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Baroness Thornton: There may be occasions when it is one of his colleagues’ responsibilities to solve the problem. That is not to say that he will not be responsible for it, but it may not be something that he or she should necessarily deal with. It is important to

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recognise that there will be cases when it will not be appropriate to provide all forms of support—for example, in the most serious cases, when a criminal prosecution is being undertaken. I do not think that that is the purpose of the amendment, although I have a great deal of sympathy with the intention behind the noble Baroness’s amendment.

Amendment No. 149 proposes that the responsible officer role should be piloted in at least two geographical areas. I understand the reasoning behind the amendment but I hope that I can reassure the Committee that, in creating responsible officers, we are putting existing best practice on a statutory footing. A principal element of the role of responsible officer is clinical governance. Much of the role that we are proposing for responsible officers is already undertaken, as has been said, in the best organisations and has already been shown to be effective. However, we know that this best practice is being inconsistently applied, which is one reason why we have introduced these measures in this Bill.

The noble Earl, Lord Howe, asked about the safeguards to ensure that responsible officers have a good reputation and can be trusted to do the job properly. The requirements for appointments will be set out in secondary legislation. However, we expect that responsible officers will have to be registered with the GMC and that they will be senior doctors in their organisation. As such, they can be expected to have already established a reputation and standing among their peers. In most organisations, that senior doctor will be the medical director or someone similar.

The noble Earl and the noble Baroness, Lady Cumberlege, also asked how GMC affiliates fit in with responsible officers. The responsible officer will work for the NHS and other healthcare organisations and he or she will be based in the organisation. The GMC affiliate will work for the GMC. He or she will be the GMC’s local representative. Clearly, the GMC affiliate will be the responsible officer’s link point to the national regulatory framework of the GMC to ensure that there is a sensible relationship between legal clinical governance and national professional regulation. That is what is intended. I hope that I have been able to reassure noble Lords—

Baroness Tonge: I am sorry to interrupt the Minister but I am extremely unhappy about this. She says that the responsible officer is the representative of the GMC within that organisation.

Baroness Thornton: That is not what I said.

Baroness Tonge: Is there not the potential here to undermine an organisation’s whole board of management? I cannot see how it will work in practice. The Minister says that this person will be a member of the board, but surely all members of the board, whether it is the chief nursing officer or the medical director, are responsible officers. That is what they are there for; they are responsible for what is happening in their bit of the organisation. I do not see the point in having another person—who will require extra training and be taken away from his or

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her clinical duties—roaming around as a sort of spy on the staff. I really do not understand how this will work in practice without causing a huge amount of ill feeling.

Baroness Thornton: The medical director’s line of accountability will continue to be to the board. Clearly, responsible officers will need to work closely with the GMC over issues relating to the revalidation of doctors’ fitness to practise. I think that the noble Baroness may be confusing the post of responsible officer outlined in the Bill with people who take responsibility. Obviously, they are not the same. The GMC says:

Baroness Finlay of Llandaff: I am most grateful to the Minister and I am particularly grateful to the noble Earl, Lord Howe, and the noble Baroness, Lady Cumberlege, who spoke so eloquently to these amendments—far more eloquently than I was able to do. They filled in a lot of the areas that I had not done adequately when I moved the amendment.

The Minister spoke about regulations. I am reassured that the responsible officers will always be medical practitioners and that there will be guidance to accompany their role. I hope that that will include clear guidance on remedial action, including training, retraining, support and so on. However, I am still concerned about system failures and how they will be rectified. I hope that in the guidance power will be given to the responsible officer to ask questions about system failures. These failures will almost inevitably involve people from other professional groups, clerical staff and possibly volunteers and so on, and they may involve other trusts as well where, ultimately, the problem has landed on the clinician. However, an accumulation of system failures may have occurred—for example, out in the community before a patient went into hospital or in the hospital before a patient went back out to the community, or it may be a system failure in a relationship between health and social care.

When a crisis occurs, it seems to land in the doctor’s lap. I have a real concern that this does not seem to be clearly thought through in relation to system failures, remedial action across the board and the powers that the responsible officer will have, because unless that officer has powers, when they try to investigate something they will hit a brick wall and be told that it is outside their area of jurisdiction or whatever, yet the matter may be really important in terms of what needs to be done. With that in mind, I have been minded to suggest pilot schemes. I hope that the Government will think carefully about pilots before simply rolling out their proposals across the board, so that lessons can be learnt and problems ironed out.

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The final group about which I am concerned is locums, whom the Minister did not address in her reply. When people work in a hospital trust in either a training post or a permanent post, it is easier for them to be attached to a responsible officer, but locums are very mobile and they may leave their problems in one area and move into a different area. They might move from England to Wales or vice versa, or up to Scotland. Allocating responsible officers to them will be particularly difficult. I know that the noble Earl, Lord Howe, raised the issue of the Armed Forces, which also needs to be addressed. I would be interested to hear the Minister’s response to my questions.

Baroness Thornton: I shall need to reflect on the questions that the noble Baroness asked, because she has made legitimate points. I am sure that someone, somewhere, knows all the answers—but it is certainly not me at this moment. I would like to reflect and perhaps discuss those issues with the noble Baroness. We will write to her.

Baroness Finlay of Llandaff: I am most grateful to the noble Baroness for her reply. In light of that, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 143 and 144 not moved.]

Lord Tunnicliffe moved Amendment No. 145:

(a) contains regulations made by the Secretary of State under section 45A, and(b) is not subject to a requirement that a draft of the instrument be laid before, and approved by a resolution of, each House of Parliament,is subject to annulment in pursuance of a resolution of either House of Parliament.

The noble Lord said: I shall also speak to the other amendments in the group. This group of government amendments has been tabled in response to the recommendations of the Delegated Powers and Regulatory Reform Committee published on 12 March. The Government have accepted all the committee’s recommendations in full and these amendments amend the Bill accordingly. A copy of the formal response from my honourable friend Ben Bradshaw to the committee has been placed in the House Library. In view of the fact that the amendments simply insert the committee’s recommendations into the Bill, I shall not speak to them at length, although I will be happy to respond to any points that noble Lords may have. I shall speak briefly to Amendment No. 197, however, because it touches on the delicate issue of hybridity.

Although this was not included in its report on the Bill, the committee also helpfully identified an oversight in relation to a regulation-making power in Part 3, which Amendment No. 197 seeks to correct. Under

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Part 3, in urgent situations, proposed new Section 45R of the Public Health (Control of Disease) Act 1984 enables regulations to be made under an emergency procedure. This would be necessary where it was deemed that an urgent action was needed to protect the public from a significant health risk. In such a circumstance, regulations could be made to come into force immediately and would later be required to be approved using the affirmative resolution procedure, or they would cease to have effect after 28 days.

I should point out that such regulations could be considered hybrid if they affected only a certain group of individuals or businesses where a public health risk was identified, not others of a similar class. As noble Lords will know, the parliamentary procedure for hybrid instruments can be lengthy. This would not be appropriate where the public could be at risk. That is why Amendment No. 197 seeks to remove that requirement for the hybrid instrument process to take place where the public health risk requires urgent action. The principal aim of Clause 123 is to protect public health. As such, the overriding concern of regulations should be public safety rather than private interests. I beg to move.

On Question, amendment agreed to.

Baroness Thornton moved Amendment No. 146:

(a) contains regulations made by the Department of Health, Social Services and Public Safety in Northern Ireland under section 45A, and(b) is not subject to a requirement that a draft of the statutory rule be laid before, and approved by a resolution of, the Northern Ireland Assembly,is subject to negative resolution within the meaning of section 41(6) of the Interpretation Act (Northern Ireland) 1954.

On Question, amendment agreed to.

Clause 114, as amended, agreed to.

Clause 115 [Additional responsibilities of responsible officers: England and Wales and Northern Ireland]:

[Amendments Nos. 147 and 148 not moved.]

Clause 115 agreed to.

[Amendment No. 149 not moved.]

Baroness Thornton: I beg to move that the Committee do now adjourn for 10 minutes and that we reconvene at 5.57 pm.

Moved accordingly, and, on Question, Motion agreed to.

[The Sitting was adjourned from 5.47 to 5.57 pm.]

Clause 116 [Co-operation between prescribed bodies]:

Earl Howe moved Amendment No. 150:

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The noble Earl said: In moving the amendment, I shall speak also to Amendment No. 151. We now come to the sensitive issue of information sharing. Clause 116 provides for regulations to be made to require NHS trusts and other bodies to provide and share information about healthcare workers in circumstances where that person,

There is an issue here that I am sure all noble Lords appreciate. Sometimes there can be a situation in a hospital where a doctor or healthcare worker has been found to have put patient safety at risk through some aspect of his practice. Let us say it is a doctor. If that doctor moves to another hospital, there needs to be a way for that hospital to be aware of the adverse incident. I have little problem with that. Where I have a problem is with a system of information sharing that fails to draw the line between hard facts and soft intelligence. There is all the difference in the world between an adverse incident that has been investigated with the full knowledge of the doctor concerned and where the facts have been firmly established and unsubstantiated rumblings about something that might have happened.

It is not acceptable for unproven gossip or tittle-tattle to be treated as if it were fact and passed on as such. If a concern arises about the performance of a hospital doctor, whether from a firm allegation or simply as a product of the rumour mill, an employer should investigate to see whether there are any grounds for the concern and the doctor should be informed of what is going on so that he can comment on it. This is in the interests of the doctor as well as everyone else. Any doctor will understand how important it is for him and for his patients that concerns of this kind are properly investigated and dealt with. Then, if the concerns turn out to be unfounded, they should be removed from the doctor’s file.

What an employer should not do is to allow soft intelligence to lie on a file when that does not amount to grounds for serious concern. All that that does is create a delay in acting on the concerns as well as the potential for misunderstanding on the part of anyone reading the file about the limited value that the information has in protecting patients. It is also inherently unfair to the doctor. With modern appraisal and clinical governance systems there is no reason for that sort of thing to happen. The national clinical assessment system is in operation across the country. If an issue for any reason needs to be taken up the chain, the GMC can issue a warning or retraining order in circumstances where a doctor’s fitness to practise is not completely impaired. All those systems are designed to address concerns about professional competence in a timely and businesslike way.

The other aspect of this, as I have indicated, is the need for the doctor to be aware of any concern that may be raised about his performance. If he is not, there is huge scope for false information to be spread about and the doctor will have had no opportunity to give his side of the story or to put the record straight. On the other hand, if the concerns turn out to have substance, the doctor will have had no opportunity to

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improve his conduct or performance so as to prevent a similar problem from arising in future.

The difficulty that I have with this part of the Bill lies in subsection (1)(a), which refers to,

It is the word “may” that we need to look at. Left unqualified, it looks far too tentative and wishy-washy. The noble Baroness, Lady Finlay, has tabled an amendment that would substitute “shows” for “may show”. In other words, if I understand her intention correctly, the information would have to consist of proven fact before it could be passed on. I have considerable sympathy with that amendment.

The reason for my own less tight amendment is that there could be circumstances in which serious concern could arise about the performance of a doctor where there was no opportunity to investigate it before the doctor moved from one employer to the next. In those circumstances, it would be irresponsible for the first employer to do nothing at all about passing on the concern, even though the allegation might as yet be unproven. But in those sorts of case, the sine qua non is that the doctor himself should be informed of exactly what information has been passed on to the other employer. To be honest, I think that there is a case for marrying up the amendment proposed by the noble Baroness with my own, so that the clause would refer to,

The noble Baroness may disagree with that, and I shall be interested to hear what she has to say, but she and I can certainly agree that the current wording will not do.

These are important issues. I hope that the Minister will feel able to look at them afresh. I beg to move.

Baroness Finlay of Llandaff: I would certainly like to speak to the amendment in my name but do so considering the generous invitation from the noble Earl, Lord Howe, to join it with his amendment. That might provide the solution to the problem in hand.

There are real dangers about information being passed on, based on tittle-tattle, gossip or suppositions, some of which may relate to cultural or perceptual differences between clinicians, but have no substance in how they actually affect their care of patients. For example, the fact that someone may eat their lunch on their own, join others or not join others, does not affect their clinical competence even though their colleagues might feel affronted, shunned or offended. But we are talking about clinical competence, not personal judgment, and for that reason it is very important that there is hard evidence. Indeed, when there is hard evidence to alert one to the fact that there may be a problem, it is very appropriate for it to be handed on.

Perhaps I may illustrate that with a specific example. A doctor’s handwriting may be more easily

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read by some than by others, but if it is not legible it has serious implications for the care of the patient because it is not only a clinical record but it hands on information to others. If the handwriting is so poor that the drug chart is difficult to read, that is another order of serious implication. A doctor challenged about his or her handwriting would be expected to take—and should be supported in taking—remedial action to relearn patterns of handwriting and the use of capital letters on drug charts and so on. Even when he or she has done that, it would be appropriate to hand on to their next employer the fact that there has been a problem. The hard evidence of copies of the entries in the case notes and on the drug chart would apply pressure for the doctor to keep up the remedial action.

However, that is quite different to saying that one does not like the way someone wrote or entered something in the notes where there is no hard evidence to back it up. This has implications for the registration. Hard evidence should be available to hand on. Unsubstantiated allegations may turn out to be defamatory and we could end up with some nasty cases being brought by doctors who fear that their reputation has been unfairly smeared by allegations without any substance. A second trust could inadvertently get caught up in such an action if it takes at face value hearsay evidence which has no substance to it.

Baroness Thornton: Before discussing the specific amendments I should point out that this measure is in the Bill because the common conclusion of recent inquiries into doctors who have harmed their patients, including the Shipman, Ayling and Kerr/Haslam inquiries, was that healthcare organisations failed, both singly and collectively, to “join up” the information that was available to them and that this led to the abuse and death of patients. The noble Earl is correct to say that this is a very sensitive issue and that it is important that we get it right.

There is always a balance to be struck between making sure proper measures are in place to protect patient safety and ensuring that doctors and other healthcare workers do not have their careers blighted by unfair or malicious accusations. We think we have got the balance right here. I hope that I will be able to persuade noble Lords of this and set out why I cannot support the amendments.

Amendment No. 150 would have the effect of only allowing information to be shared if the case was proven. That by itself would be a threat to patient safety. It would apply a more stringent test to the kind of information that might be shared than is currently in the Bill. Similarly, Amendment No. 150A would require the information to show a definite risk to patient safety in order for it to be shared.

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