Select Committee on Health Written Evidence

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 safety.


  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 stakeholders.

  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"[80] 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.

September 2008

Annex 1

Patient safety and the role of HSE—the 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 legislation

  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 1995 (RIDDOR).

  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.

Annex 2

Examples of patient safety prosecution cases

    —  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 of £2500.

    —  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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