Document Title: Being Open Policy

Being Open Policy

Document No. / EDRMS000102NC / Version No. / 1.0 replaces version 7
Approved by / Clinical PAG / Date approved / 24/10/2012
Ratified by / Patient Safety and Quality Committee / Date ratified / 05/07/2012
Date Implemented / 29/10/2012 / Next Review Date / 05/07/2014
Status / Approved
Target Audience / All Staff
Accountable Director / Medical Director
Policy Author/Originator / Clinical Risk Manager
Implementation Lead / Clinical Risk Manager
If developed in partnership with another agency, ratification details of the relevant agency

Equality Impact

Great Western Hospitals NHS Foundation Trust (‘GWH’) strives to ensure equality of opportunity for all service users, local people and the workforce. As an employer and a provider of health care, GWH aims to ensure that none are placed at a disadvantage as a result of its policies and procedures. This document has therefore been equality impact assessed in line with current legislation to ensure fairness and consistency for all those covered by it regardless of their individuality. This means all our services are accessible, appropriate and sensitive to the needs of the individual.

Contents

1Document definition

1.1Introduction

1.2References & Further Reading

1.3Glossary / Definitions

1.4Purpose

1.5Scope

1.6Regulatory Position

1.7Special Cases

1.8Comments

2Roles and Responsibilities

3Introduction

3.1The principles of Being Open

3.1.1Acknowledgement

3.1.2Truthfulness, timeliness and clarity of communication.

3.1.3Apology

3.1.4Recognising patient and carer expectations.

3.1.5Professional support.

3.1.6Risk management and systems improvement.

3.1.7Multidisciplinary responsibility.

3.1.8Clinical governance.

3.1.9Confidentiality.

3.1.10Continuity of care

4Being Open Advisors

5Being Open Process

5.1Stage 1: Incident detection or recognition

5.1.1Patient Safety incidents which have occurred elsewhere

5.1.2Initial assessment to determine level of response

5.2Stage 2: Preliminary team discussion

5.2.1Timing

5.2.2Choosing the individual to communicate with the patients, their families and carers

5.2.3Assistance with the initial Being Open discussion

5.2.4Responsibility of junior healthcare professionals

5.2.5Involving the healthcare staff who made mistakes

5.3Stage 3: Initial Being Open discussions

5.4Stage 4: Follow-up discussions

5.5Stage 5: Process completion

5.5.1Communication with the patient, their family and carers

5.5.2Continuity of care

5.6Documentation

6Patient issues to consider

6.1Communication

6.2Advocacy and support

6.3Particular patient circumstances

6.3.1When a patient dies

6.3.2Children

6.3.3Patients with mental health issues

6.3.4Patients with cognitive impairment

6.3.5Patients with learning disabilities

6.3.6Patients with a different language or cultural considerations

6.3.7Patients with different communication needs

6.3.8Patients who do not agree with the information provided

7Supporting staff

7.1Training support

7.2Monitoring

Appendix A – Quick reference guide to Being Open

1Document definition

1.1Introduction

Being Open is a set of principles that healthcare staff should use when communicating with patients, their families and carers following a patient safety incident in which a patient has been harmed.

1.2References & Further Reading

Ref. No. / Document Title / Document Location
1 / NPSA – Being Open – Communicating Patient Safety Incidents With Patients And Their Carers /
2 / Confidentiality: NHS Code of Practice /
3 / Records Management: NHS Code of Practice /
5 / Code of Practice on Openness in the NHS /
6 / Health Service Circular – Caldicott Guardians, HSC1999/012 /
7 / Health Service Circular – Data Protection Act 1998: Protection and use of patient information /
8 / Use and Disclosure of Health Data (Guidance on the application of the Data Protection Act 1998) /
9 / Medical Defence Union. MDU encourages doctorsto say sorry if things go wrong. MDU, May 2009 /
10 / NHS Litigation Authority. Apologies and Explanations. NHSLA, London. May 2009 /
11 / Welsh Risk Pool. Technical Note 23: Apologies and Explanations. WRP, July 2001. /
12 / Incident Management Policy / Trust Intranet
13 / Whistle Blowing Policy / Trust Intranet
14 / Data Protection Policy / Trust Intranet
15 / Code of Confidentiality for Employees in Respect of Confidentiality, 2GEN-POL-025 / Trust Intranet
16 / Information Disclosure Policy / Trust Intranet
18 / Information Security Incident Reporting Procedure, 2ITDPRD001 / Trust Intranet
19 / Your Health Record – Protecting Your Information, Avon NHS IM&T Consortium / Trust Intranet
20 / Information Sharing Principles, Avon NHS IM&T Consortium / Trust Intranet
21 / The Caldicott Principles, 4ITD-LFT-001 / Trust Intranet

1.3Glossary/Definitions

The following acronyms and abbreviations are used within the document:

AvMA / Action Against Medical Accidents
CHC / Community Health Councils
CNST / Clinical Negligence Scheme for Trusts
eForm / Electronic form used to submit reports to the NRLS
GMC / General Medical Council
ICAS / Independent Complaints Advocacy Services
IDT
MDU / Incident Decision Tree
Medical Defence Union
MORI / Market and Opinion Research International
MPS / Medical Protection Society
NHSLA / National Health Service Litigation Authority
NPSA / National Patient Safety Agency
NRLS / National Reporting and Learning System
PALS / Patient Advisory and Liaison Service
RCA / Root cause analysis
RPST / Risk Pooling Schemes for Trusts
SI / Serious Incident
WRP / Welsh Risk Pool

The following definitions are used within the document:

Adverse event / See ‘Patient safety incident’.
Anonymous / Information that has had patient identifiable features removed; without making the information of no use for its purposes.
Apology / A sincere expression of regret offered for harm sustained.
Being open / Open communication of patient safety incidents that resulted in moderate harm, severe harm or death of a patient while receiving healthcare.
Carers / Family, friends or those who care for the patient. The patient has consented to their being informed of their confidential information and to their involvement in any decisions about their care.
Clinical governance / A framework through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.
Clinical risk manager / An officer within a trust assigned primary coordination responsibility for issues of clinical risk management. See Risk management.
Harm / Injury (physical or psychological), disease, suffering, disability or death.
Healthcare professional / Doctor, dentist, nurse, pharmacist, optometrist, allied healthcare professional, or registered alternative healthcare practitioner.
Healthcare organisation / Organisations that provide a service to individuals or communities to promote, maintain, monitor or restore health. See also ‘NHS organisation’.
Injury / Damage to tissues caused by an agent or circumstance.
Intentional unsafe acts / Incidents resulting from a criminal act, a purposefully unsafe act, or an act related to alcohol/substance abuse by a care provider. These are dealt with through performance management and local systems.
Liability / Legal responsibility for an action or event.
National Reporting and Learning System (NRLS) / A confidential and anonymous computer-based system developed by the NPSA for the collection and analysis of patient safety incident information. It receives incident reports from NHS organisations, staff and contractor professions and, in time, patients and carers.
Near miss / See ‘Prevented patient safety incident’.
NHS-funded healthcare / See ‘NHS organisation’
NHS organisation / Any area where NHS-funded patients are treated, i.e., NHS establishments or services, independent establishments including private healthcare or the patient’s home or workplace. Either all or part of the patient’s care in these settings is funded by the NHS. This may also be referred to as NHS-funded healthcare.
NPSA / The National Patient Safety Agency was set up in July 2001 following recommendations from the Chief Medical Officer in his report on patient safety, An organisation with a memory. Its role is to improve the safety of patients by promoting a culture of reporting and learning from patient safety incidents.
Patient safety / The process by which an organisation makes patient care safer. This should involve risk assessment, the identification and management of patient related risks, the reporting and analysis of incidents, and the capacity to learn from and follow up on incidents and implement solutions to minimise the risk of them recurring. The term ‘patient safety’ is replacing ‘clinical risk’, ‘non-clinical risk’ and the ‘health and safety of patients’.
Patient safety incident / Any unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS-funded healthcare. The terms ‘patient safety incident’ and ‘prevented patient safety incident’ will be used to describe ‘adverse events’ / ‘clinical errors’ and ‘near misses’ respectively.
Prevented patient safety incident / Any unexpected or unintended incident that was prevented, resulting in no harm to one or more patients receiving NHS-funded healthcare.
Risk / The chance of something happening that will have an impact on individuals and/or organisations. It is measured in terms of likelihood and consequences.
Risk management / Identifying, assessing, analysing, understanding and acting on risk issues in order to reach an optimal balance of risk, benefit and cost.
Root cause analysis (RCA) / A systematic process whereby the factors that contributed to an incident are identified. As an investigation technique for patient safety incidents, it looks beyond the individual concerned and seeks to understand the underlying causes and environmental context in which an incident happened.
Safety / A state in which risk has been reduced to an acceptable level.
Standard / Sets out agreed specifications and/or procedures designed to ensure that a material, product, method or service is fit for the purpose and consistently performs in the way it is intended.
Significant event audit (SEA) / An audit process where data is collected on specific types of incidents that are considered important to learn about and improve patient safety.
Suffering / Experiencing anything subjectively unpleasant. This may include pain, malaise, nausea and/or vomiting, loss, depression, agitation, alarm, fear, grief, or humiliation.
Systems failure / A fault, breakdown or dysfunction within operational methods, processes or infrastructure.
Systems improvement / The changes made to improve operational methods, processes and infrastructure to ensure better quality and safety.
Treatment / Broadly, the management and care of a patient to prevent or cure disease or reduce suffering and disability.

1.4Purpose

Being Open is a process rather than a one-off event. With this in mind, ten principles have been drawn up to underpin the policy. Some of the principles listed are discussed in more detail in subsequent sections of this policy document.

This policy provides guidance for Health Care staff on the principles of open communication with patients and carers following patient safety incidents. This policy should be followed in conjunction with the Incident Management Policy in the event of patient safety incidents which have resulted in harm.

1.5Scope

The scope of this document is Trust wide and applies to the wider organisation encompassing Wiltshire Community Health Services

In the case of near miss or no harm incidents, patients are not usually contacted or involved in investigations and these types of incidents are outside the scope of the Being Open policy.

1.6Regulatory Position

  • Data Protection Act 1998
  • Human Rights Act 1998
  • Freedom of Information Act 2000
  • Care Quality Commission Outcome 4
  • NHSLA Risk Management Standards

1.7Special Cases

None.

1.8Comments

Any comments on this document should, in the first instance, be addressed to the Clinical Risk Manager.

2Roles and Responsibilities

Trust Board / The Trust board retains corporate responsibility for the Being Open policy.Ensuring that a Being open policy is in place and fully implemented throughout the organisation
Chief Executive / The Chief Executive has overall responsibility for Being Open within the Trust, ensuring that the principles and policy are embedded in the organisation The Chief Executive will fulfil this responsibility by leading by example in fostering a culture of fair blame and non-punitive reporting within the Trust.
The Chief Executive will be made aware of individual serious incidents via the Medical Director and the Director of Workforce and Education.
Non-Executive Director / The Chair of the Patient Safety and Quality Committee is responsible for ensuring that the Being Open principles and policy are embedded in the organisation.
Medical Director / The Medical Director will be made aware of all serious incidents. They have executive responsibility for ensuring that these incidents are managed, external reports made as necessary and investigations undertaken appropriately and that the Being Open policy is implemented and forms part of the incident management process.
Associate Director of Quality and Patient Safety / The post maintains an overview of all incidents and ensures a robust monitoring and reporting system is in place.
The post also oversees and ensures serious incident reports inform the clinical and corporate governance committees.
Investigation Executive lead / An Executive lead will be identified for each Serious Incident investigation. They are responsible for identifying the Lead Investigator in conjunction with the Clinical Risk Team, overseeing the investigation and for ensuring that Being Open is an integral part of the incident management process.
Investigation Lead / An Investigation Lead will be identified by the Investigation Lead Executive for all Serious Incidents. The Lead Investigator should be a member of staff who has undertaken incident investigation training or equivalent experience. The Lead Investigator will usually be identified within the directorate in which the incident occurred but outside of the immediate speciality or department.
The Investigation Lead is responsible for ensuring the robust investigation of an incident and for ensuring that Being Open forms an integral part of the incident management process.
Patient Safety and Quality Committee (PSQC) / The Patient Safety and Quality Committee function is to improve quality and reduce clinical risk by co-ordinating the implementation and monitoring of cross directorate clinical governance and clinical risk management.
They will review all serious incidents on a monthly basis and make recommendations for directorate and organisational improvements in clinical practice.
Being Open Advisors / Provide mentoring and support to colleagues. A Being Open advisor should only be asked to lead Being Open discussions when appropriate. Their primary role is to provide support to their colleagues in implementing Being Open.
Senior managers (e.g. modern matrons, AMDs, general managers) / On notification of an adverse incident the senior line manager, must ensure that all appropriate steps have been taken and that the situation has been made safe. They must insure that the Incident Management Policy and Being Open policies are followed within their directorate and that staff are adequately supported to implement the polices effectively.
Responsible for ensuring that staff within the directorate are provided opportunity to access short term and long term support following a patient safety incident, complaint or claim.
Line managers / On notification of an adverse incident the line manager, must ensure that the situation has been made safe and that the incident is managed in line with the Incident Management Policy.
They are responsible for ensuring that the Being Open process described within this policy is followed for all low andmoderate harm incidents.
As a line manager they have responsibility for ensuring that all staff reportable to them have adequate immediate and ongoing support following a patient safety incident, complaint or claim.
All staff / The Being Open policy applies to all staff that have key roles in patient’s care.
Clinical Risk Team / The Clinical Risk Team are responsible for advising on and ensuring compliance with the Incident Management and Being Open policies throughout the organisation.
The Clinical Risk Manager will champion the Being Open Policy and act as a Being Open advisor.
Patient Advice and Liaison Service (PALS) / Responsible for highlighting patient safety incidents to the clinical risk, litigation and health and safety teams which are uncovered through the complaints procedures.
Ensuring that the principles and processes described in the Being Open policy are considered as part of the management of complaints. See Also Trust Complaints Policy.
The Head of Patient Experience will champion the Being Open Policy and act as a Being Open advisor within the Trust.

3Introduction

Being Open is a set of principles that healthcare staff should use when communicating with patients, their families and carers following a patient safety incident in which a patient has been harmed.

Being Openinvolves:

• acknowledging, apologising and explaining when things go wrong;

• conducting a thorough investigation into the incident and reassuring patients, their familiesand carers that lessons learned will help prevent the incident recurring;

• providing support for those involved to cope with the physical and psychologicalconsequences of what happened.

In 2005, the National Patient Safety Agency (NPSA) issued a Safer Practice Notice advising the NHS to develop a local Being Open policy and to raise awareness of this policy with all healthcare staff.

In November 2009 the NPSA published the revised Being Open framework in order to strengthen the Being Open throughout the NHS.

Communicating effectively with patients, their families and carers is a vital part of the process of dealing with patient safety incidents in healthcare. Research has shown that patients are more likely to forgive medical errors when they are discussed in a timely and thoughtful manner and that Being Open can decrease the trauma felt by patients following a patient safety incident.

Openness also has benefits for healthcare professionals as it can: help to reduce stress through the use of a formalised, honest, communication method; alleviate the fear of ‘being found out’; and improve job satisfaction by:

  • ensuring that communication with patients, their families and carers has been handled in themost appropriate way;
  • helping the healthcare professional to develop a good professional reputation for handlingdifficult situation properly;
  • improving the healthcare professional’s understanding of incidents from the perspective of the patient, their family and carers.

The benefits of Being Openare widely recognised and supported by policy makers, professional bodies, and litigation and indemnity bodies, including the Department of Health, General Medical Council (GMC), National Health Service Litigation Authority (NHSLA), Medical Defence Union (MDU) and the Medical Protection Society (MPS).

The NHS Constitution for Englandembeds the principles of Being Openas a pledge to patients in relation to complaints and redress. It states: