NWLHT Incident Reporting Policy New

Incident, Complaints and Claims Reporting and Investigation Policy

This document is uncontrolled once printed.

Please check on the Trust’s Intranet site for the most up to date version.

North West London Hospitals NHS Trust


(Includes Serious Incidents Reporting requirements)

Version 2

Ratified by Patient Safety and Quality Committee.

Date ratified March 2013

Name of Author Catherine Thorne, Director of Governance

Name of Ratifying Committee Patient Safety and Quality Committee

Date issued May 2013

Review Date May 2015

Target Audience All Trust Staff

Equality impact outcome Low

Associated documents Risk management strategy guidance and policy Complaints policy Claims policy Supporting staff policy Being open policy Whistleblowing policy Please note use the Interim Guidelines for managing incidents in the NHS Bowel Screening Programme, available on the Intranet.


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Version Control

Version number Issue date Revision from previous issue

1 As per document date This is a new policy. It replaces the Incident Reporting and SUI policy and it incorporates the investigations aspect from the Incident and Complaints policy.

2 Provide guidance on management of incidents relating to NHS Bowel Screening Programme,


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TABLE OF CONTENTS Section Page

1. Introduction 5 2. Purpose 6 3. Scope of Policy 6 4. Definitions 6 5. Key Responsibilities and Duties 8 6. Policy Statements 13

6.1 General statement on the Incident, Complaints and Claims Reporting and Investigation Policy 6.2 Statement on culture of openness 6.3 Statement on Fair Blame 6.4 Principles of effective communication, data protection & Caldicott Principles

7. Policy Development and Consultation 15 8. Policy Implementation 15 9. Policy Monitoring, Review and Archiving 15 10. Specific Incidents, Complaints and Claims 16

10.1 Incidents, complaints and claims relating to Safeguarding Children 10.2 Incidents, complaints and claims relating to a Vulnerable Adult

11. Incidents, Complaints and Claims- Reporting and Immediate Action 17 11.1 Claims 11.2 Incidents and complaints 11.3 Being Open 11.4 Supporting staff involved in any incident, complaint or claim 11.5 Incidents involving more than one provider organisation 11.6 Process for involving and communicating with external/internal stakeholders and of sharing lessons learnt

12. Incident, complaints and Claims grade and score 19


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13. Actions to take following grading of an incident - (Reporting 20 and Lines of communication)

13.1 RED – HIGH RISK - grade 5 or SUI 13.2 AMBER – MODERATE RISKS – Grade 4 13.3 YELLOW / GREEN – LOW RISK - Grade 1-3 Incidents

14. Investigating Incidents, complaints and claims 22 14.1 Investigation procedures and general guidance 14.2 Meeting with staff, patients and relatives directly involved in the incident or complaint

15 Investigating Serious Complaints 26 16 Investigating Serious Claims 26 17 Memorandum of Understanding 26 18. Learning lessons and making improvements as a 27 result of investigating incidents, complaints and claims

19. Recommendations and Monitoring of Action Plans 27 20. Feed back of Incident, Complaint or Claim Investigation Outcomes 28 21. Staff Training and Assistance with Incident, complaint 28 and claim investigation 22. Reporting to External Agencies. 28 23. References 29 24. Bibliography 30 25. List of Associated Policies 30

Appendices 1 Guide to incident form completion (DIF1) and managerial review (DIF2) 31 (Datix web reporting) 2 Reporting to External Agencies 37 3 Establishing and Running a Hotline 44 4 Log sheet for hotline calls 42 5 Standards for SUI Panel and Serious Complaints investigation 45 6 SUI Report Template 45 7 Witness Statements Guidance 63 8 Guidance for Staff writing a Statement 65

9 KEY AREAS OF ORGANISATIONAL RISK AND KEY CONTACTS 66


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1. INTRODUCTION

This policy covers both clinical and non clinical incidents, complaints and claims. This policy is best read in conjunction with the Trust’s Risk Management Strategy, Policy and Guidance document and NHS London’s SUI Reporting Policy available at http://www.london.nhs.uk/webfiles/Corporate/Serious%20incidents/NHSL%20Serious%20Incident%20Policy%20November%202010.pdf When investigating a particular incident, the relevant Trust policy must also be consulted, for example, Safeguarding Adults and Safeguarding Children Policies, Complaints Policy and Procedure, Claims Handling Policy, Slips Trips and Falls Policies, Medicines Management Policy, Incident Complaints and Claims: Analysis, Learning Lessons and Improvements Policy, Supporting Staff Policy and Being Open Policy. Please note use the Interim Guidelines for managing incidents in the NHS Bowel Screening Programme, available on the Intranet- The Trust’s risk management system is based on a proactive, fair blame approach aimed at identifying things which can go wrong as part of a systematic approach to incident management. This approach is in line with: “An Organisation with a Memory” DH, 2000; Care Quality Commission requirements, National Health Service Litigation Authority Risk Management Standards April 2010/11and the Management of Health and Safety at Work Regulation 1999. The Trust aims to establish the causes of incidents, complaints and claims, understand these and make sure lessons are learnt and suitable improvements are made to minimise any further recurrence. This policy also outlines the arrangements for reporting Serious Untoward incidents (SUIs) to NHS London and the commissioning Primary Care Trust for the purpose of performance monitoring. Serious untoward incidents relating to information governance are managed in line with this policy and with consideration of Department of Health guidance and Checklist for reporting, managing and investigating information governance serious untoward incidents (Jan 2010) available on the Trust intranet. The policy has drawn from the guidance produced by the NHSLA Risk Management Standards and the National Patient Safety Agency; it includes Root Cause Analysis guidance from the protocol used by the Association of Litigation & Risk Managers (ALARM), which was developed by the University College London. The policy also includes information on the requirements arising from the Health and Social Care Act 2008 which means that organisations are required to notify the Care Quality Commission (CQC) about events that indicate or may indicate risks to ongoing compliance with the CQC registration requirements or that lead or may lead to changes in the details about the organisation in the Commission’s register.

http://www.london.nhs.uk/webfiles/Corporate/Serious%20incidents/NHSL%20Serious%20Incident%20Policy%20November%202010.pdf



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2. Purpose

The policy aims to: -

Minimise human, organisational and financial impacts of incidents, complaints and claims through effective management.

Ensure that, where appropriate, lessons are learnt to reduce risk and improve patient care.

Identify practices, systems or equipment that is not contributing to the highest standard of patient care and to correct them.

Maintain public confidence in the Trust’s services.

Prevent any recurrence, by identifying the root causes in incidents complaints and claims and minimise the risks from legal claims which divert funds and staff away from patient care.

Provide information to the relevant managers for action or further investigation and to enable local records to be kept for inspection and periodic review.

Enable the compilation of statistics for monitoring risk management performance.

Provide an archive of the essential facts for possible use by the Trust’s legal advisors/insurers.

Ensure compliance with all mandatory reporting schemes.

3. Scope of the Policy This policy applies to all employees of North West London Hospitals NHS Trust. The procedures for incident, complaint and claims reporting and investigation also apply to other workers in the Trust who may be from another organisation working in the Trust under a service level agreement. This includes all employees, bank, locum or agency staff, contractors and volunteers. The incident, complaints and claims reporting and investigation procedures apply to all incidents/events occurring on Trust premises or connected with Trust activities.

4. Definitions

Adverse event/incident

An adverse incident is an event which causes or has the potential to cause unexpected or unwanted effects involving the safety of the patients, users or other persons.

Hazard Something which has potential to cause harm e.g. substance, equipment, method of work, other aspects of work

Accident An unexpected event that causes injury/damage

Serious d Incident (S.I )

Something out of the ordinary or unexpected, with the potential to cause serious harm and/or likely to attract public or media interest that occurs on NHS premises or in the provision of NHS Commissioned services.

Harm Is defined as injury, (physical or psychological) disease, suffering or death.

Injury Any wrong or damage done to a person, their rights, reputation or goods.

Patient Safety Incident

Any unintended or unexpected incident(s) that could have or did lead to harm for one or more patients receiving NHS funded healthcare.

Patient safety event

Generic term applied to complaints claims and incidents


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Non-clinical Incident

events or omissions that cause a physical or psychological injury to any person on Trust premises, such as verbal and/or physical abuse, theft, sharps injuries, slips, trips etc

Near miss – applies to all of

above categories

A near miss is a situation in which an event or omission, or a sequence of events or omissions, arising during clinical care fails to develop further, whether or not as a result of compensating action, thus preventing injury.

Investigation Detailed systematic search to uncover facts and determine the truth of the factors (who, what, when, where, why and how) of incidents.

Claim Allegations of negligence and/or demand for compensation made following an untoward incident resulting in personal injury (to a member of staff, a patient or a member of the public) or damage to property.

Complaint This is any expression of dissatisfaction, which requires a response. “All complaints whether oral or written, must receive a positive and full response, with the aim of satisfying the complainant that his/her concerns have been heeded, and offering an apology and explanation as appropriate, referring to any remedial action that is to follow.”

Root Cause Analysis

A process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of a sentinel event.

External Body / Agency

An organisation that has an official advisory or regulatory role that has been mandated to regulate the corporate and professional activities of NHS Trusts.

Information Governance SI

Any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals must be considered as serious (Dept of Health 20th Feb 2008 Gateway 9571)

RIDDOR Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), place a legal duty on employers to report incidents/accidents

Never Events “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’. To be a “never event”, an incident must fulfill the following criteria;

• The incident has clear potential for or has caused severe harm/death. • There is evidence of occurrence in the past (i.e. it is a known source of risk). • There is existing national guidance and/or national safety recommendations on how the event can be prevented and support for implementation. • The event is largely preventable if the guidance is implemented. • Occurrence can be easily defined, identified and continually measured

Further guidance on Never Events can be found by accessing http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_124552

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_124552



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5. Key Responsibilities and Duties

Chief Executive Officer The Chief Executive is accountable and responsible to the Board for ensuring that resources, policies and procedures are in place to ensure the effective reporting, recording, investigation and treatment of incidents, complaints and claims and that there are suitable and sufficient arrangements for the support of those staff involved in any of these events. In practice the Chief Executive may delegate the day-to-day responsibility for this duty to Executive Directors and Heads of Departments. Trust Board The Trust Board collectively is responsible for ensuring the proper reporting, recording, investigation and management of all incidents, complaints and claims. The Trust Board delegates responsibility for receiving, assessing and acting upon incidents, claims and complaints to two key committees, firstly the Patient Safety and Quality Committee which in turn reports to the Governance Compliance and Risk Committee, a formal subcommittee of the Trust Board.

Medical Director The Chief Executive has nominated the Medical Director as the Executive Lead responsible for Patient Safety and Clinical Risk. The Medical Director shares responsibility for declaring SUIs with the Chief Executive Officer.

Director of Governance The Director of Governance is responsible for ensuring the functioning and management of corporate systems detailed within this policy related to incidents and claims and in the support of identifying, recording, reporting to management, investigating and learning from both. The Chief Executive has also nominated the Director of Governance as the Executive responsible for Non-Clinical Risk Management (Health and Safety). The Director of Governance is the designated Executive Director with responsibility for the operational management of risk systems and is responsible for reporting and follow up of serious incidents with the appropriate body within the appropriate timescales. They are also responsible for ensuring that relevant staff are informed of incidents, including, as appropriate, the Chief Executive and other members of the Executive team. Director of Nursing The Director of Nursing is responsible for corporate complaints management and the operational delivery of the complaints system.


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Executive Directors All Executive Directors through their Managers ensure all staff within their sphere of responsibility is aware of the policy and it is implemented effectively. Executive Directors are responsible for ensuring that systems are in place to monitor incidents, complaints and claims within Directorates and that they investigated according to Trust policy. Executive Directors are also responsible for facilitating the learning of lessons from incidents, complaints and claims ensuring that these are discussed at Divisional meetings. They have a responsibility to ensure any lessons learnt from investigations, which involve system errors, that may affect other areas are made known to other relevant Divisions to prevent reoccurrence and to facilitate the review of these systems and policies with operational managers. Executive Directors must ensure any formal complaints usually (but not necessarily) written, are notified as per Trust policy

Divisional General Managers It is the responsibility of the Divisional General Managers (DGM’s) to ensure the Directorate structure supports the systems for identifying, recording, reporting to management, appropriately investigating and learning from incidents. They are responsible and accountable for:

Enabling and ensuring staff attend Trust training in relation to the management of patient safety events.

Ensuring that within their areas of responsibility this policy is followed and all incidents and complaints are reported (Appendix 1) graded, investigated and actions taken, to the level commensurate with the risk grading outlined in this policy and that the investigation is documented.

Escalate incidents as detailed in this policy.

Ensuring that the impact of a patient safety event across the Trust is brought to the attention of other Directorate and Senior Managers.

Ensuring that lessons learnt following the investigation of an incident, complaint or claim, which may apply to areas outside of their remit are brought to the attention of other Directorate and Senior Managers.

Ensuring patients and relatives are informed when patient safety events occur in accordance with the Being Open policy. Where appropriate patient and relatives are informed of the Trusts policy for investigating incidents complaints and claims. Inviting discussion as appropriate to facilitate a positive outcome.

Ensuring that the Complaints policy is followed and facilitate the investigation of complaints

Ensuring that modification to local policy and procedure are undertaken following the results of incident, complaints and claims investigation. That these are brought to the attention of their staff and any information, instruction or training required is given.

Ensuring that risk assessments and the departmental risk registers are reviewed regularly.

Provide information to the Medico - Legal Services Department in order to enable the investigation of claims and apply any recommendations within their areas following identification of lessons learnt as described in the Claims Policy


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Line Managers It is the responsibility of line managers to ensure that: -

Staff attend training as described in the Statutory and Mandatory training

Staff working in their area are aware of the incident reporting procedure, cooperate in the investigation and know how to report an incident via Datix web (Appendix 1) reporting or, where not available via an incident recording book.

Staff are guided through the incident reporting process and also guided, where required, to provide information in relation to complaints and claims.

Staff are suitably supported following an incident, complaint or claim referring to other support services as required e.g. Occupational Health, counselling services

Any incidents, complaints or claims which come to their attention which are graded higher than low are reported to the appropriate Senior Manager.

Any formal complaints / concerns usually (but not necessarily) written, are reported as per the Trust Complaints policy

The patient's clinician has informed the patient or relatives, of the incident, complaint or claim in line with the Being Open Policy; this must be done before any media are informed.

Appropriate liaison with the Governance (Risk and Medico legal services) and/or Patient Relations Department takes place to identify which stakeholders need to be informed of the incident/event and ensure they are informed.

All relevant documentation is gathered, completed and securely stored including statements

Any equipment or scene of incident is appropriately quarantined

Governance Department The nominated Risk Officers for Clinical Risk and Non Clinical risk are responsible and accountable for:-

Facilitating the effective application of the incident reporting policy and associated policies and procedures, supporting staff and managers alike.

Reviewing both non-clinical and clinical incident web reports and incident forms received, in order to obtain an overview of the action taken.

Ensuring appropriate escalation through the Director of Governance or nominated deputy to Medical Director or CEO of any red (high) graded incidents

Monitor the ‘open’ incidents on the Datix web system until evidence of investigation and action submitted online

Ensuring where necessary that statutory bodies have been notified within the appropriate timescales.

The transfer of data to external databases as appropriate e.g. NPSA, MHRA

Analysing incidents and producing relevant reports to encourage and monitor appropriate actions are taken to reduce the risk of a recurrent incident.


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Liaising with the Patient Relations Department and the Legal Services Officer to inform them of any potential claims and complaints arising from incident report forms

Identification and delivery of corporate training needs, developing training criteria and training programmes and delivery of Risk Management, Health and Safety and incident reporting training programmes to identified staff

Notification of the Health and Safety Executive, of any RIDDOR reportable incidents (See Appendix 2)

Liaison with incident reporters regarding appropriate grading of an incident. Production of regular and ad hoc reports as requested on incidents and action plans

where appropriate to the Divisional Governance meetings, The Patient Safety and Quality Committee and the Governance, Compliance and Risk Committee

Head Of Patient Safety

Provides an operational link between the incident, complaints and claims management systems and has management responsibility as lead officer for the Trusts Datix Risk management system. They:-

Are responsible for day to day management of Clinical risk functions, liaising with Medico legal and Patient Relations services as appropriate Ensures that systems are in place to ensure action plans for incidents are submitted to and reviewed at the by the Patient Safety and where appropriate the Governance Compliance and Risk Committee or other suitable delegated Committee

Ensures that serious incidents are notified to the Director of Governance or nominated deputy and that a panel of investigation is appointed in accordance with this policy.

Ensures records of Serious incidents investigations are kept and updated Ensure systems are in place and functioning to provide submission and collection of

incident data and to provide internal/external reports. Head of Health Safety

Are responsible for day to day management of non - Clinical risk functions, liaising with Medico legal services as appropriate. Ensures that systems are in place to ensure action plans for incidents and claims are submitted to and reviewed at the by the Health and Safety committee and where appropriate the Governance Compliance and Risk Committee or other suitable delegated Committee

Ensures that serious incidents are notified to the Director of Governance or nominated deputy and that a panel of investigation is appointed in accordance with this policy.

Ensures records of Serious incidents investigations are kept and updated Ensure systems are in place and functioning to provide submission and collection

of incident data and to provide internal/external reports.


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Complaints Department

Ensure that complaints are graded, recorded and investigations and responses are carried out appropriately.

Provide regular update reports to the Patient Safety and Quality Committee and Trust Board

Medico legal department

Claims are assessed and graded by the medico legal team who ensure appropriate levels of investigation occur. They notify relevant external bodies where appropriate, and, if applicable, monitor implementation of action plans.

Provide regular update reports to the Patient Safety and Quality Committee and Trust Board

All Staff There is a general requirement for employees:-

To take care of themselves whilst at work and not put patients or colleagues at risk by any act or omission on their part.

To cooperate with their employer to enable their employer to comply with their statutory duties.

To bring to the notice of their line manager any workplace health and safety risks , incidents

Work to resolve any concerns expressed by patients, their representatives, visitors or other people concerned with the work of the Trust

Escalate to their managers and Pals, any concerns which cannot be resolved locally or where the complainant indicates that they wish to make a complaint

Following an incident employees are specifically required to:- where possible, make the situation safe for themselves and others bearing in mind

the retention of evidence and possible crime scene or scene of investigation

perform any treatment or first aid where competently trained to do so following an incident

summon appropriate support where able following an incident

complete an incident report form including the grading section via Datix web reporting (Appendix 1) or incident form within time-scales described in the main procedure (this applies any member of staff who has knowledge of a particular incident or event or who witnesses such an event.)

Provide a statement of events when requested by officers investigating an incident, Complaint or claim

Governance, Compliance and Risk Committee The Governance, Compliance and Risk Committee is the Trust Board sub-committee with overall responsibility for risk management. The Committee meets six times a year with the purpose of ensuring appropriate clinical, non-clinical and corporate governance, compliance and risk management arrangements are in place.


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The committee leads on ensuring implementation of both the Risk Management Strategy and monitoring the risk management objectives and performance. It also reviews the risk register at each meeting and the Trust receive an update on risk every month and a review of the risk register quarterly. Patient Safety & Quality Committee The Patient Safety & Quality Committee is responsible for overseeing incidents, claims and complaints activity and reports to the Governance, Compliance and risk committee. It monitors themes and trends of incident reporting, claims and complaints (complaints now quarterly) via a monthly Patient safety report. Action plans resulting from SUIs are monitored for implementation via this committee. This committee is responsible for approval of policy documents related to patient care. Infection Control Committee The Infection control committee are responsible for overseeing the incidents and complaints related to infection control. The Committee reports to the Governance and Compliance Risk Committee. Healthcare Environment Committee This committee oversees incidents related to health and safety issues and other and non clinical issues within Trust. The committee reports to the Governance, Compliance and Risk Committee. Health and Safety Committee The Health and Safety Committee has responsibility for the health, safety and welfare of Trust staff and its users. It was convened under the Safety Committees and Safety Representatives Regulations 1977, with members from recognised Trade Unions (safety representatives) and Joint Staff representation. The committee reviews themes and trends of non clinical incident reporting, RIDDOR reportable incidents and claims related to health and safety claims. The committee is responsible for approval of health and safety related policies. 6. Policy Statements

6.1 General statement on the Incident, Complaints and Claims Reporting and Investigation Policy North West London Hospitals NHS Trust considers incident and near miss reporting investigation and analysis of incidents complaints and claims to be the foundation of an effective risk management system. The systems in place for incident reporting and incident complaints and claims investigation provide the Trust with tools by which to identify problems implement changes and measure improvement. The Trust promotes the development of a positive safety culture requires the creation of an open


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environment in which healthcare professionals can feel safe and confident to report adverse events and near misses. 6.2 Statement on culture of openness The Trust encourages a culture of openness within the organisation through continuous support and feedback to staff involved in incidents. The Trust realises that it is important that staff understand that the purpose of reporting an incident is not to apportion blame to any individual or group of people, but to identify problems and to remedy them. Without an open culture, the reporting of inappropriate care or the reporting of incidents may not take place and it may be difficult to learn lessons thus preventing similar situations. In addition and in support of this policy the Trust has a Whistle blowing Policy which provides an alternative avenue for staff to report inappropriate care if they do not feel confident to report matters through the normal incident procedure. 6.3 Statement on Fair Blame The Trust advocates a fundamental principle of Fair Blame. The Trust accepts that many incidents, complaints and claims are caused by a combination of system failures and seeks not to apportion individual blame without just reason. The Trust always seek to improve its standards of risk management following any incident, complaint or claim which on investigation concludes deficiencies in the provision of training, equipment, guidelines, etc., or recommend changes in working practices. If the circumstances surrounding an event are such that one or more members of staff are to be the subject of a disciplinary investigation or hearing, this is conducted in accordance with the Trust’s established disciplinary procedures. The Trust advocates use of the NPSA incident decision tree which is designed to guide managers and ensure a fair and consistent approach with staff. 6.4 Principles of effective communication, data protection & Caldicott Principles Good communication is central to all aspects of incident, complaints and claims reporting and investigation. In the majority of cases the Trust must comply with Caldicott data protection and information governance requirements. When reporting serious incidents individuals must not be referred to by name or give other identifiable information and must restrict access to patient information by enforcing a strict need to know basis for example the content of some reports must not contain the names of the practitioner or the patients. Person identifiers must be documented separately. However in the interests of public interest it may be necessary to identify an individual for example in making a safeguarding alert. Whether communicating with staff or patients and their families and carers, it is a fundamental part of the common core. It involves listening, questioning, understanding and responding to what is being communicated by the investigating staff.


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It is important to be able to communicate both on a one-on-one basis and with other team members and other members of the investigation team. Communication is not just about the words used, but also your manner of speaking, body language and, above all, effective listening. To communicate effectively it is important to take account of culture and context, for example where English is an additional language. Effective engagement of staff in the processes for reporting and investigation requires consultation. A key part of effective communication and engagement is trust, between those involved in the investigation. Managers and those involved in the investigation process must remember that information given to them in order to carry out the investigation is on a need to know basis. Information must not be discussed with anyone outside of that individual incident complaint or claim process and confidentiality should be maintained as far as is possible. Information should only be passed on to managers where there could be an adverse effect on patients or staff by failing to do so e.g. where the investigation concludes that a member of staff had not had training, where a staff member has not acted in accordance with that expected of their role. 7. Policy Development and Consultation This policy was developed by the Director of Governance in conjunction with the Governance and Patient Relations Department and key Trust risk committees. It was circulated to members of the Patient Safety and Quality and Governance, Compliance and risk committees for comments and appropriate amendments made before ratification. 8. Policy Implementation This policy is uploaded to the Trust Intranet. Staff are advised of any new policy version by the Trust’s Internal Communication system, In Brief. The policy is further disseminated through discussion at Trust Induction and via incident reporting training provided as outlined in the training needs analysis. 9. Policy Monitoring, Review and Archiving Compliance with this policy will be monitored by the Patient Safety and Quality Committee and reported up to the Governance, Compliance and Risk Committee via the minutes and reporting template. This provides Board assurance. In addition the Board receive a monthly review of SUI, RIDDOR and Security incidents and quarterly report in respect to Complaints. An Incident and Safety report is produced by the Director of Governance presented to the Board monthly. This report monitors the requirements for SUI reports and associated timescales. A similar report is produced quarterly by The Director of Nursing for the monitoring of Complaints.


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Incident final reports include information on

process for compiling report and investigating the incident

Involving and supporting staff, patients and others Reporting to external agencies

Action plan

Complaints reports include

The number of complaints received in the quarter/ year and the Trust performance in handling them

The number of complaints the Trust decided were upheld

The number of complaints referred to the Parliamentary and Health Service Ombudsman

The report will also summarise:

The subject matter of complaints the Trust received

Actions taken to learn from complaints and to improve services as a consequence of those complaints

Other monitoring mechanisms include,

Audit of the Datix and SUI process by the Internal Auditors as agreed by the Audit Committee

The Trust’s Executive Committee receive monthly information from the incident, complaints (weekly Executive complaints summary is provided as well as quarterly reports) and claims systems for analysis and review

Each Division will directly receive reports from Datix and is expected to analyse and monitor these reports locally for Clinical Governance meetings

The Patient Safety and Quality Committee receive a monthly patient safety report, produced by the Head of Patient Safety and Quality which includes information related to patient safety events

Staff Training is monitored by the Education and Training Department in accordance with the Trust Policy for Induction and Statutory and Mandatory Training. The policy is to be reviewed in 2013; at each review all relevant comments from key risk management committees are incorporated. Amendments are undertaken by the Director of Governance. If monitoring indicates mechanisms outlined in the policy are not being complied with or are failing to address issues, the policy may be reviewed earlier. The policy may also be reviewed as a result of recommendations from approved bodies or the introduction of new legislation. Revised versions of the policy will be uploaded to the Trust intranet following ratification and an archived copy kept in line with Trust Policy.

The policy may also be reviewed as a result of recommendations from approved bodies or the introduction of new legislation. Revised versions of the policy will be uploaded to


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the Trust intranet following ratification and an archived copy kept in line with Trust Policy.

10. Specific Incidents, complaints and claims 10.1 Incidents, complaints and claims relating to Safeguarding Children Any incident, complaint or claim which specifically relates to a child protection concern is also sent to the Named Doctor and/or Nurse for Child Protection and the Executive Lead for Safeguarding Children. 10.2 Incidents, complaints and claims relating to an Adult at risk Any incident or complaint which relates to the possible abuse of an adult at risk should be sent to a Trust designated and responsible for safeguarding adults at risk (Responsible) Manager who will assess the incident or complaint and decide whether the Adult at Risk Policy needs to be invoked. 10.3 National Cancer Screening programme incidents Any significant / major failures (e.g. fire, flood, effects to service greater than two days, significant pathway deviations and or sustained loss of service) in the screening services should be reported to the Director of Governance who will then inform the QA Director for the specific programme at the SHA. Risk categories are defined by specific programmes and include minor, intermediate, major and fatal. The Director of Governance and the programme lead, for the trust, will then initiate the relevant screening programme management of incident guidelines, referenced in Appendix 2.If unsure regarding categorisation and requirement to inform the Director of Governance, please contact either the Director or the Patient Safety Department for clarification. Refer to appendix 9 Decontamination Incident management flowchart and key screening Trust contact list. Appendix 8 lists key areas of the organisation and the contact person for information or advice with an incident or identified risk. 11. Incidents, complaints and claims – Reporting and Immediate action 11.1 Claims The immediate action on receipt of a claim differs from that required for a complaint or incident in that it is often sometime since the original event. The Medico Legal Services undertakes an initial review of the facts to determine the level of risk (as shown in section 12) and establish if there may be any residual risk. This is followed by gathering of information, statements for investigation. 11.2 Incidents and complaints Following an incident or complaint the immediate needs of the patient, member of staff or visitor must be attended to and remedial action must be taken to re-establish a safe environment. An incident form must be completed via Datix web by the person involved immediately following any incident. The Datix system allows for designation of an incident handler, this is usually the Departmental Manager, Matron, lead Consultant or General Manager


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will ensure all immediate action required has been undertaken and is documented. Any incidents categorised as High Risk (Red) (grade 5 / SUI) must be verified by the Line Manager or the person in charge immediately following the incident. The line manager must reassess the grade and where the incident grade remains high notify the Governance department as soon as possible. Where the incident is out of hours see section 13. A panel investigation will be undertaken for all SUI incidents.

Any complaints received which are considered to be high risk as defined by the Trust’s Risk matrix are notified to the Director of Nursing and Medical Director by the Patient Relations Manager. Where possible all evidence must be retained intact (subject to infection control procedures) and in safe keeping for examination and any defective equipment, drugs or other materials withdrawn from use.

The incident or complaint must be communicated to the relevant clinician or manager who will undertake an investigation as described in section 14. An incident Datix web report form must be completed for incidents as appropriate. Where the event was a staff accident and there were witnesses present witness statements must be obtained. Witness statements must also be obtained where applicable for all moderate and red graded events. Witness statements must be obtained at the earliest opportunity. 11.3 Being Open The Being Open Policy must be followed for any incident, complaint or claim. Where the Being Open Policy indicates, the patient's clinician or the clinician's delegated representative must inform the patient or next of kin and fully document this in the relevant record. The media must not be informed without the patient or next of kin first being informed of any incident. 11.4 Supporting staff involved in any incident, complaint or claim All staff are supported as appropriate by their line manager Staff involved in a traumatic or stressful incident (usually grade 5 or SUI) are supported by the line manager involved following the Supporting Staff Policy. 11.5 Incidents involving more than one provider organisation If more than one organisation is involved in a serious incident the organisation that identified the incident may make the initial notification to the PCT and other external agencies. Wherever possible this organisation must first make contact with the organisation where the incident originated. The lead organisation must be identified at this point with the others involved and clear roles and responsibilities agreed. Once the lead has been agreed STEIS or local serious incident management systems need to be updated / closed.


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11.6 Process for involving and communicating with external/internal Stakeholders and of sharing lessons learnt As appropriate, information should also be communicated to external stakeholders in order to ensure appropriate involvement in the investigation and to share lessons learnt from incidents, complaints and claims. e.g. Primary Care Trust (PCT), Strategic Health Authority (SHA), MHRA, National Patient Safety Agency (NPSA), and Health & Safety Executive (HSE). The GP will be notified by the relevant Department as appropriate. Incidents & Claims - The Director of Governance or nominated Deputy is responsible for ensuring the appropriate responses to external stakeholders this may be verbal information but it is advisable to follow up with written clarification. For guidance on external agencies see Appendix 2. Complaints- the Patient Relations Manager is responsible for ensuring processes for complaints as described in the Complaints policy. Some information relating to incident and external stakeholders may be provided electronically via agreed data submission. 12. Incident, complaint or claim grade and score

Not all patient safety events need to be investigated to the same extent or depth. Categorising incidents, complaints and claims according to the actual impact and the potential future risk to patients/ visitors/ staff and the organisation establishes the level of local investigation and causal analysis that should be carried out. Incidents Ward/Departmental Managers/Supervisors are responsible for grading the incident, within 24hrs of the incident occurring, using the incident categorisation matrix below. Complaints The Patient Relations team will register complaints on DATIX and carry out an initial risk grading .This will inform the investigation process including the level of investigation which is initiated. If, following investigation, a complaint is more, or less, serious than initially perceived, the risk grading can be altered. If the complaint raises issues that the Patient Relations team are unable to risk grade, the complaint will be escalated to the divisional lead. Claims Claims are categorised by the medico legal team using the matrix below. Categorisation of claims usually informs the financial and safety risk to the organisation.


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To categorise the patient safety event first, select the Most Likely Consequence or outcome of the incident/complaint/claim.

What is the actual impact of the incident, complaint or claim? Is it catastrophic, major, moderate, minor, or insignificant?

Secondly, identify the likelihood of a recurrence of the event. How likely will it happen again?

potential degree of harm with the actual degree of harm that occurred as this can affect the way in which the incidents are reported to the NPSA for example grading near misses (where no harm occurred) as severe harm.

degree of harm not the potential. Where a patient dies following a patient safety incident grading must reflect

whether the patient’s death was directly attributable to the incident.

In terms of scoring incidents, complaints and claims the following grades are attached to particular scores within the matrix:-

Very Low Risk Grade 1-3

Low Risk Grade 1-3

Moderate Risk Grade 4

High Risk Grade 5 / SUI

1-3 4-6 8-12 15-25

13. Actions to take following grading of a Patient safety event (Reporting and Lines of communication)

13.1 RED – HIGH RISK - grade 5 or SUI Incidents Incidents of this severity are subject to full Root Cause Analysis investigation and are completed within NHS London defined reporting deadlines. It is recognised that the effort involved in investigating this severity of incident that have not resulted in harm may sometimes be less than that required for those resulting in harm. The Medical Director (or nominated deputy) in conjunction with The Director of Governance and/or nominated Deputy, identify an individual to co-ordinate the review and also a panel chair. Complaints If a complaint is risk graded as High risk and events complained of are defined as a SUI, the complainant is acknowledged and informed of the investigation process for SUI. The complaint is then forwarded to the Clinical Governance team and The Medical


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Director, Director of Nursing (or nominated deputy) in conjunction with the Director of Governance and/or nominated Deputy, identify an individual to co-ordinate the review and also a panel chair. (Please refer to the Complaints policy)

During normal working hours:

Inform the Governance / Risk Management team and Patient Relations Manager as soon as is practically possible with details of the incident or complaint

Out of Hours:

Inform the Site Practitioner, who informs the on call General Manager and Executive Director; immediate action(s) are then agreed.

Clear factual records of all detail (including times and dates) must be kept locally and centrally by those dealing with the incident.

The patient/relative must be spoken with immediately by the most senior clinician available and/or lead investigator to receive an explanation of the incident and how the Trust will investigate it.

It is the responsibility of the lead investigator to inform the Governance and Risk Department of the incident and any actions taken at soon as possible.

OUT of hours- Executive Director on call takes the following action:

Manage the incident or delegate its management to an appropriate person

Ensure the patient's clinician has informed the patient or relatives, this must be done before any media are informed of the incident.

Provide an update to the Chief Executive and escalate to the PPCT and NHS London as appropriate

Ensure as applicable that all media enquiries are handled according to Trust Policy.

Liaise with the Governance department within normal hours to ensure that relevant stakeholders are informed of the incident/event.

Establish a ‘hotline’ if required (see Appendix 3)

Ensure that all documentation and equipment is gathered and securely stored.

Inform as necessary other relevant individuals/departments e.g. Occupational Health, Human Resources.

An investigation panel is nominated & convened by the Chief Executive or Medical Director

See Appendix 5 for Standards for the Panel Investigation of RED incidents (Appendix 7 provides advice on witness statements and incident management).

Gathering of evidence and obtaining statements should be undertaken as soon as possible when events are fresh in people’s minds and when staffs are still allocated in the area. Where witnesses are recorded, statements must be provided for all moderate and red investigations to substantiate the facts.


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Witness statements must also be obtained and provided to any witnessed staff accident/incident resulting in a RIDDOR.

13.2 AMBER – MODERATE RISKS – Grade 4

During Normal Working Hours, immediately report to: - For clinical incidents,

The Senior Nurse and Consultant in charge of the patient. In the event of a non-clinical incident –

Seek assistance from the departmental manager and report the incident via Datix web reports.

The Senior Manager will complete the appropriate documentation and obtain witness statements if required.

Senior Managers should seek advice from the relevant Executive Director in the event of any doubt or queries concerning the management of the incident.

Outside Normal Working Hours, immediately report to:- For clinical incidents:

The Site Practitioner/Ward Manager who will inform the Senior Medical Staff on duty. The Site Practitioner and senior clinician on duty liaise to decide whether the incident needs reporting immediately to the Consultant in charge of the patient. If the decision is that the incident does not need to be relayed to the Consultant immediately provision must be made to inform them at the earliest opportunity.

In the event of a non clinical incident, e.g. Major Electrical supply loss, loss of Medical Gas Supply

Contact the Site Practitioner who will decide whether or not to contact the Facilities / Estates Services on Call.

The Site Practitioner will contact the Senior Manager on call as appropriate.

The Governance department Risk Management leads must be informed of the incident at the next practical opportunity within hours.

The Senior Manager on call will take the following action: -

Manage the incident or delegate its management to an appropriate person.

Provide an update to the Executive Director on call as appropriate / necessary. It is the responsibility of the person in charge of an area/department to complete the local investigation and ensure all necessary immediate remedial action is taken and complete the documentation in the management section of the Incident reporting form via Datix web reporting.

13.3 YELLOW / GREEN – LOW RISK - Grade 1-3 Incidents It is the responsibility of the person in charge of an area/department to complete a local investigation and ensure all necessary immediate remedial action is taken and complete


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the documentation in the management section of the Incident reporting form via Datix web reporting. Claims Following the grading of a claim the legal team will start the investigation process as stated below. 14. Investigating Incidents, complaints and claims Adverse incidents and events must be given an appropriate level of investigation and application of root cause analysis in order to identify the true reason for the problem. Not all incidents, complaints or claims need to be investigated to the same extent or depth. However all complaints and claims are required to be investigated to the level that provides the complainant / claimant with a comprehensive/full response. Having assessed each event against the risk grading matrix, the amount of investigation and analysis effort should be expended in relation to the risk category. See following section for guidelines on amount of time to be spent on investigation for each grade of event. Green / Yellow (low) grade 1-3 Incidents An aggregate review should be undertaken and investigated locally by the ward or dept manager. Data should be reviewed by the DMT to identify any trends. These are unlikely to warrant individual investigation, but root cause analysis of trends should be undertaken, perhaps as part of a local working group, and a preventative risk management strategy established to prevent recurrence. Local actions should be documented on the incident form.

Complaints and Claims Complaints and claims graded as low will still need to be fully investigated so that a response can be made to the claimant or complainant. This includes notifying the relevant department manager and collecting witness statements as outlined in both the complaints and claims policies. For complaints the nominated lead investigator will have responsibility of the actual investigation but the Patient Relations Manager facilitates the investigation process. For claims the legal service Manager still has overall responsibility of the investigation. Amber (moderate) grade 4 Incident A root cause analysis should be undertaken to identify contributor factors leading to the incident. The use of experts may be relevant in order to learn lessons and to identify actions required. These are managed locally and learning points and action plan implementation is monitored through Divisional Governance meetings. The total average time taken in investigation should be no more than 1-3 days. The lead investigator/ investigating officer may find it useful although not essential to use the guidance contributory factors Appendix 6


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Complaints and Claims The process highlighted above under grade 1-3 complaint or claims apply. In addition if any recommendations are made and action plan will have to be completed and monitored by the Divisional governance meeting. If they are trust wide recommendations, the Patient Safety committee will be informed of the recommendations through the divisional exception reports. The Patient Safety Committee will then monitor the implementation of the recommended changes across the trust. Red (high) score grade 5 / SUI Incidents All red incidents will be investigated by a multi-professional panel of staff that have either received full training in root cause analysis or have extensive experience in incident or complaints investigations. Where there is involvement of the police or Counter fraud service or a regulatory or licensing organisation, consultation must take place with the organisation before commencing a local investigation through the Director of Governance or nominated Deputy. The Trust should consider the requirements under the Memorandum of Understanding. Where a local investigation is taking place and it becomes apparent that another investigation is taking place then liaison should take place with the relevant body. Appointment to the investigation panel will be made by the CEO, Medical Director and/or nominated deputies. Standards and timescales for the investigation of red incidents, are detailed in Appendix 5 The Trust has a specific investigation reports and action plan templates for RED incidents and complaints. See Appendix 6. Details and guidance on Witness statements can be found in Appendix 7. All investigation reports on RED clinical incidents are reported to the Trust Board and action plans monitored through the Patient Safety and Quality Committee. See Appendix 6 for list of possible contributory factors which must be considered when carrying out an investigation. In addition the NPSA Incident Decision Tree must be considered to ensure fair blame. Available at: https://report.npsa.nhs.uk/idt2/(S(ursyah45cpm3kde3bqhwca45))/login.aspx STEIS reportable incidents (SUIs) Serious Untoward Incidents must be managed and reported in line with NHS London’s SUI reporting Policy http://www.london.nhs.uk/webfiles/Corporate/Serious%20incidents/NHSL%20Serious%20Incident%20Policy%20November%202010.pdf

They should also be reported to the relevant host Commissioner.

https://report.npsa.nhs.uk/idt2/(S(ursyah45cpm3kde3bqhwca45))/login.aspx




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14.1 Investigation procedures and general guidance Complaints

For complaints the lead investigator informs the Patient Relations team if there is a potential delay in resolving the complaint, with the reason for the delay, so that the complainant can be notified of when they can expect a response. However, in line with the 2009 statutory regulations1 all complainants obtain a written response within the negotiated timeframe of the complaint.

Complaints graded as moderate or high risk must have an action plan in place to manage the risk or prevent a recurrence. Divisional leads must ensure that action plans are written, in collaboration with the named investigator, general or service managers and clinicians. These action plans are recorded electronically via the shared drive

Once the complaint response is completed and the complaint is deemed to be

upheld, the lead investigator will ensure that the action and learning plan is developed, and shared with the Patient Relations Team and other appropriate staff.

Completion of action plans relating to Parliamentary & Health Service Ombudsman review is monitored by the Patient Safety & Quality Committee. Other action plans are monitored by divisional governance boards, with feedback to the Patient Safety & Quality Committee.

Incidents

Where work required to prevent the incident happening again is not immediate an action plan is required. A copy of the initial action plan should be sent to the Patient Safety and Quality Department. Following investigation of a moderate Incident the action is monitored by the Patient Safety and Quality Committee. For red Incidents the action plan will be submitted with the final report to the Patient Safety and Quality Committee as well as the Trust Board.

In relation to actions which may have significance across a number of departments, or divisions completed action plans will have the evidence and any related new documentation embedded within the electronic plan for future reference.

Contributory factors leading to a moderate/red incident will be identified and an action plan learning the lessons will be prepared and implemented. The action plan will be monitored and signed off by the relevant manager when all actions have been completed. A copy of this should be returned to the Head of Patient Safety for the central file.

1 The Local Authority Social & NHS Complaint (England) Regulations 2009.


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When an investigation starts and at periods during the investigation it is good practice to use the NPSA incident decision tree. This can help managers and clinicians to decide whether it is appropriate to suspend staff from duty following an incident and to consider alternatives and other possible measures as the investigation continues. The incident decision tree is a web based tool and is available :https://report.npsa.nhs.uk/idt2/(S(ursyah45cpm3kde3bqhwca45))/login.aspx

Where patient safety has thought to be compromised due to concerns about performance of an individual the correct Human Resources policies relating to conduct and capability must be followed by the relevant managers to ensure fairness and consistency across the organisation. In addition external reporting to professional bodies and or other agencies needs to be carried out where applicable.

14.2 Meeting with staff, patients and relatives directly involved in the incident or complaints or Claims. Consideration should be taken of the Trusts policy for Being Open. If a meeting is arranged with the person directly involved in the patient safety event in, the Lead Investigator/ Investigating Officer or Legal service manager ensures that an appropriate time and setting for the meeting has been arranged, that enough time for discussion has been allowed, that the person involved in the event has been advised they can bring a friend, relative or member of an advocacy service to the meeting, and that the relevant Trust personnel are present at the meeting. The Lead investigator Investigating Officer, within 4 weeks maximum of the meeting, provides a written record, summarising what was said and agreed, in the form of a letter to the person involved in the patient safety event. Meeting minutes are written and sent to the person involved for their approval re: accuracy and completeness. Any suggested amendments are made and a final copy sent to the person. 15. Investigating Serious Complaints Serious clinical complaints are dealt with by way of in the establishment of an investigation panel and production of a report and action plan overseen by the Patient Safety and Quality committee. Serious complaints would be defined as those in which there have been allegations of a major departure from accepted standards of diagnosis, treatment or care. See Appendix 5 for Standards for the Panel Investigation of RED incidents, complaints or claims. Note: This appendix also includes advice on witness statements, format of report and template for action planning, possible contributory factors which give rise to the event.

https://report.npsa.nhs.uk/idt2/(S(ursyah45cpm3kde3bqhwca45))/login.aspx


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16. Investigating Serious Claims The processes for investigating serious claims differ from that of complaints or incidents in that they are at this point subject to litigation and therefore led primarily by the Medico Legal Manager and where applicable the Trusts solicitors. Investigation/witness statement gathering will be required by the Trust or solicitors. Claims may have been previously reported and investigated as an incident or complaint and this is identified by the Medico Legal Services Department on receipt of the claim. The Medico Legal Services Manager brings to the attention of the Director of Governance and the Head of Patient and Safety & Quality together with the Patient Safety and Patient Safety & Quality committee any relevant learning points and actions required by the Trust following evidence gathering by the Solicitors and subsequent investigation. These action points/ lessons learnt and improvements for claims are discussed at the Patient Safety & Quality committee. Serious claims would be defined as those in which there have been allegations of a major departure from accepted standards of diagnosis, treatment or care or where there has been a major departure from the accepted standards of Health and Safety. 17.Memorandum of Understanding The 'Protocol for liaison between the NHS, Chief of Police and the Health and Safety Executive' is a Memorandum of Understanding which sets out the general principles for the NHS, Police and HSE to observe when liaising with one another. The protocol takes effect in the event of an unexpected death or serious untoward harm, patient safety incident. This will normally be the case if an incident has arisen from or involves

Criminal intent

Recklessness and or gross negligence Or in the context of Health and Safety involves

A work related death or serious injury Guidelines for the NHS in support of the Memorandum of Understanding along with a link to the full Memorandum of Understanding document can be found on the Department of Health website or by clicking this link: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_062975

18. Learning lessons and making improvements as a result of investigating incidents, complaints and claims The Trust requires investigations to be carried out in a timely and thorough way at a level appropriate to the severity of the event in order to use Trust resources effectively and to minimise recurrence of incidents, complaints and claims. Lessons should be learnt both locally and organisationally from the outcomes following investigation. On an individual basis each case investigated in accordance with the severity and action plans put in place to correct any problems or to implement changes as a result. The Trust has a separate policy on Incident, Complaints and Claims Analysis and Improvements which looks at analysis and improvement of data and information as whole.




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The results of Serious Untoward Incident investigations and actions taken must be updated on the STEIS database by the Director of Governance or Assistant Director of Governance.

19. Recommendations and Monitoring of Action Plans After a serious clinical incident, or complaint the recommendations and action plan are presented with the investigation report to the Patient Safety and Quality committee In addition the Trust Board are presented with SUI reports and action plans and sign off the recommendations and action plans, also considering whether further action is required. The Patient Safety and Quality Committee monitor the progress of relevant action plans. The red incident or complaint remains active is not considered closed off until the Committee is assured that actions have been completed. Investigation reports and action plans from serious non-clinical incidents are discussed at the Healthcare Environment and Amenities committee and/or the Governance compliance and Risk Committee and Trust Board, depending upon the nature of the incident. Outstanding action plans form part of the committee’s monthly agenda items, and are required to be presented three monthly until fully implemented The investigation reports from serious untoward incidents reported on STEIS are monitored by NHS London according to their Incident Reporting Policy. Where delays in investigation are unavoidable the Cluster are notified of the reason for the delay via the Clinical Quality Group report. Low graded incidents do not normally require an action plan (complaints do if they are upheld) and immediate actions should be recorded on the web based incident form. Recommendations and action plans from incidents which have been investigated at moderate level Divisional or local level are monitored by the appropriate Divisional or local manager and reported back into any appropriate Committees or Groups e.g. clinical governance meetings. 20. Feed back of Incident, Complaint or Claim Investigation Outcomes Incidents The outcome of investigations into moderate or red investigations is fed back to those who reported the incident and those who were involved in the investigation of the incident. Complaints and Claims A copy of the final signed response letter is sent to the Lead investigator to share with staff involved) or claim. In the case of complaints or claims the patient and their relatives will receive feedback from the response letter or through the legal process. 21. Staff Training and Assistance with Incident, complaint and claim investigation The training for investigation of claims, complaints and Incidents, is as outlined in the Trusts Training needs analysis and enrolling and follow up as described in the statutory mandatory training policy. NPSA e-learning course on Root Cause Analysis


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The National Patient Safety Agency (NPSA) has an e-learning course on root cause analysis which can be accessed at any computer which has an internet link via- http://www.npsa.nhs.uk/patientsafety/improvingpatientsafety/patient-safetytools-and-guidance/rootcauseanalysis/ Follow instructions on using e-learning course provided. 22. Reporting to External Agencies. A number of legal requirements are placed on the Trust to report incidents to external agencies irrespective of the severity of the incident. When reporting to these agencies, a Trust incident report form is required. The responsible department for reporting to the external agency will also complete the relevant submission forms required by the agency. Appendix 2 provides a list of particular incidents and external agencies which need to be informed. The Care Quality Commission is informed of a number of incidents via the NPSA incident reporting system (NRLS) or, where deemed appropriate in relation to the incident severity, by the Director of Governance directly. In addition Serious Untoward Incidents (SUI’s) are reportable to the commissioners and NHS London as described in Section 14.

http://www.npsa.nhs.uk/patientsafety/improvingpatientsafety/patient-safetytools-and-guidance/rootcauseanalysis/

http://www.npsa.nhs.uk/patientsafety/improvingpatientsafety/patient-safetytools-and-guidance/rootcauseanalysis/


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23. References NHS London SUI Reporting Policy NPSA Root Cause Analysis e-learning www.patientsafety.ucl.ac.uk. Vincent CA, Adams S, Stanhope N (1998). A Framework for the Analysis of Risk and Safety in Medicine. BMJ 316 1154-7 Vincent CA, Adams S, Hewett DH et al. (2000) How to investigate and analyse clinical incidents: CRU & ALARM protocol. BMJ320, 777-781 NHSLA Risk Management Standards for Acute Hospitals, NHSLA. 'Memorandum of Understanding: Investigating patient safety incidents involving unexpected death or serious untoward harm - A protocol for liaison and effective communications between the National Health Service, Association of Chief Police Officers and Health and Safety Executive' DoH Feb 2006 Information Resource to support the reporting of serious incident NPSA 2010/09 NPSA Never Events Framework Safely does it – Implementing safer care for Patients Healthcare Commission March 2009 Guidelines for Managing Incidents in the NHS Cervical Screening Programme 2nd Edition NHSCP Publication No 11

Guidelines for managing incidents in the Breast Screening Programme 3rd Edition NHSBSP Publication No 44 Bowel Screening: INTERIM Guidelines for Managing Incidents in the NHS Bowel Cancer Screening Programme - NHS BCSP PUBLICATION NO 7 APRIL 2012

http://www.patientsafety.ucl.ac.uk/


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24. Bibliography None 25. List of Associated Policies

This list is not exhaustive:

Whistle blowing Policy Approved document for the management of a major incident Management of claims Policy Management of complaints Policy Approved document for the management of media relations Health and safety Policy Infection control Policy Risk Management strategy Being open Policy


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Appendix 1

Guide to incident form completion (DIF1) and managerial review(DIF2) (Datix web reporting)

DIF 1 – Incident form completion

Who to contact if there is a problem? In event of queries please contact the Patient Safety Facilitator on ext (1) 3628 the Patient Safety Assistant on ext (1) 2714

What do the red stars mean? The red stars indicate the mandatory fields. The form does not save or submit if these fields are not completed. What do I do if my manager does not appear in the drop down list? There is an option to select ‘Datix Admin’. By selecting this option an alert is sent to Datix Web Incident reporting administrators alerting them of the problem. The incident is reviewed and your manager contacted and invited to attend a training session. By selecting your manager you will be informing them of the incident. The ‘Datix Admin’ option can also be used if you wish to report an incident but do not want your manager to be informed. In this event, the Datix Web administrator reviews the incident and assesses who needs to be informed of the incident. The Datix Administrator also ensures the correct manager is informed of the incident. What are non-clinical incidents and patient safety incidents? A non-clinical incident is what was formally known as a Health and Safety Incident. This includes slips, trips and falls, sharps injury and any violence and aggression incidents. Patient safety incidents are those where a patient’s safety is or could be compromised. How to populate the directorate and speciality fields? If the incident being submitted did not involve a patient, then these fields should be populated with the directorate and speciality of the area the incident occurred. If the incident involves a patient, these fields should be populated with the directorate and speciality the patient was admitted under. How to grade an incident? Information regarding the scoring of risk is found in Section 12 of the Incident, complaints and Claims reporting and Investigating Policy which can be found on the Intranet. This provides information for the reporter to select an initial grading for the incident NB – this is not the final incident grade. Circumstances may change and the original grading could change during managerial review.


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What to do if the hospital number is not known? If the incident involves a patient a hospital number should always be entered. However, if the incident does not involve a patient and therefore a hospital number is not relevant this box should be populated with an X. What to do if the date of birth is not know? If the incident involves a patient the date of birth should always be entered. However, if the incident does not involve a patient the date of birth is not relevant this box should be populated with an X. How to obtain feedback on the incident you have reported? Once the incident has been submitted a reference number will appear and you will also receive an email informing you of the reference number (subject to your email address being entered in the first section of the form). This reference number can then be quoted to the line manager you selected, or to the Risk Department; either of these contacts will be able to provide feedback on actions related to specific incidents where updated on Datix. Dif 2 – Managerial review How do I know when I need to look at an incident? As a manager you receive an email informing you that you have been allocated an incident that needs to be reviewed. Click on the link included in the email which allows you to log on and review the incident. How do I access the incident? There are two options to access an incident. The first is by following the link that is included in the email notifying you that an incident has been assigned to you. By clicking this link you will be taken to a log in screen. When your log in details have been entered you will be taken into the incident from which relates to the email received. The second is by accessing an incident reporting form from the intranet. At the top of the reporting form you can log in. Once you have logged on to Datix web you will need to open the incidents section and select ‘List incidents in the holding area awaiting review’ option. This will then show you all incidents you have been informed of that you have not yet reviewed. Once the incident has been reviewed changing the approval status to ‘still being reviewed – not yet sent for final approval’ will log that you have reviewed the incident. If an incident is not reviewed within 7 days of the incident being submitted, or if the approval status is not changed, the Risk Department will be alerted that an incident is overdue.


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The menu options You will see a number of menu options within the Incident module. These will be:

• Incidents in the holding area awaiting review • Incidents still being reviewed • Incidents awaiting final approval • List incidents with final approval status

The first time an incident is accessed it will be located in the ‘Incidents in the holding area awaiting review’ option. When an incident has been acknowledged or the ‘save to approve later button’ is selected the incident automatically moves to the ‘Incidents still being reviewed’ option. The incident remains here until next time it is accessed. Once and incident investigation has been completed or the ‘Approve’ button is selected it automatically moves in to the ‘Incident awaiting final approval’ option. When the incident has reached this stage the Datix Administrator reviews the incident. If further information is required the Datix Administrator will contact the handler/ investigator and the incident is moved back to the ‘Incidents still being reviewed’ option. If the Datix Administrator reviews the incident and no further information is required the incident will be closed and moved the ‘List incidents with final approval status’ option. Only the Datix Administrator can moved incidents to this option. Incidents can be accessed by the handler at all stages including when an incident has final approval status.


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36


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What do the different screens do? There is a menu down the left side of the form. Each screen on this menu holds a different tool for a full incident investigation. The details screen and investigation screens are covered above. The feedback screen – this screen can be used to feedback investigation results or to communicate with the handler (using the drop down box) or to other members of staff (using the free text ‘additional recipients’ field) to provide an audit trail. All emails that are sent using this screen are saved to the incident. Equipment and medication screens – this will be automatically populated from any equipment and/or medication entered on the Dif 1 form. Documents screen – this screen allows you to attach any type of document to the incident that has been saved to your PC or drive. Notification sent screen – this screen gives a full list of all staff that have been informed of this incident. Print screen – this screen will allow you to print the entire incident including all screens listed above. NB – Printed or paper incident forms should not be filed in medical records.


Appendix 2

Reporting to External Agencies

A number of legal requirements are placed on the Trust to report incidents, complaints and claims to external agencies irrespective of the severity of the event. When reporting incidents to external agencies, a Trust incident report form is required. The responsible department for reporting to the external agency will also complete the relevant submission forms required by the agency. Medicines and Healthcare Products Regulatory Agency (MHRA) The Patient safety department will report adverse incidents to the MHRA when the incident involves a medical device. An adverse incident involving a medical device is defined as ‘an event, which causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, users or other persons’. The Pharmacy department will report any suspected Adverse Drug Reactions (ADR). Where medicines are involved, reports should be made where a clinician suspects that there is a causal link between the medicinal product and the suspected reaction experienced. Serious adverse reactions or events related to blood transfusion are reportable to the MHRA. These incidents are reported via the Pathology Department manager. . Health and Safety Executive (H.S.E.) The Health and safety department will report injuries or harm to the Health and Safety Executive under RIDDOR. This is a legal requirement that requires the reporting of work related accidents, diseases and dangerous occurrences. It applies to all work activities, but not all incidents. Patient accidents will be reported when significant injury (not related to healthcare) has occurred to the patient. In addition any events leading to accidental death or serious harm to staff, patients or visitors on NHS premises or involving NHS equipment are reportable to the H.S.E. including screening and immunisation/radiation errors serious injury or unexpected deaths of any individual to whom the organisation owes a duty of care including staff visitor, contractor or any other person. When reporting any of these incidents also consider the need to report to the Coroner and Police. National Blood Transfusion Service Where there has been an incident or substantiated complaint or claim following transfusion of blood and/or blood components, it will be reported by pathology department under SHOT – Serious Hazards of Transfusion. It will also be required to be reported to the NPSA and it may also be necessary to report the incident to the Medicines and Healthcare Products Regulatory Agency (MHRA). Consideration should also be given to reporting to the European Blood Safety Directives/Blood Safety Regulations (BSQR). National Patient Safety Agency (NPSA) The Governance Department report all patient incidents to the NPSA, irrespective of the severity. This is undertaken using a direct electronic link from the Trust’s incident


reporting system. Incidents are reported through the National Reporting and Learning System (NRLS) to the National Patient Safety Agency (NPSA) that produces feedback reports and benchmarking statistics. The NRLS reports are reviewed at the Patient Safety and Quality Committee. Strategic Health Authority (SHA) The Governance department report all serious untoward patient incidents to the Strategic Health Authority in accordance with STEIS guidelines by way of completing an electronic report form to their Strategic Electronic Incident System (STEIS) this includes serious untoward information governance incidents. NHS Protect – formerly Counter Fraud & Security Management Service (NHS CFSMS) The Local Security management Specialist reports any staff incidents involving violence and aggression to the above authority in accordance with the guidance produced. All occasions where the Trust Emergency Plan/Major incident plan is invoked should be reported to NHS Protect this includes any terrorist threats or incidents, potential or confirmed chemical, biological radiological or nuclear incidents. In addition reporting should take place where there is suspicion of fraud, malicious activity such as tampering with equipment, serious damage to Trust property or serious disruption to services i.e. such as evacuation of patients due to fire. When reporting incidents consideration is given to informing the PCT/SHA, police, Local transport Services, Local Ambulances Service. In cases of terrorism consider informing the Armed Forces and Ministry of Defence. Health Protection Unit The Control of Infection Team will report to the Health Protection Unit any matters relating to outbreaks of infections, communicable diseases and notifiable infections. In addition consideration should be given to reporting communicable diseases and health protection incidents to the Health and Safety Executive, Police, Local Council, other healthcare organisations and other local bodies such as age concerns and local Transport Services. CEMACH The Maternity unit report any maternal, stillbirth or neonatal death (within 12 months of birth) to the NHS Confidential Enquiry into Maternal and Child Health. Adults at Risk Any incident which relates to the possible abuse of a vulnerable adult is reported by The Trust designated Safeguarding Adults lead, Deputy Director of Nursing to the Borough Safeguarding Adults Team. In addition abuse of an adult is reportable to the CQC via the NPSA reporting system consideration is also be given to reporting adult abuse events to the police and social services and other partner agencies. Safeguarding Children The Trust’s Safeguarding Children’s lead report relevant paediatric events to the local Children’s Board and relevant Local safeguarding Boards.


Consideration should also be given to notifying Education Authority, Health Visitor, School nurse, Centre for maternal and Child Enquires (CMACE), Confidential Enquiry into patient outcome and death (CEPOD). Professional Bodies Advice on reporting to Professional Bodies should be sought from the Director of Nursing in relation to Nurses; the Medical Director/Executive Director of Human Resources in relation to Medical Staff; the Professional Head of Department/Executive Director of Human Resources in relation to all other professions. Radiation Protection Incidents complaints and claims involving Ionising radiation should be reported and investigated in accordance with this policy. In addition they should immediately be reported to the Senior Superintendent Radiographer who will inform the Radiology Manager and the Radiation Protection Supervisor. They contact the appropriate external body i.e. CQC, Health & Safety Executive. (The Trust’s IRMER guidelines should be consulted) National Health Service Litigation Authority (NHSLA) The Trust must report claims in line with guidance from the NHSLA Summary of NHSLA Clinical Negligence Reporting Requirements

Report relevant cases to the NHSLA within 2 months of request for records or sooner if event is serious;

All letters of claim and Part 36 offers to be notified to the NHSLA immediately;

Acknowledge letters of claim within 14 days;

Detailed response due within 3 months;

All legal proceedings to be notified immediately. Information Commissioner Major Breaches of confidentiality such as the loss or theft of personal identifiable records or information including missing case notes or incidents involving the actual or potential loss of personal information which could lead to identity fraud should be reported to the CQC via the NPSA reporting system the information Commissioner and the police if applicable. The SIRO is responsible for these incidents. Care Quality Commission (CQC) The Care Quality Commission requires the reporting of certain events to them. For Acute Trusts this is undertaken using the NPSA reporting system. There are a number of events directly reportable, which include;

Homicide committed by an individual in receipt of mental health and or learning disabilities.

Action of a patient which results in serious harm or injury to staff or which place the lives of staff members in serious danger, staff death or serious injury, a member of staff is a victim of abuse.

Coroner Events reportable to the Coroner are:-

Clusters of unexplained or unexpected deaths

Maternity, maternal deaths neonatal deaths and unexpected still births


Suicide of any patient currently in receipt of NHS Services on or off NHS premises or who has been discharged within the last 12 months.

Grade 3 or above pressure sores present on a deceased patient In addition

Any events leading to accidental death to staff, patients or visitors on NHS premises or involving NHS equipment.

Situations where a patient has required additional interventions as a result of failures in the assessment or diagnosis process

Death where foul play is suspected

Abuse that has been perpetrated within the remit of the organisation, this may be abuse by a member of staff visitor or member of the public

When reporting to the Coroner it should also be considered whether reporting to professional bodies, local supervisor of Midwives and police is appropriate. Commissioners Local commissioning bodies must be informed of any incidents which occur which are listed as Never events. In addition Serious Untoward Incidents are to be entered onto the STEIS database system and should also be notified. Professional Bodies and National Clinical Assessment Service Consider reporting incidents, complaints or claims which identify concerns about individuals or where there is a risk of adverse media interest.

Any serious criminal acts involving patients or staff

Suspicion of serious error or errors by a member of staff

Where a member of staff is suspected of abusing or harming patients

A serious drug error such as mal administered spinal injections

Where professional competence is in question (use the incident decision tree to determine whether competence was a causative factor)

A serious breach of confidentiality

Where a member of staff is suspected of committing serious fraud (also report to NHS Protect )

Where a member of staff shows gross disrespect for the dignity of a patient/deceased patient

National Cancer Screening programme The lead investigator for the cancer screening programme should ensure they follow the relevant guidelines for managing the incident: Cervical Screening, Cervical Screening Programme Publication No 11 F000130_Guidelines for Managing Incidents in the NHS Cervical Screening Programme.pdf Breast Screening Guidelines for managing incidents in the Breast Screening programme Publication No 44 Bowel Screening: INTERIM Guidelines for Managing Incidents in the NHS Bowel Cancer Screening Programme - NHS BCSP PUBLICATION NO 7 APRIL 2012

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Appendix 3

Establishing and running a Hotline Service - 24 hours 1 Introduction

For incidents where there is likely to be multiple enquiries from patients and relatives, the Head of Communications or member of Communications Team, in consultation with appropriate senior staff e.g. Chief Executive, Director of Nursing, Medical Director, Director of Operations or Duty Director, will invoke the Hotline Service.

The designated Hotline room is the A&E Conference Room at Northwick Park Hospital. It is equipped with multiple telephone and data sockets to allow a team to operate phones and computers at the same time. There are also white boards on the wall to record key details of project progress. Additional phone handsets are available to the Head of Communications at short notice via the Telecoms Manager.

Depending on the nature of the incident and expected number of calls the Hotline is may be operational for 24 hours a day, however generally it is manned between 9.00am and 5.00pm. If some cover is needed overnight then a member of staff will carry a bleep or mobile phone.

The Hotline service is staffed by those with the appropriate skills and knowledge base; this knowledge base will be dependent on the specialty/ department involved. Staff are trained and provided with explanatory guidance on the most likely questions likely to arise to ensure consistency of advice.

The numbers of staff required to man the Hotline Service is dependent on the anticipated number of incoming calls. Should the number of calls exceed the anticipated volume, additional staff (with the appropriate knowledge base) are drafted in.

2 Head of Communications

The Head of Communications on behalf of the Executive Team ensures appropriate structures are in place to allow the Trust to invoke a Hotline.

3 Role of Head of Communications or member of Communications Team

Before invoking a Hotline Service, the Head of Communications or Deputy will ensure, in liaison with the lead Executive Director, that :

The designated Hotline room (in A&E at Northwick Park) is cleared and set up for call centre use with phone handsets and computers as necessary.


Ensure appropriate and sufficient numbers of staff are available to man the Hotline. Where possible staff are drawn from those staff groups with call handling and counselling skills e.g. patient relations and PALS.

There is a common brief drawn up for staff members taking calls

Staff involved are aware of when, and from whom, they should seek further advice

All staff manning the Hotline Service are provided with on the spot training by the communications team in techniques for answering calls from distressed/anxious members of the public (in the context of the reasons for the Hotline being established).

IT support is available for the area which will hosts the Hotline

Additional needs are identified for postal arrangements.

The Post room is located a couple of minutes walk from the Hotline room. When sending post, staff should be aware that the postal collection from the post room is 4.30pm (Mon-Fri). A later 17.00 collection is available via the post box outside the Social Club.

4 Training/Preparation brief for staff who will man the Hotline

The Head of Communications ensures staff members manning the Hotline Service receive the following training/information before manning the telephones:

Outline of the incident giving rise to the Hotline Service being invoked.

List of potential enquiries that callers to the Hotline Service may make.

List of potential/suggested answers that might be given to callers

Advice on how to deal with distressed callers to the Hotline Service.

Advice to be given to callers on the availability of a call-back service, (this can be used if callers appear to be very distressed or appear to have difficulty in assimilating the information provided.) It may be appropriate that the call-back line is to an alternative member of staff e.g. chaplaincy or more senior member of staff from a specialty/department.

Staff maintain a written record of all calls and advice given – see Appendix 4 and a letter of confirmation will follow all calls.

Instruction on the completion of log used to record the calls received by the Hotline Service. This log is and stored for further reference.

Staff manning a Hotline will have been under great deal of pressure and may have suffered some degree of stress. Counselling and support is made available to staff as required.


Flowchart – setting up hot-line service

SERIOUS INCIDENT OCCURS

COMMUNICATIONS MANAGER +

APPROPRIATE SENIOR STAFF

MEDIA TO BE CONTACTED TO FACILITATE PUBLICITY OF

INCIDENT AND HOTLINE

STAFF INTERNAL/EXTERNAL

STAKEHOLDERS TO BE INFORMED

Red Alert Notice

Global e-mail

Target e-mail

HOTLINE TO BE SET UP

IN AGREED LOCATION

TELECOMMUNICATIONS

MANAGER

STAFF TO MAN HOTLINE SERVICE APPROPRIATE NUMBERS/SKILLS

(Dependant on scale/type of incident)

SCRIPT TO BE WRITTEN (By head of service)

STAFF TO BE PROVIDED WITH APPROPRIATE

Training

Refreshments

Working Hours

ALL CALLS TO BE LOGGED

ALL LOG SHEETS TO BE

ARCHIVED (In health records library)

BANK OF TELEPHONES DESIGNATED TELEPHONE

NUMBERS

Manned 24 hours or during working hours with answer phone message

does this conflict with earlier timings..

STAFF TO BE OFFERED POST-INCIDENT COUNSELLING

(via Occupational Health)

DECISION TAKEN AS TO HOW LONG HOTLINE

SERVICE REMAINS IN EXISTENCE

(by CE/Communications

Manager/Head of Service

ANSWERPHONE MESSAGE TO BE LEFT ON HOTLINE NUMBER

(Dependent on type of incident)


Appendix 4

Log sheet for Hotline calls

NAME OF STAFF MEMBER: …………………………………………. SIGNATURE ………………………………………………………… TIME ON DUTY …………. TIME OFF DUTY …………

TIME CALL IN

(24 hr clock)

TIME CALL END

(24 hr clock)

DETAILS OF CALLER (Name, address, telephone

number, relation to incident)

ISSUES RAISEDADVICE GIVEN FURTHER ACTION AGREED WITH CALLER

Appendix 5

Standards for the SUI Panel and serious Complaints Investigation

Introduction This procedure describes the Trust’s standard for incident and complaint investigation and report writing when an SI event occurs. When a SUI is declared or a serious complaint occurs, the Director of Nursing (complaints) or the Director of Governance and/or the Medical Director (SUI) establish an investigating panel with a nominated senior lead. This panel must not include any one with direct involvement in the event thereby ensuring external input. However, due consideration is given to the composition of the team, given the nature of the incident or complaint to be investigated. Assistance and administrative support to the investigation panel and process is provided by the Patient Safety department for incidents and Patient Relations dept for complaints. 1. Panel allocation The investigation team is notified by the Head of Patient Safety and Quality/ Patient Safety dept of their involvement in the panel within one week of allocation of the panel by the Director of Nursing/Medical Director/Director of Governance. 2. Initial handover meeting At the initial handover meeting, the Patient Safety/Patient Relations Coordinator (PSRC) informs the lead panel member (Chair) of the facts and assists in clarifying the scope and direction of investigation. Further dates for investigation panel meetings are planned by the panel lead. 3. Investigation Process 1. The PSRC meets with the Chair within one week of allocation of the panel and case handed over. 2. The Chair arranges for the panel to meet as necessary to clarify the scope and direction of the investigation, this is coordinated by the PSRC. 3. The PSRC and Chair organise the investigation to enable a draft report to be available within reporting deadlines. 4. The report will incorporate the key headings set out in Appendix 6. 5 If the investigation panel wish to undertake interviews of staff, these are planned at the start of the investigation where possible however the investigation may uncover the need for further interview at a later date. A record of any interview must be made, and all evidence collected must be sorted and catalogued systematically.. 7. Witness statements are called for & must be of good standard. See Appendix 7. 8. An action plan is drafted by the panel from the recommendations. The draft action plan is finalised and formally ratified by the Trust Board and its implementation overseen by the Patient Safety and Quality Committee.

4. Report and Action Plan Preparation The report will follow the format prescribed in Appendix 6 and is prepared in line with external reporting requirements.( For SUIs reported on STEIS report must be completed within 45 working days from the date reported on STEIS.) A draft report should be prepared for sign off by the investigating panel as follows where possible: a) Production of first draft report with panel’s recommendations to be drafted and circulated to Panel members by the end of week 5. b) Comments back to the Chair and PSRC by week 6. c) The final draft report and proposed action plan, is presented to the next sitting of the Trust Board.

Appendix 6

Report template

Report of the findings of the Serious Incident (SI) Investigation

Incident:

Incident Date:

Incident Report date

STEIS Reference:

Author of report:

Executive approval

Date approved by Trust:

1 Reasons for the inquiry - to include the incident severity, how the incident was detected and the level of Investigation

2

2 Incident Description and incident date

2

3 Initial report

2

4 Inquiry panel’s Terms of Reference Members of the panel

4

5 Conduct of the Inquiry

4

6 Involvement and support of patient / relatives

5

7 Actual effect on patient / service

5

8 Clear, fact based chronology of events leading up to the incident

5

9 Any Care and/or Service problems

7

10 Contributory factors

8

11 Root Causes

8

12 Lessons learnt

8

13 Conclusions

9

14 Recommendations

10

15 Arrangements for shared learning

10

16 Action Plan – suggested time scales and leads

1. Reason for the inquiry ( this includes level of investigation)

2. Incident Description and incident date

3. Initial Report

4. Inquiry Panel’s Terms of Reference

Members of the Panel

5. Conduct of the inquiry and RCA investigation method States method of RCA used, information and evidence gathered 6. Involvement and support of patient / relatives ( being open )

7. Actual effect on patient / service

8. Chronology of events leading up to the incident

9. Any Care and/or Service problems

10. Contributory factors

11. Root Causes

12. Lessons learnt

13. Conclusions

14. Recommendations

15. Arrangements for shared learning

16. Monitoring arrangements for actions

Action plan

Issue Action Lead Timescale Completed Monitoring

arrangements

Possible Contributory Factors in an Incident, complaint or claim

Factor Definition Examples

Patient factors Physical, mental, emotional and behavioural aspects of the patient that contributed to the event.

May include DTs, hallucinations, sleep walking, obesity, senility, the patient's response to treatment, and any co-morbidity. Includes the patient's choice to ignore instructions.

Task factors Tasks performed or not performed by any member of the care team that contribute to the event. These factors include all disciplines following policies and procedures established in the Trust.

May include failure to undertake appropriate risk assessment e.g. falls Failure to follow surgical time out checklist Failure to evaluate any patient's behaviour or failure to act upon that assessment Failure to formulate or implement properly a standard plan of care from any discipline for the specific needs of the patient.

Individual staff factors Those factors solely attributable to the action of an individual

Failure to follow Trust Policy and protocols attributable to an individual. Issues of individual professional misconduct.

Team factors Failure of the members of the care team to work together appropriately.

Failure of the staff to "speak-up" to the surgeon prior to/during wrong site surgery.

Education and Training factors Failure to orient and train any staff member in his/her job requirement and Trust policies. Failure to adequately oversee any staff member in any discipline to ensure that he/she is doing their job

Includes all staff groups

Equipment and Resource factors Any lack of or malfunction of equipment including a medical device that causes harm to the patient. The adverse event may be due directly

May include IV pumps, ventilators, orthopaedic drill bits, catheters, radiology equipment Also may include stretchers, wheelchairs,

Factor Definition Examples

to malfunction of equipment, to use of the equipment for an unapproved purpose, or improperly used equipment.

among others.

Communication factors Failure of the staff to obtain and share with the multi disciplinary team all pertinent information related to the comprehensive care of the patient in a timely manner. Failure to obtain all pertinent information from the patient and the family about the patient's status at home, recent changes, and the current presentation of symptoms and medical condition. Failure of the staff to communicate with the patient and family pertinent aspects of care.

May include any type of communication (written, oral or implied)

Working / Environmental factors Failure to maintain a physical environment conducive to the proper care of a patient

May include inappropriate lighting, inappropriate noise level, inadequate space, clutter, alarms that sound alike, or unfamiliar sounds to the staff. Lack of an appropriate staff taking into account patient acuity as well as staff training and experience.

Organisational / Strategic factors Failure of the Trust to facilitate and support safety

May include lack of, or unclear policies or protocols. Lack of medical or nursing leadership.

Appendix 7

Standards for the Panel Investigation of incidents, complaints Witness statements

Purpose When a statement is requested, the purpose for which it is required must be made clear. Access must be given to medical\nursing records if requested. In some situations it may be wise for a witness to write down a brief account of the events immediately. Guidance The person writing the statement can always seek advice from their professional representative, their line manager or the governance staff. Quality of witness statement The investigation panel should only accept good quality statements. The panel should look for the following points to be included in statements. Accuracy It is essential that only those facts which took place should be recorded. There should be no exaggeration of minimisation. Avoid hearsay The statement should not repeat what someone else has seen or heard. The statement should be a first-hand account of the person's personal involvement or observation. Facts – Not Opinion The statement should avoid value judgements and should keep to the facts. For example, a health visitor might have formed the opinion that one of her clients was lazy. If this is relevant to the statement it is of far more value if she were to write down a description of the facts which led her to that opinion than to make value judgements. Thus ‘there were 12 dirty milk bottles on the living room floor and piles of papers on every seat, etc’ is more useful than expressing an opinion which may or may not be acceptable and is not on its own very meaningful. There are occasions where it is necessary to express opinions, especially where they led one to act in a particular way. It is still necessary to record the facts which led to those opinions. For example: ‘Because I felt she was a danger to herself I put the cot sides up’. This statement needs to be amplified in order to expand on what has caused the nurse to believe that the patient was a danger to herself, for example, had she fallen out of bed? Had she tried to leave the ward? Was she in a confused state and if so, how did she show it?


Where concerns have been made regarding care management, the person raising the concerns must give a detailed account of the situation. For example, a health professional raises concerns about another health professional's care of a patient. The person raising the concern must provide specific details of how the care was lacking and in what way the care deviated from normal protocol. Facts made in a statement should be checked. For example, a statement that a patient had a high temperature should be checked against the patient’s record; similarly a description that the patient had been written up for a particular form of medication should be checked against the drug card. Sometimes it is helpful to obtain a sketch of the ward layout or where the patient was found or where there is a need to identify the exact location. Essential elements in a statement

date and time of incident; 24 hour clock, e.g., 4pm = 16.00hrs

full name of person completing the incident form, position, grade and location;

full name of any person involved, e.g. patient, visitor, other staff.

a full and detailed description of the events which occurred;

date and time the statement was made;

signature AND PRINTED NAME


Appendix 8

Guidance for Staff Writing a Statement

The Statement should include the following detail: INTRODUCTION 1. Your statement should begin with your full name, qualifications, job title and

area of employment. 2. Provide a chronological account of your involvement, from your first to your last

contact with the situation. You should pay particular attention to dates, times, dosages of drugs etc. You should include where appropriate risk assessments, and care plans/medication/referrals/second opinions obtained, to those risks. Assume that the person reading the statement knows nothing about the situation except for what you are writing.

3. What information did you have of the patient’s condition prior to this contact with them? Had you previously cared for them? Did you receive a hand over of the patient’s current condition?

4. State how patient presented to you upon your first contact. What were the symptoms? Include any information received from other colleagues or from the patient/family. State, were there any risks/concerns? What was the risk management plan to those concerns? What was the medication regime?

Other Helpful Tips 1. Write your statement as soon after the event as possible while the facts are still

clear in your mind. You do not need the notes to write the statement. 2. Write in simple terms and avoid jargon or official language. 3. Stick to the facts and do not express subjective opinions unrelated to your area

of involvement. 4. When mentioning other professionals clearly include their name and status. 5. When describing hospital procedures explain what they are. Avoid general

statements such as “routine observations recorded” instead explain what this included. If normal procedures were not followed, explain first what is normal and then why there was departure from the accepted procedure.

6. If using abbreviations ensure that the full terminology is given at least once, followed by the conventional abbreviation in brackets. Try and explain technical terms in lay terms wherever possible.

7. Date your statement; where possible have your statement typed; if this is not possible please write clearly in black ink or ballpoint pen as this statement will probably be copied more than once.

Send a copy to the Patient Safety team – Governance Division and retain a copy for your information.

You may be requested to provide further information throughout investigations


Appendix 8 Key Areas of Organisational Risk and Contacts

Area of Risk Contact person(s) & roles in relation to risk

Risk Management Health and Safety

Head of Patient Safety and Quality Head of Health &Safety Asst Director for Occupational Health In conjunction with the Director of Governance, provides practical advice and support on the assessment, treatment and management of risks within the organisation. Provides expert source of reference in the interpretation of Risk, Incident & Health & Safety Policy.

Occupational Health Risk Manager (Health and Safety) Director of Infection Prevention and control Asst Director - Occupational Health Provide advice on all areas relating to staff health, including illness, accidents, inoculation injuries, exposure prone activities and inoculation status.

Buildings Divisional General Manager for Estates and Facilities Risk Manager (Health and Safety) Provides expert advice on all areas of risk as they relate to plant and the built environment

Complaints Patient Liaison Manager In conjunction with Director of Nursing, manages an effective complaints system including provision of reports and statistics. Supports staff involved in management &investigation of complaints. Provides assistance in the interpretation and implementation of local & national complaints regulations & guidance.

Consent to Treatment Director of Nursing Medico legal manager Medical Director Provide advice on the interpretation of consent guidance in generic settings / specific cases.

Patient Confidentiality/ Data Protection Act 1998

Information Governance Officer Medico legal Manager In conjunction with Director of IM&T and Director of Governance, provides systems for the safe and confidential use of patient data. Advises individuals, departments etc. on implications of local and national guidance - works with managers & clinicians to ensure compliance.

Medicines Management

Chief Pharmacist Provides an expert source of reference for all issues relating to the


effective ordering, storage, prescription, dispensing and administration of all medicines within the hospital.

Contracted services (G4S)

Head of Facilities Provides systems in which the quality and effectiveness of contracted – out services are monitored. Deals with problems or issues arising from or within the operation of such contracts

Emergency Preparedness

Assistant Director of Operations Manages the production of the Trust Major Incident Plan, facilitates the Trust Emergency Planning Group, and has responsibility for ensuring that the Trust has the infrastructure, resources and facilities required to for optimal emergency preparedness in collaboration with key managerial and clinical staff.

Fire

Head of Facilities Risk Manager (Health and Safety) Ensures that appointed Fire services provides monitoring systems, training and advice on all aspects of fire hazards/safety issues

Fraud

Director of Finance Has overall responsibility for operation of counter fraud Policy and services.

Health Care Records

Health Care Records Manager Ensures that Health Records are stored safely, effectively, efficiently and in such as way as to facilitate retrieval. Advises managers and clinical staff on specific issues of health records utilisation and disposal.

Incident Reporting

Head of Patient Safety and Quality Operationally manages risk and incident reporting systems and supports staff in their operation

Infection Prevention and Control

Director of Infection Prevention and Control Infection Control Doctor Ensures that all of the Trust operates in such a way as to prevent the spread of infection. Provides advice to individuals and departments regarding the implementation of infection prevention and control policies and guidance in both generic contexts and in relation to specific infection control problems.

Information Management and Technology

Director of IM&T Ensures the operation of effective and safe data systems. Acts as SIRO and advises the management of information risks and preventive action.


Security

Local Security Management Specialist Provides guidance, training and specific advice and guidance in relation to security risks Works with managers in the investigation of security incidents Acts as link manager for police liaison

Safeguarding Children Director of Nursing – Executive lead

Named doctor

Named Nurse

Named Midwife

Safeguarding Adults Director of Nursing – Executive lead

Deputy Director of Nursing – operational lead

Violence & Aggression

Local Security Management Specialist Risk Manager (Health and Safety) Asst Director Occupational Health Provide support, advice and specific interventions in relation to specific incidents

Waste Management

Head of Facilities Provides monitoring systems, training and advice on all aspects of hazards and safety issues relating to waste procedures & materials.

Patient Care Whistleblowing

Specific patient risk issues are brought to the attention of ward managers, matron, Heads of Nursing, Consultant leads or service heads, as appropriate. Incidents are reported via Datix and / or contact Patient safety and Quality team. If in doubt contact the Director of Nursing, Medical Director or Director of Governance. Director of Human Resources

Other Information Governance issues, including clinical record keeping, corporate records Management (retention periods) and Freedom of Information Act requests

Information Security Officer Provides advice on policy and operational queries in these areas.

Training

Head of Education & Development Provide monitoring systems and resources for training and advises on aspects of risk in relation to training

Appendix 9 Incident management: Endoscopy Services Contact numbers: Diagnostic Services Manager: 0208 235 4107 Endoscopy Decontamination Services manager 0208 869 5382 Exec team secretary/ Wolfson Unit: 0208 235 4225 Divisional General Manager / General Manager - secretary: 0208 235 4006 Site Manager: Bleep 013 Director of Governance: 07887 751826 - mobile Head of Patient Safety: 0208 869 5848 Urology General Manager: 0208 869 3841 or 0208 869 3832 ENT General Manager 0208 869 4244 - CNS ENT x 3098 Endoscopy Sisters St Mark’s: Endoscopy Recovery 4141 /4142 Endoscopy Sisters ACAD: 6 8911/8828 Endoscopy Pre-assessment staff: 0208 235 2044 and 0208 235 4135 Programme Manager Bowel Cancer Screening: 0208 869 3543 Q Despatch: 0207 424 9559 (State need suitable transport to transport clean and dirty endoscopes)


Appendix 10

Root Cause Analysis Interviews

Preparation Listening to the first-hand accounts from those involved in an incident as soon as possible after it has happened will help the investigation team start to build a picture of what happened and potentially highlight what other information will be required. The optimum time for holding an interview is between two1 and 72 hours after the incident.2 The interviewer needs to establish who they want to interview and make arrangements to do so as soon as possible. The identified staff should be invited to attend; told the purpose of the interview; what to expect; and what preparation they need to do. It is essential that the interviewer and the room are prepared prior to the interview.

Inviting the member of staff to attend for an interview Where appropriate, a written invitation to the interview can be provided and the details below included. Where this is not practical due to the need to see staff as soon as possible after the incident, staff should be advised in advance and be given the following information verbally: • the purpose of the interview and details of the incident being investigated; • the time, place and estimated length of the interview; • who will be conducting the interview and their role; • how the cognitive interview will be conducted and the first-hand account recorded (e.g. the interview will be informal, notes will be taken to inform the investigation, but these will not act as a formal witness statement and do not need the interviewee’s signature); • what documentary evidence will be available to them during the interview; • the fact that they can bring a friend or colleague for support (explanations need to be given regarding the role of this friend/colleague e.g. confidentiality, their involvement); • advice on what will happen after the interview.

Interviewer preparation • The interview should take place in a quiet, relaxed setting and, if possible, away from the interviewee’s usual place of work and not at the scene of the incident. ). • Where possible, the interviewee should have the opportunity to attend the interview in work time and arrangements may need to be made with their line manager to ensure this. • Depending on the nature of the case or the interviewee’s personal involvement, they may find the process of recounting the events either upsetting or disturbing. The interviewer will need to have information available on staff support/counselling. • The interviewer should ensure they have all the relevant documentation available at the interview.


It is important to remember in the cognitive interview to only interview one staff member at once. Conducting the interview Introductions (where appropriate) should be made of those present in the room. Include details on roles and an explanation of the sequence of the interview and approximate length. The RCA process should be explained and an estimate given of how long it will take to complete. It is important to reinforce that this is not part of a disciplinary process. The interviewer should explain that notes will be taken throughout, for the purpose of informing the investigation. It must be stressed that these notes will not act as a formal witness statement and therefore do not need the interviewee’s signature. The interviewee should be asked to confirm they have understood all of the above and should be reminded that they should offer only factual information, but include everything regardless of whether they think it is relevant or not. The interviewee should be discouraged from making ‘off the record comments’. The interviewee should also be advised that the first-hand account and the final report will be written with due anonymity to staff and the patient. Completion of the interview On completion, the interviewer should ensure the interviewee feels appropriately supported and that any further support required is organised. The interviewer should reconfirm what will happen with the information gained from the interview and how this will be used in the RCA process.
