Draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The Committee consisted of the following Members:
† Adams, Nigel (Selby and Ainsty) (Con)
† Alexander, Heidi (Lewisham East) (Lab)
Austin, Ian (Dudley North) (Lab)
† Burstow, Paul (Sutton and Cheam) (LD)
† Corbyn, Jeremy (Islington North) (Lab)
Field, Mark (Cities of London and Westminster) (Con)
Hillier, Meg (Hackney South and Shoreditch) (Lab/Co-op)
† Kirby, Simon (Brighton, Kemptown) (Con)
† Lamb, Norman (Minister of State, Department of Health)
† Luff, Sir Peter (Mid Worcestershire) (Con)
McDonagh, Siobhain (Mitcham and Morden) (Lab)
† Metcalfe, Stephen (South Basildon and East Thurrock) (Con)
† Penrose, John (Lord Commissioner of Her Majesty's Treasury)
† Reed, Mr Jamie (Copeland) (Lab)
† Robertson, Sir Hugh (Faversham and Mid Kent) (Con)
† Rotheram, Steve (Liverpool, Walton) (Lab)
† Shannon, Jim (Strangford) (DUP)
† Weatherley, Mike (Hove) (Con)
Danielle Nash, Sharon Maddix, Committee Clerks
† attended the Committee
Sixth Delegated Legislation Committee
Thursday 16 October 2014
[Katy Clark in the Chair]
Draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
11.30 am
The Minister of State, Department of Health (Norman Lamb): I beg to move,
That the Committee has considered the draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
It is a great pleasure again to serve under your chairmanship, Ms Clark. I am delighted to introduce the debate on the new fundamental standards that we are setting as a requirement for providers of health and adult social care registered with the Care Quality Commission. The Government have made many improvements to the system of regulation operated by the CQC. We have made the CQC more independent of Government. We have made it even more honest and open about the quality of care and treatment that it finds. We have put in place three chief inspectors, who now lead teams of specialist inspectors. We have legislated to allow the CQC to publish ratings of providers over and above mere compliance with minimum standards, to give patients and service users fuller information about the quality of care provided locally. Those ratings will provide an incentive to improve, to achieve a better rating or to maintain an excellent rating.
Those important developments have improved the effectiveness of the CQC and are providing more reliable and fuller information to patients and service users. We must not, however, lose sight of the fact that the key and enduring role of any regulator is to take action where standards fall below the acceptable.
Nothing is more important than our health and the health and well-being of those whom we love. That is why poor care must be challenged effectively wherever it occurs. It is vital that an organisation responsible for poor care is held to account, be it a hospital, a care home, a GP practice or a care provider in the community. The CQC must be able to step in and protect patients and users of services from the risk of poor care. It is essential that those providing and responsible for poor care are held to account.
One of the Government’s priorities has been to ensure that anyone who needs care or treatment is, first and foremost, kept safe, looked after properly and treated with honesty, dignity and respect. The failures to achieve that in places such as Mid Staffordshire and Winterbourne View serve to underline the importance of that and make the point that, wherever care is provided, whether by a state provider such as Mid Staffordshire or a private one such as Winterbourne View, the same principles must apply across the board.
In our response to the Winterbourne View scandal, we set out the need for the CQC to have effective enforcement powers. I felt strongly that the existing
system was flawed. If something dreadful happened, such as at Winterbourne View, under those existing rules, a notice had to be served first before moving to prosecution. If the provider complied with the notice, nothing could be done. In such awful cases, we surely have to be able to prosecute without first having to serve a notice.In the inquiry into the Mid Staffordshire NHS foundation trust, Robert Francis reinforced the point that the legislative basis on which the CQC was operating was undermining the effectiveness of the regulator. He said that
“there is a lack of clarity in the regulations, which the CQC is obliged to work under”
“the structure…is over-bureaucratic and does not separate clearly what is absolutely essential from what is merely desirable.”
“Fundamental standards…to make it clear what is the minimum required to protect patients from avoidable harm, and what is treatment and care which falls below a tolerable standard. Failure to comply with such fundamental safety and quality standards should not be tolerated, whether in individual cases or within an organisation…Breach of these standards should result in regulatory consequences for an organisation”.
The draft regulations implement that recommendation. They set out new fundamental standards of care that all registered providers of health and adult social care must meet, reflecting the views that we have received from several consultations during the past 18 months. They improve the current registration requirements by being clearer and fewer in number, and they introduce two new requirements: a duty of candour, which is incredibly important, and a fitness test for directors of NHS bodies. Importantly, they bolster the power of the regulator to take enforcement action, including bringing prosecutions against providers of poor care, providing additional protections for people from unsafe care.
Through those changes, we are putting in place a system whereby patients, staff, families and carers know the basic standards that must always be met—the fundamental standards. Those are that patients must receive safe care that meets their needs and reflects their preferences; patients must be treated with dignity and respect; they must be properly fed; their views must be listened to; they must be protected from abuse of any kind; the environment in which they are cared for must be clean, safe and secure; and care organisations must be well run, properly staffed and open and transparent with people about their treatment. Those are indeed fundamental standards, ones that we all have a right to expect whenever and wherever we need care. Every organisation providing care must meet them.
The vast majority of people already experience those things when they receive health and care services. It is important that we recognise and pay tribute to the many tens of thousands of care workers who do amazing work, often for low pay. They provide fantastic, dedicated support to very vulnerable people. However, that is no comfort to those who do not receive good care. Care that falls short of those standards must not be tolerated. The fundamental standards give the Care Quality Commission the power to take action where providers fail patients and service users.
Our response to Winterbourne View recognised the need to improve the Care Quality Commission’s ability to prosecute poor providers, and when Sir Robert Francis
recommended the introduction of fundamental standards, he recommended that where a breach of the standards leads to death or serious harm, it should be possible to prosecute the provider without first having to serve a notice. We have met those ambitions. Once the regulations are in place, the Care Quality Commission will be able to bring prosecutions against providers whose services breach fundamental standards and such a breach results in avoidable harm or poses a serious risk of harm. For the first time, poor providers will be properly accountable before the courts. In future, the Care Quality Commission will be able to bring a prosecution without, as I said, having to issue an advance or warning notice where a provider fails to gain consent—consent to do something to the individual service user—or where failure to provide care in a safe way, to protect service users from abuse or to meet their nutritional needs results in avoidable harm. The penalty on prosecution will be an unlimited fine.It was always clear that Parliament intended the Care Quality Commission to be able to prosecute providers for the most serious failures of care. It was equally clear that the current regulations make it very difficult to achieve that objective, as I have explained. The regulations give the Care Quality Commission an effective power to prosecute such cases for the first time, which is a major step forward in protecting patients and service users from the risks of poor care.
It is important to recognise that it will always be the case that dreadful things happen sometimes. We cannot eradicate examples of poor care, but where it happens, there have to be consequences. There has to be proper accountability for that care, and we need a framework that makes it much less likely to happen in the first place.
Providers must also be accountable for the services that they provide to patients. Transparency is key to safety. Without it, lessons go unlearned and poor care goes unchallenged. The regulations introduce a new duty of candour. From next month, this will require NHS bodies to be open and honest with people about their care and treatment. In particular, where failings in care lead to death, or where severe harm, moderate harm or prolonged psychological harm arise or could still arise, the provider will be required to inform the patient or their representative and to provide an apology. I am confident that that will help to drive progress in openness among providers, encouraging them to reflect on and improve their practice.
The duty of candour set out in the regulations applies only to NHS bodies. However, I am clear that the principle of openness should apply not just to the NHS, but to all health and adult social care services. We therefore aim to extend the duty of candour to all providers registered with the CQC in April 2015.
I want to finish by focusing on a further measure to deliver corporate accountability. Care providers must take their responsibilities seriously, and the measures are designed to ensure that they can be held to account for poor care. The tone and culture of an organisation is set by the people at its head. All too often, individuals at the head of an organisation have been out of reach even where they have overseen the most shocking standards of care. The regulations put an end to that by giving the Care Quality Commission new powers to remove directors who are responsible for poor care. They place, for the first time, a legal requirement on NHS bodies registered
with the Care Quality Commission to ensure that their directors are fit and proper to fulfil their role, and we plan, by next April, to extend that requirement to all providers of health and adult social care—the same principle must apply whether it is state, private or the voluntary sector—registered with the Care Quality Commission.The requirement will cover health and adult social care providers, as I said, in the public, private and voluntary sectors. Providers will have to check that their directors are competent and have the skills to lead organisations towards delivering safe, high-quality care. Importantly, the new regulations enable the Care Quality Commission to insist on the removal of directors who are not fit and proper, including where they have been responsible for serious misconduct or mismanagement of a regulated activity.
The responsibility for ensuring that patients and service users are kept safe and treated well lies first and foremost with the care provider. The fundamental standards in the regulations set out what the responsibilities are. They define a standard below which care must never fall. Regulation in health and adult social care is essential to protect patients and service users from the risks of harm, but such regulation must be proportionate to the risks that it is seeking to address. The fundamental standards that we are considering today strike that balance. They impose fewer regulations than those they replace. They do so in a clearer way that will make more sense to both providers and service users. They impose criminal sanctions in relation to just those specific areas where a breach results in avoidable harm to patients and service users. Where providers do not meet the fundamental standards, they give the Care Quality Commission the power to take effective action to protect patients and service users. I commend the fundamental standards and the regulations to the Committee.
11.43 am
Mr Jamie Reed (Copeland) (Lab): It is a pleasure to serve under your stewardship, Ms Clark, for what I think is the first time. If it is not, I apologise. I do an awful lot of these things, and they all tend to blur into one—[Interruption.] Such honesty indeed. But I think this is the first time.
The regulations fill in the blanks left in clause 80 of the Care Act 2014, which in turn amends the Health and Social Care Act 2008. I am sure that the Minister, like me, remembers fondly those days in January when we were barricaded in, I think, this very room in Committee. I do not want to go through or repeat at length what I said in Committee, and with that in mind I will keep my remarks mercifully brief today.
I will not seek to divide the Committee today. I said in the Bill Committee that improving care and ensuring high standards is an end that we are all striving towards. There are, however, a number of questions that I would like the Minister to help to shed light on with some answers today.
Could the Minister explain why the fit and proper persons requirement will apply only to NHS bodies and why it could not have been extended to all providers at the same time? I understand the different time scales that he set out, but it would be useful if he could explain why that could not be done at the same time. He will
remember, too, that as the specific clause to which the regulations relate was being debated in Committee, Opposition Members tabled amendments to ensure that the duty of candour was in line with the recommendations made by Robert Francis QC in his report. The duty of candour as it stands in regulation 20 will apply only to health care providers, but the standards in care provisions in regulations 8 to 19 apply to registered persons. Will the Minister set out what discussions he and his officials have had with professional bodies regarding extending the duty of candour to the individuals providing care, as Francis originally recommended? Indeed, have there been any discussions at all?Regulation 20(7) explains that the duty of candour applies in the event of unintended actions resulting in death, serious harm, moderate harm, and prolonged psychological harm. That of course should be welcomed. However, why are not all incidences of harm included, and how were the definitions arrived at? For example, what is the definition of harm below moderate?
On regulation 18, it is right that sufficient staff must be deployed to provide safe care, but who will determine what level of staff is sufficient and what are the consequences of not meeting such standards? It is particularly important that we understand the answer to that question as more hospitals slide into special measures and as staff shortages are consistently cited as a reason for deteriorating standards.
In January, when the matter was being discussed in detail, I remarked that the Opposition would have preferred to have the detail that is laid out in the regulations to be contained in the Act, so that the provisions could be debated and scrutinised in a more public forum. It is a shame that such important provisions are being debated in a Delegated Legislation Committee today, rather than in a more outward-looking, public-facing, and more engaged manner, but that is the prerogative of the Government. All that notwithstanding, the provisions are important.
There is a duty on the Government to ensure that their legislation is effective. I know that the Minister, like me, cares about the efficacy of government, not simply posturing. With that in mind, will he place before Parliament an independent assessment of the impact of the regulations in ensuring safe care after they have been in place for 12 months? We need to ensure that the regulations achieve the desired outcomes and that they do not simply serve as a symbol of legislative intent. Given the prominence given to the duty of candour by Robert Francis in his recommendations, both the House and the public deserve to be informed as to how effective the regulations are at ensuring safe care and improving care. I am sure that Members of all parties would support the sentiment with which that request is made. I have repeatedly made the point that effective legislation is born from an iterative process. Iterative processes facilitate consistent and constant improvement, and I hope the Minister agrees to the 12-month review.
11.47 am
Norman Lamb: I am grateful to the shadow Minister for confirming that there will be no Division and that there is support for the measures. They are incredibly important. They give us an opportunity to drive up
standards and, critically, to hold people to account when serious failures occur. I equally have fond memories of the Care Act 2014 Committee and the many hours that we spent debating it in this room.The fit and proper person test applies only to the NHS in the regulations—the same applies to the duty of candour—simply because of the processes we have to go through when regulations apply to non-Government bodies. The Regulatory Policy Committee is the appropriate body, but the intent is absolutely clear, as I tried to say in my opening remarks. The principles must apply equally, whoever is providing care. Everyone must be held to account and must be forced to be transparent in dealing with failures of care.
The duty of candour will apply to partnerships. GP practices, for example, are subject to the duty of candour, as are corporate bodies, and individual directors will be held to account where they are culpable. Where they have in effect overseen a cover-up of failures of care, they can be prosecuted under the provisions. Whether the provisions should apply to individual clinicians is a much more difficult question. We had that debate in Committee on the 2014 Act and when I questioned the shadow Minister on the Opposition amendment, he was not entirely clear as to whether he intended for there to be criminal sanctions against individuals, because that, in effect, is what would happen: individual clinicians would be made criminally liable if the regulations were breached. Bodies such as the Royal College of Nursing and the British Medical Association have expressed concern about the potential for creating a culture of fear in organisations.
On the shadow Minister’s point about the level of harm, we want to encompass all examples of significant harm. I described the different classifications in my opening remarks. The danger is that, if we go too far, we create a bureaucratic nightmare in which people feel that, if they do not report everything, they will potentially face prosecution, so we need to get that balance right. Following discussion and consultation, we have extended the scope of the classification. We brought in Sir David Dalton to look at that and have followed his recommendations. I think that we have got that balance right.
The critical principle, however, which I suspect we all share, is that we should seek to instil a culture of complete openness about anything that happens. We need to encourage a learning culture in which, if something goes wrong but there is no culpability because it was not deliberate, the organisation’s objective is to learn from it and ensure it does not happen again. That can be done only through a culture of complete openness in which people feel able to speak out about poor standards of care they have experienced.
The shadow Minister asked about ratios of staff—I think he was talking about staffing on wards and so forth. We have already introduced the requirement that all hospitals must publish on their websites the levels of safe staffing that they have established for the level of acuity on their individual wards, and how they are performing against those standards. Again, the focus is on total transparency. The National Institute for Health and Care Excellence has done work on how safe staffing levels can be determined and the steps we have taken have been widely welcomed. The Care Quality Commission also has a role. The much more robust inspections that
have been introduced mean that, when it inspects organisations, it will have a much better chance of exposing failures when it feels that there is insufficient staffing, whether in a care home or a hospital.The shadow Minister made a point about the measures not being in the 2014 Act. Introducing the measures in this way provides flexibility. It would be a nightmare if we got into a situation in which we could see clearly that the provisions were not working effectively. He talked about having a review in 12 months, but if we monitor how things are going and find out that change is needed, but the only way to make changes is through a new Act of Parliament, that creates an inability to do anything until the next turn in the legislative process, which could result in years of delay. The use of secondary legislation gives the flexibility to make any necessary adjustments, so I think this is the right way of doing things.
Finally, on a review, it is incredibly important that we monitor constantly how effective the measures are and what impact they are having on standards of care. The
Care Quality Commission, through both its inspections of individual providers and its annual report on the state of care, will be able to provide a basis for such an assessment.Incidentally, we must ensure that we hold the Care Quality Commission to account. We are introducing the ability to prosecute and that power must be used. My message to the Care Quality Commission is this: if in future there are examples of poor care and the standard for a prosecution is met, I expect such a prosecution to be brought. The measures must be used to hold people to account. The Care Quality Commission has excellent leadership who recognise that they must act where appropriate and hold people to account when serious failures occur.