The
Committee consisted of the following
Members:
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 regulatorthe 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 regulationsthis point is very much related to
themI 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 Governments 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 Committees 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 Governments
preparedness for the introduction of the CQCs 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 Committees 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 Governments 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
sheeps clothing is still a wolf, and it seems that
Labours 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
Committees 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 Committees 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 registerfrom 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 chairmanas she insisted on
being called, notwithstanding anything that has been put before us by
the deputy Prime Minister of tricksof 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 States conference on social care reform during the
recess? Does that not suggest that the Government do not take the issue
sufficiently
seriously?
Regulation
14 on page 8 deals with meeting nutritional needs. I am glad that
nutrition made it into the regulations. We had long debates about the
importance of highlighting the issues of nutrition and health care
associated infections during the Committee stage of the Health and
Social
Care Bill in 2008. The Government went out of their way to boast about
the reduction in health care associated infections, and particularly
cases of MRSA, but to this day they have failed to acknowledge the
scale of malnutrition in the NHS. In the light of the fact that
malnutrition failed to make it into the Health and Social Care Act
2008, from which the regulations originatethe Minister at the
time set his face against the proposalwill the Minister today
give me an answer to the same old question? Why does she view HCAIs as
being more important than malnutrition, which affects more people, and
which results in breaches of articles 2, 3 and 8 of the European
convention on human
rights?
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 countrys 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 soonby 2012emerge. 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?
While
we are speaking about pregnancy, it is worth highlighting that
paragraph 12 of schedule 1 regulates abortion. The presence of that
paragraph emphasises the importance of ensuring that the regulations
are
both watertight and flexible enough to deal with the hugely diverse
range of activities that they seek to regulate. Regulated activities
range from abortion to care homes to surgery. It is vital that the CQC
can accommodate that diversity without watering down the way in which
it regulates each service.
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 Committees 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.
I want to
put it on the record very strongly that the Liberal Democrats firmly
support the principle behind these orders. It is the principle of
trying to ensure that those who are in receipt of what we call
health care and those who are in receipt of what we
classify as
social care have the same protection all the way through
our systems. I hope that the formation of the CQC and the movement to a
single regulatory framework will do somethingif only a
littleto bridge the rather artificial divide between health and
social care. I think we would all acknowledge that that divide is a
problem in policy making and that we must all focus on trying to close
it and, in the longer term, on trying to bridge it
altogether.
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