Serious Incident Policy

(1)

NCCG Serious Incident Policy 2.0 P a g e | 1

Serious Incident Policy

Author Jackie Cairns, Associate Director of Commissioning Owner Katharine McHugh, Business Director – Engagement

& Quality

Date: 11 December 2012

Version 2.0

Previous version & Date: 1 Draft – October 2012 Equality analysis undertaken

on:

17 December 2012 Approved by CCG Board on: 19 December 2012 Planned review date: December 2013

(2)

Section 1: Introduction

1.1 Introduction

1.1.1. The NHS treats over one million patients every single day. The vast majority of patients receive high standards of care however incidents do occur and it is important they are reported and managed effectively. 1.1.2. As a commissioner of health care services Northumberland CCG is

committed to promoting patient safety and making an effective contribution to the North East vision of no avoidable deaths, injury or illness and no avoidable suffering or pain.

1.1.3. Northumberland CCG as a Commissioner seeks to assure that all services which may be commissioned meet nationally identified standards and this is managed through the local contracting process. Compliance with serious incident reporting is a standard clause in all contracts and service level agreements as part of a quality schedule.

1.1.4. The role of Northumberland CCG as a Commissioner is to gain assurance that incidents are properly investigated, that action is taken to improve clinical quality, and that lessons are learnt in order to minimise the risk of similar incidents occurring in the future. It is intended that intelligence gained from serious incidents (SI’s) will be used to influence quality and patient safety standards for care pathway development, service

specifications and contract monitoring.

1.1.5. This policy is intended to support and interface with the Cumbria, Northumberland, Tyne and Wear Area Team SI Policy which should be read in conjunction with this document.

1.2. Policy Statement

1.2.1. It is the duty of each NHS body to establish and keep in place

arrangements for the purpose of monitoring and improving the quality of healthcare provided by and for that body. Northumberland CCG as a commissioner of services is committed to this policy and the

implementation of a consistent approach to the implementation of robust arrangements for the management of Serious Incidents.

1.3. Purpose

1.3.1. The purpose of this policy is to identify what is meant by a Serious Incident and to describe the processes for the reporting, management of and

learning from an SI by NHS providers of services, commissioned by NHS North of Tyne. This will include community services providers, foundation trusts and independent contractors. The policy aims to ensure that

Northumberland CCG as a Commissioner complies with current legislation as well as National Guidance, Area Team and National Patient Safety Agency (NPSA) requirements with regard to accident/incident reporting generally, but in particular reporting, notifying, and investigating SI’s.

(5)

1.3.2. Services that are jointly commissioned under consortium arrangements are managed separately by the host organisation which may include the Local Authority e.g. Mental Health and Continuing Health Care who will provide assurance to commissioning partners via compact and/or memorandum of understanding agreements.

1.3.3. This policy applies to all employees of Northumberland CCG and the services they commission. Local contracts with Independent Practitioners, Service Providers, and Foundation Trusts will ensure that they meet the standards set out in this document.

1.4. Duties & Accountability

1.4.1. The Chief Clinical Officer as Accountable Officer has responsibility for ensuring that the organisation has the necessary management systems in place to enable the effective management and implementation of all risk management and governance policies and delegates the responsibility for the management of serious incidents to the Transformation Director.

1.4.2. The Transformation Director has executive responsibility for ensuring the necessary management systems are in place for the effective

implementation of serious incident reporting for commissioned services and independent contractors and delegates’ management of serious incident reporting to the Lead Nurse. The Transformation Director also has

executive responsibility for ensuring lessons learned from Serious Incidents (SI’s) influence quality and safety standards for care pathway development and service re-design and that monitoring is incorporated into all contracts for services commissioned by Northumberland CCG. The Transformation Director is the designated Accountable Officer for serious incident reporting for Independent Contractors who do not have direct access to STEIS. 1.4.3. The Business Director - Engagement and Quality has overall executive

responsibility for quality.

1.4.4. The Chief Finance Officer has executive responsibility for ensuring that lessons learned from Serious Incidents (SI’s) influence quality and safety standards for finance, information technology, information governance and estates.

1.4.5. The Strategic Head of Corporate Affairs has overall responsibility for ensuring that all areas identified from serious incidents as high risk are included, if appropriate, in the Corporate Risk Register and Assurance Framework in accordance with the Risk Management Policy. The Strategic Head of Corporate Affairs is supported by a Corporate Affairs Manager. They are a member of the Quality Forum.

1.4.6. The Lead Nurse has responsibility for management of serious incidents within the patient safety agenda, and is a member of the Quality Forum.

(6)

1.4.7. The North East Commissioning Support Service (NECs) is responsible for managing the serious incident process, developing links with provider organisations to encourage serious incident reporting, and ensuring investigations are managed and monitored appropriately in accordance with the SI Risk Grading Matrix and patient safety standards.

1.4.8. NECs on behalf of Northumberland CCG will make explicit reference to serious incident reporting in contracts with all providers. In particular, expectations regarding serious incident reporting and management, indicators and the process for performance management of these incidents. Appendix 1 provides an example of the standard contract information for Foundation Trusts.

1.4.9. The Area Team will be responsible for oversight of the management of serious incidents originating from the Northumberland CCG Commissioning Function and will monitor performance of the CCG in the management of serious incidents for commissioned services.

Lead Committees Duties and Accountability

1.4.10. The Quality Forum is directly accountable to the Joint Locality Executive Board (JLEB) and will be responsible for scrutiny, reporting,

recommendation and actioning of required change related to serious incidents through monthly exception and full quarterly reports.

General Duties and Accountability

1.4.11. Primary Care Community Provider Services, Foundation Trusts and Independent Contractors will need to ensure that they have robust mechanisms in place for reporting of all incidents meeting the criteria for a serious incident.

1.5. Definitions Serious Incident (SI)

1.5.1. A serious incident requiring investigation is defined as an incident that occurred in relation to NHS-funded services and care resulting in one of the following:

 Unexpected or avoidable death of one of more patients, staff, visitors or members of the public;

 Serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/ medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or

psychological harm (this includes incidents graded under the NPSA definition of severe harm);

 A scenario that prevents or threatens to prevent a provider

organisation’s ability to continue to deliver healthcare services, for example, actual or potential loss of personal/ organisational

(7)

information, damage to property, reputation or the environment, or IT failure;

 Allegations of abuse;

 Adverse media coverage or public concern about the organisation or the wider NHS;

 One of the core sets of ‘Never Events’ as updated on an annual basis.

Never Events

1.5.2. Never Events are defined as serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers. There are twenty-five ‘Never Events’ as listed in Appendix 9.

1.6. Related Documents

 Area Team Policy for reporting and management of Serious Incidents.

 The NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (March 2010).

 SI Section of commissioned service contracts and service level agreements.

 Northumberland CCG Risk Management Strategy. 1.7. Equality and Diversity

1.7.1. All public bodies have statutory duties under the Equality Act 2010 to set out arrangements to analyse and consult on how their policies and

functions impact on people who possess a protected characteristic, i.e. in terms of age, sex, disability, sexual orientation, religion and belief,

pregnancy and maternity, gender reassignment and race. Northumberland CCG analyses all its policies before making the relevant policy decision and include consideration as to whether any detrimental impact can be mitigated. Northumberland CCG has adopted the use of Equality Analysis to its approach when assessing and updating its policies, all completed Equality Analyses will be uploaded to the website for public consumption. 1.7.2. Northumberland CCG is committed to providing services that meet the

equality and diversity needs of staff and service users within the framework of the Equality Act (2010) and to tackling all types of discrimination where they arise. It is the responsibility of managers and staff to ensure that they act on this policy in a manner that meets the needs of people from these protected groups and beyond. It is always best to check with individual staff/service users what their needs are, but needs may include providing information in an accessible format, considering mobility and

communication issues, being aware of sensitive and cultural issues. 1.7.3. This policy has been Equality Analysis assessed; recommendations from

the assessment have been incorporated into the document and have been considered by the approving committee. A copy of the EA summary is on request.

(8)

Section 2: Criteria for Reporting Serious Incidents

2.1. Criteria for Reporting Serious Incidents

2.1.1. The definition of an SI is quite broad, the following criteria outline the type of incidents which are likely to be included:

2.1.2. Patients, individuals, or groups of individuals suffering serious harm or unexpected death whilst in receipt of health services. This includes screening and immunisation, radiation errors, and equipment failures. National and regional guidelines exist in relation to specific areas i.e. breast screening and cancer which should be addressed in conjunction with this policy (see section 4 for more information).

2.1.3. Serious injury or unexpected death of an individual to whom the organisation owes a duty of care including staff, visitor, contractor, or another person.

2.1.4. A serious offence including homicide committed by an individual in receipt of mental health and/or learning disability services.

2.1.5. A confirmed death of a patient due to hospital acquired infection including MRSA and Clostridium Difficile confirmed by notification on Parts 1 or 2 of the Death Certificate.

2.1.6. Any serious Information Technology related incident occurring which impacts, or has the potential to impact, on clinical care of patients and service users including all systems used or required to deliver patient and or service user care e.g. PAS, GP systems, results reporting systems etc. 2.1.7. Actual or potential loss of personal information that could lead to identity

fraud or have other significant impact on individuals (see section 8 for more information).

2.1.8. Allegations of serious professional misconduct.

2.1.9. Adverse incident which would invoke an emergency plan (affecting business continuity including multiple ward or practice closure, due to infection, serious damage to occupied NHS property through fire, flood or criminal damage, IT failure).

2.1.10. Patients detained under the Mental Health Act (1983) who abscond from health services and who present a serious risk to themselves and/or others.

2.1.11. The admission of a child of under the age of 16 to an adult psychiatric ward must be notified as an SI. Where a child is over 16 and not yet 18 years of age there are specific criteria which must be met with regard to their accommodation, namely:

(9)

 The beds must be specifically set aside for this use and are single sex

 Staff are Criminal Record Bureau checked and have support and training available to them from child mental health professionals

 Local Safeguarding Children Board is satisfied with the measures in place

 Adult mental health staff and CAMHS work closely together to plan the care, discharge and after care utilising the Care Programme approach

 Education, recreational facilities, and advocacy services are

available to children and young people. Advocates, trained in mental health legislation, work with children and young people

 Local Authority and voluntary social care, vocational and housing services are part of the network supporting the young people

2.1.12. In the event of any of these criteria not being met the incident with regard to the child aged 16/17 should be notified to Northumberland CCG and their designated commissioning support organisation as a serious incident.

2.1.13. Reporting leads will need to exercise a degree of judgement when reporting incidents and can seek advice from the Lead Nurse or NECS.

Section 3: Guidance for Northumberland Commissioned Service

Providers including Independent Contractors

3.1.1. Each provider is responsible for identifying serious incidents and taking effective action in each instance. It is expected that clear procedures are in place for identifying, reporting and investigating serious incidents.

3.1.2. Each provider must nominate a single point of contact or lead officer for the management of all SI’s.

3.1.3. The reporting arrangements for SI’s vary. NHS Community Providers and Foundation Trusts report SI’s via the STEIS system (see Appendix 2) whereas other services such as independent contractors who do not have access to STEIS are required to report an SI via a dedicated NHS mail account using the report form identified in appendix 4, to

sui.northoftyne@nhs.net

3.1.4. Internal investigations will commence immediately on notification of the incident in line with individual organisation’s incident management policies which should incorporate the principles of ‘Being Open’ and the

‘Memorandum of Understanding’. Where no request for a same day report has been made, the service provider will forward their routine internal investigation report to the NHS North of Tyne as advised, as soon as it is completed and within a timescale in line with the national requirements of serious incident reporting. An example of the contents for a report and

(10)

action plan can be found in Appendix 5.

3.1.5. Under the Data Protection Act (1988) organisations need to be open and transparent with regards to investigation processes, unless there are specific exceptions. Arrangements may need to be put in place to support patients and family members through the investigation process and sharing of the outcomes of investigations. The appointment of a Family Liaison Officer may be appropriate.

3.1.6. If an incident spans organisational boundaries, it is the responsibility of the Trust/provider where the incident took place to formally report it through STEIS. All other organisations/providers involved must contribute and fully co-operate with the process in line with agreed timescales. If an incident involves more than one NHS organisation a decision will be made (mutually agreed) regarding who will be the lead investigating organisation.

3.1.7. The information within this document must not interfere with existing lines of accountability and does not replace the duty to inform the police and/or other organisations or agencies where appropriate. The commissioner expects providers to utilise guidance from the DH Publication Memorandum of Understanding: Investigating Patient Safety Incidents (June 2004) and the NPSA guidance for Serious Incidents (March 2010). The need to involve outside agencies should not impede the retrieval of immediate learning

3.1.8. If there is evidence to indicate that a serious incident could be part of a cluster or trend, or where the circumstances or consequences of the incident are of particular concern, the commissioner may instigate a wider review. It is difficult to be prescriptive, as the extent of that case review will depend upon the nature of the incident. The commissioner may require the provider to undertake further enquiries or suggest a particular course of action.

3.1.9. Incidents which have impacted or have had potential to impact on children and/or vulnerable adults must be investigated in conjunction with the identified safeguarding lead and in accordance with related guidance. Where an incident is subject to the involvement of a coroner, an

independent inquiry, serious case review, or any safeguarding issues, this should be highlighted clearly within the STEIS report as this will affect the incident grading and may affect closure date.

3.1.10. The Northumberland CCG Lead Nurse will support the development of processes which allow for sharing of information between organisations and other sectors to ensure lessons are learned. A variety of approaches will be utilised to facilitate this process.

(11)

Section 4: Additional Guidance

4.1. Mental Health or Learning Disability Services

4.1.1. Any SI involving a former patient who has been discharged from Mental Health Services within the previous six-month period must be reported by the Mental Health Trust through STEIS.

4.1.2. If the SI involves a former patient who has been discharged from the

service in excess of six months, the Mental Health Trust should contact the CCG Lead Nurse or NECs Clinical Quality Team to seek advice about whether or not to report the incident through STEIS.

4.1.3. If an individual is referred to secondary care services by their general practitioner and is involved in an SI before being assessed and accepted by secondary care services, it is the responsibility of the relevant primary care organisation to report the incident and to lead the investigation process. Once the assessment of the individual is complete and the individual is accepted by secondary care services, this responsibility transfers to secondary care.

4.2. Children and Young People

4.2.1. Clinical Commissioning Groups are the lead health agency within their area and provide the health lead in inter-agency co-ordination and planning for Safeguarding Children. PCO’s ensure health agencies from which they commission services contribute effectively to safeguarding arrangements. 4.2.2. In addition to the ‘SI Categories’ set out above, CCGs must also inform the

Area Team by the SI procedure when a Local Safeguarding Children Board (LSCB) serious case review sub-group has decided that a serious case review under Section 8 of ‘Working Together to Safeguard Children’ (2006) is to be undertaken, or, if a single agency (health) management review involving the CCG or any of its provider health agencies is requested by the LSBC.

4.2.3. The CCG must ensure that a copy of the single agency health report and action plan is sent in a timely manner to the Serious Incident Manager. 4.2.4. The Northumberland CCG Designated Safeguarding Lead will sign off on

behalf of the organisation the final completed report. Due to the possibility of public interest or potential to share lessons in some individual cases, a copy of the overview report, action plan and executive report should be sent to the CCG Lead Nurse.

4.2.5. Northumberland CCG may discuss serious case reviews and share their correspondence relating to serious case reviews in accordance with

(12)

safeguarding board information sharing agreements. The CCG should ensure that the local guidance for undertaking a serious case review

includes a section confirming that the CCG will be responsible for reporting the decision to undertake a review to the Area Team.

4.2.6. PCO’s and Trusts should inform Northumberland CCG through the serious incident policy if they refer a member of staff to the Protection of Children Act (1999) list. The process for the management of information sharing when concerns are identified about health professionals through the Child Protection system will be refined and clarified by the Area Team

Safeguarding Lead (see Appendix 6) 4.3. Safeguarding Vulnerable Adults.

4.3.1. Provision for the protection of vulnerable adults is made in Part 7 of the Care Standards Act (2000). Trusts/PCO’s are required to fully participate in interagency working to ensure the protection of vulnerable adults using health care services (No Secrets: Guidance on developing and

implementing multiagency policies and procedures to protect vulnerable adults from abuse Department of Health (2000), Protection of Vulnerable Adults Scheme: A Practice Guide Department of Health (2006). This guidance provides the bedrock for local multi-agency policies and

procedures necessary to protect vulnerable adults. Trust/CCGs should also fully participate in Multi Agency Public Protection Arrangements (MAPPA) in all relevant cases. They should also be mindful of the Safeguarding Vulnerable Groups Act (2006) as its provisions are phased in, and ensure that they have appropriate arrangements in place to meet its requirements. 4.4. The Multi-Agency Public Protection Arrangements (MAPPA)

4.4.1. NHS bodies must fulfil their ‘Duty to Co-operate’ with the Multi-Agency Public Protection Arrangements (MAPPA) as defined in the Criminal Justice and Court Services Act (2000). The purpose of MAPPA is to minimise the risk to the public by those who may re-offend either violently or sexually. Northumberland CCG is expected to:

 Attend Multi Agency MAPPA panels

 Provide advice about the assessment and management of particular cases

 Contribute to the development of risk management plans

 Share information about particular offenders so as to enable the responsible Authority (police and probation) to work together effectively

4.4.2. Participation in safeguarding and MAPPA arrangements are complimentary to, not instead of, the SI arrangements. Northumberland CCG expects Trusts to inform them using the SI procedure when a serious case review has been requested and/or a staff member, including agency staff, has been referred to the POVA list.

(13)

4.5. Prisons Health Care

4.5.1. The Prisons and Probation Ombudsman (PPO) is responsible for investigating all deaths in prisons, probation hostels and immigration detention accommodation. It will be vital that the local NHS works closely with the PPO to ensure appropriate investigation of clinical aspects of death in custody and of residents in approved premises. There is also a need to avoid any unnecessary duplication with the NHS system for investigating adverse clinical events, and maintain clear lines of accountability for services. The ombudsman is responsible for

investigating clinical issues relevant to the death where the healthcare services are commissioned from the Prison Service by a contractually managed prison or by the Immigration and Nationality Directorate. The ombudsman will obtain clinical advice as necessary, and will make efforts to involve the local NHS provider in the investigation. Where the

healthcare services are commissioned by the NHS, the NHS providing organisation’s Chief Executive will have the lead responsibility for investigating clinical issues under its existing procedures.

4.6. Domestic Homicide Reviews

4.6.1. In the event of a homicide involving a patient in receipt of health services the NHS may be asked to participate in a Domestic Homicide Review. 4.7. Maternity Services

4.7.1. Under the current legislation governing midwifery practice rule 15 of the Midwives Rules and Standards (NMC 2004) it states: ‘ensure incidents that cause serious concern in its area relating to maternity care or midwifery practice are notified to the local supervising authority midwifery officer’. Therefore the existing arrangements in place to report incidents to the LSA midwifery officer remain in place (‘trigger list’). Serious incidents in

maternity care need to be reported through STEIS. The aforesaid

categories are not exhaustive. If in doubt, the local supervising authority midwifery officer should be contacted for advice.

4.7.2. Serious Incidents in maternity care are reported to Confidential Enquiry for Maternal and Child Health (CEMACH). However the following should be reported to STEIS and Northumberland CCG:

 Unexpected intra-partum still birth

 Unexpected death of a mother and/or baby including a cot death in hospital

 Baby abduction

4.8. Additional guidance for SIs linked with national screening programmes 4.8.1. There are a number of immunisation or screening programmes which

require a broader approach to handling incidents. Important points to remember with regard to these incidents are:

(14)

 Incidents affect the whole pathway and not just the local department or organisation in which the incident occurred

 Local incidents can affect the national reputation and alter public participation in the programme nationally

 “Potential “incidents are relevant to the rest of a national programme for which it may highlight real incidents elsewhere

 Lessons need to be learned in the rest of the National Programme

 The volumes involved in screening can give individually minor incidents a major population impact

 There are established regional/national networks of experts who can help with the identification and handling of incidents

 Local Trusts are responsible for highlighting their local incidents to others in the health system that may be impacted by their local incident. These experts can help the local Trust make contact with the relevant people/networks outside the organisation in which the incident took place

 Some of the National Programmes already have defined protocols and tools for handling incidents which will be of value in the

investigation and the experts can help to guide the local Trust through these e.g. Breast and cervical

4.8.2. The Quality Assurance Reference Centre (QARC) is accountable to the Regional Director of Public Health/LAT Medical Director for the quality of the breast and cervical screening programmes. The QARC also has advisory roles for developing national programmes such as the bowel cancer screening programme.

4.8.3. Serious incidents linked to the breast and cervical screening programmes should, in addition to normal reporting, also be reported to the QARC within 5 working days. For serious incidents, the QARC should be informed

immediately, and a member of the QARC team should be involved in the Incident Co-ordination Group. The QARC will inform the national Cancer Screening Programmes office as appropriate.

4.8.4. Further details on the management of incidents within the breast screening programme are available in “Guidelines for Managing Incidents in the Breast Screening Programme”

http://www.cancerscreening.nhs.uk/breastscreen/publications/pm-09.html 4.8.5. Further details on the management of incidents within the cervical

screening programme are available in “Guidelines for Managing Incidents in the Cervical Screening Programme”

http://www.cancerscreening.nhs.uk/cervical/publications/pm-07.html 4.8.6. For serious incidents linked to other national screening programmes (e.g.

ante natal and child health screening, retinal screening etc.) the LAT

Screening Lead will provide advice to local organisations and will inform the national co-ordinating bodies as appropriate. Further advice and Regional Contacts are included in Appendix 7

(15)

4.9. Additional guidance for breach of confidentiality Sis

4.9.1. The Department of Health have provided additional guidance for how Sis relating to breaches of confidentiality should be dealt with.

4.9.2. Any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on

individuals should be considered as serious.

4.9.3. Appendix 8 provides a table to allow NHS organisations to assess the severity of the incident on a scale of 0-5 with incidents being dealt with in accordance with their severity level. If a Trust is unsure of the level of the incident, further guidance can be sought from the NECs Information Governance Manager.

4.9.4. Incidents rated 1-5 must be reported to the Northumberland CCG through the STEIS system as soon as possible (and no later than 24 hrs. after the incident during the working week). These must be categorised in STEIS using the “Confidential Information Leak” category.

4.9.5. Individual organisations are responsible for informing the Information Commissioner of any incident of severity level 3-5

4.9.6. The Area Team is responsible for notifying the Department of Health of any category 3-5 incident and will do this as soon as possible after they have been made aware of such an incident (either through STEIS or other means)

4.9.7. Consideration should always be given to informing patients/service users when person identifiable information about them has been lost or

inappropriately placed in the public domain.

4.9.8. When reporting to the Northumberland CCG, the reporting organisation should provide the following information:

 Short description of incident and associated actions

 How the information was held (paper, memory stick etc.)

 Any safeguards to mitigate risk e.g. encryption

 Number of individuals whose information is at risk

 Types of information e.g. demographic, clinical

 Whether individuals concerned have been informed, or whether a decision has/is being made whether to inform

 Whether the Information Commissioner has been informed or whether a decision has/is being made whether to inform

 Whether the SI is in the public domain and extent of media interest or publication

 Category of incident (1-5)

4.9.9. Northumberland CCG will be responsible for publishing a summary of their data loss SIs on their public website on a quarterly basis

(16)

4.9.10. The Lead Nurse will pass this information on to other key individuals within Northumberland CCG and NECs namely the Communications Team, the Information Governance Manager, and the Caldicott Guardian. 4.9.11. Loss of encrypted media should not be reported as an SI unless the data

controller has reason to believe that the encryption did not meet the Department of Health Standards, that the protections had been broken, or were improperly applied.

4.9.12. Details of SIs relating to data breaches should be included in

organisations annual reports and reference to managing information risks should be made in annual statements of internal control.

Section 5: Information for Training Organisations

5.1. In the event an incident involves a student or trainee the relevant academic institution will be notified by the NHS organisation as appropriate.

5.2. Where a serious incident concerns the commissioning or provision of medical or dental education or training, or a medical or dental trainee or trainees, there will be appropriate communication between Northumberland CCG and the Northern Deanery in the investigation of the incident and subsequent action planning.

Section 6: Document Consultation, Approval & Ratification 6.1. Consultation

6.1.1. This document has been produced utilising the NHS North of Tyne SUI Policy 2012 by representatives of the Patient Safety Group. In preparing the document for official ratification the stakeholders listed on the front sheet were consulted upon and their comments added to the document as appropriate.

6.2 Document Approval & Ratification

6.2.1. The Joint Locality Executive Board is the committee with authority for making policy decisions with ratification of organisational policies and procedures being undertaken by the Governing Body. The Patient Safety committee has ensured that a full and proper consultation has been carried out and that the content of the document has been considered in terms of current best practice, guidelines, legislation and mandatory and statutory requirements .In considering the document for approval the committee also take into account the results and recommendations of the Equality Impact Assessment.

6.3 Document Development

6.3.1 The Quality Forum and nominated author are responsible for the development, review, implementation, performance management and

(17)

distribution of this policy in accordance with the procedures set out in this document.

6.4 Version Control & Review

6.4.1 Version control of this document is the responsibility of the author in conjunction with the Strategic Head of Corporate Affairs. The author must ensure that timely reviews are completed and informed to the Strategic Head of Corporate Affairs who will in turn maintain a register of approved documents and issue index numbers.

6.4.2 This policy will be reviewed after one year and thereafter every three years by the Quality Forum or as and when significant changes make earlier review necessary.

Section 7: Training, Distribution & Implementation 7.1 Training

7.1.1 There are no specific training requirements for the implementation of this policy although it is important that both staff and independent contractors are aware of their responsibilities regarding reporting and investigation of Serious Incidents (SI’s). All commissioning staff will receive information regarding their involvement in serious incidents.

7.2 Distribution

7.2.1 This policy is available for all staff to access via the Infonet/extranet. Staff without computer network access should contact their Line Managers for information on how to access policies.

7.2.2 All staff will be notified of a new or revised document via the Chief Clinical Officer Update.

7.2.3 This document will be included in the Publication Schemes for

Northumberland CCG in compliance with the Freedom of Information Act (2000).

7.3 Implementation

7.3.1 It is the responsibility of all commissioning leads to ensure that this policy is implemented throughout their areas of responsibility.

Section 8: Monitoring Compliance

8.1 Standards and Key Performance Indicators 8.1.1 Key Performance Indicators for this policy are:

(18)

 All contracts for services commissioned Northumberland CCG will identify serious incident reporting requirements.

 All serious incidents will be managed within identified timescales.

 There is documented evidence that lessons learnt from serious incident are disseminated.

8.2 Monitoring of Compliance

8.2.1 The Key Performance Indicators set out above will be monitored for

compliance via an annual audit. The audit will be carried out by the Quality Forum with the results shared with the Joint Locality Executive Team and Governing Body.

Glossary

Strategic Executive Information System (STEIS) – a means of reporting serious incidents to the Area Team.

References

 DH (2004) Memorandum of Understanding: investigating Patient Safety Incidents

 DH (2000) No Secrets: Guidance on developing and implementing multi agency policies and procedures to protect vulnerable adults from abuse.

 DH (2006) Protection of Vulnerable Adults Scheme; A Practice Guide

 National Patient Safety Agency (2009) Being Open – communicating patient safety incidents with patients, their families and carers

 NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation, March 2010

 DH The ‘never events’ lists 2011/12: Policy framework for use in the NHS, February 2011

(19)

Appendix 1

1. Serious Incident and Patient Safety Incident Reporting

1.1 The Provider shall, in accordance with the timescales set out in Schedule 12 (Serious Incidents and Patient Safety Incidents), send the Coordinating

Commissioner a copy of any notification it gives to a Regulator or Monitor where that notification directly or indirectly concerns any Patient.

1.2 The Parties shall comply with:

1.2.1 the arrangements for notification and investigation of Serious Incidents; and

1.2.2 the procedures for implementing and sharing Lessons Learned in relation to Serious Incidents

that are agreed between the Provider and the Co-ordinating Commissioner and set out in Schedule 12 (Serious Incidents and Patient Safety Incidents).

1.3 The Commissioners shall have complete discretion to use the information provided by the Provider under this clause 15 (Serious Incident and Patient Safety Incident Reporting) and Schedule 12 (Serious Incidents and Patient Safety Incidents) in any report which they make to Monitor, to any Regulator, any NHS Body, any Area Team, any office or agency of the Crown, or any other appropriate regulatory or official body in connection with such Serious Incident or in relation to the prevention of Serious Incidents, provided that they shall in each case notify the Provider of the information disclosed, and the body to which they have disclosed it.

1.4 The Provider shall comply in all respects with:

1.4.1 the procedures relating to Patient Safety Incidents; and

1.4.2 the procedures for implementing and sharing Lessons Learned in relation to Patient Safety Incidents

that are agreed between the Provider and the Co-ordinating Commissioner and set out in Schedule 12 (Serious Incidents and Patient Safety Incidents).

1.5 The provisions of this clause 15 (Serious Incident and Patient Safety Incident Reporting) shall in respect of any Services performed under this Agreement survive its expiry or its termination for any reason.

(20)

Appendix 2

Flow Chart for Reporting Serious Incidents NHS Provider Organisations and Foundation Trusts

Serious Incident occurs in NHS Organisation or NHS Provider Unit

In all cases Complete STEIS Report Form

If immediate action is required contact

Assessment by Lead Nurse/NECS Lead

will liaise with organisation for further information if required

Acknowledgement letter sent to organisation (CE , Quality

Lead, Reporting Officer) identifying the date final report

is due

Reporting Officer emails copy of

within agreed timescales

Report received & reviewed by

Case closed. letter sent to reporting officer confirming this

OUT OF HOURS IF IMMEDIATE INVOLVEMENT IS NECESSARY Assessment by if appropriate

Liaise with DH Media Centre if considered necessary

Agree any further level of investigation and agree timescales for submissions

(21)

Appendix 3

FLOW CHART FOR REPORTING SERIOUS INCIDENTS NHS INDEPENDENT CONTRACTORS

Serious Incident occurs in Provider Unit

Lead provider officer to via email xxxxxxxx and begin

internal investigation Tel xxxxxx

completes STEIS Report

Assessment by Lead Nurse/NECS Lead

will liaise with provider for further

information if required

Acknowledgement letter sent to provider identifying the date

final report is due

Provider Lead emails copy of within agreed timescales

Report received & reviewed by

Case closed. letter sent to reporting officer confirming

this OUT OF HOURS IF IMMEDIATE INVOLVEMENT IS NECESSARY Assessment by if appropriate

Liaise with DH Media Centre if considered necessary

Agree any further level of investigation and agree timescales for submissions

(22)

Appendix 4

SERIOUS INCIDENT (SI)

REPORTING FORM FOR INDEPENDENT CONTRACTORS Please email the completed form to the Northumberland CCG SI Officer Reporting Provider:

Reporter name: Reporter job role: Telephone number: Provider address: Telephone number: Email address: Date of incident: Time of incident: Site of incident:

Date Incident Reported to Northumberland CCG:

Gender: Male Female (delete as applicable) Date of birth:

Media interest: Yes No (delete as applicable)

Description of event – to include the location of the incident, job title of person /people involved in the incident, any equipment involved.

NB: Facts not opinions

(23)

Has incident been reported anywhere else? YES / NO (Please delete as appropriate)

IF “YES” please state where (i.e. National Patient Safety Agency, Coroner’s Office, Local Safeguarding Children’s Board)

(24)

Appendix 5

Report and Action Plan Template for Serious Incidents Reported to Northumberland CCG

SUI Incident Number: Introduction / Background

Chronology of Events

Membership of Investigation Team

Investigative Procedure / Methodology

Findings

Conclusions

Recommendations

Action Plan Remember to

 Clearly set out the actions needed to complete the recommendations

 Identify who is responsible for the action

 Specify Timescales please do not enter “On-going” – except if t is to be incorporated in to the practices everyday business for example the practice annual programme of audit.

(25)

Appendix 6

Allegations Management

Management of Information Sharing when Concerns are identified about Health Professionals whose Children are the Subject of Child Protection Procedures.

The Local Authority Designated Officer (LADO) works within Children’s Services and should be alerted to all cases in which it is alleged that a person who works with children has:

 behaved in a way that has harmed, or may have harmed, a child

 possibly committed a criminal offence against children, or related to a child

 behaved towards a child or children in a way that indicates s/he is unsuitable to work with children.

This includes situations where a member of staff has allegations against them involving children or as a parent/carer and the following guidance sets out good practice on how to manage the sharing of information when child protection concerns have been highlighted.

1. Where allegations have been made that harm to a child has occurred within the professionals place of work, the agency’s investigative procedures are implemented and the LADO informed within one working day.

2. Where allegations involve the professional’s role as a parent or carer, and the alleged harm has occurred outside of the workplace, the safeguarding

process must consider if the individual may present a risk to children professionally.

3. Employment issues should be considered at the earliest opportunity during the child protection process, this is most likely to be at a strategy meeting, however it may be that concerns are identified in other multi-agency fora e.g. Child in Need Care Team Meeting. When a concern is identified, it should be agreed in the multi-agency team, whether the concerns are such that there the health professional may be a risk to children in their professional role. 4. The meeting should agree what information needs to be shared, with whom

and who will be tasked with this.

5. Where employment concerns are identified, the Local Authority Designated Officer (LADO) must be informed, this may be done by the Chair of the Strategy meeting or other nominated professional, e.g. SW team

manager/social worker. The LADO will contact the Nominated Officer in the health professional’s organisation, who will inform the designated nurse of the action to be taken. This may result in a further strategy meeting to discuss the professional risk, Chaired by the LADO.

6. It is the role of the Named Professional /agency safeguarding lead attending the strategy meeting or discussion to ensure employment issues and sharing of information is discussed at the earliest opportunity and to inform the

(26)

designated nurse of the concerns.

7. In the event that the Named Professional is concerned about the outcome of the Strategy Meeting with regard to employment issues, they should discuss these concerns with the Chair and the Designated Nurse who will contact the LADO.

8. If the Named/Designated Professional remains concerned, they should contact the LADO’s Line Manager (this will differ within each area) and ultimately speak to the Director of Children’s Services if the issues are not resolved.

9. If concerns are raised at any point following a Strategy Meeting, advice will need to be sought from the Agency Named Nurse/Safeguarding Lead who should contact the Designated Nurse for Safeguarding as to the best way to facilitate the appropriate discussion at a multi-disciplinary meeting.

10. For further information please refer to Working Together to Safeguard Children (2010) and NSCB LADO guidance.

(27)

Appendix 7

Additional Advice and Regional Contact Details for SIs in Screening or Immunisation Programmes

Quality Leads in Trusts are advised to

 Be aware of the wider needs of Screening or Immunisation Programmes

 Inform the staff involved in screening or immunisation that they should communicate with their Regional lead contacts if there is a potential incident

 Inform the regional contacts at an early stage when investigating potential incidents. They will advise on investigating and handling the incident and of the other people to inform (e.g. PCO’s and others in the pathway)

 Ensure a relevant Regional representative(s) of the Programme is a key member of the incident investigation team

 Make sure that local organisations’ policies on Incident Handling reflect the Area Team policy in respect of screening and immunisation

 Continue to formally report SIs to the Area Team in accordance with the

Regional Policy “Guidance for reporting and management of Serious Incidents In event of an incident or potential incident in screening/ immunisation, Trusts should make sure the following are informed in addition to required reporting through STEIS Primary Contact for all Screening or immunisation incidents in North East

Fergus Neilson, SHA Screening and immunisations Lead, Public Health North East, Government Office for the North East, 7th Floor Citygate, Gallowgate, Newcastle upon Tyne NE1 4W

Email: Fergus.neilson@dh.gsi.gov.uk Tel: 0191 202 3718 mob:07880500641

Cancer Screening

Dr Keith Faulkner, Regional QA Director, Quality Assurance Reference Centre, 9 Kingfisher Way, Silverlink business Park, Newcastle upon Tyne, NE28 Email: keith.faulkner@nhs.net Tel: 0191219 7014 Mob: 07747795629

Ante-natal and Newborn

Kim Moonlight, Public Health North East, Government Office for the North East, 7th Floor Citygate, Gallowgate, Newcastle upon Tyne NE1 4WH

Email: kim.moonlight@dh.gsi.gov.uk Tel: 0191 202 3644 Mob: 07980729726

Immunisations Julia Waller

Regional immunisation Advisor, Health Protection Agency, Appleton House, Lanchester Rd., Durham DH1 5XZ

Email: Julia.waller@hpa.org.uk and Julia.waller@cdd.nhs.uk Tel: 0191 3333372 Mob: 07990 526549

(28)

Appendix 8

Reporting serious incidents (SIs) relating to actual or potential breaches of confidentiality involving person identifiable data (p.i.d), including data loss It is essential that all serious incidents that occur in the Trust are reported

appropriately and handled effectively. This document covers the reporting arrangements and describes the actions that need to be taken in terms of

communication and follow up when a serious incident occurs. Trusts should ensure that any existing policies for dealing with serious incidents are updated to reflect these arrangements.

Definition of a Serious Incident in relation to Personal Identifiable Data

There is no simple definition of a serious incident. What may at first appear to be of minor importance may, on further investigation, be found to be serious and vice versa. As a guide, any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals should be considered as serious.

Immediate response to Serious Incident

The Trust should have robust policies in place to ensure that appropriate senior staff are notified immediately of all incidents involving data loss or breaches of

confidentiality.

Where incidents occur out of hours, the Trust should have arrangements in place to ensure on-call Directors or other nominated individuals are informed of the incident and take action to inform the appropriate contacts

Assessing the Severity of the Incident

The immediate response to the incident and the escalation process for reporting and investigating this will vary according to the severity of the incident. Risk assessment methods commonly categorise incidents according to the likely consequences, with the most serious being categorised as a 5, e.g. an incident should be categorised at the highest level that applies when considering the characteristics and risks of the incident.

(29)

NCCG Serious Incident Policy 2.0 P a g e | 29 0 1 2 3 4 5 No significant reflection on any individual or body Media interest very unlikely Damage to an individual’s reputation. Possible media interest, e.g. celebrity involved Damage to a team’s reputation. Some local media interest that may not go

public

Damage to a services reputation/ Low key local Media coverage. Damage to an organisation’s reputation/ Local media coverage. Damage to NHS reputation/ National Media coverage. Minor breach of confidentiality. Only a single individual affected Potentially serious breach. Less than 5 people affected or risk assessed as low, e.g. files were encrypted Serious potential breach & risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected Serious breach of confidentiality e.g. up to 100 people affected Serious breach with either particular sensitivity e.g. sexual health details, or up to 1000 people affected Serious breach with potential for ID theft or over 1000 people affected

Reporting to Area Team/NECS

The Trust should report the SI, i.e. all incidents rated as 1 – 5, to the Area Team/NECS through the usual SI process. The following information should be provided in each case:

 A short description of what happened, including the actions taken and whether the incident has been resolved

 Details of how the information was held: paper, memory stick, disc, laptop etc.

 Details of any safeguards such as encryption that would mitigate risk

 Details of the number of individuals whose information is at risk

 Details of the type of information: demographic, clinical, bank details etc.

 Whether a) the individuals concerned have been informed, b) a decision has been taken not to inform or c) this has not yet been decided

 Whether a) the Information Commissioner has been informed, b) a decision has been taken not to inform or c) this has not yet been decided

 Whether the SUI is in the public domain and the extent of any media interest and/or publication

Reporting to the Area Team/NECS should be undertaken as soon as practically possible (and no later than 24 hours of the incident during the working week). If there is any doubt as to whether or not an incident meets the SI reporting criteria, the Trusts’ Risk Manager or the Area Team/NECS should be contacted by telephone for advice. Early information, no matter how brief, is better than full information that is too late.

(30)

The Trust should keep the Area Team/NECS informed of any significant developments in internal/external investigations, as appropriate. The Area

Team/NECS should continue to keep a watching brief on developments including following up further details/outcomes of the incident.

The Trust’s communications team should contact the Area Team/NECS Communications team immediately if there is the possibility of adverse media coverage in order to agree a media handling strategy. Where necessary, the Area Team/NECS Communications team will brief the Department of Health Media Centre.

Reporting to the Department of Health

The Area Team/NECS will be responsible for notifying the NHS Commissioning Board (NHS CB) of any category 3-5 incident reported by forwarding details to the appropriate dedicated mailbox established within the NHS CB. Incidents should be notified to NHS CB communications only if only the lighter shaded risk areas in the top two rows in the table apply and to both NHS CB Comms and the Ministerial Briefing Unit if the significant risks in the darker shaded area at the bottom right of the table apply. This latter, most serious category is the one that should be

referenced as a nationally reported SI. Those reported to NHS CB Comms alone should be referred to as a communications alert derived from a local SI. Once an incident has been reported to NHS CB any subsequent details that emerge relating to the investigation and resolution of the incident should also be supplied.

The NHS CB will review the incident and determine the need to brief Ministers and/or take other action at a national level.

Reporting to the Information Commissioner or other Bodies.

The Information Commissioner should be informed of all Category 3-5 incidents. The decision to inform any other bodies will also be taken, dependent upon the

circumstances of the incident, e.g. where this involves risks to the personal safety of patients, the NHS CB may also need to be informed.

Informing Patients

Consideration should always be given to informing patients when person identifiable information about them has been lost or inappropriately placed in the public domain. Where there is any risk of identity theft it is strongly recommended that this done.

(31)

Appendix 9

‘Never Events’ Core List.

Effective from February 2011, the following is the expanded core list of ‘never events’ from the Department of Health policy framework.

1 Wrong site surgery

2 Wrong implant/ prosthesis

3 Retained foreign object post-operation

4 Wrongly prepared high-risk injectable medication 5 Maladministration of potassium-containing solutions 6 Wrong route administration of chemotherapy

7 Wrong route administration of oral/enteral treatment 8 Intravenous administration of epidural medication 9 Maladministration of insulin

10 Overdose of midazolam during conscious sedation 11 Opioid overdose of an opioid-naïve patient

12 Inappropriate administration of daily oral methotrexate 13 Suicide using non-collapsible rails

14 Escape of a transferred prisoner 15 Falls from unrestricted windows 16 Entrapment in bedrails

17 Transfusion of ABO-incompatible blood components 18 Transplantation of ABO or HLA-incompatible organs 19 Misplaced naso- or oro-gastric tubes

20 Wrong gas administered

21 Failure to monitor and respond to oxygen saturation 22 Air embolism

23 Misidentification of patients 24 Severe scalding of patients

25 Maternal death due to post-partum haemorrhage after elective Caesarean section

Please refer to the DH ‘never events’ lists 2011/12: Policy framework for use in the NHS, February 2011 for definitions/descriptions

Serious Incident Policy