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Renewed focus on patient safety

Change in healthcare is often slow and seldom comes without tragedy.

The horrific failures in maternity services at Midland Regional Hospital, Portlaoise, shocked a public that has seen many health scandals. Minister for Health Leo Varadkar said he was “ashamed” of the manner in which patients were treated “by members of my own profession and other professions”.

Early last week, the HSE received damning condemnation from those most painfully affected by this scandal.

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Minister for Health Leo Varadkar

Ms Amy Delahunt, whose baby daughter Mary Kate Kelly died following poor care in Portlaoise in May 2013, told the Oireachtas Health Committee: “The HSE management team is clearly incapable and cannot be trusted to implement the recommendations of this or previous investigations by the Health Information and Quality Authority.”

HSE Director General Mr Tony O’Brien said HIQA’s Portlaoise report represented “a watershed”. But faith in the Executive’s ability to change is in short supply and in many cases non-existent.

Recommendation

One of the recommendations that emerged in HIQA’s investigation into the safety, quality and standards of services at Portlaoise (see panel) concerned the establishment of an “independent patient advocacy service”.

The report recommended that the Department of Health commence discussions with the HSE to establish this advocacy service, with a view to having it in place by May 2016.

“This service’s role would be to ensure that patients’ reported experiences are recorded, listened to and learned from,” it stated. “Such learning needs to be shared between hospitals within hospital groups; between hospital groups; nationally throughout the wider health system; and published.”

This is not the first time that a patient safety agency or authority has been mentioned. In fact, until quite recently, it was a central plank of Government policy

In the meantime, the Department of Health and HSE should provide regular updates on their websites, informing on the progress of establishing this service, stated the report.

This is not the first time that a patient safety agency or authority has been mentioned. In fact, until quite recently, it was a central plank of Government policy. In March of 2014, in the aftermath of CMO Dr Tony Holohan’s report into perinatal deaths at Portlaoise, the then Minister for Health Dr James Reilly told the Dáil: “This report shows that the planned Patient Safety Agency has a vital place in our health service, which is why it is included in this year’s HSE Service Plan. The Agency will be established shortly and applications for a CEO will be invited. The PSA will be a ‘patients’ champion’, supporting patients to ensure that they receive an appropriate response to the safety issues they raise. The PSA will also promote and disseminate learning on how we can build and enhance a safety culture in all our healthcare services.”

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Former Minister for Health James Reilly

However, as with other elements of Dr Reilly’s ambitious reforms, plans to establish it on a statutory basis were shelved soon after he left Hawkins House. According to a report in The Irish Times, senior HSE managers were urged by the Department of Health to exclude any reference to the proposed agency in this year’s service plan.

In a letter to Secretary General at the Department of Health, Mr Jim Breslin, dated 12 December, Mr Tony O’Brien wrote that, during the autumn, the Executive had been “requested not to specifically reference progression of the Patient Safety Agency (or as per my more recent correspondence, Patient Advocacy Agency) in the service plan”.

Mr O’Brien also wrote that the recruitment process for a Chief Executive had been paused.

There is no reason that a patient safety agency could not have been advanced, irrespective of whether it was part of the HSE

“I am conscious that at this time, we must either complete or cancel the recruitment campaign and I am concerned to ensure that the HSE and the Department of Health are fully aligned in any approach we take to this matter.

“The cancellation of the recruitment campaign requires communication from us to each of the shortlisted candidates, telling them that the establishment of the Patient Safety Agency is not proceeding at this time.”

However, Minister Varadkar now wants a patient advocacy body to be in place and fully independent of the HSE, sooner than the May 2016 target date. But available details on this development are few.

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Minister of State Kathleen Lynch

On May 9, following her speech at the ICGP annual conference in Galway, Minister of State at the Department of Health, Kathleen Lynch TD, said her Department was the most likely funder of a “Patient Advocacy Service” promised by Minister Varadkar in the wake of HIQA’s Portlaoise report.

Speaking to MI following a session on patient-centred care at the conference, Minister Lynch said she was currently “not certain where exactly it would sit,” but not within the HSE.

Asked whether the Department would be the funder, Minister Lynch said it was usually the Department that funded initiatives of this nature. “That has to be decided yet, but they can’t fund themselves,” she said.

Politicians of various hues have emphasised that such a body should already have been in place.

Programme for Government

Following the fallout from the Portlaoise scandal, Fianna Fáil spokesperson on Health, Billy Kelleher TD, accused the Government of failing patients by not establishing the long-promised Patient Safety Agency.

“Not only was a new Patient Safety Authority promised in the Programme for Government, in 2012 the then Health Minister James Reilly promised that a new patient safety agency would be established on an administrative basis in 2013. However, this was clearly a watering-down of the Programme for Government commitment, as it would not have incorporated HIQA in the new structure.

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Fianna Fail spokesperson on Health, Billy Kelleher TD

“In any case, the Patient Safety Agency was not established in 2013. Nor was it established in 2014, despite the Taoiseach telling the Dáil in February 2014 that Minister Reilly had directed ‘that a new patient safety agency would be established this year’.”

He also accused Minister Varadkar of requesting the HSE “to break commitments made in both the 2011 Programme for Government and in the 2012 Future Health Framework”.

“This is truly shocking and absolutely deplorable. Bear in mind that this request would have been made some months after the Prime Time exposé of maternity care and a year after the HIQA report into Savita Halappanavar’s death. Minister Varadkar stopped it on the basis that the agency should not be a part of the HSE. This is absurd. There is no reason that a patient safety agency could not have been advanced, irrespective of whether it was part of the HSE. In any case, doesn’t the Government want to abolish the HSE?

“Now it seems that there will be another year at least to wait until a patient advocacy body is set up. It’s yet another broken health promise by the Government and the latest in a long list of missed deadlines.”

Sinn Féin’s Caoimhghín Ó Caoláin TD, meanwhile, said that a Patient Safety Authority should be a priority.

In Scotland, the Scottish Patient Safety Programme reduced mortality and adverse events in acute adult hospitals by 12.4 per cent across the country

“Such a body would be able to enforce the standards laid out and investigated and reported on by HIQA. It is clear that, at present, while HIQA can make sound recommendations, they often fall on deaf ears. A Patient Safety Authority would be able to ensure implementation of recommendations arising from HIQA reports. Evidently, things are not working at present and I believe that such a body could ensure quality and standards are kept, as they must be across all health delivery settings throughout the State.”

While there is fresh impetus for the establishment of this structure, what shape it may take remains unknown.

According to the 2011 Programme for Government, the Patient Safety Authority would not only incorporate HIQA and its current functions, it would also act as the mechanism for the introduction of hospital trusts.

Previously, it was reported that this body would have considerable powers to impose financial penalties on hospitals which failed to “adequately” inform patients or their families about safety incidents. It was further reported that it could facilitate immunity against prosecution for doctors and hospitals which admitted safety incidents.

The Department in the past informed the Medical Independent (MI) it had met with “experts from a number of countries including Canada, Denmark and Scotland” regarding this initiative.

In Scotland, for example, the Scottish Patient Safety Programme (SPSP) reduced mortality and adverse events in acute adult hospitals by 12.4 per cent across the country.

Now entering its second phase, the programme’s successes cannot just be measured in mortality rates alone. Holyrood Magazine reported that the success of the scheme, co-ordinated by Healthcare Improvement Scotland, is based on “10 patient safety essentials” which were outlined to all boards in September 2013, and represent a key part of the future development of the acute adult safety programme. These essentials include hand-hygiene, leadership walk-rounds, communication, and steps to reduce infections related to ventilators and cannulas.

In a just culture, errors and unsafe acts will not be punished if the error was unintentional. However, those who act recklessly or take deliberate and unjustifiable risks will still be subject to disciplinary action

The ‘surgical pause’ or ‘timeout’ is also included in the package of measures that are to be a “fundamental expectation of every person experiencing acute hospital care,” according to Prof Jason Leitch, Clinical Director of the Quality Unit at the Scottish Government.

While initially focusing on acute hospitals, the SPSP’s remit now includes acute adult, maternity and children, mental health and primary care. Reporting and transparency are emphasised.

As reported in Holyrood Magazine in 2014, changes have been staff-led, with staff monitoring improvements through the collection and analysis of data from within their own clinical area.

The current affairs magazine stated: “The next stage of the SPSP aims to reduce hospital standardised mortality ratios from 15 per cent to 20 per cent and to provide 95 per cent harm-free care by the end of 2015. It has a significant focus on reducing infections, sepsis/VTE, and preventing falls and pressure ulcers.”

Irish healthcare

The Irish Centre for Patient Safety is a research group made up of academics and clinicians from NUI Galway and the Saolta University Healthcare Group.

Dr Paul O’Connor, who lectures in primary care at NUI Galway, says an agency for patient safety would be very welcome, but that models must be adapted to the Irish healthcare system.

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Dr Paul O’Connor, Irish Centre for Patient Safety

“I would certainly welcome the move to set up a patient safety agency. As the main stakeholder in the healthcare system, I believe it is crucial that patients have an organisation that advocates on their behalf. However, I would also agree with the current Minister for Health that it is important that this agency should be clearly independent from the HSE,” he tells this newspaper via email.

“I think it’s a good idea to examine how these types of agencies operate in other countries. However, it is important that whatever model is used should be tailored to the Irish healthcare system.”

When asked if a system of ‘no fault’ compensation should be initiated, Dr O’Connor is emphatic.

“Although I have great sympathy for those working in healthcare in terms of the ever-present risk of litigation, particularly those in maternity, I think a ‘no fault’ clause is likely to be counter-productive.

“It implies that even when unjustifiable risks have been taken by healthcare professionals, hospital management (eg, failing to act on known concerns), or the HSE (eg, not resourcing a particular unit sufficiently) then there is no fault. This does not seem to be fair for the patient.”

For Dr O’Connor, the real issue is that healthcare must try and move away from a ‘blame culture’ and foster what has been described as a ‘just culture’.

“In a just culture, errors and unsafe acts will not be punished if the error was unintentional. However, those who act recklessly or take deliberate and unjustifiable risks will still be subject to disciplinary action. The point is to try and develop a culture in which the primary focus is not blame, but rather learning from what has gone wrong so that the same errors are not repeated over and over again. A serious adverse event is a tragedy, but failing to learn from that event is a catastrophe.”

For those affected by inadequate care at Midland Regional Hospital, Portlaoise, the process of retrieving honest information from the HSE has been a long, painful one.

This starkly underlines the need for a patient advocacy service. But whether this body is established before the May 2016 deadline, and how exactly it will operate, remains to be seen.

Report of the investigation into the safety, quality and standards of services provided by the Health Service Executive to patients in the Midland Regional Hospital, Portlaoise (HIQA, 2015)

Recommendations

Recommendation 1

The Department of Health should commence discussions with the HSE to establish an independent patient advocacy service, with a view to having a service in place by May 2016. This service’s role would be to ensure that patients’ reported experiences are recorded, listened to and learned from. Such learning needs to be shared between hospitals within hospital groups; between hospital groups; nationally throughout the wider health system; and published. In the interim, the Department of Health and the HSE should provide regular updates on their websites to inform the public on the progress of establishing this service.

Recommendation 2

The Department of Health should, in line with its published Profile Table of Priority Areas, Actions and Deliverables for the Period 2015-2017, ensure implementation of the recommendations contained in this investigation report and previous investigations undertaken by the Authority.

Recommendation 3

a) The Department of Health must now develop a national maternity services strategy for Ireland, as specified in recommendation N7 of the Authority’s October 2013 Investigation into the safety, quality and standards of services provided by the Health Service Executive to patients, including pregnant women at risk of clinical deterioration, including those provided in University Hospital Galway, and as reflected in the care and treatment provided to Savita Halappanavar.

b) The Department of Health should provide regular updates on its website to inform the public of progress with developing and implementing this national maternity strategy.

Recommendation 4

In line with the Department of Health’s policy to develop independent hospital groups, the Department should expedite the necessary legal framework to enable the group Boards of Management and Chief Executive Officers of each hospital group to comprehensively perform their governance and assurance functions.

Recommendation 5

The HSE should ensure the appointment of a Director of Midwifery, before September 2015, in all statutory and voluntary maternity units and hospitals in Ireland that currently do not have such a post.

Recommendation 6

The HSE, along with the Chief Executive Officers of each hospital group, must ensure that the new hospital groups prioritise the development of strong clinical networks underpinned by:

a) A group-based system of clinical and corporate governance informed by the National Standards for Safer Better Healthcare.

b) A clearly-defined, agreed, resourced and published model of clinical service delivery for each hospital within the group. This must be supported by clearly-defined, agreed and documented patient care pathways to ensure that patients are managed in, or transferred to, the most appropriate hospital.

c) Regular evaluation and audit of the quality and safety of services provided.

d) Systems to support a competent and appropriately-resourced workforce.

e) A system to proactively evaluate the culture of patient safety in each hospital as a tool to drive improvement.

f) Systems in place to ensure patient feedback is welcomed and used to improve services and that patient partnership and person-centred care is promoted, as per the National Standards for Safer Better Healthcare.

g) Effective arrangements to ensure the timely completion of investigations and reviews of patient safety incidents and associated dissemination of learning. These arrangements must ensure that patients and service users are regularly updated and informed of findings and resultant actions.

Recommendation 7

The HSE, in conjunction with the Chief Executive Officer of the Dublin Midlands Hospital Group, should:

a) Review all of the findings of this investigation and address the patient safety concerns at the Midland Regional Hospital, Portlaoise.

b) Immediately address the local clinical and corporate governance deficiencies in the maternity and general acute services in Portlaoise Hospital.

c) Publish an action plan outlining the measures and timelines to address the safety concerns and risks at Portlaoise Hospital, to include both general and maternity services. This action plan should include a named person or persons with responsibility and accountability for implementation of recommendations and actions in internal and external reviews and investigation reports, and be continuously reviewed and updated in order to drive improvement and mitigate risk.

The HSE and hospital group CEOs must now ensure that every hospital undertakes a self-assessment against the findings and recommendations of this investigation report, and develop, implement and publish an action plan to ensure the quality and safety of patient services.

Recommendation 8

The HSE, the Chief Executive Officer of each hospital group and the State Claims Agency must immediately develop, agree and implement a memorandum of understanding between each party to ensure the timely sharing of actual and potential clinical risk information, analysis and trending data. This information must be used to inform national and hospital-group patient safety strategies.

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