House of Commons Health Committee ‘Special Report’ on Patient Safety

The Health Committee has published a ‘special report’ on patient safety relating to the Committee’s patient safety report published in July 2009 (click here).

The Government responded to the patient safety report on 13 October (click here).

This special report sets out the responses to the patient safety report  by the Care Quality Commission and Monitor. It also contains a response by Professor Sir Ian Kennedy (formerly chair of the Healthcare Commission) and a reply to his response from the chairman of the Health Committee.

Of particular interest in the report is Monitor’s responses to various issues around boards highlighted in the original patient safety report.

Download the 27 page ‘special report’ Patient Safety: Care Quality Commission, Monitor, and Professor Sir Ian Kennedy’s Responses to the Committee’s Sixth Report of Session 2008-09 here.

Draft regulations for registration system in England breathe new life into clinical governance

The new registration system for health and adult social care in England is described in the post below.

Healthcare Governance Review notes that the draft regulations that will, when finalised and published, set the legal standards framework for registration, require ‘registered persons’ to have “a system of clinical governance and audit.”

According to para. 23(3) of the draft regulations, a “system of clinical governance and audit” means a framework through which the registered person endeavours continuously to -
(a) evaluate and improve the quality of the services provided; and
(b) safeguard high standards of care by creating an environment in which clinical excellence can flourish.

Download the draft regulations here.

New registration system for health and adult social care in England from April 2010

From 1 April 2010, the regulation of health and adult social care in England will change. Legislation is bringing in a new system that applies to all regulated health and adult social care services.

All health and adult social care providers, who provide regulated activities, will be required by law to register with the Care Quality Commission. Subject to the new legislation, new registration comes into effect on 1 April 2010 for NHS trusts (including primary care trusts) and 1 October 2010 for adult social care and independent healthcare providers.

By law, the CQC is required to produce guidance about compliance. This makes clear to providers what they need to do to be compliant with the new regulations. The new regulations will replace the existing Standards for Better Health and the National Minimum Standards. There are similar themes from these  in the new guidance about compliance. Some of the evidence that providers used to demonstrate they met the old standards can be used for the new standards.

The CQC stresses, however, that it is important that providers begin to develop new systems which show how they:

• deliver positive outcomes for people who use services;
• capture information about how people experience the services they provide.

Unlike the National Minimum Standards and Standards for Better Health, the guidance about compliance has an enhanced legal status. It can be used as evidence in criminal or civil proceedings and the CQC has stated that it will use it in their enforcement action.

The CQC website is the definitive source of information on the new registration system and will be regularly updated. Find out more, including all about the developing guidance to underpin the new system of registration, here.

CQC CEO wants to “ring alarm bells in the boardrooms” of poorly performing organisations

The Care Quality Commission (CQC) has published performance ratings for 2008/09 all 392 NHS trusts in England. Their assessment, also known as the ‘annual health check,’ shows big improvements for patients. According to the CQC, there is a reduction in MRSA and Clostridium difficile, and more people are:

- seen in A&E within four hours;
- receiving treatment within eighteen weeks of referral; and
- screened for Chlamydia.

Overall, the CQC says that the NHS is performing well on quality and has significantly improved its financial management.

However, the Commission is concerned about the 20 trusts rated weak on quality, particularly those rated weak over a number of years, and trusts rated fair for too long without improving.

Cynthia Bower, CQC Chief Executive, says:

“I want to ring the alarm bell in the boardrooms of these organisations. Next year, all trusts must register with us to legally function. It is clear that many have significant work to do to and a short time in which to do it. They should be in no doubt that we will take firm action if we deem it necessary.”

Of particular interest is the self-reported state of compliance with the Core standards for better health. The standards with highest rate of compliance are:

C08a (100% compliance) – support for staff to raise concerns about services
C10b (100%) – professionals abide by relevant codes of professional practice
C14a (99.8%) – providing information about how to complain
C22a&c (99.8%) – organisations cooperate to improve health of the community
C06 (99.6%) – health and social care organisations cooperate
C07b (99.6%) – promote openness, honesty, probity, and accountability

Core standards with lowest rate of compliance are:

C11b (87.6%) – participation in mandatory training
C09 (88.3%) – systematic and planned approach to records management
C04c (88.3%) – reusable medical devices are properly decontaminated
C04b (89.6%) – minimise risks of medical devices
C07e (90.5%) – challenge discrimination, promote equality and respect human rights
C02 (90.7%) – protect children by following national child protection guidelines

Full information on the 2008/09 annual health check can be found here.

Monitor publishes lessons learnt from Mid Staffordshire….and (re)defines clinical governance

Following the significant failings in quality of care at Mid Staffordshire NHS Foundation Trust, Monitor commissioned KPMG, its internal auditors, to consider how the way Monitor operates and works with others could be improved. The KPMG report and Monitor’s response has been published by Monitor (See below).

The KPMG report makes fourteen recommendations; all of these have been accepted by Monitor and, says Monitor, agood progress has already been made against many of these. There are two main themes:

1. The need for better sharing of information across the healthcare system. Monitor has already taken action in this area. We have agreed arrangements with the Care Quality Commission (CQC) to ensure that we are informed about concerns that they might have about the quality of care delivered by applicants to be foundation trusts and that these concerns are resolved before a decision is taken to authorise the applicant. Arrangements have also been agreed to share information about under-performing foundation trusts and to coordinate any action. These agreements are part of the Memorandum of Understanding which Monitor and the CQC have now signed and can be downloaded below.

2. The need for Monitor to focus on developing an approach to assuring itself that appropriate clinical governance is in place in applicant or existing foundation trusts. Monotor has (re)defined clinical governance as “the combination of structures and arrangements in place at, and immediately below, the Board level to manage and monitor clinical performance, plan and manage continuous improvement, identify performance that may be below standard or out of line, investigate it and take management action.”

Healthcare Governance Review feels the definition of clinical governance does nothing to bring clarity to the governance versus management debate.  The Monitor definition is a confusing ‘jumble’ of governance and management statements. Indeed, the majority of Monitor’s definition speaks to management rather than governance concerns. Monitor would have been better to adopt the Scottish definition of clinical governance, which is “Corporate accountability for clinical performance.”

Download the KPMG report, Monitor’s response and the Monitor/CQC Memorandum of Understanding here.

Monitor to practice ‘good governance’?

According to the Health Service Journal (HSJ – 18 June 2009) Monitor, regulator of NHS foundation trusts, might be forced by Department of Health to split Bill Moye’s executive chair job into two – chair and chief executive.

To some it has always been a bone of contention that Monitor should, in its Code of Governance for foundation trust, advocate the “best practice” of separating the roles of chair and CEO, yet fail to follow that guidance itself.

Read the HSJ article here.

Mid Staffordshire – Weak and fragmented regulation?

An interesting article by Calum Paton in the Guardianon 19 April raises the issue of the role of regulation in relation to Mid Staffordshire.

According to Mr Paton “Regarding the Stafford hospital meltdown, we see a ……… “system” of weak and fragmented regulation. Whatever the rights and wrongs of that hospital board’s approach – and it seems to have driven elective targets and finance at the expense of emergency care quality – it was operating in a highly confused regulatory, and indeed policy, system.”

It is interesting to reflect on the role of the principal regulators at the time – the Healthcare Commission and Monitor. What lessons are there to be learned. And what about the role of the National Patient Safety Agency? Whilst not a regulator, with a National Reporting and Learning System (NRLS) that has been over 8 years and more than £10 million in the making, then should it not have picked up something about the state of patient safety in emergency care at Mid Staffordshire – or was Mid Staffordshire not reporting incidents?

Read the full Guardian article here.

Healthcare Commission publishes its ‘legacy report’

The Healthcare Commission, which is being replaced on 1 April 2009 by the new Care Quality Commission, has published a document describing its experiences over its 5 year life. Specifically, the publication:

1. Sets out the background to the establishment of the Healthcare Commission.
2. Summarises the approach to information-led, risk-based regulation taken by the Commission.
3. Considers the contribution that regulation of healthcare has made to better outcomes and quality of care for people.
4. Reviews the lessons that have been learned about the approach to regulation, and the implications for future regulatory models.
5. Highlights the lessons from regulation for the healthcare system as a whole.

Download the publication The Healthcare Commission 2004-2009: Regulating healthcare – experience and lessons here.

‘What gets measured gets done’ says Sir Ian Kennedy as Healthcare Commission prepares to bow out…..

The Healthcare Commission (HCC) will be replaced by the new Care Quality Commission (CQC) from 1 April 2009.

In the final State of Healthcare report for 2008, Professor Sir Ian Kennedy, Chair of the HCC, believes that the Commission has painted a ‘richer picture’ of NHS performance than has existed in this past. This, he says, “has led boards of trusts to concentrate ever more intensively on what matters.” Indeed, his parting words of wisdom for the NHS appears to be the old maxim “what gets measured gets done.”

According to the HCC, the NHS must now focus on enhancing the quality of care by doing more to measure outcomes for patients, the experience of patients, and the journey people make through the system of care.

Sir Ian Kennedy said: “It is crystal clear that there have been major improvements in the care provided by the NHS over the past five years.

“We have seen more money going in, more staff providing services and more patients being treated. People are getting care much more quickly than they used to, notably for cancer. NHS trusts have, for the first time, a clear understanding of the core standards of service that they should be providing. We are seeing signs of real progress in driving down rates of healthcare-associated infection. People are living longer and there have been some remarkable reductions in premature deaths from the major killer diseases.

“But there are a small number of trusts trapped at a level of performance that is unacceptably poor. It’s also clear that, while patients overall indicate high levels of satisfaction with care, the NHS is still playing catch up when it comes to consistently providing the patient-centred care that people rightly demand. This is particularly true for those least able to make themselves heard when it comes to getting the best care, such as older people, children and those with mental health needs or learning disabilities. There have been some real improvements in mental healthcare but significantly more remains to be done to support people, especially young people, in the community.”

He added: “We have made the safety of care our highest priority. Safe care is the first building block of good quality care. It’s clear that safety is higher on the agenda than ever, but we are also a long way from an NHS that hungrily and systematically examines its own performance, gathers in and learns from mistakes, reinforces good practice, and does things differently for the future.

“The Healthcare Commission is four years into what was planned as a long-term project. The improvements so far are clear but the pace of change has varied. It is very important that the momentum be maintained.”

Key points from the report include:

- The NHS has benefited from major increases in funding and now has more resources than at any time in its history
- Demand for care has also risen dramatically
- The health of the nation is improving
- There have been sustained improvements in meeting the government’s standards and targets, with dramatic    improvement in waiting times
- There is a small number of trusts trapped at a level of performance that is unacceptably poor
- Services are still not always as patient-centred as they should be and there are groups of patients whose needs are still not sufficiently well served
- The safety of care is higher up the NHS agenda but trusts are still not doing enough to monitor and learn from incidents and ensure good practice is followed
- Commissioning must improve, as must measurement of patient outcomes, the experience of patients, and the journey people make through the system of care.

In relation to the safety of care, Sir Ian said Sir Ian said the issue of patient safety had risen up the Government’s and the NHS’s agendas. “But in my view the NHS is really only just out of the starting blocks,” he said. “There’s a great deal to do before we can be confident that the care patients receive is as safe as it reasonably can be.

“We are a long way from an NHS which systematically and hungrily examines its performance, reinforces safe practice, gets in and learns from things that go wrong and does things differently and more safely as a consequence.”

Download the HCC’s State of Healthcare 2008 report here.

Regulation of Health Care Provision in England

The Kinds Fund has produced a very helpful 11 page briefing note on the regulation of health care provision in England.

From April 2009 the new Care Quality Commission will take over the work of three existing health and social care regulators – the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission. The government is also introducing new arrangements for regulation of the market in health care.

This briefing examines the recent history of the quality and safety, financial and economic regulation of health care providers in England; describes the new regulatory machinery that is being introduced; and considers how the relationship between these different regulatory systems may develop in the future

Download the briefing here.

Health Committee reckons ‘FTs have some proven strengths, but much is unknown’

The House of Commons Health Committee has published a short report on Foundation Trusts (FTs) and Monitor.

The report finds that FTs have some proven strengths. They have performed well financially and generated surpluses. They have been high performers in routine NHS process quality measures. However, much is unknown. With a lack of objective evidence, it is not clear whether their high-performance is the result of their changed status, or simply a continuation of long term trends, since the best trusts have become FTs.

Key aims of FTs were the promotion of innovation and greater public involvement. While the Committee was provided with examples of good practice in both of these areas, again there was a lack of
objective evidence. 

In relation to public involvement, while the Committee saw some examples of good practice in FTs’ new governance arrangements, in general they seem to be slow to deliver benefits and despite numerous small studies, there remains a lack of robust evidence of their effectiveness. The governance process currently costs circa £200,000 per trust, giving a total of around £20 million per annum. We recommend that the Department of Health make it a priority to evaluate rigorously the FT governance system and to give guidance on best practice so that public money as well as members’ and governors’ time can be used as effectively as possible to improve services.

The Committee also found that while FTs do not appear to have yet exploited the full potential of their autonomy, witnesses from FTs told them that the ability of boards to make decisions more quickly was important and made a ‘tangible’ difference to the dynamic of their organisations. Unfortunately, concerns persist about what level of Government intervention in FTs’ affairs is legitimate, and the Government must clarify what the appropriate levels of intervention are.

Finally, the Committee found that Monitor’s application process and regulatory regime seems to be well regarded. However, a complex regulatory environment of other organisations also surrounds FTs, and in particular there is potential duplication between the Healthcare Commission and Monitor both of which evaluate the quality of FTs’ services.

Download the Health Committee report Foundation trusts and Monitor here.

Healthcare Commission ratings show ‘major improvement’ in NHS performance

The performance of the NHS in England appears to have significantly improved since publication of last year’s Healthcare Commission ratings.

Figures published on Thursday 16 October 2008 show that “trusts are improving the quality of services and managing money more effectively.”

Interestingly, Foundation trusts continue to outperform non-foundation trusts. Thirty-eight out of the 42 trusts rated “excellent-excellent” have foundation trust status. Eight foundation trusts were “fair”, while just one was “weak” for quality of services.

For further information click here.

Health Care Risk Report Vol 14 Issue 9 September 2008

This issue of Health Care risk Report (HCRR), like so many others, has something for everyone.

The cause of healthcare governance is addressed in an article by Healthcare Governance Review editor Stuart Emslie. Essentially, Stuart reviews the new ‘governance between organisations’ debate paper and argues that it’s better management between organisations that is needed to improve services and reduce risks. Governance between organisations is, essentially, the “next taxi off the rank” in the wider world of ‘governance creep’.

There are three articles under the heading ‘risk management.’ The first explores how NHS trusts can use purchasing power to improve patient safety. The second argues that patients and trusts need a clearer view of the risks of infection. And the third provides guidance and advice to community nursing and other community staff on implementing the Mental Capacity Act and contains case examples.

Two legislation updates are provided. The first looks at the future of health care regulation in England, focusing on the role of the Care Quality Commission and the potential for confusion between the Commission and Monitor. The second provides an update on the Mental Health Act.

Finally there is the usual helping of helpful clinical negligence case reviews, plus an article looking at the health service ombudsman’s latest report on learning from complaints, which finds that poor communication is still a recurrent theme.

If you or your organisation do not currently subscribe to HCRR then please consider doing so. A subscription form can be downloaded here.

Declaration of interest: Stuart Emslie, editor of Healthcare Governance Review, is on the editorial advisory board of, and is a regular contributor to, Health Care Risk Report.

Implementing Trust, Assurance and Safety – DH publishes guidance on building effective boards

The Department of Health (DH) has published Niall Dickson’s final report and the DH’s own response to his recommendations in relation to enhancing confidence in healthcare regulators.

A significant dimension to the report relates to the development of effective boards.

At Appendix 3 of the publication is a report on the characteristics of effective boards by the Council for Healthcare Regulatory Excellence (CHRE). The CHRE report is based largely on John Carver’s book Boards That Make a Difference, which, they say, “offered the most relevant and sensible advice, focussed on the public/not for profit sector, and widely respected.” The CHRE offer, based on Carver’s work, “12 key principles of an effective board” as follows:

1. The board should determine the purpose and values of the organisation, and review these regularly
2. The board should be forward and outward looking, focussing on the future, assessing the environment, engaging with the outside world, and setting strategy
3. The board should determine the desired outcomes and outputs of the organisation in support of its purpose and values
4. For each of its desired outcomes and outputs, the board should decide the level of detail to which it wishes to set the organisation’s policy
5. Any greater level of detail of policy formulation should then be a matter for the determination of the chief executive and staff
6. The means by which the outcomes and outputs of the organisation are achieved should be a matter for the chief executive and staff; the board should not distract itself with the operational matters
7. The chief executive should be accountable to the board for the achievement of the organisation’s outcomes and outputs
8. In assessing the extent to which the outcomes and outputs have been achieved, the board must have pre-determined criteria which are known to the chief executive and staff
9. The board should engage with its ownership regularly and be confident that it understands its ownership’s views and priorities
10. The membership of the board should be capable and skilled to represent the interests of the ownership; this should not be done in a tokenistic way
11. Information received and considered by the board should support one of two goals – to enable decision making, or to fulfil control and monitoring processes
12. The board must govern itself well, with clear role descriptions for itself, its chair, and its members, with agreed methods of working and self-discipline to ensure that time is used efficiently

Paul Stanton, former Director of Board Development at the National Clinical Governance Support Team, has recently stated in a Health Service Journal article, that his own thought on good governance are “influenced by the work of John Carver, whose model of ‘policy governance’ is admirably clear……….” (see Healthcare Governance Review post here).

Download a copy of the publication Enhancing Confidence in Healthcare Professional Regulators – Niall Dickson’s final report and DH response to the recommendations here.

Regulations regarding suspension and dismissal of non-executive directors are in force: DH is now consulting on “Phase two” proposals

The Primary Care Trusts and National Health Service Trusts (membership and procedure) Amendment Regulations 2008 came into force on 16 June.

The purpose of these amendment regulations is to enable the Secretary of State in England to suspend the chairman or non officer members of a Primary Care Trust (“PCT”) and the chairman or non-executive directors of a National Health Service trust (“NHS trust”). The regulations also provide for:
- how a suspension should be notified,
- the period of suspension,
- reviewing, revoking and extending a suspension, and
- amending the number, or maximum number, of members of PCTs and NHS trusts where a member has been suspended

An explanatory memorandum to the new regulations can be downloaded here.

In addition, a useful article providing further explanation on the new regulations was published in the Health Service Journal on 8 August 2008. The article, written by Mark Leach, a partner in the employment team of Weightmans Solicitors, can be viewed here.

The Department of Health is now consulting on proposals for ”Phase two” of its introduction of new powers of suspension. The new proposals aim to extend powers of suspension to chairs and non-executive members of SHAs, SpHAs and other Health Bodies. The deadline for consultation feedback is 9 October 2008. For durther information, click here.

Related link here.

DH lunches consultation on regulating NHS bodies in relation to healthcare associated infections

The Department of Health (DH) in England has launched a 10 week consultation on ‘Changes to arrangements for regulating NHS bodies in relation to healthcare associated infections for 2009/10.’

The consultation document describes the draft regulations which will make it a legal requirement to protect patients, healthcare workers and others from identifiable risks of acquiring a healthcare associated infection. Under the draft regulations, individuals found gulty of an offence can be fined up to £50,000.

The document also explains the link with the restructured Code of Practice for the prevention and control of healthcare associated infections which enables the Care Quality Commission to use it as criteria for monitoring compliance with regulations. NHS providers will need to comply with these regulations as a requirement of their registration with the new Care Quality Commission.

In addition, the document describes the system of enforcement powers in the Health and Social Care Act 2008 that is intended to apply to providers should they fail to comply with the requirements of registration and makes proposals for secondary legislation to support these powers. The DH says that the  Care Quality Commission will publish further details of its enforcement policy in due course.

Download the DH consultation document here.

Building a culture of patient safety through effective governance in Ireland

The report by the Commission on Patient Safety and Quality Assurance in Ireland is now published. Titled ‘Building a culture of patient safety’ the report sets out a governance framework for patient safety and quality in Irish public healthcare.

At 242 pages long, this is a comprehensive and extensive report (and it contains 219 mentions of the word ‘governance’ – Ed.).

The vision around which a health system-wide governance framework for patient safety should be based is stated in the report as “Knowledgeable patients receiving safe and effective care from skilled professionals in appropriate environments with assessed outcomes.”

Healthcare Governance Review spoke to Dr Deirdre Madden, Chairperson of the Commission on Patient Safety and Quality Assurance, about the report. In particular we asked her about the report’s focus on effective governance as a means by which a culture of patient safety and quality can be effected.

Dr Madden said that “Medicine is not a risk-free enterprise; errors occur in every healthcare system in the world. However, we must never be complacent about errors, and must recognise and face the serious consequences that errors have for patients, their families and the clinicians involved. We must develop a positive patient safety culture by putting in place structures and systems that ensure effective governance in our healthcare facilities based on strong and clear reporting relationships and delegated levels of authority, robust accountability mechanisms and patient involvement at all levels of healthcare decision making. We must ensure that the potential for error is minimised to the greatest extent possible by strong professional leadership on safety and quality, active participation in audit, and commitment to sharing lessons learned from adverse events. A system-wide approach to safety and quality will help to ensure that wherever a patient receives care, it will be safe and effective, delivered by appropriately skilled professionals in facilities that are well governed, fit-for-purpose and have patient safety as their paramount priority in all that they do.”

Readers are strongly encouraged to read the report, which, in the opinion of Healthcare Governance Review, paints the most complete and comprehensible understanding of healthcare governance that presently exists anywhere in the world.

Download a copy of the report here.

Related link.

Irish report on ’system of governance’ for quality and patient safety imminent

According to the Irish Medical Times (18 June 2008) the Department of Health in Ireland has announced that the Commission on Patient Safety and Quality Assurance will publish its report on the licensing of public and private healthcare providers and services in July 2008.  Currently, there is no system of regulation for private healthcare providers.

The Commission will develop proposals for a system of governance based on corporate accountability for the quality and safety of health services, the Department stated. They will apply to both public and private providers, essentially creating one standard. The Commission will also devise:

* a system of leadership for clinicians and managers which would underpin robust corporate accountability for institutional and clinical performance;
* a statutory system of licensing for public and private healthcare providers and services;
* the process of quality assurance of clinical services (with an emphasis on clinical outcomes) for public and private healthcare providers and services;
* procedures for healthcare professionals and managers to anticipate risks and promote good performance through effective risk identification, near-miss and critical incident reporting;
* the governance of regulatory bodies in the health system and ways in which effective integration can be enabled between the various bodies.

Progress on foundation trust governance and local accountability

Monitor, regulator of NHS foundation trusts, has published a research report showing that NHS foundation trust governors are making local accountability a reality. The report – Developing the role of NHS foundation trust governors – indicates that that the majority of governors are clear about their role, have good relationships with their executive board, and are using their statutory powers to make a difference.

The foundation trust governance model is rooted in local accountability. The Prime Minister has said that he wants to see 3 million foundation trust members by 2012, up from 1 million today, and he wants members to have an even greater say in the workings of their trust.

Monitor has determined, from the research, that there are five opportunities for improving boards of governors:

1. More thorough induction programmes for new governors to help them get to grips with their new role.
2. Improved operation of the board of governors, especially in relation to obtaining appropriate information from trust executives and ensuring informed, productive meetings.
3. Better interaction with the board of directors.
4. Better communication between the board of governors and the membership.
5. More resources to assist board of governors to understand and discharge their statutory duties.

In relation to item 5, Monitor believes it has a leading role to play as the regulator. Monitor’s work in this area will include a review of the NHS Foundation Trust Code of Governance with a view to publishing more specific guidance for governors regarding their statutory duties later in 2008/09.

The report on Developing the role of NHS foundation trust governors can be downloaded here.

Healthcare Commission launches biggest ever NHS check on infection control

The Healthcare Commission has, today – 24 April 2008, launched a major programme of infection control inspection covering all 172 acute trusts annually as part of a drive to: reduce death and illness from healthcare-associated infections (HCAIs); improve the experience of patients in hospital; and increase public confidence in the NHS. The programme was established at the request of the Secretary of State for Health.

The Commission this week wrote to all acute trusts, calling on them to ensure that they have the necessary systems in place to minimise the risk to patients of catching a HCAI such as MRSA or Clostridium difficile.

In particular, trusts should check they are meeting the 11 mandatory duties outlined in the government’s hygiene code, which came into force as part of the Health Act 2006.

For further information on the Commission’s infection control inspection programme, click here.