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House of Lords Hansard
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
05 November 2014
Volume 756

Motion to Approve

Moved by

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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

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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

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At end insert “but that this House regrets that they undermine the protection of care home residents by removing current requirements in respect of complaints procedures, emergency procedures and choice of food”.

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My Lords, I should say right away that, overall, I welcome the thrust of these regulations. I am going to raise a number of points covered by my amendment to the Motion. I do so on the basis of broadly accepting the point raised by the Minister in relation to the CQC’s role and the way in which it is performing. However, there is particular concern about residents in care homes and the impact of the regulations which I would like to put to the Minister. My real concern is in respect of the three areas mentioned in my amendment in that, far from enhancing quality and public safety, the regulations actually reduce current protections in relation to complaint systems, food and emergency procedures.

I listened with great care to the Minister. He prayed in aid the remarks of Sir Robert Francis, and I will come back to them in a moment, but can the Minister also confirm that, in a sense, the regulations are a victim of the Government’s desire for lighter-touch regulation? The CQC clearly has a critical role in protecting some of the most vulnerable citizens in our country. This is not the moment for lighter-touch regulation. On any count, knowledge of the complaints system is important, particularly in view of concerns about standards of care in the health service and in many care homes. The current regulation states that the registered person must,

“bring the complaints system to the attention of service users and persons acting on their behalf in a suitable manner and format”.

The regulation goes on to require that,

“service users and those acting on their behalf,

are provided,

“with support to bring a complaint or make a comment, where such assistance is necessary”.

My understanding is that the Minister’s department is briefing that the new regulations are more outcome-focused and less specific about processes. However, if being less specific about processes means not telling people about them, it meets that test, I suppose. I also understand that his department is briefing that having an accessible and open culture is the same as having a specific duty to inform people about the complaints procedure.

However, the point I should like to put to your Lordships is that most residents and relatives have little idea of what to expect from a care home. Surely it is a relief to relatives and advocates when they are informed about these rights. It makes it easy for them to raise questions about care, knowing that that the regulations have the force of law and the matter cannot simply be left to local discretion. Few people comparing the two sets of regulations on rigour about complaints could argue that the proposed replacement is an improvement.

If one considers the tragic case of Winterbourne View—which I suspect a number of noble Lords will refer to—and other reports and the reports of the Health Service Commissioner, they continually emphasise that many providers’ stances on complaints are not fit for purpose. We know in relation to NHS complaints that there are continuous problems about people wondering whether they really can use them effectively. Almost all recent major care scandals have had their roots in people not being listened to or not knowing that they can complain. That is the basis of my major concern about these regulations.

Having emergency procedures in place seems pretty important, too. I do not understand the logic of deleting this important regulation. It may be that the Minister will say that it is covered by the new Regulation 17, but that states merely that, as part of good governance, the provider must establish systems or processes which enable the registered person to,

“assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others who may be at risk which arise from the carrying on of the regulated activity”.

That could easily be interpreted by providers to mean the normal, day-to-day risk assessments that they are required to carry out. I remind the Minister that care homes are pretty fragile organisations, often with very few qualified staff, and a significant proportion are without managers in place. That is why it would be much better to be absolutely explicit that emergency procedures should be in place.

On the choice of food, I would have thought that it is pretty integral to the quality of life. I understand that the Department of Health is stressing that the new regulations have to be read in conjunction with proposed CQC guidance, which may in many respects be stronger in stating that care home residents must have their needs and preferences taken into account. That is better than the simple provision of two alternative meals, neither of which the resident likes. Frankly, if the food is neither desired nor suitable, it breaches other regulations. The way it is being described shows a limited concept of the importance of food and of having a choice in care, when many people forget to eat and may need sensitive encouragement and real choices to tempt them into nutritious and sufficient eating habits.

I refer the Minister to the evidence I have received from Action on Elder Abuse. It is not unsympathetic to where the broad thrust of the regulations is going, but it is concerned that the regulations are now very top-line, leaving the detail to be fleshed out in guidance, and that some requirements have been weakened as a result, particularly those relating to complaints procedures, food and emergency planning, which I have referred to.

The Minister says that the fundamental standards do not undermine the overall quality. He mentioned that services should not be degrading, nor should they significantly disregard needs. Of course, I very much understand that. However, there is a real concern that the department’s approach is based on the assumption that there will always be well informed inspectors who will be on the spot to sort things out on a regular basis. The Minister will know that there are many examples of homes that have not been inspected for some considerable time. The new CQC guidelines also give inspectors far more leeway about what they choose to inspect. He will also know—given that we debate this so many times—that when it comes to issues to do with being signposted to complaints systems or food choices, if they are not in the regulations they may well be seen by inspectors as optional, rather than mandatory. The Minister made a telling comment when he referred to what Sir Robert Francis said about trying to divorce the essential from the desirable. My argument is that being signposted to complaints procedures and food choice are elements of essential need.

I agree with the Minister about the CQC and its approach. I like the approach that the new board and the chief inspectors are taking. They are starting to build up confidence. However, I want to ask the Minister about CQC capacity. I noted with interest an interview a few weeks ago with David Behan, the CQC chief executive, in which he reported that the CQC has scaled back its inspection ambitions for 2014-15 in order to ease pressure on CQC staff. Is the Minister in a position to update the House on this issue of capacity and whether it is affecting the programme of inspections? I am particularly interested in the issue of care homes and the regular nature of inspections of those homes.

On the duty of candour, the Minister has answered the first question I was going to ask about the criteria, and I fully accept his answer. He will know that the Secondary Legislation Scrutiny Committee rather took his department to task on the issue of having to bring forward two regulations, one in relation to the NHS and the duty of candour, which we are seeing tonight. I guess that another SI will be brought forward in the next few months. Given the different definitions there are likely to be, particularly in relation to safety incidents, the Secondary Legislation Scrutiny Committee has asked the department to ensure that the Explanatory Memorandum in relation to the second statutory instrument provides a very full explanation of the different definitions of a safety incident. Will the Minister confirm whether the department intends to do that?

Overall, I am sure that these regulations are going in the right direction, but there is concern in the care home sector around complaints, food choice and emergency procedures. I am particularly appreciative of the Relatives & Residents Association, which brought that to my attention. I hope very much that the department will be able to respond positively on those points. I beg to move.

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My Lords, the Minister, the noble Baroness, Lady Greengross, and I have a fair degree of form on this subject, going back over a number of years. Indeed, as I listened to the Minister introducing this matter to the House tonight, my mind wandered back to the dreaded days of the NHS Redress Bill, when the noble Lord, Lord Warner, sought to assure those of us who, in those days, sat on the other side of the Chamber that all would be well in the NHS and there was no need for a duty of candour because a new culture of openness was going to work its way through the NHS.

I have to say that things have changed because back then the professional bodies representing the staff of the NHS fought that duty of candour tooth and nail, so it is rather pleasing to have the news this week that they now have changed their minds and are willing to accept that they should uphold the duty of candour. They are moving to a point of discussing with their members not whether, but how, they do that.

I agree with the Minister that the CQC in its present form is a long way from CSCI and its predecessors in their various guises. It is properly constituted, far better resourced and has a focus to its work. Albeit that it works across a far bigger canvas than it ever did in the past, it is already performing to a much higher degree than before.

However, I return to the point the noble Baroness, Lady Greengross, and I made during the passage of the Care Bill. In that legislation, in relation to care homes and incidents where vulnerable adults may be thought to be at risk of abuse, this House fell short in its legislative function in that it did not give a power of entry to people or bodies who suspected that there might be abuse taking place. It is with that deficiency in the law sitting in place that we have to judge all the regulations and guidance such as this that come before us and ask ourselves whether, if a person was being abused or maltreated in a care home, it would be detected.

Therefore, the noble Lord, Lord Hunt, is right to focus, as he has done, on the issues of complaints procedures and emergency planning. I accept that within the overall framework service providers are now required not only to provide their services but to report on outcomes for individuals and standard of care, but nonetheless, there is something slightly amiss. For me, it goes back to the issue of power of entry. It goes back to the point at which a concerned relative has the power to override things.

I would also like to ask the Minister for a point of clarification. It seems that Ministers are quite clear that the introduction of new basic standards rectifies what was clearly an unsatisfactory position whereby one could not prosecute a provider unless and until an improvement notice had been issued. That was clearly wrong, and a number of providers got off the hook on that technicality. Will the Minister clarify, if he can, that under these regulations a breach of fundamental standards is still not in and of itself a reason to trigger a prosecution and that a reason to trigger a prosecution is a breach of the regulations? I would like to know how the department sees that working in practice to cover the deficiency to which I alluded a moment ago.

Finally, I welcome the fit and proper person test. It is long overdue. It is a good job that it is coming to the statute book as quickly as it is.

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My Lords, the quality of the provision in old people’s care homes varies widely. In the best of them, the residents are treated with respect and solicitude. In the worst of them, as we have witnessed recently, they are treated callously and brutally by underpaid and badly trained staff.

The increasing longevity of our population is leading to a rising demand for the provision of care for the elderly. Until recently, the implications of these developments have been ignored by all but a few concerned parties. The matter was brought forcefully to the attention of the public at large by the financial collapse of the Southern Cross enterprise, which was responsible for at least 20% of the national provision of residential places in care homes. It was running 752 homes when it collapsed in 2011 with losses of £300 million.

Southern Cross had been acquired by the private equity firm Blackstone Capital Partners for £162 million in 2004. Thereafter, it expanded rapidly. Through acquisitions, it tripled the number of homes that it was managing. The directors became multimillionaires. Inspections that were conducted during the period of its expansion raised grave concerns over the provision of care by homes within the Southern Cross portfolio. Indeed, the enterprise was warned about failing standards in its homes as it prepared to float on the stock market.

A more dramatic instance of the failure of care was provided by the scandal of Winterbourne View, a public-funded private hospital. A “Panorama” investigation broadcast in 2011 exposed the physical and psychological abuse suffered at the hospital by people with learning disabilities and with challenging behaviour.

The problems besetting care homes have been due, in part, to the inadequacy of their regulatory oversight. They have also been due, in large measure, to the increasing financial stringency under which they are operating. The income received by the homes from fees has been falling. Those fees have been paid on behalf of the great majority of residents by local authorities. Their income has been driven down by the Government’s austerity measures. At the same time, their costs have increased through factors outside their control, such as rising energy prices.

Another adverse condition is that the borrowing of the care home sector averages 75% of its net assets. This abnormally high level of indebtedness has been a result of the borrowings that were linked to the spate of acquisitions that preceded the general financial crisis of the sector. It has been pushed even higher by trading losses. This will expose the sector greatly to the widely anticipated rise in interest rates in the not too distant future.

The Government have reacted to these problems in a manner that many people regard as inadequate. They have not sought to improve the financial circumstances of the care homes. Instead, they have sought to improve the regulatory framework affecting the care homes via amendments to the secondary legislation associated with the Health and Social Care Act 2008, which will come into force in April 2015.

According to the testimony of the Minister of State for the Department of Health in the Commons on 16 October, the new regulations will,

“bolster the power of the regulator to take enforcement action, including bringing prosecutions against providers of poor care”,

and issuing penalty notices.

He remarked that, under the existing regulations,

“a notice had to be served first before moving to prosecution. If the provider complied with the notice, nothing could be done”.—[Official Report, Commons, Sixth Delegated Legislation Committee, 16/10/14; col. 4.]

The essential purpose of the new regulations is, therefore, to encourage improvements in the quality of care by strengthening the sanctions for failures.

Some additional provisions in the new regulations should also be mentioned. One much vaunted provision introduces a duty of candour, as we have heard, which is intended to facilitate the inspection regime. Another provision is a fitness test for directors of NHS bodies. That the test does not apply to the directors of other bodies concerned with the provision of care to the elderly appears to be a major lacuna. Finally, there is an allowance for the Care Quality Commission to publish ratings of care providers, which would be analogous to the league tables of schools.

The new regulations have been influenced by the Government’s overarching philosophy of deregulation. Certain duties that were imposed by the previous regulations have been omitted. It has been claimed that these omissions have been in pursuit of simplification, that existing regulations are overbureaucratic, and that they do not separate what is essential from what is merely desirable. Guidance will be offered in place of what have been deemed to be inessential regulations. Standards that were previously mandated by the regulations will now have the status merely of advice.

The claim that this will lead to simplification is belied by the nature of the voluminous and ill crafted advice of the Care Quality Commission. The inevitable result will be confusion and partial compliance. Moreover, it is doubtful whether, in such circumstances, the added threat of prosecution will be effective in raising standards.

We have been alerted, as we have heard, to some major lacunae in the revised regulations. Care homes will no longer be required to tell their residents about the existence of a complaint procedure. They will not be required to plan for and to have in place an emergency procedure. They will no longer be required to give residents a choice of food. A careful deconstruction of the revised regulations will doubtless expose many other omissions.

The new regulations reflect a very different philosophy on the part of the Government from the philosophy of our party. The Conservatives tend to characterise rules governing social provision as impediments to enterprise and initiative. Many on our side hold an opposite view. Such regulatory provisions as the ones we are now considering are seen as reflections of our social aspirations. They serve to define the civilised standards to which we feel bound to adhere.

The removal of a regulatory framework is liable to inflict significant damage on our society. A good example of this, on a practical level, has been provided by the Government’s National Planning Policy Framework. This replaced more than 1,000 pages of guidance and regulations with 50 pages, written simply and clearly, that were aimed, so it was claimed, at allowing people and communities to participate in the business of planning. In reality, a set of sophisticated and carefully crafted documents, which had provided policy guidance in many specific circumstances and which had been developed and refined over the past 25 years, has been tossed into the rubbish bin, to be replaced by 50 pages of vacuous pieties. The same damage is being inflicted on the regulatory framework governing the provisions for our care homes. We believe that it is not too late for the Government to think again.

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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.

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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.

The noble Lord, Lord Hunt, expressed the worry that care residents might not be aware of their ability to improve services. Regulation 17(2)(e) states that providers must,

“seek and act on feedback”,

from service users,

“for the purposes of improving … services”.

Providers who do not do this will be in breach of the regulations.

The noble Lord also asked whether the Explanatory Memorandum in the second set of regulations will cover clear definitions of a notifiable safety incident. The answer to that is yes. The harm thresholds for NHS bodies and other providers will be as closely aligned as possible. Our approach has been to use the same definitions as are already used in each existing sector to report harm to make the implementation of the duty of candour as straightforward as possible.

The noble Lord asked about CQC capacity. The CQC has been proactive in increasing its capacity. Its new inspections will take longer and more inspectors are needed. While the CQC is recruiting, it will ensure that the quality of inspections is not compromised. The CQC has taken significant steps in the past year to change the way in which it inspects and regulates providers. Since the appointment of the three chief inspectors, it has worked hard with providers to develop new models of inspection, as I know the noble Lord appreciates. It has successfully begun to use these new-style inspections in hospitals, in adult social care and in general practice, and I am confident in the progress that it is making.

My noble friend Lady Barker suggested that the CQC would be able to prosecute only breaches of the regulations rather than breaches of the fundamental standards. It is correct that the CQC will prosecute breaches of the regulations, but the regulations lay down the standards. A breach of the fundamental standards will therefore be a breach of the regulations.

I hope that I have been able to reassure the noble Lord, Lord Hunt, and all other noble Lords who have spoken sufficiently to make them feel confident that these regulations are the right way forward. I hope that the noble Lord will see fit to withdraw his amendment.

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My Lords, I am grateful to all noble Lords who have taken part in this short but very interesting debate. I say to the noble Baroness, Lady Barker, that I agree with her on the importance of the duty of candour. We do not really have time to discuss this in detail, but alongside a statutory responsibility on duty of candour there is a need to address culture, particularly within the National Health Service. I am not convinced that the current regulators are helping the duty of candour. I think that we have a blame/risk-averse culture currently operating in the health service which is often driven from the centre. Alongside a duty of candour, we have to look at the need to change the culture to one which is far more collaborative in support of organisations dealing with very difficult issues.

I agree with the noble Baroness, too, on power of entry. Her point on prosecutions being based on breach of regulations was important, which is why the language is so important.

The Minister said that this was not a deregulatory measure. I presume that he is saying that the Department of Health is not chalking it up to the Cabinet Office as an example of deregulatory action. However, we have all had experience of deregulatory approaches taken by Governments and I have to say that some aspects of these regulations seem to have been influenced by a deregulatory approach—I know that the Minister rather chided my noble friend on this point. In the end, some regulations are essential and sometimes advice and guidance alone are simply not sufficient. The noble Baroness, Lady Howarth, acknowledged that there are strengths in the regulations, and I do not disagree with her about that. Sometimes there is a need to use regulations to be absolutely clear to those who are providing services and those receiving them. That is the case when it comes particularly to issues around food choice, emergency procedures and complaints.

The Minister explained why the Government have gone for what they describe as an outcome-based approach—I understand that—and he then quoted to us Regulation 17(2)(e), which states that the providers must,

“seek and act on feedback from relevant persons and other persons on the services provided in the carrying on of the regulated activity, for the purposes of continually evaluating and improving such services”.

That is elegantly written, as one would expect from his department, but it does not say to me that residents are going to be told how to make complaints. Let us think not about the chains but about the individually owned care home. I really doubt whether that would be very clear to the people in charge. It would have been better if it were explicit in the regulations.

I was going to ask the Minister if he would ensure that the CQC read the debate, but I am grateful to him for already giving us that assurance. I hope that when CQC inspectors go into care homes, they are clear that the regulations mean that there should be a proper choice of food, people should have complaints systems signposted to them, and there should be an emergency procedure in place.

This has been a very useful debate. I will withdraw my amendment. I wish the regulations godspeed. I support the CQC in its approach, but, when it comes to care homes, the CQC needs to be explicit both to the homes and the inspectors about the basic standards that need to be provided.

Amendment to the Motion withdrawn.

Motion agreed.