Adverse Events and Duty of Candour Policy Version 1 · Stage 1: Risk Assessment and prevention ±...

Doc: Adverse Event and Duty of Candour Policy Author: Sarah Stevenson / Fay McNicol

Date April 2019 Version 1.00 Review Date: March 2020

Adverse Events and Duty of Candour Policy Version 1.00



DOCUMENT CONTROL SHEET: Key Information:

Title: Adverse Event and Duty of Candour Policy – supersedes Adverse Event Framework

Date Published/Issued: April 2019

Date Effective From: April 2019

Version/Issue Number: Final Version 1.00

Document Type: Policy and Procedure

Document status: Final Approved

Author: Sarah Stevenson/ Fay McNicol

Owner: Risk Manager

Approver: Please see table below

Contact: [email protected]

File Location: @SAS> Departments>Risk & Resilience>Risk/Datix/SAER>Risk

Revision History:

Version: Date: Summary of Changes: Name: Changes Marked:

1 February 2015

Initial Issue

S.S. N/A

1.00 Mar 18 Reformatted to new template and Policy and Guidance separated. Update to Organisational Structures and responsibilities added.

S.S/ FMc N/A

Approvals: This document requires the following signed approvals.

Name: Date: Version:

Executive Team April 2018 2.00 draft

Health Safety and Wellbeing Group 22nd June 18 2.01 draft

National Clinical Operational Governance Group 2nd Nov 18 2.02 draft

Policy Review Group 12th Dec 18 2.03 draft

National Partnership Forum 8th Feb 19 2.03 draft

Clinical Governance Committee 11th Feb 19 2.03 draft

Staff Governance Committee 10 April 19 2.04 draft

Distribution: This document has been distributed to

Name: Date of Issue: Version:

Senior Leadership Team April 2019 1.00 final

All Staff via @SAS April 2019 1.00 final

Linked Documentation:

Document Title:

1. Guidance for Managing an Adverse Event Process 2. Clinical Governance Framework

Equality and Diversity Impact Assessment: Completed



CONTENTS PAGE 1 Policy Statement 4 2 Scope 4 3 Aim 5 4 Roles and Responsibilities 5 5 Overarching Principles 9 6 What are Adverse Events 10 7 Governance routes for the management of adverse events 12 8 Key Performance Indicators 12 9 Risk Matrix 12 10 Review 13 11 Implementation 13 APPENDIX 1 – Adverse Event Review flowchart 14 APPENDIX 2 – Governance process for Adverse Events 15 APPENDIX 3 – Key Performance Indicators 16 APPENDIX 4 – NHS Scotland Risk Matrix 17 APPENDIX 5 – Duty of Candour Policy 19



1 Policy Statement

1.1 Learning from adverse events is crucial to continually improve person centred,

safe and effective care. In turn, this contributes to achieving Scotland’s 2020 vision of sustainable, world leading and high quality health and care services for the people of Scotland (HIS National Framework for Adverse Events).

1.2 The Scottish Ambulance Service (The Service) recognises its duty to comply with

the Health and Safety at Work etc Act (HSWA) 1974 and all subordinate regulations, such as Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 2013.

1.3 Therefore, the Service is committed to ensuring, so far as is reasonably

practicable, the health, safety and welfare of all its employees and will do all that is reasonably practicable to protect staff and patients within its care. This policy outlines how we will learn from adverse events.

1.4 The Service accepts that sometimes things will go wrong, care will never be risk free but we can minimise these risks in order to provide high quality care.

1.5 Supporting cultural change is at the heart of this Policy. We all want to achieve a positive safety culture that is open, just and informed, in which reporting and learning from error is the norm. Achieving cultural change is challenging and will take time, but this approach and the tools developed will support the behavioural change we want to see within the Service.

1.6 The Service’s adverse event reporting tool (DATIX) will be used to monitor and record adverse events that impact upon our staff, patients and those who come into contact with our Service. Adverse events can vary from hazards and near misses through the spectrum to the most serious of events. The Service will maintain appropriate processes and procedures (see linked documents) to review and learn from these events.

1.7 Line Managers are responsible for reviewing all adverse event reports and for the more serious events a formal, in depth review process will be launched.

1.8 A flow chart showing the process(es) for the management of adverse events is shown in Appendix 1.

2 Scope

2.1 This policy applies to all adverse events and near misses that could have caused, or did result in, harm to people or groups of people, or damage to equipment or property by the work carried out by The Service throughout Scotland.



3 Aims

3.1 The aims of the Policy are to: Improve the safety of Staff, Patients, Visitors or Carers and others affected by

our actions; Learn from adverse events locally and nationally to make service

improvements that enhance the safety of our Service for everyone; Have a standardised approach to adverse event management across the

Service, including consistent definitions and the establishment of measures to monitor implementation;

Ensure a consistent and co-ordinated approach to the identification, reporting and review of adverse events to allow best practice to be actively promoted across the Service;

Have an approach that allows the reflective review of events, seeking out root causes, identifying human factor failings, and identifying system failings that can be adapted to different settings;

Develop the skills, culture and systems required to effectively learn from adverse events to improve services across the Service.

Ensure the Duty of Candour Procedure (Scotland) Regulations 2018 are complied with.

4 Roles and Responsibilities 4.1 Employees 4.1.1 Employees are responsible for:

Reporting all events, these can vary from hazards and near misses through to significant adverse events. These should be reported onto the Service’s adverse event Reporting system (Datix), ideally within 2 days of the event;

Ensuring escalation to line manager or reporting to Ambulance Control Centre (ACC) in the Out of Hours period;

Attending any training or completing e-learning packages; Following policy and procedures including adhering to timescales and health

and safety obligations; Participating in reviews; Implementing recommended actions and learning points.

4.2 Chief Executive

4.2.1 The Chief Executive has, on behalf of Scottish Ambulance Service (The Service), overall responsibility for health and safety, and Risk Management matters including those related to Adverse Event Reporting, for the final approval of Significant Adverse Event Reviews (SAER).



4.3 Executive Directors 4.3.1 Director of Human Resources and Organisational Development The Director of Human Resources and Organisational Development has designated authority for the implementation of all Health and Safety policies within the organisation.

Director of Human Resources and Organisational Development is responsible for:

Ensuring that all Health and Safety issues are appropriately considered for

all Board decisions; Ensuring that Health and Safety is appropriately resourced; Ensuring that competent Health and Safety advice is available; Ensuring the Health and Safety system is effective and audited annually; Ensuring the dissemination of shared organisational learning with regard

to non clinical adverse event reviews. The dissemination of shared organisational learning with regard to non-

clinical SAERs 4.3.2 Medical Director The Medical Director has designated authority for the implementation of all clinical policies within the organisation.

The Medical Director is responsible for:

Providing Board assurance in relation to the reporting and reviewing of

clinical SAEs involving the Service; Clinical Governance and Patient Safety; Ensure robust systems are in place and operating effectively for the

identification, assessment and reviewing of all potential SAEs, both within the organisation and for independent contractor services;

The dissemination of shared organisational learning with regard to clinical reviews;

Be responsible for the decision and subsequent grading up or down of all potential SAEs;

Receive and approve the final review report and associated action plan and be assured that learning has been realised and implemented.

4.3.3 Regional and National Operational Directors are responsible for ensuring:

That this policy is effectively implemented; Action plans are implemented and staff are released to conduct the

review processes; That staff and patient safety is considered at all times.



4.3.4 Director of Finance: Has overall responsibility for ensuring funding is

available to support this policy. 4.3.5 All other Directors/ Deputy Directors have responsibilities to ensure that

the necessary arrangements are in place for the Service to be able to manage adverse events.

4.4. Head of Operations/Operational Managers/Other Senior Managers 4.4.1 Heads of Operations/Operational Managers/Other Senior Managers will be

responsible for:

Implementing this policy within their areas of responsibility; Ongoing review of adverse events to implement organisational learning; Having an understanding of this policy and the associated arrangements; Ensuring that resources and structures are in place to comply with relevant

regulations. 4.5. Line Managers 4.5.1 Line Managers are responsible for:

Ensuring staff awareness and compliance with adverse event policies and

procedures;

Supporting staff following adverse events;

Providing the necessary information / access to employee assistance

programmes

Ensuring adverse events are escalated appropriately in and out of hours;

Managing adverse events including review, progress of actions,

dissemination and implementation of learning;

Reviewing local themes and trends. Ensuring that employees are aware of

this policy;

Raising any concerns with their line manager and the health and safety

department or Clinical teams as appropriate;

Ensuring that all Adverse Events are reviewed

Completing Situation Background Assessment Recommendations

(SBARs) and where appropriate patient safety reflections.

4.6. Head of Health and Safety 4.6.1 Head of Health and Safety is responsible for:

Monitoring all Non Clinical Adverse Events and providing relevant incident analysis;

Providing advice and guidance to managers and staff to assist them;



Providing guidance to managers on the investigation of all reported events to prevent reoccurrence, where requested and / or appropriate

Co-ordinating the Non Clinical SAER process from inception to completion, i.e. receive signed off reviews and action plans at all stages and to confirm review has identified appropriate learning. To assist with developing action plans for national/regional themes that emerge from SAERs and Adverse Events, etc.

4.7. Risk Manager(s)

4.7.1 The Risk Manager(s) are responsible for:

Maintenance of the Service’s adverse event reporting systems; Ensuring that all Adverse Events are reviewed; Providing guidance to managers on the review of all reported adverse

events to prevent reoccurrence Where requested and or appropriate ; Co-ordinating the SAER process from inception to completion, i.e. receive

signed off reviews and action plans at all stages and to confirm review has identified appropriate learning. To assist with developing action plans for national/regional themes that emerge from SAERs and Adverse Events, etc.

4.8. Patient Experience Team 4.8.1 The patient experience team is responsible for:

The identification of trends and learning from Complaints, Concerns and Commendations

Identifying potential SAERs from Complaints and Concerns 4.9 Patients 4.9.1 Our commitments and responsibilities to patients and families are covered in the Duty of Candour Policy, Appendix 5 4.10 Governance Groups 4.10.1 Clinical Governance Committee

To receive quarterly reports from the Risk Managers and to assure the board that appropriate clinical reviews are taking place and learning is being implemented.

4.10.2 Staff Governance Committee To receive quarterly reports from the Risk Managers and to assure the board that appropriate staff related reviews are taking place and learning is being implemented.



4.10.3 National Clinical Operational Governance Group (NCOGG)

To receive quarterly statistical reports from the Risk Managers. To receive clinical signed off reviews and action plans at all stages and to

confirm review has identified appropriate learning. To assist with developing action plans for national/regional themes that emerge from clinical SAERs.

4.10.4 Health, Safety and Wellbeing Group

To receive quarterly statistical reports from the Risk Managers. To receive non clinical signed off reviews and action plans at all stages

and to confirm review has identified appropriate learning. To assist with developing action plans for national/regional themes that emerge from non clinical SAERs.

5.0 Overarching Principles

These principles were initially developed by Health Improvement Scotland and have been modified to fit with the Service’s context.

5.1 The 2020 Workforce Vision re-affirms NHS Scotland’s key values, which are

care and compassion; dignity and respect; openness, honesty and responsibility; quality and teamwork. These are the principles of the Service’s approach to learning from adverse events.

5.2 Emphasis on learning and promoting best practice across the Service – the system is focused on learning, locally and nationally, and makes extensive use of improvement methodology to test and implement the necessary changes.

5.3 Near misses – are reviewed regularly to promote learning and system improvements.

5.4 System approach – adverse events act as a ‘window’ on the healthcare system allowing a systems analysis. This is important to allow a reflection on any weaknesses of the system, or in the case of near misses, the strengths, and prevent future events.

5.5 Openness about failures – errors are identified, reported and managed in a timely manner, and patients and their families are told what went wrong and why as part of the Duty of Candour procedure. Reviews of events happen frequently and quickly following their occurrence. We expect adverse event reporting to increase as we move to a more open culture.

5.6 Just culture – individuals are treated fairly. Organisational culture is based upon the values of trust, openness, equality and diversity which encourages



and supports staff to recognise, report and learn from adverse events.

5.7 Positive safety culture – avoidance, prevention and mitigation of risks is part of the organisation’s approach and attitude to all its activities and is recognised at all levels of the organisation. Decisions relating to the management of adverse events are risk-based, informed and transparent to allow an appropriate level of scrutiny.

5.8 Personal, professional and organisational accountability – everyone is responsible for taking action to prevent adverse events, including speaking up when they see practice that endangers safety, in line with the whistle-blowing policy. Roles and responsibilities will be explicit and clearly accepted with individuals understanding when they may be held accountable for their actions. The principal accountability of all NHS care providers is to patients, their families and carers.

5.9 Team Members – everyone who works for the Service is an essential and equal member of the team and needs to be valued, treated well and empowered to work to the best of their ability. Teamwork is recognised as the best defence of system failures and is explicitly encouraged and fostered within a culture of trust, mutual respect and open communication.

6.0 What are Adverse Events

6.1 An adverse event is defined as an event that could have caused, or did

cause, harm to people or groups of people or damage to equipment or property.

6.2 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, injury or personal stress / anguish, the inherent risk of an investigation or treatment, system failure, provider performance issues, service disruption, financial loss or adverse publicity.

6.3 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.

6.4 People are defined as:

members of staff patients service users carers family members members of the public visitors contractors volunteers



6.5 Categorisation of Adverse Events

The following categories should be used to group adverse events. Category I (SAER)– Events that may have contributed to or resulted in permanent harm, for example death, intervention required to sustain life, severe financial loss, damage to property or equipment (>£100k), ongoing national adverse publicity (likely to be graded as major or extreme impact on NHSScotland risk assessment matrix). A SAE requiring review is defined as an incident that occurred in relation to Service operations and results in one or more of the following:

Unexpected and avoidable death of one or more patients, staff, visitors or members of the public, i.e. Category 1 Events. This is where natural causes are not suspected.

Serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm;

Permanent harm – directly related to the incident and not to the natural course of the patient’s illness or underlying conditions, defined as permanent lessening of bodily functions, including sensory, motor, physiological or intellectual.

Prolonged pain and/or prolonged psychological harm – pain or harm that a service user has experienced, or is likely to experience, for a continuous period of 28 days.

Major surgery – a surgical operation within or upon the contents of the abdominal or pelvic, cranial or thoracic cavities or a procedure which, given the locality, condition of patient, level of difficulty, or length of time to perform, constitutes a hazard to life or function of an organ, or tissue (if an extensive orthopaedic procedure is involved, the surgery is considered major).

Abuse – a violation of an individual’s human and civil rights by any other person or persons. Abuse may consist of single or repeated acts. It may be physical, verbal or psychological, it may be an act of neglect or an omission to act, or it may occur when a vulnerable person is persuaded to enter into a financial or sexual transaction to which he or she has not consented, or cannot consent. Abuse can occur in any relationship and may result in serious harm or exploitation of the person subjected to it. This is defined in No Secrets for adults and in Care Quality Commission (CQC) guidance about compliance. Working together to safeguard children (2006) states that “abuse and neglect are forms of maltreatment of a child. Somebody may abuse or neglect a child by inflicting harm or by failing to act to prevent harm”.

A scenario that prevents or threatens to prevent the Service’s ability to



continue to deliver healthcare services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or ICT failure;

Public concern about the organisation or the wider NHS;

One of the core set of Never Events that results in death or serious harm (currently working on a specific set for SAS), these are events that should not occur due to the preventative measures in place at a national level.

Any consideration of whether an incident meets the definition of Significant should consider the spirit of Service policy and the gravity of each incident. The definition of what constitutes a significant adverse event is not exhaustive and should not inhibit awareness of items which, although not listed specifically as SAEs, are SAEs.

It is assumed that any event involving unexpected death or serious harm may be treated as a Significant Adverse Event Review (SAER) incident.

Category II – 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, damage to property or equipment (<£100k) adverse local publicity (likely to be graded as minor or moderate impact on NHSScotland risk assessment matrix). Please see appendix 2.

Category III (Near miss) – 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 (near

misses). These results can occur either by timely intervention or due to good fortune.

7.0 Governance Routes for the management of adverse events A Flowchart is included in appendix 2 which shows the governance routes for all Adverse Events. 8.0 Key Performance Indicators The Key Performance Indicators associated with this policy are included in Appendix 3. 9.0 Risk Matrix The Service has adopted the NHS Scotland risk matrix produced by NHS QIS. A copy can be found in Appendix 4.



10.0 Review

This policy will be reviewed every three years or sooner if there are any relevant changes to legislation or best practice. The Policy review schedule overseen by the Risk Manager will be updated to capture the review date. 11.0 Implementation, (including raising awareness)

11.1 The policy will be implemented and communicated to managers and staff within the Service via the Chief Executive Weekly Bulletin and directly through the Senior Leadership team for dissemination through regions and teams. The policy will be published on @SAS (the service internet portal).

11.2 The policy and procedure will come into effect during 2018.



Appendix 1 – Adverse Event Review Flowchart.

Stage 2: Immediate

actions following an

adverse event

Stage 3: Initial reporting

and notification

Stage 4: Analysis and

categorisation

Stage 5: Review

Stage 6: Improvement

planning and monitoring

Adverse event

occurs

Make person/area

safe and attend to any

medical requirement

Implement any

immediate operational

actions to reduce risk

of re-occurence eg

removal of trip hazard

or faulty equipment

Stage 1: Risk Assessment and prevention – risk assessment should identify the hazards present in the SAS systems by evaluating the

likelihood of potential harm from the hazard occuring, and evaluating the potential severity of that harm. Mitigating actions should be in place,

that are proportionate to the risk to prevent it occurring.

Report onto Service

Incident reporting

system – DATIX can

be found on @SAS

Grade Adverse

Event using

impact definitions

E-mail Notification

sent to Line manager

for review

Develop action

plan, if required

Submit review report and

action plan via the Risk

Managers for exec team

approval

Updates to be

provided through

appropriate governnce

structre

Implement action plan

Share learning and

implement key learning

points

Review of

implementation of

actions

Flow chart of actions to be taken to effectively manage adverse events

Adverse event framework flowchart V2 updated 19/01/18

Email notification

to Subject Matter

Experts depending

on categories

selected

Identification of level of

review required to be

undertaken – dependant

on category - Risk

Managers will support

If CAT 1 ie SAER follow

the SAER process

If Cat 2 or 3 Follow

Guidance contained

within Appendix 5

Independent reviewers appointed

by Risk Managers to carry out

review as per SAER process

Line Manager

conducts review

Risk Managers to update

each governance structure

re: Outstanding Actions



Appendix 2: Governance Process for Adverse Events

Divisional Health, Safety

and Wellbeing Groups

Divisional Clinical

Governance and

Quality

Adverse Event / Near Miss

National Clinical

Governance and

Quality Groups

Staff Reporting / Escalation

Staff Governance

Committee

National Health, Safety and

Wellbeing Group

Clinical Governance

Committee

Executive Team

Risk Manager Review – decision on

level and type of review

Non Clinical Incidents, i.e.

staff safety

Governance Process for the Management of Adverse Events V1.2 Updated 15/01/18

Clinical Incidents, i.e.

patient safety

YES - All themes / trends

recommended actions to prevent a re-

occurence and redacted version of

report to taken to

Significant Adverse Event Y/N NO - All themes / trends to be

reported at



Appendix 3 – Key Performance Indicators The table below sets out the standards and indicators for the management of adverse events.

Description of Measure KPI

%age of Incidents reported within 2 days > 90%

%age of Cat 1 Incidents (SAER) completed within 3 months

> 90%

%age of Cat 2 Incidents (minor or moderate) completed within 1 month

> 90%

%age of Cat 3 Incidents (negligible) completed within 10 days

> 90%

Number and nature of Incidents where Duty of Candour procedure has been applied

100% of SAER cases

%age of high priority actions completed within set timescale

> 90%

%age of RIDDOR compliance > 90%



Appendix 4: NHS Scotland Risk Matrix Table 1 – Impact/Consequence Definitions

Descriptor Negligible Minor Moderate Major Extreme

Patient Experience

Reduced quality of patient experience/clinical outcome not directly related to delivery of clinical care.

Unsatisfactory patient experience/ clinical outcome directly related to care provision – readily resolvable.

Unsatisfactory patient experience/ clinical outcome; short term effects – expect recovery <1wk.

Unsatisfactory patient experience/ clinical outcome; long term effects – expect recovery >1wk.

Unsatisfactory patient experience/ clinical outcome; continued ongoing long term effects

Objectives / Project

Barely noticeable reduction in scope, quality or schedule.

Minor reduction in scope, quality or schedule.

Reduction in scope or quality of project; project objectives or schedule.

Significant project over-run. Inability to meet project objectives; reputation of the organisation seriously damaged.

Injury (physical and psychological) to patient/visitor/ staff

Adverse event leading to minor injury not requiring first aid.

Minor injury or illness, first aid treatment required.

Agency reportable, e.g. Police (violent and aggressive acts).

Significant injury requiring medical treatment and/or counselling.

Major injuries/long term incapacity or disability (loss of limb) requiring medical treatment and/or counselling.

Incident leading to death or major permanent incapacity.

Complaints / Claims

Locally resolved verbal complaint.

Justified written complaint peripheral to clinical care.

Below excess claim. Justified complaint involving lack of appropriate care.

Claim above excess level. Multiple justified complaints.

Multiple claims or single major claim Complex justified complaint

Service /

Business Interruption

Interruption in a service which does not impact on the delivery of patient care or the ability to continue to provide service.

Short term disruption to service with minor impact on patient care.

Some disruption in service with unacceptable impact on patient care. Temporary loss of ability to provide service.

Sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked.

Permanent loss of core service or facility. Disruption to facility leading to significant “knock on” effect

Staffing and Competence

Short term low staffing level temporarily reduces service quality (< 1 day).

Short term low staffing level (>1 day), where there is no disruption to patient care.

Ongoing low staffing level reduces service quality.

Minor error due to ineffective training/implementation of training.

Late delivery of key objective / service due to lack of staff. Moderate error due to ineffective training/implementation of training. Ongoing problems with staffing levels.

Uncertain delivery of key objective/ service due to lack of staff.

Major error due to ineffective training/ implementation of training.

Non-delivery of key objective/service due to lack of staff. Loss of key staff. Critical error due to ineffective training/ implementation of training.

Financial (including damage / loss / fraud)

Negligible organisational/ personal financial loss. (£<1k).

(NB. Please adjust for context)

Minor organisational/personal financial loss (£1-10k).

Significant organisational/personal financial loss (£10-100k).

Major organisational/personal financial loss (£100k-1m).

Severe organisational/personal financial loss (£>1m).

Inspection / Audit

Small number of recommendations which focus on minor quality improvement issues.

Recommendations made which can be addressed by low level of management action.

Challenging recommendations that can be addressed with appropriate action plan.

Enforcement action.

Low rating.

Critical report.

Prosecution.

Zero rating.

Severely critical report.



Table 2 – Likelihood Definitions

Descriptor Rare Unlikely Possible Likely Almost Certain

Probability Can’t believe this

event would happen –

will only happen in

exceptional

circumstances.

Not expected to happen, but definite

potential exists –

unlikely to occur.

May occur occasionally, has

happened before on

occasions –

Reasonable chance of

occurring.

Strong possibility that

this could occur –

Likely to occur.

This is expected to

occur frequently / in

most circumstances –

more likely to occur

than not.

Table 3 - Risk Matrix

Likelihood Impact/Consequences

Negligible

Minor Moderate Major Extreme

Almost Certain Medium High High V High V High

Likely Medium Medium High High V High

Possible Low Medium Medium High High

Unlikely Low Medium Medium Medium High

Rare Low Low Low Medium Medium

Adverse Publicity / Reputation

Rumours, no media coverage.

Little effect on staff morale.

Local media coverage – short term. Some public embarrassment. Minor effect on staff morale/public attitudes.

Local media – long-term adverse publicity.

Significant effect on staff morale and public perception of the organisation.

National media/adverse publicity, less than 3 days.

Public confidence in the organisation undermined.

Use of services affected.

National/international media/adverse publicity, more than 3 days. MSP/MP concern (Questions in Parliament). Court Enforcement. Public Inquiry/ FAI.



Appendix 5 – DUTY OF CANDOUR POLICY

CONTENTS PAGE 1 Introduction 18

1.1 Purpose 18 2 The need for candour 18

3 When must the duty of candour procedure be activated? 18

4 Duty of Candour Procedure 20

4.1 Stage 1: Identification and Notification to ‘Relevant Person’ 20

4.2 Stage 2: Apology 21

4.3 Stage 3: Arrange a Meeting 21

4.4 Stage 4: Carry out a Review 22

5 Record Keeping 22

6 Reporting and Monitoring 22

7 Training and Support 22

APPENDIX 5a - Duty of Candour Procedure 24 List of Tables Table 1 Decision Making Process 20 1 Introduction The Duty of Candour Procedure (Scotland) Regulations 2018 came into force on the 1st April 2018. This creates a legal requirement for health and social care organisations to be open, honest and supportive when there is an unexpected or unintended incident resulting in death or harm. This formalises the Services previous approach of ‘the principles of Being Open’. 1.1 Purpose The new organisational duty of candour underpins the Services commitment to openness and learning which is vital to the provision of safe, effective and person-centred health and social care and will ensure a consistent process is followed. 2 The Need for Candour The focus of the duty of candour legislation is to ensure that the Service tell those

affected that an unintended or unexpected incident has occurred; apologise; involve

them in meetings about the incident; review what happened with a view to identifying

areas for improvement; and learn (taking account of the views of relevant persons).

3 When must the Duty of Candour procedure be activated?

The Service must activate the duty of candour procedure as soon as reasonably

practicable after becoming aware that:



An unintended or unexpected incident occurred, that in the opinion of a registered

health professional:

(a) appears to have resulted in or could result in any of the outcomes mentioned

below; and

(b) the outcome relates directly to the incident rather than to the natural course of

the person’s illness or underlying condition.

The relevant outcomes are as follows:

A. The death of the person.

B. Permanent lessening of bodily, sensory, motor, physiologic or intellectual

functions (including removal of the wrong limb or organ or brain damage)

(“severe harm”).

C. Harm which is not severe harm but which results in one or more of the

following criterion:

An increase in the person's treatment;

Changes to the structure of the person's body;

The shortening of the life expectancy of the person;

An impairment of the sensory, motor or intellectual functions of the

person which has lasted, or is likely to last, for a continuous period of at

least 28 days;

The person experiencing pain or psychological harm which has been,

or is likely to be, experienced by the person for a continuous period of

at least 28 days.

D. The person requires treatment by a registered health professional in order

to prevent:

The death of the person, or

Any injury to the person which, if left untreated, would lead to one or

more of the outcomes mentioned in paragraph B or C.

Please see Table 1 below – decision making process for further guidance.



Table 1 – Decision Making Process

The decision making process must be carried out by a registered healthcare

professional not directly involved in the event and once confirmed this is the

procedure start date.

4 Duty of Candour Procedure (Please see Appendix 5a – Duty of Candour

procedure)

4.1 Stage 1: Identification and Notification to ‘Relevant Person’

The first stage is to identify the relevant person and make contact with them

as soon as reasonably practicable, ideally within 10 working days of the

procedure start date.

The Service must take reasonable steps to find out the relevant person’s

preferred method of communication. They must also take reasonable steps to

ensure that communication with the relevant person is in a manner that they

can understand. Establishing contact by telephone in the first instance might

be necessary to find out what method of communication to use afterwards

and to begin dialogue on what steps might need to be taken in following the

duty of candour procedure.

The notification must include:

an apology;

an account of the incident;

an explanation of the actions that the Service will take as part of the

procedure; and

Event Happened

Resulted in Harm / May (In the reasonable opinion of a

professional) Result in Harm

Duty of Candour MUST be activated

Unlikely to Result in Harm / Did not result in harm (but could have) / Event did not happen (Near miss)

Duty of Candour does not need to be activated



in the case where the procedure start date is later than one month after

the date on which the incident occurred, an explanation of the reason

for the delay in starting the procedure.

If the Service is unable to contact the relevant person or the relevant person

does not wish to engage, the attempts made to contact them require to be

noted in the duty of candour section on the Datix record.

If the person lacks capacity or has died it is the Services responsibility to

identify the relevant person to communicate with taking into account any

existing arrangements for power of attorney and guardianship.

The Regulations do not permit or require the Service to disclose any

information that would prejudice any criminal investigation or prosecution or

contravene any restriction on disclosure arising by virtue of an enactment or

rule of law.

4.2 Stage 2: Apology In addition to any apology provided at the time of the incident, as part of the duty of candour procedure the Service must offer the relevant person a written apology (this can be by electronic communication if that is the relevant person’s preferred means of communication) in respect of the incident. The written apology should be personal and provided at an appropriate time during the duty of candour procedure, taking account of the facts and circumstances in relation to the particular incident. It is best practice to ensure that this is personalised to the circumstances relating to the relevant person and, wherever possible, takes account of the known personal meaning or impact of the unexpected or unintended incident.

4.3 Stage 3: Arrange a meeting

The Service must invite the relevant person to attend a meeting and give

them the opportunity to ask questions in advance taking cognisance of any

needs they may have, for example linguistic or disability requirements. Plain

English should be used, without the use of jargon.

The meeting must include:

A verbal account of the incident;

An explanation of any further steps that will be taken by the Service

to review the incident;



An opportunity for the relevant person to ask questions and express

their views about the incident;

Any other ongoing legal processes in respect of the incident

After the meeting

Provide note of the meeting

Contact details for the relevant person

4.4 Stage 4 Carry out a review

Refer to the adverse events guidance documents regarding the Review

procedure and ensure that the Review contains information on how the Duty

of Candour was applied.

The relevant person must be offered a copy of the written report, detailing any

support services available to them and an offer of a final meeting to discuss

the content of the review.

4 Record keeping

All aspects of the Duty of Candour procedure must be recorded on the Datix record

including all documentation and correspondence relating to the incident.

5 Reporting and monitoring

An annual report must be published on the Services website as soon as possible

after the end of the Financial Year and notified to Scottish Ministers via

[email protected].

6.1 The report must include:

Information about the number and nature of incidents to which the

procedure has applied

An assessment of the extent to which the procedure was carried out

Information about the Services policies and procedures in relation

to the Duty of Candour, including the procedures for identifying and

reporting incidents and the support available to staff and the person

affected

The learning implemented following review of the incidents

6 Training and Support

mailto:[email protected]



A Duty of Candour e-learning module is available for all staff to complete with a link

to the module on the Service’s Intranet site @SAS.

The Service’s commitments to staff when a Significant Adverse / Duty of Candour event occurs are:

We will ensure that you are safe and fully supported throughout the process;

We will communicate with you respectfully and honestly, in a way that compassionately acknowledges and recognises the emotional impact the event may have had on you. This communication will be provided by a named contact person;

We will involve you in the review process, listening to your experience and ensuring this informs the process and the resultant learning;

We will ensure that the review is completed thoroughly, openly, fairly and as quickly as possible;

We will keep you informed of progress of the SAE review, through your named contact, from the time that the event happens through to the point when we have identified the learning and improvements to be made; and

We will ensure you receive feedback on the findings, recommendations and wider learning.

Employees requiring additional support following an Adverse Event can access this through the employee counselling services as a self or management referral. Managers must ensure this aspect has been discussed with the member of staff and all details can be found on @SAS under - health and safety and occupational health sections. The Service must also advise the relevant person involved of Services and Support which is available to them.



Appendix 5a – Duty of Candour Procedure



• Do you know who they are?

• Establish how they would like to be communicated with – note this and all contacts on the Datix record, including unsuccessful attempts

Step 1: Identify and Contact the Relevant Person

•Provide an Apology

•Provide an account of the incident and the actions the Service are going to take

• If more than 1 month has lapsed – provide an explanation for this

Step 2: Notification and Apology

•Provide an opportunity for questions to be asked before the meeting

•Tell the person what happened

•Tell them what further steps are being taken

•Allow questions to be asked and views expressed

• Inform of any other ongoing processes

•Provide them with contact within the Service and a note of the meeting

Step 3: Arrange a meeting

• Include the duty of candour process followed in the report

•Offer to send a copy of the report with subsequent actions being taken

•Ensure written apology is provided

•Offer a meeting to discuss the report

Step 4: Carry out a review

•Relevant person to be notified of support services available to them

• Staff enacting the procedure to ensure they have completed the Duty of Candour e-learning module (learnPro)

• Employees to be provided with occupational health support relating to their needs arising from the incident

THROUGHOUT

Support and Assistance for

Relevant Person & Staff

Adverse Events and Duty of Candour Policy Version 1 · Stage 1: Risk Assessment and prevention ±...

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