Established just over a decade ago, HIQA has become an integral part of the health and social care landscape in Ireland. The Authority’s presence is so all-encompassing that it is never far from the headlines. Whether it is findings of staff shortages in nursing homes, or the injunction sought by the National Maternity Hospital (NMH) to prevent an inquiry by HIQA into the death of a pregnant woman during surgery, the Authority’s name is found whenever concerns surface about the quality and safety of health and social care services.
With HIQA’s responsibilities due to expand into hospital licensing and other areas, the organisation is set to become even more ubiquitous over the coming years.
This growth in responsibility brings many challenges, one of which is financial. If HIQA is not provided with the necessary resources to do its job, then any new regulatory regime has little chance of success.
Similarly, raising standards is largely futile if hospitals and other services do not have the funds or ability to make requested improvements.
<h3><strong>Ten years on </strong></h3>
HIQA CEO Mr Phelim Quinn is acutely aware of the issues facing the organisation.
“Services have started to move on in the way in which they are delivered,” Mr Quinn told the <strong><em>Medical Independent</em></strong> (<strong><em>MI</em></strong>). “Similarly, I think regulations also need to move on.”
The Authority has always operated within a challenging environment, given that it was set up in 2007, just before the financial crash. Mr Quinn was full of praise for his predecessor Ms Tracey Cooper for the work she did in establishing HIQA during this difficult time.
“Under the guise of the 2007 Health Act, HIQA had to establish itself in the first instance,” he said.
“My predecessor Tracey Cooper was very, very, clearly charged with establishing the Authority, but I think also establishing the independence and the authority of the Authority. I think that Tracey did that extremely well and what she and some of the founding leaders of the organisation did was, they made HIQA a very recognisable name in the Irish citizens’ lexicon. She created a ‘brand’ of health watchdog that I suppose really provides independent, objective assessment of services, particularly with health services, because within that early phase, there were a significant number of statutory investigations conducted.”
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<strong>Mr Phelim Quinn, CEO, HIQA</strong>
Early investigations included the Rebecca O’Malley report and the Barrington’s review into the misdiagnoses of patients with symptomatic breast disease in Ireland. These reports, along with investigations such as the one into the quality and safety of services at the Mid-Western Regional Hospital, Ennis, proved fundamental in how Irish health services would evolve over the last decade.
<h3><strong>‘Instrument of rationalisation’ </strong></h3>
However, in its early days, HIQA was accused by some critics of being an instrument of the Government to rationalise health services. Reduced health budgets gave these criticisms some sting, even if Mr Quinn said they could not have been further from the truth.
“That angle sometimes is used — we have heard in the past that HIQA is used as an excuse to downgrade or rationalise a particular service,” said Mr Quinn.
“But I have to say, from our perspective, our focus is continuously on quality, safety and compliance. We can’t look beyond that. That is and will remain our focus.”
The tensions that have arisen between HIQA, as regulator, and the Department of Health and HSE, as providers, have meant that doubts over the Authority’s impartiality have become much less frequent over recent years.
At the end of 2011, HIQA strongly criticised the slow pace with which the HSE was implementing recommendations in the Authority’s reports on Ennis and Mallow hospitals. A letter from the then CEO Ms Cooper stated that there had been limited consideration given to the management and mitigation of immediate and current clinical risks. Mr Quinn admits there is tension at times between HIQA and healthcare providers, but he argues that this is ultimately for the good of the health service.
“Critically for us, we would see that in order for us to be effective, in order for us to deliver on our corporate objectives of safer services, and better services, and assurance to the Government and the public about the quality and safety of services, we need to deliver that in some way in partnership with other organisations.
“That includes the Department of Health, it includes the HSE and it includes all sorts of providers of care. Of course, I believe there will always be a natural tension and a natural antagonism, because at times the messages that HIQA delivers are not always that palatable. It is the nature of regulation; you go in to look at compliance and naturally, I think, non-compliance rises to the top. I certainly think the press and media are always very, very interested in probably where there are challenges, rather than where there are positives within services. So I think we always need to work on that relationship, work to make sure that relationship — either with the HSE or Department — is a constructive one, that we have shared objectives in relation to the quality and safety of services.”
In the consultation process conducted by the Oireachtas Committee on the Future of Healthcare, HIQA recommended new commissioning arrangements, which would explicitly define and separate the roles of purchaser and provider of services. Currently, both of these functions are usually performed by the HSE. Mr Quinn said it was disappointing that the Committee’s <em>Sláintecare Report</em> did not seek reform in the area.
“We were disappointed by it, because we have always said that as a result of our investigative work, that accountability needed to be improved in our systems and we believed that by having a commissioning system in place, we were proposing the creation of an accountability framework,” said Mr Quinn.
According to HIQA, implementing a national commissioning approach would involve a radical review of the current health and social care service funding model and allow for the discontinuation of the ineffective practice of legacy ‘block-funding’.
“We looked at that from two very specific levels,” he said.
“One is that macro level, where the HSE has some system in place whereby it knows what the population needs are, and it purchases that service from the local provider and then it adequately performance-manages that service as well — that is, both in terms of the activities which that service becomes involved in and the throughput of patients, and also takes account of the quality and safety of that service as well. So the sorts of information and the sorts of intelligence that HIQA develops becomes very, very, important under that commissioning model.
“We believe there needs to be, and there should be, an interaction at that commissioning level in any organisation with a national regulator. The other aspect of that, which is not specifically linked to maternity services or health services per se, is looking at a model where commissioning can also be done at a local level, at a Community Healthcare Organisation level, when they are actually purchasing care on behalf of an individual who has got long-term needs.”
However, in general, Mr Quinn was positive about the <em>Sláintecare Report</em>.
“I think the <em>Sláintecare Report</em> points our health service in the right direction. The emphasis that there is on primary and community care is exactly the right direction… Again, we are starting to see what the national population needs are for health and social care. I do think we need to see momentum placed behind it.”
The relationship between politics and regulation can be difficult. The delay in introducing hospital licensing can be attributed to a lack of political will, given that the proposal was made in 2008 in the <em>Report of the Commission on Patient Safety and Quality Assurance</em>, a process that was chaired by medical law and ethics expert Prof Deirdre Madden.
Despite the recommendation dating from a decade ago, it is only now that serious progress is being made, with the Government having approved the drafting of the Patient Safety (Licensing) Bill at the end of last year. Mr Quinn admitted that the delay on the issue has been frustrating.
“I think it is disappointing that we haven’t moved further and faster in that intervening time. That is 10 full years ago. Certainly, I think the speed at which legislation is developed within the country has contributed to the delay, but maybe as well it is a reticence to recognise the implications of what licensing might mean. They are quite challenging from a service delivery perspective, but also from a political perspective. It is a challenging thing to do within the healthcare system.”
Giving HIQA the power to license hospitals, both public and private, would fundamentally change the nature of the current regulatory framework. Although the Authority has such powers over nursing homes, for example, extending licensing responsibility to the acute sector would have widespread ramifications. Currently, HIQA’s legal responsibilities under the 2007 Act are only to develop standards and to monitor against those standards in respect of hospitals.
“We hear sometimes that HIQA needs ‘more teeth’, and in fact under the current legislation, really all we can do is monitor and report on what it is that we find,” said Mr Quinn.
“We have no powers of enforcement of any recommendations that we make [in acute hospitals]. So really, it is quite an informal model of monitoring and oversight. I think the licensing regime will bring in a very clear set of requirements under regulations, and/or national standards for service providers to adhere to. It will bring about some form of mechanism whereby HIQA will be required to inspect.”
Mr Quinn said that the precise model of licensing (ie, full hospital inspection or thematic inspections within a hospital) has yet to be determined, but whatever framework takes shape, the powers of HIQA will be strengthened.
“Where we do find non-compliance, there will be a repertoire of sanctions available to us. I imagine that would be up to and including the cancellation of services, either in the private or public sector. That in itself creates a challenge. We have actually produced a scenario-testing paper for the Department of Health, which sets out [that] if there is significant non-compliance in an essential service, it is one thing giving us the legislation to act in accordance with that non-compliance, but how palatable politically would that be? If it involves a large intensive care unit or a very busy emergency department, it doesn’t just raise challenges for HIQA, but it raises challenges for the health system generally.”
One need look no further than the recent injunction sought by the NMH to prevent an investigation into the death of a pregnant woman during surgery to see how contentious the prospect of a HIQA inquiry can be, even where it lacks licensing powers.
NMH Master Dr Rhona Mahony said an investigation into out-of-hours surgery has the potential to radically change clinical practice, as clinicians would avoid high-risk procedures at certain times of the day or night. Although Mr Quinn said the injunction was a matter for the courts, he added that HIQA is aware of the implications for services arising out of its investigations, particularly when a licensing regime is introduced.
However, he stressed that the Authority also attempts to be “reasonable” and “realistic” in its findings.
“If you place a regime of regulation over a healthcare system, there is always the potential for significant deficits to be found by the regulator, and the requirement therefore for the regulator to act in accordance with the powers given to it,” he stated.
“And that might be up to and including closure. But I think we are a reasonable, as well as a realistic, regulator here. We often, before we would take any action within the adult social care sector, would always look at the impact on residents. It is easy to say that a service should have been cancelled, but I also think we have to recognise that the service was the home of those residents over a long period of time, so I think we need to look at the consequences of regulation. And I think it would be same when we are regulating within healthcare. We have to look at the availability of critical services to the wider general public. As well as that, we need to look at the implications of any actions by a regulator on professional staff working within those services.”
He acknowledged that licensing private hospitals would pose particular challenges.
“I think what we would recognise is that certain large private healthcare providers have been the subject of well-recognised accreditation schemes over a period of time and would be used to some form of external benchmarking and self-assessment against a standards framework. However, there are other private providers who aren’t engaged in that sort of activity and I think there would be significant challenges to achieve compliance with the national standards and regulations. Again, when we think about the way the public engages with those services, either in the past or currently, that would pose significant challenges.”
The creation of Hospital Groups adds complexity to the issue of licensing, particularly given that the groups are not yet established under a legislative framework.
“One of the big debates within the public system is, at what level is a license held — is it at the level of the Hospital Group, or is it at the level of the individual hospital? Remember, as well, what we continue to have in those Hospital Groups is that mixed economy of voluntary and public hospitals. So where does accountability sit — does it sit with the board of the voluntary sector hospital, or will it sit within the newly-formed board of the Hospital Group? Those sorts of things all need to be sorted out.
“Even the levels at which we interact with the HSE; at times we make an assessment or an inspection, whether it be under our infection prevention and control programme, or antimicrobial stewardship programme, or in the forthcoming maternity services programme, certainly we interact with people at a hospital level, we sometimes then interact with them at group level, then sometimes we often have to interact with them at national level. Sometimes it is very, very difficult to actually get a handle on where the accountability sits.”
<h3><strong>Ionising radiation </strong></h3>
Licensing is just one of the new responsibilities that HIQA is due to take on in the near future. The Authority will soon assume responsibility for monitoring ionising radiation and will oversee expansion of the programme for the National Patient Experience Survey. Regarding ionising radiation, the EU Council Directive 2013/59/EURATOM required that responsibility for the area be transferred to HIQA by February 2018. However, the transfer has not yet taken place. Every effort is being made to finalise the transposition in the coming weeks, a spokesperson for the Department of Health told <strong><em>MI</em></strong>.
“When you look at the scale of what it is that we have been asked to look at, there would be somewhere in the region of 12,000 users of ionising radiation across the country, which includes the large diagnostic radiology units, radiotherapy units, then the smaller users of ionising radiation, such as chiropractors and dentists,” outlined Mr Quinn.
“Now, we are not saying that we will be in all places at all times, but you have to be able to take a risk-based approach to the regulation of these new regulations. And there are also additional functions in there around selling national population doses as well that we need to develop the competence for.”
Another new area of work is expanding the National Patient Experience Survey. The results of the first survey were published in December 2017. The purpose of this survey is to find out what is working well in Irish hospitals and what needs to be improved. The information is intended to help set priorities for the delivery of a better healthcare service.
While the first survey concentrated on the acute service, the next survey will also incorporate maternity services.
“We learned a lot from last year and we believe that HIQA has the potential to develop a competency centre for the development of patient experience surveys, whether they be service-specific, acute services,” said Mr Quinn.
“Interestingly, we have been approached in recent times by the Irish Hospice Foundation around surveys of bereaved relatives, and as well as that, expanding the survey into the New Children’s Hospital service.”
In addition, a new regulatory regime for special care units for children with challenging behaviour has recently commenced.
All of this new work and future plans mean the resources, in terms of finance and staff, will have to increase. Yet, until very recently, HIQA was unsure of its financial allocation for 2018, which made it difficult for the Authority to plan its work. Mr Quinn admitted that the time waiting for approval of its business plan for 2018 had been frustrating. However, <strong><em>MI</em></strong> can report that the budgetary allocation for HIQA for 2018 has now been approved. The allocation of €16.269 million represents a rise of €3.146 million over the previous year. Mr Quinn acknowledged that this increase is “substantial” and will allow HIQA to take on additional responsibilities.
“HIQA is pleased with the allocation sanctioned, as it will enable HIQA to undertake important work in areas identified by us in our business plan to the Department of Health,” said Mr Quinn.
“The allocation reflects on HIQA’s need to evolve and mature as an organisation working on behalf of people who use our health and social care services.”
Currently, the Authority has 228 members of staff, which is expected to increase by 20-to-25 by the end of the year. This will rise further when hospital licensing is introduced. After years of operating in a very tight financial environment, like all other public sector bodies, HIQA is now receiving additional investment instead of having to deal with shrinking budgets and the public sector moratorium.
<strong>HTA leader </strong>
HIQA is in the process of developing its next corporate plan, and with that comes consideration of how the Authority should evolve as a regulator.
“Moving forward into 2018 and beyond, we have to start thinking as well about what is the next phase of evolution and maturation of this organisation as a regulatory body, as a body that is charged with service improvement,” he reflected.
“… What we have started to see in the course of the last year is better academic links, a better underpinning evidence-base for what it is that we do,” noted Mr Quinn, “and actually placing HIQA at a significantly high benchmark against some of our comparator organisations. I think HIQA with its function under HTA [Health Technology Assessment] has become a leading light within the European HTA network. Similarly, we have been doing a lot of work with our international colleagues in standards development.”
Mr Quinn also believes that the Authority’s monitoring approach, which was designed following a review of how HIQA monitors and inspects designated centres for older people and people with disabilities, is an innovation that other regulators can learn from.
“I think we have created something that is quite unique in terms of the regulation of health and social care services and it would be useful for us to present to regulators in other jurisdictions as a potential model for regulation internationally,” he said.
“It is quite a robust and unique framework. It simplifies regulation to some extent. I think it recognises that regulation is a process whereby a regulator receives, assimilates and risk-assesses information on an ongoing and pretty continuous basis… And it is how we actually process that information and reach conclusions as to what is the most appropriate regulatory intervention.”
<div style=”background: #e8edf0; padding: 10px 15px; margin-bottom: 15px;”> <h3><strong>HIQA’s CEO on:</strong></h3>
<strong>Improving maternity services</strong>
“I believe the national maternity strategy sets a framework for modernisation. And then obviously, the establishment of the Women and Infants Programme as well in terms of the delivery of the strategy, which is a very positive step forward. Another positive change is the development of the national maternity standards, because in the absence of a set of standards up to that point — a clear set of guidelines for the national maternity services — I am not sure people knew what to expect from their maternity services, and what staff were expected to actually provide. I believe if [there is] significant progress in the implementation of those standards and significant progress in relation to the implementation of the national maternity strategy, we will see significant improvement within our national maternity services.”
<strong>Monitoring of healthcare-associated infections in acute hospitals</strong>
“Where we have identified risk issues, we have highlighted them through publication and escalated our concerns to the appropriate level within the health service. More recently, we note the publication by the Government of a national action plan in the area of antimicrobial resistance, coupled with the fact that the Minister for Health [Simon Harris] declared CPE [carbapenemase-producing <em>Enterobacteriaceae</em>] to be a National Public Health Emergency in October. We welcome and fully support both developments and believe that now is a time for concerted, urgent action in response to these measures across the health service. For our part, in 2018, HIQA intends to continue monitoring hospitals in this area, and we will be taking note of how hospitals are addressing the CPE issue. In particular, we recognise the importance of compliance with national screening guidelines for CPE as a vital initial measure to fully quantify and properly address this key threat. Given that CPE has been declared a National Public Health Emergency, we expect as part of our monitoring to find full compliance with these guidelines in all hospitals.”
<strong>Inspections of private versus public nursing homes</strong>
“The 2007 Act and the underpinning regulations for the care and welfare of older people living within designated centres makes no distinction between private or public nursing homes. So [that guides] our application of our regime of regulation right across that [area]. I think we have heard that being said previously [that HIQA is more lenient on public nursing homes], but I don’t think there is any specific evidence for that.”