Pseudomonas Statement

Mr [Deputy] Speaker, I welcome this opportunity to update the Assembly on Pseudomonas in neonatal units and the actions that are being taken to protect babies and address the problem.

No-one could fail to be distressed by the death of the three babies in the Royal and one from Altnagelvin. I can’t even begin to imagine, let alone put into words, the heartache which those parents have suffered and continue to suffer. I have written to the parents of each of the babies who died, expressing my deepest condolences. I have also spoken to those parents that it has been possible to contact. The Trusts have facilitated sending out these letters and I will respect each family’s choice about whether or not they wish to meet.  I know that all members will wish to respect and be 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 Hospital. This week I can report that this number is unchanged. Sadly three of the babies died in the Royal neonatal unit: one baby recovered from Pseudomonas but died later from unrelated causes; while the remaining three babies are progressing well. So, there have been no new cases of Pseudomonas infection in the Royal, or indeed any of our neonatal units in the past week.

Last week I reported that there were there were six babies who had been associated with the Royal who were 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.

There are also six babies colonised with Pseudomonas who have had no association with the Royal: two in Altnagelvin; three in Craigavon; and one in Antrim.

It is obviously too early to say that the outbreak in the Royal Jubilee Maternity Hospital is over, but I can assure you that every possible action is being taken to protect these vulnerable babies.

I want to emphasise again that the Pseudomonas infections in the Royal and Altnagelvin were different strains. These 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 the presence of 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 and that results indicate that no baby has tested positive for Pseudomonas. There are NO babies colonised or with active Pseudomonas infection in the Ulster Hospital.

I explained to members last week 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 these. Pseudomonas can be found in sinks, taps and water systems and is difficult to eradicate completely and permanently. Because Pseudomonas is in the environment, if we start to look for it, we will find it.  This is clearly what is happening at present. As each of the units has tested water coming from taps, a small number of these samples have returned positive results. This is clearly 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 scientific evidence.

Yes, we can test babies for Pseudomonas. Yes, we can test water. Yes, we can replace taps. But we are in relatively unknown territory with Pseudomonas. There is currently no national guidance sitting on a shelf waiting to be used. For this 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 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 these babies by doing the wrong thing.

So, you will see that Northern Ireland is breaking new ground in the context of the UK and Ireland in responding systematically to this situation. We are providing ongoing care for babies and support for parents. At the same time, we are investigating the outbreaks; 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 of this work has resulted in publication of interim guidance for Trusts in Northern Ireland, drawing on the best scientific evidence and expert advice available to us at this time.

Mr Speaker, let me remind the Assembly what we are doing. There will be no contact between the tap water and babies themselves, as a precautionary measure, while the taps and water systems are being checked. Only sterile water will come in contact with babies. This 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 are visiting their babies will also need to take these steps. This approach had already been adopted in Altnagelvin, then implemented in the unit in the Royal, and has now been extended to all other units caring for these very vulnerable babies.

These crucial steps are protecting the babies in these units. This gives time for estates 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 this approach protects the babies while at the same time ensures 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 these taps will also be tested as part of the investigation. Once the new taps are in place, the 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.

There is no single, simple ‘quick fix’ for this situation. While we need to move swiftly and decisively, we must be sure we 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 this continues to be our approach.     

I want to elaborate further on the interim guidance which has been developed in Northern Ireland. My Chief Medical Officer has already shared this with all Chief Medical Officers across the UK and 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 too.   

Outbreaks of Pseudomonas have occurred in some intensive care facilities around the world as patients in these facilities are frequently immunocompromised. The causes of these outbreaks have not all been the same. They have included various medical devices and environmental reservoirs such as antiseptic solutions; ventilator apparatus; and artificial fingernails as well as water.

There were a number of outbreaks in English and Welsh hospitals in the summer of 2010 and 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, and this work is nearing completion.

I have asked my Chief Medical Officer to take action on this. He has already written to the CMO in England stressing the need to expedite publication of the national guidance, and I am told that this is expected in the near future. All four CMOs are holding a teleconference later today to discuss this issue.   

In addition, the chair of the advisory group on Antimicrobial Resistance and Healthcare Acquired Infection (ARHAI) has been asked to take this forward at a UK level.  The question of Pseudomonas is on the agenda for the next meeting of the group, which takes 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 the solutions which we are developing for dealing with the problem. We also have a responsibility to inform approaches elsewhere.

I want to be absolutely clear that there was no delay on the part of my department and the wider service in responding and managing this situation appropriately.

The Department of Health received notificationfrom the Western Health and Social Care Trust ofa suspectedincident of Pseudomonas infection on the 13 December 2011.A tap was also identified as positive for Pseudomonas the following day. No information was available at this stage to establish definitively if any ofthe strains werethe same.

Despite this, the Department decided to proactively issue a further letter as a precautionary step, rather than awaitany results confirminga link. Additional specialised testswhichidentifiedthat the samples fromthe tapandthe samplesfrom some of the babies were of the same strain,werenot available until after the letter was issued.Given the possible implications, the Departmentjudged it was important to reinforce and reiterate previousadvice and did so.

However, whileit is important to actquickly,the Department must ensure it has sufficient and accurate information in order to give thecorrect adviceon appropriate actions to take. In these infectious diseaseincidents,it is not always immediately apparent what has caused the problem.Detailed investigative workis 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, acting quickly, yet doing the right thing. This incident wasan evolving situation with the Department working closely with the Trusts, the PHA, and the HSC Board.

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 where there are immunocompromised or debilitated patients. Professional, medical and environmental health advice and guidance is regularly issued to the health service for awareness and action. I expect such guidance issued from my Department to be treated with utmost seriousness.  And because we need the HSC to respond properly to such guidance it must be authoritative and credible, and I believe this Assembly can rely on the professional team in the Department to make expert judgements on the guidance that they issue, often – as in this case – managing a number of complex risks where any action can have unintended and undesirable consequences

However, Mr Speaker, 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 CMOs 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 CMO on 22 December reinforced the advice and guidance in the previous letters. I will return to this matter later in my statement.  

Let me assure members that while my immediate priority is to keep the current outbreak under control and take all necessary precautionary steps to keep these babies safe, a second vital strand of work must now begin. I am very conscious of the grief of the parents who have lost babies, but I also know that they want answers. I know that members of this 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 staff must be feeling when tragic events such as this happen.  While I recognise that this is a complex situation, I need to know what happened, why it happened, and what we now need to do to minimise the risk of this happening again.

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

I have already written to the Chief Executive of the Regulation and Quality Improvement Authority (RQIA) requesting that they assist me to develop and facilitate a full, rigorous and independent investigation and review into these incidents and their tragic consequences. This will be chaired by Professor Patricia Ann (Pat) 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 level. Professor Troop will be assisted by a team to include the full range of relevant expertise that is required. The terms of reference which I will determine include a thorough investigation into the role of my department and each of the other HSC organisations. Given the gravity of what has 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 RQIA also investigate the experiences of the families of those babies who died and also those who have been affected in other ways. This is understandably a difficult and sensitive undertaking, which cannot be rushed. This is why I have separated the investigation into two parts. It must provide me not only with urgent answers, but it must also be extensive and encompass all relevant aspects of this incident.  I can assure members, 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 that RQIA develop, with expert public health input from the PHA, a range of specialised audit tools. These will provide independent assurance to the public and to myself, as Minister, of the standards of infection prevention control within neonatal units and other augmented care settings. This audit tool will provide self-assessment standards for Trusts. RQIA will provide the necessary independent assurance that these are being fully followed and implemented.

Mr Speaker, 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 these units are functioning to the highest possible standard. RQIA will provide that independent assurance.

This leads me to my next point. And it, Mr Speaker, it is an important point. I know that many pregnant women and their families are understandably concerned and anxious at this time. I want to assure you that our maternity hospitals and neonatal units continue to provide a safe and effective service, despite the practical challenges they face.  The quality and safety of the care that you and your baby receive remain their 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 risk from Pseudomonas.

In terms of service capacity, all Trusts continue to work together to make sure that neonatal unit capacity in Northern Ireland is maintained.

Well established arrangements also remain in place to ensure babies have access to the level of neonatal care they require. As would be routine within Northern Ireland and across the UK, from time to time babies may have to be transferred between units. Indications are that we have sufficient cots in Northern Ireland to cope with demand. I stated last week in the Assembly that we have 105 cots, however on the basis of more up-to-date information I can confirm the figure is actually 106. Very occasionally babies may also have to be transferred to a unit outside of 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 Hospital.

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

Mr Speaker, I want to acknowledge that this is also a difficult time for staff in the health sector. I want to 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 take the proper action.

In addition I would recognise to 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 want to 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 we could not hope to replicate in Northern Ireland and my department and Public Health Agency colleagues are indebted to them for this support.

Coordination of the 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 together to ensure safe continuity of care for babies, support for their parents and families, and ongoing management of this outbreak and ensuring the public are kept fully informed.    

Members, this remains a complex and dynamic situation.  I can assure you that everything that needs to be done is being done and that I am determined to make sure that our neonatal units are the safest they can be and that babies are protected.

In closing, I want to reiterate: safeguards are in place to protect babies, and as a precautionary step, any potential risk as a result of contamination of taps and water outlets is being addressed.

Mr (Deputy) Speaker I commend this statement to you. It reflects the situation as it is today. Further updates will be issued as and when there is any change.