HSE is the national independent regulator for health and safety in the workplace. This includes private or publicly owned health and social care settings in Great Britain. We work in partnership with our co-regulators in local authorities to inspect, investigate and where necessary take enforcement action.
There are many other bodies responsible for regulating different aspects of these sectors, many of whom have more specific powers and legislation than HSE and may therefore be in a better position to respond to patient or service user incidents or complaints.
HSE does not, in general, investigate matters of clinical judgement or matters related to the quality of care. HSE leads on employee health and safety and may also deal with non-clinical risks to patients such as trips and falls, scalding, electrical safety etc; and with some aspects of risks that apply to both staff and patients alike, such as manual handling. Such incidents are normally reported to HSE under the Reporting of Injuries Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), and HSE follows its published incident selection criteria when deciding whether to investigate.
From 1 April 2011, HSE has followed its ‘Guidance for Field Operations Directorate (and associated situational examples) in responding to patient and service user incidents where Section 3 of the HSW Act 1974 applies’ but RIDDOR does not require reporting.
It will also follow this guidance for RIDDOR reportable incidents with respect to initial enquiries, reviewing investigations and recording decisions for incidents harming members of the public.
Health and social care are devolved matters and there are different regulators in England, Scotland and Wales. The powers, roles, remits and ways of working of each of these regulators are all different. A brief summary of their roles and responsibilities follows. Further information can be found on their websites:
CQC register and therefore license care services under the Health and Social Care Act 2009 and associated regulations. They take into account the ‘Essential Standards of Quality and Safety ’ and monitor providers to make sure they continue to comply with the requirements. CQC focuses on outcomes for people who use services and assess these using information from a wide range of sources. This includes reports of incidents, as well as information from both people who use services and that which CQC seeks directly. CQC have a wide range of enforcement powers that they can use, if they find care services are not meeting essential standards.
Medicines and Healthcare Products Regulatory Agency (MHRA) - The MHRA is a government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. It is an executive agency of the Department of Health. The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.
As the UK Competent Authority, the MHRA is responsible for the regulation of devices throughout the UK and for issuing Medical Devices Alerts (MDAs). In Scotland, Health Facilities Scotland (HFS), which is part of NHS Scotland, works closely with the MHRA, and will notify MHRA of each adverse incident report in Scotland and the results of any investigation. For example, HFS may identify a need for a MDA and will liaise with MHRA on the need for and drafting of the alert.
HFS, receives adverse incident reports from NHS Boards and Local Authorities. It is responsible for coordinating investigations so that, as far as possible, root causes can be established and remedial action taken to prevent or reduce any identified risks.
In addition to these regulators, there are also professional regulatory bodies who aim to ensure that proper standards are maintained by health and social care professionals and act when they are not. In order to practice in the UK, professionals are required to register with the appropriate body.
These bodies fulfil similar functions for different professions across the UK. Their main duties are to:
A summary of the professions covered by each body follows. For further information on their role, please check their websites:
