Policy for the Management of Safety Learning Events and Near Misses

Version / 4.1
Name of responsible (ratifying) committee / Serious Incident Review Group
Date ratified / 28 June 2016
Document Manager (job title) / Head of Risk Management
Date issued / 21 July 2016
Review date / 31 July 2018
Electronic location / Management Policies
Related Procedural Documents / Risk Management Strategy
Management of Serious Incidents Requiring Investigation
Management of Complaints, Concerns, Comments and Plaudits
Duty of Candour and Being Open Policy
Management of Claims, Clinical Negligence Liabilities to Third Parties and Property Expenses Scheme Disclosure of Information to the Police Policy
How to Report a Safety Learning Event
Key Words (to aid with searching) / Incident; Serious Incident; Safety Learning Event
Version / Date Ratified / Brief Summary of Changes / Author
4.1 / 15/05/2018 / Extension agreed by the Chair of SIRG as awaiting outcome of external Serious Incident Process review / -
4.0 / June 2016 / ·  Change of policy title from ‘Adverse Event and Near Misses Management Policy’
·  Updated process
·  Updated Responsibilities / A Green
3.1 / - / ·  Chairs action to extend review date / -
3 / January 2014 / ·  Alignment to NRLS definitions
·  Inclusion of Duty of Candour requirements
·  Addition of screening incidents
·  Update to responsibilities
·  Changes to monitoring
·  Removal of Guidance on Grading Incidents replaced by NRLS definitions / A Green

CONTENTS

QUICK REFERENCE GUIDE 4

1. INTRODUCTION 5

2. PURPOSE 5

3. SCOPE 5

4. DEFINITIONS 5

5. DUTIES AND RESPONSIBILITIES 6

6. PROCESS 7

7 TRAINING REQUIREMENTS 10

8 REFERENCES AND ASSOCIATED DOCUMENTATION 11

9 EQUALITY IMPACT STATEMENT 11

10 MONITORING COMPLIANCE 12

As a minimum, the following elements will be monitored 12

Appendix A: Reportable incidents 13

Appendix B: How to Report an Adverse Incident 15

Appendix C: Guidance on grading incidents 33

Appendix D: SIRI Pathway 34

Appendix E: Reporting to External Agencies 35

Appendix F: Informing external agencies: when, why and by whom 36

Appendix G: VTE Reporting and Investigation Process 38

38

Title of Procedural Document: Safety Learning Event and Near Miss Management 39

Date of Assessment 39


QUICK REFERENCE GUIDE

For quick reference the guide below is a summary of actions required. This does not negate the need for those involved in the process to be aware of and follow the detail of this policy.

PROCESS FOR THE REPORTING AND MANAGEMENT OF A SAFETY LEARNING EVENT (SLE)

1.  INTRODUCTION

In a service as large and complex as the NHS, things will sometimes go wrong. When they do, the response should not be one of blame and retribution, but of learning and a drive to reduce risk for future patients, visitors and staff. Therefore, the Trust is committed to developing a just culture and to encouraging a willingness to admit mistakes without fear of punitive measures. In support of this, the Trust accepts that completion of an Safety Learning Event (SLE) form does not constitute an admission of liability and will not result in automatic disciplinary action. There are occasions, of course, when it may be necessary to take action against individuals which will be governed by appropriate HR policies: acts of maliciousness or criminal or gross/repeated professional misconduct.

The policy has been formulated in response to the Department of Health publications An Organisation with Memory, Building a Safer NHS, Doing Less Harm and the National Patient Safety Agency publications Building a Memory: preventing harm, reducing risks and improving patient safety, Seven Steps to Patient Safety and Being Open: Communicating Patient Safety Incidents with Patients and their Carers. The policy is also designed to ensure compliance with the requirements of external agencies. However, the ultimate aim is to reduce the risk of harm to patients, staff and other users of Trust premises through improving the safety and quality of services and the environment.

2.  PURPOSE

This policy sets out the processes for the appropriate identification and reporting of Safety Learning Events (SLEs) and near misses.

3.  SCOPE

This policy applies to all permanent, locum, agency, bank and voluntary staff of Portsmouth Hospitals NHS Trust, the MDHU (Portsmouth) and Carillion, whilst acknowledging that for staff other than those directly employed by the Trust the appropriate line management or chain of command will be taken into account

‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’.

4.  DEFINITIONS

Safety Learning Event (SLE): an event or omission relating to a patient, visitor or staff member or any event or circumstances arising during NHS care that could have or did lead to unintended or unexpected harm, loss or damage. See Appendix A for more information on incidents that should be reported.

Patient safety incident: any unintended or unexpected incident which could have, or did, lead to harm for one or more patients receiving NHS-funded healthcare.

Serious incident requiring investigation (SIRI): (commonly classified as an incident causing severe harm or death) an incident that occurred during NHS funded healthcare (including in the community) which resulted in one or more of the following:

§  unexpected or avoidable death or severe harm of one or more patients, staff or members of the public.

§  a ‘never event’ – all never events are defined as a SIRI although not all necessarily result in severe harm or death.

§  a scenario that prevents, or threatens to prevent, an organisation’s ability to continue to deliver healthcare services including; divert of ambulances, breaches of the 12 hour decision to admit (DTA) target, data loss, property damage or incidents in population programmes like screening and immunization where harm potentially may extend to a large population.

§  allegations or incidents of physical abuse and sexual assault or abuse.

§  loss of confidence in the service, adverse media coverage or public concern about healthcare or an organisation.

§  All grade 3 and 4 pressure ulcers, death attributable to either C Diff or MRSA (part 1 of death certificate), death attributable to VTE, falls resulting in fractures requiring surgical intervention or death.

If in doubt, it is better to report an incident as a potential SIRI, as this can then be confirmed by the Clinical Service Centre (CSC) or at the Initial Investigation Panel meeting. Once confirmed the incident will be managed according to the Serious Incident Requiring Investigation Policy.

Never Event: a largely preventable patient safety incident that should not occur if the available preventative measures have been implemented.

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

Harm: an injury (physical or psychological), disease, suffering, disability or death to patients, staff or members of the public. In most instances, harm can be considered to be unexpected if it is not related to the natural course of the patient’s illness, treatment or underlying condition.

Root Cause Analysis: A well recognised way of investigating incidents, claims and complaints, which offers a framework identifying what, how and why the event happened. Analysis can then be used to identify areas of change, develop recommendations and look for new solutions.

DatixWeb: A Patient Safety and Risk Management System that provides a comprehensive picture of our organisation’s risks by collating information from incidents affecting patients, staff & visitors.

5.  DUTIES AND RESPONSIBILITIES

Associate Director of Governance and Quality

The Associate Director of Governance and Quality has responsibility for the strategic implementation of this policy.

The Head of Risk Management

The Head of Risk Management has responsibility for the operational and day-to- day implementation of this policy.

Associate Director of Infection Control & Patient Safety

The Associate Director of Infection Control & Patient Safety attends all moderate harm panels, ensuring that lessons are identified and that organisational learning has taken place.

Clinical Service Centre (CSC) Governance Leads (or nominated deputy)

The Governance Leads are responsible for ensuring that all SLEs or near misses are reported and managed in line with this policy; are discussed at CSC SIRG/Governance meetings and shared with staff.

CSC Boards

The CSC Board reviews events reports, ensuring that recommendations arising from investigations are implemented as required and that any identified local or organisational learning has been shared.

Risk Management Team

The Risk Advisors are responsible for supporting and advising staff at all levels across the Trust, to ensure that this policy is implemented across the Trust and for ensuring external agencies (Appendices D and E) are informed, if required.

All Managers

Managers are responsible for ensuring their staff are released for training, are fully assisted and supported throughout the reporting and handling of an adverse incident or near miss and receive feedback on the outcome of any investigation. Where staff experience particular difficulties associated with an adverse incident or near miss, managers should consider referring the staff member or members to the Occupational Health Department or the AQUILIS counseling service, in accordance with the Human Resources Policy for Supporting Staff

The Reporter of any incident must:

·  Ensure the immediate safety of those directly affected by the SLE or near miss

·  Complete an on-line electronic adverse incident form

·  Immediately inform the appropriate senior member of staff/line manager

6.  PROCESS

6.1 Near Misses (No harm to patient, impact prevented).

The reporter must:

·  Complete an on-line electronic SLE form.

·  Inform the appropriate senior member of staff / line manager.

The Governance Lead must:

·  Review the incident within 5 days, and confirm the grading.

·  Allocate the event to an investigator.

Note: consideration should be given to the potential severity of the near miss had it actually impacted upon a patient, staff member or visitor and the appropriate level of investigation pursued.

·  Ensure details of any long-term actions necessary and/or learning are appropriate (these will be fed back to the reporter via Datix) and close the incident on DatixWeb.

The Risk Management Team:

·  Will check that all actions are appropriate and finally approve the event on DatixWeb.

6.2 Incidents graded No Harm or Low Harm to patient.

The reporter must:

·  Ensure the immediate safety of those directly affected by the incident.

·  Complete an on-line electronic SLE form.

·  Inform the appropriate senior member of staff / line manager.

The Governance Lead must:

·  Review the incident within 5 days, and confirm the grading.

·  Allocate the event to an investigator.

·  Ensure details of any long-term actions necessary and/or learning are appropriate (these will be fed back to the reporter via Datix) and close the incident on DatixWeb.

The Risk Management Team:

·  Will check that all actions are appropriate and finally approve the event on DatixWeb.

6.3 Incidents graded Moderate Harm to patient.

The reporter must:

·  Ensure the immediate safety of those directly affected by the incident.

·  Complete an on-line electronic SLE form.

·  Inform the appropriate senior member of staff/line manager

·  Governance Leads, Risk Advisors and Line Managers will be automatically notified of the incident via email.

The Governance Lead must:

·  Review the incident to confirm the grading and organize an initial panel within 48 hours;

·  Initial panel to be chaired by a member of the CSC Management team and include the Associate Director of Infection and Patient Safety as a panel member.

·  As part of the investigation process, complete a Root Cause Analysis (RCA), ensure a member of staff is identified to communicate with the patient or relatives and ensure compliance with Duty of Candour requirements. Further guidance is available in the Trust’s Duty of Candour & Being Open Policy.

·  In conjunction with the CSC Management Team; ensure an investigation is instigated following the agreed timescales for a SIRI investigation.

·  When the investigation is concluded: ensure details of any long-term actions necessary and/or learning are appropriate (these will be fed back to the reporter via Datix) and close the incident on DatixWeb.

·  In accordance with Duty of Candour; arrange to share the final report with the patient/relatives, where this has been requested, within 10 working days.

The Risk Management Team:

·  Will check that all actions are appropriate and finally approve the event on DatixWeb.

· 

6.4  Incidents graded Severe/permanent Harm or Death.

·  Guidance on grading can be found at Appendix C. Advice can also be sought from the Risk Management Department

·  Incidents graded Severe/permanent Harm or Death should be managed in accordance with the Trust Policy for the Management of Serious Incidents Policy. Pathway-Appendix D

6.5  All incidents must be documented in the patient’s health records, including a note of the incident number

6.6  Safeguarding

6.6.1  If a concern is regarding the welfare of an adult patient and a suspected safeguarding incident, staff should refer to the Adult Safeguarding policy, fill in the adult safeguarding section of the SLE reporting from on Datix and the event will automatically be sent to the central Safeguarding Mailbox. The reporter should also complete the referral form (found on the intranet) and sent to the central Safeguarding mailbox.

6.6.2  If a concern is regarding the welfare of a child, and a suspected safeguarding incident, staff should refer to the Child Safeguarding policy, complete the reporting form and contact the named nurse or midwife for safeguarding children.

6.7  Screening Incidents

Incidents relating to national screening programmes must be discussed with the Regional Quality Assurance Director in line with local and national guidelines and escalated to Commissioners as appropriate.