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International Accreditation of Healthcare Facilities

Standards › Standard BASIS › Standard operating procedures (SOPs)

SOP · SIR-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee

Supports: B2.6

At a glance

  • Every serious incident is reported to the clinical director the same day, and the patient is kept safe and supported.
  • A named investigator is appointed within 5 working days, and the investigation follows a recognised root cause analysis method.
  • The investigation findings and an action plan with owners and dates are approved by the governing body.
  • The patient and family are told the outcome, through the disclosure process (CAN-POL-001).
  • Stop and get help straight away if: a serious incident is not reported the same day, or no investigation is started.

1. Purpose

To make sure every serious incident is reported, investigated thoroughly, and turned into action that prevents it happening again (B2.6).

2. Scope

Applies to Clinical and support staff in the hospital
Locations All wards, clinics and departments of the facility
When Whenever the activity described is carried out
Does not apply to Activities covered by another document listed in section 15

3. Definitions

Term Meaning
Serious incident An unexpected event that causes, or could cause, death, serious injury or serious harm to a patient, a member of staff or a visitor, or a major loss of service.
Root cause analysis A structured method that looks at the system factors behind an event, rather than blaming an individual.
Action plan The list of changes agreed from the investigation, each with an owner, a due date and a way of checking it has worked.

4. Background

To make sure every serious incident is reported, investigated thoroughly, and turned into action that prevents it happening again (B2.6).

5. Responsibilities

Role Responsibility Competence
Clinical director Receives every serious incident the same day, appoints the investigator, and reports to the governing body Governing body
Investigator Leads the investigation, interviews those involved, and writes the report with the action plan Clinical director
Governing body Approves the report and action plan, and checks progress each quarter Owner or board
All staff Report any serious incident the same day and keep evidence safe Ward or department lead

6. Materials and equipment

Item Requirement Condition
Records and forms named in this document Current version Checked before use

7. Safety

8. Before you start

9. Procedure

Step 1. Report.

  • Report the incident to the clinical director the same day, using the incident form.
  • Keep the patient safe and supported, and preserve the records and equipment involved.

Key point: Incident reported the same day.

Step 2. Appoint.

  • The clinical director appoints an investigator with no direct involvement in the event, within 5 working days.

Key point: Investigator appointed.

Step 3. Investigate.

  • Collect the records, interview those involved, and map the events and system factors using a recognised root cause analysis method.
  • Complete the report within the timescale set by the governing body (a draft of 45 working days is suggested).

Key point: Report completed.

Step 4. Act and close.

  • Agree an action plan with an owner and due date for each action, and check each action when it is due.
  • Tell the patient and family the outcome through the disclosure process (CAN-POL-001), and record it in the register (SIR-REG-001).

Key point: Actions agreed and outcome shared.

10. Decision points

11. Special situations

Situation Action
Out of hours Follow the same steps. Use the on-call contact on the wall of the area.

12. Escalation

13. Monitoring

Measure Target Frequency Owner If not met
Serious incidents reported the same day 100% Quarterly Clinical director Escalate to the governing body
Investigations completed within the set timescale 90% or more Quarterly Clinical director Review the investigator workload and timescales
Action plans with owner and due date 100% Quarterly Clinical director Escalate to the governing body

14. Records

Record Kept in Retention
Record named in this document Patient record or the area file the period set by the facility’s records policy years

15. Training

16. Related documents

ID Title Use
SIR-REG-001 Serious incident register (existing) Register
CAN-POL-001 Duty of candour and disclosure policy (existing) Policy

17. Evidence

Reference Note
E-006 ASF Policy Framework v1.2. Adapted.
E-009 ASF Expert Committee consensus.

18. Change history

Version Date What changed Approval
1.0 the date of approval First version set Expert Committee approval

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