Managing safety incidents in NHS screening programmes

Question 1

Accountability, roles and responsibilities

Accepted Answer

This section describes core roles and functions, how parts of the system should collaborate and resolve disagreements.

All parties should agree accountability, responsibilities and governance. The RASCI model (responsible, accountable, supporting consulted, informed) is a method for doing this. Local differences in commissioning structures and ways of working can be accommodated. It is recommended in the NHS England serious incident framework (updated 2015).

Providers

All providers contributing to a local screening service have joint responsibility to ensure safe and coherent screening for the population in accordance with the national service specification.

Each provider is accountable for the safe and coherent delivery of their part of the screening pathway. There is joint accountability at the interface between providers.

Providers of screening services are responsible for operating within this guidance. It applies to safety concerns, screening safety incidents and serious incidents. The NHS England serious incident framework (updated 2015) applies to serious incidents in screening programmes. Provider organisation incident policies should reference both sets of guidance.

When a screening safety incident is suspected or declared, the provider will:

notify SQAS (region) and the PHE screening and immunisation team embedded in/associated with the commissioner of the service
fact find, manage and investigate the safety issue taking account of QA advice and reporting to the screening and immunisation team
collaborate effectively with other providers and, where agreed, assume a lead provider role

If a serious incident is suspected or declared the provider provides reports to the commissioner of the service and, where this different, to the commissioner that leads on contracting with the provider organisation.

Commissioners

NHS England is responsible for commissioning local NHS screening services that deliver quality and outcomes in accordance with NHS Screening Programme requirements. Commissioners achieve this by monitoring and assessing the quality of services. They work in partnership with providers but challenge when needed.

PHE provide the public health expertise required to commission and oversee local NHS screening services. These screening and immunisations teams are embedded within the commissioning teams of NHS England at sub-regional level. A team with equal functions operates within NHS London. References to the functions carried out by screening and immunisation teams throughout this guidance are applicable to the public health screening team embedded within NHS London.

The commissioning organisation’s role in screening safety incidents varies across the country. As a minimum it includes reviewing trend data and discussion as part of general quality reviews.

The NHS England serious incident framework sets out the commissioner’s involvement in a serious incident. It will:

hold the provider(s) to account for their response(s) to a serious incident occurring in services it commissions
be responsible for ensuring that there are clear governance arrangements for managing the serious incident, for quality assurance and formal closure
ensure a responsible commissioner provides leadership and oversight where multiple commissioners are involved
decide whether to discuss a screening serious incident at the local quality surveillance group

Providing leadership and oversight includes agreeing a RASCI model, where appropriate, so that all parties are clear about their responsibilities at the outset. It is clear which organisation is responsible for leading oversight of the investigation, where the accountability sits and who should be consulted and/or informed as part of the process. This allows the accountable commissioner that is the commissioner holding the contract, to delegate responsibility for managing the investigation of the incident to an alternative commissioning body. This does not remove the overall accountability of the commissioner who holds the contract.

If there are many providers involved or the screening incident occurs in primary care, the responsible commissioning organisation may need to take an active investigation and management role. To keep this separate from the commissioner’s oversight and closure function, the PHE screening and immunisation lead may undertake this role on their behalf.

PHE screening’s national programme team has a direct commissioning role in managing pilots, roll-out of new screening programmes or extensions to screening programmes. To carry this out, it collaborates with the commissioner associated with the local screening service.

If there is a screening safety incident, NHS screening programmes will oversee the provider’s response along with the appropriate screening and immunisation lead. If there is a serious incident, NHS screening programmes will also work with the responsible commissioner to make sure the provider meets the requirements of NHS England’s serious incident framework (updated 2015).

NHS screening programmes manage screening safety incidents and serious incidents occurring in IT software or equipment that it commissions.

PHE screening and immunisation teams

Screening and immunisation teams, led by screening and immunisation leads, oversee how provider organisations manage screening safety incidents and serious incidents, working with SQAS. They are embedded within NHS England, at sub-regional level and will use commissioning mechanisms to ensure that providers follow this guidance and act on QA advice.

If a screening safety incident or serious incident is suspected or declared, the screening and immunisation lead associated with the responsible commissioner will take a lead role using their public health expertise. This includes ensuring that there is an appropriate RASCI model, particularly where:

there are multiple providers and commissioners contributing to the screening pathway
the incident has occurred in primary care or involves independent sector providers
the incident has occurred at the interface between screening and the next stage of care

Management and investigation of the screening safety incident or serious incident is appropriate, including assuming the lead role if necessary.

All screening safety incidents and serious incidents are reviewed by the local screening programme board (usually chaired by the screening and immunisation lead).

In serious incidents, the screening and immunisation lead will work closely with the commissioning and patient safety functions of the lead commissioner to ensure that the requirements of NHS England’s serious incident framework (updated 2015) are met. The screening and immunisation lead will notify the relevant PHE centre director and director of public health when a serious incident is declared.

PHE screening quality assurance service

SQAS (national) will:

develop guidance and processes for managing and monitoring screening safety incidents and serious incidents
develop resources and training packages to support the management of screening incidents
collate and disseminate the learning from incidents at national, regional and local level

SQAS has a responsibility to ensure patient safety. It must have mechanisms to ensure swift action if patients are at risk. It will:

provide expert advice to providers, screening and immunisation teams and commissioners of screening programmes so safety concerns, safety incidents and serious incidents are assessed, investigated and managed effectively. This includes advising providers to seek communications support from NHS England
access specialist clinical and policy advice for specific incidents from PHE screening’s national programme team
check that PHE regional communications are aware of incidents escalated to NHS England regional communications
make sure that the relevant PHE centre director is informed when a serious incident is declared

PHE centres

PHE centres want to be aware of all serious incidents in their area. The screening and immunisation lead will keep them informed supported by SQAS (region).

PHE centre directors provide professional support for screening and immunisation leads (SILs) and make sure that there is adequate public health support for screening incidents.

PHE centre directors may help resolve disagreements about the classification and handling of a screening safety or serious incident.

Involvement of regional and national tiers

PHE and NHS England national and regional levels must be informed and may work together to manage, co-ordinate or advise if:

the suspension of screening is recommended
the scale and complexity of the problem requires cross boundary leadership, support and communications
disagreements about classification and handling are not resolved locally
there is a need to co-ordinate providing information to interested parties

Local authority directors of public health

Directors of public health working within local authority health and wellbeing boards will want assurance that screening services provided for their resident population meet national standards and deliver the public health outcomes framework.

In the case of a serious incident the screening and immunisation lead should inform the director of public health in a timely way.

Directors of public health are responsible for independent scrutiny and assurance. They should be kept informed of serious incidents but consider potential conflicts of interest before joining a serious incident team

Care Quality Commission (CQC) and NHS Improvement

The NHS England serious incident framework summarises the roles of the Care Quality Commission (CQC) and when the provider should notify them. Find out more about CQC notifications.

The duty to inform CQC of serious incidents is discharged for NHS secondary care providers by reports made to the National Reporting and Learning System (NRLS). All other providers must notify CQC directly and without delay.

There may be circumstances where the commissioner of the provider notifies CQC direct, for example if there is concern about governance or a culture of bullying and harassment.

NHS Improvement (NHS I) is the successor organisation to Monitor and the Trust Development Agency. It is responsible for overseeing NHS foundation trusts, NHS trusts and independent providers. NHS Improvement will provide national guidance for managing serious incidents. This guidance will provide the framework for the CQC and commissioners (including clinical commissioning groups and NHS England) to assess the quality of investigations undertaken across the NHS.

Resolving disagreements

Local discussion should resolve disagreements about the classification, handling and closure of a suspected or declared screening incident.

Where there is disagreement between the provider and PHE (SQAS and the screening and immunisation team), the responsible commissioner should mediate and use their contractual powers to resolve the issues.

Where there is disagreement between the provider and the responsible commissioner, SQAS will advise both parties but the commissioner is responsible for securing agreement (see above).

Where there is disagreement between the commissioner and PHE (either QA or the SIL) NHS England region will resolve this supported by the PHE centre director or the regional director of public health. Who this will be depends on availability and a judgement by the parties about who will be best placed to assist. Where there is disagreement between SQAS (regional) and the screening and immunisation team. The regional head of QA and PHE centre director will mediate.

If individuals or groups have concerns about progress or inaction in relation to a screening incident, they should take these concerns to the responsible commissioner.

Question 2

Assessing and managing screening safety incidents

Accepted Answer

Safety concerns

In most cases, safety concerns that maybe screening incidents are raised by staff of the local screening service or through internal quality monitoring. There may be a specific event, complaint, or media interest.

The screening and immunisation team and SQAS may identify safety concerns to investigate through routine monitoring or other activities such as a formal QA visit. A local authority may raise concerns arising from its scrutiny activities.

Assessing a suspected screening incident

The organisation identifying the safety concern should consider whether it meets the definition of a screening safety incident or serious incident. If unsure the organisation should seek advice from SQAS (regional).

The problem must have occurred within the screening pathway.

Isolated minor events/errors with little or no safety risk which will not reoccur locally or in other screening services should not be managed as screening incidents. These issues should be resolved internally and reported at the next the screening programme board meeting.

Only performance failures that meet the screening safety incident or serious incident definitions should be dealt with using this guidance.

If there is a potential screening safety incident or serious incident the provider must inform SQAS (regional) and the screening and immunisation team. The responsible commissioner must be informed if there is a potential serious incident.

SQAS (regional) and the screening and immunisation team must ensure that the other party is notified.

SQAS (regional) and the screening and immunisation team must be informed immediately if there is:

actual harm or risk of harm to individuals eligible for screening
actual harm or risk of harm to staff
concern about competence of a member of staff or team that meets the safety incident or serious incident definitions
failure or misuse of equipment
failure or malfunction of the IT system
breach of patient confidentiality or data security
systematic failure to comply with national guidelines or local screening protocols that has an adverse impact on screening quality or outcome

This immediate verbal notification should be confirmed in writing.

Initial quality assurance assessment

SQAS (region) will assess the seriousness of the safety concern immediately. They will consider the scale, risk of harm and potential for recurrence and advise the provider whether to complete the screening incident assessment form (SIAF). The SIAF is used to inform a decision about how the safety concern should be classified and handled.

If an incident has occurred outside of the screening service pathway , for example within diagnostic or treatment services, SQAS (region) will advise the provider that:

it is a non-screening incident and outside the remit of the screening programme
the organisation’s normal governance processes should be followed
the responsible commissioner should be informed

SQAS (regional) will provide a summary of the facts to the screening and immunisation lead for them to hand over responsibility to the relevant commissioner.

Screening incident assessment: fact-finding

Summary of the screening incident assessment process, which should be completed within 5 working days:

1. SQAS recommends SIAF is completed

2. Provider completes section 1

This includes the facts known to date. They then send to SQAS and SIT within 3 working days.

3. SQAS completes section 2

This includes the classification and recommendations. They then send to SIT and provider.

4. SIT completes section 3

This covers the summary of agreed actions and timescales. They sends this to SQAS and provider. Steps 3 and 4 to be completed within 2 working days.

Establishing the facts is the first stage. This is to ensure a measured assessment of the seriousness of the problem and the immediate actions required.

The screening incident assessment form (SIAF) should be completed so that key questions are addressed. Section 1 of the 3 part form is a summary of the facts and should be completed by the provider.

Quality problems in screening programmes tend to be complex and may need considerable resources to investigate. More time is allowed for fact finding and assessment compared with other incidents. The maximum period is 5 working days. The provider has 3 working days to establish the facts as far as possible. Then SQAS (regional) and the screening and immunisation team have 2 working days to assess, classify and agree the next steps.

A serious incident may be identified at any point during this 5 working day period. Where this is the case, NHS England’s serious incident framework (updated 2015) applies. The provider must report the serious incident to the strategic executive information system (STEIS) (or its successor) and the responsible commissioner within 2 working days of the incident being identified as a serious incident.

The organisation where the incident occurred should lead the fact finding. The screening and immunisation lead, as part of the responsible commissioning organisation, may lead if the incident spans multiple providers or has occurred in primary care.

The investigating method will vary depending on the incident and is the responsibility of the organisation leading the fact finding.

SQAS (regional) advice must be taken into account. SQAS may involve specialist clinical, screening programme and IT experts from NHS screening programmes or its professional and clinical advisors.

In provider-led fact finding, the provider must keep the screening and immunisation team and SQAS (region) informed.

Whether a fact finding team is needed and its membership will depend on the nature and scale of the incident. As it is important to establish the facts quickly, the team should be small but have access to the necessary skills/expertise.

In a screening safety incident the fact-finding team is likely to include:

screening and immunisation lead or manager
lead professional from screening service in each provider organisation
senior manager from each provider organisation
SQAS (region)
risk manager representative drawn from provider organisations involved

Screening incident assessment: recommendations

The provider completes the fact finding section of the screening incident assessment form (SIAF) (section 1) and sends it to SQAS (region) and the screening and immunisation team. The SIAF should not contain any personal identifiable data (PID).

SQAS (region) will assess the implications for individuals, the population, the local screening service and NHS screening programmes and comment on the adequacy of actions taken or planned (section 2 of the screening incident assessment form). This may include making changes to the local screening service so that it can continue screening. If there is a significant safety risk SQAS will recommend restricting or suspending screening.

SQAS (region) will recommend a classification. These are:

no concern – no further action required
problem still suspected, cause not yet identified, further investigation required
not a screening incident
problem confirmed – this can be managed internally (no further QA action required)
problem confirmed – this should be managed as a screening safety incident (internal investigation and incident report)
problem confirmed –this should be managed as a screening safety incident (multi-disciplinary/multi-organisation investigation panel and incident report)
problem confirmed – this should be managed as a serious incident (declaration, concise or comprehensive or independent investigation)

SQAS (region) completes section 2 of the screening incident assessment form and sends this to the provider organisation and the screening and immunisation team. If a serious incident classification is recommended, a copy should be sent to the chief executive of the provider and the responsible commissioner.

The provider, SQAS (region) and the screening and immunisation team should reach consensus on the classification of the problem, the follow up action required and the timescale. Differences of opinion should be resolved through local discussion. In exceptional circumstances further advice and mediation may be needed.

The screening and immunisation team record the decisions made in section 3 of the screening incident assessment form and send the completed form to the provider and SQAS (region).

Where further investigation is needed, the action required is recorded in section 3 of the screening incident assessment form. This should detail the actions, who will take them and the timescale. The screening and immunisation team should ensure that the investigation is timely.

In serious incidents the screening and immunisation team should liaise with the responsible commissioner. They may use RASCI to confirm roles and responsibilities and the distribution of the completed screening incident assessment form.

National discussion is needed before implementing a recommendation to suspend a local screening service.

The screening and immunisation team send copies of the screening incident assessment to the responsible commissioner, any co-commissioner(s), the PHE centre director and director of public health as detailed in the RASCI.

SQAS (region) distributes the completed assessment within SQAS and NHS screening programmes.

Managing a screening safety incident

The provider should register the safety incident on their organisation’s local risk management system. In NHS trusts this will link to the National Reporting and Learning System (NRLS). All patient safety incidents must be reported to the NRLS.

Providers without a local risk management system linked to the NRLS should report all screening safety incidents to the NRLS via the eform at NRLS Reporting.

The provider organisation that led the fact finding will carry out any further investigation, and remedial actions. The screening and immunisation lead oversees this and SQAS (region) provides expert advice. The provider organisation must keep the screening and immunisation team and SQAS informed.

Screening safety incidents involving multiple professional areas or organisations may need a panel to investigate and take remedial action. The team assembled for fact finding may carry out this role until the incident closes. The panel should include SQAS (region) and the screening and immunisation team.

In these situations, the principles for managing serious incidents should be followed but scaled down so that the handling of the incident is proportionate to its severity.

When investigations and remedial actions are complete the organisation should send its draft incident report to SQAS (region) and screening and immunisation team. This should be within 60 days of the incident being declared unless an alternative timescale is agreed. SQAS will advise if further work is needed. The screening and immunisation team may also comment on the report. The final incident report should be issued within 80 working days of the incident being declared unless an alternative timescale is agreed.

The provider organisation should submit the final incident report according to its governance structures. The commissioner-led screening programme board should also consider the report. Closing safety incidents is the responsibility of the commissioner after taking SQAS advice.

The level of detail in the report should be proportionate to the severity of the incident. It should include what happened, the investigations carried out, the cause(s) and actions taken or required to mitigate harms and prevent the incident happening again.

The completed screening incident assessment report should be part of the incident report.

SQAS (regional) will identify lessons for wider dissemination and implications for national policy and guidance for consideration by PHE screening.

Question 3

Managing a serious incident

Accepted Answer

See the Reporting and managing screening incidents flowchart.

Declaring and reporting a serious incident

Organisations are to declare and report a serious incident in a screening service in line with this guidance which is consistent with NHS England’s serious incident framework (updated 2015). This is in addition to local organisational requirements for reporting incidents.

Serious incidents are to be reported on STEIS or its successor serious incident management system. They are also reported to the NRLS and if appropriate to regulators such as the Care Quality Commission (CQC).

A serious incident can be declared at any stage. In the fact finding, assessment, investigation or handling process. The NHS England’s serious incident framework (updated 2015) applies from this point. A number of organisations can call for a serious incident to be declared.

A serious incident can be downgraded if during the investigation there is evidence that no serious incident has occurred. Similarly a safety incident may be escalated to a serious incident.

In accordance with the serious incident framework (updated 2015) the chief executive of the organisation declaring the serious incident, or the officer with relevant delegated authority, is responsible for ensuring that it is reported formally to appropriate bodies including the responsible commissioner within 2 working days of identification.

Any organisation identifying an incident should inform:

SQAS
screening and immunisation lead (embedded within the responsible commissioner)
accountable commissioner of the provider organisation (such as CCG)
PHE centre director (to be informed by the screening and immunisation lead and SQAS (region)
director of public health (to be informed by the screening and immunisation lead)
NHS screening programmes and SQAS (national) (to be informed by SQAS (regional))

The screening and immunisation team may develop a RASCI to decide the other interested parties to be notified.

Programme suspension or pause

This is where SQAS recommends that the local screening service is suspended or paused for patient safety reasons. SQAS (region) informs the provider and commissioner of the recommendation verbally and confirms this in the completed screening incident assessment form.

The recommendation is made to the provider, commissioner and PHE screening (national). They will consider the recommendation and consult with the NHS England Public Health Commissioning Central Team and the regional director of public health.

If a commissioner wants to suspend a screening programme this must be discussed with SQAS (region), PHE screening (national), the NHS England Public Health Commissioning Central Team and the regional director of public health.

The decision to suspend a screening programme is communicated by the commissioner of the service.

Setting up a serious incident team

The chief executive of the organisation declaring the incident (or the senior officer with delegated responsibility) should set up a serious incident team within 2 working days of the serious incident being declared. If the management of the serious incident is being led by the responsible commissioner, the screening and immunisation lead (SIL) will usually undertake this role. This should prevent a conflict of interest with the commissioning organisation’s responsibility for quality assurance and closure of serious incidents. Membership of the team should be explicit and agreed between the organisation declaring the incident, the SIL and SQAS (region).

Membership will depend on the nature and scale of the serious incident but is likely to include:

the chief executive of the organisation declaring the serious incident (or senior officer with delegated authority) (chair)
the manager and clinical lead of the screening service (unless the performance of the individual(s) has been identified as part of the serious incident)
the screening and immunisation lead working within the responsible commissioner
the senior manager from the provider organisation’s accountable commissioner (if different from above)
a representative from SQAS (region)
a patient safety/risk manager/clinical governance lead with expertise in root cause analysis
a communications expert

If there are multiple providers and commissioners involved the RASCI model should be used. In most cases the chief executive of the host organisation will identify an appropriate chair for the incident team, but this role may be carried out by the responsible commissioner.

Administration and documentation is essential. The chair of the incident team should identify adequate administrative and IT support.

Each team member will brief their own organisation about the incident and any actions taken. The PHE centre director will be kept informed by the screening and immunisation lead and may also provide professional support.

Depending on the incident the team may need ready access to:

external clinical expertise in the screening programme
legal advice
human resources advice
counselling advice
IT system or equipment commissioner and/or supplier
specialist communications advice NHS England and PHE region

The serious incident team should agree the role of external expert(s) at the start. They are to provide advice on specific issues but are not part of the decision making process

Role and actions of the serious incident team

The serious incident team should have clear objectives formalised in terms of reference reflecting its responsibility to:

take immediate action to make the screening service safe
produce/implement an action plan to manage the consequences of the problem, including its impact on members of the public, services and staff
establish the root cause(s) of the incident
oversee the progress of the recovery actions
agree timescales for closure of the incident
identify lessons to be learnt from the incident and its handling

The following checklist provides a guide to the action plan of the serious incident team.

Define the cohort of people at risk of being harmed (case definition).
Identify the individuals directly affected and at risk of being harmed.
Set up a secure database of the individuals affected (names, addresses, date of birth and general practitioners) and use data bases such as Open Exeter to confirm current details.
Decide the action to take for individuals who have been affected by the incident. A key decision is whether to recall the individuals for repeat screening. However, the options and need for recall will vary by screening programme.
Develop/implement a communications strategy.
Brief the staff groups involved and arrange any necessary support.
Agree/implement recovery actions with timescales to make the screening service safe and any follow up audit.
Commission/agree a root cause analysis of the incident as part of an incident report, with timescales.
Decide whether immediate notification is needed to other local screening services.

SQAS (regional) member of the team will provide impartial expert advice on the investigation either in person or through a delegated expert. This includes:

the format and methodology for any further investigation into the causes and extent of the incident
whether routine screening should be suspended/restricted for the period of the incident
whether individuals screened should be re-offered screening and how this should be done
how the problem should be resolved to minimise risks
when it is safe to resume routine screening, if routine screening has been suspended

NHS England’s serious incident framework (updated 2015) defines 3 levels of investigation in order that the investigation is proportionate. These are concise, comprehensive and independent investigations. The serious incident team should agree the scale of the investigation and include this in the 72 hour report required by the serious incident framework (updated 2015). The completed screening incident assessment form should provide the information on which to base this decision.

Due to the nature and complexity of screening serious incidents, it is likely that a level 2 comprehensive investigation will be needed. NHS England’s serious incident framework (updated 2015) details the criteria and process for setting up an independent investigation.

The following aspects of managing a serious incident need particular focus.

Duty of candour

The statutory duty of openness and transparency applies to notifiable screening incidents where death, severe and moderate harm or prolonged psychological harm has occurred or could occur.

The expectation that providers are open and transparent when things go wrong is not new and it should be noted that the duty of candour has been included in NHS contracts since April 2013.

For the duty of candour to apply, the incident investigation will have reached a point where the individuals affected are known.

It does not apply where no harm has resulted but the provider(s) may decide to disclose.

Providers should be able to show they have undertaken due diligence in assessing how the duty of candour applies to each serious incident and seek legal advice where necessary.

Individuals affected should be told the facts; the further enquires being carried out and receive an apology in person that is confirmed in writing.

Applying duty of candour to screening is complex due to the characteristics of screening. Further guidance on applying the duty of candour to screening is available.

Patient notification exercises

The National Patient Safety Agency’s being open framework (2009) provides detailed guidance on how to ensure good communications with patients, families and carers.

The incident team should consider carefully how to contact members of the public.

Usually this will be through the clinical professionals that are the normal first point of contact for patients.

These clinical professionals should be briefed in advance so they are able to respond to questions, concerns and access extra information where needed.

The incident team should consider the communication needs of the individuals to be contacted and the level of support to minimise psychological harm. It is good practice to carry out an equity impact assessment and test out planned communications with patient experience experts and staff with no knowledge of screening.

Communications strategy

The aim of the communications strategy is to support the effective management of the incident. It needs to be tailored to the incident.

It should distinguish between operational communications to manage the incident, communications to professionals and communications to those affected and the wider public.

The goals are to minimise anxiety and maintain confidence in the screening programme as a whole.

Communications should initially focus on those directly affected.

Staff working in the programme and primary care professionals must be kept informed and supported so they are able to answer questions from their patients.

Arrangements must be in place for answering queries from the media and general public where the scale and severity of the incident warrants this.

The local organisation to provide communications input to the serious incident team should be agreed at the outset. This should be the organisation in which the incident has occurred, but this depends on the severity of the incident, provider size/capacity and whether there are implications for screening services beyond the area affected by the incident.

A communications lead with experience of handling incidents and dealing with national and local media should be part of the incident team from the start. The communications lead should advise on developing a communications strategy (proactive or reactive) and subsequent activity.

If media interest is likely, the provider communications lead should work with the regional communication teams of NHS England and PHE to agree a consistent message. The focus should be to coordinate communications activity. It should be transparent, so that patients and the public receive timely and accurate information as soon as possible.

For incidents requiring NHS England and PHE communications input, NHS England should leads and co-ordinate communications, in conjunction with the provider. PHE will provide expert advice on the specific screening programme to support the communications plan.

National and regional level serious incidents

Providers, commissioners and quality assurance staff should remain vigilant for serious incidents which may have widespread implications or raise public concern. They should share information with the provider chief executive, PHE’s national lead of SQAS and the NHS England Public Health Commissioning Central Team.

NHS England and PHE screening will work together in national/regional level serious incidents so that there is a coordinated and common approach. There may need to be discussion with the CQC as it may decide to carry out a section 48 investigation.

NHS England may convene and lead a national and/or a regional serious incident team depending on the scale, size and complexity of the serious incident. The PHE commissioning central team will identify a suitable director to lead the incident response.

NHS England’s serious incident framework (updated 2015) sets out that NHS England region typically commission and quality assure an independent investigation. For screening serious incidents this decision should be made in consultation with PHE’s director of screening.

Informing the Department of Health about an incident should be agreed at a national director level of PHE and NHS England.

If the serious incident spans a number of screening services or public health programmes, PHE may set up a national expert reference group to co-ordinate its advice to NHS England.

A communications strategy should be agreed with local, regional and national stakeholders to ensure that all communications are consistent. NHS England and PHE communications teams should agree the content, the dissemination plan, and which agency is the most appropriate to lead on communications activity including DH counterparts where appropriate.

A briefing to describe the issue, current position in terms of incident management and investigation should be produced. The briefing should be reported up through each agency and the joint national governance structures that oversee screening. Information should be disseminated through the appropriate professional accountability and commissioning routes including nursing, medical, operational and commissioning teams.

Question 4

Closing the serious incident

Accepted Answer

Final report and action plan

The serious incident team should agree and produce a report on behalf of the chair. The report should cover:

the root causes of the serious incident
identification and investigation of the problem, including the methodology used for the root cause analysis
findings of the investigation and outcome of any look back/recall (for example, positive cases found)
contributory factors including service delivery problems
lessons learned
recommendations directly in response to the incident
recommendations for improvements to existing systems
an evaluation of the process of managing the incident
recovery actions for the future, including clear timescales and leads – the NPSA action plan template should be followed (see NHS England serious incident framework (updated 2015))

Submission and distribution of final report

The chair of the serious incident team should decide on a distribution list for copies of the report using the agreed RASCI for reference. The list should include:

chief executive of the provider organisation(s)
director/clinical lead and programme manager of the screening service
screening and immunisation lead, who will distribute the fact finding report within the commissioning organisation in which they are based and to the PHE centre director and director of public health as appropriate
members of the serious incident team
accountable commissioner of the provider organisation(s)
SQAS (regional), who are responsible for dissemination within QA and NHS screening programmes
NHS trust development authority (NHS trusts only)

The screening and immunisation lead should ensure the report is submitted to the local screening programme board.

Closure of the serious incident

This is the responsibility of the commissioner overseeing the serious incident. This follows a quality assurance review of the final report and action plan.

The provider should submit the final report to the responsible commissioner within 60 working days of the incident declaration to comply with NHS England’s serious incident framework (updated 2015). If the incident is particularly complex, a longer time frame may be agreed with the commissioner in advance of the deadline. The provider should produce the report within 6 months if there has been an independent investigation.

The commissioner should acknowledge receipt of the final report in writing.

The responsible commissioner should complete its quality assurance review of the final report within 20 calendar days. Reference should be made to the closure checklist included as an appendix in NHS England’s serious incident framework (updated 2015).

The report should evidence:

an appropriate investigation that identifies findings, based on root causes and recommendations
a satisfactory action plan with action points to address each root cause recommendation(s) and with a named lead and timescale for implementation
that actions are either implemented or that local monitoring arrangements are in place to ensure action points will be implemented
lessons learned, including partners or stakeholders with whom the learning has been shared
full completion of the STEIS record covering the above points for example, date investigation completed and population of root cause analysis (RCA) /lessons learned section

The responsible commissioner may involve other commissioning organisations, such as the accountable commissioner of the provider organisation in the assurance and closure process, for example where there is a risk of conflict of interest. SQAS (region) will review and may comment on the report. The commissioner will need to be satisfied that the report meets required standards and that satisfactory progress is being made to complete the action plan before closing the incident on STEIS. If a screening programme was suspended due to the incident, then routine screening will have been recommenced.

The screening programme board should review the action plan until completed.

It is important that lessons for other screening services and NHS screening programmes are identified, alongside learning about managing the incident and dealing with the consequences. It maybe that changes to screening protocols and guidance would minimise the risk of a similar incident occurring.

SQAS (national) is responsible for ensuring that:

screening safety incidents and serious incidents are recorded, monitored and analysed systematically
recommendations for changes in screening guidance are considered and changes enacted where appropriate
learning identified from incidents is disseminated to all local screening services and commissioners via briefings, meetings and reports
all screening incidents are reviewed to ensure that lessons are disseminated across screening programmes and geographical areas

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Incidents in NHS screening programmes

Policy content

Purpose

Scope

Screening safety incidents

Serious incidents

Serious incident definition from NHS England serious incident framework

Definitions