Health and Social Care Act 2008 (Regulated Activities) Regulations 2010

My Lords, the Committee will be grateful to the Minister for her explanation of these regulations, which, as she said, take us to the next stage of the journey for the Care Quality Commission in setting out the full range of its statutory functions as a regulator of health and social care services. In reading the regulations, as I have, I am struck immediately by the length of the list of regulated activities and, hence, the sheer size of the task that the commission faces. The commission has within it a lot of dedicated and hard-working people, and not all of the activities listed have to be tackled immediately. Dentists and GPs are not to be registered until 2011 or 2012. Nevertheless, I feel that I should start by asking the Minister the simple question of whether the CQC's programme of work to register all relevant providers by 1 April this year or, as the case may be, 1 October, is on track. Is she aware of any hint from the CQC that the commission may find the timetable difficult to meet? It is a slight pity that the regulations are so difficult to interpret. Perhaps it is just me but, if we look at Schedule 2, we find a list of general exceptions to the regulated activities named in the earlier part of the order. However, paragraph 5 of Schedule 2 sets out a list of exceptions to the exceptions listed in paragraph 4. Paragraph 5(e) even has an exception to the exception to the foregoing exception. I had to think about that one quite hard. But that is not all, because we then have to remember that paragraphs 3, 6, 7, 9 and 11 of Schedule 2 are only exceptions for a limited length of time, as is made clear in Regulation 3 at the beginning of Part 2. I am still unclear whether hyperbaric therapy, which is excepted in Regulation 5 and then de-excepted from the exceptions in Schedule 2, is, or is not to be, a regulated activity. On a more substantive level, will the Minister explain for the record why defence medical and dental services are not to come under the wing of the CQC and why medical services provided by employers or government departments are not covered? One of the criteria which the CQC is to use when deciding whether or not to register an individual or a partnership as a registered provider of regulated services is whether the person or persons concerned are of good character and physically and mentally fit to carry on the regulated activity. There are similar requirements in relation to managers and those in charge of organisations other than partnerships. What tests will be used to determine whether someone is of good character, and how do you prove that you are? It does not seem to me that an absence of criminal convictions is sufficient to meet that test. How does a person show that he or she is physically and mentally fit? Unless the guidance on these things is crystal clear, we may be in danger of creating hurdles that are not simply bureaucratic but also highly subjective. That surely cannot be the way to go. I do not intend to spend time discussing each and every regulated activity. However, there is one activity which perhaps merits special attention, as it is one to which the Minister referred, which we have debated on several occasions in the past—the one listed in Regulation 14, meeting nutritional needs. The regulation is framed in a way that I cannot fault. It speaks of the need to ensure that service users are protected from the risks of inadequate nutrition and dehydration by means of the provision of a choice of suitable and nutritious food and hydration in sufficient quantities to meet service users' needs. My question relates to the standards that the CQC will take as its benchmark for this purpose. There is an initiative in train, which the Minister will know about, called the Healthier Food Mark, to be promoted in public sector organisations. This potentially has a lot going for it, but, unfortunately, in my view, it is flawed. There are three levels of Healthier Food Marks: bronze, silver and gold. If the idea is to raise the quality of nutrition in hospitals to the highest standard, it is questionable whether having three levels of attainment will serve to achieve that. The CQC is concerned, above all, with upholding minimum standards of quality. It might be thought that a bronze certificate under this initiative served to define what those minimum standards should be. However, the bronze Healthier Food Mark sets standards that, frankly, could be achieved by an organisation that was not doing a great deal. For example, the need to cut down on salt is emphasised only in relation to cooking vegetables without added salt, but there is nothing about making sure that salt levels in other food are reduced. Nor is there any detailed prescription about keeping the level of saturated fat to an acceptable level. There is nothing about portion sizes or offering a choice of drinks without added sugar. The problem is that anyone seeing a bronze certificate on the wall of a hospital may well conclude that that hospital was achieving a level that was only a rung or two below excellent. What incentive would the hospital have to improve its performance in those circumstances? It would surprise me if the Healthier Food Mark initiative did not in some measure act as a guide or benchmark to the CQC. I should be grateful if the Minister could say something to indicate how the CQC will be approaching its functions in this area. I would, however, like to move on to a larger set of issues. The Merits Committee of your Lordships' House drew attention to a number of concerns relating to the way in which these regulations have been framed. The first of these is what it saw as a lack of sufficient clarity in the wording to enable someone to decide whether they are or are not in breach of the regulations. To the extent that this criticism is justified, which I believe it may be, it is a serious concern bearing in mind that the maximum penalty for breaching the regulations is set at £50,000, which is a large sum of money. Despite the Minister’s remarks just now, it is not clear why it has been thought appropriate that all breaches of the regulations should potentially attract a penalty of that order. I would like to ask the Minister why it was felt right to set the maximum figure at that level for offences that are not directly to do with harm to patients. What all this opens up, of course, is the potential for highly subjective judgments to be made by inspectors, which then rebound on service providers. We are told that the regulations have been deliberately framed so as to focus on outcomes rather than process. As a principle, I am all for outcome-based measures; but the problem is that inspectors are powerful people, and if they decide that they wish to be prescriptive in pursuit of a particular outcome, it is likely that few service providers will feel brave enough to argue with them. The Merits Committee has therefore raised the question of how inspectors will be trained and how it will be possible to achieve consistency of assessment around the country. What we cannot have is marked differences of approach being taken, depending on geographical location. This really has to be a concern that the CQC takes seriously, and I should be glad to hear what the Minister has to say about it. Nor is this a theoretical concern. I have spoken to several people who have already been on the receiving end of the CQC's ministrations. Apart from the rudeness and officiousness encountered in inspectors—which I confess dismayed me—they report something even more serious, which is an overzealous quest for information which has little or no bearing on the quality of care given to patients and service users. The proprietors of a small outpatient clinic, in order to be registered, had to complete a voluminous form, some of which was barely comprehensible to them, and much of which demonstrated, if proof were needed, that the tick-box, process-driven approach to regulation is alive and kicking. Questions about gas meters and the positioning of electric sockets are not obviously to do with patient outcomes. One doctor who sought advice from a CQC inspector on how to complete a form was told quite candidly that the CQC was collecting a great deal of information that no one there really knew how to interpret. It is as if questions had been included in the registration form simply to preserve the appearance of thoroughness against the remote risk of a rare adverse event. We can never legislate against the rare event; rare events will happen. They are rare because most professionals are competent. However, in the eyes of the CQC, most professionals are slapdash and need checking up on to make sure that they are achieving basic levels of patient care. One doctor told me that he was almost on his knees with exhaustion after the paperwork between him and the CQC had gone backwards and forwards several times long after his registration had been agreed. I am afraid that we may have unwittingly created a monster. We are in danger of losing sight of what is common sense. If we are not careful, the result will be that we will land up with a bureaucracy that is effectively out of control. I recount this feedback from service providers only because the stories they have told me are so consistent. The questions with which I leave the Minister are these: will she make it her business to look at first hand at the registration processes employed by the CQC, and will she bring the comments that I have made to the attention of the chief executive?