Lord Willis of Knaresborough Portrait Lord Willis of Knaresborough (LD)
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My Lords, I am delighted to follow the noble Baroness, Lady Emerton. May I say—not as an aside but as genuine comment—that we are all in awe of her commitment to nursing and the care profession? It is not just eight weeks, but a lifetime of commitment. I think the whole House is enormously grateful for the contribution she makes.

I rise to support Amendment 144 in the name of the noble Lord, Lord Hunt, having first thought that it was not required. It seems fairly obvious that the Care Quality Commission shall, in carrying out its functions,

“have regard to any official guidance on staffing numbers and skills mix”.

The idea that any inspector or regulator would look at the guidance and then apply that as criteria would seem an absolutely normal process. Yet on reflection, having read the Francis report and the Winterbourne View report, one suddenly realises that, certainly from 2009 but far back in time as well, the department under successive Governments has offered guidance about safe staffing levels. It has done that in everything, but particularly in acute settings, I appreciate that. The fact that that was not taken into consideration makes the noble Lord’s amendment absolutely appropriate. I cannot see for the life of me why my noble friend would not accept it as a very sensible addition for making sure that the CQC, when it carries out inspections, takes that into consideration.

I would like to spend a little more time on Amendment 159, which has been so superbly introduced by the noble Baroness, Lady Emerton. Amendment 159 covers a lot of the same ground but goes further in spelling out the direct link between staffing and patient safety. It is important for my noble friend to understand what it does not do; nobody on either side of the House has sought to impose statutory staffing limits in legislation. That would be counterproductive in getting the sorts of outcomes that we want.

I prefer, as I am sure colleagues on all sides of the House do, to have strong statutory guidance with good inspection, which is what we have had in the past. The amendment of the noble Lord, Lord Hunt, does this—it completes the circle. I am very concerned that this House and the department spend too little time addressing the question of safe staffing. What does that actually mean? I declare an interest as an honorary fellow of the Royal College of Nursing. The RCN associates safe staffing with nursing because nurses, together with healthcare assistants under their supervision, do most of the care. But safe staffing is about the total product, not simply about nursing. It is also about the ward managers and everything else that goes into ensuring that when patients go into any setting, whether it is domiciliary, a care home or an acute hospital, there is an appropriate level of staffing.

When I was writing the Willis Commission report last year, one of the things that came up over and over again was a demand for mandatory staffing levels. I spent some time looking at the literature on safe staffing levels to see whether there was a correlation between having the right number of staff—registered nurses, care assistants, doctors or consultants—and outcomes. Frankly, it is very difficult to find empirical evidence to support it one way or another, simply because nobody in the healthcare system works in isolation from their colleagues. You are only as good as the team that works around you and their skills and training mix. I looked up what was happening in California where for more than 10 years they have had mandatory staffing levels for registered nurses. No other state has followed that. In April Senator Barbara Boxer introduced a Bill in the Senate to try to establish a federal system of ensuring that all hospitals had particular staff levels but nobody has followed that through.

There is some research being done in the UK, such as Anne Marie Rafferty’s 2007 study, with which Members are familiar. It was a really good piece of work which showed a 26% higher mortality rate in the cases of very high patient to nursing ratios. Kane’s meta-analysis in 2007 of all the literature indicated an emerging consensus that there are particular staffing levels beyond which the situation becomes dangerous. It is an issue for the department to constantly keep that under review. The amendment does not go over that ground but makes it clear in terms of safe staffing that there would be a duty on the provider, such as the hospital or the care home or those providing domiciliary care, to ensure that staff levels were appropriate and that staff competence is such to carry out safe care. After all, there is nobody in this House who does not want to see safe staffing within all NHS and other providers of health and care. That seems to be a basic starting point for a high-quality health and care system. We need to be able to ensure that that is the case. You will only find out what safe staffing levels are in a particular scenario and setting if you monitor them. That is why there is a requirement in the amendment to report on it. We are not talking about a report every three or five years, but there should be a continuous report so that when the CQC goes into a setting, it can look at the correlation between safe staffing levels, acuity and mortality rates and other factors, to see whether outcomes are dependent on particular mixes of staff.

Nor is the amendment saying that there should be annual reports. The Secretary of State would decide how often the department should be able to look at those reports. In essence, however, we are trying to establish that ensuring that the staffing mix is appropriate to the setting and to the patients who are being cared for is fundamental to healthcare. I hope that the Minister can give us some serious comfort on that. If we can get that right, we will have a good healthcare system.

Baroness Gardner of Parkes Portrait Baroness Gardner of Parkes (Con)
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My Lords, I am of course impressed by what has been said by the noble Baroness, Lady Emerton, who always knows so much about this subject. We have benefited from her great expertise over time. I am also interested in what the noble Lord, Lord Willis, has just said on the same amendment; he cited Amendment 159 but I thought it was Amendment 158.

Lord Willis of Knaresborough Portrait Lord Willis of Knaresborough
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It was Amendment 159.

Baroness Gardner of Parkes Portrait Baroness Gardner of Parkes
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I leave it to the department to work out whether it was Amendment 158 or 159, but that is not too important.

In many ways Amendment 144 does not go far enough. I am sure that the point of the noble Lord, Lord Willis—that the Care Quality Commission should be capable of thinking of these things for itself in any case—is right. However, the phrase “the skills mix” concerns me. There can be huge differences in the skills mix. I was concerned that the Chelsea and Westminster Hospital, having waited for perhaps as long as 10 years, at last got a specialist nurse for neurological conditions. The hospital was delighted because it had had huge demand for such a service. I am a great supporter of specialist nurse services.

The Royal Free then came along and poached that nurse from the Chelsea and Westminster, which then looked at what it could do. I was informed by word of mouth that there was no question or even thought of a replacement because there was a long list, and it was a case of “the first cab on the rank” as to who was deemed to be most needed. It could have been an ordinary nurse, it could have been a surgical nurse or anyone. You moved on and did not replace the person with the skills that you needed and wanted. You had to replace your missing person with whatever the next thing on the waiting list was. That seemed to be a serious cause for concern.

It is essential to know what skills mix is needed. The amendment mentions “official guidance”. It would have to go much wider than official guidance. It has to be attributable to the particular hospital or service that is involved. Although the amendment covers many of the important points, it does not cover the need for every facility to have cover within that department and not to then find that they have lost it because someone left—they could have gone off on maternity leave, they could have left for any reason, but in this instance they were poached by another NHS hospital.

Whatever the answer, it is important. The relationship between the staffing levels is hard to assess and has to be individually done. The Care Quality Commission should be capable of having an indication of what it should be looking at, and needs to be aware of all these problems. Of course, not one of us could oppose having enough staff on the wards, which the noble Lord, Lord Hunt, said was necessary. However, we are now faced with positions where budgets are limited and they have to look at and work out what they need most. I do not agree at all that it should be just a progression from whoever has been waiting the longest; it should be whatever the hospital, or a particular department, needs the most. Although I support the principle, perhaps it needs more than this. I am hoping that the Minister will be able to assure us that he can incorporate some words within those he already has to make it clear that there must be this obligation. I strongly support Amendment 144 and I am open to conviction about Amendment 158 or 159.

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Earl Howe Portrait Earl Howe
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My Lords, I hope that I can give noble Lords considerable reassurance on the Government’s position on these important issues. It is almost axiomatic that safe, high-quality care is dependent on people and that right-staffing, in terms of numbers and skills, is vital for good care. The importance of having the right staff with the right skills and in the right numbers is central to the delivery of high-quality care. Where staff are stretched because they are too few in number, corners will be cut, with inevitable adverse consequences for patient care. Equally, where staff do not have the right skills to carry out their tasks, the quality of care will suffer.

Patient safety is the first priority, and safe staffing levels really matter. The quality of care provided to patients is ultimately the responsibility of the leadership of provider organisations. It is their responsibility to ensure that they have the right staff with the right skills in the right place at the right time in order to provide high-quality care. In the final analysis, it is for hospitals themselves to decide how many nurses they employ, and they are the best placed to do that. Nursing leaders have been clear that hospitals should determine and publish staffing details and the evidence to show that staff numbers are right for the care needs of the patients that they look after.

Although local providers are best placed to do this based on local need, we expect them to look to authoritative guidance and evidence-based tools and learn from best practice to deliver cost-effective and safe care. We recognise that there is a need for national action to ensure that local organisations meet those expectations. As a result of the national nursing and midwifery strategy and vision published in 2012, Compassion in Practice, a considerable amount of work is going on across England to ensure that providers use evidence-based tools, using acuity and dependency measures to set staffing levels, and for boards to publish these staffing levels on a regular basis.

I want to explain what we are now doing to build on that work. First, the Chief Nursing Officer, supported by the National Quality Board, is developing guidance for the system, including a set of expectations, to support provider organisations in securing the appropriate staffing capacity and capability for nursing, midwifery and care. This guidance is being developed with the intention of ensuring safe patient care and that patient outcomes are not compromised. It will include expectations on transparency and publication of information on staffing.

This guidance is being developed jointly by the statutory organisations responsible for quality across the NHS, which are brought together as part of the National Quality Board and which include the Care Quality Commission, Monitor, the NHS Trust Development Authority and NHS England. It will be published next month. I can therefore only agree with the intention behind the amendment that providers need to be open and transparent about their staffing numbers. The positive news is that action is already in place to ensure that this happens.

Lord Willis of Knaresborough Portrait Lord Willis of Knaresborough
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What my noble friend has said is incredibly encouraging. However, before he leaves that point, could he take up the very important issue raised by the noble Lord, Lord Warner? This is not just about hospitals; it is also—particularly in my case—about care homes and other community settings. Will the regulations apply to all those settings, so that we get continuity throughout the system?

Earl Howe Portrait Earl Howe
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My Lords, I am happy to come to that point. The short answer is that that is certainly our intention.

I turn to Amendment 159, about which I will be a little critical. We consider that requiring health or care service providers to,

“publish a report containing staffing levels based on evidence of safe staffing levels supported by acuity and dependency levels for each patient”,

is really not a viable alternative to what we are already putting in place and would not work in practice. It would be burdensome to implement in precisely that form and could detract from the ability of staff to deliver good clinical care.

I understand, of course, the thrust of the thought behind the first part of the amendment, which says that,

“the first duty that a health or care service provider must consider for any decision is patient safety”,

However, it carries the risk of unintended consequences. It could lead to other important factors, such as innovation and service improvement, not being given sufficient weight and providers becoming unduly risk averse. We need to reflect that any innovative treatment—which we want to encourage in the health service—carries some risk. That is always justified by benefits for the wider system. We do not want clinicians to become reluctant to take risks if this amendment were passed.

Also, we do not feel that specifying report requirements for provider boards is the role of the Secretary of State any more. Rather, the focus has to be to allow for local accountability and local decision-making. However, as I have said, we recognise that decision-making tools are needed and I agree with my noble friend Lord Willis about that. We are working with the CQC, NICE and others to ensure that providers have the evidence-based tools they need to make decisions to secure safe staffing levels. These decisions will then be subject to external scrutiny and challenge by commissioners, regulators and the public, and to inspection by the Chief Inspector of Hospitals.

However, at the end of the day we come back to the fundamental point, that it is the responsibility of individual providers to be accountable for staffing levels in their organisations. The existing registration requirements, which are enforced and monitored by the CQC, already recognise the importance of that. That is my response to Amendment 144. The requirements state that providers must take steps to ensure that at all times there are sufficient numbers of suitable staff to carry on the regulated activities that the organisation provides. Additionally, the Chief Inspector of Hospitals has also made it clear that appropriate staffing levels are part of the requirements of registration for the CQC.

In assessing whether a provider meets the registration requirement on staffing, the CQC refers to relevant guidance about staffing levels and skills mix published by professional councils and relevant expert and professional bodies. These include the Department of Health, Skills for Care, Skills for Health, the NHS and the Royal College of Nursing. Where a provider does not meet the staffing registration requirement, the CQC is able to use its enforcement powers to protect patients and service users from the risks of unsafe care associated with inadequate and/or poorly trained staff.

In its consultation document A New Start, published in June this year, the CQC stated that the focus of its new inspection methodology would be on five key domains. Are services safe, effective, caring, responsive to people’s needs, and well led? These domains will cut across all areas of activity, including levels of staffing and skill mix.

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The Government recognise the concerns expressed on previous occasions in your Lordships’ House about the training of this critical part of the workforce. However, I hope that the House will recognise our commitment to bringing greater consistency and quality to the training provided to healthcare assistants and social care support workers, enabling them to place compassionate care at the heart of everything they do. I beg to move.
Lord Willis of Knaresborough Portrait Lord Willis of Knaresborough
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My Lords, I rise, somewhat gobsmacked, as they say in Yorkshire, at the launching by my noble friend of what has been a major breakthrough in the training of healthcare support workers. I notice that the noble Baroness, Lady Gibson, is nodding in approval as this is an area with which she too has been very closely concerned. I thank my noble friend for making that commitment. It makes most of my speech totally irrelevant but, nevertheless, I will add one or two bits just for good measure.

There is no doubt that there is an overwhelming case for appropriately training the 1.3 million healthcare support workers who do such a fantastic job in care homes and domiciliary settings, as well as in hospitals. This has been a national scandal so far. These people are a hugely valuable part of the workforce and it is important to recognise them as such.

I should like to ask some brief questions. Camilla Cavendish recommended that the certificate of fundamental care be a baseline on which there would be an advanced certificate. That would lead directly into nurse training so that there would be no glass ceiling for healthcare support workers, particularly since nursing has moved on to being an all-graduate profession. When the Minister responds, I hope that he will be able to say whether that is within the psyche. The idea of having student nurses working alongside healthcare support workers, particularly those training for the advanced level, is a good one, so that you know the skills mix that you are working with.

In Amendment 153, I railed at the word “may”. The amendment states:

“Regulations made under this section by virtue of subsection (3)(d) may in particular include provision for a specified person”.

Surely, the Minister could go one step further and say that, at Third Reading, it will become a “must” and not a “may”. The one thing we must not have—there are a lot of musts—is a situation where people can move away from this need to be able to make sure that within a short period the whole of our social, health and care workforce will be properly trained to a standard approved by the sector skills council and the Nursing and Midwifery Council. That is a major breakthrough.

My noble friend is right that there are some excellent training programmes. I have seen many of them. I remember one for healthcare support workers at John Radcliffe Hospital in Oxford within the hospital setting. I know that many care homes give superb training to their staff because that leads to good patient outcomes which sell the product. Has any thought gone into existing training being recognised so that people do not have to go through another hoop for the sake of getting their certificate? Perhaps Health Education England can do that with this. I hope other noble Lords will comment on our amendment.

Amendment 160 remains a thorny issue. A mandatory regulatory system for healthcare support workers has been on the table. Francis himself made it clear that this workforce should be regulated. Until now, my problem with that has been that there has been very little to regulate because if people are not trained to approved standards, how on earth do you have a regulatory system by which you can judge their competence? Now that we are getting one, I hope that the Minister will look again at regulation so that we get the complete package and, my goodness, this will be a Care Bill that we can really celebrate.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath
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My Lords, the noble Lord, Lord Willis, has just referred to my Amendment 160. It relates to the regulation of health and care support workers. I have long thought that the regulation of support workers is necessary, desirable and inevitable because they play such an important role in caring for so many people. I pay tribute to the noble Lord, Lord Willis, for the outstanding work he did for the RCN’s independent commission which has informed this debate about standards of care workers.

I very much welcome what the Minister said about the development of a certificate of fundamental care. My noble friend Lord Young reminded me that I ought to ask the Minister at what level that is going to be because anyone who understands these issues will know that the level of a certificate is very important.

I want to draw together Amendments 153, 158 and 160. Given that in future when employers wish to take on care workers they will expect a certificate of fundamental care, does the Minister not think it inevitable that there will be a list of people who have been awarded the certificate? Does he not also think it inevitable that once you have that list, if you then have a person with a certificate and they transgress and there is concern about the way they care for people, there will inevitability be a drive to ask how you get that certificate off them? I believe regulation is inevitable now. There is no way away from the fact that once you have a certificate like this, there will have to be a list or a register and people will have to be evaluated. I for one very much welcome what the Minister has announced because it is a very important step along the road of regulation.

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Earl Howe Portrait Earl Howe
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My Lords, at this point it will be convenient to consider also Amendments 166, 167 and 168. We have previously had some valuable debates about the Health Research Authority’s role in promoting transparency in research. I thank the Joint Committee that scrutinised the draft Bill and the Science and Technology Select Committee in the other place for their reports, which have informed Amendments 166 and 167.

In previous stages of the Bill’s passage, the noble Lords, Lord Patel, Lord Turnberg, Lord Warner and Lord Winston, the noble Baroness, Lady Wheeler, and my noble friend Lord Phillips of Sudbury have made particularly valuable contributions to the debate on this issue, which I have listened to with considerable interest. The Government have also discussed the Health Research Authority’s role in promoting transparency with stakeholders and with the existing special health authority.

The life sciences industry plays a key role in the Government’s strategy for economic growth and makes a valuable contribution to both the health and wealth of our nation. The Government agree that there is a powerful case for increasing transparency in clinical trials. Ensuring that research is registered and published and that data, information and tissue are available where relevant will help to make the best use of research, thereby maximising the health benefits for patients and the public from research undertaken and thus maximising the return on our investment in research. Amendment 166 makes it explicit that the Health Research Authority’s objective of facilitating the conduct of safe and ethical research includes promoting transparency in research. Amendment 167 lists some of the ways in which the HRA must promote transparency.

The existing special health authority is already making great strides in promoting transparency in research. The Health Research Authority published an action plan in May 2013, which received widespread support from a range of stakeholders including researchers, research sponsors, funders, professional bodies, stakeholders and members of the public with an interest in transparent research. Since 30 September, registration of clinical trials in a publicly accessible database has been a condition of favourable ethical approval from a research ethics committee.

These amendments will ensure that the Health Research Authority continues to promote greater transparency in research when it becomes a non-departmental public body. By doing so, that authority will continue to reassure people who participate in research that research is not duplicated unnecessarily and that unnecessary risks and burdens continue to be avoided. As promoting transparency in research is specifically included within its objective under Amendment 166, the Government would expect that the annual report would cover the authority’s measures to meet this section of its objective. While there is more to be done in this area, including by research funders, I hope that I have been able to reassure noble Lords that great strides are being taken and will continue to be taken.

Amendment 165 clarifies that the Health Research Authority may delegate any of its functions to any of its committees, sub-committees, members or any other person. The amendment mirrors a similar amendment that we have already debated with respect to Health Education England in Schedule 5—it was Amendment 157.

Finally, I would like to explain briefly Amendment 168, which corrects an oversight in the drafting of the Bill. It ensures that an appropriate body under the Mental Capacity Act (Appropriate Body) (England) Regulations 2006 is a research ethics committee recognised or established by or on behalf of the Health Research Authority, rather than a research ethics committee recognised by the Secretary of State.

I thank noble Lords and others for the contributions that have informed the amendments on the HRA’s role in promoting transparency in research. I hope that they will be welcomed. I beg to move.

Lord Willis of Knaresborough Portrait Lord Willis of Knaresborough
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My Lords, first, I declare an interest as the chair of the Association of Medical Research Charities. The brief comments that I am about to make are an amalgam of those made with the Academy of Medical Sciences, Cancer Research UK and the Wellcome Trust. On behalf of all those organisations, I can say how much we welcome these amendments and the way in which the HRA has so quickly become embedded into the research psyche. The work that it is doing ensures that on each of the major obstacles—of which ethics was the first, particularly in local ethics committees, but going right through to the regulation that it is starting to streamline, particularly with the Human Tissue Authority—we are really seeing a march forward. Frankly, the progress that has been made has staggered me. I congratulate not only the chairman and chief executive of that organisation but the Minister himself.