CQC/HSE Liaison Agreement

Foreword

This agreement between the Care Quality Commission (CQC) and the Health and Safety Executive (HSE) is intended to ensure that both organisations share appropriate information in a timely manner so that people who use services are properly protected. It also sets out a framework that will help ensure that, where appropriate, we co-ordinate activities in relation to incidents that result in avoidable deaths or major injuries to service users. At present this agreement only covers healthcare settings regulated by CQC, but we hope to develop it further with other regulators so that it covers both health and social care. CQC and HSE inspectors may also find it helpful to follow the principles set out in this agreement in other settings which they both regulate.

The agreement provides clarity on our roles and responsibilities where these overlap and helps ensure that we reflect the principles of the Government’s regulatory reform agenda. It also provides a framework for us to work together effectively and efficiently.

Both organisations recognise the need to share information about very serious incidents and investigations. The agreement sets out the criteria which will help inspectors decide when and how to liaise. In this way, it aims to decrease the regulatory burden on providers/employers and ensure that the actions we take are proportionate. We also appreciate that the public wants to be confident that we are doing all that we can to co-ordinate our activities, and co-operate with each other in the best interests of those affected by serious incidents in healthcare. This agreement will help both organisations achieve this in practice.

We endorse this agreement and believe that its implementation will help ensure that both organisations work in partnership to meet our statutory duties and deliver the standard of liaison and co-operation expected by the public.

signature signature

CE CQC CE HSE

July 2012 July 2012

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Introduction This agreement sets out the principles for effective liaison in response to unexpected deaths and serious safety incidents arising from systemic management failures to meet established standards. It also addresses situations where the sharing of information is clearly in the interest of service users. CQC and HSE have different roles and responsibilities in the regulation of health and social care and this agreement refers to the operational practices of each organisation which underpin its implementation. Roles and responsibilities HSE is responsible for enforcing the Health and Safety at Work etc. Act 1974 (HSWA) and associated legislation throughout Great Britain. As a national regulator it aims to reduce death, injury and ill health by securing the health, safety and welfare of workers and protecting others, such as contractors or patients, who may be affected by work activities. Whilst HSE focuses on the health and safety of employees, it also has a role in patient safety under section 3 of HSWA. For more detail refer to Annex 1. CQC was established under the Health and Social Care Act 2008 (HSCA) as the independent regulator of health and social care in England. It registers providers of registered activities that are carried on in hospitals, dental practices, ambulance services, care homes, people’s own homes and elsewhere. It also protects the interests of vulnerable people, including those whose rights are restricted under the Mental Health Act. It monitors compliance with the HSCA and associated regulations, and also has powers to conduct investigations into serious failures of care. For more detail refer to Annex 2. The importance of working together to investigate thoroughly and to prosecute appropriately those responsible for work-related deaths is emphasised in Work-related Deaths Protocol (WRDP). The police and the Medicines and Healthcare products Regulatory Agency (Medical Devices Division) (MHRA - MDD), who are signatories of WRDP, may also have an enforcement role in healthcare settings. CQC is not a signatory of the WRDP, but has agreed to follow the overall approach to working together, as set out in that protocol. When making decisions regarding incidents that meet the circumstances to which this agreement applies, CQC and HSE will:

o review the evidence according to the underlying principles of the WRDP, where relevant;

o maintain effective mechanisms for liaisons and information sharing; and,

o make decisions regarding potential regulatory and enforcement action without undue delay, whilst respecting the statutory responsibilities of each organisation.

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In what circumstances will this agreement apply? This agreement applies to unexpected deaths of service users and serious safety incidents resulting in an injury to a service user, where all of the following circumstances have been met:

o both HSE and CQC have regulatory responsibilities; o the unexpected death or injury of a service user has arisen out of, or in

connection with work, within healthcare settings; o the death or injury cannot clearly be attributed to a clinical decision; o the criteria for notification to CQC have been met; and, o HSE’s Incident Selection Criteria or HSE’s guidance on responding to

public safety incidents where Section 3 of HSWA applies have been met.

Further information about these circumstances is given in Annex 3. The agreement will also apply where matters of concern that have a realistic potential to cause deaths or major injuries that fit the above circumstances come to CQC or HSE’s attention. There may be cases in which it is difficult to determine whether this agreement applies. Each case will need to be considered according to its individual circumstances. Where there is uncertainty, CQC and HSE will discuss the facts of the case and agree an appropriate course of action. The agreement also applies to more general sharing of information (for example about complaints, or evidence of systemic management failure) where this is clearly in service users’ interests. Statement of intent CQC and HSE will work collaboratively by:

o notifying each other as soon as possible about incidents that meet the circumstances set out in this document;

o coordinating regulatory activity as appropriate and ensuring that it is conducted in a thorough, appropriate and timely manner;

o responding promptly to queries; o routinely sharing relevant information to support the operation of this

agreement; o agreeing the most appropriate enforcement action to ensure that

further harm is avoided.

It is not always apparent whether, or what, action will result from regulatory activity. Decisions in relation to who will lead the intervention, and the direction it will take, should be timely, informed by the best available evidence and technical expertise, and should take account of CQC’s and HSE’s

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published policies and procedures. CQC and HSE will work together in the best interests of people who use services. Initial action by CQC and HSE Each organisation should, in line with the principles of this agreement:

o consider if there is a role for the other regulator from the outset; o identify and secure potential evidence and avoid compromising it; o involve a senior supervisory officer, where they think there is potential

for involvement of the other partner; and o contact the other regulator, in accordance with operational guidelines

and contact arrangements set out in this agreement, when they become aware of an incident that meets the circumstances set out in this agreement (See Annex 4).

Where incidents are covered by these circumstances, CQC and HSE will:

o determine whether or not joint, parallel or solo regulatory action will be conducted;

o keep a record of this decision and agree criteria for review; and o designate appropriate contacts within each organisation to establish

and maintain dialogue throughout the course of the regulatory action. Ongoing management All regulatory activity should be managed in a professional manner in accordance with internal operational guidelines and standards. In some cases, both organisations will each need to take their own regulatory action in parallel, co-ordinating their actions. Each will keep the other regularly updated, sharing relevant information. In other cases, CQC or HSE may await the outcome of the other’s activities. In any event, the relevant CQC and HSE inspectors should agree:

o the necessary actions to prevent further harm; o what regulatory activity will be undertaken and how it will be

coordinated (where appropriate); o how evidence is to be gathered, retained and disclosed between the

parties; o how the interviewing of witnesses, the instruction of experts and the

forensic examination of exhibits is to be co-ordinated; o how, and to what extent, corporate or organisational failures should be

reviewed in addition to any failings by individuals; o how to coordinate the reporting and publication of any findings, taking

into account any ongoing regulatory activity by the other body; o milestones and arrangements for monitoring progress;

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o to notify each other of any proposed enforcement action by either body in advance of a final decision being announced or major report published.

All policy and key decisions should be recorded in accordance with each organisation’s operational procedures for future reference and to maintain a robust audit trail. All regulatory action should be subject to regular review by both parties to determine whether there is any change in the circumstances that may necessitate a change in regulatory response or activities. CQC and HSE should always be aware of the need to involve the police and potentially the CPS, and any other enforcing authorities (e.g. the MHRA or professional councils), where appropriate. They should also be aware of the need to invoke safeguarding procedures where appropriate. Information sharing Where there has been regulatory activity in relation to an incident to which this agreement applies, information and evidence should be shared - where appropriate and subject to any legal restrictions - between CQC and HSE. Special handling procedures may be necessary in certain cases. The organisation responsible for retaining the exhibits, documents and other relevant material should also be agreed. CQC and HSE will benefit from routine information sharing about risks in areas of common interest. The exact data streams and arrangements for exchanging information will be set out in a separate information sharing agreement. Communications Good communication is central to the effective operation of this agreement. In the event of large-scale or complex cases, for example involving multiple deaths, it may be appropriate to form a strategic communications group to ensure effective inter-organisational communication, and to share relevant information and experiences. There should be an agreed communications strategy for keeping the victims, witnesses, and other interested parties such as commissioners, MPs, the police, the coroner and the media informed of progress in a consistent and sensitive fashion.

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Disclosure of material Disclosure must always follow the established law (including the Data Protection Act 1998 and the Freedom of Information Act 2000) and internal procedures or guidance. If CQC or HSE receive requests for disclosure of information originating from the other organisation, they will consult before any disclosure. Particular care needs to be taken to ensure that disclosure of material into the public domain, including via third parties e.g. coroners, does not prejudice any future legal proceedings. Review of this agreement A national review group will be established, led by CQC’s Regulatory Development Directorate and HSE’s Public Services Sector. This group will, as often as necessary, and at least annually:

• review the agreement and consider improvements in the light of feedback from operational staff and the lessons learned from implementation;

• recommend action that needs to be taken to enable more effective implementation.

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ANNEX 1 Role of HSE

HSE is responsible for the enforcement of the Health and Safety at Work etc. Act 1974 and associated legislation throughout Great Britain. Its work includes ensuring that ‘risks to people’s health and safety from work activities are properly controlled’.

Within the health and social care sector, HSE’s role includes health and safety risks to healthcare workers and others who might be affected by the work activity. Local authorities also have some enforcement responsibility for social care.

HSE has a role in relation to patient safety under section 3 of the Health and Safety at Work etc. Act 1974 (HSWA) and investigates certain patient related deaths and serious incidents in accordance with its incident selection criteria.

However, as the scope of section 3 of HSWA is so wide-ranging, HSE’s policy is that it will not, in general, investigate matters related to clinical judgement, or quality of care, as others (such as the General Medical Council and CQC in England) regulate in this area. For further information see - http://www.hse.gov.uk/enforce/hswact/priorities.htm

HSE deals with the major non-clinical risks to patients such as:

• trips and falls; • scalding; and • with some aspects of risks that affect both staff and patients alike, such

as manual handling/people 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.

HSE follows its guidance for the Field Operations Directorate (FOD) in responding to public safety incidents where section 3 HSWA applies:

• Guidance for FOD • Flowchart for the guidance for FOD • Situational examples

This guidance applies in full where section 3 of HSWA applies but the incident is not RIDDOR reportable.

HSE’s inspectors have the power to investigate fatalities, injuries, dangerous occurrences and complaints. Inspectors conduct investigations and carry out

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enforcement in line with HSE’s Enforcement Policy and Enforcement Management Model (EMM).

HSE’s objective in investigating incidents and complaints is to determine the underlying causes and ensure that:

• action has been taken by the dutyholder to manage any ongoing risk and prevent similar incidents in the future;

• wider lessons are shared with other dutyholders where appropriate; and,

• HSE can determine whether there has been a significant failure to comply with health and safety law and consider whether enforcement action is appropriate.

HSE is also responsible for enforcing health and safety at care homes with nursing, and independent health and social care providers, GP surgeries and dental services within the health and social care sectors.

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ANNEX 2 Role of the CQC The Care Quality Commission (CQC) is the independent regulator of health and social care in England. It checks that care in hospitals, dental practices, ambulances, care homes, people’s own homes and elsewhere meets government standards of quality and safety as set out in the Health and Social Care Act 2008, the Registration Regulations 2009 and the Regulated Activities Regulations 2010. It also protects the interests of vulnerable people, including those whose rights are restricted under the Mental Health Act (MHA), and has other specialist regulatory functions including the Ionising Radiation (Medical Exposure) Regulations and in the use of controlled drugs.

To do this, CQC:

o registers care providers then checks whether they are meeting essential standards. If not, it takes action – they must put problems right or face enforcement action;

o publishes what it finds as quickly as possible; o shares what it knows with partner organisations; o puts a premium on users/whistleblowers; and o monitors the care of those detained under the MHA

When monitoring compliance with the Health and Social Care Act 2008 and associated regulations, CQC takes into account the Essential Standards of Quality and Safety. These describes the outcomes we expect people using a service will experience when registered persons are compliant with the regulations. In particular, regulations 15: safety and suitability of premises and 16: safety, availability and suitability of equipment (outcome areas 10 and 11 of the essential standards, overlap with HSE’s remit for health and safety. Other outcome areas (such as those about staffing and management) may also have an impact on the health and safety of people who use services.

In monitoring compliance with the regulations and essential standards, CQC will in most cases respond to concerns about health and safety of people who use services by using its usual processes of inspection, reporting and requiring improvement. For more information about the way CQC regulates and inspects click here. Inspectors have access to internal advice and guidance, and to advice published by HSE to inform their assessments and judgements. Its powers of inspection, entry and to require documents and information are described in sections 60 to 64 of the Health and Social Care Act 2008. CQC has a range of regulatory responses to failure to comply with the legislation. It uses these when there is a need to protect people who use services from harm by requiring providers to improve the care they receive,

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and/or to hold registered people to account for such failures. These include requiring compliance actions, issuing warning notices, taking civil action that impacts on the provider’s registration, and taking criminal action. CQC’s principles of enforcement, enforcement powers and the way in which they are used can be found in the Enforcement Policy. Investigations The Enforcement policy also describes CQC’s powers to undertake investigations under Section 48 of the Health and Social Care Act 2008 where there is a risk to the health, safety or welfare of persons receiving health or social care and the criteria that are used to determine when such action is appropriate. CQC’s powers to investigate do not extend to the provision of wholly private healthcare. An investigation differs from an inspection to monitor compliance in that it normally necessitates a much wider and deeper look at a range of concerns, potentially across all locations within a single provider or a major location, such as an NHS hospital, or even a local care economy. We will consider using our investigatory powers where there has been a serious failing in care or exercise of functions by providers of NHS funded care, providers of adult social care and health authorities in England, which has affected (or may affect):

• people’s basic safety; • the effectiveness of a service; or • the responsiveness of a service to people’s needs.

And one or more of the following criteria are met:

• providers have failed to respond to conventional enforcement activity with the required improvements in a reasonable timescale;

• further enforcement activity will result in adverse consequences for people using services, for example as a result of geographical isolation;

• there are indications that there are capacity issues either within the provider itself or across the local care system, which impede the required improvements;

• we become aware of evidence of a significant problem affecting a whole local care system;

• local commissioning and performance management authorities are not effectively supporting the required improvements in terms of leadership, skills and expertise;

• broader systemic failures which lie outside the remit of our routine inspection and enforcement powers.

Generally, we will not investigate:

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Individual incidents; Individual complaints about professional misconduct; Changes to how a service is organised (such as mergers); Employment or disciplinary matters; Matters being considered by a legal process; Specific matters already considered by a legal process; Issues which fall under the proposed regulations conferred on Monitor,

i.e. to investigate complaints against the NHS Commissioning Board or clinical commissioning consortia, the market, competition, and referrals from Foundation Trust governors (unless explicitly agreed before hand);

Investigations and enforcement by or on behalf of other professional regulators. However, CQC may refer relevant matters for investigation to professional regulators where appropriate.

In all its inspection and investigation work, CQC is committed to working closely with other regulators and key partners to ensure the safety and welfare of people who use services. The way in which it works with partner agencies to ensure that registered persons achieve compliance is described in detail in the Enforcement Policy.

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ANNEX 3 Detailed circumstances in which this agreement will apply The relevant regulatory responsibilities and roles of HSE and CQC are described in Annexes 1 and 2 and each have specific requirements for incidents to be reported to them. This agreement will apply where incidents are notifiable to CQC and also meet HSE’s criteria for investigation. Sometimes there are circumstances that have a realistic potential to cause incidents that would be notifiable to HSE and CQC. This agreement will also apply where such circumstances are evident to CQC and HSE inspectors, including through observation or being brought to their attention. CQC or HSE will also share information where they become aware of concerns that are unlikely to lead to joint action, and that relate primarily to the remit of the other organisation. These circumstances are illustrated by the examples in Annex 5. Incidents notifiable to CQC For an incident to be notifiable to CQC, it must be a:

• death whilst services were being provided in, or as a consequence of the carrying on of a regulated activity and which cannot, in the reasonable opinion of the registered person, be attributed to the course which that service user’s illness or medical condition would naturally have taken if that service user was receiving appropriate care or treatment, or

• serious safety incident which results in an injury to a service user, which in the reasonable opinion of a healthcare professional, has resulted in:

• an impairment of the sensory, motor or intellectual functions of the service user which is not likely to be temporary;

• changes to the structure of a service user’s body; • the service user experiencing prolonged pain or prolonged

psychological harm; or, • the shortening of the life expectancy of the service user.

HSE’s criteria for investigation Certain accidents or injuries arising out of or in connection with work are reportable to HSE under the requirements of the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR). Whether an unexpected death of a service user or serious safety incident resulting in a major injury to a service user has arisen out of or in connection with work will depend, amongst other things, on whether the accident was related to:

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• the way the work was carried out; • any machinery, other plant, substances or equipment used for the

work; and/or • the condition of the site or premises where the accident happened.

There is no requirement to report to HSE deaths or injuries arising out of the conduct of any operation, examination or other medical treatment, which is administered by a registered medical practitioner or a registered dentist, or conducted under their supervision. In general, HSE is only likely to investigate the unexpected death of a service user or serious safety incident resulting in a major injury to a service user where their s3 HSWA policy has been met and:

• the accident or incident is reportable to HSE and falls within HSE’s Incident Selection Criteria; or,

• the accident or incident is not reportable to HSE but has clearly been caused by well established standards not being achieved and this has arisen from a systemic failure in management systems.

Systemic failures in management systems may include:

• absence of, or wholly inadequate, arrangements for assessing risks to health and safety;

• inadequate control of identified, or well recognised health and safety risks; or,

• inadequate monitoring, or maintenance, of the procedures or equipment needed to control such risks.

‘Established standards’ in the context of this agreement may include:

• NHS, Department of Health, or other ‘safety alerts’, or similar warnings, that are widely known across the sector; or,

• HSWA dutyholders’ (i.e. healthcare providers’) internal guidance, or well established guidance from others, where this addresses issues that fall within HSE’s broader selection criteria; or

• widely followed, recognised and expected practices for dealing with a particular issue.

. HSE will not, in general, investigate where:

• the incident arises from poor clinical judgement (rather than a failure to implement the actions flowing from that judgement);

• the incident is associated with ‘standards of care’, such as the effectiveness of diagnostic equipment; or the numbers and experience of clinicians;

• the incident is associated with quality of care, such as hydration and nutrition; or

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• the incident arose from the disease or illness for which the person was admitted (whether or not that disease was properly diagnosed or treated) - unless the prime cause was inadequate maintenance of, or training in the use of equipment needed to treat the disease or illness; or otherwise falls within the criteria set out above.

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ANNEX 4 Arrangements for contacting CQC or HSE when aware of an incident that meets the circumstances set out in this agreement HSE All initial contact should be to publicservicessector@hse.gsi.gov.uk to determine the relevant HSE office. CQC Regional contacts – Deputy Regional Directors South Ian Biggs Tel: via PA - 0117 372 7124 Email: Ian.Biggs@cqc.org.uk London Matthew Trainer

North Deputy Director – Malcolm Bower-Brown

Central Deputy Director – Andrea Gordon South Deputy Director – Ian Biggs (interim)

London Deputy Director – Matthew Trainer

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Tel: via PA - 020 7448 4528 Email: Matthew.Trainer@cqc.org.uk Central Andrea Gordon Tel: via PA - 0121 600 5381 Email: Andrea.Gordon@cqc.org.uk North Malcolm Bower-Brown Tel: via PA – 01772730122 Email: Malcolm.Bower-Brown@cqc.org.uk

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ANNEX 5 Case examples illustrating ways of working together using this agreement These focus on CQC and HSE working together, although other agencies are also often involved. These are intended to help inspectors and others understand how this agreement works in practice. They have been simplified for this purpose and do not represent the totality of actions that CQC and HSE might take. In particular, CQC and HSE will take a wide variety of actions to ensure that lessons are learnt (for example by providing alerts, informing key stakeholders and updating guidance) and may conduct wider investigations at a particularly duty holder. The purpose of these wider investigations, which may look particularly at underlying management arrangements, is to ensure that necessary improvements are made across the whole of the organisation. Further information about the aims of investigation is given in annexes 1 and 2.

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Case example – fall from height

A vulnerable patient fell from a second floor hospital window and sustained multiple serious injuries.

Why it is within this agreement There are well-established standards for the effectiveness of window restrictors and for where they should be fitted. The risk was not identified because staff had not been properly trained and there was no procedure to ensure this risk was assessed. The safety incident resulted in serious injury to a service user of a severity that would require notification to CQC and HSE.

Roles CQC’s role was to monitor compliance with the Regulated Activities Regulations, and informed by the essential standards for quality and safety. Following a review of all the available evidence, CQC carried out an unannounced inspection. HSE investigated as this was a RIDDOR reportable injury that met its incident selection criteria.

How CQC and HSE coordinated As part of planning the inspection CQC liaised with HSE and other bodies including the police, NHS commissioners and social services. All evidence was used and triangulated to support the judgements made. In this case a judgement of ‘major concerns’ were made relating to three outcomes. HSE and CQC inspectors held regular telephone discussions, in order to share emerging evidence and concerns. Each regulator followed its own mandate and procedures and worked within its regulatory powers, but by coordinating activity and communication each avoided unreasonable requirements, duplication of effort or the contamination of evidence. CQC shared the draft press release and report with HSE once factual accuracy checks were complete. HSE kept CQC informed about progress with its investigation and liaised on a media communications strategy. Both regulators shared information about the trust’s compliance and progress in reducing risks and improving management systems.

Outcome CQC issued a warning notice and published an inspection report prior to HSE completing its investigation. The report noted that an HSE investigation was ongoing. HSE considered serving an improvement notice, but CQC’s warning notice had already secured all of the necessary improvements to window restrictors and associated management arrangements. HSE prosecuted for the failure to manage the risk prior to the patient falling.

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Case example – outbreak of C. diff

Major outbreak of Clostridium difficile at a NHS hospital notified to CQC. Why it is within this agreement

Many elderly patients died and others became seriously ill in one area of the hospital because infected patients had not been isolated and other procedures for infection control were not followed. The hospital had its own policies based on clearly established guidance on infection control, but these were not followed.

Roles CQC’s role was to monitor compliance with the Regulated Activities Regulations, informed by the essential standards for quality and safety. Following a review of all the available evidence, CQC carried out an unannounced inspection. The deaths and the outbreak were not reportable to HSE, but HSE considered the circumstances described by CQC. The outbreak was serious and directly linked to the lack of isolation – this systemic failure to meet the expected standards meant that potential breaches needed investigation.

How CQC and HSE coordinated CQC contacted HSE as soon as they became aware that there was evidence of widespread non compliance with the regulation about cleanliness and infection control. Staff had not followed their own procedures when meeting the needs of isolated patients. This suggested very serious systemic management failures and HSE undertook an investigation to gather evidence with regard to potential prosecution. CQC served a warning notice to require compliance and minimise risks to patients. HSE and CQC kept each other informed of emerging evidence and concerns through regular telephone discussions, and kept records of agreed actions and developments. By coordinating activity and communication, CQC and HSE inspectors avoided placing unreasonable regulatory burdens on the trust, duplication of effort, or contamination of evidence. CQC shared the draft press release and report with HSE once factual accuracy checks were complete. Both regulators shared information about the trust’s compliance and progress in reducing risks.

Outcome CQC monitored compliance with their warning notice to ensure sustained improvement. HSE liaised with the police in accordance with the Work Related Death Protocol (WRDP) and prosecuted for breach of HSWA section 3.

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Case example – Clostridium difficile infection

A patient died and several become infected with Clostridium difficile. Why it is it within this agreement

The incident resulted in the unexpected death of a service user and therefore required notification to CQC. HSE was notified of the outbreak by the relatives of the patient who died. They alleged that it had been caused by systemic management failings to comply with standards needed to control the risk of such outbreaks. The incident may therefore have been one that fell within HSE’s investigation selection criteria.

Roles CQC’s role was to monitor compliance against the essential standards for quality and safety. HSE’s role was to decide if investigation was appropriate, based on the facts as described to them.

How CQC and HSE coordinated CQC and HSE discussed the outbreak and the best approach. The outbreak appeared to be linked to serious failings on the part of the Trust and CQC therefore decided to visit to establish the facts and assess compliance against essential standards for quality and safety. It was agreed that CQC would notify HSE if they became aware of circumstances that brought the incident within scope.

Outcome CQC’s investigation revealed that an individual doctor had been inappropriately prescribing broad spectrum antibiotics and that this may have been a relevant factor. The Trust had adequate policies in place for this issue and had made them clear to medical staff. There was no evidence of systemic management failure. The incident did not therefore meet HSE’s criteria for investigation as there was no evidence that the outbreak was linked to systemic management failure. CQC published their findings in an inspection report and confirmed that the Trust had contacted the GMC

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Case example – Fire in hospital ITU One patient suffered 25% burns as a result of a fire in a hospital’s ITU, which the Fire and Rescue Authority concluded had been caused by an oxygen bottle. The incident happened shortly after CQC had carried out an inspection.

Why it is within this agreement The hospital’s risk assessment did not consider risks to patients of using oxygen, and there was clear evidence that adequate control measures were not implemented. Well established standards for the storage of oxygen bottles were not met, thus leading to reportable injuries to a patient and employee.

Roles CQC’s role was to monitor compliance with the Regulated Activities Regulations, and informed by the essential standards for quality and safety. HSE investigated as this was a RIDDOR reportable injury that met its incident selection criteria.

How CQC and HSE coordinated HSE contacted CQC and they shared evidence that they had gathered during the recent CQC inspection, this included the unsafe storage of oxygen bottles. There was early discussion between HSE and CQC on how evidence would be secured and collected and each kept a record of discussions and agreed actions. HSE committed to share evidence with CQC arising from its investigation, but explained that it would take some time to complete. HSE issued an improvement notice with regards to storage of oxygen bottles and shared a copy with CQC. Both regulators shared information about the trust’s compliance and progress in reducing risks.

Outcome Evidence from HSE was used to triangulate other evidence CQC had gathered and compliance actions were issued against the trust. The trust provided CQC with an action plan to identify how and when compliance would be achieved. The action plan was robust and CQC shared this with HSE. HSE prosecuted for failures to manage risks to staff and patients.

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Case example – outbreak of legionnaire’s disease

An outbreak of legionnaire’s disease in a hospital affected patients with suppressed immunity and was traced to contamination of the hot water system. HSE and CQC were notified by the provider.

Why it is within this agreement There was a failure by the trust to follow established standards as set out in the Approved Code of Practice and guidance ‘Legionnaires Disease: The control of legionella bacteria in water systems’ published by HSE. The failure to carry out suitable and sufficient risk assessment and to implement the right maintenance systems led to patients being very ill.

Roles CQC did not undertake any immediate regulatory activity but recorded the evidence to use for the ongoing monitoring of compliance. The illness to the patients was not reportable to HSE, but HSE specialist inspectors provided advice on the initial actions taken by the Trust to prevent further cases of disease and these enquiries suggested there had been serious management failings that required further investigation.

How CQC and HSE coordinated As part of its investigation, HSE issued an improvement notice and shared a copy with CQC. HSE requested information from CQC about the hospital, which had been gathered through their ongoing monitoring of compliance, and this helped HSE to understand the failures. The way that HSE and CQC shared information reduced the burden on the hospital and optimised their respective use of resources.

Outcome HSE prosecuted for a breach of HSWA arising from the failure to manage the risk to service users. The trust had failed to meet the requirements of the Approved Code of Practice for the management of Legionella, or take other effective precautions. CQC used HSE findings, along with other intelligence, to plan an inspection which would include a review of compliance with regulation 15.

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Case example – injuries due to physical restraint

CQC contacted HSE because of a large number of reports they received about patients suffering significant injuries as a consequence of being inappropriately restrained.

Why it is within this agreement Provision of training in appropriate de-escalation or restraint techniques needed to deal with challenging behaviour is an established standard across the NHS. There was a clear management failure to assess risks to service users and to put adequate control measures in place. Staff had received inadequate training in understanding and dealing with the issues that service users presented with.

Roles CQC’s role was to monitor compliance with the Regulated Activities Regulations, informed by the essential standards for quality and safety. Although most of the incidents were not reportable to HSE, CQC’s contact with HSE amounted to a complaint about a significant systemic failure. Combined with the potential for serious injury, HSE decided to investigate in line with its HSWA S3 criteria.

How CQC and HSE coordinated CQC contacted HSE as soon as it became apparent that there has been a serious management failure that was endangering both staff and service users. HSE checked its records and found only one reported incident to a patient, which had not been investigated, as it did not meet its selection criteria. HSE and CQC liaised with the NHS Protect to agree related actions.

Outcome CQC issued a warning notice, requiring substantial and immediate improvements in staff training and the management of challenging behaviour. HSE prosecuted for breaches of HSWA regarding the failure to manage the risk to patients and staff.

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Case example – poor standards of infant clinical care An infant died because clear indicators of serious infection had not been picked up by medical staff.

Why it is within this agreement The incident resulted in the unexpected death of a service user and therefore required notification to CQC. It is not reportable to HSE, but HSE was asked to investigate by the bereaved parents. Systematic management failures were apparent in that medical staff did not appear to have the required level of knowledge or competence, there were communication errors between members of staff, and questions were raised about whether an adequate number of consultants were available.

However, the relevant standards dealt with clinical issues and consequential errors in medical judgement and provision of care. The incident is not therefore one that HSE would in general investigate and only falls within the information sharing part of this agreement.

Roles CQC’s role was to monitor compliance against the essential standards for quality and safety. HSE’s role was to decide whether investigation was appropriate, based on the circumstances described to them, and to ensure that CQC was aware of the incident so that lessons could be learnt. HSE informed the relatives that they would not investigate and that they had informed CQC about their concerns.

How CQC and HSE coordinated HSE provided CQC with the information supplied to them. CQC decided to carry out a review, as this was not the first such query raising serious concerns about clinical standards at the Trust.

Outcome CQC issued a warning notice and published a critical inspection report. They continued to monitor standards at the Trust.

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Case example – risk of suicide A patient known to be at clinically diagnosed risk of suicide was admitted to mental health unit where they committed suicide by hanging from a standard curtain rail.

Why it is within this agreement The curtain rails were not ‘breakaway’ contrary to national standards. The patient had been placed on one to one supervision for their safety, but management had failed to ensure this was carried out properly. Such failures were widespread and the management had not monitored whether implementation was effective.

Roles CQC’s role was to monitor compliance with the Regulated Activities Regulations, and informed by the essential standards for quality and safety. In this example, relating particularly to safety and suitability of equipment Although the death is not reportable under RIDDOR, HSE has an interest with regard to Section 3 of HSWA because the management failure to meet clearly established standards resulted in a death.

How CQC and HSE coordinated CQC contacted HSE as soon as it became apparent that the death might have resulted from a serious management failure to meet a clearly established standard. HSE decided to investigate and liaised with the police in accordance with WRDP. CQC and HSE exchanged information throughout the investigation, and agreed and recorded actions.

Outcome CQC issued a warning notice requiring substantial improvements in the mental health unit, including removal of a number of ligature points. Improvements in management were also required to secure compliance with essential standards. HSE prosecuted for breach of HSWA section 3.

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Case example – poor manual handling During an inspection, CQC was concerned about poor manual handling and unsafe use of bedrails. They contacted HSE for further advice

Why it is within this agreement There was a clear failure to implement adequate manual handling control measures and a lack of patient hoists. Bedrails were wrongly fitted and staff unsure of the correct procedure for using them. There are well established standards, provided by MHRA, on the safe use of bedrails. There are also well established standards for the safe moving and handling of people and the need for effective training in the use of safe techniques and equipment to assist them.

Roles CQC’s role was to monitor compliance with the Regulated Activities Regulations, informed by the essential standards for quality and safety, which in this case dealt with the training of staff. HSE’s role was to investigate complaints raised, as these concerns met its selection criteria.

How CQC and HSE coordinated CQC shared their concerns with HSE immediately after their inspection. Based on the information received, HSE identified a wide range of concerns and issues two improvement notices for the provision of equipment and staff training. HSE provides CQC with verbal updates and shares copies of the notices served.

Outcome CQC monitors the trust to secure ongoing and sustained improvement. HSE ensured the trust had complied with the improvement notices.