INCIDENT REPORTING, EVENT INVESTIGATION, ANALYSIS AND ...

Incident Reporting, Event Investigation, Analysis and Improvement and Being Open Policy Approval Date– January 2012

INCIDENT REPORTING, EVENT INVESTIGATION, ANALYSIS AND IMPROVEMENT

AND BEING OPEN

POLICY


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DOCUMENT CONTROL INFORMATION

NAME OF LOCAL GROUP / FORUM APPROVING THE POLICY

Quality Committee

DATE OF LOCAL GROUP APPORVAL January 2012

DATE OF EMT 24 January 2012

DATE OF IGC AUTHORISATION 27 January 2012

REVIEW DATE January 2014

VERSION NUMBER 4

RELATED DOCUMENTS Policy for supporting staff involved in complaints, claims & incidents

Complaints Policy

Claims Policy

Risk Management Strategy

Guidance on the management following drug errors

AUTHOR (POLICY FACILITATOR) Risk Manager

DIRECTOR / POLICY SPONSOR Director of Nursing Governance

SERVICE UNIT Governance

THIS DOCUMENT REPLACES Serious Untoward Incident Policy, Incident Policy and Root Cause Analysis Policy

IMPLICATIONS FOR IMPLEMENTATION COMPLETED

Y

CONSULTATION TRACKING SHEET COMPLETED

Y

EQUALITY IMPACT ASSESSMENT

EQUALITY IMPACT ASSESSMENT COMPLETED

Y

PUBLISHED ON WEBSITE January 2012


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CONSULTATION TRACKING SHEET This document must be completed and accompany the policy procedure or guideline through the final ratification and authorisation process. A copy of this sheet should be included at the front of the final published policy. Name of Policy, Procedure or Guideline: Incident Reporting, Serious Event Investigation & Being Open Policy

Name of person / team / committee asked to provide feedback

Date request for feedback sent

Feedback received Y/N

Feedback incorporated into policy Y/N

EMT Jan 2012 Y

Director of Nursing & Governance Jan 2012 Y Y

LSMS Jan 2012

Senior Nurse Child Protection Jan 2012

HR Manager Jan 2012 Y Y

Learning & Development Manager Jan 2012

Company Secretary Jan 2012 Y

Senior Nurses & Ward Managers Jan 2012 Y

Information Governance Manager Jan 2012 Y Y

Operational Managers / Clinical Service Managers

Jan 2012 Y

Clinical Directors Jan 2012 Y

Quality Committee Members Jan 2012 Y

PALS & Complaints Manager Jan 2012 Y Y

Deputy Director of Nursing & Governance

Jan 2012 Y

Risk Manager Jan 2012 Y Y

Public & Patient Services Team Jan 2012 Y

Health and Safety advisor Jan 2012 Y Y

Deputy Director of Finance Jan 2012

Audit Clerk Jan 2012 Y

Network Manager Jan 2012

Virtual SIRI Group Members Jan 2012 Y Y

Audit and Information Officer Jan 2012 Y Y

DI (Designated Individual) with responsibility for compliance with the HTA – Pathology Manager

Jan 2012 Y

PCT Jan 2012 Y


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CONTENTS 1.0 Introduction 2.0 Policy Statement 3.0 Scope of Policy 4.0 Roles & Responsibilities 5.0 Reporting & Management of Incidents 6.0 Event Investigation, Analysis & Follow Up 7.0 Serious Event Investigations (incidents, complaints,

accidents and claims) 8.0 Being Open When A Patient Has Been Harmed 9.0 Raising Concerns 10.0 External Reporting Tasks 11.0 Training 12.0 Compliance Monitoring & Success Indicators 13.0 References Appendices Appendix 1: Definitions Appendix 2: Procedures for Being Open When a Patient

Has Been Harmed Appendix 3: NPSA Tool Kit Matrix Appendix 4: The Different NPSA Tools to Use When

Conducting a Root Cause Analysis Appendix 5: NPSA Incident Decision Tree Appendix 6: External Reporting of Incidents Appendix 7: Risk Scoring Matrix Appendix 8: Risk Scoring Supporting Tool Appendix 9: Accompanying Documentation for Policy

Approval (2) Appendix 10: SBPCT SUI Notification Form

Appendix 11: SOP For Serious Adverse Reactions / Serious Adverse Events Relating To Bone & Cartilage Tissue Appendix 12: Automatic Red Incidents Appendix 13: Never Events Appendix 14: Virtual SIRI Group TOR


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1.0 INTRODUCTION The Royal Orthopaedic Hospital NHS Foundation Trust is committed to providing high quality care within a safe environment for patients, staff and members of the public. Accurate and appropriate reporting and recording of all incidents, accidents, errors, near misses and events is essential to reducing risks. Through the implementation of this policy, the Trust aims to demonstrate that it has robust mechanisms to enable all incidents, serious events, accidents, errors, near misses, untoward events, complaints and claims to captured and acted upon in a systematic, appropriate and effective way. "I believe patient safety must be a fundamental component of a modern health service. It is closely connected with issues such as clinical governance and evidence-based practice. The culture of the NHS must change from a closed, blame-centered culture, to an open, learning one. We must not only ask the question 'who made the mistake?' but 'what features of the health organisation created the conditions where mistakes were more likely?‟ All the evidence from elsewhere indicates that this 'systems thinking' is vital to safety."

Chief Medical Officer Professor Liam Donaldson, 13/6/2000

2.0 POLICY STATEMENT The Royal Orthopaedic Hospital NHS Foundation Trust (ROH) is committed to providing high quality care within a safe environment for patients, staff and members of the public. This includes maintaining a constant vigilance on the systems that support clinical practice and service delivery. The ROH sees incidents, accidents, errors and near misses, both clinical and non-clinical, as opportunities for system improvement. The Trust is also committed to shifting the focus from reactive management to a proactive approach to the prevention of incidents / accidents. To this end, this policy supports increased notification and analysis of near misses, with the aim of reducing the frequency and/or impact of actual incidents / accidents and to develop the capacity to learn from failures through the promotion of an „open and honest culture‟ This policy sets out processes which aim to ensure incidents, accidents, errors, near misses, serious events, complaints and claims are notified, analysed and investigated appropriately and the resulting information shared so that learning can occur across the Trust in a consistent, supportive and professional manner. The policy also includes procedures for dealing with those events that are serious. Serious events may include serious incidents, accidents, complaints and claims. All employees have a major role to play in identifying and minimising clinical and non-clinical risks. All employees have a duty to report incidents, accidents, errors, near misses and events when they occur and to cooperate with investigations. Risks can only be minimised if there is a progressive, honest and


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open work environment where issues are identified quickly and acted upon in a constructive way, without any unnecessary recourse to disciplinary procedures. The occurrence of an incident, accident, errors, near miss or any other such event, however serious the outcome, is not in itself evidence of neglect, carelessness or dereliction of duty. The Trust wishes to make it clear that reporting an event / incident will not result in disciplinary proceedings save in the most exceptional circumstances as follows:

If there is criminal negligence or criminal actions

A further occurrence of a similar or related incident involving the same individual

Actions so far removed from reasonable professional practice that the registration body for the profession concerned would be likely to take action if the matter were referred to them

If an individual has knowingly been involved in, or witnessed, an incident / event but has failed to report it or cooperate with the investigation

If events are so severe as to require an external inquiry NOTE: For the purposes of this policy the term „incident‟ will also include accidents, errors, near misses, concerns and any other issues or events raised through the incident reporting process. In addition, the serious event investigative process outlined in this policy will be applied to all concerns which require further investigation whether raised through complaints, claims or incident reporting. 3.0 SCOPE & DEFINITIONS The reporting of incidents applies to all persons working within the ROH including locums, contractors, students, GPs with a special interest, agency staff and volunteers. This policy includes how the analysis and shared learning of serious events should occur and this includes complaints, incidents, claims accidents and near misses. Please see Appendix 1 for definitions of terms and for examples of the types of incidents to report. 4.0 ROLES & RESPONSIBILITIES Different groups of staff within the trust have different responsibilities regarding the reporting of incidents and at various stages during the investigation process. Chief Executive The Chief Executive of the Trust is responsible for ensuring that mechanisms are in place for overall implementation, monitoring and revision of this policy.

The Trust Board It is the responsibility of the Board to:


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Ensure that appropriate policies are in place for the reporting of incidents and serious events, for the follow up, investigation, analysis implementation and sharing of changes, learning and improvements following incidents, events, complaints and claims

To receive regular reports on aggregated analysis of incidents, complaints and claims along with any improvements identified & learning to be shared within the Trust (Governance Quarterly Quality Report)

To receive and consider in full the implications from any serious events with major implications to the Trust

The nominated subcommittee of the Board responsible for the ongoing monitoring of risk management issues, incidents, serious events, complaints and claims and of reporting relevant information back to the Board is the Integrated Governance Committee

Integrated Governance Committee The Integrated Governance Committee is the designated sub committee of the Trust Board with responsibility for overseeing all governance and risk management activity within the Trust. The committee will oversee the activity of the Quality Committee. The Committee will be responsible for:

Receiving exceptions regarding the implementation of actions to manage High Impact (Red) risks

Receiving details of any risks or issues which may have an impact upon the organisations ability to deliver its key objectives

Receiving the Governance Quality report containing aggregated analysis of incidents, complaints and claims, details of serious event investigations and any improvements identified, changes & learning to be shared within the Trust

Receiving the bi-annual litigation report

Acting as the nominated sub committee of the Board with responsibility for ensuring that appropriate policies are in place for the reporting of incidents and serious events, for the follow up, investigation, analysis implementation and sharing of learning following incidents, events, complaints and claims

Quality Committee It is the responsibility of the Quality Committee to:

Regularly receive details of all incident / event investigation reports / root cause analyses including details of ongoing investigations

Approve and agree the actions once a serious event investigation has taken place and learning points / recommendations have been proposed

Receive regular reports regarding the implementation of actions following serious event investigations

Monitor progress regarding the implementation of actions contained within serious event investigations

Make a decision for a risk to be incorporated on the Trusts Corporate risk register following a serious event investigation


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Deputy Director of Nursing & Governance It is the responsibility of the Deputy Director of Nursing & Governance to: Be the Trust lead for the management of litigation claims Act as a central point to co-ordinate the aggregated analysis of complaints,

incidents, events and claims Ensure that the aggregated analysis of incidents complaints and claims

takes place quarterly and that this information along with any improvements identified, changes made or learning shared is incorporated into the Governance quarterly quality report

Support the Risk Manager / PALS & Complaints Manager in undertaking root cause analysis investigations or where relevant identifying other appropriate lead investigators

Support the Risk Manager / PALS & Complaints Manager to engage the Executive Management Team regarding risk management priorities including their role in the reporting, analysis, investigation, following up and implementing learning, improvements and change following incidents, events, complaints and claims

Produce a 6 monthly litigation report which is presented to IGC Risk Manager It is the responsibility of the Risk Manager to: Ensure that robust systems for reporting, investigating and analysis of

incidents / events exist Maintain the electronic incident reporting system and liaise regularly with the

IT department and „Ulysses‟ the service provider in the event of any problems arising with the system

Ensure that adequate training is provided to all staff regarding their responsibilities in relation to risk management, incident reporting, investigation and analysis of incidents / events

Provide advice on incident reporting, investigation and analysis to all staff Ensure different levels of investigation take place according to the severity

of the event Facilitate the Root Cause Analysis process regarding the investigation of

serious events To either undertake the Root Cause Analysis investigations or identify an

appropriately qualified lead to undertake the RCA investigation of a serious event

Analyse data and trends in incident / event reporting and to liaise with the PALS and Complaints Manager to coordinate the investigation and analysis of events, to ensure aggregated learning from complaints, claims and incidents and to identify improvements which can be made.

Ensure regular trend and feedback reports are shared at all levels within the organisation and to all relevant groups so that lessons learnt are disseminated

Communicate learning and actions to relevant staff to promote changes and improvements following incidents / events investigation and analysis

Ensure monitoring and follow up occurs regarding the effectiveness of actions taken to prevent recurrence of serious events / incidents / accidents / near misses


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Ensure that the relevant Director, Chief Executive Officer and communications officer has been informed of any serious events

If a serious event may involve a media interest, the Company Secretary should also be notified

Support staff in being open with patients when errors have occurred or patients have been harmed

Ensure appropriate external reporting of incidents / events Ensure regular audits are carried out to evaluate compliance with this policy

in accordance with the success indicators included in this policy; and that the results of the audit are reported to the Quality Committee, recommendations made and action plans developed

PALS and Complaints Manager It is the responsibility of the PALS & Complaints Manager to: Analyse trends in data in relation to complaints Co-ordinate the investigation of events relating to complaints in line with the

process outlines in this policy Liaise with the Risk Manager to ensure aggregated learning from

complaints, claims and incidents and to identify improvements which can be made

Ensure regular trend and feedback reports are shared at all levels within the organisation and to all relevant groups so that lessons learnt are disseminated

Work closely with the Risk Manager to ensure monitoring and follow up occurs regarding the effectiveness of actions taken to prevent recurrence of serious events / accidents / near misses / complaints and claims

Communicate learning and actions to relevant staff to promote improvements and changes following events investigations and analysis

H&S Advisor It is the responsibility of the H&S advisor to:

Review, monitor and escalate incidents relating to H&S issues

Analyse trends in incidents relating to H&S issues

Coordinate the reporting of relevant incidents to the HSE and MHRA

Coordinate the investigation and follow up of H&S incidents

Contribute to the analysis of H&S incidents within the quarterly report

Report and escalate H&S issues to the H&S committee Manager / Clinical Lead (person who the incident /event is reported to): It is the responsibility of the Manager to: Take responsibility for the local management of incidents / events Ensure they have a full understanding of their role and the role of their staff

in the management, follow up and investigation of incidents and serious events

Ensure that serious events have been reported to the Risk Manager, Chief Executive Officer, on-call manager and any relevant Directors

Ensure that following an incident / event staff have secured and made safe the environment for patients and staff


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Ensure that for serious events, relevant clinical records, documentation, equipment etc has been secured and that these remain as they were when the event occurred

Ensure copies of incident forms have NOT been retained in the patients clinical record, but a note that a form has been completed has been documented in the clinical record

Ensure information from incidents / events is used to inform local risk registers and that information from local incidents / events is monitored and reviewed regularly in conjunction with the local risk register

Ensure that all staff within their services are actively supported to take part in the reporting, investigation, follow up and implementation of learning following incidents, events, complaints and claims

Monitor and review trends in reportable events occurring within the service Undertake the management review of incidents reported within their area

and submit the completed forms with details of appropriate management actions and lessons learnt

Lead or assist in undertaking root cause analysis where appropriate and when appropriate training and support have been provided

Provide assistance with investigations e.g. helping to gather and collect witness statements, evidence and information

Ensure that mechanisms are in place to support the prevention or re-occurrence of incidents / events locally and where these involve more than one service

Where relevant ensure that ongoing actions are regularly discussed as agenda items at local / staff meetings and Directorate Meetings and lessons to be learnt are disseminated and implemented locally

Monitor the effectiveness of actions taken to prevent recurrence and provide details and documentation to the Risk Manager / PALS & Complaints Manager as appropriate

Update the Risk Manager / PALS & Complaints Manager on the status of actions taken as a result of an incident, event, complaint or claim

Where incidents involve more than one service, ensure the timely response to requests for information from other service‟s

Take proactive steps to prevent similar incidents / events from re-occurring again

Support staff and take an active lead in being open with patients when errors have occurred or patients have been harmed

Ensure that all staff know about and are aware of the contents of the Trusts Whistle blowing Policy

Ensure staff attend mandatory training in relation to the reporting and follow up and investigation of incidents, events, complaints and claims

Ensure that as managers they themselves attend relevant management training and management development programmes in relation to the management, reporting, investigation and follow up of incidents, events, complaints and claims; including RCA training

Be aware of which other external organisations require notification regarding specific types of incidents / events


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Information Governance Manger It is the responsibility of the Information Governance Manager to take the lead on any SUI‟s relating to the actual or potential loss of personal information. Operational Managers Operational Managers are responsible for reviewing information and data relevant to their specific service area, regarding risk management activity, incidents, complaints and claims namely:

Regularly receive details of all incident / event investigation reports / root cause analyses including details of ongoing recommendations relating to their area of responsibility

Approve and agree the actions once a serious event investigation has taken place and learning points / recommendations have been proposed relating to their area of responsibility

Receive regular reports regarding the implementation of actions following serious event investigations relating to their area of responsibility

Monitor progress regarding the implementation of actions contained within serious event investigations relating to their area of responsibility

Other Committees There are a number of other committees across the Trust who are responsible for reviewing, monitoring and overseeing specific types of incidents. An overview of these groups and their responsibilities is as follows:

Group / Committee Type of Incidents

Medication Safety Group Medication Errors

VTE Committee VTE incidents

Information Governance Group Data loss incidents

Clinical Service Units / Directorate Meetings Local area incidents

Virtual SIRI Group Serious Event Investigations

Ward Managers Ward Managers are responsible for reviewing and monitoring information relevant to their specific ward regarding risk management activity, risk assessments, risk registers, incidents, complaints, PALS issues and claims. The ward managers ensure that ward level reports are reviewed and acted upon as necessary, namely:

Regularly receive details of all incident / event investigation reports / root cause analyses including details of ongoing recommendations relating to their area of responsibility

Approve and agree the actions once a serious event investigation has taken place and learning points / recommendations have been proposed relating to their area of responsibility

Monitor, follow up and receive regular reports regarding the implementation of actions following serious event investigations relating to their area of responsibility


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All Staff All staff are required to: Take immediate action following an incident / event to secure and make

safe the environment for patients and staff For serious events: immediately notify the local manager or most senior

person on duty in the area For serious events out of hours: contact the duty bleep-holder to inform

them For serious events: relevant clinical records, documentation, equipment

etc should be secured. Staff are required to ensure that these remain as they were when the incident occurred

For serious events: these should also be reported to the Risk Manager, Chief Executive Officer, on-call manager and any relevant Directors

For all incidents, errors and near misses complete the web based incident form promptly, fully and accurately. On the rare occasion that a computer is not accessible a paper incident reporting form may be used

Report accurate factual details only regarding the circumstances surrounding an incident / event

Ensure copies of incident forms are NOT retained in a patients clinical records, but a note that a form has been completed should be documented in the clinical record

Inform managers of all incidents reported within their area of responsibility. Copies of electronic incident forms which are reported on Ulysses will automatically be forwarded to managers for management review. Paper incident reporting forms should be reviewed by the manager prior to being forwarded to the risk management department or alternatively photocopied for management review at a later date.

Cooperate and take part in the process of incident analysis and investigation and to help to identify learning

Take proactive steps to prevent similar events from re-occurring and take steps to identify and implement improvements to systems

Ensure patients are informed where an incident / event involves them i.e. to support being open with patients and service users if mistakes are made or accidents happen


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5.0 REPORTING & MANAGEMENT OF INCIDENTS


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Diagram 1: Procedure for Reporting an Incident on Ulysses

Incident Occurs: Take immediate

appropriate action

No

Within 24 hours - Report the incident by clicking on the Ulysses / Incident

Reporting link on the Trust intranet site

Complete all relevant sections as fully as possible, Note mandatory fields and

provide ACCURATE FACTS only

Check content of form before you

submit and print a copy if required

Submit the Incident

Manager receives incident, identifies appropriate actions and submits

completed management actions form for

incident within two working days

E.g. Administer First Aid. Ensure immediate safety of personnel and property, notify doctor, seek assistance etc.

Contact the Clinical Lead/Manager. If after hours call the Bleep Holder, On-call Manager or other relevant staff

Immediately secure relevant clinical records, documentation, equipment etc. and ensures that these remain as they were when the incident occurred.

Ensure the patient is informed

The manager should liaise with the Risk Manager to ensure Root Cause Analysis is carried out as required

The manager should inform the relevant Director, Clinical Service Unit Manager, Risk Manager, CEO & Chairman

See Diagram 2 for analysis of serious events

N.B. Copy of Incident Form must NOT be retained in patient’s clinical record, but a note that a form has been completed

must be documented in clinical record

Manager/Clinical Lead:

Monitors effectiveness of actions taken to prevent recurrence.

Provide details and documentation of actions taken to Health & Safety Advisor, Risk Manager or PALS & Complaints Manager as appropriate

ASK - IS IT A ‘SERIOUS INCIDENT, EVENT OR

ACCIDENT’ ?

Inform the on-call manager or clinical lead immediately

All serious incidents are to be reported to the appropriate Clinical Service Manager

Yes

Definition of Serious Event A ‘Serious Event’ may be an incident, complaint, accident, claim, or near miss which is of sufficient concern to warrant a thorough investigation. A serious event may arise when a patient, member of staff (including those working in the community), or member of the public suffers serious injury, major permanent harm or unexpected death (or the risk of death or serious injury) on either premises where health care is provided, or whilst in receipt of health care, or where actions of health service staff are likely to cause significant public concern. A serious event may also relate to any significant loss, damage or abuse of Trust assets or information or inappropriate use or disclosure of confidential information. A serious event which is likely to produce significant legal, media or other interest and which, if not properly managed, may result in loss of the Trust’s reputation or assets.


5.1 Procedure for Reporting Incidents

Incidents, accidents, events and near misses can be reported by accessing the Ulysses web form on a computer and sending the completed form to the Risk Management Department. Incidents, accidents, events and near misses are to be reported by the member of staff / employee / contractor / student:

who first becomes aware of the event, or

who is most involved in the event, or

to whom an event is notified (if a paper form has already been completed)

NOTE: At the ROH, incidents, accidents, events and near miss notification forms are not completed by patients / clients / visitors. The Ulysses incident reporting system can be accessed via the link which is on the Trust intranet site. This system is accessible on all pc‟s across the Trust. The procedure for reporting an incident on Ulysses is illustrated in Diagram 1. Please refer to Section 4.0 of this policy for details of roles and responsibilities of staff in relation to reporting incidents. See Appendix 1 for definitions of terms and for examples of the types of incidents to report. The Trust has a single unified incident reporting system. Regardless of the nature of the incident; all incidents are reported in the same way using the same system. The Trust encourages the reporting of all incidents and near misses; and promotes steps to implement system barriers to prevent potential as well as actual errors. The risk management department produces leaflets and guidance for staff in order to support staff in their understanding of how to report incidents within the Trust. As an example, a copy of the information leaflet which is provided to staff who attend mandatory training is included in Appendix 15 of this policy. There are a core number of mandatory fields within the electronic incident reporting system which much be completed in order for an incident form to be submitted. These mandatory fields have been kept to a minimum in order to facilitate ease of reporting and so as to minimise barriers to incident reporting. The mandatory fields which must be completed for all electronic incidents, are as follows:

Person Reporting:

First Name

Surname

Type (i.e. nurse, doctor, OT, HCA etc)

Status (i.e. Permanent, contractor, student etc)

Incident Details:

Incident Date

Incident Description

Site

Location


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Once an incident form has been completed this form can then be submitted by selecting the submit button on the screen. If a paper copy of the form is required, a copy should be printed before the form is submitted. Once the form has been submitted, it will disappear from the screen. The person reporting the incident will then be notified of the incidents unique reference number. This number can be retained for future reference. As soon as an incident form is submitted, electronic notification will be sent to the relevant manager for that areas or department. The risk management department will also receive automatic electronic notification of all incidents which are submitted. Electronic notification is received into the risk management department via the e-mail account „incident reporting‟ which has been set up for the purposes of electronic management of all incidents. This e-mail account is directly available and accessible by the Risk Manager, Audit and Information Officer and Health & Safety Manager. On the rare occasion that a computer is not accessible a paper incident reporting form may be used. These are available as a backup mechanism (please refer to Governance Department Business Continuity Plans) and can be used for incident reporting if there is any failure in the electronic system. Paper forms can be obtained from local managers or from the risk management department.

5.2 Risk Rating Classification All incidents are locally graded/classified using the Trusts risk matrix. The Trusts risk matrix is included in Appendix 7. The Trust has a standardised risk matrix which is used for determining and assigning a relative comparative risk score for all risks regardless of their origin. All risk issues are unique in nature but require a standardised approach and standardised risk scoring methodology to be applied. Health and Safety risks, finance risks, security risks, etc are all scored using this same risk scoring tool. The risk matrix is included on the web based incident reporting form. The initial score is determined by the person who reports an incident. These scores are reviewed and amended as necessary upon receipt of a form by a manager or by a member of the Risk Management Team. The Risk Management Team use the risk matrix supporting tool in Appendix 8 to assist in standardising the scoring of incidents to maximise the objectivity of the scoring. Risks derived from complaints and claims are assessed using the same methodology.

5.3 Anonymous Incident Reporting

The Trust prefers all incidents to be notified by a named member of staff. Having the details of the person who has reported an incident assists in following up the incident and gathering any additional information which may be required. Those incidents which are reported


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anonymously will be analysed and acted upon at the discretion of the manager/clinical leader. In circumstances where an individual feels uncomfortable about reporting an incident and wishes to maintain anonymity, the Risk Manager can be contacted directly. Reporting an issue in this way may be applicable where the situation is very sensitive, however situations where anonymous reporting would be appropriate should be very rare (refer to Trust‟s whistle-blowing policy).

5.4 Local Management of Incidents

All managers are responsible for undertaking a management review of the incidents which have been reported by staff within their area of responsibility. This is possible by the review of the monthly area reports, as produced by the governance department. Managers should provide details of actions taken and local lessons learnt. . Locally reported Incidents should be discussed at departmental and team meetings. Individual managers should inform the Risk Manager of progress regarding ongoing actions to ensure up to date reports regarding the implementation of ongoing actions are provided to the Quality Committee. Individual managers should also ensure staff within their area receive feedback regarding actions implemented. Managers should ensure that information from incident reporting is used to inform the development of local risk registers.

5.5 Incidents Involving Other Service Areas

Ulysses enables the reporting of incidents that impact on more than one service area. Managers must respond to requests for information from other service‟s on the reporting and analysis of incidents in which other areas or departments are affected or involved. .

5.6 Legal Requirements

Completion of the incident form does not constitute any admission of liability of any kind. Incident forms are however potentially legally disclosable documents. In the event of legal proceedings, completed forms may therefore be requested and required to be made available to all parties. It is essential therefore that incident forms are completed fully, accurately and factually. The content of the form should identify facts not opinions and provide an objective clear account of what has happened. If an incident form is required in relation to or in conjunction with a litigation claim against the Trust, the request for disclosure should be made through a solicitor. The request should not be made directly with the risk management department.

5.7 Protection of Information & Storage & Retention

It is important that the incident reporting system maintains appropriate confidentiality for patients and staff. All ROH documentation relating to incidents / accidents and near misses is confidential to the Trust, and must be held in a manner which protects the privacy rights of patients and staff.


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The Risk Manager will retain all incident reports and they will be made available only to those staff involved at the time of the incident or who are involved in its follow-up. It is also recognised that there are specific statutory duties that require disclosure of certain reports. For example the HSE are notified of all incidents reportable under RIDDOR. Where a patient, member of staff or agency requests information relating to an Incident / accident or near miss, this must be forwarded to the Risk Manager who will address the request. Services may keep copies of incident / accident / near miss documentation for reference, but the confidentiality of staff, patients must be maintained. Copies of incident forms must not be filed in clinical or staff records. The ROH maintains a central electronic register (Ulysses) of all reported incidents / accidents / near misses. All incident report forms including paper forms will be kept for a minimum of 8 years in accordance with the Records Management: NHS Code of Practice (DOH 2006).

5.10 Support for Staff Involved in an Incident Please refer to the Trusts policy on supporting staff involved in incidents, complaints, claims and inquests.

6.0 EVENT INVESTIGATION, ANALYSIS & FOLLOW UP 6.1 Investigation of Incidents

All managers are responsible for undertaking a management review of the incidents which have been reported by staff within their area of responsibility. Managers should provide details of actions taken and local lessons learnt. The Trust Risk Management department will review and follow up all incidents which are reported. The level of investigation will be determined by the risk classification of the incident. All incidents are locally graded/classified using the Trusts risk matrix. The Trust has a standardised risk matrix which is used for determining and assigning a relative comparative risk score for all risks regardless of their origin. All risk issues are unique in nature but require a standardised approach and standardised risk scoring methodology to be applied. Health and Safety risks, finance risks, security risks, etc are all scored using this same risk scoring tool. Risks derived from complaints and claims are assessed using the same methodology. Risks will be assigned one of the following classifications:

Red = High Impact Risks

Amber = Medium Impact Risks

Green = Low Impact Risks


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The following general definitions can be applied: GREEN: Low impact risks with low probability of reoccurrence with only minor potential for causing harm or loss. YELLOW: Moderate impact risks with a medium probability of re-occurrence and the potential for causing semi permanent harm or moderate loss. RED: Major or catastrophic impact risks with the potential for causing permanent harm, death or large financial loss. A list of automatic red incidents can be found in Appendix 12 of this policy. The level of investigation applied is determined according to the level of risk classification. The levels of investigation are as follows: Low Impact Incidents: Incidents which are classified as green or minor will receive a local management review. These incidents will also be reviewed by the risk management department and where necessary additional actions will be identified and documented. Where relevant these incidents may be forwarded to other relevant managers within the trust for information purposes. Medium Impact Incidents: Incidents which are classified as moderate will receive a local management review. Local managers are responsible for following up these incidents and for developing and monitoring ongoing action plans in relation to these incidents. Where necessary discussions will take place with other relevant members of staff to gather additional information and to determine the underlying causes and what controls can be put in place in relation to these incidents. Local Managers should provide feedback to the risk management department regarding outcomes and resolutions following these incidents. These incidents will also be reviewed by the risk management department and where necessary additional actions will be identified and documented. Staff are encouraged to regularly raise these incidents for discussion at relevant staff / departmental meetings and to monitor closely trends in the occurrence of these incidents. These incidents will also be forwarded to other relevant managers within the trust for additional actions and control measures to be implemented. The issues derived from these incidents should be considered for inclusion in local risk registers and underlying causes will seek to be eliminated. Trends in relation to these incidents are monitored and incorporated in the Trusts quarterly quality reports. High Impact Incidents: Serious, red. major, catastrophic and high impact incidents will be investigated according to the procedure outlined in section 7.0 of this policy for the management and investigation of serious events.


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6.2 Investigation of Complaints & Claims

All complaints and claims are managed in accordance with the Trusts complaints and claims policies and in accordance with the relevant time scales allocated for the management of complaints and claims. In addition to fulfilling the statutory requirements regarding the management of complaints and claims; certain complaints and claims may also be subject to additional internal investigation. Using the same approach that is adopted for incidents; the level of investigation will be determined by the severity of the event. All complaints and claims are registered and recorded on the relevant modules of the Trusts Ulysses Risk Management System. The claims and complaints modules within Ulysses have the facility for recording and assigning a risk classification ratings to each case (the risk scoring fields are located in the outcomes tab). The scoring methodology within the complaints and claims modules utilises the Trusts standardised risk matrix. Risk classifications relating to complaints and claims are therefore assessed using the same methodology as that applied to incidents. As with incidents; complaints and claims will be assigned one of the following classifications:

Red = High Impact Risk

Amber = Medium Impact Risk

Green = Low Impact Risks

Complaints and Claims which are recorded as red / high impact risks will be subject serious events investigations which will be undertaken in accordance with the protocol contained with section 7.0 of this policy.

6.3 Treatment Options & Risk Reduction Measures

Whenever an incident, events, accident or near miss is investigated, a decision will be made regarding which is the appropriate risk treatment option for the incident in question. The treatment options available are listed below. These treatment options outline the different ways that the risk may be managed. A decision is reached regarding the appropriate treatment option taking into consideration the classification of the incident and the outcome of any investigation. These decisions should ideally be made with the agreement and discussion of several people in a group setting. The treatment options are as follows: Avoid: Reaching an agreement to avoid the risk by deciding either to stop the cause of the risk by not proceeding with the activity that causes or contains the unacceptable risk or by terminating the risk in some other way. Transfer: Reaching an agreement to transfer, or share the risk / activity with another party.


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Retain & Accept: Reaching an agreement to retain and accept the activity / risk as it is, following a review of the existing controls which suggest that these controls are adequate. Reduce: Reaching an agreement to reduce the likelihood and / or consequence of the risk by agreeing to take action to change or modify the activity which is causing the risk. An action plan is required for those activities where a decision or recommendation has been made to reduce the risk. When reaching a decision to reduce a risk, consideration should be given to the cost/benefit implications of the proposed actions.

6.4 Links to Risk Registers Local managers should monitor incidents within their area and ensure information from incidents, complaints, claims, events, accidents and near misses is used to inform local risk registers and that information from incidents, complaints, claims, events, accidents and near misses is monitored and reviewed in conjunction with the local risk register. Local risk registers allows the facility for formal evaluation of the measures currently in place to control a risk by undertaking a control evaluation. Control measures in place can be classified as follows: E = Excellent V = Very Good G = Good A = Adequate U = Unacceptable N = Non-existent Once a control evaluation has been undertaken; treatment options are then assigned to each risk on the risk register. Any item on a local risk register for which the decision is reached to „Reduce‟ the risk will then have actions identified to help to mitigate or reduce the risk. These risk reduction measures are monitored through the implementation of risk register action plans. Local risk register action plans are monitored and reviewed regularly at a local level . Risk register action plans represent risk reduction records of risk reduction measures identified, recorded, implemented and monitored. Each risk item on a local risk register will then be assigned a residual risk score; this score represents the risk assigned to that risk issue once treatment options and identified actions have been implemented. Information within local risk registers can be escalated for consideration for inclusion in the corporate risk register, (please refer to the Risk Management Strategy). The Quality Committee review the findings from all serious event investigations and where necessary a decision may be made for a risk


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issue to be escalated for incorporation as a new risk on the Trusts Corporate risk register.

6.5 Monitoring & Follow Up of Actions

Various levels of monitoring and follow up are in place regarding incidents, complaints, claims, events, accidents and near misses. General monitoring and follow up of incidents takes place through the review of incidents which remain open on the Ulysses incident reporting system. Serious events monitoring and follow up also takes place following serious event investigations. Monitoring of risk register action plans is another mechanism for follow up as is complaints and claims follow up and monitoring. General Incident Follow up & Monitoring: Incidents will remain open as long as they continue to require follow up, monitoring or management review. Details of incidents which remain open will continue to remain in the web holding file on ULYSSES. The Risk Manager, Audit and Information Officer and Health & Safety Advisor will continue to monitor and follow up these incidents. Serious Event Follow up & Monitoring: In order to monitor progress and the implementation of actions following serious events, a regular report will be generated by the Risk Manager. This report will provide an update for the Quality Committee regarding the status and progress of actions identified from serious event investigations. Managers will be required to provide updates for this report at the request of the Risk Manager. This report will be reviewed and monitored by the Quality Committee. Any exceptions regarding the implementation of actions following serious events investigations will be reported to IGC. Risk Register Action Plan Monitoring: Issues arising from incidents, complaints, claims, events, accidents and near misses are used to inform the development of local risk registers and are incorporated as necessary into local risk registers. Risk register risk reduction measures are monitored through the implementation of risk register action plans. Local risk register action plans should be monitored and reviewed regularly at least quarterly at a local level by managers / team leaders. Complaints & Claims Follow Up & Monitoring: The Trusts PALS & Complaints Manager and The Deputy Director of Nursing and Governance will monitor and follows up issues arising from complaints and claims to ensure that these issues are addressed locally or incorporated as necessary into the Trusts corporate risk register.


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6.6 Governance Quality Report The Governance quality report is produced quarterly covering issues which have been raised, addressed and reported during the previous 3 month period. Ulysses allows a single point of co-ordination for the analysis of data relating to incidents, complaints and where relevant claims. Reports are generated from Ulysses to determine common themes and trends arising from the incidents, claims and complaints. Monitoring of common themes helps to facilitate aggregated learning and enable a co-ordinated approach to the management of risks identified from a variety of sources. The aggregated analysis includes quantitative and qualitative data which is incorporated into the quarterly quality reports. The quarterly quality reports are produced as follows: Quarter 1: April – June Quarter 2: July – September Quarter 3: October – December Quarter 4: January – March The quarterly quality report includes the following information: i) A graph showing monthly figures for the total number of incidents reported over a 12 month period to illustrate incident reporting rates across the Trust. ii) iii) A highlight report containing quantitative and qualitative information regarding the „top‟ categories / classifications of incidents for the quarter including further detail and discussion regarding the types of issues raised and how some of these issues have been addressed and tackled. iv) Details regarding the number of incidents classified as red within each month of the quarter. v) Progress and update reports regarding any ongoing root cause analysis investigations, serious event reviews and monitoring of ongoing actions following serious events investigations. vi) The number of incidents within the quarter in relation to the monthly figures for consultant episode / FCEs. vii) Details and descriptions of any incidents / events during the quarter which have been reported to the PCT / SHA as serious untoward incidents (SUIs). viii) Details of any child protection issues raised during the quarter. ix) Details and information regarding any incidents reported to HSE as RIDDOR reportable. x) Details and discussion regarding any deaths which have occurred within the Trust during the quarter including the outcome of any inquests etc. xi) Details of NICE guidance issued during the quarter and any action in progress in relation to these.


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xii) Information regarding infection control figures including the number of MRSA bacteraemias, number of cases of clostridium difficile and surgical site infection data. xiii) The number of complaints received within the quarter and details regarding the % which were acknowledged within the 2 day target and % which were responded to within the 25 day national target. xiv) A graph demonstrating the categories of the complaints received during the quarter and an analysis of the issues raised. xv) Details regarding any complaints which are with the Ombudsman xvi) Discussion of any issues raised through aggregated analysis of complaints, claims and incident reporting. The quarterly quality reports are reviewed at the Quality Committee and the contents is discussed in detail in order to identify and discuss lessons learnt from the analysis of the report. The Quality Committee continue to monitor and follow up ongoing issues to ensure lessons learnt from analysis result in change in organisational practice.

6.7 Feedback Reports & Sharing Lessons Learnt

Health professionals are highly motivated to avoid error and the ROH has a responsibility to ensure robust systems support safe clinical practice. The Trust promotes learning from events to ensure more robust systems are continually developed. All services should be Supported to learn from the errors that occur both within their own areas and from errors that have occurred within other services. The main mechanisms within the Trust for providing feedback are as follows: Quarterly Quality Reports: Analysis and feedback regarding incidents, accidents, near misses, complaints and claims is included in the quarterly governance report. In order to demonstrate organisational and cross-organisational learning, the quarterly report is distributed as follows: Quarterly to the Integrated Governance Committee Quarterly to the Chief Executive and the Executive Management Team Quarterly to the Board Quarterly to Quality Committee Quarterly to the Commissioning Primary Care Trust Quarterly to the Local Security Management Specialist Monthly Managers Reports: Monthly reports are also provided for heads of departments/Ward Managers in order for trends and issues arising to be discussed with staff locally and to enable staff to be aware of monthly incident reporting figures, complaints, and claims and to facilitate local learning. Learning from Serious Events: The ROH is keen to disseminate learning from serious event investigations. Following serious event investigations, learning points will


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be developed and this information will be cascaded and fed back throughout the organisation. The key mechanism for this feedback is the quarterly quality report. In order to monitor progress and the implementation of actions following serious events, a regular report will be generated by the Risk Manager. This report will provide an update for the Quality Committee regarding the status and progress of actions identified from serious event investigations. Managers will be required to provide updates for this report at the request of the Risk Manager. This report will be reviewed and monitored by the Quality Committee. Other Mechanisms for Feedback: Staff are also regularly informed and updated regarding issues, learning points, implementing changes in practice and actions following incidents, complaints, claims, accidents, near misses and serious events via other mechanisms such as newsletters, ROH-all e-mails, managers monthly reports and local alerts. Relevant incidents are also discussed and reviewed as necessary at appropriate committees and forums e.g. Drugs & Therapeutics Committee, Health & Safety Committee, Directorate Meetings etc. Individual Feedback: If individual members of staff wish to discuss or obtain feedback in relation to a specific incident, complaint or claim the Governance department welcomes any enquiries and will seek to provide individual feedback to staff when this is requested and wherever this is possible and appropriate. National Lessons Learnt: The contents, findings and lessons to be learnt from national reports such as NPSA Patient Safety Observatory Reports and other national safety alerts are also distributed widely within the Trust to help to promote learning and awareness regarding risk management priorities and the prevention of risk. Please also refer to the Trust policy on responding to external reviews/guidance for further details on responding to and learning from national reports.

6.8 Process of Local Dissemination The mechanisms for providing information and feedback within the organisation are detailed above. Managers are responsible for ensuring that sufficient feedback and dissemination takes place at a local level to staff within their area / in relation to issues that have been reported. This should include: actions taken, lessons learnt, links to local risk registers, dissemination of Governance newsletters, notification and discussion of e-mail alerts and raising awareness of issues and trends following manager‟s monthly reports.

6.9 Cross Organisational Learning

In order to facilitate cross organisational learning a representative from the local commissioning PCT is a member of the Quality Committee.


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The Trust also provides a copy of the quarterly quality report to the local commissioning PCT. Examples of cross organisational issues & learning points which are raised and included in the Governance quarterly quality report include: transport, blood handing / traceability, appointments, discharge process, deaths, security incidents and learning from serious event investigations. Several services at the ROH are shared with University Hospital Birmingham NHS Foundation Trust. Where this is the case combined meetings take place to facilitate learning across both organisations. The Risk Manager regularly attends local network meetings to help to facilitate shared learning and to promote best practice amongst neighbouring Trusts. The Strategic Health Authorities Serious Untoward Incident Reporting process also provides the opportunity to record lessons learnt and for organisations to agree for this learning to be shared across the region and between other organisations. This therefore also provides an opportunity for cross organisational learning.

7.0 SERIOUS EVENT INVESTIGATIONS (INCIDENTS, COMPLAINTS, ACCIDENTS, CLAIMS) In order to ensure that local analysis occurs of all serious incidents, complaints, accidents and claims a local procedure for addressing these has been developed using best practice tools. The aim of the process is to ensure that a thorough analysis takes place in order to support the implementation of required actions and to facilitate learning. The purpose is to identify what happened and why it occurred rather than seeking to apportion blame regarding „who‟ is responsible. 7.1 Serious Event Definition

A „Serious Event‟ may be an incident, complaint, accident or claim which is of sufficient concern to warrant a thorough investigation. A serious event may arise when a patient, member of staff (including those working in the community), or member of the public suffers serious injury, major permanent harm or unexpected death (or the risk of death or serious injury) on either premises where health care is provided, or whilst in receipt of health care, or where actions of health service staff are likely to cause significant public concern. A serious event may also relate to any significant loss, damage or abuse of Trust assets or information or inappropriate use or disclosure of confidential information. A serious event is something which is likely to produce significant legal, media or other interest and which, if not properly managed, may result in loss of the Trust‟s reputation or assets. The Trust identifies serious events based on the definition of a serious event above. Those events considered to be serious are evaluated using the Trusts Risk Matrix. See Appendix 7 & Appendix 8 for matrix and supporting tool. The Strategic Health Authority refer to


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serious events as ‟Serious Untoward Incidents / SUIs‟ and requires that these events are reported to them. Refer to Section 10.3 of this policy for more details of the Trusts SUI reporting process which takes place via the PCT.

7.2 Objectives of a Serious Event Investigation The objectives of a serious event investigations are as follows:

To develop the capacity to learn from mistakes

To focus on systems and processes not individual performance

To examine extensively for underlying causes

To develop actions and follow up review to improve safety and quality

To modify systems and procedures where necessary

7.3 Procedures to follow for Serious Events Analysis An approved NPSA root cause analysis tool should be used when undertaking a serious event investigation. See Appendix 3 for overview details of the NPSA root cause analysis tools. The Royal Orthopaedic Hospital NHS Foundation Trust endorses the use of the NPSA root cause analysis tools. The Royal Orthopaedic Hospital believes that an appropriate root cause analysis tool should include the following elements:

Identification of human / other factors most directly associated with the event

Determination / investigation of, processes and systems related to the event

Analysis of the underlying systems and processes e.g. using a series of „why‟ questions

Identification of circumstances where redesign might help to reduce risk

Identification of risk points and their potential contributions to the event

Determination of potential improvements in processes or systems that would decrease the likelihood of such events in the future, (or a determination, after analysis that no such improvement opportunities exist


Diagram 2: Procedure for Analysis of Serious Events

A document is produced containing where relevant a chronology of events, any questions arising from the initial investigation, details of the RCA tool used / to be used and any other supporting information

In this meeting the document is reviewed, the content is clarified and changes made if required.

The panel will use the appropriate RCA tool to analyse the event, to look at each occurrence, to establish why events happened the way they did and to enable each root cause to be identified

This process should include a facilitator, to keep a record of the discussions as the team reviews the information and record the attendance at the meeting

An agreement should be reached on ‘what’ happened and ‘why’

Recommendations and proposed actions are made.. Compliance with these agreed actions is then monitored by the Quality Committee and exceptions sent to Integrated Governance Committee. Relevant Directors, Clinical Service Managers and Heads of Departments will also be provided with copies of RCA / Serious Event reports

Statements, reports chronologies etc are gathered together from all key staff involved

Key staff involved in the event

are identified

A lead investigator is identified to co-ordinate the collection of information, incident forms, complaints letters, coroners letters, statements, clinical records etc. This person will produce an initial report / chronology of events. The lead investigator will make a decision regarding which Root Cause Analysis tool is the most appropriate to be used. See Appendix 3. The lead investigator may be the risk manager, PALS & complaints manager, another senior manager or senior nurse or other appropriately trained member of staff. The relevant Directors and relevant Clinical Service Manager will either be directly involved in identifying the lead investigator or will be fully informed of who is co-ordinating the investigation

From the initial information provided a report will be

produced

The first report and the supporting information pack is sent to the staff involved for comments prior to a serious event panel meeting to review

the events

Is it a serious

event?

NO

Event managed via usual process as per policy

YES

Staff read / review report and send amendments in order for a complete draft to be ready for a serious event panel to meet to discuss the event

Final report completed and details sent to Quality

Committee

If Necessary A Serious Event review panel is set up to complete the analysis and produce recommendations

Check Appendix 1 for definitions or discuss with the Risk Manager / Health and Safety Advisor if the event

does not clearly fit into a definition

Quality Committee monitor & follow up completion of

recommendations / actions

Learning points developed and issued to all staff via, Reports, Newsletters, ROH All e mails managers monthly reports etc

Relevant staff / managers / Clinical Service Managers /

directors are sent details

Details from serious event analyses are included in Governance department quarterly reports

Quarterly reports are circulated to the Trust Board, CEO, EMT and Integrated Governance Committee to ensure the Trust Board & Directors / senior managers are informed and aware of the details & status of serious events


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7.4 Serious Event Panel A review panel may need to be established that reviews the events and findings and makes decisions regarding appropriate ongoing actions. This panel should comprise staff involved in the event, any relevant professional advisors and also any relevant Directors. There should be one other Director / Clinical Service Managers / Clinical Director present from a service area other than that in which the serious event occurred. They should review the report and Root Cause Analysis tool and make amendments and further recommendations as required. A acilitatator should support this process. . Relevant managers / Directors / staff should be informed of the agreed actions. Actions are to be implemented and progress reported to the Quality Committee to monitor progress

7.5 Serious Event Final Report

The serious event final report should contain the following information:

Details of those involved in investigating the event

Details of staff involved in the incident / asked to provide statements

Details of those who attended the investigation panel

A chronology of events

Questions arising from the initial investigation

Summary of findings from the Root cause Analysis

Recommendations

Appendices with other reference material as relevant

A template for the format of the final investigation report is available from the Governance Team. All investigation reports should be produced using this template format.

7.6 Monitoring Of Progress & Actions Following Serious Events In order to monitor progress and the implementation of actions following serious events, a regular report will be generated by the Risk Manager. This report will provide an update for the Quality Committee regarding the status and progress of actions identified from serious event investigations. Managers will be required to provide updates for this report on the request of the Risk Manager. This report will be reviewed and monitored by the Quality Committee.

7.7 Serious Untoward Incidents Relating To Personal Information Loss

There is a specific process for managing an SUI relating to personal information loss which is detailed in the Department of Health “Checklist for Reporting, Managing and Investigating Information Governance Serious Untoward Incidents (Gateway ref: 13177 - January 2010 )” available on the following website and held by the Information Governance Manager and in the Governance Department:


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http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/security/risk/suichecklist.pdf

The process followed is determined by the severity of the incident defined as follows:

0 1 2 3 4 5

No significant reflection on any individual or body Media interest very unlikely

Damage to an individual‟s reputation. Possible media interest, e.g. celebrity involved

Damage to a team‟s reputation. Some local media interest that may not go public

Damage to a services reputation/ Low key local media coverage.

Damage to an organisation‟s reputation/ Local media coverage.

Damage to NHS reputation/ National media coverage.

Minor breach of confidentiality. Only a single individual affected

Potentially serious breach. Less than 5 people affected or risk assessed as low, e.g. files were encrypted

Serious potential breach & risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected

Serious breach of confidentiality e.g. up to 100 people affected

Serious breach with either particular sensitivity e.g. sexual health details, or up to 1000 people affected

Serious breach with potential for ID theft or over 1000 people affected

7.8 Serious Adverse Reactions / Serious Adverse Events Relating To Bone & Cartilage Tissue

The reporting, investigation and management or SAEs and SARS events to the HTA should be managed in accordance with the SOP which is detailed in Appendix 11 of this policy.

7.9 Promoting Learning & Providing Feedback to Staff

Root Cause analysis reports are circulated to relevant heads of Departments, Director Leads and the Safety and Quality Committee. Sometimes an investigation will reveal an underlying system failure and when this is the case actions will be proposed and these will be followed up and monitored via the Quality Committee. Individual managers should inform the Risk Manager of progress regarding ongoing actions to ensure an up to date report is provided to the Quality Committee. Individual managers should also ensure staff within their area receive feedback regarding actions implemented. This may be by means of staff or departmental meetings. The ROH is keen to disseminate learning from serious event investigations. Following serious event investigations, learning points will be developed and disseminated. If individual members of staff wish to discuss or obtain feedback in relation to a specific serious event the risk management department welcome any enquiries and will seek to provide individual feedback to staff when requested and wherever this is possible and appropriate.




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7.10 Staff Performance Issues Related To a Serious Events

The NPSA Incident Decision Tree will be used as a tool for all patient safety related Serious Events to ensure that all staff are treated fairly. See Appendix 5. The emphasis of this tool is on exploring the contributory factors, which if allowed to persist, could create the potential for the incident to be repeated. Where the analysis of a patient safety event shows that there may be staff performance issues, decisions about the appropriate action to take should be made using this tool. This tool helps to clearly identify if there is a performance related issue or not. If it is decided there is a performance issue that needs to be addressed, this should be followed up via the normal Human Resources processes in conjunction with the line manager and relevant professional advisor. For repeated poor performance which breaches professional standards, or conduct, grossly unprofessional errors, criminal or malicious acts, further action should be considered.

7.11 Witness Statements

Formal signed witness statements would not normally form part of a Root Cause Analysis investigation report produced for learning purposes. Staff may wish to write factual reflective notes, but if these are shared with the organisation, they can become legally disclosable. Formal, signed witness statements are more relevant and appropriate to disciplinary or criminal investigations (see „Investigative interview guidance‟: www.npsa.nhs.uk/rca). Witnesses should be made aware that documents referred to in any interview or multidisciplinary review meeting may be disclosed in future (this may include reflective practice documents, personal and professional diaries, etc).

7.12 Never Events

Never Events are serious, largely preventable patient safety incidents that have been identified by the NPSA as incidents which should not occur if the available preventative measures have been implemented by the healthcare provider. Never Events must be reported as Serious Untoward Incidents and therefore be investigated. When a Never Event occurs

Follow the current ROH SUI and incident policy

Communicate with the patient, family or their carer as soon as possible in line with the Being Open requirements of this policy

Report as a Serious Untoward Incident to the governance department via Trust management reporting systems within two working days

Governance department to report to the commissioning PCT within 2 days

Governance department report to the National Patient Safety Agency

Undertake incident investigation


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Ensure learning is disseminated across the organisation to help prevent recurrence

For a list of Never Events, please refer to Appendix 13 of this policy.

7.13 Virtual SIRI Group The Virtual SIRI Group is a group of senior clinicians including surgeons, anaesthetists, senior nursing staff, the Trusts revalidation lead and where necessary relevant managers. The Group has been set up with the role and remit of reviewing and providing feedback and comments regarding the findings and recommendations of serious event investigations. The Virtual SIRI Group TOR can be found in Appendix 14 of this policy.

7.14 Point of Contact For Patients and Families

Serious event investigations may be triggered following incidents, letters of complaint or letters of claim. Depending upon the source; investigations are managed by the Risk Manager, Deputy Director of Nursing or a member of the Public & Patient Services Team. Patients and families need to have a point of contact whilst an investigation is taking place in order that any on-going queries can be addressed and in order that they know who to approach to make enquiries about progress with the investigation. During the investigation, the point of contact for the patient or family should be the department where the issue or concern was first identified or raised. Therefore the point of contact for investigations relating to incidents should be the Governance team and the point of contact for investigations relating to complaints should be the Public & Patient Services Team. If an issue has arisen from more than one source i.e. a letter of complaint is received and an incident form is also received, then a joint decision should be made regarding the coordination of the investigation and regarding the first point of contact.

8.0 BEING OPEN WHEN A PATIENT HAS BEEN HARMED 8.1 Principles of Being Open

In the majority of incidents, no harm occurs to patients. However where harm has occurred, patients have a right to expect openness from staff. Patients should be well informed regarding the healthcare they receive and if any errors, omissions or unforeseen circumstances have arisen during the course of their care. It is important to acknowledge an error, apologise and truthfully explain what has happened when patients have been harmed, even though this may be very difficult. The ROH is committed to ensuring that patients and/or careers should receive an apology as soon as possible after harm has occurred. Staff should feel able to apologise on the spot. Staff should be supported to do this. It is also important to note that saying sorry is NOT an admission of liability and it is the right thing to do.


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Where the issue is serious, a meeting to formally explain what has happened may be the most appropriate approach to being open. See Appendix 2 for the procedures to follow. When reporting a patient safety incident on Ulysses you will be asked to provide details of the severity of harm caused to the patient, whether the patient has been informed about the incident and details of the member of staff who spoke to the patient. Staff should provide all of this additional information when reporting a patient safety incident.

8.2 Support for Victims & Families Following a Serious Event The Trust are keen to ensure that patients and the families of patients who have been involved in a serious event are fully supported. The provision of support, advice and information following on a serious event is a priority for the Trust. The nature of the support that will be provided will be determined by the nature of the events that have occurred. Examples of the kind of support that may be required includes recall visits to the Trust, letters of explanation, provision of and access to helpline numbers, setting up a help desk, provision of information packs, 1-2-1 meetings with consultants or Trust staff, feedback from serious event investigations and so on. Arrangements for the provision of support following a serious event will be overseen and co-ordinated by the Governance Department. The Trust will maintain a record of all support offered and contacts made. No patient will be discriminated against on the basis of any incident which has occurred or complaint that has been made. Contact details of advocacy and support organisations are included in Appendix 2 of this policy.

8.3 Truthfulness, Timeliness and Clarity of Communication

Information about a patient safety incident must be given to patients, their families and carers in a truthful and open manner by an appropriately nominated person. Patients should be provided with a step-by-step explanation of what happened, that considers their individual needs and is delivered openly. Communication should also be timely; patients, their families and carers should be provided with information about what happened as soon as practicable. It is also essential that any information given is based solely on the facts known at the time. Healthcare professionals should explain that new information may emerge as an incident investigation is undertaken, and that patients, their families and carers will be kept up-to-date with the progress of an investigation. Patients, their families and carers should receive clear, unambiguous information and be given a single point of contact for any questions or requests they may have. They should not receive conflicting information from different members of staff, and the use of medical jargon, which they may not understand, should be avoided.


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8.4 Grading of Patient Safety Incidents to Determine Level of Being Open Response

8.4.1 No harm (including prevented patient safety incidents) Patients are not usually contacted or involved in investigations and these types of incidents are outside the scope of the Being open policy. Individual healthcare organisations decide whether „no harm‟ events (including prevented patient safety incidents) are discussed with patients, their families and carers, depending on local circumstances and what is in the best interest of the patient. 8.4.2 Low harm Unless there are specific indications or the patient requests it, the communication, investigation and analysis, and the implementation of changes will occur at local service delivery level with the participation of those directly involved in the incident. Reporting to the risk management team will occur through standard incident reporting mechanisms and be analysed centrally to detect high frequency events. Review will occur through aggregated trend data and local investigation. Where the trend data indicates a pattern of related events, further investigation and analysis may be needed. Communication should take the form of an open discussion between the staff providing the patient‟s care and the patient, their family and carers. Apply the principles of Being open 8.4.3 Moderate harm, severe harm or death A higher level of response is required in these circumstances. The risk manager or equivalent should be notified immediately and be available to provide support and advice during the Being open process if required. Apply the Being open process

8.5 Being Open Documentation

Throughout the Being open process it is important to record discussions with the patient, their family and carers as well as the incident investigation. Required patient safety incident documentation includes:

a copy of relevant medical information which should be filed in the patient‟s medical records;

incident report(s);

records of the investigation and analysis process. The incident report and record of the investigation and analysis process should be filed separately to the patient‟s medical records as a patient safety incident record, and kept as part of the healthcare organisation‟s clinical governance reports. Written records of the Being open discussions should consist of:

the time, place and date, as well as the name and relationships of all attendees;


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the plan for providing further information to the patient, their family and carers;

offers of assistance and the patient‟s, their family‟s and carers‟ response;

questions raised by the family and carers, and the answers given;

plans for follow-up meetings;

progress notes relating to the clinical situation and an accurate summary of all the points explained to the patient, their family and carers;

copies of letters sent to the patient, their family and carers, and the GP for patient safety incidents not occurring within primary care;

copies of any statements taken in relation to the patient safety incident;

a copy of the incident report.

A summary of the Being open discussions should be shared with the patient, their family and carers.

8.6 Point of Contact For Patients and Families

Please see section 7.13 above. 9.0 RAISING CONCERNS Whistle blowing Policy It is the responsibility of the local manager / clinical lead to ensure that all staff within their area of responsibility know about and are aware of the contents of the Trusts Whistle blowing Policy. The Trust encourages a climate of openness and honesty between managers and staff, where staff feel that they have the opportunity to raise issues in the knowledge that legitimate concerns will be dealt with speedily and appropriately. The Trust‟s Whistle blowing policy aims to:-

Encourage staff to feel confident in raising serious concerns and to question and act upon such concerns;

Provide avenues for staff to raise concerns and receive feedback on any action taken;

Ensure that staff receive a response to their concerns

Ensure staff are aware of how to pursue concerns if they are still not satisfied

Reassure staff that if they raise concerns in good faith reasonably believing these concerns to be true, they will be protected from possible reprisals or victimisation.


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10.0 EXTERNAL REPORTING TASKS 10.1 External Reporting Requirements

There is a wide range of external organisations that are required to be informed and notified of a Serious Event occurring. This reporting supports shared learning for these events. Staff must inform the relevant organisation and also let the Risk Manager know when this requirement has been fulfilled and when an external report has been completed. External organisations to whom reports may need to be made include: Strategic Health Authority via STEIS Health and Safety Executive Medicines Healthcare and Regulatory Agency including SABRE National Patients Safety Agency General Practitioner Relevant Primary Care Trust NHS Litigation Authority / Trust Solicitors Coroner‟s Office Public Health Department General Medical Council Nursing and Midwifery Council Patients Advice and Liaison Services Police Social Services Safeguarding Children Committee Health Protection Agency Counter Fraud and Security Management Service South Birmingham PCT SHOT / SABRE Human Tissue Authority DOH - The Ionising Radiation Regulations 2000 CQC Ombudsman It is the responsibility of the Governance Department and the Risk manager to monitor that the appropriate bodies are informed and that this information is kept with the incident information.

10.2 Mandatory External Reporting Requirements

Incidents required to be reported externally are listed in Appendix 6 along with details of who within the Trust is responsible for reporting to each of the relevant external authorities. These incidents must be notified to the risk management department and managed in the same way as all other incidents in accordance with the requirements of this policy. It is the responsibility of the Governance Department and the Risk Manager to monitor all external reporting and to ensure that the Trusts external reporting requirements are met. The risk manager must first be informed


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of any externally reported incident. The risk manager will keep a record of all incidents that have been externally reported.

10.3 Process for Reporting Serious Untoward Incidents to the Strategic Health Authority / PCT

The Strategic Health Authority requires Trusts to report to them „Serious Untoward Incidents‟. The Trust reports incidents to the Strategic Health Authority in accordance with the Strategic Health Authorities Serious Untoward Incident Reporting Policy and Procedure. If an incident constitutes a SUI based on the definitions provided by the Strategic Health Authority, the Trust must immediately inform the Strategic Health Authority via the local commissioning PCT. An update report must be submitted to the Strategic Health Authority within 72 hours. The PCG will update the UNIFY / STEIS system on behalf of the Trust. . As a Foundation Trusts the ROH route of reporting to the Strategic Health Authority will be via the South Birmingham PCT to ensure the Trust fulfils its obligations to the PCT in terms of providing them with appropriate notification of SUIs. The PCT SUI notification form (See Appendix 10) will be completed by the Risk Manager and sent electronically to the PCT in accordance with the timeframes as outlined above. If an incident is being reported to the SHA / PCT as a SUI the Trusts relevant senior manager will be briefed and notified of the details and circumstances relating to the incident.

10.4 Process for Reporting Incidents to the National Patient Safety Agency (NPSA)

The Trust will regularly report patient safety incidents to the NPSA via the national reporting and learning set (NRLS) using the uploading facility between Ulysses and the NRLS. If this system fails the trust will manually report serious patient safety events using the web based e-form which is available on the NPSA website. This fall back system of reporting will be used only if the link fails and until such time as the links between NPSA and the NRLS are restored. All staff can access the NPSA website and may anonymously report events to the NPSA at any time. The NHS are required by Common law duty of confidentiality and the Data Protection Act (reference DPA98 first principle) not to send any person identifiable data to third parties including the NPSA, without the consent of the persons concerned. The NRLS is designed in such a way as not to capture person identifiable data in its reporting dataset, however, in order to ensure that no patient identifiable information is potentially included elsewhere in the incident form (for example in the free text used for the description of what happened), the Risk Manager will review the contents of all incident forms before they are submitted to the NRLS.


38

10.5 Process for Reporting Incidents to the Medicines & Healthcare Products Regulatory Agency

The Trust will manually report relevant incidents relating to medicines and medical devices to the MHRA using the web based incident reporting form found on the MHRA website.

10.6 Process for reporting RIDDOR Reportable Incidents to the Health & Safety Executive

The Trust will automatically report any incident reportable under RIDDOR this will be done using the link on the HSE website to the RIDDOR reporting centre in Wales and in accordance with the required timeframes i.e. within 10 days of the incident / accident occurring. This will be done by the Health & Safety Advisor.

11.0 TRAINING 11.1 RISK MANAGEMENT TRAINING – LEVEL 1 (Overview)

The Risk Manager is responsible for the provision of general Risk Management awareness training for staff as per the Trust‟s training needs analysis (see Mandatory Training Policy). This includes generic risk management training which includes introductory information regarding risk registers, incident reporting, being open and root cause analysis awareness.

11.2 RISK AWARENESS & RISK MANAGEMENT – LEVEL 2

The Risk Manager and Governance Team are responsible for the provision of Level 2 Risk Management and risk awareness training for staff as per the Trust‟s training needs analysis (see Mandatory Training Policy). This includes the management of incident outcomes, action plans, learning lessons, dissemination, local and corporate risk registers, escalation of risks and policy development etc. The Trusts Learning & Development Department also run a Management Development Programme for managers. There is a component of this programme which covers Governance, Risk, Complaints and legal processes.

11.3 RISK AWARENESS INTRODUCTORY TRAINING – LEVEL 3 The Director of Nursing and Governance is responsible for the delivery of induction and update training around risk management including incident, investigations, sharing learning and dissemination, risk registers, assurance framework, MaPSaF, NHSLA standards, CQC requirements, incident reporting and being open. etc. as per the Trust‟s training needs analysis (see Mandatory Training Policy).

11.4 ROOT CAUSE ANALYSIS (SERIOUS INVESTIGATIONS)

Nominated investigators who are likely to play a key role in supporting root cause analysis investigations should also receive root cause analysis awareness training as per the Trust‟s training needs analysis (see Mandatory Training Policy). The cascading of RCA awareness training


39

amongst those likely to have a role in supporting RCA investigations will be provided by the Governance Department.

11.5 Governance Road shows

The Governance department run roadshows to promote awareness amongst all staff regarding key Governance & Risk Management priorities. For examples incident reporting roadshows to raise awareness amongst staff regarding the system for reporting incidents, what type of events to report, the importance of reporting near misses, their role in incident reporting, the principle of being open etc.

11.6 Risk Assessment Training

Please refer to the Risk Management Strategy and Mandatory Training Policy.

11.7 Monitoring and non-attendance

The Governance Team record attendance at the specific risk management/ incident training and the Learning and development team will collate this information along with subject matter covered as part of the Mandatory training days (See Mandatory Training Policy). Non attendance at training is followed up as per the Trust‟s Mandatory Training policy.

12.0 COMPLIANCE MONITORING & SUCCESS INDICATORS Policy compliance audits will be undertaken annually as part of the Governance Departments Audit Programme. Ad-hoc audits will also be carried out as necessary or as required by external agencies e.g. Care Quality Commission, DoH, Strategic Health Authority, Social Care Inspectorate etc. Audits of success indicators will be carried out annually.. Results and feedback reports will be provided for the Quality Committee. Recommendations & implementation plans will be developed. Monitoring of ongoing actions will be overseen by the Quality Committee. In action plans arising from audits of compliance, specified Managers will be named and given responsibility for carrying out required actions. The following is a list of the key performance indicators that can be measured and monitored to ensure this policy is being complied with. These success indicators will be audited regularly and feedback reports will be provided for the Quality Committee. Following these audits recommendations and implementation plans will be developed. Monitoring of ongoing actions will take place. Monitoring will be overseen by the Quality Committee. 12.1 Success Indicators for Incident Reporting

No Indicator Factor to be Monitored Method of Monitoring

Incid

ent

Reporti

ng

1 Role and responsibilities of staff

Are staff aware of their responsibility for reporting errors, near misses and incidents

Spot questionnaire

2 Role and Are managers aware of their Spot questionnaire and


40

responsibilities of managers

responsibility for completing the electronic management review of incidents

analysis of incidents

3 Staff awareness re: incident reporting

% of staff who know how to report an incident

Spot questionnaire

4 Reporting of Incidents in all areas throughout the Trust

Incident forms are received from all areas across the Trust

Analysis of Incidents

5 External Reporting to the NPSA

Appropriate incidents are reported to the NPSA

Figures for Incidents reported to NPSA and review of the 6 monthly NPSA summary reports

6 Reporting of SUIs to the Strategic Health Authority / PCT

Appropriate incidents are reported to the Strategic Health Authority / PCT

Figures for Incidents reported to SHA / PCT

7 Staff awareness re: whistle blowing policy

% of staff who are aware of the process for raising concerns and existence of the Trusts Whistle blowing policy

Spot questionnaire

12.2 Success Indicators for Investigation of Events

Investig

atio

ns


1 Role and responsibilities of staff

Staff understand the purpose of RCA investigations and co-operate as required in gathering / providing information

Spot questionnaire

2 Reporting and investigation of incidents, complaints and claims is included in mandatory training

Provision of appropriate training to staff Contents of mandatory training programme

3 Completion of management review of Incidents

% of incidents which have received a management review

Analysis of Incidents

4 Communication to all staff regarding lessons learnt

Quarterly quality reports are produced & disseminated appropriately within the Trust

Review minutes of relevant meetings and undertake spot questionnaire of staff

5 Sharing information with external stakeholders

Quarterly quality reports are provided to the PCT and representatives from the PCT are members of the Trusts Quality Committee

Minutes of Quality Committee and evidence of dissemination of reports to the PCT

6 Provision of staff training in undertaking RCA investigations

Number of current members of staff trained in and leading root cause analysis investigations

Figures on numbers of RCA trained staff

7 Severity of the event

% of staff who are aware that there are 3 categories of incident (minor, moderate and serious)

Spot questionnaire


41

8 Levels of investigation in relation to the severity of the event

% of staff who are aware that there are different levels of investigation based on the classification and severity of the event and that more serious events require a full RCA

Spot questionnaire

9 Monitoring of progress against action plans

% of Quality Committee minutes where ongoing actions following serious event investigation is discussed

Review of minutes

10 Levels of investigation

Evidence that a full range of different levels of investigation have been undertaken in the preceding 12 months including details of the number of SIRI investigations.

Review of 12 months worth of investigation reports

12.3 Success Indicators for Analysis of Events


Analy

sis

1 Duties: The PALS & Complaints Manager and Risk Manager work closely together to categorise and analyse trends in complaints, incidents and claims

Aggregated analysis of complaints, claims and incidents takes place and is incorporated into the quarterly quality reports

Review contents of the quarterly governance reports

2 Risks derived from individual incidents, complaints and claims are assessed using a standardised methodology

Do the relevant policies all use the same matrix for assessing the risks derived from each of these sources? Do each of the modules on Ulysses use a standardised methodology

Review contents of the incident, claims and complaints policies and review the modules of the Ulysses web based system

3 Data relating to complaints claims and incidents is gathered and stored in centralised database in order to facilitate joint analysis of events

Ulysses is actively used for recording data relating to incidents, complaints and claims

Review of Ulysses database to ensure data is being gathered for incidents, complaints and claims

4 There is a co-ordinated approach to the management of risks and use of treatment options

The treatment options listed in this policy are reflected in the treatment options on local risk registers

Review contents of local risk register s from across the Trust.

5 Reports are regularly produced every quarter to analyse trends arising from incidents, complaints and claims

Frequency of quarterly quality reports

Number of quality reports produced in the last 12 months

6 Governance quarterly reports include qualitative & quantitative data as outlined in this policy

Details are included regarding the number of events, type of events and there is also inclusion of a discussion regarding trends in relation to complaints, claims and

Review contents of the quarterly governance reports


42

incidents

7 Information and feedback regarding analysis is communicated to the relevant groups and individuals

Distribution of the Governance report takes place to the relevant committees. Data is provided on a monthly basis for the CSMs Directorate performance meetings. Data is incorporated in mandatory training

Review contents of minutes of relevant committees, IGC, Quality Committee, Trust Board & CSMs Directorate performance meetings. Review contents of mandatory training programme.

12.4 Success Indicators for Learning & Promoting Improvements

Impro

vem

ents

No

Indicator Factor to be Monitored Method of Monitoring

1 Local learning from incidents complaints and claims takes place

Does the incident reporting form have the facility for recording local lessons learnt? Is information recorded in this section of the incident form?

Review of completed incident forms submitted on Ulysses

2 Directorate meetings and s reports to support local learning from incidents complaints and claims

Do managers receive monthly reports regarding details of incidents, complaints and claims for use, discussion and dissemination within local areas

Monitoring minutes of directorate meetings to show evidence of discussion of complaints, claims and incidents within the previous 12 months

3 Organisational learning from incidents, complaints and claims takes place

Details of learning points following incidents, complaints and claims are discussed at The Quality Committee

Review minutes of Quality Committee meetings

4 Opportunities for cross organisational learning from incidents complaints and claims are actively identified and utilised

The Trusts quarterly quality reports are provided to the PCT

Review frequency with which reports are provided to the PCT

5 Opportunities for cross organisational learning from incidents complaints and claims are actively identified and utilised

The NPSA Patient Safety Observatory reports are regularly discussed at the Quality Committee

Review minutes of Quality Committee meetings

6 Lessons learnt from root cause analysis investigations results in changes which are embedded into the organisational culture and practice

Is information regarding lessons learnt and changes implemented following root cause analysis investigations included in Governance newsletters / Trust wide reports, e-mails etc

Review of the information which has been disseminated from the Governance Dept and Public & Patient Services Team in terms of reports, newsletters , e-mails etc

7 Continuous monitoring of the effectiveness of risk reduction measures takes place

Are risk registers and risk register action plans regularly monitored and updated to allows continuous monitoring of risk reduction measures

Review corporate risk register and residual risk scores. Monitor existence of local risk registers and local risk register action plans and frequency of review.


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12.5 Success Indicators for Being Open if a Patient Has Been Harmed

Bein

g O

pen


1 Staff are aware of the existence of the Trusts Being Open policy and the steps which are involved in the being open process

% of staff who are aware that the Trust has a „Being open‟ policy

Spot questionnaire

2 Processes are in place for encouraging and ensuring open communication with patients, relatives and carers when things go wrong

Is there evidence that when things go wrong the Trust shares the findings of investigations with patients, relatives and carers?

Evidence that copies of investigation reports have been shared with patients, families and relatives in the last 12 months

3 Processes are in place for acknowledging and explaining to patients, relatives and carers when things go wrong

Is there evidence that when things go wrong the Trust acknowledges and provides an explanation to the patients, relatives and carers regarding what has happened?

Evidence from the contents of complaints response letters and correspondence and meetings with patients, relatives and carers that the Trust acknowledges and explains when things go wrong

4 Being Open culture % of staff who recognise the requirement for encouraging open communication with patients, relatives and carers and who would choose to acknowledge and apologise to a patient if they had been involved in a patient safety incident

Spot questionnaire

5 Timeliness, truthfulness and clarity of communication regarding being open

% of staff who are aware of the requirements for truthfulness, timeliness and clarity of communication when being open

Spot questionnaire

6 Staff awareness regarding how to access additional support for patients if required e.g. PALS, Counselling services etc

% staff who are aware how to access additional support e.g. PALS, counselling services, advocacy support groups, charities, etc

Spot questionnaire

7 Staff awareness regarding requirements for documentation of communication

% staff who are aware of the requirements regarding documentation of communication

Spot questionnaire


44

13.0 REFERENCES

NHSLA Risk management Standards, (NHS Litigation Authority, April 2009)

http://www.nhsla.com/

Seven Steps to Patient Safety, A guide for NHS staff (NPSA, Dec 2003)

http://www.npsa.nhs.uk/site/media/documents/499_sevensteps_overview(2).pdf

Being Open (NPSA, safer practice notice 2009)

http://www.npsa.nhs.uk/display?contentId=4238

Building a Safer NHS for patients Implementing An (Department of Health, 2001)

Organisation with a Memory

http://www.npsa.nhs.uk/site/media/documents/250_building%20safe(1).pdf

Doing Less Harm (Department of Health, Aug 2001)

An Organisation with a Memory (Department of Health, 2000)

http://www.dh.gov.uk/assetRoot/04/08/89/48/04088948.pdf

Reporting of Injuries, Diseases and (Health and Safety Executive, 1995)

Dangerous Occurrences Regulations (RIDDOR)

http://www.hse.gov.uk/

Incident Decision Tree (NPSA, 2005)

http://www.ahrq.gov/downloads/pub/advances/vol4/Meadows.doc

Records Management: NHS Code of Practice (DOH 2006)

http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4131747&chk=tMmN39

Regulation of Investigatory Powers Act 2000 (Office of the Public Sector

Information) http://www.opsi.gov.uk/acts/acts2000/ukpga_20000023_en_1

Working together to Safegaurd Children – 2006

Childrens Act 2004

Checklist for Reporting, Managing and Investigating Information Governance Serious Untoward Incidents (Department of Health Gateway ref: 13177 - January 2010 )


http://www.nhsla.com/

http://www.npsa.nhs.uk/site/media/documents/499_sevensteps_overview(2).pdf

http://www.npsa.nhs.uk/display?contentId=4238

http://www.npsa.nhs.uk/site/media/documents/250_building%20safe(1).pdf

http://www.dh.gov.uk/assetRoot/04/08/89/48/04088948.pdf

http://www.hse.gov.uk/

http://www.ahrq.gov/downloads/pub/advances/vol4/Meadows.doc




http://www.opsi.gov.uk/acts/acts2000/ukpga_20000023_en_1




45

APPENDIX 1 Definitions Error Failure of a planned action to be completed as intended (i.e. error of execution) or the use of a wrong plan to achieve an aim (i.e. error of planning) (as defined in „To Err is Human‟, Institute of Medicine, 2000). Staff Harm As defined by Health and Safety - Relates to employees, contractors, subcontractors, students, volunteers and visitors. Means illness or injury or both; and “to harm”, “harmed”, and “unharmed” have corresponding meanings Incident An incident is an untoward event that has happened to or occurred in relation to a patient(s), staff, visitor(s), Trust asset, property or information; the result of which is harmful, potentially harmful, leads to harm, causes damage or loss of reputation or represents a failure to act in accordance with relevant professional codes or legislation. This definition includes near misses. An event may be an action or omission to act. Examples are:

any event that contravenes any law, regulation, ROH policy, procedure or standard;

any event that causes any person to be harmed or, in different circumstances, might have caused any person to be harmed;

any event that has resulted in harm to patients/clients, staff, contractors or visitors that has occurred during service provision, or that has been discovered upon entry to the service;

Medicine events. This includes all incidents related to the administration of medicines (patient related);

patient falls;

any event that results in disruption in services;

Any event that results in unsatisfactory quality of services. This may include events related to ROH‟s interface with other organisations e.g. service providers.

any event that may result in legal action, including any claim or any threat of any claim against ROH, verbal or written;

any occurrence that has the potential to result in negative media coverage (not otherwise listed);

a product fault (consumables or equipment);

unexpected return of a patient to operating theatre;

admission resulting from adverse consequences following treatment by another health provider;

unexpected infection known to have been acquired in the course of treatment provided by ROH;

injury arising from treatment or care e.g. diathermy burn, development of pressure ulcers;

deliberate self-harm and/or attempted suicide of any person while in ROH;

acts of aggression/harassment, whether physical or non-physical;

damage to, or loss of, property, plant or equipment belonging to patients / clients, staff, visitors or ROH occurring in the course of service provision

events that results in damage to the environment

breach of patient confidentiality

misuse or abuse of Trust property

security issues or breaches of security


46

Serious Incident A „serious untoward incident‟ (SUI) may also be known as a (SIRI). The term SIRI stands for „serious incident requiring investigation‟. In the context of this policy and in the context of the management of serious events, the terms SUI and SIRI are used interchangeably. An SUI or a SIRI is an accident or incident when a patient, member of staff (including those working in the community), or member of the public suffers serious injury, major permanent harm or unexpected death (or the risk of death or serious injury) on either premises where health care is provided, or whilst in receipt of health care, or where actions of health service staff are likely to cause significant public concern. A serious incident may also be any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals. This applies irrespective of the media involved and includes both loss of electronic media and paper records. . A serious untoward incident is an event which is likely to produce significant legal, media or other interest and which, if not properly managed, may result in loss of the Trust‟s reputation or assets. Serious incidents require reporting to the Strategic Health Authority either directly or in the case of Foundation Trusts via the local commissioning PCT. See the section of this policy on external reporting. Serious Event A „Serious Event‟ may be an incident, complaint, accident, claim, or near miss which is of sufficient concern to warrant a thorough investigation. A serious event may arise when a patient, member of staff (including those working in the community), or member of the public suffers serious injury, major permanent harm or unexpected death (or the risk of death or serious injury) on either premises where health care is provided, or whilst in receipt of health care, or where actions of health service staff are likely to cause significant public concern. A serious event may also relate to any significant loss, damage or abuse of Trust assets or information or inappropriate use or disclosure of confidential information. A serious event which is likely to produce significant legal, media or other interest and which, if not properly managed, may result in loss of the Trust‟s reputation or assets. Clinical Incident Any incident affecting the patient‟s treatment, care or clinical outcome. Manager The person to whom an incident / event has been reported and who has management responsibility for the incident including the acknowledgement of the incident and the completion of the management actions on the relevant section of the electronic form. Near Miss A near miss will be defined as „a situation in which an event or omission does not develop to cause harm but had the realistic potential to do so (Department of Health 2001). Accident An accident is any unplanned or unexpected event, other than a clinical incident which results in personal injury, loss or damage to property. Ill-Health Any medical condition, which is either caused by, or made worse by work or by an adverse incident. Security Incident


47

Any incident that requires the attention of the security manager (LSMS). The Counter Fraud & Security Management Services (CFSMS) requires that the LSMS is kept informed of all security related incidents. Incidents which are reportable to CFSMS are any occurrences of physical harm resulting from a security incident. These incidents are to be reported to CFSMS by LSMS. Fire Any incident which has resulted in a fire or a fire alarm being sounded. Radiation Incident Any of the above situations which involve ionising or non-ionising radiation. Confidentiality Any breach in the security and confidentiality of patient information or misuse of Trust Business information or incident relating to equipment security is to be reported. This includes data loss or corruption of data. Root Cause Analysis (RCA) This is a structured analysis that aims to identify the true cause of an incident and the actions necessary to eliminate it. Medication Error Any error or omission relating to the prescribing, dispensing, preparation, storage, administration, authorisation or recording of drugs and medication whilst on hospital premises or whilst a patient is under the care of the hospital. LSMS Local Security Management Specialist MaPSaF Manchester Patient Safety Framework PCT In 2011, the roles of neighbouring Primary Care Trusts (PCTs) were amalgamated and brought together into the newly formed Primary Care Clusters. Within this policy term PCT is used to reflect the roles and functions of the Trust‟s local commissioning cluster, the Birmingham and Solihull Cluster.


APPENDIX 2 Procedures for Being Open When a Patient Has Been Harmed

If a meeting is required ask the patient and/or their carers who they would like to be present. This will usually be the most senior person responsible for the patient‟s care and/or someone with experience and expertise in the type of incident that has occurred should meet with the patient/carer. If necessary hold a pre-meeting so that everyone knows the facts and understands the aims of the meeting.

Ensure that those members of staff who do attend the meetings can continue to do so; continuity of care is very important in building relationships

The person taking the lead should be supported by at least one other member of staff, such as risk manager, nursing or medical director, or member of the healthcare team treating the patient

Consider each team member‟s communication skills; they need to be able to communicate clearly, sympathetically and effectively

Meet as soon after the incident as possible and consider the patient‟s and/or their carer‟s home and social circumstances and that the time is suitable / where possible confirm the details in writing.

Use a quiet room and remember to not host the meeting near to the place where the incident occurred if this may be difficult for the patient and/or their carers. Maintain privacy and confidentiality.

Speak to the patient and/or their carers as you would want someone in the same situation to communicate with a member of your own family - Do not use jargon or acronyms: use clear, straightforward language. Consider the needs of patients with special circumstances, for example, linguistic or cultural needs, and those with learning disabilities.

Introduce and explain the role of everyone present to the patient and/or their carer and ask them if they are happy with those present.

Acknowledge and explain what happened and apologise on behalf of the team and the organization (expressing regret is not an admission of liability)

Ensure truthfulness; stick to the facts that are known at the time and assure them that if more information becomes available, it will be shared with them

Do not speculate or attribute blame, and suggest sources of support and counselling e.g. PALS service

Check they have understood what you have told them and offer to answer any questions and provide a named contact who they can speak to again.

Clarify in writing the information given, reiterate key points, record action points and assign responsibilities and deadlines

The patient‟s notes should contain a complete, accurate record of the discussion(s) including the date and time of each entry, what the patient and/or their carers have been told, and a summary of agreed action points


49

Maintain a dialogue by addressing any new concerns, share new information once available and provide information on counselling, as appropriate.

Ensure that the patient understands that there will be no discrimination against them because of what has happened and that there will be no adverse effects regarding the care or continuity of care that they receive

If the patient feels that they have lost confidence in the healthcare professionals treating them they should be provided with support and the opportunity for their treatment to be continued with their wishes taken into consideration and for these wishes to be accommodated wherever possible

Offer alternative options for the provision of additional support if required


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Being Open - Contact Details For Support Services & Organisations Faith Representatives

Please see details on the Trusts intranet or contact a member of the Governance team for a contact list. Coroners Office

Coroner's Court, 50 Newton Street, Birmingham, B4 6NE - Tel: 0121 303 4088 Police

Lloyd House, 2 Colmore Circus Queensway, Birmingham, B4 6NQ - Phone: 0845 113 5000

ASSIST

Web Address http://www.assisttraumacare.org.uk/home-page Helpline : 01788 560800

Disaster Action Web Address http://www.disasteraction.org.uk/ - Tel: 01483 799 066

Cruse Bereavement Care - Day by Day Helpline Web Address http://www.crusebereavementcare.org.uk/ - Day by Day Helpline: 0844 477 9400 -

British Red Cross Society

HQ: 44 Moorfields, London, EC2Y 9AL Tel: 0870 170 7000 – Local Office: Bradbury House, 7 Lowe St, Camp Hill, Birmingham B120ER, Tel: 0121 766 5444, Fax: 0121 722 4944 Cruse Bereavement Care - Birmingham

3rd

Floor, King Edwards Building, Corporation St, B‟ham, B4 6SE, Tel: 0121 687 8011 Mind

17 Graham St, Hockley, B‟ham, B1 3JR, Tel: 0121 608 8001 Raynet

Web Address: http://www.raynet-uk.net/main/zones.asp?zone=9 24-hour Emergency Contact number: 0303 040 1080

Salvation Army

West Midlands Division: 102 Unett St, Hockley, Birmingham, B193BZ, Tel: 0121 507 8500 Email: [email protected] Samaritans

Local Office: 13 Bow St, B‟ham, B11DW – 0121 666 6644. National help line: 0845 790 9090 Search and Rescue Association in Disasters (SARAID)

Web Address: http://www.saraid.org.uk/ St John Ambulance - West Midlands

100 Lionel St, Birmingham, B3 1DG. Tel: 0121 236 6660 Victim Support - West Midlands Regional Area Office

Winton House, Stoke Road, Stoke-on-Trent, Staffordshire, ST4 2RW Tel: 0300 303 1977 Women's Royal Voluntary Service

Registered office: Cardiff Gate, Beck Court, Cardiff Gate Business Park, CARDIFF CF23 8RP

SARI – Support Against Racial Incidents

P.O. Box 2454, Bristol, BS2 2WX - Telephone: 0117 942 0060

POhWER (Incorporating ICAS - Independent Complaints Advocacy Service and IMCA – Independent Mental Capacity Advocates)

iBIC Holt Court South, Jennens Road, Aston Science Park, Birmingham , B7 4EJ Tel: 0300 456 2370 - Minicom: 0300 456 2364 - Fax: 0300 456 2365

http://www.assisttraumacare.org.uk/home-page

http://www.disasteraction.org.uk/

http://www.crusebereavementcare.org.uk/

http://www.raynet-uk.net/main/zones.asp?zone=9

mailto:[email protected]

http://www.saraid.org.uk/


APPENDIX 3 NPSA Tool Kit Matrix

The NPSA has developed tools for use when investigating incidents. The NPSA website: http://www.npsa.nhs.uk/ has the full details. Listed below is a brief description of the various tools, as recommended by the NPSA:

Tool

When to use

Description

Attributes

Difficulties

Narrative chron-ology

Best suited for compact and non-complex incidents. Fits well at the start of a more complex investigation report to give a concise overview of what happened.

Straightforward chronological account of what happened.

Well accepted format for presenting information.

Difficult to pick out the salient points. Not ideally suited to forming a complete understanding of what happened when multiple directorates / departments are involved.

Timeline

Where it is anticipated that the incident contains more than one isolated episode of procedural failure.

Method for mapping and tracking the chronological chain of events involved in an incident.

Clarity about the key components of the incident. Views the whole incident in one diagram. Identifies information gaps and questions needed for interviews. Makes sense of complex data and information.

Not always suited to episodes of care which are lengthy or extremely complex e.g. mental health cases. Requires a level of computer literacy to integrate timelines into a final report.

Time Person Grid

When a number of people were involved in an incident or part of an incident and you need to know where they were.

Tabular mapping tool that enables you to track the movements of people.

A quick and efficient tool to identify where all staff were when an incident was happening. A useful mechanism for identifying where you have data or information gaps. It maps onto a timeline effectively.

It can only be used for short timeframes. People cannot always remember where they were at specific times, especially if the case did not seem particularly significant to them at the time. Focuses on individuals.

Tabular Timeline

Any type of incident, very useful for those that involve a long time scale and those in primary care and mental health or where multiple agencies are involved.

Development of the timeline, but Includes additional fields – supplementary information, good practice and care/service delivery problem.

Allows the investigation team to map the chronology in a diagrammatic format, but allows additional information (e.g. CDP/SDP, supplementary information and good practice) to be mapped at the

Some people prefer to map a case in a more fluid and dynamic way than this format allows.

http://www.npsa.nhs.uk/


Tool

When to use

Description

Attributes

Difficulties

appropriate point on the chronology. This makes the technique easy to read and resource efficient. Technique allows you to identify data gaps quickly. Additional information can be added where needed, without the need of reformatting.

Brain-storming

To generate a list of problem areas that can be improved. Identify possible contributory factors Consider what error reduction strategies or recommendations the organisation should instigate.

Mechanism to generate as many ideas as possible around a given subject area. Can be: Unstructured – everyone is free to produce ideas. Structured – each participant produces an idea in turn.

Quick and simple. Does not have to involve detailed case review. Allows free thought and consideration of unusual ideas. Good for on the spot problem analysis and solution generation.

Can be unstructured. May result in group think as dominant voices may sway the group. May fail to consider deep-rooted organisational, cultural and leadership issues Can be dominated by individuals.

Brain-writing

To protect the anonymity of participants. There is a mixture of senior and junior personnel in the group. Complex ideas are expected. Feared that some people may dominate the brainstorming.

Essentially the same as brainstorming but allows the group to generate ideas anonymously and in a short time frame. These can be mapped onto a flip chart and considered by the group.

Retains anonymity of individual. Encourages all participants to take part. Complex ideas are expected. Effective if sensitive issues to be discussed. Structured approach.

Poor facilitation may threaten the anonymity of individuals and thus the safety aspects of the technique. Can be seen as secretive for individuals who have an open style. Can generate an unmanageable list of ideas or a list that is difficult to prioritise.

Nominal group technique (NGT)

To prioritise the group as a whole. Gain consensus about what ideas to explore further.

Simple consensus building and voting tool that enables all participants to achieve a consensus. To assist a MPT in achieving consensus about care/service delivery problems.

Allows people to provide their views anonymously and safely. Quick and simple. Limits group think and produces good census building within the group. Is time efficient?

Poor facilitation can Threaten:: anonymity and safety aspects The ability of this technique to enable a democratic consensus to be achieved.


Tool

When to use

Description

Attributes

Difficulties

Change analysis

Flexible tool that lends itself to a variety of uses. When a system, task, piece of equipment has worked and then fails. When it‟s difficult to know where to start with problem identification or exploration. Suspect a change may have contributed to inappropriate action or equipment failure.

Compares a process when it is well defined and effective with the same process when it has not functioned well or, following a failure.

Useful when the cause of the incident is obscure, not sure where to start, don‟t understand the specialty. To identify where a failure occurred in a process. Systematic, structured and rational process – reduces the risk of oversight. Can be used for both simple and complex incidents.

May raise more questions about the normal procedure, or the process employed in the care of the patient (s) than answers. May require the analyst to research the subject area further.

Barrier analysis

Can be used proactively and retrospectively to identify missing or failed barriers. Evaluate proposed corrective actions by assessing the strength of each action and selecting the strongest ones.

Critical analysis of the defenses or control measures in place. Identifies missing or failed defenses.

Unbiased analysis of control measures in place. Identification of additional control measures that may have prevented the incident from occurring. Assists in the identification of causal factors.

Inexperienced analysts assume more compliance with human action and administrative barriers than actually occurs. Danger in not recognising / identifying all failed barriers. Can be possible to overlook the stress on individuals that results from over-reliance on human barriers.

Five whys

To question each identified primary cause of a problem, to identify whether this is a symptom, an influencing factor or a root cause.

Allows deeper questioning as to the cause of a problem and identify whether it is a symptom or a root cause. To question each CDP / SDP identifying the primary cause of the problem.

Allows individuals / groups to drill down the causal pathway. Simple and effective tool Works well in a group and individually.

Causal analysis can be constrained by mind set and lack of breadth and depth. Why can be asked as frequently as required to get to the root cause, asking 5 times may be inappropriate.

Fishbone diagram

To represent contributory factor information related to a single problem.

Diagrammatic tool used to capture causes contributing to a single problem under nine classification headings.

Diagrams are easily constructed. Based on verified causal factors. Provides a base for reliable improvement plans.

Not all users feel comfortable with this tool. Causal data which has not been verified may lead to inappropriate


Tool

When to use

Description

Attributes

Difficulties

improvement strategies.


APPENDIX 4 The Different NPSA Tools to Use When Conducting a Root Cause Analysis

Gather information, for example:

Interviews (for example cognitive interviewing)

Brainstorming/writing

Retrospective clinical records

Multidisciplinary team reviews

Photographs, diagrams or drawings

Map the incident, for example:

Narrative chronology

Timeline/tabular timeline

Time person grid

Cause and effect chart Identify care and service delivery problems, for example:

Multidisciplinary review meeting

Brainstorming/brain writing

Nominal group technique

Change analysis Analyse problems to identify contributory factors and root causes, for example:

Fishbone

Contributory factors classification/framework

5 whys Generate solutions and recommendations, for example:

Barrier analysis

Risk benefit analysis


The Different NPSA Tools to Use When Conducting a Root Cause Analysis - templates

Brainwriting Template

Incident/Issue/CDP/etc

Idea(s)

Normal Procedure

Procedure as occurred

during Incident

Is a change

in proces

s evident

?

Did the change cause the problem

or influence it?

Proactive Barrier Analysis Reactive Barrier Analysis

Incident: Giving a controlled drug to a specified person Target: Patient

Hazard(s)

What B/C/D are in

place?

Importance

to safe

practice?

Failsafe

?

Improve by additional B/C/D

Importance to

safe

practice?

Failsafe?

Cost implications

Who’s responsibility

Event:

What barriers/defences or controls were in place?

Did the barrier/defence or control work?

Why did the barrier/

Defence or control fail and what was its impact?


APPENDIX 5 NPSA Incident Decision Tree

File location http://road52/sites/ROH Home Site/Policies and Procedures/Policies and Procedures/Governance/Risk Management/Incident Reporting, Event Investigation, Analysis and Improvement and Being Open Policy 0114.doc

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APPENDIX 6 External Reporting of Incidents Details of the external reporting of all incidents must be forwarded to the Governance Department for collation and overview of reports submitted.

Organisation / Department

Type of Incidents Reported Person(s) Responsible

SHA & PCT (Strategic Health Authority) (Commissioning PCT)

All serious untoward incidents in accordance with the SHA Serious Untoward Incident Reporting Policy & Procedure

Governance Dept / Risk Manager

HSE (Health and Safety Executive)

All incidents which are RIDDOR reportable e.g. incidents that have resulted in a member of staff being absent for 3 days or more, the cause of which occurred whilst in the work place

Health & Safety Advisor

NPSA (National Patient Safety Agency)

All incidents that are classified as patient safety incidents

Governance Dept / Risk Manager

Professional Bodies (e.g.

GMC) All incidents when professional rules and codes have been contravened

Professional lead/ Manager

Child/Adult Protection Agencies / Social Services

Any event or circumstances in which abuse is suspected or has occurred

Paediatric Lead / Safeguarding Lead (LSMS to be informed)

DoH: The Ionising Radiation (Medical

Exposure) Regulations 2000, (IR(ME)R 2000)

Certain high dose radiological incidents Senior Radiographer

SHOT (Serious Hazards of

Transfusions)

Adverse incidents relating to blood transfusions

Blood Transfusion lead

MHRA (Medicines and Healthcare regulatory agency)

All failures/concerns regarding medical devices and medications

All staff / Medical Devices Trainer

NHSLA (NHS Litigation Agency)

All events that are related to Litigation cases Litigation staff within Gov Dept

HPA (Health Protection Agency)

Occurrences of communicable diseases All staff who discover an issue, but to be overseen by Governance Dept

Coroners Office

All Deaths on Trust premises R&D Audit Clerk

Police

All occurrences that require police intervention/investigation

All staff who discover an issue

CFSMS (Counter Fraud and Security Management Service)

Events that are security or fraud related Local Security Management Specialist LSMS

Finance Department Theft / Loss of Trust Property All staff who discover an issue (LSMS to be informed)

IM&T

Loss or misuse of data, information or IT equipment

Governance Dept (LSMS to be informed)

HTA (Human Tissue Authority)

SAEs & SARs relating to bone and cartilage tissue

DI (Designated Individual)


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GREEN: Low impact risks with low probability of reoccurrence & insignificant risks with no harm or loss

YELLOW: Moderate impact risks with a medium probability of re-occurrence. Semi permanent harm or moderate loss

RED: Major or catastrophic impact of risk with permanent harm, death

or large financial loss

APPENDIX 7 Risk Scoring Matrix All incidents will be locally graded/classified using the Trusts risk matrix. This matrix is included on the web based incident reporting form. The classification / level of risk is determined by the person who reports an incident. These classifications are reviewed and amended as necessary upon receipt of a form by the Risk Management Team. The Risk Management Team use the risk matrix supporting tool in to assist in standardising the scoring of incidents to maximise the objectivity of the scoring. The risk scoring matrix and supporting tool are used to assess the risks derived from individual and aggregated incidents. Risks derived from complaints and claims can be assessed using the same methodology.

R (Risk) = C (Consequence) x L (Likelihood)

Red = High Impact Risk

Amber = Medium Impact Risk

Green = Low Impact Risk

RISK SCORING MATRIX:

Likelihood (L)

Consequence (C)

1 – Insignificant

2 - Minor 3 - Moderate 4 - Major 5 – Catastrophic

5 – Certain 5 10 15 20 25 4 – Highly Likely

4 8 12 16 20

3 – Likely 3 6 9 12 15 2 – Possible 2 4 6 8 10 1 – Remote / None

1 2 3 4 5

.


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APPENDIX 8 Risk Scoring Supporting Tool TABLE 1: CONSEQUENCE SCORE

Choose the most appropriate descriptor for the risk issue you have identified from the left hand side of the table. Working along the row, what could happen if this risk were to materialise? The consequence score is the number at the top of the column. A single risk area may have multiple potential consequences.

1 2 3 4 5

Descriptor Insignificant Minor Moderate Major Catastrophic

Objectives / Projects

Insignificant cost increase /

schedule slippage.

Barely noticeable

reduction in scope / quality

< 1% over budget / schedule slippage. Minor reduction in

quality / scope

1 - 5% over budget / schedule slippage.

Reduction in scope or quality requiring client

approval

5 - 25% over budget / schedule slippage.

Doesn't meet secondary objectives

> 25% over budget / schedule slippage.

Doesn't meet primary objectives

Injury Minor injury not requiring first

aid

Minor injury or illness, first aid

treatment needed

RIDDOR reportable or equivalent.

Increased LOS

Major injuries, or long term incapacity / disability (loss of

limb)

Death or major permanent incapacity

Patient Experience

Unsatisfactory patient

experience not directly related to patient care

Unsatisfactory patient experience - readily resolvable

Mismanagement of patient care – short term consequences

(1 week or less)

Mismanagement of patient care – Long term consequences (More than 1 week)

Totally unsatisfactory patient outcome or

experience

Complaint / Claim

Potential

Locally resolved complaint

Justified complaint peripheral to clinical

care

Claim < £10 000. Justified complaint

involving lack of appropriate care

Claim > £10 000. Multiple justified

complaints

Multiple claims or single major claim (e.g. Obstetrics)

Service / Business

Interruption

Loss / interruption > 1

hour

Loss / interruption > 8 hours

Loss / interruption > 1 day

Loss / interruption > 1 week

Permanent loss of service or facility

Staffing and Competence

Short term low staffing level temporarily

reduces service quality

(< 1 day)

Ongoing low staffing level

reduces service quality

Unsafe staffing level or competence

(< 1day).

Unsafe staffing level or competence

(< 1 week)

Ongoing or critical unsafe staffing level

or competence

Financial Small loss(<

£500) Moderate Loss

(> £500) Loss > 0.005% of budget(> £5,000)

Loss > 0.05% of budget(> £50,000)

Loss > 1% of budget(> £1,000,000)

Inspection / Audit

Minor recommendations. Minor non-

compliance with standards

Recommendations given. Non-

compliance with minor standards

Reduced rating. Challenging

recommendations. Non-compliance with

core standards

Enforcement Action. Critical report.

Multiple challenging recommendations.

Major non-compliance with core standards

Prosecution. Zero Rating.

Severely critical report

Adverse Publicity /

Staff morale Rumours

Local Media - short term

Minor effect on staff morale

Local Media - long term

Significant effect on staff morale

National Media < 3

Days

National Media > 3 Days MP Concern

(Questions in House)

Fire Safety

System

Minor short term (<1 day) shortfall in fire safety system

Temporary (<1 month) shortfall in fire safety system / single detector etc (non patient area)

Fire code non-compliance / lack of single detector etc

(patient area)

Significant failure of critical component

of fire safety system (patient area)

Failure of multiple critical components of

fire safety system (high risk patient

area)

Environmenta

l Impact

Minor non-compliance

with standards Minimal

Non-compliance with non-core

standards Small increase in

Non-compliance with core standards

Significant increase in environmental impact

Enforcement Action. Critical report.

Major non-compliance with

Prosecution Severely critical report

Severe impact on environment


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increase in environmental

impact

environmental impact

core standards Unacceptable inc. in

environmental impact

TABLE 2: LIKELIHOOD SCORE

What is the likelihood of the consequence Occurring? A frequency based score will be appropriate in most circumstances, except in the case of time-limited projects or objectives, where the probability based score should be used

1 2 3 4 5

Descriptor Remote / None Possible Likely Highly Likely Certain

Frequency Not expected to occur for years

Expected to occur at least

annually

Expected to occur at least monthly

Expected to occur at least

weekly Expected to occur at least daily

Probability

< 0.1% 0.1 - 1% 1 - 10% 10 – 50% > 50

Will only occur in exceptional

circumstances

Unlikely to occur

Reasonable chance of occurring

Likely to occur More likely to occur than not


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APPENDIX 9 Accompanying Documentation for Policy Approval

IMPLICATIONS FOR IMPLEMENTATION OF THIS POLICY

This document must be completed and accompany the policy, procedure or guideline through the final ratification and approval processDate: January 2012

Name of Policy, Procedure or Guideline: Incident Reporting, Event Investigation, Analysis and Improvement and Being Open Policy

Name of Policy Facilitator: Helen Walker

Name of Policy Sponsor: Lindsey Webb The following points include those aspects that need to be considered prior to the authorisation of this policy: Staffing issues arising from the implementation of this policy: -Ulysses Safeguard system maintenance and system support -Day to day monitoring, recording, review and updating of incidents -Provision of training for staff (see below) -Provision of support for staff involved in serious events and support for the provision of a debriefing service - Follow up and implementation of action plans following serious events Training issues arising from implementation of this policy: -Managers training in the provision of support to staff following a serious event -Staff training in reporting serious events -Managers training in root cause analysis investigation -Managers training in completing and undertaking management review of incidents Funding / Cost Issues arising from implementation of this policy: -Ongoing annual license renewal for Ulysses Safeguard system Barriers to implementation of this policy: -Challenges related to the aggregated analysis on incidents, claims & complaints -Timely and accurate external reporting of incidents and recording of this information - Follow up and implementation of action plans following serious events -See staffing issues arising from implementation of this policy (see above) Implications on other services or processes from implementation of this policy: -All departments need to know how to appropriately report incidents externally and internally


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Equality Impact Assessment Form A – Policy Screening Impact Assessment

Name and details of those involved in the screening equality impact assessment

Helen Walker – Risk Manager

Date of screening assessment January 2012

The policy or strategy

Give the title of the policy or strategy and a short description

Incident Reporting, Event Investigation, Analysis & Improvement & Being Open Policy

Negative Impact

Could the policy or strategy have a significant negative impact on any of the protected characteristics? Could the policy or strategy:

Presenting any problems or barriers to any staff, community or group

Excluding people as a result

Worsening existing discrimination and inequality

Having a negative effect on relations with staff or the community

Yes

No

Age √

Disability √

Gender Reassignment √

Marriage and Civil Partnership √

Pregnancy and maternity √

Race √

Religion or Belief √

Sex √

Sexual Orientation √

Please give any relevant information / details


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Positive Impact

Could the policy or strategy have a significant positive impact on equality by reducing inequalities that already exist? Could the policy or strategy help meet our duty to:

Promoting equality of opportunity

Eliminating discrimination and harassment

Promoting good community relations

Promoting positive attitudes towards disabled people

Encouraging participation of disabled people

Considering more favourable treatment of disabled people

Promoting and protecting human rights

Yes

No

Age √

Disability √

Gender Reassignment √

Marriage and Civil Partnership √

Pregnancy and maternity √

Race √

Religion or Belief √

Sex √

Sexual Orientation √

Please give any relevant information / details

Evidence

What is the evidence for the above What does any research say What additional research is required to fill any gaps in

Full impact assessment

In light of the above does the policy or strategy require a full equality impact assessment (refer to the flowchart on page 3)

Yes No

Is a full Equality Impact Assessment required √

Please rate the priority High / Medium / Low


Local Group Approval Checklist for New or Renewed Policies

Name of Policy: Incident Reporting, Event Investigation, Analysis and Improvement and Being Open Policy

Date Form Completed: January 2012

Name of Policy Facilitator / Policy Sponsor: Helen Walker, Risk Manager / Lindsey Webb, Director of Nursing and Governance

Question Response Y/N

Does the policy have the appropriate approved front cover layout including the ROH NHS Foundation Trust Logo

Y

Is the policy written in 12 point arial font Y

Is there a completed consultation tracking sheet included at the front of the policy

Y

Is there a completed document control information sheet included at the front of the policy

Y

Has a completed equality impact assessment form been completed and a copy provided to the group

Y

Has an implications for implementation form been completed and a copy provided to the group

Y

Has a review date that is a maximum of 2 years from the date of ratification / approval been included in the document control information

Y

Are the pages in the policy numbered Y

Is the policy name included in the footer Y

Does the policy include success indicators for the purposes of future monitoring and to be used to undertake audits of compliance

Y

If this policy replaces a previous document, have the results of a previous audit of compliance (undertaken in the previous 2 years) been provided to the group

N/A

Does the policy include an implementation plan including timescales and responsible leads

N

Does the policy include references Y

Additional comments from the group approving the policy

Name of group approving the policy Quality Committee

Chair of the group approving the policy

Helen Walker, Risk Manager

Signature on behalf of the group

APPENDIX 10 SOUTH BIRMINGHAM PCT SUI NOTIFICATION FORM


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SERIOUS UNTOWARD INCIDENT FORM FOR NOTIFICATION OF INCIDENTS TO SOUTH

BIRMINGHAM PRIMARY CARE TRUST

PLEASE COMPLETE THIS FORM AND IMMEDIATELY FORWARD YOUR OWN RISK MANAGEMENT TEAM OR RELEVANT LEAD OFFICER COPY THE FORM VIA E-MAIL TO: [email protected] THERE IS ALSO A REQUIREMENT TO INFORM THE RELEVANT COMMUNICATIONS MANAGER WITHIN 24 HOURS OF ANY INCIDENTS WHICH MAY ATTRACT MEDIA ATTENTION.

Reporting Organisation:

Log No: Internal Reference / relevant incident number if applicable

Health Authority:

Status:

When, Where & Your Details

Date of Incident: (dd/mm/yyy)

Reporter Name:

Time of Incident:

Reporter Job Title:

Site of Incident:

Reporter Tel. No.:

Location of Incident:

Reporter Email:

Who

Care Sector:

Type of Patient:

Clinical Area:

Gender:

Date of Birth (dd/mm/yyyy, N/A or Not Known):

Ethnic Group:

What Happened?

Type of Incident:

Actual / Near miss:


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Immediate action taken:

Has Root Course Analysis commenced ? If yes, please provide details. If not, please indicate when investigation will commence and expected completion date.

Further Information:

Please include other agencies notified if appropriate.

Media Interest: Yes / No Line being taken by Organisation

Externally reportable:

Yes / No Externally reportable to:

Report to Health Protection Agency:

Microbiology results

Apparent outcome of incident:

Likelihood of recurrence:

Most likely consequences:

Potential risk to future patients

Provider File Details

Lead Officer at Provider:

Lead Officer Tel No.:

Current File Holder:

BF/wd Date: (dd/mm/yyyy)

Reports: Date Completed: (dd/mm/yyyy)

Date copy form received by SBPCT

Date reviewed by CQPS Committee

Findings of CQPS Committee to include requests for additional information if necessary

Feedback of review to service provider


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Appendix 11

SOP – CHECKLIST FOR SERIOUS ADVERSE EVENT

AND REACTION REPORTING: COMPLIANCE WITH THE HUMAN

TISSUE ACT REGULATIONS 2006 AND 2007

The Trust has a DI (Designated Individual) who has assigned responsibility

for compliance with the Human Tissue Act regulations 2006 and 2007. The DI

will notify the risk manager of any changes or amendments to the

requirements for the reporting of SARS and SAE incidents.

Procedure

This procedure is designed to describe the process for reporting serious

adverse events/reactions in the use of bone tissue at the Royal Orthopaedic

Hospital, Birmingham, and the hospitals which are served in relation to the

supply of bone tissue, namely Birmingham Children’s Hospital, BMI – the

Edgbaston and Priory Hospitals.

1. Any serious adverse event/reaction caused by the use of the supplied

bone tissue, must be reported immediately, to the Designated Individual

at ROH, by telephone – 0121 685 4395 or 0121 685 4000 ext.

55956/55168. In the event of the DI’s absence, the event/reaction must

be reported to the Musculoskeletal Pathology manager, at Birmingham

University, by telephone -- 0121 414 7644/7640 and the theatre

manager at ROH, 0121 685 4000, ext. 55125.

2. The details of the event/reaction must be fully documented and sent by

mail to the Designated Individual/Musculoskeletal Pathology manager,

within 24 hours of the event/reaction occurring. This detail must include

the product number, expiry date, time received and time used, and any

processing steps applied and materials/additives which may have come

into contact with the bone tissue, which may have affected quality.

3. It is the Designated Individual’s responsibility to inform the Trust’s

Governance department, NHSBT (supplier of bone tissue) and the HTA

of the event/reaction, and supply the full details described above. In

addition, the date the tissue was procured, source of procurement,

transport date and the destination of the transported tissue, if applicable.


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4. The Designated Individual must also inform the HTA of any recall of

bone tissue by the supplier, which may be related to a serious adverse

event/incident.

Investigation of Incidents

The investigation of SARS and SAE incidents will be undertaken in-line with

the Trusts procedures for undertaking serious event investigations.

Additional External Reporting Requirements

Any SARS and SAE incidents will be reported also via the SUI reporting

route.

Staff Training

Awareness of this policy will be raised amongst all theatre staff via the theatre

management group.

Definitions

Serious Adverse Event = any untoward occurrence associated with the

procurement, storage and distribution of bone and cartilage tissues, that might

lead to the transmission of a communicable disease, to death or life-

threatening, disabling or incapacitating conditions for patients, or which might

result in, or prolong, hospitalisation or morbidity.

Serious Adverse Reaction = an unintended response, including a

communicable disease, in the donor or recipient associated with the

procurement or human application of bone and cartilage tissue, that is fatal,

life-threatening, disabling, incapacitating or which results in, or prolongs,

hospitalisation or morbidity.

Appendix 12


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AUTOMATIC GRADING OF RED FOR CERTAIN INCIDENTS

The following incident types should be automatically graded as Red until review by a senior manager who will review them within 1 working day:

1. Possible NEVER Events (list available in each dept) 2. Pressure ulcers grade 3 and above 3. Safeguarding concerns 4. Failure/ delay to rescue 5. Fall with bony injury 6. Fall with head injury and altered GCS 7. Fall with head injury on anticoagulant therapy 8. Hospital acquired C Difficile 9. Hospital acquired bacteraemias 10. Physical Violence 11. Contamination incidents: Needlestick injury, eye splash

etc. 12. Injury to staff resulting in cessation of duty/ absence from

duty 13. Embolic/ thrombotic events 14. Deterioration requiring transfer (internal or external) 15. Human error (including medication) errors resulting in

patient harm/ treatment to counteract 16. Retention of minor surgical equipment/ tools Wrong site

injection 17. Near miss incidents considered to have narrowly avoided

catastrophic events 18. Mis-identification of patient 19. Loss of Controlled drugs 20. Transfusion product incidents 21. Failure to act on clinical investigation results 22. Unexpected Death 23. Controlled drug related

Appendix 13


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NPSA 'NEVER EVENTS' "NEVER EVENTS" are serious, largely preventable patient safety incidents that should not occur if the relevant preventative measures are in place. Please see below details of those incidents which are reportable as “NEVER EVENTS”. This list was revised in February 2011 from an original list of 8 to a new list of 25.

“NEVER EVENTS” form part of the ROH‟s contract with the PCT. All incidents relating to “NEVER EVENTS” must be reported via the Trusts incident reporting system on the day of the incident. The list is as follows:

1. Wrong site surgery (existing)

2. Wrong implant/prosthesis (new)

3. Retained foreign object post-operation (existing)

4. Wrongly prepared high-risk injectable medication (new)

5. Maladministration of potassium-containing solutions (modified)

6. Wrong route administration of chemotherapy (existing)

7. Wrong route administration of oral/enteral treatment (new)

8. Intravenous administration of epidural medication (new)

9. Maladministration of Insulin (new)

10. Overdose of midazolam during conscious sedation (new)

11. Opioid overdose of an opioid-naïve patient (new)

12. Inappropriate administration of daily oral methotrexate (new)

13. Suicide using non-collapsible rails (existing)

14. Escape of a transferred prisoner (existing)

15. Falls from unrestricted windows (new)

16. Entrapment in bedrails (new)

17. Transfusion of ABO-incompatible blood components (new)

18. Transplantation of ABO or HLA-incompatible Organs (new)

19. Misplaced naso- or oro-gastric tubes (modified)

20. Wrong gas administered (new)

21. Failure to monitor and respond to oxygen saturation (new)

22. Air embolism (new)

23. Misidentification of patients (new)

24. Severe scalding of patients (new)

25. Maternal death due to post partum haemorrhage after elective

Caesarean section (modified)

Further information and definitions of these „NEVER EVENTS‟ can be found at the following web-site: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_124552

Appendix 14

“Virtual” SIRI Review group

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


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TERMS OF REFERENCE

Name of Group/Committee SIRI Review Group

Purpose

The SIRI review group is administered by the Deputy Director of Nursing and Governance and Risk Manager, having delegated responsibility from the Director of Nursing and Governance to ensure that all serious incidents are investigated in line with national and local policy, that improvement plans are put in place where necessary, that the planned improvements are reasonable, effective, sustainable and carried out successfully and learning from incidents is shared throughout the organisation in the interests of improved quality and safety. The SIRI review group will review all relevant draft SIRI reports from a multidisciplinary perspective.

Key Objectives

To review electronic final drafts of SIRI reports which will be circulated buy the Risk Manager ensuring that timescales for reporting are met in line with the Trust contract.

To support the DDNG/ Risk Manager in delivering constructive comment, challenge and supportive input to investigation leads regarding their draft reports.

Be the main body offering a multidisciplinary input to SIRI investigations and reports.

Lead and contribute to the development of SIRI action plans if and when appropriate for particularly complex cases.

Support and review development of reports for submission to high level committees and commissioners.

Formally and informally identify trends and themes from SIRI‟s and ensure these issues are raised at the appropriate forums providing an objective and collaborative view point on key learning points.

Identify on-going local and Corporate level risks arising from SIRI investigations that require escalation within or outside of the organisation.

Agree policies related to SIRI management, reporting and investigation.

Mutual and collective support, briefing and exchange of information, peer accountability.

Provide representation/ nominated attendance from the group at table top review meetings of relevance determined by the Chair.

Level of Authority and reporting

This group reports to the Quality Committee and on request to the Integrated Governance Committee.


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Membership

Deputy Director of Nursing and Governance (Chair)

Risk Manager (Deputy Chair)

Consultant Surgeon x 2

Trust Revalidation Lead (This position may be represented by one of the two consultant surgeon members as detailed above, or this may be an additional member)

Consultant Anaesthetist x 2

Clinical Lead for ANP service

Clinical Nurse Tutor

Chief Pharmacist (where appropriate)

Therapies Manager (where appropriate)

PALS & Complaints Manager (where appropriate)

Substantive Membership All members may suggest appropriate opt–in reviewers for specific cases in agreement with the chair.

Quorum

This is a “virtual” group requiring input on an electronic/ email format only. Where incidents are of particular relevance to a specialist field, it is anticipated that feedback from at least one group member or their nominee of that specialist field be submitted for the report to be finalised.

Meeting Frequency

Group members may suggest face to face meetings to address specific issues where appropriate. Minutes kept by Records of review discussions will be collated by the Risk Manager for audit purposes.

Terms of Reference Review Date

September 2012

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