House of Commons portcullis
House of Commons
Session 2008 - 09
Publications on the internet
Public Bill Committee Debates

The Committee consisted of the following Members:

Chairman: Ann Winterton
Bradshaw, Mr. Ben (Minister for the South West)
Byers, Mr. Stephen (North Tyneside) (Lab)
Cooper, Rosie (West Lancashire) (Lab)
Curtis-Thomas, Mrs. Claire (Crosby) (Lab)
Efford, Clive (Eltham) (Lab)
Gidley, Sandra (Romsey) (LD)
Hepburn, Mr. Stephen (Jarrow) (Lab)
Johnson, Ms Diana R. (Kingston upon Hull, North) (Lab)
McCartney, Mr. Ian (Makerfield) (Lab)
Mates, Mr. Michael (East Hampshire) (Con)
Mulholland, Greg (Leeds, North-West) (LD)
O'Brien, Mr. Stephen (Eddisbury) (Con)
Purchase, Mr. Ken (Wolverhampton, North-East) (Lab/Co-op)
Soames, Mr. Nicholas (Mid-Sussex) (Con)
Syms, Mr. Robert (Poole) (Con)
Wilson, Mr. Rob (Reading, East) (Con)
Ed Waller, Committee Clerk
† attended the Committee

Second Delegated Legislation Committee

Tuesday 3 February 2009

[Ann Winterton in the Chair]

Draft Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009

4.30 pm
The Minister of State, Department of Health (Mr. Ben Bradshaw): I beg to move,
That the Committee has considered the draft Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009.
These are the first regulations that implement the Government’s new registration requirement for health care providers and the powers of the new integrated health and social care regulator, the Care Quality Commission. Some hon. Members present will remember discussing and agreeing both measures in the Health and Social Care Bill Committee last year. We have focused deliberately on healthcare-associated infections because of the level of public concern on the issue and the high level of priority the Government are giving to tackling them. We are focusing on the NHS as opposed to all providers to give the new Care Quality Commission space to prove itself in its first year of existence and to close the current gap which means that NHS providers are the only ones not subject to existing registration requirements. We intend to bring both public and independent providers of care into a single regulatory system from April 2010.
The current regulatory system, overseen by the Healthcare Commission, has played an important role in helping to reduce healthcare-associated infections. The latest figures show that methicillin-resistant Staphylococcus aureus infections have been reduced by more than half since 2003-04, which exceeds the Government’s MRSA reduction target. Clostridium difficile cases have fallen by 33 per cent. compared with the same quarter last year, which means that we are on course to meet our C. difficile reduction target too.
The regulations provide the Care Quality Commission with powers to do more in respect of hygiene and infections. It will be able to issue warnings or penalty notices to providers in breach of the regulations. It will be able to apply conditions to registration, such as a condition stating that the provider must not use a particular piece of equipment. It will be able to suspend or cancel a provider’s registration, effectively stopping the provision of care. Ultimately, it will be able to prosecute a provider through the courts, which can impose fines of up to £50,000. The regulations set the amount that the Care Quality Commission can fine individual NHS providers for a single offence at between £1,250 and £4,000. The regulations will give the Care Quality Commission the power to issue a penalty notice for every offence committed.
It is important that the public and the commissioners have access to information about services and service providers. The regulations require the commission to make publicly available certain enforcement action, such as the suspension or cancellation of registration or a court conviction. The commission will have to publish prescribed information about penalties and prosecutions within three months of the completion of proceedings, including any appeal.
The Care Quality Commission will have an important role to play in providing high quality health and social care for people in England. The regulations will ensure that it has the powers to make a difference in the fight against healthcare-associated infections.
4.33 pm
Mr. Stephen O'Brien (Eddisbury) (Con): I am pleased to serve under your chairmanship, Lady Winterton.
The context of the regulations is the Health and Social Care Act 2008. That was predominantly enabling legislation, giving rise to the tautological title of the statutory instrument “(Registration of Regulated Activities) Regulations”. That the 2008 Act was enabling also meant that the House was limited to discussing legislative frameworks rather than substantive issues. It is disappointing that the Government have sought to keep these important discussions on the regulations off the Floor of the House, although I welcome this limited opportunity for debate.
The regulations are made under powers conferred by, inter alia, section 20 of the 2008 Act, which enables regulations about managers of, workers on, the process of, the premises of and the finances and accounting of “regulated activities”, and the handling of complaints about “regulated activities”. The Government also chose to mention explicitly healthcare-associated infections in section 20(5) of the Act. It remains unclear why the Government chose to be explicit about HCAIs but not about other issues that have an adverse impact on the patient experience, such as malnutrition. Perhaps the Government find it more important to deal with issues that have a high media profile and so neglect other issues that patients and service users are facing. The exclusive emphasis on HCAIs persists in the regulations, which do not seek to address any other issues.
I have some questions about the working behind the regulations, as outlined in the explanatory memorandum, and about their wider impact on the NHS. I should be grateful if the Minister would comment on the extent of the regulations. I am concerned that under regulation 5(1) visitors do not come into the groups that must be protected. Why have the Government chosen to leave that group out? I also wonder whether the regulations will lead to a clearer picture of healthcare-associated infections within care homes. As recently as November of last year, Ministers were telling hon. Members:
“The information...specifying the number of cases of healthcare associated infections in care homes is not available.”—[Official Report, 29 October 2008; Vol. 481, c. 1054W.]
The Minister also knows that HCAI contraction is growing outside hospitals, in the community. Do the regulations address that in any way?
I remind the Minister of Anna Walker’s oral evidence. She is the outgoing head of the Healthcare Commission, which is to be replaced by the Care Quality Commission. When referring to the process at Maidstone and Tunbridge Wells, which is topical and important in the area of hospital-acquired infections, she said that
“at the end of a process like that, there is often considerable public anger and concern about what has gone on and I wonder whether some of the penalty issues need to be recognised in that context. The maximum fine allowed under the new legislation would be £50,000. There is an issue about public concern which that measure does not meet”.——[Official Report, Health and Social Care Public Bill Committee, 8 January 2008; c. 25, Q36.]
Mr. Nicholas Soames (Mid-Sussex) (Con): I support my hon. Friend’s point. Does he agree that even though there are many excellent managers in the health service, the scale of pay for many of them is outrageous? The maximum fine of £50,000 is out of all proportion when one looks at the salaries paid to senior NHS managers.
Mr. O'Brien: I am grateful to my hon. Friend, who takes a keen interest in health and care matters, particularly in his constituency and local NHS facilities. He has looked at such matters over many years, and he puts his finger on the deterrent effect of the maximum fine of £50,000, which is relevant to these regulations. After all, changing behaviour, getting people to be more hygienic in their approach as professionals, in hospitals in particular, will help to bring down hospital-acquired infection rates and support the Government’s target. He is right to draw an analogy about what is likely to have a behavioural effect in achieving the goal of much healthier environments in which to get better, which we all want to achieve. That may be to do with salary levels or, as I perceive it, with anxiety that the fund may be insured against such matters and that there would therefore not be a personal effect on those involved. Notwithstanding what everyone thinks about the pay levels, the big issue about pay is that there is a continuing collapse of productivity in the NHS that is of equal concern.
The point was also made that not only is a wider spectrum of sanctions needed—I refer back to Anna Walker—but it will also 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. In fairness, I think that the Minister raised that point. Why, for example, is the Crown court not available in the pursuit of sanctions? The Minister, in column 282 of the Official Report, assured the Health and Social Care Bill Committee that he would speak informally to Anna Walker on that point. Will he take this opportunity to confirm that he has done so and what the upshot was?
The explanatory notes speak of the CQC having a broader set of tools under the regulations, to deal with failures by service providers. One of the most controversial is the ability to close down wards or entire hospitals, which Baroness Young, who becomes the new chairman of the CQC, has said she will not be shy about using. Given that attitude, has the Department made any assessment of the number of wards that will be closed when the CQC takes over from the Healthcare Commission in a couple of months’ time? Has the Department a plan for the extra medical cover that will inevitably be needed, or is the Minister expecting the CQC’s bark to be worse than its bite?
Regulations 7 to 11 create a large amount of bureaucracy both for the CQC—something that Baroness Young has mentioned to me and I am sure she is having meetings with others too—and for any service providers on the receiving end. Can the Minister explain how the CQC will deliver without significant cuts in monitoring elsewhere, given that its staff is being reduced even as its work load is increasing? The Minister will be aware that Lady Young has already had to ditch the very helpful annual reports of the Commission for Social Care Inspection—also being disbanded to be subsumed in the CQC—which would seem to suggest that despite all the Minister’s protestations social care is taking a back seat in the concerns of the commission. As the Minister is aware, I am particularly exercised about that as we move into the merger.
One of the major absences in the regulations—I hope the Minister will be able to explain why—is how the CQC will be alerted to breaches of the code. Will it be through whistleblowing or through the now light-touch inspection regime? One of the key methods of alert under the old system was the handling of complaints by the Healthcare Commission. The Government have got rid of that power, although they have still not come clean on the costs to the parliamentary ombudsman, who is taking over that responsibility. We had lengthy discussions about that during the Health and Social Care Bill Committee. It is a pity that in reforming the complaints system in hospitals, the Government rejected calls from the official Opposition to reform complaints procedures in the social care sector, but I am glad that they have seen the light and intend to do that as part of the NHS reform Bill. At the time the Minister opposed our calls and said rather bluntly:
“Self-funders can, of course, take their custom elsewhere. They can choose civil remedies through the courts”.——[Official Report, Health and Social Care Public Bill Committee, 17 January 2008; c. 348.]
That statement was not well received at the time, so I am glad the Minister has had a conversion and I hope that it will be built upon as we proceed.
Will the Minister explain why the regulations focus on HCAIs and why he is willing to bind the hands of the commission on that issue but not on others? According to the Government, MRSA affected about 6,000 people in 2006-07 and clostridium difficile about 56,000. In contrast, in 2006-07, 139,127 people—more than twice as many—were malnourished during their stay in hospital. I acknowledge that he and I have touched on that point in the past and that he has had some issues about the way episodes are recorded; none the less, in the published figures to date—we are waiting for the delayed figures on the latest experience of malnourishment—the Government have not yet come clean on how many of those patients were discharged in a state of malnourishment, having gone into hospital malnourished. Possibly, all of them were. The number marks an 84 per cent. increase since 1997.
The explanatory memorandum makes it clear that the code of practice has been consulted on but in somewhat classic tones it states:
“The responses to the consultation were broadly supportive...and no major areas of concern...were consistently raised.”
The Committee will notice that such words cover a multitude of sins and it is unfortunate that we have not heard the results of the consultation and the responses in full, in order to have them made available to the House. I hope the Minister will be willing to share some of them with the Committee, including the more negative comments—or at least to put them in the Library. They would obviously have had a large impact on the way the debate took place when we were considering the Health and Social Care Bill in Committee.
In paragraph 10 of the explanatory memorandum we are informed:
“There is no impact on business, charities or voluntary bodies.”
Tellingly, some of the online text is in red, suggesting a last-minute excision of the tracked changes. Can the Minister explain how the regulations will bear on hospitals run by private companies or charities, or on other care settings in the charitable sector, such as hospices, which are crucial in all our constituencies? We are all concerned about the hospices’ continuing struggle to raise funds, particularly because their receipts from public bodies are declining. Why have they fallen through the scope of the impact assessment? Finally, can the Minister explain why he is debating these regulations, when his colleague, the Minister of State, Department of Health, the right hon. Member for Bristol, South (Dawn Primarolo), signed off the risk assessment? I hope that there has been at least some consistency.
I want to touch on a very interesting phrase in the impact assessment. Page 6 of the explanatory memorandum states that
“current powers of enforcement have not achieved the reduction in HCAI that research suggests is attainable.”
Is the Minster prepared to admit that the Government have not yet managed to combat HCAIs even to the level and scale of their own targets? Although we welcome the decrease in the last quarter, there were 45,000 cases of clostridium difficile in England in the past year and it is of great concern that annual deaths from clostridium difficile are now more than eight times higher than when Labour took office. There have been almost 37,000 deaths from MRSA and clostridium difficile under Labour and hospital-acquired infections now kill three times as many people as are killed on our roads every year—the sources for those figures are in my notes.
Far too many patients are catching infections such as clostridium difficile from having to share overcrowded wards. The Committee will be aware that the official Opposition have a zero-tolerance policy to tackle that situation.
“The Government said in 2001 that all new hospitals would have 50 per cent single rooms”—[Official Report, House of Lords, 26 February 2008; Vol. 706, c. 500.]
However, 82 per cent of new hospitals opened since 2001 do not have them. We have argued that it is possible, and it is our policy, to provide 8,000 more single rooms across the NHS, specifically to ensure that infected patients can be isolated. Furthermore, hospitals should not be paid or paid in full for treatment that leaves the patient with an infection such as MRSA. That approach has been well trialled and practised elsewhere in the world.
Even though there has been a welcome reduction—I emphasise that it is welcome—it is behind the curve of the Government’s target. They moved the goalposts so that they could “achieve” their target last April. If they had measured the target as originally agreed, they would have missed it by a whacking 14 per cent. That desire to ensure that the measures for tackling MRSA are somewhat difficult to follow seems to come from a concern about presentational values; indeed, we only have to look at the Prime Minister’s cynical deep clean gimmick to be reminded of that. It is the only major initiative on hospital infections since he took the premiership and has been widely criticised as having no effect by experts such as The Lancet and microbiologist Stephanie Dancer. What guarantees can the Minister give that the regulations will fare any better than the raft of broken promises and failed strategies that we have already had from the Government on HCAIs?
The impact assessment says that we need to look more closely at the research. The maths outlined on page 12 of the explanatory memorandum is an embarrassment. I would have thought that the Minister was embarrassed enough by the lack of evidence underpinning the health in pregnancy grant, over which we had many an argument, to try a similar thing on now. The memorandum assumes that a reduction in HCAIs of between 5 and 30 per cent. is possible through the regulations. However, that is based on four reports, none of which deals directly with the issue of HCAIs or even the health sector.
Three of the cited reports deal with penalties for contravening the United States occupational health and safety administration regulations—where is the link between occupational health and HCAIs? The reports stretch back to the 1990s, so the Committee must wonder why the Government did not tumble to them earlier—I might suggest that it is because they only come in useful when trying to shore up poor policy. The fourth report was a 2002 survey of UK top executives, which found that companies responded to sanctions. I am surprised the Labour Back Benchers do not have more to say about the use of that private sector study in the public sector. The report shows where the Labour Government have got things so wrong. Instead of changes at local level, which would make the difference to HCAIs, they are imposing another central target and bureaucracy on the NHS—surprise, surprise. As my hon. Friend the Member for Mid-Sussex pointed out, imposing top-down targets tends to be very counter-productive when it comes to motivating anybody to make a judgment and to carry out necessary action.
According to the memorandum, the measure will cost £1.6 million. Can the Minister say where that money will come from, and whether the hospital and social care funding is to be uplifted to match the bureaucratic costs providers will incur, or whether it will have to come out of patient care budgets? It is worth asking about proportionality too. If the Government did nothing, they could expect, according to the memorandum,
“five severe breaches of the Code by acute Trusts and ten severe breaches by non-acute Trusts”.
If the memorandum’s calculations are right—although that is highly unlikely given the irrelevance of the evidence—the number will only be reduced by a maximum of five, probably fewer. There would be 36 fewer MRSA cases in those trusts, and a maximum of 2,000 fewer C. difficile infections, in a cohort of 45,000.
I should be grateful if the Minister could clarify the local costs of the measures. The memorandum says:
“Maidstone and Tunbridge Wells Trust has indicated that it now spends £1 million more on cleaning”.
That is in addition to the thousands it has cost the Department through the Secretary of State’s somewhat confused position on the Rose Gibb case, which is currently sub judice. We will no doubt all want to know what the legal costs of that case alone are in due course.
The memorandum continues,
“assuming similar upper boundary costs in other Trusts, adjusted to be proportionate to size, it is likely that the cost of compliance will still be less than the avoided cost to the NHS of treating the infections.”
But according to the impact assessment only £28 million could be saved through a fall in infections. If Maidstone is spending an extra million it seems a bit far-fetched that the costs to the NHS will not exceed £28 million, given that there are many more than 28 trusts.
The Government have presided over an explosion in HCAIs during their tenure and although recent falls are welcome, they are behind their target. They have also done too little to look at the problem outside the hospital setting. Broken promises, in particular over single rooms, and political gimmicks are not the answer. These regulations mark an attempt to legislate out HCAIs and the estimates herein are based on the flimsiest of evidence. Only bottom-up change at local level will deliver on all our aspirations for better care. The regulations are better than nothing, but worse than the many more constructive lines of action the Government could have taken.
4.52 pm
Greg Mulholland (Leeds, North-West) (LD): Thank you, Lady Winterton. I will keep my comments brief. It seems a long time since we discussed this important issue in the Committee stage of the Bill. The Opposition clearly support moves to improve the system of dealing with healthcare-acquired infections and to push towards the robust system that all agree we need. Speedy action should come first, which has not always been the case in the past, followed by genuine action and enforcement involving reasonable yet effective penalties. That is what the Government say they are providing. It is for them to bring that forward and to convince all of us with an interest in health care that this is the right way to go. It is a huge improvement on the current system.
I have three queries for the Minister. They are more specific than some of those raised by the hon. Member for Eddisbury, although one echoes some of his concerns. Could the Minister clarify the reason for focusing only on certain environments that are subject to HCAIs? Concern was raised during the consultation process about the fact that general medical and dental practices would not be registered with the Care Quality Commission at this stage.
Secondly, I reiterate the point made by the hon. Member for Eddisbury about care homes. We are all increasingly concerned about that area. It is essential that the House should send a clear message that older people and members of other vulnerable groups who are in care homes—whether private, voluntary sector or NHS—deserve and are entitled to the same sort of protective system against healthcare-acquired infections. How does the Minister envisage that those people will in time be covered?
Another concern to arise from the consultation process was about clarity; some of the guidelines are perhaps a little ambiguous. Specifically, some of the regulations leave it up to the Care Quality Commission to judge what is “appropriate” in a given situation. It is reasonable to empower the CQC to use some judgment; but as we are dealing with the regulations today, it is important to be clear about what the guidelines say should be judged as appropriate.
Finally, I should like reassurance about whether the time scale for the process will be sufficiently quick. If it is to work and have the effects we all hope for, it will be necessary to stick to a clear and fairly rigid time scale. In particular, the turnaround, from the time when the CQC takes action and the time when it reports, needs to be quick. There is a three-month period for disciplinary action with respect to the commission. Will the Minister comment on cases of healthcare-acquired infections? What time scale does he envisage, and is it sufficiently robust?
4.57 pm
Mr. Ian McCartney (Makerfield) (Lab): I want to ask my colleague several questions, for clarification. Before I do so, I declare an interest, as I have a case before the Care Quality Commission, although that is not the subject of my questions.
I welcome the fact that the regulations include powers of enforcement. One of the problems in the past in the organisation and reorganisation of the various bodies that have regulated on behalf of patients who are the consumers of health care, and which have dealt with issues of advocacy, patient protection or complaints, has been the different commissions’ inability, or varying levels of ability, to act on their recommendations. With complex patient needs, and aspects of patients’ care coming within all three of the relevant disciplines—the social care sector, mental health or general NHS health care—it has been helpful to bring together all three commissions. I welcome that creation of a newer, more effective body.
Will my colleague say something about the relationship between the new commission and the NHS ombudsman? How will the progression from the complaint, through hospital ward or care home stage, all the way through to the NHS ombudsman, if it is necessary to go that far, be explained to patients and their advocates?
Secondly, will the new body also have a relationship with professional bodies? For example, in the case of complaints against a particular care home or mental health institution, the same type of complaint might arise over a period, relating not so much to the organisation of the institution as to potential professional problems with those who administer care. Is that likely to lead to the commission taking the responsibility for alerting professional bodies? Alternatively, will it be left to the patient and their advocate, or their Member of Parliament, to say that the matter should be taken further with those bodies?
In many instances, as things stand, a person’s only recourse, if the process up to commission level does not work, is to legal action. We are trying to resolve people’s complaints at an early stage and deal with them effectively—not just to say sorry when they are proved, but to take action on the complaint, and change either the culture of the organisation or a lack of professionalism. In consulting with patients or patient representatives who make complaints, will the new body have the capacity to pass the complaint to a professional body to consider whether there should be action against the professionals concerned?
I welcome the Minister’s comments on infections. I disagree with the hon. Member for Eddisbury because deep clean should not be seen in isolation, nor was it introduced in isolation. In my area, the trust consulted with local authorities, the social care sector, Members of Parliament and patients’ organisations to bring in five changes that have seen significant improvement in levels of C. difficile, MRSA and other infections that arise in the system. Cultural changes, organisational initiatives, treatment in aftercare regimes and prescription strategies, alongside a deep clean, have improved the situation significantly. Without trying to sound complacent, they will continue to do so.
The system is prone to breach in one area. In layman’s terms, that is brought-in infection. I have asked my trust to use its reporting system to look at the care home sector. In a reporting period of six or 12 weeks, as clients come into the acute sector from the care home sector, the number of cases of infection coming from each care home is recorded. We should work with care home owners to eradicate infections at care homes so that they do not breach the systems we are putting in place in the acute sector.
Brought-in infection puts everything at risk, including people who are already in the sector. It is not only unfortunate, but unacceptable, that elderly vulnerable patients are under constant threat of infection not from being in hospital, but from being in a care home. The logical extension is to consider what we should do to deal with brought-in infections. We must identify the care homes where infections are endemic.
Finally, local trusts seem to have individual control over examining unexpected or premature deaths due to medical interventions. Some are very good at that, but some are pretty poor. It is important for the Healthcare Commission and individual trusts to work together on a regular basis to find out why certain trusts have higher than average levels of unexpected or premature death, or near-death experiences.
My trust has come up with a new solution to that problem. It has appointed an independent consultant who grades all deaths that happen across the trust into four categories on a weekly basis. The fourth category is unexpected or premature deaths. That is my language, but I am sure that there is a more eloquent way of putting it. That gives the opportunity to investigate on a regular and ongoing basis why such deaths take place. Are they down to a lack of professional care, the structures within the trust or faulty treatment or aftercare regimes? From that, we may be able to give proper explanations to the families of those who have lost their lives.
Contents Continue
House of Commons 
home page Parliament home page House of 
Lords home page search page enquiries ordering index

©Parliamentary copyright 2009
Prepared 5 February 2009