Pulse oximetry is a simple and non-invasive technique that monitors the oxygen saturation of the haemoglobin — the percentage of blood loaded with oxygen. Pulse oximetry has many uses and is now routinely used in critical care anaesthesia in accident and emergency departments. It is also used in neonatal intensive care units, and there has been research into its potential role in screening for congenital heart defects, which are among the most common congenital anomalies. They affect between 4% and 10% of 1,000 live births and are responsible for up to 40% of deaths from congenital malformations. Congenital heart defects comprise a wide range of different structural cardiac malformations, which vary in clinical presentation, prevalence and prognosis.
Many congenital heart defects are identified before the baby is born. Some may present immediately at birth, others within a few days or weeks and others after 12 months or more. Whatever the nature of the defect, it is essential that we diagnose babies who have a critical congenital heart defect as early as possible. We need to be able to do this so that we can provide anticipatory care at delivery or soon after birth so that we prevent deaths occurring before definitive management can be initiated and prevent the morbidity that results from cardiovascular collapse.
In Northern Ireland, screening for congenital heart defects is offered antenatally and neonatally. Cardiac defects are looked for as part of the 18-to 20-week fetal anomaly ultrasound scan that is offered to all pregnant women. The scan has variable success in detecting heart defects.
Detection rates vary by defect type, and, indeed, some are not detectable at all in early pregnancy because of their natural history of development. Rates are also influenced by the expertise of the person doing the scan, the standard of the equipment used and maternal body mass index. After birth, all babies are screened for congenital heart defects as part of the newborn physical examination, which is usually done within 72 hours of birth and, ideally, within 24 hours. They are also screened at six to eight weeks of age. Clinical examination involves looking for cyanosis, which is a blue colouring of the lips; listening for abnormal heart sounds with a stethoscope; and feeling the pulses in the groin for decreased or delayed blood flow. Detection rates vary by congenital heart disease subgroup. Defects such as coarctation and aortic stenosis are less likely to be detected before the baby is discharged from hospital.
No single screening test will detect all congenital heart defects equally well. This is because of the natural history of their development and their variable clinical presentation. Antenatal screening appears to detect between 30% and 50% of congenital heart defects, newborn clinical examination may detect between 30% and 60%, and around 25% of defects are not diagnosed before discharge.
Pulse oximetry is now considered as an adjunct to clinical examination. Screening using pulse oximetry involves attaching the probe of the oximeter to the infant's hand or foot. The oxygen saturation is displayed as a percentage, and the examination can be performed or by a junior doctor, a midwife or other health professionals, and the equipment is portable.
A number of studies have used pulse oximetry to screen for congenital heart defects, and their findings are encouraging. Pulse oximetry may identify babies with congenital heart defects that result in cyanosis, but it will not identify defects that are associated only with murmurs or with delayed or absent pulses. It will also identify babies who are cyanotic for reasons other than heart defects, such as lung disease or infection.
In 2013, the UK National Screening Committee issued for consultation a review of the evidence on adding pulse oximetry to the screening pathway to detect congenital heart disease in newborns. The consultation closed in December 2013. It is expected that the outcome of the consultation will be discussed at the next meeting of the National Screening Committee (NSC), which is due to be held on Wednesday 12 March.
The NSC review of the evidence raised some important questions that require further consideration. One is that a significant number of babies who have a positive screening result will not have a heart defect. In other words, those babies will be false positives. Although some of them may have a serious illness that is causing their low oxygen levels, clear pathways for investigating non-cardiac causes have not yet been established or evaluated. Another issue to resolve is the timing of the screening test. If it is done at less than 24 hours old, the false positive rate will be higher, but if it is done after 24 hours, some babies may already present with symptoms of a heart problem.
Another question that needs to be resolved is whether the test should be repeated if the result is abnormal, and, if so, after how many hours. The site of the test also needs to be considered. Should it be the foot, the right hand, or, indeed, both? There is also a limitation, which I have already mentioned, in that the screening test will not identify defects that are associated only with murmurs or with delayed or absent pulses.
On the positive side, the National Screening Committee review has found that pulse oximetry is a clinically effective and cost-effective screening modality for detecting critical or life-threatening congenital heart defects. It has the potential to reduce the number of babies leaving hospital before certain types of congenital heart defects are recognised, and so increase the likelihood that those babies will be treated before they become more seriously ill. The NSC review has concluded that, as there are still significant uncertainties about its use in a routine screening context, a pilot or staged introduction may be the best way forward.
A pilot could address a number of key issues. One is the question of who to screen. Some babies will be excluded, including premature babies, those already diagnosed with congenital heart defects and babies with significant malformations. Optimal test procedures need to be defined for oxygen saturation measurement and newborn clinical examination. Those include the timing, the positioning of the oximeter probes, the number of repeat tests that should be undertaken and the relationship between pulse oximetry and clinical examination.
It will be necessary to clarify and test pathways for referral for further investigations after a screen positive result for cardiac causes and non-cardiac causes. Information needs to be developed for parents and health professionals across the antenatal and newborn continuum. A training curriculum will need to be instituted for midwives and others involved in newborn screening using pulse oximetry. A pilot could also help to establish routine data systems for audit, quality assurance and monitoring longer-term outcomes.
In conclusion, the National Screening Committee has done a significant amount of work to assess the potential of pulse oximetry for screening newborn babies for congenital heart defects. The research evidence indicates that pulse oximetry, used as an adjunct to clinical examination, may increase the detection rate for critical or life-threatening congenital heart defects as a newborn screening opportunity.
At this point in time there remain a number of uncertainties with regard to optimising the screening and referral pathways, and work is in hand to address those uncertainties. So, I am awaiting with great interest the recommendations of the National Screening Committee, and I will consider its recommendations before I make a policy decision on the matter. Given that that should happen in the course of this month, I hope to be able to come back to the Assembly in the not-too-distant future with a position on the matter.
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I wish to make a statement to the Assembly following the completion of the investigations into the allegations of abuse at Ralphs Close Residential Care Home and sign off of the Safeguarding Report by the Western HSC Trust Board.
Members will recall that following the initial allegations of abuse in July 2012, and in response to members questions, I informed the Assembly of the actions being taken by the Trust to protect and ensure the immediate safety and well-being of residents including the initiation of the Joint Protocol arrangements for the Investigation of Alleged and Suspected Cases of Abuse of Vulnerable Adults which led to an investigation by the PSNI and a Safeguarding Investigation by the Trust. Both these investigations are now complete.
The outcome of the PSNI criminal investigation, which lasted nine months, concluded there was no evidence of wilful neglect and in the absence of witness evidence it was unlikely that the burden of proof threshold required in a court of law would be met. The Public Prosecution Service (PPS) has advised that in the absence of witness evidence there is no other evidence against identifiable individuals of any offences. This highlights the challenges we face in protecting the most vulnerable people in our society, people who cannot always speak for themselves and who rely on others for their care. There is no room in the health and social care family for those who exploit their position of trust by inflicting suffering and harm, or indeed, standing by and ignoring others who do.
I welcome the assurance that the Trust has undertaken a very thorough safeguarding investigation, carried out by an experienced team of senior managers and professionals. As recommended by my Department, the senior team was assisted and advised by an independent external expert in Adult Learning Disability appointed by the Trust. The findings are disturbing, but it is always important that such issues are brought into the open so that we can take all appropriate action and secure improvements in services.
The report has concluded that on the balance of probability there has been abuse perpetrated by a number of staff in Ralphs Close over a period of time. The nature and type of abuse includes physical and psychological abuse and neglect by omission. Over 50% of allegations made have been substantiated and on the basis of these findings disciplinary proceedings are now progressing as well as investigations by the relevant regulatory bodies. Members will understand that I cannot say more on that subject at present, other than to say that individuals who abuse those in their care will be held to account for their actions.
I have already had an urgent meeting with the Chief Executive of the Western Trust and the Chair of the Trust Board to seek their assurance that individuals will be held to account for identified failings and that every effort has been made to ensure, as far as possible, that poor or abusive practice is not happening elsewhere in any setting within the Trust.
I am truly appalled and angered that anyone in a position of responsibility and trust, caring for vulnerable people, could in any way cause them hurt or distress. I deeply regret that individuals have suffered directly and their families. As a consequence I am hugely disappointed that vulnerable people and their families have been let down by the service. The Trust have apologised directly to those involved.
Members will be aware that this will have a personal resonance for many families who have loved ones being cared for in similar settings. I am aware that the findings in this case will impact on families’ level of trust and confidence in our system.
As far as possible, I want to be assured and to assure the public that there is strong vigilance and proactive management in all health and social care settings in Northern Ireland, including private and voluntary sector settings where care is provided to vulnerable adults. I want to be assured that there is a determined and sustained focus on promoting high standards of care and safety and on preventing, detecting and, where necessary, dealing robustly with poor or abusive practice at every level in the HSC system.
Consequently, I have sought assurance from the Chairs across all the Trusts that facilities, which are caring for vulnerable adults, have robust safeguarding arrangements in place, that they are confident these are being adhered to; and that a culture is promoted within those settings, and throughout the organisation, that has a zero tolerance of poor practice, negligence or deliberate harm of any kind.
It is important that we recognise and acknowledge that the vast majority of staff who care for our loved ones do so with compassion, kindness and a commitment to doing their best. I would acknowledge and thank those individuals who persisted in bringing the abuse in Ralphs Close to light. And, as I have said consistently in my role as Minister for Health, anyone who has a concern about the standard of care should not be afraid to come forward. Preventing abuse or neglect is the responsibility of all of us and none of us should tolerate vulnerable people being abused in any way.
My Department is in the process of developing new adult safeguarding policy, which I have instructed officials to finalise and issue as a matter of urgency. The policy will place a renewed emphasis on preventing harm to adults who are vulnerable and, at the same time, seek to ensure that effective protections are provided in circumstances where harm has occurred or is suspected. It will advocate a policy of zero-tolerance of adult abuse in any setting and make respect for their dignity and rights non negotiable. It will also make it clear that effective safeguarding of those who are vulnerable is the responsibility of us all.
At the same time, we are in the process of implementing new safeguarding legislation, the majority of which is already in operation. The aim of the legislation is to ensure that individuals found to have harmed adults who are vulnerable are removed from the workforce, added to barred lists where this is appropriate and, consequently, prevented from obtaining work with vulnerable adults in the future while they continue to remain on a barred list. The legislation will in future make it a requirement for employers and volunteer managers to check against the barred lists prior to permitting an individual to work or volunteer with vulnerable adults.
Trust can be abused in every sphere of care within our society. Some people are capable of terrible cruelty. There are corrupt and immoral individuals who, in spite of all our best efforts, will find ways to subvert the system and harm others. I am doing, I have done and I will continue to do all within my power to stamp out abuse and create a system where there is no hiding place for those who abuse their position of trust. I cannot do this alone. It requires everyone to be vigilant and to take responsibility to protect those who are vulnerable.
People who use our services, their families and relatives, carers and members of staff or managers must feel confident and able to come forward to speak out and express any concerns they have about the quality or standard of care, whatever the context. Where individuals do not have the capacity or ability to do so themselves they must be supported to have a voice.
Creating a culture of openness and transparency within the health and social care system so that there is no hiding place for poor or abusive practices is my priority and it must be everyone’s priority.
The movement of patients from an institutional setting to community based facilities is reflective of the strategic vision to de-institutionalise the care of individuals and to provide person-centred, community-based approaches which promote the rights of, respect for, choice and independence of individuals. The move to Ralphs Close had the potential to be a positive development for individuals who had previously resided in a hospital setting. Regrettably this was not the case.
The lessons from Ralphs Close highlight that the transition from institutional living to community based living requires careful planning and management. It is not simply about the transfer of location but requires a change in ethos and working practices. These lessons will need to inform the planning and implementation of the reform of the health and social care system, to ensure that the vision set out for Transforming Your Care is realised and that those responsible for implementing the reforms learn from this.
I have instructed the Health and Social Care Board to ensure that the lessons learned from this case are disseminated across all Trusts and service providers in the voluntary and private sectors who are commissioned to provide services by the HSC Board and/or Trusts.
Since the first allegations were made in July 2012 the Regulation and Quality Improvement Authority has undertaken more than ten announced and unannounced inspections of Ralphs Close. The most recent unannounced inspection was earlier this month and I can confirm to members there are currently no concerns regarding the standards of care in this facility. Indeed, there has been a transformation in the care provided to residents over the past 18 months.
I want to pay tribute to those staff in Ralphs Close who, in spite of the intense scrutiny and adverse publicity around this case, have continued to care for the residents and have worked tirelessly to create a new culture of person-centred care. We owe them our thanks and gratitude.
Ballinderry, Ballymacash, Ballymacbrennan, Ballymacoss, Blaris, Derryaghy, Dromara, Dromore North, Dromore South, Drumbo, Glenavy, Gransha, Harmony Hill, Hilden, Hillhall, Hillsborough, Knockmore, Lagan Valley, Lambeg, Lisnagarvey, Maghaberry, Magheralave, Maze, Moira, Old Warren, Quilly, Seymour Hill, Tonagh, Wallace Park.