This article provides a broad introduction to the complex landscape of formal regulation of health care in Northern Ireland (NI). It also includes reference to some related and supporting bodies. It highlights a range of key organisations involved in statutory regulation in the main areas of quality and safety of care; medicines and medical devices; regulation of key medical staff and the social care workforce.
Regulating the quality of health and social care services and the professionals who provide the care is mainly designed to limit the risk of harm to patients and maintain public confidence in services and health care professionals.
It is worth mentioning, first of all, that the bodies involved with commissioning and delivering health and social care services (such as the Health and Social Care (HSC) Board and the HSC Trusts) govern and ‘regulate’ themselves in the first instance through their management and clinical governance structures. The Belfast HSC Trust, for example, has a Board of Directors responsible for the strategic direction and management of the Trust’s activities. Each Trust also has an Executive/Management Team (led by its Chief Executive) responsible for clinical and corporate matters and responsible to the Board. For example, the Belfast Trust has ten such directors.
If any service user, or their representative, is unhappy with the care or treatment received from the health service, they have the right to complain confidentially. All health service organisations have someone who is responsible for dealing with complaints.
This article will now explore the complex and multi-layered nature of formal regulation of health care in NI.
Quality of healthcare
The quality of healthcare services in NI is regulated principally by the independent Regulation and Quality Improvement Authority (RQIA), established in 2005 as a Non-Departmental Public Body (NDPB). It registers, monitors and inspects health and social care services, while encouraging improvement in their quality. The three main areas of RQIA work are:
- Registration and inspection of statutory and independent (private) health and social care services;
- Assuring the quality of services provided by HSC Trusts, the HSCB and other agencies; and
- Protecting the interests of individuals with learning disabilities and those with mental health conditions.
General Practice (GP) practices are currently not subject to regulation by the RQIA. The inspection of GP practices lies with the Health and Social Care Board (HSCB).
Using as a basis the quality standards (2006) for health and social care in NI, the RQIA inspects an array of services, including HSC Trusts and hospitals; independent healthcare providers; dental services; mental health and learning disability services; prisons; care homes; children’s homes; and radiology services. It holds current and publicly available information on all registered health and social care services in NI, including nursing homes, residential care homes and domiciliary care agencies.
‘Quality 2020’ (2011) is a 10-year strategy to improve the quality of healthcare in NI. The strategy defines quality under three themes: safety, effectiveness and patient and client focus. It serves as a general framework for health and social care services and the RQIA to follow.
RQIA inspectors can visit health care providers at any time, request information, conduct private interviews and examine premises. The focus is on whether care is safe, effective, compassionate and if services have good leadership. Following recommendations made in the 2014 Donaldson Review, the RQIA conducts unannounced inspections of all acute hospitals in NI.
In its inspection reports it does not give ratings but does provide:
- Recommendations for improvement where standards are not being met, with progress to be reviewed;
- Housekeeping points to assist providers to make rapid improvements to more minor problems; and
- Examples of good practice.
The RQIA can take a range of enforcement actions, including issuing improvement notices, cancellation or alteration of registration and prosecution. The RQIA also has the authority to recommend to the Department of Health (NI) that special measures should be taken in respect of the performance of a HSC Trust.
Quality and inspection of General Practice
The HSCB is responsible for the inspection and appraisal of HSC GP practices and works in partnership with the Public Health Agency, Integrated Care Partnerships, GP Federations and with GPs to develop the range and effectiveness of all General Medical Services. HSCB medical advisers operate a rolling programme of visits to GP practices across NI, with each practice visited at least once every three years. Medical advisers assess and discuss the management of a practice, as well as clinical records, waiting times, training and overall performance.
Its role is to promote safety and quality, for example, monitoring practices’ achievements through the Quality and Outcomes Framework (a UK-wide set of mainly clinical outcomes covering long term conditions such as diabetes).
To further drive improved quality, in recent years, GP Federations have been established in NI with two main aims:
- To support and protect GP practices; and
- To help deliver the transformation agenda in health and social care.
Regulation of medicines and medical devices
The Medicines and Healthcare Products Regulatory Agency regulates medicines, medical devices and blood components for transfusion, for the whole of the UK, through its three centres (the Medicines and Healthcare Products Regulatory Agency, the Clinical Practice Research Datalink and the National Institute for Biological Standards and Control). Its key responsibilities are:
- Ensuring that medicines, medical devices and blood components meet standards of safety, quality and efficacy and that the supply chain is safe and secure;
- Promoting international standardisation to assure the effectiveness and safety of biological medicines; and
- Educating the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components.
Regulation of healthcare professions and the ‘super-regulator’
Professional regulation has evolved over centuries in the UK as a whole and some regulated professions have grown out of medieval guilds, whereas others have been regulated when a new profession emerges.
There are 32 regulated professions under current statutory healthcare regulation across the UK, ranging from doctors, dentists and nurses to pharmacists, opticians and osteopaths. To work in any of these 32 professions in a jurisdiction of the UK, professionals must be registered with one of nine regulators – General Chiropractic Council, General Dental Council, General Medical Council (GMC), General Optical Council, General Osteopathic Council, General Pharmaceutical Council, Health and Care Professions Council, Nursing and Midwifery Council (NMC) and Pharmaceutical Society of Northern Ireland.
These councils often have a central office(s) in England with regional offices or representatives in Scotland, Wales and NI, or in some cases members on the council from all the jurisdictions of the UK. For example, the NMC has a NI council member and the GMC has an office in Belfast. With regard to pharmacists there is a separate Pharmaceutical Society of Northern Ireland, which regulates pharmacists in NI.
The Professional Standards Authority for Health and Social Care is referred to as a ‘super-regulator’ and regulates the nine regulatory bodies of the professions. Every year it assesses how these regulators are performing against a set of standards called the Standards of Good Regulation.
As key examples, the regulation of doctors, nurses and midwives, and pharmacists are now considered in more detail.
The General Medical Council (GMC) is responsible for the regulation of doctors across the UK. The GMC:
- Decides which doctors are qualified to work in the UK:
- Oversees UK medical education and training;
- Sets the standards doctors need to follow throughout their careers;
- Takes action, where necessary, to prevent a doctor from putting the safety of patients, or the public’s confidence in doctors, at risk.
Although not a regulatory body, the Northern Ireland Medical and Dental Training Agency (NIMDTA) is an Arm’s Length Body sponsored by the Department of Health (NI) which commissions, promotes and oversees postgraduate medical and dental education and training throughout NI. The NIMDTA is accountable to the GMC for ensuring that the standards set by the GMC for medical training are achieved.
Nurses and midwives
The Nursing and Midwifery Council (NMC) regulates nurses and midwives across the UK. The Council is made up of twelve members: six lay members and six nurses or midwives, from England, NI, Scotland and Wales. The NMC:
- Maintains a register of nurses and midwives allowed to practise in the UK;
- Sets standards of education, training, conduct and performance;
- Ensures that nurses and midwives keep their skills and knowledge up to date and uphold professional standards; and
- Investigates nurses and midwives who fall short of the standards.
In addition to the NMC, the Northern Ireland Practice and Education Council for Nursing and Midwifery (NIPEC) supports the development of nurses and midwives by promoting high standards of practice, education and professional development.
The Pharmaceutical Society of Northern Ireland registers and regulates pharmacists and pharmacies in NI. It has an appointed Council of seven lay and seven registrant members. The Society seeks to protect the public by:
- Setting and promoting standards for pharmacists’ admission to the register and for remaining on the register;
- Maintaining a publicly accessible register of pharmacists and pharmacy premises in NI;
- Handling concerns about the ‘Fitness to Practise’ of registrants; and
- Ensuring high standards of education and training for pharmacists in NI.
Regulation of the social care workforce
The NI Social Care Council (NISCC) regulates the social care workforce in NI and is helping to improve quality of care by registering social care workers; setting standards for their conduct and practice and supporting their professional development. This workforce includes social care workers, social care managers, social workers, probation officers, education welfare officers and social work students.
The Council is made up of a Chair and 12 non-executive members. The members represent a wide range of interests in social care:
- Lay members – service users, carers and voluntary workers;
- Stakeholder members – namely, people and providers involved in: service delivery/commissioning, trade unions, education/training, professional bodies, or allied professions; and
- Registrant members – those employed as social care workers.
Partnership Committees and working groups within the organisation also involve service users, carers, workers, employers, education providers, trade unions and representative bodies to ensure that stakeholders are given a voice in setting standards and improving social care.
Other related bodies
The quality of care being provided is a key issue for regulators, therefore they will be looking for evidence that best practice is followed. The National Institute for Health and Care Excellence (NICE) is the body tasked with providing guidance on current best practice in health treatment and care. The Department of Health in NI has a formal link under which NICE guidance is reviewed locally for its applicability to NI and, where found to be applicable, is endorsed by the Department for implementation.
The work of the Patient and Client Council (PCC) aims to raise the quality of care in NI by providing an independent voice in NI for patients, clients, carers, and communities on health and social care issues, for example, by:
- Representing the public’s views to HSC organisations;
- Promoting the involvement of patients, clients, carers and the public in the design, planning, commissioning and delivery of health and social care; and
- Providing assistance to individuals making a complaint relating to health and social care.
This article has shown that formal regulation of health care in NI is complex and multi-layered, including both local and UK-wide bodies covering the statutory regulation of many health care professions, facilities, medicines and services.
Regulation is also a dynamic field with the emergence of new treatments, medicines and healthcare professions, for example the decisions being taken regarding the regulation of ‘medical associate professionals’.
The fact that good clinical governance, in essence self-regulation, starts at a lower level, including for example, the workings of the HSC Board and Trusts governance structures should not be overlooked, neither should the impact of best practice guidance from related bodies such as NICE, which forms a distinct part of the wider quality of care landscape.