HIQA braced for expanded role in regulation

Paul Mulholland speaks to HIQA CEO Ms Angela Fitzgerald about the challenges and opportunities arising from the Authority’s growing remit

In the early years of HIQA, which was formed in 2007, its current CEO Ms Angela Fitzgerald was the Deputy Chief Executive at St James’s Hospital in Dublin. Ms Fitzgerald admitted HIQA was often viewed with “trepidation” by healthcare providers at the time. She recalled there were a number of points of disagreement between HIQA and St James’s management in its first registration inspection of the hospital’s older persons’ long-stay unit.

“We were very afraid of HIQA,” Ms Fitzgerald said in an interview with the Medical Independent (MI)*. “But we were also very clear that we wanted to call out and challenge where we disagreed with the findings.” According to Ms Fitzgerald, the dialogue between the hospital and HIQA was productive and ultimately agreement was reached on areas of contention.

In March 2022, Ms Fitzgerald was appointed HIQA CEO after a long and varied career in senior healthcare management (see panel). With hindsight, she recognises the challenge for the Authority to establish itself as a new regulator in the healthcare landscape.

Ms Fitzgerald said collaboration with healthcare providers has become more typical as HIQA has evolved.

“There is an opportunity for response, and a right of reply. And we won’t always get it right, we won’t always get all of the context right…. It is fair to say that when HIQA was established first, the system was in trepidation; if HIQA was coming in, the word got out very quickly.

“But I think it’s more mature now. Our Chair refers to us as a ‘teenage organisation’. And maybe in our early teenage years we might have been more forthright, as teenagers are. I think as we move into adolescence and adulthood, we are trying to decide what is ‘big’ and what is ‘small’, and where is appropriate for us to intervene.”

In addition to its current functions, HIQA is continuing preparations to take on new responsibilities and commitments set out in the Programme for Government. These responsibilities largely arise from the Patient Safety Act, which was enacted in May, and the Human Tissue Bill, which the Government intends to enact in the near future.

The commencement of both pieces of legislation will represent a major expansion of HIQA’s current remit. They will place a statutory responsibility on HIQA to monitor private healthcare facilities against national standards, to receive and respond to notifiable patient safety incidents, and to make provisions for the carrying out of post-mortems. In regard to the Patient Safety Act, Ms Fitzgerald said the regulation of the private hospital sector will be a significant body of work.

“The whole question of open disclosure is also central to the Patient Safety Act and that is going to bring with it increased demand for review,” she said.

“And the threshold for investigation for us in the Act is lowered, so we may find ourselves with a requirement to do more investigations. On the social care side, there are very specific obligations under the Act for the Chief Inspector to investigate individual events.”

Private hospitals

MI asked Ms Fitzgerald whether HIQA’s powers under the Act could lead to similar tension with private hospitals as those experienced between healthcare bodies and the Authority when it was first established. She replied that it would be “unnatural” if private providers were not slightly apprehensive.

Before taking the role of HIQA CEO, Ms Fitzgerald was HSE Deputy National Director of Acute Operations. In this position, she was responsible for negotiating the ‘safety net’ arrangement with private hospitals during the Covid-19 pandemic. “I think having that [previous] relationship and trust is a good starting point,” she said.

Ms Fitzgerald also referred to how HIQA has engaged with the sector in its role regulating medical exposure to ionising radiation. She said that “by and large they have been high performers” and this has been reflected by HIQA in its findings. “That would provide some degree of reassurance, but they have concerns.”

What are the concerns? “They are concerned that most of them are JCI [Joint Commission International] accredited. They are worried that we will bring a dual process that would place a burden on them. We are in that dialogue with them at the minute. I’d say they are worried about will we be proportionate. They don’t know us enough yet. They pride themselves on their independence. And certainly, if I’ve learned from the private hospital arrangement, you’ve got to respect that independence.”

Ms Fitzgerald noted that private hospitals have some advantages over public facilities.

“One of the strengths they have is they have the capacity to act. So if it’s a resource-based issue, they often have the capacity to respond quicker, which we’ve seen in ionising radiation.”

She also said that “reputation and brand is everything to them”.

“So it is important for them that we would give them a clean bill of health. I can understand a degree of anxiety. But I think our approach will be very strong engagement and collaboration in the planning stage.”

There is also the potential for tension in more established regulatory relationships given the lower threshold for investigation under the Patient Safety Act.

“Our approach when things go wrong with hospitals generally is to seek an assurance that they have been addressed and [for them] to understand what they have done. I think by and large we would seek to continue with that. To the extent that the Act imposes specific obligations in the early stages you may have other stakeholders asking for an investigation. And we have to use our judgement on that. The relationship with the Department of Health is crucial in that context. And I think we have a shared view around doing the right thing and doing it right. An overuse of that investigation power would be detrimental when we really have to apply it.”

Healthcare Regulation Directorate

In response to its growing remit, HIQA is undergoing a restructuring process. A new Healthcare Regulation Directorate was established in late 2021. Traditionally, most HIQA inspections took place in social care settings such as the disability, nursing home, and children’s services sectors. The creation of the Directorate reflects the requirement for HIQA to conduct more healthcare inspections. The Directorate has been central in developing its role in ionising radiation and will also include the monitoring of homecare services and international protection accommodation services, which are other new areas of responsibility.

Ms Fitzgerald pointed out that social care and healthcare have different regulatory approaches. In this context, the role of Chief Inspector and Director of Regulation has been split into two separate positions.

“We don’t have powers of enforcement in healthcare. We don’t have a licensing system; we don’t have the power to cancel a registration. It means that you have a different approach to regulation. So the Directorate gives recognition to those different approaches and also recognises the significant growth.”

In 2022, HIQA launched a new monitoring programme against the National Standards for Safer Better Healthcare in acute and community healthcare services. The experience and learning gathered from the thematic inspections over the past decade informed the revised consolidated approach.

EDs

In total, HIQA conducted 20 inspections of acute and community hospitals in 2022. It also published nine individual hospital reports and an overview report of HIQA’s early findings in emergency departments (EDs) in December 2022. The overview report aimed to provide clarity on the findings from HIQA’s first seven inspections under the new monitoring approach. The larger aim was to inform policy across the health service. HIQA found the level of crowding in EDs posed a risk to the health and safety of patients and compromised their dignity and respect. The problem will continue unless a system-wide approach is taken to address major structural issues, according to the Authority.

The report confirmed the conclusions of many previous assessments, such as that of the HSE taskforce convened in 2006. A meeting between the group and the then Minister for Health Mary Harney led to her declaration that the situation in EDs was a “national emergency”. Ms Fitzgerald was Chair of the taskforce at the time. She admitted to MI that its findings still have “validity”.

“You might say, it was a great piece of work, or you might say it didn’t work. Both are probably true.”

According to Ms Fitzgerald, the taskforce highlighted the issues of “capacity, capability, and control”.

“If you come to now, and you look at the [HIQA] overview report, and the engagement with the Department, there’s an attempt to bring those three things
into harmony.”

She said at political level, the need for additional capacity had been the subject of debate for many years, but has finally been accepted.

“There’s a significant investment in community. That’s going to take time to pay off. But it’s about having the capacity. What I mean by capability is using the capacity effectively. That’s about internal system processes for driving patient flow, for managing demand, understanding your demand and capacity requirements, and being able to titrate that up and down. And some hospital managers are very good at that, others are challenged.”

Earlier this month, HIQA published two reports that highlighted examples of good practice within the area. The inspections found that the EDs in Beaumont Hospital, Dublin, and University Hospital Waterford (UHW), demonstrated good overall levels of compliance with standards. HIQA found the services had managed to move from a situation of persistent ED crowding to one where such crowding was well managed or not present. In UHW, this has been helped by 72 additional beds in a new block which is fully operational since 2019.

“If you are at 85 per cent capacity, you have the capacity to manage changes in demand easily,” Ms Fitzgerald said.

“If you are at 100 per cent capacity, your ability to surge or respond to shocks is completely compromised. Then you do immediate things, like opening areas that are not properly staffed or opening ward areas, and you end up in a perpetual cycle of escalation. If you are starting with adequate capacity, you have the ability to meet both types of demand – emergency and elective. But when you have that capacity, you do have to manage it.”

Nursing homes

HIQA conducted 947 inspections of nursing homes in 2020 and 2021, a period when the sector faced unprecedented challenges due to the Covid-19 pandemic. Despite these difficulties, the overall findings showed a high level of regulatory compliance. Nursing homes were found to be either compliant or substantially compliant with 85 per cent of the regulations that were assessed. However, areas for improvement such as fire safety, governance and management, premises, and infection control, were identified.

Ms Fitzgerald acknowledged that deaths in some nursing homes during the pandemic have come under scrutiny, and said it is correct that they are investigated. At the same time, she stated the huge pressure that Covid-19 placed on facilities should not be forgotten. She noted the “extraordinary efforts” of the caregiving sector was “beyond what we could have imagined”.

Earlier this year, MI reported on correspondence about nursing homes from Ms Fitzgerald to Secretary General of the Department of Health, Mr Robert Watt, in November 2022. Ms Fitzgerald wrote that HIQA could contribute to supporting “sustainable delivery” within the sector.

She said discussions have since taken place with the Department and HSE on the issues facing nursing homes. One of these issues is consolidation – 15 nursing home groups currently own approximately 40 per cent of all private nursing home beds, according to a recent audit.

“And that brings new responsibilities to the State because market oversight becomes relevant. So we need to guard against the sudden collapse of providers and people being left with no homes,” Ms Fitzgerald said.

Discussions also focused on infrastructure, capacity, and Ireland’s aging population. Regarding infrastructure, the regulatory requirement for renovations under statutory instrument No 293 has been a source of contention between the Authority and the HSE in the past.

“While there may have been an initial tension around it, I think the effect of regulation and the focus of that regulation by us collectively has resulted in the significant improvement of the living conditions of people who have to live within a confined space.”

In regard to the situation for the nursing home sector post-pandemic, Ms Fitzgerald said there has been a “reset”.

“For providers, there’s fatigue. I think there was a real challenge in dealing with death and loss and loss of staff… certainly post-pandemic there has been a renewed focus on regulation and safety at a time when they are challenged in terms of staffing…. I think the expectations of the public and the discussion now around what people expect has gone back to the way it was before. And we have to navigate a careful path. We have to make sure that our messaging is proportionate.”

Disability sector

The disability sector is facing similar challenges. Ms Fitzgerald admitted the focus on infection control contributed to a decline in overall performance. HIQA’s 2021 overview report for the sector, published in July 2022, found a “notable deterioration” in the levels of compliance with governance and management over the course of 2021. This was partly due to remote or offsite management and oversight arrangements since the Covid-19 pandemic, according to the report.

“The vast majority of centres are good providers with a strong track record,” she said.

“To the extent that we have challenges it does come back to good governance and management. Often that sector is challenged by turnover of staff and in some cases, you could have a significant turnover in a whole team. What we have seen is where you have a strong person in charge, you have good governance and good management structures and good relationships whether it is a private provider that owns it or… HSE… that is the single biggest determinant of safe services. That’s where we try to support both sides of the system and we work very closely with the HSE on the response to inspections.”

Evidence synthesis

Covid-19 highlighted another important aspect of HIQA’s work – evidence synthesis. This perhaps is not as well recognised as its regulatory functions, but Ms Fitzgerald referred to the area as “one of the jewels of our crown”. In addition to its role in conducting health technology assessments, HIQA produced a number of evidence-based reports during the pandemic on how Ireland compared to other countries in its response. She said this area “really came into its own in Covid because the requirement for rapid evidence and strong evidence to underpin decision-making became central to everything we did”.

Ms Fitzgerald noted there has been “significant investment” in the Authority’s evidence synthesis team. She said this was necessary due to the extra requirements for reports such as those produced during the Covid period. Ms Fitzgerald said the HSE Chief Clinical Officer Dr Colm Henry and the Department of Health “have a strong desire for us to take on a broader role”.

“We have been supported to do that. We wouldn’t have always been able to respond to everything, but that’s not surprising. So the conversation we’re having now is, does it make sense to step up what we do on behalf of the HSE, and the Department to a greater extent, so that we can meet the unexpected. There will always be the unexpected. We have a good prioritisation process. We do it conjointly with the Department and the HSE. What we are finding now is the demand is growing for this. And I think the value of it is understood.”

Resources

In 2022, HIQA received €34.6 million in funding. This year its income budget is €39.6 million. Asked whether the general level of resourcing was sufficient, Ms Fitzgerald pointed to a good relationship with the Department of Health.

“We are adequately resourced for the work we are doing now. That’s a testament to the relationship and engagement. We are about to step into a much bigger stage. And it would be important that we would continue to be resourced. I am confident with the relationship that we have.”

The investment provided to HIQA for its major digitally enabled regulation (DER) project is one example of the support it has received. The DER project involves replacing HIQA’s current information system, PRISM, with a more modern solution, described by Ms Fitzgerald as a “game changer”.

HIQA has also been given greater freedom in appointing staff. While all new roles require sanction from the Department, HIQA now has delegated sanction to fill any replacement roles that arise. The Authority currently employees approximately 370 staff. This could rise to over 500 under the new arrangements.

Ms Fitzgerald added she is aware of “competing pressures” and the need providers have for increased funding and support.

“There is a balance between the resources that we need to regulate, and the resources needed to deliver the service. We are entering a new era of expansion and it coincides with real pressures for the system, so I think there will be challenges.”

Overall, Ms Fitzgerald said there is a sense of optimism among staff as HIQA stands on the brink of a new era.

“I think we are energised,” she said. “My strong sense is that people are geared and locked and loaded for change and being able to extend their remit.”

However, Ms Fitzgerald said she wants to ensure that positive aspects of HIQA’s organisational culture are not undermined by the expansion.

“People go that extra mile here. We are small, we are personable. When you get wider and more diffuse, it can be harder to hold onto that. And the other thing that I would be alert to is we’ll have a lot more external stakeholders to relate to, who won’t know us. So it won’t be an easy road. It will take time.”

* This interview took place before the recent revelations concerning Children’s Health Ireland at Temple Street.