On behalf of the Health Information and Quality Authority (HIQA), I would like to thank the Joint Oireachtas Committee on Health and Children for giving me the opportunity to discuss the overall work of the Authority, and I am joined today by Marty Whelan, our Head of Communications and Stakeholder Engagement.

We very much welcome the opportunity to appear before you. This is our first opportunity to appear before the current Committee and we appreciate the opportunity to engage with you on our work.

The Authority was established in May 2007 and we are very conscious of our responsibilities to Government, the Oireachtas and the public and we look forward to hearing your views and working with you over the coming years.

HIQA was established as an independent Authority reporting to the Minister for Health with a wide range of regulatory and non-regulatory functions, most of which are set out in the Health Act 2007. All of our functions contribute towards driving continuous improvements in the safety and quality of care and support for people using our health and social care services.

While many of you may be familiar with many aspects of our work, I would like to briefly describe the functions of the Authority and then focus on the specific areas that members of the Committee have asked us to address today.
 

1 Functions of the Authority

The Authority was established on 15 May 2007. Reporting to the Minister for Health, the role of the Authority is to promote safety and quality in the provision of health and personal social services for the benefit of the health and welfare of the public. This means that the Authority has responsibility for:
 

• setting standards on safety and quality for people using our health and social care services, with the exception of mental health services
• monitoring compliance against these standards
• regulating social care services for adults and children including inspecting and registering designated centres for older and dependent people (nursing homes) and inspecting children’s services (foster care, special care, residential care and children detention schools)
• supporting providers and staff in bringing about improvements in the safety and quality of services for service users
• undertaking investigations where there is a serious risk to the health and/or welfare of a person, or people, using services
• evaluating, and providing advice on, the cost and clinical effectiveness of health technologies (for example, the evaluation of new and existing drugs and vaccines, medical equipment and cancer screening programmes) and, more generally, promoting the better use of resources in our health and social care services
• setting standards and advising on the collection and sharing of information across health and social care services
• publicly reporting on our work and providing information about health and
• social care for the public, users of the services, health and social care policy makers and the government.

I would now like to focus on the specific areas that members of the Committee have asked us to address today.

2 Assessing the Safety and Quality of Hospital Services

In our assessment of performance of any given service, we focus primarily on the experience, safety and quality of the service for the patient. Our approach in assessing services always aims to be proportionate and risk-based. We are fully cognisant of the economic and fiscal challenges that our health system is facing at the moment and what our reasonable expectation of providers should be as a result. In recognition of this, the emphasis for us, and providers, must be on ‘getting a service safe and keeping it safe’ – there is no excuse for unsafe care. Quality can then build from this basic platform.

The Authority’s current powers in healthcare are derived from the 2007 Health Act and differ from our powers in social care. Currently, and in advance of the licensing of healthcare services, the Authority’s main functions for assessing the safety and quality of healthcare services are undertaken through:

• setting evidence-based standards on safety and quality which, when approved by the Minister for Health, service providers are required to implement. Currently the healthcare standards that have been approved are National Standards for Hygiene Services, Prevention and Control of Healthcare Associated Infections, Symptomatic Breast Disease.
• monitoring the compliance of providers against the standards using a variety of different assessment tools, making recommendations for improvement where required and publicly reporting on the performance of a provider
• setting and monitoring Key Performance Indicators (KPIs) that focus on significant and specific aspects of safety and quality for patients receiving those services
• undertaking statutory investigations, instigated by the Authority or at the request of the Minister for Health, where there are serious risks to the health and or welfare of people using those services. The Authority has completed four statutory investigations across a range of aspects of the health service and is currently concluding its fifth. One Inquiry has also been conducted
• a variety of different interactions and interventions with providers in relation to specific hospitals and/or services aimed at ensuring safety and quality in the provision of the services.

In undertaking this work, we work closely with professionals, providers, service users and professional bodies – both nationally and internationally where required. We actively do this through engaging with them on Advisory Groups for setting standards, accessing their advice in monitoring compliance against standards as necessary, and in relation to all of our statutory investigations - as authorised members of investigation teams and in the provision of expert advice to us from the professional bodies. This enables us to have access to the most up-to-date evidence-based practice from leading professionals who are expert in their field when we interpret our findings and in making recommendations for change.

2.1 Monitoring Against Standards

We use a number of well established assessment tools to monitor and assess the quality and safety of services against standards. These include self-assessment by the provider against standards and subsequent validation by us, focused assessment against specific standards - often for the purposes of following up on particular areas previously requiring improvements or where new information comes to light that gives rise to a concern relating to a specific aspect of the service - to a full review of performance against all of a given set of standards. Each of these approaches involves:

• ongoing assessment and consideration of information that we receive from many sources regarding any particular hospital that is being assessed
• specific information relating to the standards can be requested at any time. It is requested from every hospital in advance of an on-site monitoring visit, or in the case of an unannounced visit, the information is requested on arrival at the hospital
• where there is an on-site visit, observation of relevant clinical areas and interviews of relevant staff and patients takes place
• any immediate risks are brought to the attention of a provider at the time and action is requested
• all elements of information from different sources are considered and verified, a report is compiled, issued to interested parties for the purpose of factual accuracy and on completion, recommendations are made and the report is made public
• ongoing monitoring against the standards occurs as and when required.

Our approach in monitoring the performance of providers against standards is to enable continuous and sustainable improvement to be embedded in services in order for providers to ensure, and be able to demonstrate, that they are providing good quality, safe and reliable care in similar services right across the country.

The new draft National Standards for Safer Better Healthcare are awaiting the approval of the Minister for Health. These standards, when implemented, will drive substantial improvements in the safety, quality, governance and reliability of healthcare services. Based on national and international best practice, there are eight quality ‘themes’ each of which has underpinning standards. These are Person Centred Care; Safe Care; Effective Care; Better Health and Wellbeing; Governance, Leadership and Management; Use of Information; Use of Resources and Workforce. Following, and subject to, the approval by the Minister, the Authority will commence a national monitoring programme against these standards.

It is anticipated that these standards will be the underpinning standards for the licensing of designated healthcare facilities/services when licensing is commenced. From that point, all existing and new designated healthcare facilities/services will be required to meet new regulations that will be developed, and these standards, in order to operate. Only designated facilities/services that are well governed and managed, that provide the appropriate types and range of services that can be safely provided by them, and that are of a high quality, will be licensed to do so.

2.2 Statutory Investigations

Where the Authority believes on reasonable grounds that there is a serious risk to the health and/or welfare of a person or people receiving those services then it may instigate an investigation. Alternatively, the Minister for Health may request the Authority to undertake an investigation.

Each investigation has clearly defined terms of reference that are agreed by the Board of the Authority and published. They reflect the scope of the investigation that is required. The process for each investigation is open and transparent and guidance is issued to the relevant provider, all individuals who are interviewed and made public on the Authority’s website. As part of this process, clear ‘lines of enquiry’ are developed that provide guidance to the hospital that is being investigated and outline the types of safety and quality elements that will be covered in the investigation. They provide the hospital and the Investigation Team with a clear framework for assessing whether there are satisfactory arrangements in place for the provision of high quality, safe services.

An investigation team is established for the investigation which is typically comprised of members of the Authority and key experts – both nationally and internationally, as required. These experts relate to the types of services being investigated. A lay person/patient representative is also a member of the team. All members have statutory powers to investigate through a process of authorisation by the Minister for Health with the consent of the Minister for Public Expenditure and Reform. In addition to having authorised experts on the investigation team, the Authority establishes a formal arrangement with the respective Professional Colleges in Ireland for the provision of professional expert advice pertaining to each investigation to ensure that we have access to additional advice as required, to inform our recommendations and to ensure that they are appropriate, up-to-date and evidence-based.

The lines of enquiry for the last two investigations have reflected the Authority’s draft National Standards for Safer Better Healthcare, the findings of previous reviews and investigations carried out by the Authority and the recommendations of the report of the Commission on Patient Safety and Quality Assurance. Generally speaking, the lines of enquiry are framed around themes as follows:

• governance, leadership and management
• safe and effective care
• workforce
• use of information
• and, where relevant, the measures put in place by the provider and/or the Health Service Executive (HSE) to implement recommendations of previous reports issued by the Authority and other relevant bodies.

Our approach involves the review and evaluation of information derived from multiple sources including documentation, data and observations in the hospital. In addition, interviews may take place with clinical and non-clinical staff, those involved in the management of the service, patients and their family members, Board members and wider HSE managers where appropriate. Information pertaining to the investigation may be sought from the hospital, the HSE Region and/or the HSE nationally.

It is important to note that every investigation that has been undertaken involves recommendations for improvement specifically for the hospital that has been investigated, and also, as importantly, recommendations have been made where improvements nationally may be required as a result of the findings of the investigation. It is the responsibility of the provider of the service to implement the recommendations. The Authority requires periodic assurances from the provider that the recommendations have been implemented and sustained.

It is important to us that the recommendations made by the Authority are developed with the expertise of the Authority and with leading professional expert advice. Where recommendations regarding patient safety risks in services provided at the hospital being investigated have been made, and they relate to similar services that may be provided elsewhere in the country, the HSE, and other relevant providers, are required to consider those relevant services against the recommendations and implement them in other hospitals as required.

Investigations have an extremely important role to play in driving and shaping safer, better care for patients. Our investigation reports to date have had important patient safety implications. We publish all our inspection and investigation reports at the earliest opportunity so that the lessons learned are in the public domain, and to allow the HSE and other providers to begin to address our findings and recommendations.

The Authority will continue to evaluate the HSE’s implementation of the recommendations from our investigations, alongside its compliance with the new national standards for Safer Better Healthcare when mandated.
 

2.3 The Investigations into the Quality and Safety of Services Provided at Ennis and Mallow Hospitals

The Authority’s two statutory investigations into Ennis (published in April 2009) and Mallow (published in April 2011) hospitals identified serious concerns for patient safety at these and similarly sized hospitals – particularly in relation to the range and scope of patients requiring emergency care that were being treated in these hospitals. The reports contain a series of recommendations aimed at improving patient safety across the system that should be implemented in full.

The Authority has not recommended the closure of any hospital. However, the Authority has, and will continue to, advise and make recommendations where it believes that changes need to be made to services provided, including the types and range of services, if they are not safe for patients.

In all of its investigations, the Authority has made recommendations on how to improve the quality and safety of services for patients. The investigations into Ennis and Mallow Hospitals identified that these smaller, often stand-alone, hospitals must have a pivotal role in providing a wide range of safe services to their communities that can safely be provided by these hospitals. However, they were not able to safely provide the full range of emergency care for patients. This was due to these types of hospitals not being able to provide the underpinning services needed to safely treat all types of patients who may arrive and require emergency care. In addition, certain types of acutely ill patients achieve better outcomes when treated at centres that are used to treating higher volumes of such patients. The Authority made a number of recommendations in the Ennis report that outlined what was required to ensure that the range and scope of services that were being provided at these types of hospitals was done so safely.

The Authority required the HSE to identify all similarly-sized hospitals that faced these types of challenges, put in place the appropriate risk management actions required and service changes if required to protect patients. That was in 2009.

The Mallow investigation was instigated following a patient safety event that took place in a model of care that was reflected as being unsafe in the Ennis report and sufficient mitigating clinical risks for patients had not been disseminated or implemented sufficiently by the HSE to similarly-sized hospitals by that time.

The findings of our investigation reports have clearly stated that these hospitals should not be providing services that they cannot provide safely. It was clear from a HSE report (provided to the Authority during our Mallow investigation and published with the Mallow report) that a number of smaller hospitals had continued to provide 24-hour emergency care despite insufficient measures having been put in place to safeguard patients, or outline how clinical risks were being identified and managed. There has been ongoing progress by the HSE in addressing this since that time.

It is also important to note that in the Ennis report (page 50), we outline that the types of medical patients who can safely be cared for in small hospitals is dependent on the ability of a hospital to safely provide suitable acute surgical and anesthetic/critical care services 24 hours a day, seven days a week. Where this cannot be provided, acutely ill, undifferentiated (all types of patients) medical patients cannot safely be cared for in such hospitals. However, we recommended that the HSE should establish a model for medical care to ensure that as wide a range of lower acuity medical services as possible, including out-patients, day procedures, day patient facilities and inpatient services can be safely cared for in such hospitals (recommendations 5.1, 5.2, 5.4).

It is important to note that, following persistent requests of the HSE to outline how they were managing clinical risks for patients in small hospitals of a similar type to Ennis and Mallow since April 2009, the HSE confirmed to the Authority that it had serious concerns regarding the range and type of services provided at Roscommon Hospital which reflected the risks to patients in small hospitals that had previously been identified in the Ennis and Mallow reports, and that these risks were also being compounded by the shortage of non-consultant hospital doctors (NCHDs) at that time.

The HSE also informed the Authority that it had made the decision to change the services in Roscommon in order to address the patient safety issues. These changes are fully consistent with the recommendations of the Ennis and Mallow reports going back over two years, and the Authority supports the new model of services that was implemented by the HSE in Roscommon.

At a corporate level, it is the responsibility and accountability of the Board of the HSE to oversee the implementation of the recommendations from the Ennis/Mallow reports and to ensure that the necessary decisions that are required, are made to services at a local level – which should be informed and based on the recommendations of the Authority and the professional experts nationally. The Authority will continue to hold the HSE to account in implementing these recommendations.

Those responsible for providing services in a health system have a duty to be responsive in applying system-wide learning from adverse patient safety events in one part of the system, to their own service where it is applicable to do so. This is a fundamental part of a modern-day reliable health system and in the absence of this we may be exposing our patients to unnecessarily unsafe care.

The Authority will continue to highlight patient safety concerns as they arise and evaluate and monitor the HSE’s implementation of our recommendations and future compliance with national standards.

3 Conclusion

The Health Information and Quality Authority has now been in existence for over four years. The members of the Authority are committed to discharging the responsibilities that you have bestowed on us in a person-centred, robust, professional, objective and independent manner. In doing this our focus is, and always will be, on driving high quality and safe care for people using our health and social services.

We are conscious that the well being of some of the most vulnerable people in our community will depend on our capacity to set appropriate and high standards, to follow through on their delivery, to work in effective partnership with all involved in the delivery of care and to be a resource of knowledge and experience for the future.

I thank you for this opportunity and look forward to working closely with you in achieving our shared purpose.

ENDS

Tracey Cooper
Chief Executive
Health Information and Quality Authority

Further Information: 

Marty Whelan, Head of Communications and Stakeholder Engagement, HIQA
01 814 7481 / 086 2447 623
mwhelan@hiqa.ie