Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

Earl Howe Excerpts

Wednesday 5th November 2014 Lords Chamber

Moved by

[Earl Howe]

That the draft Regulations laid before the House on 7 July be approved.

Relevant documents: 6th Report from the Joint Committee on Statutory Instruments and 8th Report from the Secondary Legislation Scrutiny Committee

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, I am glad, but not surprised, that the noble Lord, Lord Hunt of Kings Heath, has shown such a keen interest in the importance of providing protection for users of health and care services. I thank him for bringing this issue to the Floor of the House. Naturally I am disappointed to understand from his amendment that he feels that the new fundamental standards are not satisfactory and undermine protection of care home residents. I seek to reassure him that that absolutely is not the case.

I begin by emphasising that the Government are serious about improving the protections offered to health and adult social care service users, both through the legislation that we have before us and through the system of regulation of health and adult social care carried out by the Care Quality Commission, of which these regulations form a part. I am sure that noble Lords will agree that the CQC has made enormous strides forward over the past two years, supported by many of the changes that we debated in this Chamber a year ago during the passage of the Care Act. Under the leadership of the three chief inspectors, the CQC’s specialist teams of inspectors are holding providers to account more thoroughly than ever before. The CQC’s inspections now look beyond mere compliance with registration requirements to provide ratings for each provider against five key questions. Are services safe? Are they caring? Are they effective? Are they responsive? Are they well led?

The first of these ratings is now being published. I am sure that noble Lords will agree that the new system provides much valuable information to patients and service users and commissioners, as well as to providers themselves. However, it is axiomatic to say that the key purpose of a regulator is to regulate—to take action where standards of care fall below acceptable levels. The regulations that we are discussing are central to this. They set the requirements for registration with the CQC, the fundamental standards that all registered providers must meet and against which the CQC can use its enforcement powers to protect patients and service users from the risks of poor care.

I will outline briefly how the new fundamental standards are an improvement on the existing registration requirements, before moving on to the detail. We are changing the regulations in order to address the issues raised by Sir Robert Francis, in his inquiry into Mid Staffordshire NHS Foundation Trust. He highlighted that the legislative basis on which the CQC was operating was undermining the effectiveness of the regulator. He criticised current regulations for being “overly bureaucratic” and said that they failed to separate the “essential” from “the merely desirable”. He recommended the introduction of fundamental standards which set the line below which care must never fall. He recommended that there be regulatory consequences for providers who fail to meet these standards, including the possibility of prosecution where breaches result in serious harm.

The new regulations set the following fundamental standards. Patients must receive safe care that meets their needs and reflects their preferences. Patients must be treated with dignity and respect, be properly fed, their views listened to, and be protected from abuse. The environment in which they are cared for must be clean, safe and secure. Care organisations must be well run, properly staffed, and be open with people about their treatment.

In my response to the noble Lord, I seek to reassure him that the fundamental standards do not dilute the current regulations, remove protections or leave people at greater risk of abuse or harm. In fact, they provide much stronger protection for service users from abuse, neglect and unsafe care than the current regulations. They explicitly state that care must be provided in a safe way, that people must be protected from abuse and improper treatment, that care must not be degrading and that is it unacceptable to disregard someone’s need for care and treatment. The requirements covering degrading care and significant disregard of needs are completely new and not covered by current regulations. It will be an offence to breach these standards in a way that causes avoidable harm or presents a significant risk of such harm occurring, and the CQC will be able to bring prosecutions against providers for such breaches without issuing an advance notice, something that is not possible at the moment. This is a major improvement that provides extra protection for patients and service users.

I want to discuss one of the key fundamental standards recommended by Sir Robert Francis: the statutory duty of candour on providers. It is a little over a year since I brought forward an amendment to the then Care Bill that placed an obligation on the Secretary of State to include in the requirements of registration a duty on providers to inform patients and service users where there were failings in care that resulted in harm—the duty of candour. These regulations fulfil that obligation in respect of the NHS by placing a duty of candour on NHS bodies.

In the debate on the duty of candour a year ago, noble Lords made two key challenges: first, that we should give serious consideration to the threshold for the duty of candour; and secondly, notwithstanding any such threshold, that the regulation should enshrine the general principle of being open in all cases. I hope noble Lords will agree that we have met both these challenges. I shall take the second challenge—openness —first. Regulation 20 sets out the duty of candour, its first line setting out the general requirement of candour:

“A health service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity”.

This is a general duty to be open in all dealings with patients, service users and their representatives. Where a provider does not meet this duty, the CQC will have the power to use its civil enforcement powers. However, a failure to meet this general requirement will not be an offence.

The remainder of the regulation sets out the steps that providers will have to take when a “notifiable safety incident” occurs. Noble Lords were quite right in saying that the key issue here is defining the harm threshold for such an incident that would engage the duty of candour formal notification procedures. The Government took expert advice and gathered a wide range of views before setting this threshold. We asked Sir David Dalton and Professor Norman Williams to lead this work. They published their findings in March, and the department subsequently consulted on draft regulations based on their recommended harm threshold.

In the regulations, a notifiable safety incident is defined as any unintended or unexpected incident that has, appears to have or could still result in death or severe harm, moderate harm or prolonged psychological harm. By following the recommendations of the Dalton-Williams review, I believe we have struck a sensible balance between the need to respond formally to patients when significant things go wrong and the need to keep reporting burdens within manageable proportions.

Building on this work, the regulation sets a series of specific steps that an NHS body will have to take where a notifiable safety incident occurs. These are: to notify the relevant person that the incident has occurred, to advise them what further inquiries will be made, and to apologise. A failure to take these steps will be an offence. This verbal notification then has to be followed up in writing.

This new duty of candour will support and underpin the Government’s ambition to transform culture across the NHS and support openness and learning, both between staff and organisations and to patients and service users. We will extend the duty to all health and adult social care providers from next April. Over time, the duty of candour will contribute to safer care. Noble Lords will also be pleased to learn that this week the General Medical Council and the Nursing and Midwifery Council have published for consultation draft guidance on the professional duty of candour, a measure that complements the statutory duty of candour on providers.

I finish by touching on the other new registration requirement that we are introducing—the fit and proper persons test, a requirement for directors of organisations registered with the CQC. The responsibility for providing safe and acceptable care will always rest with providers themselves. The tone and culture of an organisation is set by those people at its head. No matter how effective, regulation cannot be a substitute for good leadership at a provider level. 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. These regulations put an end to this, giving the CQC new powers to remove directors who are responsible for poor care. For the first time, the regulations place a legal requirement on NHS bodies registered with the CQC to ensure that their directors are fit and proper to fulfil their role. By next April, we plan to extend this requirement to all providers of health and adult social care registered with the CQC. This new measure, alongside the ability to bring prosecutions where failures in care harm patients and service users, will greatly increase the ability of the CQC to hold corporate bodies and their senior officers to account.

Effective regulation of health and adult social care is essential to protect patients and service users from the risks of poor care. The fundamental standards will support the Care Quality Commission in holding providers to account for the quality of care that they provide. Taken as a whole, these regulations improve the legal protections offered to service users, underpin and support a more effective regulatory regime, and champion openness and transparency across the NHS. I beg to move.

Amendment to the Motion

Moved by

--- Later in debate ---

[Baroness Howarth of Breckland (CB)]

My Lords, I will be brief, as I always am. I do not want to repeat what has been said before, much as I would love to be led down the path of talking abut the problems faced by care homes in the present financial climate. I must first declare an interest as a trustee of Livability, which provides a large number of care homes for disabled people and for other groups. I am therefore, as a trustee, in the role of a provider. I also want to speak very briefly on behalf of families and carers.

First, I say to the Minister that I welcome the regulations. I was interested in his spirited defence of them, and I know his great belief in them. There are aspects of the new regulations that strengthen the potential to hold care providers—such as my organisation—properly to account. That is all positive, but I simply want to address myself to the issues around the amendment on the Order Paper, because there is an issue and I would very much like the noble Earl to think about it.

We have been approached by a number of organisations which said that families and residents are very concerned about these three aspects of the regulations. I have looked at the old wording and at the new wording, and I found that the new wording is more elegant but much more obscure for ordinary people to relate to. It is terribly important that ordinary folk in a care home—both the providers and those receiving the service—understand that they have a right to be told about complaints procedures.

Clearly, that is there already. I disagree with those who say it is not. All of it is to be found within the regulations and the follow-up documents by those who actually dig through them. I believe that the noble Earl hoped—as he listened to all the hours of discussion of these issues—that this would be absolutely crystal clear. If these issues are clear, they also help leadership and management. It is much easier for providers to tell their staff how to take things forward if the words are absolutely clear, and if there is some sense of being given flexibility or whatever the expectation is.

When it comes to proper planning for emergencies, providers have an absolute responsibility to ensure not only that they have those plans, but that in the interests of health and safety everybody understands them throughout. Not only the providers but the residents themselves must understand. It is possible to have a great discussion about these issues among those who are receiving care. It is possible to discuss complaint procedures, choice of food and what happens if there is a fire and people can only be got out of certain areas by particular routes.

What I am saying is much simpler than the rest of the discussion. I would like the Minister to look at the wording, because in my opinion this is about language rather than intent. We have excellent regulations but, if families and users are concerned about these three areas, the Government have a responsibility to listen. I know we have a listening Minister.

[Earl Howe]

My Lords, I am grateful for the questions and comments raised by noble Lords. I will do my best to answer them in the time available. Perhaps I may begin with the issues raised by the noble Lord, Lord Hunt. The noble Lord expressed his regret that certain phrases no longer appear in the regulations, and those concerns were echoed by the noble Viscount and the noble Baroness, Lady Howarth. I should like to reassure the House that, although the regulations do not include express references to the three things highlighted in the amendment tabled by the noble Lord, Lord Hunt—informing service users about complaints procedures, having emergency procedures in place, and offering choice of food—nevertheless providers must still demonstrate to CQC that they are doing those things.

This is possible because the fundamental standards work in a different manner from the current regulations. They set the outcomes about quality and safety that must be met, rather than just the processes that must be in place. They set out the ends, rather than merely the means. Because we describe these outcomes in regulation, we no longer need to spell out a long list of processes in regulation as well. However, all the areas highlighted by the noble Lord nevertheless fall within the scope of the new regulations. For example, planning for emergency procedures is covered by the new safe care regulation, which requires providers to ensure that care is provided in a safe way, and that they do all that is reasonably practicable to mitigate the risks of unsafe care. A provider that had no plans in place to deal with emergencies such as floods or staff shortages could not claim to be meeting the regulation, because they would not be doing all that is practicable to mitigate the risks to the health and safety of service users from emergency situations. In practice, not having a plan in place for emergencies will therefore be a breach of the regulations.

The obligation to offer a choice of food and drink falls within the new person-centred care regulation, and the newly drafted nutrition regulation. We have introduced a new person-centred care regulation which requires that a person’s needs must be met, and that their preferences must be taken into account and, where possible, met. I emphasise that this applies not only to food preferences, but to all other aspects of care as well. This is a significant step towards greater person-centred care, advocated by many over recent years.

In addition, the nutrition regulation states that a person’s nutritional needs must be met, and it will be a criminal offence to fail to meet this regulation in a way that causes avoidable harm or significant risk of such harm. These two regulations work in tandem to require that a person’s individual nutritional needs are met and their individual preferences are reflected wherever possible. This is a stronger position than merely requiring that people be offered a choice. Such a requirement could be met by offering a person a choice of two things that are neither desired nor suitable. On the issue of complaints, the new complaints regulation states:

“The registered person must establish and operate effectively a system for identifying, receiving, recording, handling and responding appropriately to complaints, and requests for action to be taken, by service users and other persons”.

A provider who does not make patients and service users aware of their complaints system could not claim to be making it accessible, or claim they had an effective means of identifying complaints. Therefore, they would be breaching the regulation. CQC’s draft guidance about compliance with the regulations, which is currently subject to consultation, includes more information about all of these areas. It is this guidance that sets out in more detail what CQC will look for when checking whether providers are meeting the regulations. If noble Lords are in any doubt or have anxiety after this debate and after what I have said, I assure them that I would be happy to feed in the concerns which have been raised this evening in the context of the guidance that is now in preparation.

The noble Lord, Lord Hunt, described the regulations as light-touch, and the noble Viscount, Lord Hanworth, suggested that the Government were somehow pursuing a deregulation agenda by introducing these regulations. I must say to the noble Viscount in particular that that is a complete misreading of these regulations. Indeed, his speech indicated to me that he is labouring under a number of serious misapprehensions. Past experience has shown that there are limitations to prescriptive regulation. It is very difficult to make regulation exhaustive. The list might come to be the upper limit of what is provided, rather than the floor below which care should never fall. For example, the old national minimum standards for care homes included very specific requirements that set out the minimum bedroom sizes in square metres. In practice, this minimum became the default normal size for rooms.

The guiding principle behind the fundamental standards is that they set an overall outcome that must be met. The responses to our consultation showed that the vast majority of respondents agreed with this, and thought that the regulations were clearer as a result. I hope that that reassures the noble Baroness, Lady Howarth, in particular. Importantly, this approach allows the CQC to take a more rounded look at quality and safety as it inspects, rather than taking a tick-box approach to inspecting done solely against prescriptive regulations.