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Delegated Legislation Committee Debates



The Committee consisted of the following Members:

Chair: Mr. Joe Benton
Atkins, Charlotte (Staffordshire, Moorlands) (Lab)
Creagh, Mary (Wakefield) (Lab)
Gummer, Mr. John (Suffolk, Coastal) (Con)
James, Mrs. Siân C. (Swansea, East) (Lab)
Lamb, Norman (North Norfolk) (LD)
McDonagh, Siobhain (Mitcham and Morden) (Lab)
Merron, Gillian (Minister of State, Department of Health)
Moss, Mr. Malcolm (North-East Cambridgeshire) (Con)
Mulholland, Greg (Leeds, North-West) (LD)
O'Brien, Mr. Stephen (Eddisbury) (Con)
Roy, Lindsay (Glenrothes) (Lab)
Seabeck, Alison (Plymouth, Devonport) (Lab)
Tipping, Paddy (Sherwood) (Lab)
Waltho, Lynda (Stourbridge) (Lab)
Wilson, Mr. Rob (Reading, East) (Con)
Yeo, Mr. Tim (South Suffolk) (Con)
Mark Etherington, Committee Clerk
† attended the Committee

Seventh Delegated Legislation Committee

Tuesday 9 March 2010

(Afternoon)

[Mr. Joe Benton in the Chair]

Draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2010
4.30 pm
The Minister of State, Department of Health (Gillian Merron): I beg to move,
That the Committee has considered the draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.
The Chair: With this it will be convenient to consider the draft Health and Social Care Act 2008 (Consequential Amendments No. 2) Order 2010.
Gillian Merron: It is a pleasure to serve under your chairmanship today, Mr. Benton.
From 1 April 2009, the Care Quality Commission became the regulator of health and adult social care, replacing three previous commissions: the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission. To improve the current regulatory framework, the 2008 Act empowers the Care Quality Commission to operate a registration system for health and social care providers. The draft regulations enable the Care Quality Commission to implement that new registration system, setting out services that providers must register to deliver the regulated activities and what providers must do to be registered: the registration requirements. The regulations also enable the Care Quality Commission to take action if providers do not comply with registration. The regulations replace earlier draft regulations that we withdrew to deal with the issues raised by the Joint Committee on Statutory Instruments. The Committee is now satisfied with the version of the regulations that we are discussing today.
Why the need for change? During our lives every one of us will doubtless need some form of health care, be it NHS or private, or some degree of social care. When we do, it is important that we are confident that the care and treatment that we receive is safe and that those who provide it are properly accountable. The regulations aim to give people confidence that that is so.
The current system for regulating health and social care has become fragmented. In health care, NHS and independent sector providers have to meet different standards that are set under different Acts and they face different sanctions if they are found to be in breach of those standards. Although registered adult social care providers come under a single framework, the system lacks the flexibility to keep pace with services as they become more integrated, which means that some new forms of care, such as nurse-led services, do not fit neatly in the existing framework, where registration is based on specific types of establishment and agency, such as a hospital or a care home, rather than the type of service or care offered. That means that, at present, people cannot be fully confident that the same types of services are always satisfactorily checked and controlled in every setting.
The current system is focused on process rather than outcomes. It is prescriptive, setting out what must be done rather than focusing on what happens to the person concerned, which can lead to providers providing the required standards without necessarily delivering the outcomes that people need and want.
At the moment, the range of sanctions and enforcement powers available to the CQC vary. Because social care and independent health providers must register with the CQC, they can be prosecuted if they fail to meet the conditions of their registration or if they fail to meet the requirements that apply to them, which are contained in the regulations. However, other than in respect of health care-associated infections, the CQC has no equivalent powers over the NHS. If an NHS provider fails to meet the existing standards for better health, aside from those in respect of health care-associated infections, the CQC can only inform the Secretary of State and the strategic health authority or monitor the situation. If the failure is sufficiently serious, the CQC can investigate and make recommendations, but it cannot take direct action. In an era when ever more power is devolved to the front line, that becomes unacceptable.
Under the new regulations, all health and social care providers of regulated activities, whether they are from the NHS or the independent sector, will be placed within a single legal framework under the auspices of a single regulator—the Care Quality Commission. That will enable providers to focus not on process and tick-boxing but on ensuring high-quality outcomes for patients.
The new registration system for health and adult social care aims to assure people that, no matter what service or provider they choose, they will operate under the same safety and quality requirements. It will also enable strong, independent enforcement action to be taken against those who deliver unacceptable services, including the suspension or closure of services, and will ensure a proportionate approach to monitoring and registration that does not place an unnecessary burden on providers.
We want the registration system to be fair to those receiving care and to providers, whether of health or adult social care, be they from the NHS, a local authority or the independent sector. With greater clarity, flexibility and a focus on quality and safety, as long as providers deliver care that meets the essential levels of quality and safety, they will be free to run their services as they see fit to meet the needs of local people. To make that possible, the regulations include a list of regulated activities that require registration no matter who is providing them. The activities focus on the kind of treatment or care given, such as surgery or personal care, rather than the setting in which the care is given, such as a hospital or a care home. That will ensure a consistent approach to the way in which activities are registered, irrespective of location or model of care.
A list of registration requirements has been drawn up to address the potential risk to the safety, health, well-being and dignity of the people who use the services. It reflects the outcomes that people say are important to them, such as being treated with dignity and respect, being involved in decisions about their care, ensuring that health and social care workers have the right skills and qualifications for their roles, and safeguarding people who use services from abuse.
In addition, the Health and Social Care Act 2008 (Consequential Amendments No. 2) Order 2010 amends, with effect from October this year, a number of Acts that refer to institutions in England that are registered under the Care Standards Act 2000. If the new registration system is introduced, the current system will cease to apply. The amendments are therefore necessary to ensure that the various Acts continue to cover those institutions under the new regulatory system.
In summary, the regulations and consequential amendments are essential to the implementation of the new registration system for health and adult social care providers, and I commend them to the Committee.
4.38 pm
Mr. Stephen O'Brien (Eddisbury) (Con): It is a great pleasure to serve under your chairmanship, Mr. Benton. I do not feel that I have to say “under your chairship”, although that seems to be the way that we have all been driven recently.
The purpose of the two statutory instruments is to enable the Care Quality Commission to register health and social care providers, and to regulate the activities that they provide. The regulations and the order were considered in the other place last Monday, and I have had the benefit of a meeting this morning with the chairman of the CQC, Dame Jo Williams, and the chief executive, Cynthia Bower.
The purpose of the draft Health and Social Care Act 2008 (Consequential Amendments No. 2) Order 2010 is relatively straightforward. It seeks to amend existing legislation to create scope for the CQC to oversee and implement the new registration system created by the Health and Social Care Act 2008; I spoke for the Opposition at the time. We had many a debate then, and the Act seems to be more or less as anticipated. For that reason, I shall concentrate on the draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2010, which is by far the more controversial of the two documents.
Before I turn to the regulations—this point is very much related to them—I would like to emphasise that my party supports a more joined-up approach to regulation across health and social care. However, we must ensure that providers that seek to deliver better health and social care outcomes for patients are not hampered by loosely worded penalties that could leave the regulatory system open to misuse. Nor should we adopt a one-size-fits-all approach to regulation. Instead, we must acknowledge the difference between health care and social care. Co-ordinated regulation should facilitate co-ordinated services. By no means should it water down the standards of care that the NHS and social services must meet. The British Medical Association was keen to make that point in its briefing to this Committee.
Although the BMA sees some benefit in a system of generic registration requirements, there is some worry that the new proposals could bring additional bureaucracy. There are concerns that requiring individual GP and dental services to be regulated separately will add an additional layer of bureaucracy to the system, as well as leading to duplication on many levels. Can the Minister give an assurance that the new regulatory system will not increase bureaucracy for smaller health care communities, such as GP practices?
I will begin my more detailed remarks by putting the regulated activities regulations into their somewhat controversial context. As the Minister hinted, when the Government laid the original draft regulations before Parliament last year, they came under severe criticism in the third report of the Joint Committee on Statutory Instruments. It says something about the Government’s legislative abilities, if not their desire to see potentially draconian legislation go through on the nod, that they attempted to lay before Parliament regulations that would have imposed amorphous penalties on providers and severely hamper staff with the prospect of ill-defined criminal offences. I am pleased that they took on board some of the Joint Committee’s advice in redrafting and re-laying the proposals, but it is worrying that they had intended to pass the original draft regulations.
The Joint Committee published its report in December. It criticised the Government on three main counts. I pay tribute to the Joint Committee and to its Chair, my right hon. Friend the Member for Penrith and The Border (David Maclean). The original regulations were deemed to be
“defective in failing to specify sufficiently the nature of the criminal offences”
that would be incurred by providers who contravened the regulations. The Joint Committee pointed out that the 2009 draft regulations specified that a breach of any of the requirements laid out in part 4 would constitute a criminal offence. It was concerned that the wording of the regulations struck the tone of guidance, rather than hard-and-fast rules, and that as such, it would be unfair to prosecute a provider on the basis of them.
The Government have attempted to lessen the likelihood of prosecution by mandating that a warning notice from the CQC be given to the provider who is charged with the offence. However, they have done nothing to rectify the imprecise and, frankly, woolly wording in provisions such as regulation 17. How is a provider expected to determine whether they have failed to
“treat service users with consideration”
or to encourage service users to “express their views”?
The Government have reiterated that draft guidance on how providers are expected to meet the regulations has been issued by the CQC. However, it was published only in December and the regulations will come into force as soon as April, or October for some providers. That the Joint Committee was not given sight of the guidance when it considered the regulations does not reflect well on the Government’s preparedness for the introduction of the CQC’s new registration system, nor on the capacity of providers to ready themselves in time for compliance later this year. I join the Joint Committee in expressing my regret that the Government did not think to publish the CQC guidance prior to laying the first draft of the regulations before Parliament.
Having read the guidance, I am none the wiser as to what outcomes providers are expected to deliver to ensure
“the dignity, privacy and independence of service users”.
Providers are told that to do that, they must ensure that staff understand the concepts of privacy, dignity and independence, and that they place the needs of service users at the centre of the delivery of care. That states the obvious. Surely the point of issuing guidance is to unpack broad concepts such as dignity, and define them in terms of the outcomes that staff should aim to deliver for service users.
We must remember that a lot is at stake for providers. If they are judged not to have preserved the dignity of service users, they face a maximum penalty of £50,000. We must also remember that the CQC is responsible for detecting areas of poor practice in the NHS and social services. It is difficult to see how it will perform that role with any degree of rigour with such loosely worded regulations and guidance at its disposal. If the CQC is to be given such significant powers to impose penalties, its guidance has to go into detail on how providers can avoid those penalties.
I am interested to hear whether the Minister believes that the guidance is sufficiently detailed to enable providers to avoid penalties. As the Government have not amended regulations 9 to 24 to clarify the exact nature of a provider offence, we remain dependent on the guidance for elucidation. In the light of that fact, is the Minister confident that she has fully satisfied the Joint Committee’s recommendation? It is not at all clear whether she has, and I will be interested to hear what further comments she has to make on that particular aspect.
I was intrigued to read in the Government’s explanatory memorandum that the Government perceive the regulations to have an “outcome focus”. I am afraid to say that it is very difficult to identify that focus in the order in front of us. A wolf dressed in sheep’s clothing is still a wolf, and it seems that Labour’s obsession with top-down targets continues to pervade its legislation. As the Joint Committee points out, the impact of the order is such that
“a registered person would appear to commit an offence...even where nobody has been inadequately nourished, if the means by which the registered person secures that outcome does not involve providing ‘a choice of suitable...food’ ”.
In other words, meeting the requirements of the regulations takes precedence over delivering good outcomes for patients. It is the same old story.
Even when the Joint Committee challenged the Government to adopt a more outcomes-centric approach to regulation, the Government ignored the advice and ploughed ahead with their target-driven agenda. Can the Minister explain her rationale for not heeding the advice of the Joint Committee, or for rejecting her own nutrition action plan delivery board report and experts in the field of nutrition and care more widely? She may have introduced the notice period before providers are prosecuted, but she has still not rectified the lack of consideration for the outcomes delivered by care providers and professionals in her approach to the regulations.
The Joint Committee’s third concern about the regulations is the scope for the CQC to apply the maximum £50,000 penalty for all contraventions of the requirements in part 4. Although the Government have clarified their intent to vary the penalties given to providers who are found to be in breach of the regulations, no tiered system of penalties has been added, and the CQC still has the power to fine the maximum amount for any breach of the new regulations. Will the Minister explain why she has not taken on board the Joint Committee’s comments on that matter?
Although the regulations address the issue of essential levels of safety and quality, I emphasise that the vague language of the drafting creates an open book for the CQC to misinterpret or, worse, abuse the powers given to it by the regulations. It is important that the Minister acknowledges today that I put the Government on notice of the issue during the passage of the Health and Social Care Bill. I recall telling the Committee that
“it will be important to have sanctions suitable for the body in question, given the range of providers that the CQC will register—from small care homes to giant hospitals... There is a world of a difference between what might need to be done in relation to an accident and emergency hospital facility, compared with a small care home.——[Official Report, Health and Social Care Public Bill Committee, 17 January 2008; c. 282.]
We are therefore talking about an intended inadequacy on the part of Government. The Government cannot claim in all honesty that the flaw in the regulations and the legislation is unintended, because they have been on notice since we first considered the matter.
The debate then focused on the other end of the problem. I say “debate”, but the then Health Minister, the right hon. Member for Exeter (Mr. Bradshaw), is as concise in the Chamber as he is lyrical before the cameras. In her evidence to the Committee, Anna Walker, the former chairman—as she insisted on being called, notwithstanding anything that has been put before us by the deputy Prime Minister of tricks—of the Healthcare Commission said that £50,000 was not enough as a sanction against an NHS trust. Moreover, the BMA also expressed concern in its briefing to this Committee that the penalties permissible under the regulations will not encompass sufficient flexibility to accommodate both smaller and larger health care providers.
Let me turn to the detail of the regulations. On page 3, there is a definition of “personal care”. It is worth the Committee noting that there is currently no such definition in primary legislation in England. In Scotland, personal care was defined when so-called “free” personal care was introduced in 2002. Will the Minister explain why the definition in the regulations is not more explicitly based on the activities of daily living, around which social care reform is being debated? For example, help with managing and monitoring medication counts as one of the activities of daily living, but there is no mention of that in the definition of personal care. The Minister will be aware that the activities of daily living are as follows: personal toilet, eating, drinking, managing urinary and bowel functions, managing problems associated with immobility, management of prescribed treatment, behaviour management, and ensuring personal safety.
Regulation 11 on page 7 deals with protection from abuse. Will the Minister clarify why the charity Action on Elder Abuse was not invited to the Secretary of State’s conference on social care reform during the recess? Does that not suggest that the Government do not take the issue sufficiently seriously?
Sadly, despite our warnings, the Government continue to drag their feet on malnutrition. The delayed publication of the details on the nutrition action plan delivery board shows that they did not take a sufficiently serious attitude towards it, and their somewhat vapid response to the charge of 50,000 people a year dying from malnutrition shows how little Ministers are interested in tackling the issue. All that we get is the argument on why we should not worry about the numbers; the argument is that the definitional issue is the problem, rather than people coming out of hospital more malnourished than when they went in. It cannot be argued that that is all to do with the conditions for which they were hospitalised.
Will the Minister comment on the editing of regulation 16(1)(b), where
“used in accordance with the technical specifications and guidance issued by the manufacturer, the Secretary of State or appropriate expert bodies”
has been replaced by “used correctly”? That is a widening of the definition and something of a legal catch-all. I hope that the Minister will clarify that.
Regulation 22 on page 11 states that providers must ensure that
“there are sufficient numbers of suitably qualified, skilled and experienced persons employed for the purposes of carrying on the regulated activity.”
It is clear that there is a dearth of expertise in dementia care both in the NHS and in the country’s care homes. Given that the provision of staff who are trained and skilled in the area of dementia care is key to preserving the dignity and welfare of dementia patients, can the Minister provide the Committee with an update on her pledge to introduce guidance for care home staff on best practice for dementia care during 2009-10?
Schedule 1 identifies regulated activities and exceptions to them. Might I ask you, Mr. Benton, to fasten your seat belt for this one? Regulation 11 on page 19 deals with the regulation of midwives. It is vital that we ensure that the highest care standards are maintained in midwifery, and in every other aspect of the NHS. However, the Government must act now to fill the gaping hole in midwifery staff that will soon—by 2012—emerge. The Royal College of Midwives reported in April last year that the NHS in England will still be suffering a severe lack of midwives even if Government recruitment targets for an extra 3,400 midwives are met by 2012. Will the Minister inform the Committee what action she intends to take, not only to regulate midwifery, but to provide sufficient numbers of midwives for the public in the first place?
Only yesterday, concerns about out-of-hours ambulance services were brought to the attention of the official Opposition. Providers of those services expressed fears that the new regulations would not take into account the idiosyncrasies of the service that they offer. As Earl Howe pointed out in the other place yesterday, those concerns are being voiced widely by health and social care professionals from across the NHS and social services.
I want to bring the Committee’s attention to regulation 19, which deals with the complaints procedures that providers must put in place for service users. The Health Act 2009 extended the remit of the local government ombudsman to deal with complaints from social care self-funders. Therefore, although it is early days, I would be interested to know if the Minister can tell the Committee how that system is progressing and what impact the regulations are likely to have on it.
One thing that is very noticeable in the drafting of the schedules is that as well as a list of activities that must be included, there is a list of exceptions. It turns out that there are exceptions to the exceptions, and indeed exceptions to the exceptions to the exceptions. I hope that the Minister will recognise that there is some drafting prolixity that could have been avoided. It may well be better if those drafting the schedules started again, because some of the drafting has gone full circle, and there are only so many smaller circles that one can fit into a Venn diagram before one runs out of space. That drafting needs to be looked at, but I recognise that if we are to approve the measures today, that issue may need to be considered a work in progress, rather than something that will hold up the passage of the regulation.
I welcome the establishment of the CQC. I cannot emphasise enough the importance of putting in place a robust system of regulation to protect patients and service users, and to guide the staff who care for all of them. However, the lack of rigour shown by the Government in drafting the regulations is disappointing, and to my mind there are still parts of the regulations that do not satisfy the points raised by the Joint Committee, some of the questions that I posed today, and indeed the questions put in the other place yesterday.
I hope that the Minister will take this opportunity to put at least some of my concerns to rest and, to the extent that that is not possible, I hope that my points have been noted. I also hope that it is recognised that the regulations are therefore a work in progress that will require further work.
4.57 pm
Greg Mulholland (Leeds, North-West) (LD): I have only a few brief comments to add to what has already been said.
Having said that, it is also worth putting on record that there remains the concern that, with the merging of the different organisations to form the CQC, social care might not receive the attention that it needs and that there could be a perverse impact, with social care, including mental health care, not receiving the type of focus that is clearly necessary to ensure that those people who are receiving those forms of care have the same rights and the same protection as anybody else.
The hon. Member for Eddisbury made a number of points effectively. For example, he mentioned malnutrition, which is a hugely important issue that has not had significant attention. Equally, there is the issue of dignity and the fact that we still have a problem, particularly in the social care sector where the dignity of individuals is not always assured. That also applies to some instances within the NHS. As a member of the all-party group on dementia and someone who has spoken about the condition on many occasions, I think it is well worth making that point and reiterating the specific needs of those with dementia and the importance of proper training, as well as measures such as the orders to ensure that people are properly looked after.
It would be remiss of me not to raise the concerns about the performance so far of the Care Quality Commission. It is a new organisation, but there have been teething problems and incidents in which it has failed in its duty. I ask the Minister to give us the confidence that the orders will enable the Care Quality Commission to become an organisation that delivers protection despite the problems and cases that have arisen, including the inspection of the Eccleshill independent treatment centre in Bradford, where a constituent of mine tragically died due to inadequate safety procedures. The CQC investigated the facility this year, but there was confusion about the report. It still has teething problems that need to be ironed out before we can have confidence in it. Will she tell us that the orders will do so?
As the Minister well knows, various organisations still have concerns about bureaucracy, a lack of clarity and the tendency to treat all organisations the same. Huge organisations employing thousands of people come under the same umbrella as individual practitioners. She needs to give smaller practitioners more confidence that they will not face the same penalty sanctions as larger organisations, as that would clearly have a completely different impact. Will she assure the Committee that monitoring will be ongoing, as will consultation with all the different care and health providers? We all want to ensure that everyone in the social care and health sector is properly protected. Will she give us a sense that the orders are part of an ongoing framework to ensure that we get that right? We all agree that it must be right to ensure that everyone within the social care and health sector is properly protected.
5.2 pm
 
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