The Health Act 2007 established the Health, Information and Quality Authority (HIQA). The Authority has been conferred with a number of inspection and regulatory functions in relation to the health services. In particular, this includes regulation and inspection of nursing homes, childcare centres, as well as the regulation of many health professionals.
The function of the Authority is to set standards on safety and quality in relation to healthcare services and service providers under the Health Acts, the Child Care acts, the Children Acts, and the Health (Nursing Homes) Act. It carries out certain other functions under disabilities and special needs learning legislation.
- monitors compliance with standards
- undertakes investigations
- reviews and makes recommendations in respect of services to the Minister
- operates accreditation programs
- operates schemes aimed at assuring safety and quality in health services
- evaluation of clinical and cost effectiveness of health technologies including drugs
The Authority may set standards for the HSE and service providers in relation to data and information. It may advise the Minister and executive on compliance by service providers and the Executive himself. It may provide advice and recommendations to the Minister or executive about deficiencies identified.
In carrying out its functions, the Authority is to have regard to government policy in so far as it affects the Authority’s functions. It is to have regard to its resources and the need to co-operate with other public authorities performing relevant services. It must in so far as reasonably practicable, have regard to research, statistics and other information in relation to health and personal social services provided in other jurisdictions.
The Authority may undertake investigations as to safety, quality and standards of services ,if there are reasonable grounds for believing that there is serious risk to the health or welfare of a person. This may be the result of a failure by the HSE, the designated centre provider or other service provider. The Minister may require the Authority to undertake an investigation in these circumstances.
The Authority in setting standards, considers submissions made by relevant bodies and sends them for approval by the Minister. The standards are admissible in prosecutions and procedures for contravention of the relevant legislation or regulation. Where the standards appear to give guidance to the court, they are admissible as such in evidence. They are not necessarily conclusive.
The Board of HIQA consists of twelve members. They are appointed by the Minister from persons with expertise in various matters related to the functions of the Authority. There is a chairman appointed for a five-year period. The chief executive carries on and manages generally the administration and business of the Authority. He is responsible to the Board for the performance of his functions and implementation of the board’s policies. The chief executive is accountable to the Oireachtas committee. The functions of the chief executive may be delegated to other officers. The Board has its own employees.
The Minister may give directions to the Authority for the purpose of any of its functions. He may direct that information, reports and statistics be provided.
The Authority is to prepare a corporate plan every three years. The plan is submitted to the Minister for approval who may modify or vary it. Annual business plans are to be provided.
The Office of the Chief Inspector of Social Services is established under the Act. The Authority appoints the Chief Inspector with the approval of the Minister. The Chief Inspector is responsible for
- certain inspection functions under the Child Care and Nursing Homes legislation.
- designation and registration of designated centres
- inspection of special care units.
The Chief Inspector is accountable to the Oireachtas committee in relation to certain matters.
Following the signing of the relevant commencement order by the Minister for Health, HIQA became legally responsible, under the provisions of the Health Act, 2007, as amended (The Act) for the registration and inspection of certain residential services for children and adults with disabilities, including respite services.
Services that may come under this remit include HSE-run services and services provided by organisations funded under Sections 38 or 39 of the Health Act 2004. These residential services, including Respite services for children and adults are described as “designated centres” in the Act.
A person may not carry on business as a designated centre without being registered. Persons in charge of the centre may not manage or participate in its management without registration. Designated centres cover HSE residential services, childcare services, nursing homes, homes for persons with disabilities and dependent persons, and nursing homes.
- certain institutions registered by the Mental Health Commission,
- managed by the State,
- institutions the majority of whose patients being treated for acute illness or provided with palliative are,
- institutions used for education, culture, recreational, leisure, social and physical activities primarily
- children’ detention centre
- Special care units.
A register is kept of designated centres. It is open for inspection. It includes names of the owners, address, number of residents accommodated, dates of registration, conditions of registration and such other conditions as may be prescribed by the Minister. It is an offence to carry out the business without registration.
A centre may be registered, provided the person entity is fit to be registered as provider of the centre and participate in its management and they will comply with the relevant standards and regulations. Conditions may be attached to registration.
There are provisions for cancellation and variation of registration and the imposition of new conditions. The providers themselves may apply for variation or removal of conditions. The Chief Inspector may allow the application, if it is appropriate and does not adversely affect residents.
If the Chief Inspector proposes to refuse an application, grant subject to conditions, cancel or vary registration or attach conditions, notice is given. There is a right to respond to the notice of the proposed decision. The Chief Inspector shall not decide the application until a certain time elapses or without having considered the representation. There is an appeal to the District Court within 14 days.
The certificate of resignation must be affixed in a conspicuous place in the centre. Unless a premises is registered, a person may not, with intent to deceive another, apply a name to a premises, undertaking or organisation that describes it as a designated centre of that description or holds it out as such. It may not hold itself as carrying out anything for which it is not licensed or anything which would breach a condition of registration.
Where the Chief Inspector on reasonable grounds believe any person is carrying on a designated centre in contravention of a decision of the Chief Inspector in relation to registration or terms of registration, the Chief Inspector may apply to the District Court to enforce the breach. The District Court on hearing the application may make the order in the terms sought or in other terms as is thought appropriate.
The Chief Inspector may apply to the District Court to cancel or vary the terms of registration. An emergency application may be made unilaterally.in circumstances where the best interests of the persons resident in the designated centre so require. This is to have effect for a temporary period of 28 days unless extended by agreement. The matter is then referred to a full hearing of the District Court. There is an appeal to the Circuit Court from a decision of the District Court.
If the Chief Inspector cancels registration or obtains an order to cancel registration, the HSE is to be informed. The HSE may make alternative arrangements for residents. Where the HSE itself was provider, it may continue to carry on provision on a temporary basis itself, pending making alternative arrangements. Where it is not the provider, the HSE, with the consent of the previous registered or the District Court, may take charge of the centre.
A designated centre may not be closed without notice to the Chief Inspector. Different periods of notice may apply to different categories of centres.
A person appointed to take charge of a designated centre in place of its registered provider must give at least 48 hours\’ notice to the inspector. The inspector may notify the HSE, who may make alternative arrangements for the residents.
The Authority appoints inspectors to monitor compliance with standards and to undertake investigations. The HSE has power to appoint other persons or entities to carry on inspection and examinations of designated centres.
Inspectors or persons so appointed have most of the functions normally conferred on authorised officers. They may enter premises to inspect. They may examine records and interview employees and residents. The person in charge must ensure that co-operation is given. The inspectors may enter and inspect premises owned and controlled by the HSE or used or proposed for used for the provision of services by it.
The authorised person may take copies of records, inspect computer records, remove records as necessary and interview persons. They may require persons in charge of the premises or of services to furnish information as is reasonably required.
Where the centre is occupied as a private residence by the provider of the services, a warrant is required unless the person consents to admission. District Court warrants may also be granted generally where officers or inspectors are prevented or have reasonable cause to believe there is a likelihood that they may be prevented from entering a premises. A warrant may be granted authorising entry and removal of records and other actions etc.
If necessary, authorised persons may be accompanied by members of An Garda Siochana. It is an offence to refuse to permit entry of a premises or to obstruct or impede investigation, fail to give information or give information which is false or misleading.
There are a range of offences under the legislation. Failures to comply with key obligations are offences. These include
- carrying on business without registration or outside the terms of registration.
- failure to undertake notifications and regulatory requirements
- failure to comply with directions
- breach of regulations
A person may be convicted on summary conviction and subject to a fine up to €5,000 and 12 months imprisonment or on indictment up to a €70,000 fine or two years imprisonment or both. Summary proceedings under the legislation may be prosecuted by the Authority itself.
Regulations are made under the legislation to prescribe a wide range of matters. This includes regulations governing
- the registration of designated centres.
- governing the procedures for setting standards
Regulations are made in respect of the standards in designated centres including
- standards of maintenance, care and welfare
- numbers, qualifications and availability of employees
- design, maintenance, repair, cleaning, cleanliness, ventilation, heating and lighting
- accommodation, including space, washing facilities, sanitary convenience
- food provided,
- records kept,
- requisite insurance,
- management and control requirements,
- notification of incidents,
- giving of notice during which providers or key managers will be absent
- specifying required information.
There are provisions in respect of the protection of so-called whistle-blowers. If an employee of the HSE, service provider and certain other health bodies has reasonable grounds for believing
- that the health or welfare of a person receiving services is likely to be at
- that the actions of persons employed by any such, is posing a risk to the health and welfare of the public
- that the body is failing to comply with its obligations
- that the conduct is likely to lead to a misuse or substantial waste of public funds or
- evidence of the above is being concealed
then a protected disclosure may be made
In the case of an employee of a designated centre, the following is protected
- disclosures that the actions of any persons employed on behalf of a person carrying on a centre is posing or is likely to pose a risk to the health and welfare of a resident
- that the person carrying on the business has failed or is failing to comply with regulatory or statutory requirements.
There are similar provisions for protected disclosures by employees of mental health service providers.
Similarly, certain disclosures made to professional regulatory bodies are protected where they are made by a person who has reasonable grounds for believing the activities of any person is likely to pose a risk. Complaints about certain health professionals to their regulators are protected. Certain disclosures to the Authority itself in relation to failures of its own functions
Persons making protected disclosures are not subject to civil liability unless they make it knowingly or recklessly as to, whether it is false or misleading or it is frivolous, vexatious. Persons making a disclosure may not be penalised in an employment context. In particular, they have special rights of complaint if they are dismissed or subject to other adverse consequences in their employment.
The Health Act 2007 provides for a mandatory registration and inspection system operated by the Health Information and Quality Authority (HIQA), in respect of residential centres (referred to as “designated centres” in the Act) for people with a disability.The Act provided for a transitional period during which a person who was carrying on the business of a designated centre at the time the regulatory system came into operation, could continue to do so for a period of three years without achieving the standards required to be formally registered. The effect of this provision was that all existing disability residential centres were required to achieve the standard required to be registered by HIQA by 31 October 2016, although they remain subject to ongoing inspection and monitoring by HIQA during this time.
The Health (Amendment) Act 2016 extended the period for the registration of disability centres and extended the transitional period up to 31 October 2018. HIQA continued to inspect and monitor these centres in the interim period.
The Health (Amendment) Act 2016 extended the period of time in which the relevant designated centres could continue to carry on the business of an institute and provide residential services to a period not exceeding five years after the regulations come into effect.