incident reporting and management procedureincident reporting system an outline of the management of...

Source: Governance Status: APPROVED of 23

Issue date: December 2018 Review date: November 2021 Document reference: PP(18)105b

1. Scope This procedure is a Trust-wide document and applies to all staff. It should be read in

conjunction with the Trust’s Incident Reporting & Management Policy PP105a.

This procedure was updated in the 2017 edition to incorporate the Suffolk Community Health

policy ‘Policy and procedure for the reporting of incidents and their management including Serious Incidents and Never Events’. For all staff working in Community locations of the WSFT this updated procedure now supersedes the use of that policy.

2. Aim The aim of the procedure is to provide:

Staff with clear information on how to report incidents via the Datix electronic online incident reporting system

An outline of the management of incident reporting in the Trust and to external agencies/stakeholders

The Trust’s approach on the investigation, analysis, and learning and improvement from incidents

A procedure for the investigation of reported as major or catastrophic harm including SIRIs (Serious incidents requiring investigation) and Never Events.

Procedures for investigating specific generic incident types

3. Undertaken by

All members of staff are expected to report incidents as part of their general duties under

Section 7 of the Health and Safety at Work Act 1974. Managers for an area are responsible for ensuring incidents are appropriately managed, for example investigated and lessons are learnt.

4. Reporting incidents/near misses involving staff, patients and others 4.1 Introduction

4.1.1 All incidents (including near misses) must be reported using the Trust reporting electronic

system called Datix. Datix provides a systematic process which enables incidents to be reported and then investigated.

4.1.2 All incidents should be reported as soon as the staff member is able, ideally within 24 hours

ensuring patient safety remains a priority. Do not delay reporting if some information is unavailable; this can be added later.

Trust Policy and Procedure Document ref. no: PP(18)105b

Incident Reporting and Management Procedure For use in (clinical areas): All areas of the Trust

For use by (staff groups): All Trust staff

For use for

(patients/treatments):

Adverse incidents and near misses

Document owner: Head of Governance

Status: APPROVED

West Suffolk Hospital NHS Trust Incident reporting and management procedure



4.1.3 For all incidents reported as major or catastrophic harm, reporting must be immediate to the

senior manager responsible for the area, out of hours to the Clinical Site Manager (hospital) or senior manager on call (community).

4.1.4 For all patient safety incidents reported as moderate, major or catastrophic harm, the Trust has

a ‘Duty of Candour’ to offer an apology to the patient or relevant person. The requirements are set out in the Trust Policy PP197

4.1.5 Datix electronic incident reporting forms must be completed as comprehensively as possible

and should give a clear factual and objective account of what happened i.e. who, why, what, where and how. They should also include information on the immediate actions taken following the incident together with any actions planned or taken to prevent a reoccurrence. Incident forms must contain factual information and exclude personal opinion or assumption.

4.1.6 Where drugs or equipment are involved, full details must be provided in case the incident is

reportable to the Medical Healthcare Regulatory products Agency (MHRA). For example, the drug name, dose given, manufacturer and batch number or equipment asset number. Any faulty equipment or defective medicine must not be discarded but retained for further information and external reporting requirements. (see Trust policy PP024 Management of Medical Equipment)

4.1.7 If an incident has involved a patient, clinical staff must also record what happened and any action taken in the patient’s medical records.

4.2 Initial reporter 4.2.1 It is the responsibility of the person who initially becomes aware of an incident to

IMMEDIATELY discuss it with the senior person on duty in the area at the time. 4.2.3 All incidents should be reported as soon as the staff member is able, ideally within 24 hours

ensuring patient safety remains a priority. Do not delay reporting if some information is unavailable; this can be added later.

4.2.4 The Datix reporting screen will require the person reporting the incident to state the outcome of

the incident (actual harm caused) and the actual severity (Catastrophic, Major, Moderate, Minor or None). This Matrix is provided in Appendix XX and is provided with the Datix system and accessible on the screen to assist with the grading).

4.3 Senior Person on duty

4.3.1 The senior manager responsible for the area will be alerted to the reported clinical and non-clinical incident.

4.3.2 If the incident has been graded as amber or red and is a patient safety incident, the patient or

relevant person should be made aware as per the requirements of Duty of Candour (see policy PP197). This should be undertaken by a senior member of staff such as a Consultant or Matron, who may not always be the incident reporter. Where the incident relates to medical management the senior person on duty should notify the patient’s Consultant at the earliest convenience to enable them to undertake Duty of Candour in a timely manner. The verbal Duty of Candour is required by law to be achieved within ten working days.

4.3.3 If the incident has been graded as major or catastrophic out of hours the Clinical Site Manager




(hospital) or senior manager on call (community), must also be alerted to the incident 4.4. Clinical Site Manager (Out-of-hours Procedure for Serious Incidents): 4.4.1 Should a serious incident occur out-of-hours, then the Clinical Site Manager should take

responsibility to manage the incident. 4.4.2 They should immediately inform the relevant Senior Manager who will make a decision

whether to inform the Executive Director on-call and whether it is appropriate to contact senior managers to ask them to come in from home to help assist. This is described in PP304 Internal escalation policy and plan.

4.4.4 The Serious Incident Procedure should be followed as closely as possible. This will involve

securing evidence and obtaining witness statements. All actions must be documented and be available to hand over the next working day. The next working day, the Clinical Site Manager must contact the Associate Director of Operations and/or Clinical Director (if not already done so) and handover all details of the incident and actions taken so far. Contact should also be made with the Governance department to ensure all relevant information is handed over and captured within the incident record.

4.5 Member of senior team with Datix access 4.5.1 On submission of a Datix incident report, an automated email notification will be sent to the

individuals linked to that location (e.g. Ward Manager) and; for specific incident types and grades this will be sent to key specialist individuals (e.g. Local Security Management specialist for violence incidents and Executive Directors / Associate Director of Operations / Governance for incidents graded as actual major or catastrophic harm).

4.5.2 On receipt of the Datix email notification of an incident, a member of the senior team with Datix

access will confirm the grading of the incident and assign an investigator (the Handler) and a Final Approver (to sign off the completed investigation).

4.6 Designated Member of senior team with responsibility for Duty of Candour 4.6.1 On identification of an incident resulting in moderate or severe (major/catastrophic) harm, a

senior individual will offer provide the relevant Duty of Candour apology following the process as set out in PP197.

5. Process for reporting to external agencies / stakeholders

5.1 Legislation and NHS procedures require that specific incidents are reported to external

agencies. Below is a list of agencies that require notification:

Care Quality Commission will be notified of incidents under the Ionising Radiation (Medical Exposures) Regulations 2000 via Radiology Department

Confidential Enquiries will be notified of these types of incidents via the locally agreed reporter

Coroner will be notified of all incidents involving reportable deaths as described in the Trust policies: Release of body (CG10187) and Coroners Bodies (PP156)

NHS Protect will be notified of incidents involving fraud and bribery by the Local Counter Fraud Specialist and all incidents of theft and physical violence against staff via the Local Security Management Specialist

Cancer Screening Programme incidents relating to serious failures of breast and cervical




screening will be notified to the regional QA team and the national office of the NHS Cancer Screening Programmes by the Radiology Services Manager http://www.screening.nhs.uk/incidents

STEIS (Strategic Executive Information System) will be notified of Serious Incidents Requiring Investigation (SIRIs) (see serious incident section of policy)

Health and Safety Executive will be notified of all incidents that are reportable under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 1995 via Governance Department

Health Protection Agency (Centre for Communicable Diseases Control (CCDC)) will be informed of major outbreaks and infection incidents via the lead doctor for Infection Control

Human Tissue Authority (HTA) will be notified of any incident involving a “serious adverse event” or “serious adverse reaction” relating to the use of human tissue via TPP (Transformation pathology partnerships) using the HTA on-line reporting form.

Information Commissioner serious incidents involving personal data loss must be reported in accordance with the Checklist Guidance for Reporting, Managing and Investigating Information Governance Serious Incidents Requiring Investigation. Incidents must be reported within 72 hours via the Head of Information Governance.

Medicines and Healthcare Regulatory Authority (MHRA) will be notified of incidents involving medical devices that have harmed or had the potential to harm a patient/member of staff via EBME Manager and all incidents involving defective drugs via Pharmacy Department

National Reporting and Learning System (NRLS) will be notified of all patient related incidents (data anonymised) via the online reporting portal

The Department of Health, Estates & Facilities Division will be notified of incidents involving the plant, non-medical equipment malfunction or fire by the Trusts Facilities Directorate under the ‘defects & failure reporting system’.

NHS Resolution will be notified of incidents that represent a significant litigation risk via the Litigation Manager

Police will be notified of incidents involving any suspected criminal activity via senior management

Serious Adverse Blood Reactions & Events (SABRE) will be notified of incidents involving serious adverse events and serious adverse reactions related to blood and blood components via the Hospital Transfusion Team

Security Incident Reporting System (SIRS) will be notified of any incidents relating to security this includes theft, physical or verbal assault via the Local Security Management Specialist

Serious Hazards of Transfusion (SHOT) will be notified of incidents involving the incorrect or inappropriate transfusion of blood products via the Hospital Transfusion Team

West Suffolk Hospital NHS Foundation Trust is committed to safeguarding and promoting the welfare of vulnerable children and adults. Any reported incident pertaining to safeguarding will be escalated to the Trust's safeguarding team and communicated to the relevant external partner agency as appropriate (i.e. police, social care, County safeguarding team) In some circumstances these incidents may be need to be reported to sub groups of the adult and children's safeguarding boards.

5.2 Trust incidents that have been reported by, or relate to other organisations will be managed

according to the flowchart in Appendix A.

6. Level of investigation 6.1 All incidents warrant follow-up and an exploration of events to understand what happened, how

to prevent a recurrence and achieve organisational learning. 6.2 The level of investigation required will depend on the incident severity grading (as described in

PP132 Risk Assessment) and is summarised in the table overleaf.

http://www.screening.nhs.uk/incidents



The categories for severity are set out below with descriptors to support the grading Negligible Minor Moderate Major Catastrophic

Impact on the safety of patients, staff or public (physical/ psychological harm)

Minimal injury requiring no/minimal intervention or treatment. No time off work required

Minor injury or illness requiring minor intervention. Requiring time off work for <3 days. Increase in length of hospital stay by 1-3 days

Moderate injury requiring professional intervention. Requiring time off work for 4-14 days. RIDDOR / agency reportable incident. An event which impacts on a small number of patients

Major injury leading to long-term incapacity/disability. Requiring time off work for >14 days. Increase in length of hospital stay by >15 days. Mismanagement of patient care with long-term effects

Incident leading to death. Multiple permanent injuries or irreversible health effects. An event which impacts on a large number of patients

Experience / complaints

Unsatisfactory service or experience not directly related to care. No impact or risk to provision of care

Unsatisfactory service or experience related to care, usually a single resolvable issue. Minimal impact and relative minimal risk to the provision of care or the service. No real risk of litigation. • Basic administration error • Attitude of staff but with low

impact on patient experience • Delays in outpatient clinics • Lack of communication/

information (administrative/ nursing – with low level impact on patient experience)

• Delays in TTOs (‘to take out,’ medicines to be taken away by a patient being discharged)

• Problems with facilities/ premises (eg car parking)

• Unsatisfactory patient experience, readily resolved or easily resolvable

• Low staffing levels that reduce the quality of service

Service or experience below reasonable expectations in several ways, but not causing lasting problems. Has potential to impact on service provision. Some potential for litigation. • Attitude of staff has greatly affected

patient experience (normally medical/ nursing staff)

• Serious lack of communication/ information (medical/ nursing – which has had significant effect on patient experience/ outcome)

• Unacceptable delays in treatment whilst an inpatient (eg awaiting emergency surgery/ investigations)

• Cancelled operations • Insufficient pain management • Serious problems with facilities/

premises – serious risk to patient safety

• Major changes need to be implemented to systems/ procedures

• Local media interest likely to go public

• MP concerns Late delivery of service due to low staffing levels

Significant issues regarding standards, quality of care and safeguarding of, or the denial of rights. Complaints with clear quality assurance or risk management issues that may cause lasting problems for the organisation. Possibility of litigation and adverse local publicity.

Serious issues that may cause long-term damage, such as grossly substandard care, professional misconduct or death. Will require immediate and in-depth investigation. May involve serious safety issues. A high probability of litigation and strong possibility of adverse national publicity. • Serious untoward incident • Serious drug errors • Delays in treatment which could

cause death • Clinical negligence/ equivalent • Litigation • Potential damage to reputation.

Adverse media coverage lasting more than three days

• Serious & totally unacceptable sub-optimal care

• An event which impacts on a large number of patients

• DOH concern • Not compliance with national

standards with significant risk to patients if unresolved

• Non-delivery of key service due to lack or staff

Human resources / organisational development/ staffing/competence

Short-term low staffing level that temporarily reduces services quality (<1 day)

Low staffing level that reduces service quality

Late delivery of key objectives/ service due to lack of staff. Unsafe staffing level or competence (>1 day). Low staff morale. Poor staff attendance for mandatory/key training

Uncertain delivery of key objective/service due to lack of staff. Unsafe staffing level or competence (>5 days). Loss of key staff. Very low staff morale. No staff attendance for

Non-delivery of key objectives/service due to lack of staff. Ongoing unsafe staffing levels or competence. Loss of several key staff. No staff attending mandatory




Negligible Minor Moderate Major Catastrophic

mandatory/key training

training/ key training on an ongoing basis

Statutory duty/inspections

No or minimal impact or breach of guidance/statutory duty

Breach of statutory legislation. Reduced performance rating if unresolved

Single breach in statutory duty. Challenging external recommendations/ improvement notice

Enforcement action. Multiple breaches in statutory duty. Improvement notices. Low performance rating. Critical report

Multiple breaches in statutory duty. Prosecution. Complete system change required. Zero performance rating. Severely critical report

Adverse publicity/ reputation

Rumors. Potential for public concern

Local media coverage - short-term reduction in public confidence Elements of public expectations not being met

Local media coverage - long-term reduction in public confidence

National media coverage with <3 days service well below reasonable public expectation

National media coverage with >3 days service well below reasonable public expectations. MP concerned (questions in the house). Total loss of public confidence

Business objectives /projects

Insignificant cost increase/schedule slippage

<5 percent over project budget. Schedule slippage

5-10 percent over project budget. Schedule slippage

Non-compliance with national 10-25 percent over project budget. Schedule slippage. Key objectives not met

Incident leading >25 percent over project budget. Schedule slippage. Key objectives not met

Finance including claims

Small loss. Risk of claim remote

Loss of 0.1-0.25 percent of budget. Claim less than £10,000

Loss of 0.25-0.5 percent of budget. Claim between £10,000 and £100,000

Uncertain delivery of key objectives/loss of 0.5-1.0 percent of budget. Claim between £100,000 and £1 million. Purchasers failing to pay on time

Non-delivery of key objectives/loss of >1 percent of budget. Failure to meet specification/slippage. Loss of contract/payment by results. Claim >£1 million

Service/ business interruption Environmental impact

Loss/interruption of >1 hour. Minimal or no impact on the environment

Loss/interruption of >8 hours. Minor impact on environment

Loss/interruption of >1 day. Moderate impact on environment

Loss/interruption of >1 week. Major impact on environment

Permanent loss of service or facility. Catastrophic impact on environment



Incident grading

Level of investigation Personnel responsible

Near Miss / No Harm / Negligible / Minor harm (Green)

Overview of circumstances surrounding incident. Outcome of investigation reviewed at Ward/ Department level and

action plan developed if required. Confirm level of harm

Ward / Department Manager

Moderate harm (Amber)

More in-depth investigation may be required to consider causal factors including incident chronology and discussion with key staff involved.

Outcome of investigation reviewed at Directorate level and action plan developed if required.

Confirm level of harm Concise Root Cause Analysis report completed

Service Manager / Matron / Consultant

Trust led Non-SIRI investigations

Root Cause Analysis investigation as per Serious incident process in Appendix B

External agencies appropriately involved. Written report produced including action plan in accordance with

the 60 working day Trust timeframe. Where appropriate this may be on a concise template

Confirm level of harm

Lead investigator with Clinical Director or Associate Director of Operations

Serious Incidents Requiring Investigation (SIRIs)

Root Cause Analysis investigation as per Serious incident in Appendix B and SIRI checklists in Appendix F(a, b and c)

External agencies appropriately involved. Written report produced including action plan in accordance with

the 60 working day national timeframe on a Comprehensive template


Lead investigator with Executive Director

Never Events See Appendix C Never Event flowchart Root Cause Analysis investigation as per Serious incident in

Appendix B and SIRI checklists in Appendix F(a, b and c) External agencies appropriately involved. Written report produced including action plan in accordance with

the 60 working day national timeframe on a Comprehensive template


Lead investigator with Executive Director

6.3 Investigations should be completed within the appropriate timescale.

Datix will send an automated notification to the Handler if the incident investigation is not complete within 12 days of allocation.

The Trust has an internal target of 30 working days for the completion of investigation of Trust led Non-SIRI investigations.

There is a national target of 60 working days for the completion of investigation of SIRIs.

7. Undertaking an investigation

7.1 The individual to whom the incident has been assigned (the handler) should ensure an investigation occurs. This person remains responsible for ensuring that all relevant information is documented on the online Datix investigation form and that sufficient information is provided on the feedback section of the form.

7.2 Investigations should be carried out in such a way as to promote a non-threatening

environment, with emphasis on learning from the incident, rather than apportioning blame. Confidentiality of all individuals concerned should be protected as far as possible throughout the investigation, ensuring all written documentation is stored in a secure environment.

7.3 Consideration must be given to provide appropriate support for staff affected by an incident.




Support and counselling for staff is available through the Trust’s Occupational Health Services. Further guidance is provided in the policy for supporting staff during investigation of an adverse incident (PP198).

7.4 An investigation must be carried out as soon as possible after an incident has occurred. A

good starting point is to collate and gather initial evidence, for example by speaking with staff, visiting the scene, collecting any relevant documentation, taking photographs (consider whether consent is required as per PP229 Photography & Video Recordings Policy) and securing any evidence, such as medical records, equipment involved and medication. It may also be appropriate to record the position of equipment and people involved in the incident. (see Investigators checklist – Appendix F)

7.5 Additional information that may need to be obtained includes for example, training records, risk assessments, staff duty rotas, policies and procedures, etc.

7.6 All details regarding the incident must be documented and all staff should be reminded that any records kept may be disclosable.

7.7 The information gathered should be reviewed, a chronology of events determined and the following key pieces of information established:

What happened? Where? Check exact locations and times.

Who was involved?

Who was affected?

Has it happened before?

What impact has the incident had?

Were there any witnesses?

What action has already been taken? By who?

Who has been informed?

Has an incident form been submitted?

Do written statements need to be obtained?

Who else needs to know? e.g. external agencies/stakeholders and/or internal departments/key individuals

What else needs to be done?

Is the incident classified as “serious”? (refer to section 7.9 below) 7.8 Some investigations will require staff to provide written statements of their involvement. This

can best be achieved by arranging to meet the individual and making a record of their description of events. Statement guidance is available on the Governance Department pages on the Internet.

7.9 Specific types of incidents will require an investigation pathway to be followed.

Incidents confirmed as SIRIs or Trust-led non SIRI investigations should follow the pathway set out in Appendix B (Serious incident investigation pathway).

Incidents reportable to other organisations – The investigation will need to be provided to the relevant body which may have set report content and defined timescales.

Specific Obstetric incidents should follow the pathway set out in the Trust Maternity Risk Management strategy MAT164.

Incidents identified following a notification of Inquest should follow the pathway set out in Appendix D.

Incidents identified following Mortality review should follow the pathway set out in Appendix E.

http://www.wsh.nhs.uk/AboutUs/TrustPoliciesandProcedures/ListedAlphabetically.aspx?PL1_AtoZLetter=s&PL1_List_GoToPage=3

http://www.wsh.nhs.uk/AboutUs/TrustPoliciesandProcedures/ListedAlphabetically.aspx?PL1_AtoZLetter=s&PL1_List_GoToPage=3




8. Investigation report and action plan 8.1 The Handler must record the details of the investigation and the outcome on Datix. 8.2 The Handler must confirm the incident grading. If the incident is more serious than the initial

estimate indicates, the grading should be amended and the relevant final approver chosen.

8.3 An online Concise RCA investigation tool has been developed for several incident types and these are available on the investigation pages of Datix in the drop down menu.

9. Analysis and feedback of collated incident reports

9.2.1 The Trust recognises the importance of learning. In order to ensure an aggregated review of patient safety incidents and the opportunity to learn wider lessons, the Associate Chief Nurse / Head of Patient Safety & Effectiveness will be responsible for co-coordinating a quarterly learning report to the Board, a quarterly assurance report to the Clinical Safety & Effectiveness Committee and a monthly update report to the Clinical Directors. The Head of Information Governance, Litigation & Patient Experience and the Patient Experience Lead will be responsible for providing necessary information to the Head of Patient Safety & Effectiveness as requested.

9.2.2 The learning report to the Board will include as a minimum:

Outcome of all Serious incident investigations concluded in the quarter

Investigation and actions addressing thematic issues 9.2.3 The update report to the Clinical Directors meeting will include as a minimum:

Update on outstanding Green /Amber incidents, SIRI actions and Duty of Candour outstanding

SIRI and Non-SIRI Trust led incident update

NICE and National Audit allocation and progress 9.2.4 The aggregated report to CSEC will include as a minimum:

Review of incidents reported as Red and subsequently downgraded, with the rationale for the decision.

‘Deep dive’ Monitoring implementation of individual actions for red incidents (including SIRIs), clinical risks arising from investigations and reviewing the results of compliance audits.

Review of benchmarking information including: overall rates, levels of harm and SIRI rates. 9.3 Escalating concerns/issues identified through analysis 9.3.1 The Clinical Directors meeting will receive the update report as outlined above and will

escalate any unresolved issues to the Trust Executive Group. The Clinical Safety & Effectiveness Committee will receive assurance that workstreams are progressing and will escalate any unresolved issues to the Quality & Risk Committee.

9.4 Sharing the Lessons through Incident Analysis 9.4.1 Incidents should be discussed at Ward/Department Governance meeting for all grades. Amber

and Red incidents will be discussed at the Divisional Governance Steering Groups / Quality Board. The identified actions and lessons learned should be shared both Trustwide and in the wider health community.




9.4.2 This communication could be via Medical staff bulletin, Intranet bulletin, Mandatory training,

Divisional audit afternoons, policy updates, junior doctor teaching, organisational learning events, ward based action plans. This is not an exhaustive list.

10. Monitoring

The Trust’s Incident Reporting and Management Procedure will be monitored and compliance assessed through audit and data analysis to assess whether the process for reporting and managing incidents is working across the entire organisation. Audit methodology and Key Performance indicators (KPIs) are set out in the Incident Reporting and Management Policy.

11. Document configuration information

Author(s): Associate Chief Nurse / Head of Patient Safety & Effectiveness / Compliance Manager

Other contributors: Executive Chief Nurse, Trust Secretary & Head of Governance, Head of Information Governance & Patient Experience and Divisional Governance Managers

Approvals and endorsements: TEG (October 2017) Clinical Safety & Effectiveness Committee TEG (December 2018), Clinical Safety & Effectiveness Committee (December 2018)

Consultation:

Issue no: 5

File name:

Supercedes: PP(17)105

Equality Assessed Yes

Appendices

A. Flowchart for external organisation incidents – IN and OUT B. Serious incident investigation pathway C. Never Event flowchart D. Inquest flowchart E. Mortality review flowchart F. Content of Serious incident investigation checklist

a. Executive Director b. Lead c. Governance

Appendix A – Flowchart for External Organisation incidents IN and OUT

Flow Chart for External Organisation incidents – IN




Flow Chart for External Organisation incidents – OUT



Appendix B Serious incident investigation pathway




Appendix C Never Event flowchart



Appendix D Inquest flowchart



Appendix E. Flow Chart for Mortality review classified as Preventable




Appendix F. Content of Serious incident investigation checklist:

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