Memorandum by the Medical Protection Society
(MPS) (PS 09)
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
We would support a greater emphasis on patient
safety and risk management in the medical undergraduate and postgraduate
curriculacurrently 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.
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.
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 callsa
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
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.
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
|Health and Safety (including security)
|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
8. One area where emerging patient safety risks can be
seen is the provision of OOH primary care services. MPS, including
MPS Risk Solutionsa wholly-owned subsidiary of MPSis
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
and other national standards such as Standards for Better Health.
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:
|Main reason for complaint ||% of all complaints
| Wrong/failure/delay/in diagnosis||20
|Attitude of the doctor||13
|Failure/delay to visit||12
|Breach of confidentiality||6
|Failure to investigate||3
|Failure or inadequate examination||3
|Professional conduct issues||2
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 groupsfor example, children and patients receiving
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.
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.
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
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
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.
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
(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
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
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 researchreflecting
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 thatconsequently
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.
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.
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.
Calls to MPS's medicolegal advice line
The most frequent reason for calls is to receive advice on
an ethical issuethis 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
|Medical records (disclosure and access)
|Claim for compensation||5
|Writing a report||5|
|Inquest/fatal accident inquiry||4
|Adverse incident report||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.
The most prevalent risk to patient safety we have identified
in general practice is associated with maintaining patient confidentiality
and Caldicott principlesninety-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.
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.
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.
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
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.
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.
NPSA, NRLS Quarterly data workbook, 30 June 2008 Back
Services (NHS Executive (2004) National Quality Requirements
in the Delivery of Out-of-Hours Services, Department of Health,
NHS Executive (2004) Standards for Better Health. Department
of Health, England Back
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
For practical information on risk management see Keith Haynes
and Malcolm Thomas (2005) Clinical Risk Management in Primary
NHS Confederation/British Medical Association (2003), New GMS
Contract 2003: Investing in General Practice, British Medical
Association, London. Back
See supra note 1 Back
Patient safety incident reports in the NHS: National Reporting
and Learning System Data Summary. Issue 9 England, NPSA August
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)
Vines, Prue, Apologies and Civil Liability in England, Wales
and Scotland: The View from Elsewhere  UNSWLRS 61 Back