ADVERSE EVENT / INCIDENT MANAGEMENT

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NHS LANARKSHIRE ADVERSE EVENT / INCIDENT MANAGEMENT POLICY

Author: Corporate Risk Manager

Responsible Lead Executive Director:

Executive Medical Director

Endorsing Body: Risk Management Steering Group – April 2014

Governance or Assurance Committee

Audit Committee

Implementation Date: July 2014

Version Number: Version 1

Review Date: Interim Review – December 2014

September 2015

Responsible Person Corporate Risk Manager

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CONTENTS

i) Consultation and Distribution Record

ii) Change Record

iii) Frequently Asked Questions & Answers

1. INTRODUCTION

2. AIM, PURPOSE AND OUTCOMES

3. SCOPE

3.1 Who is the Policy Intended to Benefit or Affect

3.2 Who are the Stakeholders

4. PRINCIPLE CONTENT

4.1 Adverse Events / Incidents : Recording & Reporting 4.2 Working Definitions 4.3 Reporting Adverse Incidents 4.4 Recording Adverse Incidents 4.5 Confidentiality 4.6 Grading of Adverse Event / Incident 4.7 Notification of Significant Adverse Events / Incidents to Chief Executive and

NHSL Board Members 4.8 Commissioning a Significant Adverse Event Review (SAER) 4.9 Guiding Principles for a Significant Adverse Event Review (SAER) 4.10 Significant Adverse Event Review (SAER) Pathway 4.11 Significant Adverse Event Review (SAER) Roles and Responsibilities 4.12 Undertaking a Significant Adverse Event Review (SAER) 4.13 Significant Adverse Event Review : Report Writing

5. ROLES AND RESPONSIBILITIES

6. RESOURCE IMPLICATIONS

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7. COMMUNICATION PLAN

8. QUALITY IMPROVEMENT – MONITORING AND REVIEW

9. EQUALITY AND DIVERSITY IMPACT ASSESSMENT

10. REFERENCES

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CONSULTATION AND DISTRIBUTION RECORD

Contributing Author / Authors

Carol McGhee, Corporate Risk Manager

Consultation Process / Stakeholders:

Extended email Stakeholders

Sharon Steven, Datix Systems Administrator

Christine Jack, Operational Service Manager (CHPN)

Christine Browning, Business Support Manager PSSD

Frances Moore, Operational Services Manager (CHPS)

Donna Sweeney, Operational Services Manager (Acute)

Olwen McNeil, Business Support Manager E-Health

Dina Mclellan, WGH Site Clinical Lead for Governance

Morag Holmes, Head of Internal Audit

Karen McIntyre, Senior Nurse mental Health/Learning Disabilities

Margo Cranmer, Partnership Representation

Gillian Corbett, Associate Nurse Director (Acute)

Susan Friel, Associate Nurse Director (Acute)

Philip McMenemy, Associate medical Director (Primary Care)

Craig McKay, Communications Manager

Maureen Dobbin, Senior Nurse

Linda Findlay, Consultant Psychiatrist / Medical Director for Mental Health / Learning Disabilities

Kirsty Cole, Organisational Development Manager

Maria Docherty, Associate Nurse Director Mental Health / Learning Disabilities

Stewart Campbell, Hairmyres Site Clinical Lead for Governance

Colin Cunningham, Consultant, Paediatrics

Distribution: RMSG

Audit Committee

Health & Quality Assurance & Improvement Committee

Acute Divisional Management Team

CHP North and CHP South Divisional Management Teams

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CHANGE RECORD

Date Author Change Version No.

May 2014 Carol McGhee Previous Risk Management Guidance : Incident Management August 2013, superseded by this Policy aligned to the HIS National Framework for Management of Adverse Events.

Version 1

January 2015

Carol McGhee Subsequent to the Vale of Leven Report and Recommendations (2014), specifically, recommendation 72, an addition has been made to Section 4.11.1

Version 1

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Frequently Asked Questions and Answers

QUESTIONS ANSWERS What is an adverse event / incident?

An adverse event is defined as an event that could have caused, or did result in, harm to people or groups of people. Harm is defined as an outcome with a negative effect

What is a significant adverse event (SAE)?

An event that has contributed to or resulted in permanent harm, for example death, intervention required to sustain life, or ongoing national adverse publicity.

What does the Grading /Category of Outcome mean?

Category 1 – events contributing to or resulting in permanent harm Category 2 – events contributing to or resulting in temporary harm Category 3 – events that had the potential to cause harm but -an error did not result -an error did not reach the person -an error reached the person but did not result in harm

Where would I find the guidance on adverse event/incident management?

All guidance for managing adverse events can be found within this Policy.

When do I record an event / incident and how do I record it?

All adverse events / incidents are reported to your first line manager and then recorded on to the electronic Datix system. You do not need a password to do this and the Incident Record Form will help you to record the right information needed.

What if there is no harm? It is important to still record events / incidents that do not result in any harm, to help understand how often and where the same type of incident is happening to allow management action to prevent harm actually happening.

When would significant adverse events / incidents (SAE’s) be reviewed? And, who decides when a significant adverse event review (SAER) would be carried out?

A Significant Adverse Event (SAE) is normally referred to as a Category 1 event and will have had a serious outcome, and must be considered for a Significant Adverse Event Review (SAER). As soon as a SAE happens, this will be communicated to your Divisional Nurse Director and your Divisional Medical Director by SBAR, who will then make the decision. A SAER can be commissioned for any category of incident if the situation is not clear.

If I was involved in the event / incident, how will I know if a SAER is to be undertaken?

You should be notified by letter, informing you of the SAER and inviting you to interview to give your views and version of events.

If I was involved in an adverse event / incident will I be named in the report that is produced?

No. The only persons named are the Review Team. No person(s) involved in the actual event / incident, including patients and families, will be named.

If I was involved in an adverse event / incident, will I be disciplined?

The purpose of a SAER is for learning and improvement. If the SAE review identifies evidence that requires further investigation, this will be undertaken through the existing NHSL HR Policies and Procedures.

If I was involved in the adverse event / incident, or work in the area where it happened, will I get

Yes. You will be invited by letter informing you that the report is complete and you can access it through a nominated manager. The contact name and number will be on the letter you receive.

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feedback on the findings?

QUESTIONS ANSWERS What if I feel upset by the adverse event, how will I be supported?

Firstly let your manager know how you feel. You will be advised by your manager what support is available for you and will help to arrange support. You can also self-refer to Occupational Health.

Who contacts and supports patients and families?

When SAER is commissioned, a designated operational manager is identified as the point of contact for staff, patients and families from the beginning of the review process to the sharing of the report with findings and recommendations.

How do lessons learned from a SAER get shared across NHS Lanarkshire?

The risk management team review SAER’s and bring together general lessons identified across NHSL in a quarterly safety brief. This is discussed at all safety briefing meetings in wards and departments. There are also some local lessons learned briefings, ask your managers.

Where can I find learning summaries for NHS Lanarkshire?

All Lessons Identified Safety Briefs are stored on the Risk Management Web Page :

If I am asked to be part of a review team, will I have to have training and what am I expected to do?

As a member of a SAER Team, you will be given direction by the SAER Lead and are expected to attend meetings, review policies/procedures, visit the area where the SAE happened (if required), interview staff, review casenotes, understand critical questioning and participate in identifying the causes and making recommendations for improvement.

Where are all the statements and information from a SAER held?

NHS Lanarkshire has a new system for storing all records generated for every SAER and will be kept secure and managed within the information governance standards.

Will I know about all adverse events /incidents where I work?

It is good practice for your team leader, supervisor, head of service to routinely share information with you regarding what types of adverse events / incident happen, how often they happen and what is being done to prevent them happening.

Do the management teams know about all the adverse events / incidents that happen?

Yes. Management Teams review the events / incidents you record on Datix.

Who else knows about adverse events / incidents that happen in NHS Lanarkshire?

There are many Committees and Groups that review the incidents recorded in Datix eg Clinical Governance Groups Health and Safety Groups Falls Groups Site Risk Management Groups

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1. INTRODUCTION NHS Lanarkshire (NHSL) requires to have in place, an accurate and workable incident reporting and recording system that will support good practice and compliance with legal duties from a range of bodies including Health Improvement Scotland (HIS), and the Health & Safety Executive (HSE). NHSL uses the Datix electronic recording system for recording and grading clinical and non-clinical incidents. This policy will be interdependent on other relevant policies and documentation: Being Open Effective management of Employee conduct Policy and Procedures Information Assurance Risk Management Strategy 2. AIM, PURPOSE AND OUTCOMES NHSL aims to provide a consistent framework, including definitions, for the effective management of adverse events / incidents, that is used across all areas to establish an understanding of what could, or what has gone wrong and to further establish matters of fact regarding incidents with the overall aim of improving quality and not attributing blame. This Policy is based on the principles set out in the Health Improvement Scotland (HIS) : National Framework for Adverse Events Management (September 2013). It sets out the requirement for, and the processes supporting, effective adverse event identification, grading, management actions, escalation, review and learning from adverse events. Furthermore, this Policy sets out the standard format for writing of Significant Adverse Event review (SAER), the available toolkit, roles and responsibilities. 3. SCOPE 3.1 This Policy is relevant for:

All staff identifying an adverse event / incident

Staff recording an adverse event / incident

Patients affected by an adverse event /incident

Families and Carers affected by an adverse event /incident

Staff affected by, or involved in, an adverse event /incident

Nominated Commissioners of SAER’s

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Operational Managers in ensuring due process is followed, including oversight of action plans

Operational Managers in liaising with patients / families / carers / staff

Nominated SAER Leads

Nominated SAER Team Members

Nominated operational support for SAER’s

Supporting the NHSL Assurance and Improvement Framework

Corporate Governance and Assurance

The Benefits of developing and maintaining effective adverse event / incident management:

Benefits to the Individual

Minimising the risk of harm to any patient/staff member/member of the public using or receiving care within NHSL.

Evidence of your responsibility as an employee of NHSL to record adverse events / incidents and highlight risks.

Ability to record an event / incident that is causing you concern or has resulted in harm.

Benefits to the Department

Promote safe working environment for employees and patients.

To monitor, look at trends, hot spots and common themes.

Adverse event / Incident recording will help identify risks specific to individual departments and wards that will then allow prioritisation of activities.

Encourage multidisciplinary and multi department working and decision-making.

Emerging issues empowers actions and change.

Benefits to Management and the Organisation

Identify and monitor trends

Demonstrate compliance with the National Risk Management Standards and Framework

Compliance with Corporate Governance

Maintain Overview of NHSL Risk Profile

Inform/identify training needs 3.2 NHSL has consulted with the stakeholders listed in Section i), a range of professional and managerial staff who have a specific role in ensuring the Policy and supporting procedures is the right approach for NHSL and applied as necessary.

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4. PRINCIPAL CONTENT 4.1 Adverse Events / Incidents : Reporting and Recording Why record and manage incidents?

To avoid incidents happening again. To put in place controls to stop the incident recurring. To make sure that incidents are investigated and any lessons learned are shared

across NHSL. To identify potential areas of risk by benchmarking, trend analysis and using other

statistical analysis. To improve quality.

Why record near misses?

For early alert of potential incidents 4.2 Working Definitions (as defined by Health Improvement Scotland, September

2013) 4.2.1 An adverse event / incident is defined as an event / incident that could have caused, or did result in, harm to people or groups of people. 4.2.2 Harm is defined as an outcome with a negative effect. Harm to a person or groups of people may result from worsening of a medical condition, the inherent risk of an investigation of treatment, system failure, provider performance issues, service disruption, financial loss or adverse publicity. 4.2.3 All harm is not avoidable, for example the worsening of a medical condition or the inherent risk of treatment. However, it is often not possible to determine if the harm caused was avoidable until a review is carried out. 4.2.4 People are defined as:

Service users

Patients

Members of staff

Carers

Family members, and

Visitors 4.2.5 Groups of people include any functional grouping of individuals such as an organisation. In this way, adverse events/incidents that result in, for example reputational harm or financial harm are included within the scope of the national approach.

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4.2.6 Never – Event: These are very serious, largely preventable patient safety incidents that should not occur if the relevant preventative measures have been put in place. The DoH have set-out a list of never events as adopted by NHS Lanarkshire. 4.3 REPORTING Adverse Events / Incidents and Near Miss Any member of staff observing or discovering an adverse event/incident or near miss must inform their line manager and consider if any other department or service requires an early alert e.g. PSSD, fire advisors, medical physics, pharmacy and ensure that the adverse event / incident is recorded on Datix within 24 hours. Any non NHS employees e.g. contractors or agency staff must inform their designated supervisor of any adverse event / incident as soon as possible, this person will then record an incident on their behalf. If any member of the public or visitor has an adverse event / incident and informs a staff member, the staff member will take the details and if necessary report and record the incident on their behalf. The staff member will take any remedial safety action.

(Reference : STAFF GOVERNANCE STANDARD, 2012)

Staff will ensure that they speak up when they see practice that endangers

patient safety and/or which causes upset and alarm in the workplace, in line with the NHS whistleblowing

policy

Staff will ensure that they take responsibility for protecting

and improving their own health, safety and social

wellbeing and for reporting any health and safety issues in line

with NHS Board policies

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4.4 RECORDING ADVERSE EVENTS/INCIDENTS AND NEAR MISS

Recording of an adverse event / incident should be as close to the time of the incident occurring as possible. If this is not practical then it must be recorded no more than 24 hours after the incident. The outcome of many adverse events / incidents can be identified immediately, e.g. broken bone, damaged equipment, fire etc. In some instances however, the outcome may not be apparent for a few days for example; back sprain resulting from manual handling, or a patient who develops an unexpected pressure sore or complication whilst in our care. There may also be harm to NHSL as a result of, e.g. fraudulent activity, loss of confidential information or other incidents which may impact on NHSL’s objectives.

All adverse events / incidents are recorded and managed electronically through the Datix Incident Recording System In some areas, recording in paper form may occur but only with the agreement of the Risk Management Team. These are subsequently recorded on Datix 4.5 CONFIDENTIALITY Whilst any member of staff can record an adverse event / incident on Datix only authorised staff members can access the details of the Datix record.

In line with Information Assurance information contained within adverse event / incident forms will only be disclosed when necessary to aid review of the incident. When reporting to groups or committees all information must be anonymised. 4.5.1 Legal Consideration Recording of an adverse event/incident does not constitute any admission of liability on any person. Adverse event / incident records may require to be made available in the event of legal proceedings and it is therefore essential that they are completed accurately and factually.

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4.5.2 Informing Patients and Relatives (Being Open) Staff should follow the NHSL guidance in ‘Being Open – Communicating Patient Safety Incidents with Patients and their Carers’

4.6 GRADING OF AN ADVERSE EVENT / INCIDENT (as defined by Health Improvement Scotland September 2013)

Grading of the adverse event / incident is mandatory in NHSL and facilitated through Datix.

The grading outcome will be expressed as either Category 1, Category 2 or Category 3

adverse event / incident.

Category 1 Category 2 Category 3

Extreme Major Moderate Minor No Harm

Category 1 – Events that may have contributed to or resulted in permanent harm, for

example death, intervention required to sustain life, severe financial loss (£>1m), ongoing

national adverse publicity (likely to have been graded as major or extreme impact on NHS

Scotland risk assessment matrix)

Category 2 – Events that may have contributed to or resulted in temporary harm, for example initial or prolonged treatment, intervention or monitoring required, temporary loss of service, significant financial loss, adverse local publicity (likely to have been graded as minor or moderate impact on NHS Scotland risk assessment matrix. Category 3 – Events that had the potential to cause harm but 1) an error did not result, ii) an error did not reach the person iii) an error reached the person but did not result in harm (near misses) (likely to have been graded as negligible impact on NHS Scotland risk assessment matrix). These results can occur either by time intervention or due to good fortune.

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Event / Incident /Near Miss Occurs

Immediate Management of Event

/ Incident Incident/Near Miss

Category 2 Category 3 Category 1

Individual within the ward / department may consider taking advice from the specialist or support services outside the area. Ensure actions to minimise the risk of it happening again are in place. Discuss with senior management if any further actions are required and feedback through team meetings. Close the Datix record within 30 days ensuring all documentation is attached to the Datix record. Level 2 Report – Local management review in consultation with Associate Medical Director / Nurse Director or General Manager

Any learning points / improvement measures are communicated and monitored at ward / department meetings Close the Datix record at the time of verification or within 10 days ensuring all documentation is attached to the Datix record. Level 3 Report – Further enquiries / questions. Trends should be considered for further review.

Report to Line Manager

Immediately inform site Senior Nurse/ Service Manager / Head of Function. An SBAR must be forwarded to the Divisional Medical Director / Divisional Nurse Director through the email accounts: Acute.SBAR@lanarkshire.scot.nhs.uk for Acute incidents only SignificantIncident.JointCHP@lanarkshire.scot.nhs.uk for CHPN and CHPS incidents only Validation of the categorisation with the decision taken on the commissioning of a SAER. Escalate to Divisional Directors and Board Close the Datix record within 90 days, ensuring all documentation is attached to the Datix Record Level 1 Report – Significant Adverse Event Review (SAER)

Stage 1 – Risk Assessment & Prevention – risk assessment should identify the hazards present in the healthcare system by

evaluating the likelihood of potential harm from the hazard occurring, and evaluating the potential severity of that harm. Mitigating

Actions should be in place, that are proportionate to the risk to prevent it occurring.

Stage 2 –

Identification and

Immediate Action

Following an

Adverse Event

Make person/area safe and attend to any medical requirements

Implement any immediate

operational actions to reduce

risk of recurrence eg removal

of trip hazard or faulty

equipment.

Stage 3 – Initial Reporting and

Notification

Record and Categorise the Severity of the event / incident on Datix Using the

‘grading’ field

Stage 4 Analysis

and Categorisation

Stage 5 - Review SAER Commissioned Undertake review keeping patient, their family and staff members informed

Stage 6 – Improvement,

Planning & Monitoring Develop Action Plan

Submit review report and action plan via the appropriate governance mechanism

Governance mechanism quality assurance and closure of review

Implement Action Plan Review implementation of actions Share learning and implement key learning points

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Click here for SBAR (Situation Background Assessment/Action Recommendation) definition as seen in Appendix 1

Category 1

Incident

Occurs

Commissioner returns the SAE Report to the Lead with the proposed amendments. The SAER Lead amends and returns to the Commissioner within 5 working days.

The completed SBAR on the outcome of the decision making must be attached to the Datix Record.

CG&RM Group: Review report & draft action plan Discuss event / lessons learned Direct the sharing of learning Review draft action plan and nominate responsible persons where wider actions are required Send action plan to designated general management lead to oversee Call for assurance report from overseeing manager

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4.7 NOTIFICATION OF SIGNIFICANT ADVERSE EVENTS / INCIDENT TO CHIEF EXECUTIVE AND NHSL BOARD MEMBERS

The purpose of this notification process is to ensure Executive and Non-Executive Board Members are informed of significant adverse events/incidents in a timely manner and can respond appropriately. This builds on existing mechanisms for dealing with adverse events/incidents and concerns currently in place:

Handling and Responding to Concerns and Complaints Guidance for Staff

Notification to the Chief Executive will normally be by the Operating Divisional Directors, but can be through the Commissioners of Significant Adverse Event Reviews (SAER’s) who are: Clinical Adverse Events/Incidents : the Divisional Medical and/or Nursing Directors Non-Clinical Adverse Events/Incidents : General Managers Adverse Events/Incidents that must be notified to the Chief Executive are:

Adverse Events / Incidents recorded and graded as Category 1

‘Never Events’

Exceptional Adverse Events/Incidents

The Chief Executive will assess the adverse event / incident and notify the Chair of the NHSL Board. The Notification Process is outlined in the following algorithm:

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Significant Adverse Events / Incidents to be Notified to the Chief Executive & Board

Category 1 Event / Incident Occurs or

Never Event Occurs or

Exceptional Adverse Event / Incident Occurs

Immediately inform site Senior Nurse / Service Manager / Head of Function. An SBAR should be forwarded to Divisional Director / Nurse Director / Site General Manager / Unit General Manager / Head of Department.

Validation of the grading with the decision taken on the commissioning of a SAER.

Divisional Director notifies the appropriate Executive Director : Medical Director / Nursing Director for clinical adverse events/incidents or Director of Finance for non-clinical adverse events/incidents. On Call Director for out of hours.

Notification to the Chief Executive

Chief Executive notifies the Chair of the Board and agrees notification to other Board members within 24 hours

Medical/Nursing Director informs the Healthcare Quality Assurance & Improvement Committee members for clinical events /incidents within

2-3 working days

Director of Finance informs the Audit Committee members for non-clinical events / incidents within 2-3

working days

Director of Finance or Medical/Nursing Director provide an update on the Significant Adverse Event or incident under part 2 of the agenda of the next Board Meeting and ensure a SAER executive summary is provided to

Board Members. Ensure the completed action plan is provided to the Healthcare Quality Assurance and Improvement

Committee / Audit Committee to provide the assurance that any actions or recommendations have been implemented.

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4.8 Commissioning a Significant Adverse Event Review (SAER) The purpose and aim of undertaking a SAER, is to:

identify system failures that may have contributed to the incident.

determine if there are any learning points for the area where the incident occurred, the staff involved and the service

take the opportunity to make improvements

minimise the risk of recurrence A SAER will normally be undertaken when unexpected events related to care and treatment result in death, significant harm; or required intervention to save life. The NHSL commissioning criteria for a SAER can also be referred to in appendix 2 SAERs will be commissioned by the designated SAER commissioners as follows:

For Clinical adverse events / incidents: Divisional Medical and Nursing Directors

For Non Clinical adverse events / incidents: General Managers / Directors of Hospital Sites

4.9 Guiding Principles for a Significant Adverse Event Review (SAER) SAER’s are conducted to a high level of detail and must follow the format set out in the NHSL SAER template The SAER Guiding Principles:

Includes use of a range of Root Cause Analysis (RCA) Techniques to understand why failures occurred and how they can be managed to minimise recurrence.

Undertaken by a multi-disciplinary team not directly involved in the incident. Consideration should be given to appointing an external team.

Involve experts / specialists dependent on the nature of the adverse event / incident

Led by person(s) experienced and/or trained in RCA

Includes discussion with patient / relative / carer

May require management of the media via the Communications Department

Includes plans for shared learning : locally, organisational and / or nationally as appropriate

It is recognised that not all adverse events / incidents reviewed will identify system failures and could identify areas of good practice. Learning points from both system failures and good practice should be noted during the review and shared appropriately.

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4.10 SAER PATHWAY

SBAR is completed and sent to designated SAER Commissioner

Significant Adverse Event/Incident is categorised as 1. Category 1 2. Never event

Commission SAER? (refer to commissioning criteria)

YES NO

SAER Commissioner communicates decision to management and governance committee and ensures the decision is recorded in the Datix “Notepad”. Local manager considers the need for an alternative understanding of the event/incident e.g. peer review/case note review

SAER Commissioner and SAER Team Lead will agree terms of reference / scope

SAER Team Lead forwards draft report to SAER Commissioner / Operational Manager

Review team undertake SAER and complete report.

Notify Operational Manager

Operational Manager:

Shares the report with the management team

Ensures the action plan is completed

Communicates with staff and family

SAER Commissioner signs off final report and ensures appropriate dissemination.

Datix record closed and report retained in the documentation library system.

Within 1 working

Day

Within 3 working

days

Within 80

working days

Within 90 days

D

O

C

U

M

E

N

T

A

T I

O

N

M

A

N

A

G

E

M

E

N

T

SAER Commissioner / Operational Manager agree and select SAER Team Lead and Team Members

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4.11 SAER ROLES AND RESPONSIBILITIES 4.11.1 Role and Responsibilities of the SAER Commissioner(s) The Commissioner has a vital role to play on behalf of NHS Lanarkshire in ensuring that:

A SAER is commissioned for all significant adverse events / incidents meeting the agreed criteria.

Consideration is given to all other escalated adverse events / incidents to determine if a SAER is required or not. All decisions should be recorded in the Datix record.

Relevant managers are informed of decision to proceed to SAER.

A SAER Team and Team Lead are established giving consideration to appropriate membership and liaising with departmental managers.

The SAER Team Lead is aware of their responsibilities and timescales.

Terms of Reference / scope for the review are agreed.

Any concerns found during the SAER process are highlighted and appropriate action taken.

The draft report is received within 80 working days with assurance that the appropriate management teams have agreed that the actions are achievable. Returns comments on comments on the draft to the SAER Lead.

The final SAER is received by the Commissioner for sign-off within 85 working days.

Ensure the original SBAR, final report and action plan are attached to the incident record in Datix and the incident is closed as the final report is attached.

Dissemination of SAER Executive Summary and Action Plan through appropriate governance and operational structures.

Ensures nominated operational support received intimation when SAER is commissioned to set up document control and management.

4.11.2. Responsibilities of the SAER Team Lead The nominated SAER Team Lead will be key to ensuring due process is followed during the review, ensuring that there is a nominated site or service contact for patients and families affected and will:

Receive the Datix Incident Record, SBAR and any other relevant documents.

Lead and guide the Team Members

Commence documentation management with the nominated operational support.

Ensure the checklist for the patients family / staff involved is complete (see appendix 8)

Ensure due process for each stage of the investigation by:

As recommended in the Vale of Leven Report (2014), internal investigations for significant and exceptional events (including serious outbreaks of infection) should have ‘a degree of impartiality.’ This can be achieved internally by inviting representation from the Board Internal Audit Department, and / or a Non-Executive Director of the Board and this level of representation must be considered when identifying the investigation team relevant to the incident / event.

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o Arranging team meetings o Agreeing the Terms Of Reference / scope of review with the commissioner o Assigning work to be undertaken by team members o Overseeing completion of the SAER report

Inform the Commissioner of any findings / concerns requiring immediate action at any time during the review

Manage relevant documentation (retaining/filing) o Meeting Agendas / Notes o Minutes o Initial Checklist o SBAR o Statements o Interview Records o Completed RCA records o Photographs taken as part of the investigation o Details of any equipment involved, including serial numbers and location o Final SAER report o Policies, Protocols relevant to case

Provide the draft report to the Commissioner within 80 days.

Ensure that any recommendations and actions contained within the report are achievable within the timescale.

4.11.3 Responsibilities of the Designated Operational Manager

The manager will:

Receive notification of the commissioning of a SAER or not.

Nominate a senior manager to be the contact for patients and staff from time of incident to completion of the SAER process. Information for Patients and Their Carers

Agree the SAER Team Lead and Team Members with the SAER Commissioner (should ideally be outwith the area where the incident occurred)

Receive any concerns found during the SAER process and ensure actions are taken.

Receive the SAER and receive assurance that the actions are achievable.

Dissemination of SAER Executive Summary and Action Plan through appropriate governance and operational structures.

Ensure the action plan is completed.

Ensure staff undertaking the SAER are offered de-briefing/clinical supervision/Occupational Health referral / emotional support.

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4.12 Undertaking a Significant Adverse Event Review (SAER)

4.12.1 The Review Process The review process should be undertaken timeously within the following guiding principles:

Have an agenda and take notes

Organise at least 4 meetings in advance for the team to meet

Commit to the meetings, fully participate and complete actions

Use the available toolkit

Be objective and focused

Work within the information assurance principles

Generate Questions, Answers and Solutions

Write-up the report following each meeting

Co-ordinate staff interviews and discuss with Partnership

Retain all information in one file

Liaise with the nominated patient/family contact and receive questions posed by patients and families to review and ensure you know who this is early on in the process

Refer to the risk management guidance

Use the standardised report format

Final Sign-off will be by the Commissioner of the SAER

4.12.2 Information Gathering All material facts relating to the adverse event/incident must be gathered as soon as possible after the event. In determining what information to collect, you must consider the facts leading up to, as well as the incident itself. Consideration should be given to:

The people involved or witnessing the adverse event/incident : statements, interviewing staff

The place or the environment where the adverse event/incident occurred : visiting area, reviewing plans of the area, sketch of the area or taking photographs

The equipment or objects involved : equipment involved should be removed and preserved as evidence

The paperwork related to the adverse event/incident : case notes, statements, guidelines, policies, procedures, incident report, maintenance records, manufacturer’s instructions, training records, external reports, risk assessments photographs

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Normal working processes, team relationships and adequacy of leadership in the workplace : eliciting custom and practice in the workplace.

4.12.3 Mapping the Information Mapping out the events will aid the team in understanding the chronology of events and identify issues. When mapping the incident information try to:

Avoid moving into analysis

Use one of the NHSL tools e.g. tabular timeline, time - person grid

Use the notes and statements provided

Identify any unconfirmed information requiring verification Exploration of the Contributory Factors linking cause and effect is key to supporting the full process and will generate some critical questions. The Contributory Factors Framework should be applied.

4.12.4 Analysis of Information The team will reflect on the information collected and will continue to ask ‘Why?’ for each primary cause identified and the response to each answer until there are no more causes forthcoming. This will inform the findings to be recorded in the report.

4.12.5 Identifying Problems Throughout the undertaking of the information gathering, the mapping and analysis of information, the problems will be continuously emerging and should be noted throughout and inform the findings of the review. Equally important, areas of good practice will emerge and should be noted. 4.12.6 Generating Solutions Solutions should be identified when there is agreement about the contributory factors and causes of the adverse event/incident. Solutions will be converted into recommendations within the report and must be considered with a level of reasonableness as what is achievable. 4.12.7 Learning Lessons Without accurately identifying the cause(s) of adverse events/ incidents, NHSL will be unable to identify systems weaknesses and there will be unable to facilitate change. Learning lessons is vital to minimise recurrence and must be shared across the relevant sectors within NHSL and may be required to be shared nationally.

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4.12.8 Root Cause Analysis For the purpose of this guidance, Root Cause Analysis (RCA) is referred to as the application of a range of critical questioning techniques to understand any harmful factors that may be deep and underlying within the Organisation, resulting in undesirable outcome. In understanding how ‘deep’ the harmful factors may be, there is the risk of not knowing when to stop asking the questions and this should be at the level where the most basic cause (or causes) that can reasonably be identified , that management has control to fix and, when fixed, will prevent a recurrence. In identifying the root cause(s), there should be the ability to find a solution, and the solution must contribute to prevention of recurrence, embedding knowledge and embracing the principles of being a learning organisation engaged in continuous improvement. 4.12.9 Application of Root Cause Analysis Tools & Techniques There are a number of different root cause analysis tools and to maintain clarity, these can be grouped according to their purpose for each stage of the SAER.

RCA TOOL ↓

GATHERING & MAPPING

INFORMATION

ANALYSIS OF INFORMATION

IDENTIFYING PROBLEMS

GENERATING SOLUTIONS

Narrative Chronology

√

Timeline

√

Time Person Grid

√

Tabular Timeline

√

Site Visits

√

Interviewing

√ √ √

Brainwriting

√ √

Nominal Group Technique

√

Five Why’s

√

Fishbone Diagram

√

Contributory Factors Framework

√ √ √ √

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L

All RCA templates referred to above can also be accessed on the risk management webpage in the Toolkit Section.

4.13 Report Writing 4.13.1 The purpose of this guidance is to:

Provide help and support to the nominated SAER Team Lead and Team Members

in compiling the SAER report.

Provide direction on the critical elements that should be included within the final

report.

Ensure the report will be easily read for all who require a copy and/or access to the

report (patient, family members, staff members, external partners)

4.13.2 The Style and the Presentation of the completed report should be consistently applied with the minimum:

NHS Lanarkshire Logo

Date of the Adverse Event /Incident

Name and Job Title of the Commissioner

Datix Incident Reference Number

Name and Job Title of the Author(s) of the Report

Date of Completed Report

Page numbers

Numbered paragraphs for ease of referencing

Font size 12 in Garamond (as per NHSL guidelines)

4.13.3 Guiding Principles for SAER Report Writing should be followed to ensure it presents the patient(s), families or staff involved as individuals without being overly personal or comprising confidentiality:

Reports should be written in the third person e.g. refer to ‘the patient’, ‘the doctor’,

‘the nurse’, ‘the organisation’, ‘the team’ rather than ‘I’, ‘We’ or ‘You’.

The author of the report should not assume that the reader will understand normal care delivery processes and / or hospital, health centre, community team protocols and operational working.

Ideally, names of staff should not appear in the report. Reference can be made to

‘Nurse in Charge’, ‘Dr Y’, Ms ‘X’ ( a record of the actual names against the coding

used should be retained).

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When referring to the patient involved in the adverse event/ incident, ‘the patient’

should be used at all times and avoid the use of gender specific terms eg ‘her’,

‘she’, ‘his’,’ he’.

When referring to family relationships gender specific terms such as ‘mother’,

’father’, ’brother’, ‘ sister’ etc should be avoided using alternative terms such as

‘parent’, ‘sibling’ ‘extended family member’.

The report should be evidence based and the team members are required to

analyse the facts, however, speculations should be avoided. The use of terms such

as ‘from the evidence it is concluded that..’ or ‘ from the available information it has

been observed that….’ should be used as the preferred option.

Working documents such as statements, timelines, analytical work used in the review should be managed confidentially and files and stored safely. This is overseen by the SAER Team Lead.

4.13.4 Format of the SAER Report The format of the completed report should be in 3 parts and with copyright permission, is based on work undertaken by the National Patient Safety Agency (NPSA):

1. Executive Summary 2. Main Report 3. Action Plan

4.13.5 Executive Summary

The executive summary is the short version of the full report and sets out to inform

the reader of the key points of the background information, concise analysis and

main conclusions and recommendations. It is the interaction between the writer of

the report and the target audience and therefore, it should be:

• Written in the same order as the main report and only include material

present in the main report

• Able to be read separately from the main report

• Used for sharing at management team meetings

• Contain short and concise paragraphs

The Executive Summary will feature at the front of the report, followed by the Main

Section of the Report and should be able to be copied separately for sharing. This

will be subject to the same level of redaction as required.

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4.13.6 The SAER Report Format

SECTION & REPORT HEADING Executive Summary

Main Report

1 Adverse Event/Incident Description and Its Consequence

√ √

2 Pre-Review Risk Assessment √ √

3 Background and Context of the Adverse Event/Incident

√ √

4 The Review Team √ √

5 The Scope of the Review √ √

6 The Review Type, Process and Methods Used √ √

7 Involvement and Support of the Patient and / or Families

√ √

8 Involvement and Support of Staff involved in the Adverse Event / Incident

√ √

9 Chronology of Events Leading up to the Adverse Event / Incident

√ √

10 Contributory Factors √ √

11 Lessons Learned √ √

12 Recommendations √ √

13 Shared Learning √ √

14 Distribution List √ √

15 Action Plans - √

SAER Section 1 – Adverse Event/Incident Description and Its Consequence This section should provide a clear, concise description of the adverse event/incident and its effects:

Adverse Event/Incident date

Detection of the adverse event/incident

Adverse Event/Incident type

Area where the adverse event/incident occurred

Actual effect of the adverse event/incident on the patient, staff member, service or

others.

The severity described should only be those relevant to the adverse event/ incident. Consideration should be given to physical harm, psychological harm, or reputational harm. Avoid, where possible, emotional and judgemental or value laden words to describe events.

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SAER Section 2 – Pre-Review Risk Assessment Referring to the grading of the adverse event/incident, the review team should ensure the grading of the adverse event/incident is accurate as Category 1. Immediate, intermediate and long-term recommendations and actions should reflect the assessed level of recurrence. SAER Section 3 – Background and Context of the Adverse Event/Incident A brief description should be given of the nature and size of the service and the environment where the adverse event/incident occurred. This should include whether it is a 24 hour service, community service, out-of-hours service, hospital based service, in-patient or out-patient and the constitution of the team providing the service. SAER Section 4 – The Review Team SAER ‘s are normally commissioned and undertaken when an adverse event/incident results in serious consequence, and, as such, the review team will require a high degree of leadership, experience, and seniority. Within this section, the core review team members should be identified with their names, job titles and whether they were the chair, team member, specialist advisor or admin support. SAER Section 5 – Terms of Reference/Scope of the Review This section should explain how far back the review will cover. Ideally, this should be centred on the most current episode of care/intervention; however, dependent on the adverse event/ incident, more background information may be reviewed. An explanation as to which relevant services or other agencies have or have not been included in the review and why, should be referenced. SAER Section 6 – The Review Type, Process and Methods Used Describe the analytical tools used with the process and methods used e.g. : Root Cause Analysis, interviewing of staff involved, interviewing of specialists, collating statements, using other agency reviews e.g. Health & Safety Reports, case note review, review of relevant policies and protocols, visit to area where the adverse event/incident occurred, literature search. SAER Section 7 – Involvement and Support of the Patient and/or Families Affected by the Adverse Event/Incident This section should demonstrate the extent to which those affected have:

Been given an accurate, open timely and clear explanation of what has happened,

regardless of, but with sensitivity to, the distressing nature of the incident

Received an apology in the form of a sincere expression of sorrow or regret for the

harm that has resulted from the event/incident

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Been informed of the plans regarding what can be done medically to repair or

redress the harm done

Been given a clear explanation of the SAER process and the expected report

The opportunity to outline their own questions to be taken into consideration by the

review team

SAER Section 8 – Involvement and Support of the Staff Involved in the Adverse Event/Incident In the case of a serious patient outcome, outline what support was given or offered to staff after the adverse event/incident and during the review. This may involve advising staff of the Occupational Health Services and the support from Partnership. Within the report, the team should acknowledge the staff participation, co-operation and openness during the review. Names of staff should not feature in the SAER report and staff should be advised that the report will be made anonymous as far as is possible and for particular use, will be subject to redaction. SAER Section 9 – Chronology of Events Leading up to the Adverse Event/Incident The chronology of events leading up to the adverse event/ incident will generally be related to the current episode of care / intervention and will be set-out to give the reader a clear understanding of the events leading up to the event/incident. SAER Section 10 – Contributory Factors For all adverse events / incidents the contributory factors framework must be considered SAER Section 11 – Lessons Learned Lessons learned will be collated from the log commenced by the SAER Team Lead at the beginning of the review and should be addressed by the recommendations.

SAER Section 12 – Recommendations

The recommendations should reflect the findings from the analysis of the contributory factors and any other analytical tools used, along with the lessons learned. Outline how the recommendations were arrived at, who was involved and what solution management tools (if any) were used. SAER Section 13 – Shared Learning Record in this section the degree to which sharing is required and the reassurance that where consent to publish information from patients records was necessary to the report, that it has been obtained.

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SAER Section 14 – Distribution List Within NHS Lanarkshire

Outline where the report will be distributed, ideally this should only be the Executive Summary and Action Plans that will be utilised for learning lessons and will be anonymised through redaction where necessary. Consideration must be given to management teams, local teams and distribution through the clinical governance structure. For sharing with Patient(s), Families, Staff and Statutory External Partners see Section 6 - Sharing a SAER Report.

SAER Section 15 – Action Plans

An action plan must be attached to the report and will be owned by the named responsible Operational Manager on the Action Plan. The Action Plan will set out how each recommendation will be implemented with named leads responsible for each action with reasonable timescales, depending on the action and impact. The Action Plan should be attached to the Executive Summary for internal circulation following approval of recommendations.

4.13.7 SHARING OUTCOMES FROM SAER’s

Effective management of SAER’s includes the necessary sharing of completed reports with staff involved and across the relevant areas that recommendations will impact on.

Essentially, persons affected, and/or families and/or carers, will require feedback and may request a copy of the SAER. Additionally, and when necessary, external partners will require a copy of the SAER.

The attached appendices must be used when sharing information as below:

‘Signed Off’

SAER Report

Patient / Person Affected

Staff Members involved (directly or

indirectly)

Family of Deceased Patients

External Statutory Partners

Letter the patient or person affected by the event/incident using the template in Appendix 3 and attaching an unredacted, watermarked copy of the SAER Report with evaluation request

Letter the staff member using the template in Appendix 5 making available an unredacted copy with evaluation request

Letter the NOK (and the agreed family contacts – no more than 3 contacts) using the template in Appendix 4 and attaching a redacted, watermarked copy of the SAER Report

Letter the external partner using the template in Appendix 6 attaching the appropriate level of watermarked report (either unredacted or redacted)

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5. ROLES AND RESPONSIBILITIES

‘Identification and management of risk, including adverse events, is everyone’s business’

All staff members are responsible for reporting any adverse incident that has caused harm, or could cause harm and record it on the Datix system. Nominated, trained verifiers are responsible for the verification of the record for: factual accuracy, ensuring person identifiable information is not used and accuracy of the grading of the incident. Team Leaders / Managers are responsible for reviewing trends / themes of data and discuss prevention at team meetings, escalating significant events and providing some feedback to staff. Divisional/Site/Unit Management Teams must be aware of the patterns of events / incident occurring and be fully aware of individual significant adverse events. Additionally, management teams will identify internal and/or external nominated persons to undertake, and contribute to a SAER. Management Teams will ensure immediate safety and actions to be undertaken and will nominate a contact person to ensure effective communication between the SAER Team and the affected persons, including staff members. Where improvements are recommended, management teams will oversee implementation of the improvements and action plans. Within the governance structure, incidents will be reviewed and assurance requested to confirm improvements and actions have been taken to minimise the risk of recurrence. All staff must ensure due process is followed for effective event / incident management. The NHSL Risk Management Strategy sets out the Organisation Scheme of Delegation.

6. RESOURCE IMPLICATIONS

It will be necessary for the Operational Divisions to have designated risk management and administrative support quantified and resourced within their existing budgets.

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7. COMMUNICATION PLAN

The Policy will be posted on the NHS Lanarkshire’s website and on its intranet for access by all staff. The full cascade with be through the Divisional Management Teams and staff briefings. Communication will be supported through the Staff Briefings and managed through implementation plan.

8. QUALITY IMPROVEMENT – Monitoring and Review

Implementation of the Policy will be monitored through its application in response to incident management, specifically, the KPI’s for closure of incidents and the SAER process and documentation management.

9. EQUALITY AND DIVERSITY IMPACT ASSESSMENT This policy meets NHS Lanarkshire’s EDIA (tick box)

10. REFERENCES

Health Improvement Scotland Learning From Adverse Events through Reporting and Review : A National Framework for NHS Scotland (September 2013) National Patient Safety Practice (NPSA) Safer Practice Notice 10 : Being Open When Patients Are Harmed (2005) NHS England, Patient Safety Domain Team : Never Events 2013/14 update, (December 2013)

√

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Appendix 1

Definitions SBAR (Situation, Background, Assessment/Action, Recommendation) SBAR is an easy to remember mechanism that enables individuals to summarise and provide clarity regarding information which should be communicated between members of staff and used as an early record for escalation of significant incidents, and may be added to throughout the process. The tool consists of standardised prompt questions within four sections and

ensures that staff are sharing concise and focused information

enables staff to communicate effectively

Situ

atio

n

Identify the ward/department/location where the incident occurred

Briefly state the incident, what it is, when it happened or started and how severe

State the reason for the SBAR

Describe the concerns surrounding the incident

Describe what is happening at the present time

Backgro

un

d

What do I think the problem is?

Brief background information

Assessm

ent/

Actio

n

Current Assessment of the situation

Record the immediate Actions taken

Recom

mend

atio

n

What could or should be done to correct the problem?

Information should be clear and concise, focused on the event / incident, with minimal use of person identifiable information. The Adverse Event / Incident SBAR must be used when communicating a Significant Adverse Event / Incident.

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Appendix 2 Commissioning Criteria for Significant Adverse Events/Incidents Category 1 incidents of an unexpected nature related to care and treatment that have result in death, significant harm or required intervention to save life

General Examples (not exhaustive)

Death of patient after an in-patient fall

Missed diagnosis of cancer or life limiting condition

Death from sepsis

Grade 3 or 4 pressure ulcers acquired in hospital with no previous skin problems

Unexpected anaesthetic, intra-operative or immediate post-operative death

Medication Errors (wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, wrong dispensing, wrong route of administration

Mental Health

Suicide of an inpatient either on hospital premises or during unauthorised absence from Ward

Suicide of an inpatient while on planned pass if suicide risk had been identified during admission

Suicide in the community where there has been significant suicide risk identified at the last contact prior to death

Any death where initial review suggests there have been potential deficiencies in the care offered

HIS has a reporting system for all suicides that occur within 12 months of a patients contact with mental health service. If a suicide does not meet the criteria outlined above then the incident should be graded as high and a suicide review commissioned using the HIS template. The suicide review should be completed in the same timescale 90 days, attached to Datix and forwarded to Health Improvement Scotland.

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Never Events – should be read in conjunction with the full Never Event Descriptions

See hyperlinks for full descriptions

Surgical Event Wrong Site Surgery

Wrong implant / prosthesis

Retained foreign object post op

Medication Event Wrongly prepared high-risk injectable medication

Maladministration of potassium containing solutions

Wrong route administration of chemotherapy

Wrong route administration of oral / enteral treatment

Intravenous administration of epidural medication

Maladministration of insulin

Overdose of midazolam during conscious sedation

Opioid overdose of an opioid-naïve patient

Inappropriate administration of daily oral methotrexate

Mental Health Event

Suicide using non-collapsible rails within an NHS environment

Escape of a transferred prisoner

General Healthcare Event Falls from unrestricted windows

Entrapment in bedrails

Transfusion of ABO-incompatible blood components

Misplaced naso- or oro-gastric tubes

Wrong gas administered

Failure to monitor and respond to oxygen saturation

Air embolism

Misidentification of patients

Severe scalding of patients

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Maternity Event Maternal death due to post-partum haemorrhage after elective caesarean section

NHSL Never Event Patient to patient transmission of blood borne virus

Exceptional events described in section 3 will be subject to other levels of investigation established within the organisation, e.g. major outbreak, joint review on public protection, police investigation etc. These events are:

Death or serious illness of one or more staff, patients or visitors as a result of communicable disease or environmental health

Physical or mental abuse of one or more patient(s) in a single setting (i.e. ward, team or specialty)

Malicious or wilful acts by staff or contractors

Notification required to statutory body such as HSE or Professional regulators such as GMC, NMC, HPC because of the possibility of suspension of practice

Notification Required to Criminal Justice system - the Police or Procurator Fiscal

Serious, unexpected service interruption

Likely to cause adverse public relations or involve major public figures

Serious asset loss outwith delegated financial limits – fire, major fraud

Consideration should also be given to:

Patient feedback which is not in the form of a complaint, but suggests cause for concern

Comments or complaints which describe events amounting to an adverse event or serious incident

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Appendix 3 Letter Template for Patient Dear [insert patient name] Re: Adverse Event/Incident Affecting your Healthcare We are deeply sorry for the adverse event [insert the nature of the incident] that happened whilst you were receiving health care from NHS Lanarkshire. We recognise the seriousness of the event and the impact this has had on you and your family members. We undertake a Significant Adverse Event Review in order to learn lessons about:

why the event/incident happened

what actions were taken at the time of the event/ incident

what further actions are required to reduce the risk of the event/incident happening

again

what lessons have been learned and how they have been shared with staff

We hope that you have felt supported and involved as we have undertaken the review and I now attach the report. If there is anything contained within the report that is not easily understood, please contact [insert name of nominated person to answer any questions] on [insert contact details], who will be happy to answer any questions you may have. This report contains clinical and personal information specific to your healthcare. As such it is marked for your reading as ‘Patient Copy’. This report will be shared with key members of staff to ensure that we learn from the event/incident, and can assure you that this sharing will be controlled. Any requests for access to this report will be managed through NHS Lanarkshire’s information governance framework to maintain your confidentiality. Kind Regards [insert name of Operational Manager] General Manager [insert service]

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Appendix 4 Letter Template for Family Member(s)

Dear [insert family member name]

Re: Adverse Event Affecting Your Family Member [insert deceased patient name]

We are deeply sorry for the loss of your [insert relationship, eg mother, brother]. NHS Lanarkshire recognises the seriousness of the event and the impact this has had on you and your family members. We undertake a Significant Adverse Event Review in order to learn lessons about:

why the event/ incident happened

what actions were taken at the time of the event/ incident

what further actions are required to reduce the risk of the event/incident happening

again

what lessons have been learned and how they have been shared with staff

We hope that you have felt supported and involved as we have undertaken the review and I now attach the report.

If there is anything contained within the report that is not easily understood, please contact [insert name of nominated person to answer any questions] on [insert contact details], who will be happy to answer any questions you may have.

This report contains clinical and personal information specific to your [insert relationship eg mother, brother], and some details have had to be redacted to maintain confidentiality for your [insert relationship eg mother, brother].

Additionally, it is marked for your reading only as ‘Family Member Copy’. [insert number of copies – agreed for release to relative no more than 3] have been agreed for the following family members:

Copy 1 of 3 – [insert family member name] Copy 2 of 3 – [insert family member name] Copy 3 of 3 – [insert family member name]

We thank you for continuing to protect your [insert relationship eg mother, brother] confidentiality. This report will be shared with key members of staff to ensure that we learn from the incident, and can assure you that this sharing will be controlled.

Any requests for access to this report will be managed through NHS Lanarkshire’s information governance framework to maintain confidentiality of your [insert relationship eg mother, brother].

Kind Regards [insert name of Operational Manager] General Manager [insert service]

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Appendix 5 Letter Template For Sharing SAER with Staff

Dear [insert staff members name] Re: Incident [insert Datix web reference number & date of adverse event/incident] Given the nature of the above incident in your areas of care, a Significant Adverse Event Review has been undertaken. In the spirit of being a learning organisation, it is important that all staff involved within the care area have access to the findings of the review for the purpose of understanding:

how the incident happened

the impact on persons involved

why the incident happened

what the actions are to reduce the risk of the incident happening again

what lessons have been learned and how they have been shared.

The confidential SAER report will be available for you to access through [name of nominated operation person facilitating the access for staff] and will be available until [insert the last day the report can be accessed, up to 4 weeks from approval of the report]. If you wish to read the report, please contact the nominated named person above on [insert contact details] to arrange viewing at a time convenient for you. Kind Regards [insert name of Operational Manager] General Manager [insert service]

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Appendix 6 Letter Template for External Partner

Dear [insert details of external partner] Re: Significant Adverse Event Report for [insert Datix web number and patient or person affected name] As requested and agreed, please see attached a copy of the SAER Report that has set out to understand

why the event/ incident happened

what actions have been taken

what the actions are to reduce the risk of the event/ incident happening again

what lessons have been learned and how they have been shared

This report contains clinical and personal information specific to [insert patients / person affected name] , and is marked for your reading only as [insert external partner eg For Procurator Fiscal]. In supporting NHSL to maintain confidentiality for [insert patient / person affected name] , we would ask that this report is not copied or distributed further. Requests for further access to this report will be managed within NHS Lanarkshire’s information governance framework through the Communications Department. Kind Regards (insert name of Operational Manager]

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Appendix 7 External Partners

For serious adverse events/incidents occurring within NHS Lanarkshire, and communicated within the escalation process, consideration must be given to the external communications required as outlined below. This list is not exhaustive and other organisations may be required to be notified.

Central Legal Office

Local Authorities – including Adult Support and Protection, Social Work, Child Protection, Education, Environmental Health

Food Standards Agency

Fraud Liaison Services

Health Facilities Scotland

Health Protection Scotland

Health and Safety Executive

Procurator Fiscal

Information Commissioner

Independent Care Sector

Medical Devices Agency

Medicine Control Agency

Mental Welfare Commission

Member of Scottish Parliament (MSP’s)

NHS Health Improvement Scotland (HIS)

Ombudsman’s Office

Patients and / or Relatives

Police, Fire and / or Ambulance Services

Regulatory Bodies (GMC, NMC etc)

Scottish Healthcare Supplies

Scottish Environmental Protection Agency (SEPA)

Serious Hazards of Transfusion (SHOT)

Social Care and Social Work Improvement Scotland (SCSWIS)

Staff Groups

Partnership via Employee Director

Prison Service

Voluntary Organisations

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Appendix 8

PATIENT AND FAMILY CHECKLIST

This checklist should be completed by the Significant Adverse Event Review (SAER) Lead at the outset of and during the SAER process, to enable a consistent approach to keeping patients and family members involved in the SAER process. Information for Patients and Their Carers The SAER Lead and the Designated Senior Manager where the incident occurred will maintain communication throughout the SAER to ensure patient and family involvement, and to keep all those involved updated on the SAER process through to sharing SAER Report as outlined in the Being Open Policy

Date: SAER Lead Completing Checklist:

Patient Name:

Directorate:

CHI Number:

Service:

Incident Date:

Speciality:

Datix Ref Number:

Location:

Designated Senior Manager as Contact Point for Patient / Family (and contact number):

Patient / Family / Involvement Tick Comments

Patient and family support

The patient / family have been notified of the adverse event/incident and of actions taken

A designated senior manager has been appointed to be the contact point to meet with the patient / family to discuss the adverse event/incident, the review process and to identify questions they would like to be answered

The designated senior manager has completed the debriefing and feedback for patient, family and staff members, sharing the SAER report.

Yes

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Feedback / Suggestions / Comments Please feel free to comment on this Policy through: Carol McGhee Corporate Risk Manager Kirklands Headquarters Bothwell Phone 01698 858099 Email: Carol.mcghee@lanarkshire.scot.nhs.uk

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