Key Speeches

I thank Members once again for their support. I thank the Committee for its co-operation. We have worked closely together on these issues. I know that the Committee is there as a watchdog, but I believe that, as far as possible, on the many things on which we can co-operate and work with each other, we can get good outcomes for the people we serve, which is very useful.

I believe that this is good legislation. It was brought forward by my predecessor, and I always supported it throughout that term of the Assembly.

As Mr Wells rightly points out, people lose their lives as a result of the misuse of sunbeds. That is something that we wish to reduce and, if possible, eliminate. This legislation takes us a step along that way. I am particularly pleased that we are targeting younger people very strongly. The last thing we want is for teenagers to have permanent damage or for their lives to be shortened considerably as a result of that damage.

Once again, I thank all Members for their support thus far. As I indicated, I think that this is a step in the right direction for the House.

Question put and agreed to.

Resolved:

That the draft Sunbeds (Fixed Penalty) (Amount) Regulations (Northern Ireland) 2012 be approved.

Adjourned at 4.50 pm.

I thank the Committee and the Pharmaceutical Society of Northern Ireland for the helpful role that they played in all this. It has been good to work in partnership to bring the order forward. The order is a positive move, and it got a broad welcome from the House and beyond, so that is good news.

In response to Mr McClarty, we will be very happy to have discussions with the Pharmaceutical Society in due course to look at the best way to move things forward after the order has been approved.

Question put and agreed to.

Resolved:

That the draft Pharmacy (1976 Order) (Amendment) Order (Northern Ireland) 2012 be approved.

I beg to move

That the draft Sunbeds (Fixed Penalty) (Amount) Regulations (Northern Ireland) 2012 be approved.

I seek the Assembly’s approval to introduce the aforementioned statutory rule. Subject to the Assembly’s approval, the rule will outline the amount of fixed penalties to be applied to certain offences in the Sunbeds Act (Northern Ireland) 2011. The Sunbeds Act received Royal Assent on 3 May 2011. It had a positive response and a smooth passage through the previous Assembly, and my Department promised to enact most of the Act’s main measures within 12 months of its receiving Royal Assent. Those measures entail three sets of regulations and two commencement orders.

The Sunbeds Act allows an authorised officer of a district council to issue a fixed penalty notice if there is reason to believe that a person has committed an offence under particular sections of the Act. The regulations that we are debating outline the amount of those fixed penalties, which were increased from those proposed in the consultation. Many of the responses to the consultation said that the proposed fixed penalties were an insufficient deterrent. I believe that the proposed new fixed penalties are more proportionate to the fines available on summary conviction. All but one of the proposed fixed penalties is set at £250. The fixed penalties outlined in the regulations have been agreed by the Executive and the Health Committee.

One fixed penalty, which is set at £50, remains lower than the rest. It relates to section 6 of the Act, which provides that it is an offence for an operator of a sunbed premises to provide or display any material that contains statements relating to the health effects of sunbed use. The fine on summary conviction of that offence is £200. The fine is lower than the other offences to keep it proportionate to the offence and to ensure compatibility with the European Convention on Human Rights, specifically article 10, which deals with the right to freedom of expression. These regulations allow district councils to deal with offences committed under the Sunbeds Act without the need to take all offences to the courts. The intention is that only persistent offenders will be referred to the courts.

I beg to move

That the draft Pharmacy (1976 Order) (Amendment) Order (Northern Ireland) 2012 be approved.

I seek to introduce the aforementioned statutory rule, which, subject to the Assembly’s approval, will amend the Pharmacy (Northern Ireland) Order 1976.

At the outset, I should perhaps point out that this matter is not about contractual matters in community pharmacy. Rather, it is about the regulation of pharmacists irrespective of their practice environments — professional governance, if you like, in the public interest.

I will now explain briefly to Members why the amendment is needed. The Pharmaceutical Society of Northern Ireland has, since its inception in 1925, been the regulatory and professional leadership body for pharmacists in Northern Ireland. Its current regulatory functions and powers are substantially governed by the Pharmacy (Northern Ireland) Order 1976, which is some 35 years old. The aforementioned statutory rule seeks to amend that Order to modernise and strengthen the regulatory powers of the Pharmaceutical Society of Northern Ireland, with the purpose of giving added assurance to patients and the public in respect of professional practice.

The last 10 years have brought some very substantial changes to the whole of the professional regulatory landscape in the UK and particularly across the health professions. Against that background, it has been recognised by both the Assembly and the Council for Healthcare Regulatory Excellence — the regulator of the regulators — that there is an ongoing need to update the statutory framework for pharmacist regulation in Northern Ireland to better meet the demands of modern regulation. The Department has been working collaboratively with the society to modernise pharmacy legislation, taking forward recommendations in the Government’s White Paper ‘Trust, Assurance and Safety — The Regulation of Health Professionals in the 21st Century’.

Having listened carefully to the views of stakeholders and interested parties and, indeed, the views of the House at an earlier time, I seek your approval for the current Pharmacy (Northern Ireland) Order 1976 to be amended to provide such powers to enable the society to function in such a way as to meet the standards of modern regulation. The Order will create the powers for secondary legislation, which will bring into operation the more detailed legislative requirements relating to fitness to practise and continuing professional development.

The proposed regulatory changes to the existing legislation seek to address its current shortcomings and would, in particular, mean the following amendments. The White Paper recommends that the councils of regulatory bodies should have, as a minimum, parity of membership between lay and professional members to ensure that purely professional concerns are not thought to dominate their work; should have independently appointed members to dispel the perception that councils are overly sympathetic to the professionals they regulate; and should become smaller and more board-like to enable councils to focus more effectively on strategy and oversight of their executive. Taking those points on board, the current council of 23 members would be replaced by a new council consisting of seven pharmacists and seven lay members appointed through the public appointments process, rather than elected by the membership.

The standards include core functions that professional regulators should undertake, including setting and promoting standards for entry to the register and for remaining on the register and checking that registrants continue to meet those standards. A duty will be placed on the council to set standards of continuing professional development (CPD). That will ensure that registered persons undertake to maintain their CPD as part of a process to ensure the improvement or development of their pharmacy practice, which is a condition of their continued registration.

The amendment to the Order will reconstitute the statutory committee and extend the range of sanctions available to it. Currently, the statutory committee has only one sanction — removal of a pharmacist’s name from the register. The proposed amendment will extend the range of sanctions to include warnings, interim order hearings, placing conditions on a registered person’s practice and suspension. The scrutiny committee will act as an initial, paper-based filter of cases, and it will be able, as appropriate and against established criteria, to either apply sanctions directly or refer cases for hearing to the statutory committee.

The repeal of article 18 of the Order and creation of the power for the society to establish fitness-to-practise processes for dealing with health cases will enable the society to seek medical reports concerning a registered person’s fitness to practise and more appropriately handle sensitive health cases.

The changes being made closely parallel similar changes already made to the regulation of pharmacists in GB. In GB, in line with the White Paper to which I previously referred, there is a clear separation of regulatory and professional leadership functions.

That was achieved through the formation of the General Pharmaceutical Council for regulation, with the Royal Pharmaceutical Society becoming the professional leadership body. That separation is considered necessary to demonstrate and provide assurances that public protection takes precedence over any professional self-interest.

I note that the society here has developed a partial separation through the formation of a professional forum, albeit that it is still within the same body governed by the council of the society. That is a step in the right direction, and I wish to follow up with the society how full separation can be achieved in the interests of the public and, indeed, the profession. I am also conscious that pharmacy is the only healthcare profession not regulated on a UK-wide basis. That point was raised in the consultation and noted in terms of the benefits of harmonising regulatory processes. However, I consider that, in the public interest, it is right to make important legislative changes now, without the complexity of more radical change and notwithstanding the future consideration of wider integration. In augmenting the regulatory arrangements for pharmacists, what I propose today represents a significant development for the profession. It also represents a very important provision for the public and patients by ensuring that their interests are fully provided for through the setting of and adherence to robust standards. If pharmaceutical practice or conduct falls below what is expected, appropriate procedures and disciplines can and will be brought to bear.

I am pleased that the profession recognises the need for and supports these legislative changes, which further demonstrates my support for the profession, while enabling it to maintain and develop the highest standards of practice. I commend the motion to the House.

In response to the latter part of the question, dealing with the issue has been very difficult. Obviously, the UK has been working on developing guidelines for just over a year. Experts tend to take their time, because whenever they give advice, they want it to be absolutely bulletproof. That is understandable. I expect that advice to come forward shortly. Nonetheless, its absence has made it more difficult for us, but I acknowledged in my statement the support that was received from the Health Protection Agency, which has a pool of expertise that we do not have, or could not expect to have, in Northern Ireland. The agency has been particularly helpful in assisting us with this difficult issue.

Pseudomonas microorganisms were identified in some taps in the Ulster Hospital more recently. The children in that unit have been swabbed not once but twice, and no babies have either the infection or any pseudomonas on their skin. So, no babies in that unit are colonised. As a precaution, only sterile water will be used in the unit until the report is concluded and makes recommendations. There will also be extra hand sanitisation to ensure that any potential for infection to be passed is eliminated.

I thank the Member for the question. With regard to the incident in Londonderry and what was done to alert others to the risk, the Department of Health received a notification from the Western Health and Social Care Trust of a suspected incident of pseudomonas infection on 13 November. A tap was also identified as positive for pseudomonas the following day. No information was available at that stage to establish definitively whether any of the strains were the same. So, some time was taken in between to identify that.

On the 22nd, the Chief Medical Officer and the chief estates officer wrote a further joint letter to all the trusts’ chief executives, medical directors and directors of nursing, infection, prevention and control, as well as to chief executives of the Health and Social Care Board and the Public Health Agency, to highlight water sources and potential infection risk to parents and to reinforce earlier important messages about infection control.

The additional specialised tests, which identified that the strain in the samples taken from the tap in Altnagelvin was the same as the one in the samples taken from some of the babies, were not available until after the letter was issued. Given the possible implications, the Departments and the Chief Medical Officer judged that it was important to reinforce and reiterate the previous advice in advance of receiving the definitive results from the laboratory. So, a clear and specific letter could not be issued until the Department was clear about what had happened. It is important to act correctly, with the appropriate accurate information, rather than act hastily.

Again, those things will be tested in the investigation. However, the Chief Medical Officer was in a difficult situation. He had to inform other trusts without the full and adequate information, because on 14 December the contamination was only suspected and had not been proven. The Member comes from a background in which things need to be proven and people need to have their doubts removed before they arrive at conclusions.

I thank the Member for the question.

All trusts are aware that their first statutory duty is to provide a high quality and safe service. No financial challenge would excuse a lapse in good practice on health protection. Clear standards of cleaning are required in units, such as neonatal units. Those standards have not been compromised. The cause of the outbreak will be investigated further, but our understanding is as I set out in my statement.

I informed the House last week that pseudomonas is something that is carried quite widely; as many as 10% of us could be carrying it on our skin. Therefore, it is very common in our environment and atmosphere.

There is a whole series of at-risk groups made up of people who are immunocompromised, which can include people in burns units, intensive care units, paediatric intensive care units and those who have received substantial amounts of treatment for cancer. All those whose immune systems have been compromised are much more likely to be subject to infection from pseudomonas. Between 80 and 90 people per annum are infected by pseudomonas each year.

It is quite unusual for the infection to happen in our younger childen; in most previous years, the number of cases has been in single figures. However, there are many other areas in which pseudomonas can infect people.

The letters have been sent out, and all of the trusts are aware of the risks posed by the infection to many people in the community.

Neonatal units in Northern Ireland operate as a network; therefore, transfers within it take place regularly. When it comes to the use of facilities outside Northern Ireland, we have protocols and relationships that allow that to happen and which allow us to receive babies when other people are in crisis or difficulties. At this stage, the system is coping well with the demands on it. However, some of the things that some people suggest we do would lead inevitably to neonatal units being closed; that would put babies lives at risk in a way that we have not seen heretofore. It is important that our response provides the widest possible care to those vulnerable babies who are in very difficult situations.

Professor Troop will report directly to me; she will be supported by the independent team, and I will determine her terms of reference. She will have full access to all trust records, and if there is any indication that anything is being held back, I will personally intervene. Nothing can be withheld from Professor Troop that would allow her to collect and analyse the relevant information and draw her conclusions about what happened, whether the response was quick enough and whether it was the right response. If we identify flaws, failings or problems, let us get them out on the table and make them public at the earliest possible date: I am not interested in hiding the truth from the public.

You mention the timing of the testing of taps. There are challenges. Members are asking, as am I, why the taps were not tested or changed. I understand that the Ulster Hospital tested recently, and, fortunately, no babies in that unit have pseudomonas or are carrying it on their skin. Nonetheless, the taps were not tested as early as possible. We are now on top of the situation, but that is a question that will be investigated very closely by the investigative team. That is one issue on which we want very clear answers.

The trusts have been talking to the parents throughout the process. What has been done in the facilities themselves? The taps have been changed in all the facilities. No tap water is being used in direct contact with the babies, only sterile water. Different sanitising equipment has been introduced for hand-washing by staff that is, apparently, even more effective in reducing the possibility of cross-infection. All those steps have been taken in conjunction with talking to parents and explaining to them what the best outcomes might be in their babies’ care.

I thank the Member for his question.

The guidance, released by the Department in September 2010 and reinforced in July and December 2011, applies to all such units. Any further steps will be taken on an individual risk-based approach, as advised by the PHA, based on expert advice from the Health Protection Agency in England. A trust would be very foolish not to take that advice and not to respond to a risk that it identifies in association with people who are immunocompromised. It must ensure that such people are not put at further risk.

We have asked the RQIA to do a specific piece of work on the audit tool that has been developed for the purposes of hygiene inspection. It was not designed for units that provide augmented care. I have asked the RQIA to develop a range of specialist audit tools to assess standards of hygiene and infection control in augmented care settings. The original infection-prevention hygiene inspections of the Royal Jubilee Maternity Services were conducted as part of the RQIA of intra-partem care in 2009, which examined care and delivery units across all five trusts and the 10 maternity delivery units in Northern Ireland. In areas where we identified specific concerns in relation to infection-prevention hygiene, we carried out a re-audit in 2010. The RQIA considers that clinical areas such as neonatal units and theatres require a specialist, specific audit tool and approach to inspection.

At present, the RQIA is considering how best to develop a specific audit tool for use in intensive care settings, such as neonatal units. The audit tool will be used by trusts for self-assessment against the standard sets. The RQIA will provide the necessary independent assurance that those are being fully followed and implemented. The trusts’ estates departments also monitor their water distribution systems on a regular basis, in accordance with water quality-control protocols, and that is based on current legislative requirements.

It is important that action is taken quickly. It is also important that we have sufficient and accurate information in order that we can give correct advice on appropriate actions. In infectious disease incidents, what has caused the problem is not always immediately apparent. Investigations into pseudomonas outbreaks in intensive care facilities across the world have revealed a range of causes, including various medical devices and environmental reservoirs, in addition to water. In any outbreak, detailed investigative work is required to piece together information about the circumstances and nature of the incident.

We must not jump to the wrong conclusion. However, given the receipt of three notifications and a letter from the Chief Medical Officer advising the trusts of a particular area of concern and that responses and actions need to be taken on that, it is not to be taken lightly. It is very serious. The trusts know full well the situation that we are encountering as a result of the pseudomonas outbreak in the Royal Jubilee Maternity Service. It would be very foolish to ignore that in relation to other units where people are immunocompromised.

All the issues need to be dealt with, including the issue that the Member raised. I should say that, while the letter itself did not mention that a baby had died in Altnagelvin, it was well known within the trusts that that was the case. The other trusts were not acting in the dark. When they received the letter from the Chief Medical Officer, they were well aware that a baby had died from pseudomonas in Altnagelvin Area Hospital. It should not have been the case that trusts did not respond or made a slack response on the basis of the letter from the Chief Medical Officer. It was the third letter on the issue in less than two years. Clearly, there should have been a degree of urgency in how trusts responded to such a letter.

Key advice was given to the trusts at the time, and we have asked the trusts for their response to that. They have been liaising with the Chief Medical Officer and his team on the actions that have been taken. That will all be part of the report. Identifying what exactly the trusts’ responses were and whether those actions were appropriate, prompt, timely and went as far as they should have are all things that will be tested. How quickly did the trusts test the water? How quickly, for example, were taps replaced where a problem was identified? Did tap water continue to be used on babies after it was identified that there was a problem with it, and so forth?

The trusts will be questioned about all those matters, which will be fully investigated in our efforts to ensure that we get to and identify the truth, because the parents of the children in particular deserve the truth. If we do not get to the point where we know, as far as possible, what happened that led to the pseudomonas outbreak, we are failing babies and other immunocompromised people in the future.

I thank the Member for his question. There have been calls for a public inquiry from at least one of the families, some Members and some people in the press. I realise that there is huge public concern at this time and that people want answers. I believe that an independent investigation and review will provide me with the urgent answers that I require. As I stated, I have asked the chief executive of the RQIA to assist me in developing and facilitating a full, rigorous and independent investigation of and review into the incidents. However, a public inquiry in and of itself under the Inquiries Act 2005 would not be the quickest or most effective way of getting the answers.

We are engaged in a public inquiry into hyponatraemia, which was requested in 2005. The hearings will start this year, and the report will come back next year. We will get the answers eight years after the inquiry was first requested and 18 years after the first child died as a result of hyponatraemia. I believe that we will get the answers, and I do not believe that it will be a whitewash in any shape or form.

I cannot afford to wait for years to get answers in this instance: I need to get answers in months, at the most. Therefore, bringing forward people who are truly independent of the process here and who have absolutely nothing whatsoever to do with the trusts, HSC or anything else and who also have the specialist expertise is the best way of drilling down to get to those answers. The proof of the pudding will be in the eating. This is not about covering up anything: it is about getting quick answers and solutions to the problems that we face.

To be perfectly honest, Mr Speaker, at this stage, I am not convinced that the trusts responded quickly enough. That is why I am going down this route and why I will have an independent investigation. It will be an independent investigation. Irrespective of how we get them, we will get the answers, and we will make them public.

I apologise to you, Mr Speaker, and the House, that the statement was not in Members’ pigeonholes one hour beforehand. We were still working on it, to be honest, because things continue to move on this subject.

I welcome the opportunity to update the Assembly on pseudomonas in neonatal units and the actions that are being taken to protect babies and to address the problem. No one could fail to be distressed by the deaths of the three babies in the Royal Jubilee Maternity Service in Belfast and the death of the baby in Altnagelvin Area Hospital. I cannot even begin to imagine, let alone put into words, the heartache that the parents of those babies have suffered and will continue to suffer. I have written to the parents of each of the babies who died to express my deepest condolences. I have also spoken to those parents whom it has been possible to contact. The trusts have facilitated me in sending those letters, and I will respect each family’s choice as to whether they wish to meet me. I know that all Members will wish to be respectful and mindful of the families at this time of loss.

The safety of babies is my first priority, so that is where I will begin. Last week, I reported that there were a total of seven babies associated with the outbreak in the Royal Jubilee Maternity Service in Belfast. This week, I can report that that number is unchanged. Sadly, three of the babies died in the Royal’s neonatal unit. One baby recovered from pseudomonas but died later from unrelated causes. The remaining three babies are progressing well.

There have been no new cases of pseudomonas infection in the Royal or, indeed, in any of our other neonatal units in the past week. Last week, I reported that six babies who had been associated with the Royal had been colonised but had no signs of infection. A further baby tested positive a few days later, but the number has remained at seven since then. Six babies who have no association with the Royal have been colonised with pseudomonas: two in Altnaglevin, three in Craigavon and one in Antrim.

It is too early to say that the outbreak in the Royal Jubilee Maternity Service is over. However, I can assure you that every possible action is being taken to protect those vulnerable babies. I want to emphasise again that the pseudomonas infections in the Royal and Altnagelvin were different strains. Those are two separate incidents, and there is absolutely no evidence to suggest that a baby from Altnagelvin could have introduced pseudomonas infection to the Royal.

Members will also be aware that pseudomonas has been found in a small number of water outlets in the neonatal intensive care unit of the Ulster Hospital. It is important to stress that all babies in the unit have been tested, indeed twice. The results indicate that no baby has tested positive for pseudomonas; no babies have been colonised or have active pseudomonas infection in the Ulster Hospital. Last week, I explained to Members that pseudomonas is a micro-organism that is found in many natural environments, including soil and water. There are many different types and strains of pseudomonas, and specialist tests are required to distinguish those. Pseudomonas can be found in sinks, taps and water systems, and it is difficult to eradicate it completely and permanently. Because pseudomonas is in the environment, if we start to look for it, we will find it. That is what is happening at present. As each of the units has tested water coming from taps, a small number of those samples has returned positive results. This is not a simple, straightforward situation, and there is no quick fix.

My first priority is to ensure the safety of all babies in our neonatal units, and I must be absolutely certain that whatever we do is the right thing to do; it must be based on the best available science. Yes, we can test babies for pseudomonas, and we can test water and replace taps, but we are in relatively unknown territory with pseudomonas. There is no national guidance sitting on a shelf waiting to be used. For that reason, right from the start, we have been learning from the experience in Altnagelvin. We have been learning from the Royal, and we have been in constant dialogue with the national experts in the Health Protection Agency to ensure that whatever steps we take are the right steps and that we do not create greater risks for the babies by doing the wrong thing.

You will see that Northern Ireland is breaking new ground in the context of the UK, and Ireland, in responding systematically to the situation. We are providing ongoing care for the babies and support for the parents. At the same time, we are investigating the outbreaks and developing and implementing control measures while ensuring that babies continue to have access to the full range of highly specialist medical and nursing care that they require. All that work has resulted in the publication of interim guidance for trusts in Northern Ireland, drawing on the best scientific evidence and expert advice that is available to us at this time.

Let me remind the Assembly what we are doing. As a precautionary measure, there will be no contact between tap water and babies while the taps and water systems are being checked; only sterile water will come into contact with babies. That means that even if pseudomonas bacteria are in the tap water, they cannot reach the babies. As a further protection, staff will use a special hand rub after they have washed and dried their hands, before they touch the babies. Parents who visit the babies will also need to take those steps. That approach has already been adopted in Altnagelvin and implemented in the unit in the Royal, and it has now been extended to all other units caring for those very vulnerable babies.

Those crucial steps are protecting the babies in those units, and that gives time for estate staff, infection control experts, microbiologists and public health experts to continue the painstaking task of piecing together all the evidence and information to track down the pseudomonas bacteria, wherever it is, and seek to eradicate it. Obviously, units must remain open to care for babies, so that approach protects the babies while ensuring that they continue to have access to all the specialist care that they need.

As I informed you last week, pseudomonas has been found in samples from taps. As a precautionary measure, we are changing every tap on every clinical hand washing basin in every neonatal unit in Northern Ireland. Water samples from those taps will also be tested as part of the investigation. Once the new taps are in place, water from them will be tested for seven days and then at regular intervals. Advice has also been issued on the correct process for cleaning taps to avoid contamination, based on the advice of the Health Protection Agency (HPA).

There is no single, simple, quick fix for this situation. Although we need to move swiftly and decisively, we must be sure to do the right things. I am leaving no stone unturned in my quest to reduce the risk of pseudomonas infection in neonatal units. That is what parents and the public expect, and I have directed that that will continue to be our approach.

I want to elaborate on the interim guidance that has been developed in Northern Ireland. My Chief Medical Officer (CMO) has already shared that guidance with all Chief Medical Officers across the UK and, indeed, in the Republic of Ireland. They are showing considerable interest in learning from our recent experience in Northern Ireland, as it may have implications for their health services. Outbreaks of pseudomonas have occurred in some intensive care facilities around the world, as patients in such facilities are frequently immunocompromised. The causes of those outbreaks have not all been the same. They have included various medical devices and environmental reservoirs, such as antiseptic solutions, ventilator apparatus, artificial fingernails and water.

There were a number of outbreaks in English and Welsh hospitals in the summer of 2010. In response, all Departments of Health in the UK issued guidance on best practice on the management of infection risks associated with water sources in general. At that time, an expert group was tasked with developing detailed national guidance specifically on pseudomonas. That work is nearing completion, and I have asked my Chief Medical Officer to take action on this. He has already written to the CMO in England to stress the need to expedite the publication of the national guidance, and I am told that that is expected in the near future. All four CMOs will hold a teleconference later today to discuss the issue.

In addition, the chair of the advisory group on antimicrobial resistance and healthcare-acquired infection has been asked to take this forward at UK level. The question of pseudomonas is on the agenda for the next meeting of the group, which will take place on Thursday of this week. My Department will be represented at that meeting to contribute to the discussion, share our experience and bring back the expert views. There is significant scientific interest in what has happened in our neonatal units and in the solutions that we are developing to deal with the problem. We also have a responsibility to inform approaches elsewhere.

I make it absolutely clear that there was no delay on the part of my Department and the wider service in responding and managing the situation appropriately. The Department of Health received notification from the Western Health and Social Care Trust of a suspected incident of pseudomonas infection on 13 December 2011. A tap was also identified as positive for pseudomonas the following day. At that stage, no information was available to establish definitively whether any of the strains were the same. Despite that, the Department decided to proactively issue a further letter as a precautionary step, rather than await any results confirming a link. Additional specialised test results, which identified that the samples from the taps and from some of the babies were of the same strain, were not available until after that letter was issued. Given the possible implications, the Department judged it to be important to reinforce and reiterate previous advice, which it did.

Although it is important to act quickly, the Department must ensure that it has sufficient and accurate information to give the correct advice on the appropriate actions to take. It is not always apparent what has caused the problem in infectious disease incidents such as these. Detailed investigative work is required to piece together all the information about the incident. We cannot assume. We cannot afford to jump to the wrong conclusion, leaving the underlying cause unaddressed and babies still exposed to risk. Our responsibility is to strike the correct balance by acting quickly yet doing the right thing. The incident was an evolving situation, with the Department working closely with the trust, the Public Health Agency (PHA) and the Health and Social Care Board (HSCB).

The important message from the guidance for all the trusts was to highlight the risk of pseudomonas infection and the consequences for any clinical area in which there are immuno­compromised or debilitated patients. Professional medical and environmental health advice and guidance is regularly issued to the health service for its awareness and action. I expect such guidance issued from my Department to be treated with the utmost seriousness. Such guidance must be authoritative, because we need the HSCB to respond to it properly. I believe that the Assembly can rely on the professional team in the Department to make expert judgements on the guidance that it issues, because, as with this case, it is often managing a number of complex risks where any action can have unintended and undesired consequences. However, I am not content to just assume that action was taken. I have asked each of the trusts to give an account of the action taken in response to the CMO’s guidance.

In summary, all five trusts took a range of actions following the initial letter issued in September 2010 and the subsequent letter from health estates in July 2011. The letter issued by the CMO on 22 December reinforced the advice and guidance in the previous letters. I will return to that matter later in my statement. Let me assure Members that although my immediate priority is to keep the current outbreak under control and to take all necessary precautionary steps to keep those babies safe, a second vital strand of work must now begin.

I am very conscious of the grief of parents who have lost babies but I also know that they want answers. I know that Members of the Assembly are also seeking answers and that everyone who works in the health service needs answers. I am also only too aware of the distress of staff and the sense of responsibility that they must be feeling when tragic events such as this happen. So, although I recognise that it is a complex situation, I need to know what happened, why it happened and what we need to do to minimise the risk of it happening again.

We have a responsibility to learn from this tragedy and to share that learning across the UK and beyond. We owe it to the parents and to the memory of the babies who died. I have given that undertaking to the parents. Members, I give this undertaking to you: be in no doubt that I am absolutely determined to inquire into all the circumstances of the tragedy. I resolve to investigate and understand what happened and I will not be deflected from achieving that, because it is only by doing so that we can prevent it happening again.

I have also written to the chief executive of the Regulation and Quality Improvement Authority (RQIA) requesting that the organisation assists me to develop and facilitate a full, rigorous and independent investigation and review into those incidents and their tragic consequences. The investigation will be chaired by Professor Patricia Ann Troop CBE, former chief executive of the Health Protection Agency. Professor Troop has a breadth of experience across the health service, including health protection, at both national and international levels. Professor Troop will be assisted by a team to include the full range of relevant expertise required. The terms of reference, which I will determine, will include a thorough investigation into the role of my Department and each of the HSC organisations. Given the gravity of what happened, my priority is to ensure that the review is thorough and rigorous but also makes recommendations on any immediate actions that we need to take. I want an interim report by the end of March so that urgent actions can be taken.

However, I am not content to leave it there. I have asked that the RQIA also investigates the experiences of the families of the babies who died and those who have been affected in other ways. That is, understandably, a difficult and sensitive undertaking, which cannot be rushed. That is why I have separated the investigation into two parts. It must not only provide me with urgent answers but be extensive and encompass all relevant aspects of the incident. I assure Members that we are determined to be thorough, challenging and robust. I have asked for the final report no more than eight weeks after the interim report.

We know that pseudomonas is a very difficult organism to eradicate completely and permanently. We know that it is not the only potential threat to those vulnerable babies in neonatal units. Therefore, I have directed the RQIA to develop, with expert public health input from the PHA, a range of specialised audit tools. Those will provide independent assurance to the public and to me, as Minister, of the standards of infection prevention control within neonatal units and other augmented care settings. That audit tool will provide self-assessment standards for trusts. The RQIA will provide the necessary independent assurance that those are being fully followed and implemented.

I must be assured that all our neonatal units are operating to the very highest standards. I want to acknowledge the excellent work that saves the lives of hundreds of babies each year. Thankfully, incidents such as the pseudomonas outbreaks are uncommon. Nevertheless, I need the assurance that everything that can be done is being done to ensure that those units are functioning to the highest possible standard. The RQIA will provide that independent assurance.

That leads me to my next point, and it is an important one. Many pregnant women and their families are understandably concerned and anxious at this time, and I want to assure them that our maternity hospitals and neonatal units continue to provide a safe and effective service, despite the practical challenges that they face. The quality and safety of the care that women and their babies will receive remain the overriding priority.

The neonatal network continues to provide safe high-quality neonatal services for all babies who require it, with additional precautions in place at the moment to deal with any risks from pseudomonas. All trusts continue to work together to ensure that the neonatal unit capacity in Northern Ireland is maintained.

Well-established arrangements are in place to ensure that babies have access to the level of neonatal care that they require. As would be routine in Northern Ireland and across the UK, babies may have to be transferred between units from time to time. Indications are that we have sufficient cots in Northern Ireland to cope with demand. Last week in the Assembly, I stated that we have 105 cots. However, on the basis of more up-to-date information, I can confirm that the number is actually 106. Very occasionally, babies may have to be transferred to units outside Northern Ireland. No babies requiring neonatal care have had to leave the Province over the past two weeks since the outbreak in the Royal Jubilee Maternity Service.

I also want to reassure women that the delivery wards and all other services at the Royal Jubilee Maternity Service are operating as normal. Expectant mothers should attend their appointments as scheduled, and that applies to all our maternity hospitals in Northern Ireland.

I acknowledge that this is also a difficult time for staff in the health sector. I pay tribute to all staff, not just medical and nursing staff, but estates staff, laboratory staff, cleaners and others for their continued dedication and commitment in caring for babies and for working tirelessly to investigate the problem and to take the proper action. In addition, I recognise the work of the Public Health Agency to date in providing expert health protection advice and professional service delivery advice working closely with the Health and Social Care Board as they ensure that neonatal services remain available for babies.

I thank the chief executive of the Health Protection Agency in England for establishing an incident team and for providing us with access to all the necessary expert advice required in this difficult situation. This is highly specialised expertise that we could not hope to replicate in Northern Ireland, and my Department and Public Health Agency colleagues are indebted to them for their support.

Continuation of this response is essential, and my Department, the Public Health Agency, the trusts, the HSC Board and the Ambulance Service have been working and continue to work very closely to ensure safe continuity of care for babies, support for their parents and families, ongoing management of this outbreak and that the public are kept fully informed.

This remains a complex and dynamic situation. I can assure you that everything that needs to be done is being done, and I am determined to make sure that our neonatal units are the safest they can be and that the babies are protected. I reiterate that safeguards are in place to protect babies. As a precautionary step, any potential risk as a result of contamination of taps and water outlets is being addressed.

Mr Speaker, I commend the statement to you. It reflects the situation as it is today, and further updates will be issued as and when there is any change.