3 per cent of all incidents reported to the NPSA[81].

  We would support a greater emphasis on patient safety and risk management in the medical undergraduate and postgraduate curricula—currently there is no requirement for it to be covered. We would also like to see mandatory, consistent and comprehensive induction programmes for every healthcare professional each time they start work in a new hospital.

  There is general agreement that interventions aiming to reduce adverse incidents improve patient safety. However, there is very little evidence supporting this, and we would encourage government-funded research into the effectiveness and financial impact of interventions.

KEY RECOMMENDATIONS

    1. A simple and consistent incident reporting framework should be established across primary care, encompassing all adverse incidents and near misses.

    2. All OOH providers should undergo regular independent and comprehensive risk assessments to identify and reduce organisational and operational risks. A greater focus should be given to the provision of OOH care, including a reassessment of national standards. All OOH complaints and clinical negligence claims should be reviewed so that lessons can be identified and disseminated.

    3. A formal collaborative framework of bodies with interests central to patient safety should be established. This structure would act as a repository for lessons learned and from which best practice could be disseminated.

    4. National research should be commissioned to examine to what extent risk management interventions are successful and cost effective in reducing the impact of adverse incidents.

    5. Patient safety and risk management should be embedded within the undergraduate and postgraduate curricula. Hospital induction programmes should be mandatory for all new healthcare staff. They should be consistent and comprehensive in content and quality and should include training in clinical governance and risk management.

INTRODUCTION

  1.  The Medical Protection Society (MPS) is the leading provider of comprehensive professional indemnity and expert advice to more than 250,000 doctors, dentists and other health professionals around the world. We have over 100 years' experience of the medicolegal environment and operate in 40 countries around the world. This gives us a unique perspective on patient safety. In the United Kingdom our membership consists of around half of all doctors and three quarters of all dentists.

  2.  As a mutual, not-for-profit organisation we offer members help, on a discretionary basis, with legal and ethical problems that arise from their professional practice. This includes clinical negligence claims, complaints, medical council inquiries, legal and ethical dilemmas, disciplinary procedures, inquests and fatal accident inquiries. In the last five years we have dealt with around 11,000 clinical negligence claims and pre-claims; 18,600 complaints; 1,680 inquests; 3,700 medical and dental council inquiries and 850 disciplinary hearings in the UK alone. We offer a medicolegal advice line, with 24-hour access for emergencies, to support members in resolving dilemmas and promoting good practice. In 2007, we received 19,000 calls—a breakdown of reasons for calls is shown in Appendix 1.

  3.  We are best known for representing, indemnifying and helping healthcare professionals respond to challenges to their professional practice but this is only one element of our work. Patient safety has always been intrinsic to MPS and one of our strategic objectives is to help members through education to prevent avoidable harm to patients. This means that we actively seek ways of preventing adverse incidents from occurring. We offer comprehensive education and risk management programmes, including lectures at medical schools, hospitals and other healthcare organisations; publications focusing on common pitfalls of practice and promoting best clinical practice; a medicolegal and ethical advisory telephone service; and a risk management consultancy, advisory and training service.

  4.  Our submission draws on our own experience and particularly focuses on patient safety in primary care as our experience is more comprehensive in this sector.

SPECIFIC ISSUES RAISED BY THE COMMITTEE IN THE TERMS OF REFERENCE

Question 1. What the risks to patient safety are and to what extent they are avoidable?

Patient safety risks in general practice

  5.  MPS has significant experience of adverse incidents occurring in the primary care sector. A significant proportion of adverse incidents in general practice are avoidable and the underlying cause is frequently systems failures, or a combination of systems failures and individual error.

  6.  We have identified common patient safety risks in general practice by analysing Clinical Risk Self Assessments (CRSAs) carried out by MPS during 2004-2006. The main risks are identified in the below table. A briefing note explaining the purpose of CRSAs and some of the common issues giving rise to the main risks we identified is included in Appendix 2.

Risk types identified % of practiceset
Confidentiality and issues relating to Caldicott principles 95
Prescribing92
Health and Safety (including security) 90
Communication failures85
Record keeping84
Test results 84
Infection control 71


Out-of-hours primary care services

  7.  The changing face of healthcare services brings not only new opportunities, but new risks to patient safety. As the organisation and delivery of primary care services continues to evolve there is the potential for greater patient safety and risk management challenges.

  8.  One area where emerging patient safety risks can be seen is the provision of OOH primary care services. MPS, including MPS Risk Solutions—a wholly-owned subsidiary of MPS—is the largest provider of indemnity to OOH services, which overall cater for a population of around 32 million people.

  9.  Currently patient care is provided by OOH services for 70% of the week (ie, Monday-Friday, the hours outside normal GP surgery opening times (6.30pm-8am); Saturdays, Sundays and bank and public holidays). A number of models providing OOH services have been developed.

  10.  OOH service providers have to meet standards set out in the National Quality Requirements in the Delivery of Out-of-Hours[82] and other national standards such as Standards for Better Health. [83]These standards require providers to operate robust corporate and clinical governance systems and processes.

  11.  We carried out an analysis of 526 complaints notified to MPS over a six-month period during 2006. Eighty-six complaints involved OOH as either the primary organisation complained about or in addition to the lead GP. The results, which give an indication of the emerging risks within OOH service providers, are shown in the table below[84]:


Main reason for complaint % of all complaints
Wrong/failure/delay/in diagnosis20
Attitude of the doctor13
Inadequate/inappropriate treatment/management 12
Failure/delay to visit12
Failure/delay/inappropriate referral8
Communication6
Breach of confidentiality6
Injection error6
Failure to investigate3
Failure or inadequate examination3
Prescription problem/error3
Professional conduct issues2
Inappropriate advice2
Other4


  12.  Seventeen per cent of the complaints we reviewed involved bereavement. Sixteen per cent of the complaints involved children under the age of five years, of which twenty-three per cent were related to failure to examine. We found that common conditions in this category were meningitis and pneumonia. Sixteen per cent of the complaints involved patients over the age of 65 years, with twenty-three per cent of these complaints related to failure to visit.

  13.  Our analysis found that the most common conditions in complaints about failed or delayed diagnoses (which accounted for 20 per cent of complaints) were pulmonary embolism, meningitis, pneumonia and cauda equina syndrome.

  14.  We believe that all PCTs should ensure that the OOH services they commission are underpinned by robust corporate and clinical governance systems and processes, and meet the national standards. Implementing risk management strategies is crucial for providing a safe service to patients. In our experience, the robustness of corporate and clinical governance systems in OOH services varies considerably between providers.

  15.  The delivery of safe OOH care requires a unique set of skills, particularly communication skills. Patients using OOH services usually make contact by phone, often in an anxious state. Practitioners will not usually have access to their medical records. It takes considerable skill for practitioners engaged with OOH providers to put themselves in a position to make a clinical judgement about the patient before offering advice. Training in these skills is essential, particularly where children are concerned. The development of the Summary Care Record is likely to have significant benefits in this area. It is important that there is a joined up NHS records system so that at any one point in time, healthcare professionals have access to all the relevant information.

  16.  It is also important that all OOH providers have a policy and/or systems in place to identify and appropriately treat patients who contact the OOH provider on more than one occasion about the same problem. Repeat contacts should trigger a careful re-assessment of whether a face-to-face meeting is necessary to exercise sound clinical judgment. There is the risk of false reassurance when a patient has already been reviewed by one or more colleagues during a care episode. This is particularly relevant for those patients who have communication and learning difficulties.

  17.  It is essential that there is faultless communication between the OOH provider and the patient's GP practice to ensure continuity of care. OOH providers should ensure that there are specific policies and procedures pertaining to high risk and vulnerable patient groups—for example, children and patients receiving palliative care.

  18.  OOH providers are increasingly introducing multidisciplinary teams (doctors, nurses, emergency care practitioners and paramedics) into their organisations. Nurses and other healthcare professionals are taking on more responsibility. We believe it is important that all OOH providers develop and implement mandatory high quality and comprehensive training and staff induction programmes. OOH providers should also ensure that they have appropriate indemnity provision to cover potential liabilities arising from work undertaken by all employees.

  19.  The heterogeneity of the commissioners and suppliers of these services means that it is difficult to implement common standards. We are working with our OOH provider members through Clinical Risk Assessments (CRAs) and other training and risk management programmes to help ensure safer patient services. We would like to see more research carried out on the genesis of complaints relating to OOH care. For instance, we believe that NHS complaints statistics should be broken down into OOH and in-hours care, so that lessons can be identified and learned more effectively.

Question 2. What the current effectiveness is of the following in ensuring patient safety:

 (a)   local and regional NHS bodies and how far the Boards of NHS bodies have established a safety culture

  20.  In our experience, all too often mishandled or inappropriate disciplinary action has been taken by trusts under the auspices of patient safety issues which, when properly scrutinised, is not justified. This trend has contributed to a blame culture in the NHS which is not conducive to improving patient safety.

  21.  There are wide variations in the way that PCTs and NHS trusts deal with performance issues. There is a tendency to apportion individual blame to the person who is most proximate to the adverse incident and to overlook the underlying systems failures. Investigations undertaken by the National Clinical Assessment Service (NCAS) into concerns about an individual practitioner often uncover organisational or systems failures. Individual NCAS reports can be a valuable source of information about failures of NHS management which are not, at present, captured on a national level. We suggest that steps should be taken to distil organisational learning points from these reports which could be disseminated to relevant parts of the NHS.

  22.  In recent years, there has been a greater focus on dealing with concerns locally, with an emphasis on remediation and rehabilitation. This can be most clearly seen in the proposals for reforming professional regulation in the White Paper, Trust, Assurance and Safety. We support the emphasis on early identification and local resolution but have serious concerns about the independence, fairness, practicability and consistency of the process as envisaged in the proposals. We are particularly concerned by the new roles of responsible officers who will be placed in every NHS trust and PCT and GMC affiliates who will be placed in strategic health authorities. We have grave concerns that the proposals for Recorded Concerns will militate strongly against open disclosure and undermine learning from adverse incidents. We believe that Recorded Concerns have no place in the patient safety agenda.

  23.  We would like to see a process that places emphasis on prevention, early recognition of problems, retraining and rehabilitation. We believe that there should be a supportive framework in place at trust level that allows doctors to practise safely and effectively. This framework must be reinforced by a rehabilitative approach, with mechanisms for early detection without punitive measures.

 (b)   Systems for incident reporting, risk management and safety improvement

  24.  The overwhelming majority of doctors are committed to reviewing and improving their practice to ensure that they can deliver the best care to their patients. However, in our experience, there remain barriers to incident reporting and shared learning.[85]

  25.  The concept of clinical governance has become embedded within the working practices of primary care. Every general practice is expected to participate in clinical governance activity led by the Primary Care Organisation (PCO). The GMS contract for primary care focuses on quality and outcomes, a key part of which is improving patient safety. GPs are financially rewarded under Quality and Outcomes Framework (QOF) for undertaking a specific number of significant event audits.[86]

  26.  The examples of good practice in incident reporting (both significant events and other incidents) and risk management are not evident across the board in general practice. In our analysis of CRSAs (see above) we found that fifty-six per cent of the participating general practices had no fully developed formal system for incident reporting and dealing with patient safety incidents and "near misses".

  27.  Despite initial training when significant event audits were first introduced, there has been a lack of reinforcement with adequate and accessible training for general practices.

  28.  There are no national minimum standards that underpin the process for significant event audits or incident reporting in general. Further, there is no comprehensive definition of a significant event. In our experience, many general practices do not have sufficient knowledge about what they should be reporting, who should be reporting, who they should be reporting to and how to take positive steps to prevent similar incidents recurring. The lack of knowledge is compounded by the arbitrary and interchangeable use of phraseology such as "patient safety incidents", "errors", "critical incidents" and "adverse incidents". We have contributed to a toolkit for general practice on Significant Event Audits which the National Patient Safety Agency (NPSA) is developing in conjunction with the Royal College of General Practitioners. We understand that the toolkit will be launched later this year and we intend to support its implementation with tailoring training.

  29.  It is our experience that significant events, where identified by practices, are invariably reported to PCTs for the purpose of QOF. Other incidents not identified as "significant events", mistakenly or not, or near misses, ie, where no harm was caused to the patient, are not reported to PCTs or to the NPSA through its National Reporting and Learning System (NRLS). The NPSA, in its 2008 NRLS Data Summary, states that 0.3 per cent[87] of all incidents reported to it per year come from general practice, which translates to only 2,150 incidents per year, compared to 583,567 reports from the hospital sector.[88]

  30.  A survey of 708 doctors carried out by MPS in August 2008 revealed that sixty-seven per cent of respondents agreed that doctors are willing to be open with patients when something goes wrong. However, in our experience, one of the most persistent barriers to reporting adverse incidents and near misses to PCTs is a very real fear within the profession that the information disclosed could lead to disciplinary action and multiple jeopardy.

  31.  The NRLS Incident Report Form (eForm) was, until very recently, heavily geared towards secondary care and this has proved a significant operational barrier to incident reporting in general practice. The NPSA have now revised the eForm for primary care and OOH providers and it is hoped that the process for incident reporting will now become much more accessible to general practice.

  32.  There is a clear need to improve incident reporting and risk management in primary care. We would like to see a simple and consistent incident reporting framework across primary care which encompasses all adverse incidents and near misses; this can be a valuable learning tool for the NHS, as it can highlight problems that have potential for future adverse incidents. Practices should be encouraged to hold routine meetings of relevant team members to discuss and investigate incidents and near misses.

  33.  Significant events should be prioritised and reported to the PCT, with other patient safety incidents or near misses being reported to the NRLS where appropriate. We also suggest that practices should be encouraged to develop a risk register, a log that enables an organisation to understand and assess its risk profile.[89]

 (e)   Education for health professionals

  34.  We believe that there is a need to include a greater emphasis on patient safety and clinical governance in the medical undergraduate and postgraduate curriculum. Currently, there is no requirement to cover patient safety in undergraduate or postgraduate curricula.

  35.  Most healthcare professionals, when they join an NHS hospital trust, undergo induction training. However, the quality and content of induction training varies between hospitals. It is our view that induction programmes should be mandatory, regardless of how experienced the healthcare professional may be, and should be consistent and comprehensive in content and quality, encompassing training in clinical governance and incident reporting. Induction programmes should also be tailored for specific groups, such as international medical graduates and those working as locums.

Question 3. What the NHS should do next regarding patient safety?

Research on the impact of risk management interventions

  36.  We believe that one of the most important next steps for patient safety is for the government to commission research, to examine the extent to which risk management interventions are successful and cost effective in reducing the impact of adverse incidents.

  37.  At the moment, there is broad agreement across the world that interventions aiming to reduce adverse incidents impact positively on patient safety. Many centres are piloting and anecdotally reporting results showing that, by addressing the issues of medical or system error by process redesign, education and leadership training, improvements in patient safety are being made. However, very little has appeared yet in published research—reflecting the fact that this movement is still in its infancy.

  38.  We are aware of some research in other countries that illustrates that risk management interventions reduce the frequency of clinical negligence claims and, therefore, the cost to patients and the healthcare budget. However, reduction in litigation is of limited value as an indicator of improved patient safety. Claims are often brought years after the event in question and are usually not resolved for a long time after that—consequently personnel, technology, systems and procedures will all have moved on in the interim.

  39.  Complaints are a valuable source of patient safety lessons and we hope that the national overview of complaints currently undertaken by the Healthcare Commission is not lost when the new complaints procedure is implemented in April 2009.

Encouraging greater openness

  40.  MPS has for decades supported and encouraged doctors and other healthcare professionals to be open with patients when something has gone wrong. Despite the support amongst practitioners for open disclosure, in our experience many have concerns about the process relating to their legal liability and their lack of training in the skills required to undertake it effectively. We would also like to see a greater emphasis on all non-clinical managers to be open when something goes wrong.

  41.  It is our view that the principle set out in the Compensation Act 2006, that an apology does not in itself amount to an admission of liability, should be extended further so that an apology offered to a patient is not admissible in civil or other proceedings. We believe that legislation should also encompass a definition of an apology which should include fault, and confirm that an apology does not constitute an implied or express admission of fault or void any insurance or indemnity coverage. The Apology Act 2006 in British Columbia, Canada includes similar principles on the effect of apologies.[90]

Establishment of a collaborative framework

  42.  There are many NHS and other organisations charged with disseminating good practice in the NHS and this fragments the process and learning.

  43.  We suggest that it would be helpful to establish a formal collaborative framework of bodies with interests central to patient safety. This structure would act as a central repository for all lessons to be learned and from which best practice could be disseminated. Partner organisations in such a formal collaboration might include the Parliamentary and Health Service Ombudsman, Care Quality Commission, NPSA, NCAS, NHSLA and MDOs.

Patient involvement

  44.  We believe that patients have an important role to play in ensuring their own safety. We would support the establishment of a programme to encourage patients to feel involved and confident to be able to question healthcare professionals and check what is happening to them and why.

September 2008

Appendix 1

Calls to MPS's medicolegal advice line

  The most frequent reason for calls is to receive advice on an ethical issue—this allows doctors to avoid and resolve problems at the earliest opportunity. A breakdown of reasons for calls is shown in the table below:
Main reason for calls in 2007%
Advice (ethical dilemmas)26
Complaints18
Medical records (disclosure and access) 9
Confidentiality6
Claim for compensation5
Writing a report5
Clinical judgment4
Inquest/fatal accident inquiry4
Consent3
Adverse incident report2
Disciplinary matter2
Criminal investigation1
Other15


Appendix 2

Analysis of Clinical Risk Self Assessments (CRSAs) undertaken between 2004-2006

  Clinical Risk Self Assessments (CRSAs), which typically involve a visit to a general practice by a clinical risk consultant who works closely with the practice team, help practices to identify potential areas of risk and improve practice systems and the quality of care. MPS has carried out over 400 CRSAs during the last six years. We have identified common patient safety risks in general practice by analysing CRSAs carried out during 2004-2006 by MPS.

  Many of the patient safety risks we identified can be significantly reduced or eradicated through better systems management and staff training. The CRSAs enable us to provide tailored risk management advice and, where appropriate, direct members to existing education resources, such as MPS publications or workshops on medication errors or communication skills. We are looking into conducting research to assess the impact of these interventions on the risk profiles of practices.

MAIN TYPES OF PATIENT SAFETY RISKS IDENTIFIED IN OUR REVIEW

Patient confidentiality

  The most prevalent risk to patient safety we have identified in general practice is associated with maintaining patient confidentiality and Caldicott principles—ninety-five per cent of participating practices identifying risks in this area. Common issues included breaches of confidentiality in waiting rooms and reception areas; the absence of confidentiality clauses in staff contracts post-employment; failure to shred all patient identifiable information; failure to securely store medical records; and computers left on and unattended. Concerns about confidentiality have been exacerbated by high profile losses of data, including electronic medical records. It is important to reinforce the individual practitioner's responsibility for protecting confidentiality, particularly when using mobile technology to store confidential information such as laptops and memory sticks.

Prescribing

  Ninety-two per cent of the practices we reviewed had risks associated with prescribing. Common issues included no repeat prescribing protocol; allowing administrative staff to add acute and repeat medications to the computer; medication reviews being undertaken on an ad hoc basis with no review dates set; repeat prescribing not being reviewed frequently enough to ensure that all medications are necessary; and uncollected prescriptions being destroyed with no knowledge about what happens to prescriptions not collected from pharmacies.

Health and safety (including security)

  Ninety per cent of practices in our review did not fully comply with all Health and Safety legislation and typical issues included no control of substances hazardous to health assessment; poor storage of clinical and hazardous waste; unlocked doors; and inadequate storage of medicines.

Communication failures

  We found that eighty-five per cent of practices had risks associated with communication failures. Recurring issues included no regular practice meetings and no standard messaging system. Some practices use "Post-It"ð®ñ notes to pass messages within the practice, with the risk of messages being lost or misplaced.

Record keeping

  Eighty-four per cent of practices had risks associated with record keeping. Common issues included failure to record home visits in every case; illegible writing in the records; and letters scanned onto a computer occasionally being saved into the wrong record.

Test results

  We also found that eighty-four per cent of practices had risks associated with test results and common themes included no tracker system to ensure that patients are followed up; no system of knowing when all of a patient's test results have been returned; a lack of clarity about whether it is the patient's responsibility to contact the practice for their own test results, or for the practice to proactively contact patients themselves; and non-clinical staff allowed to inform patients of their results and the treatment required.

Infection control

  Seventy-one per cent of practices had risks associated with poor infection control. Common issues included hand washing facilities and the provision of "clean" sinks.








81  
NPSA, NRLS Quarterly data workbook, 30 June 2008 Back

82   Services (NHS Executive (2004) National Quality Requirements in the Delivery of Out-of-Hours Services, Department of Health, England) Back

83   NHS Executive (2004) Standards for Better Health. Department of Health, England Back

84   We also published these findings in Price J, Haslam J, Cowan C, Emerging Risks in Out-of-hours Primary Care Services, Clinical Governance: An International Journal, 11;4 289-98 (2006) Back

85   For practical information on risk management see Keith Haynes and Malcolm Thomas (2005) Clinical Risk Management in Primary CareBack

86   NHS Confederation/British Medical Association (2003), New GMS Contract 2003: Investing in General Practice, British Medical Association, London. Back

87   See supra note 1 Back

88   Patient safety incident reports in the NHS: National Reporting and Learning System Data Summary. Issue 9 England, NPSA August 2008 Back

89   Making it Happen, A guide for Risk Managers on How to Populate a Risk Register, The Risk Register Working Group, Controls Assurance Support Unit (now the NHS Health Care Standards Unit) 2002). Back

90   Vines, Prue, Apologies and Civil Liability in England, Wales and Scotland: The View from Elsewhere [2007] UNSWLRS 61 Back


 
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