Memorandum by the Health and Safety Executive
(HSE) (PS 07)
1. The Health and Safety Executive (HSE)
has a wide-ranging statutory role to regulate risks from work
activities, this includes not only worker health and safety but
also risks to patient safety. HSE has taken formal enforcement
action including prosecution of NHS Trusts for failing to prevent
or adequately control patient safety risk in a number of areas.
The interaction between our regulatory regime and that of other
inspection bodies and regulators in the health services area is
not always clear.
2. In accordance with the Government's Enforcement
Concordat, and Hampton principles for better regulation, HSE seeks
to ensure its action is effectively co-ordinated with other healthcare
regulators to minimise overlap. However, although HSE may agree
to defer to others considered more appropriate to act in certain
areas, HSE is on occasions drawn into investigating patient safety
matters as "the enforcer of last resort" because those
other bodies do not have appropriate enforcement powers or sanctions.
This tendency has become more marked with increasing public expectation
for public bodies to be held to account and potentially prosecuted
before the courts. The recent corporate manslaughter legislation
may also result in further HSE involvement in supporting police-led
investigations. There are resource implications for HSE in this.
3. The current situation can lead to confusion
for duty holders, inhibit the establishment of improved management
practices and is not necessarily the most effective use of public
resources. It is hoped that the establishment of the new Care
Quality Commission and its associated provision of enforcement
powers can be used to ensure more effective regulation of patient
4. HSE is responsible for health and safety
regulation in England, Scotland and Wales and was established
by the Health and Safety at Work etc Act 1974 (HSWA) which is
a criminal statute. HSWA places duties on employers, the self-employed,
directors, managers, those in control of premises, and individual
employees to protect people at work and specifically to protect
others (eg patients) who may be affected by those work activities
5. Currently HSE alone has health and safety
enforcement responsibilities under HSWA for patient safety at
NHS premises. To seek compliance with the law, HSE inspectors
have powers under HSWA including prosecution and the serving of
statutory prohibition and improvement notices. Alongside this,
HSE uses a range of other tools to promote improved safety standards,
including the provision of verbal and written information and
advice, publication of guidance and liaison with the many healthcare
6. HSE is committed to improving patient
safety and works actively to support the Concordat of health service
regulatory and inspecting bodies. To this end HSE has worked closely
to influence the standards produced by bodies such as the Healthcare
Commission and the NHS Litigation Authority, and has agreed Memoranda
of Understanding with, for example, the General Medical Council
and the NHS Security Management Service. Indeed HSE is uniquely
positioned to help improve standards of patient safety as it is
the only independent regulator with the powers to bring NHS Trusts
failing in their legal responsibilities before the Courts.
7. The scope of HSWA to protect people such
as patients who may be put at risk by work activities is very
broad and consequently raises issues of both competence and availability
of resources. Given this, HSE's policy from the 1980s was that
we did not apply HSWA to patient care issues, as these fell to
the Department of Health, its agencies, and the professional regulatory
bodies such as the General Medical Council. However, subsequent
legal advice confirmed that, in the absence of a health services
body with equivalent enforcement powers to HSE (that is, access
to criminal sanctions), this policy could be subject to challenge.
We therefore changed our enforcement policy in the mid-1990s and
have, for some years, applied health and safety legislation to
many aspects of patient safety. The only exception to this is
clinical decisions about diagnosis or treatment. The background
to this policy and its implications are covered in more detail
in Annex 1. Annex 2 includes examples of specific cases where
HSE has taken action against NHS Trusts for patient safety incidents.
8. HSE routinely investigates serious accidents
to patients in a range of circumstances such as scalding during
bathing, contact with hot radiators, falls from windows or hoists,
slips, trips and falls, accidents due to faulty or inadequately
maintained equipment eg bedrails or wheelchairs, and exposure
to legionella from water systems. Such incidents are usually reported
to HSE under the Reporting of Injuries, Diseases and Dangerous
Occurrences Regulations 1995 (RIDDOR). HSE inspectors may also
deal with these issues during proactive inspections and audits
of NHS trusts.
9. Increasingly there is a public expectation
that when patient safety failings leading to serious injury or
death occur, then criminal sanctions should be applied to either
individuals or the organisation. This has led to HSE involvement
on a number of occasions. Recently HSE was drawn into two investigations
of NHS trusts on the risks to patients from healthcare associated
infection due to Clostridium difficile. In both cases,
public reports from the Healthcare Commission (HC) suggested evidence
of breaches of HSWA, and that the public interests of justice
needed to be taken account of by the appropriate enforcement authority.
In accordance with the agreed "Work-related Deaths Protocol"
arrangements with the police, HSE found in both instances that
it was not possible to link the information provided by the HC
to individual deaths.
10. The recent Corporate Manslaughter and
Corporate Homicide Act 2008 also potentially applies in this area
of risk and HSE may well be drawn in to support other police-led
investigations because of the lack of other more specific and
relevant enforcement arrangements, or expertise.
11. While HSE does not seek to intervene
proactively in these areas of clinical risk, our work inevitably
overlaps with that of other bodies inspecting healthcare standards
such as the Healthcare Commission. Conversely other bodies' roles
overlap with HSE's. For example, in 2004 the Crown Prosecution
Service prosecuted Southampton Hospitals NHS Trust under HSWA
following the death of a patient from a surgical procedure.
12. This overlap of legislation and policies
can serve to confuse dutyholders, eg an NHS Trust, whose general
standards of clinical governance and adequacy of patient service
delivery are inspected by one body (Healthcare Commission), but
whose failures may be investigated and potentially subject to
criminal sanctions by HSE and / or the police. There can also
be difficulties in ensuring that the lessons learnt from a variety
of investigations are taken forward in a coordinated way which
does not leave patient safety at risk.
13. The anticipated setting up of the new
healthcare regulator the Care Quality Commission, with its proposed
enforcement powers, provides an opportunity to examine again the
regulation of health services. The need for further improved collaborative
working in accordance with the Hampton / better regulation agenda,
and inspection and regulation by the most appropriate and adequately
resourced body, can then further safeguard patient safety without
duplication and undue burden on the dutyholder.
Patient safety and the role of HSEthe
law and policy
Section 3 of the Health and Safety at Work etc
Act 1974 (HSWA) places general duties on employers and the self-employed
to persons other than their employees, including :
Section 3(1) `it shall be the duty of every
employer to conduct his undertaking in such a way as to ensure,
so far as is reasonably practicable, that persons not in his employment
who may be affected thereby are not thereby exposed to risks to
their health or safety' ;
HSE's general policy on enforcement and overlapping
As a general principle, the Health and Safety
Executive (HSE) seeks to avoid duplication with other enforcing
authorities whilst ensuring that risks to people's health and
safety from work activities are properly controlled. In many cases,
Section 3 HSWA overlaps with other, more specific, legislation
enforced by other authorities. HSE will then seek to agree demarcation
lines with those other authorities in the light of the risks and
in accordance with certain criteria : health and safety expertise;
economy; efficiency; effectiveness; suitability. Where HSE is
confident that public safety is adequately guaranteed by the enforcement
of other legislation covering the risk in question then HSE will
not generally attempt to enforce Section 3, HSWA.
HSE policy on patient safety
All hospitals and NHS Trusts are subject to
HSWA, and must conduct their undertakings in such a way as to
ensure, so far as is reasonably practicable, that patients are
not exposed to risks to their health or safety. This application
of Section 3 was first considered in 1980, and noted that it could
be applied to virtually every aspect of patient care in hospitals,
including matters that were the responsibility of the Department
of Health, and regulatory bodies such as the General Medical Council.
It was necessary to clarify the situation, and the Departments,
professional bodies, and the now defunct Health Services Advisory
Committee were consulted.
It was agreed that it was inappropriate for
HSE to intervene in the adequacy
of patient care. The then Health and Safety Commission
(HSC) reconsidered the issue a year later and affirmed the policy,
namely that : " HSE inspectors would not concern themselves
with the professional care of patients, except so far as it might
be necessary to do so when dealing with systems of work or the
fitness of plant and equipment."
The policy was restated some years later and
commended by the then
Secretary of State in a letter to the HSC Chairman
in January 1989. However, after a review and legal advice in the
mid 1990s, the policy was modified to extend HSE's role in relation
to patient care (in effect excluding only matters relating to
clinical decisions on diagnosis or treatment).
The current policy is that "HSE does
not, in general, seek to apply HSWA to matters of clinical judgement
or the level of provision of care as other legislation and regulatory
bodies deal with these matters:"
Consequently, many other aspects of patient
care, for example failures of plant, equipment, or systems of
work, are considered relevant matters for HSE. HSE routinely investigates
serious accidents to patients such as scalding, falls from windows,
and trips and falls, where there is little or no question of clinical
judgement. Such accidents are normally reported to HSE under the
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
Less commonly, HSE may investigate deaths or
serious injuries that have occurred during medical treatment or
diagnosis (although such incidents are exempted from reporting
under RIDDOR) where the cause was primarily unsafe equipment or
systems of work. Annex 2 includes examples of such cases in addition
to other patient safety related cases.
Examples of patient safety prosecution
2008. Avon and Wiltshire Mental Health
Partnership NHS Trust was prosecuted after a 77 year old patient
fell 5.5 metres from a first floor window sustaining major injuries.
Suitable window-opening restrictors should have been in place
to prevent this accident. The Trust was fined £20,000 and
ordered to pay costs of £12,502.30.
2007. Heart of England NHS Foundation
Trust was prosecuted because they did not have preventative maintenance
systems for bed use or bed rails, and did not provide suitable
information on patient transfer from ward to ward, leading to
patients being nursed on inappropriate beds. One patient fell
from a bed when the bed rail collapsed and suffered a fracture
of the right hip. The patient later fell again when on a bed without
bed rails but suffered no further injury. The Trust was fined
£25,000 and ordered to pay costs of £30,000.
2006. Mid Essex Hospital Services
NHS Trust was prosecuted after the death of a child during a minor
operation where the tube providing oxygen to the child was blocked
by a foreign object. The Trust was fined £30,000 and ordered
to pay costs of £10,000.
2005. Cambridge University Hospitals
NHS Foundation Trust was prosecuted because it failed to manage
the risks to vulnerable inpatients of being burnt on unguarded
radiators. The Trust was fined £3000 and ordered to pay costs
2004. Basildon & Thurrock University
Hospitals NHS Trust was prosecuted following a confirmed case
of Legionnaires' disease and the identification of widespread
failure to manage microbiological risks in hot water services,
which led to the proliferation of legionella bacteria. The trust
was fined £25,000 and ordered to pay costs of £12,225.
2000. Maidstone & Tunbridge Wells
NHS Trust was prosecuted when an elderly patient died after being
given an incorrect blood transfusion. The systems of work for
ordering and collecting blood and for checking it is given to
the right patient were confused and staff had not been trained
in safe working procedures. The Trust was fined £7,000.
2000. Northgate and Prudhoe NHS Trust
was prosecuted after an inexperienced and poorly trained care
worker put a severely disabled long- term resident into excessively
hot bath water. Severe scalding occurred and the patient died
five days later. No thermostatic mixer valve was fitted to this
bath, although they had been fitted to two other baths in the
same ward and to virtually all other baths in the hospital. The
trust was fined £50,000 and ordered to pay costs of £4600.
2000. Nottingham City Hospital NHS
Trust was prosecuted after a patient died from hospital acquired
malaria following failure to provide a safe system of work for
use of intravenous saline. The Trust was fined £15,000.
1998. Norfolk and Norwich University
Hospitals NHS Trust was prosecuted following the death of a patient
during a cardiac angiography. An inadequate system of work led
to air being injected into the heart of the patient. The Trust
was fined £38,000.
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