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Standards › Standard 2A › Standard operating procedures (SOPs)

Standard operating procedure (SOP) · INC-SOP-001 · Version 1.1 · Approved by the ASF Expert Committee

Supports: 2A.6

At a glance

  • Classify the incident as serious (death, severe harm, or a near miss with high potential) within 2 working days.
  • Form a review team with no one directly involved in the event.
  • Find the causes, not the person to blame: use the root-cause method.
  • Write actions with owners and dates. Track them until closed.
  • Share the findings with staff and, where appropriate, with the patient or family.
  • Stop and get help straight away if: a serious incident is not reviewed within the time set, or the review blames an individual without looking at the system.

1. Purpose

To find out why a serious incident happened, change the system so it does not happen again, and track the change until it is complete [EC].

2. Scope

Applies to All serious incidents, including death, severe harm and high-potential near misses
Locations All services at the facility
When Within 2 working days of classification; review completed within 45 days (EC)
Does not apply to Minor incidents, which are handled through the incident policy (INC-POL-001)

3. Definitions

Term Meaning
Serious incident An event that caused or could have caused severe harm or death
Root cause The underlying system factor that, if corrected, would prevent recurrence
Action tracker A log of every action, owner, due date and status

4. Background

A brief description of what happened does not explain why. Root-cause analysis looks at systems, processes, equipment, staffing and communication to find the causes. It is what criterion 2A.6 requires.

5. Responsibilities

Role Responsibility Competence
Quality lead Leads the review; keeps the tracker; reports to governing body RCA training
Review team Gathers evidence, interviews, finds causes, writes actions RCA training
Chief executive Classifies serious incidents; approves the report Executive leadership
Action owners Complete actions by due date; report progress Competence for their action

6. Materials and equipment

Item Requirement Condition
RCA record (INC-FRM-001) Current version Complete
Action tracker (INC-REG-001) Current Updated monthly

7. Safety

8. Before you start

9. Procedure

Step 1. Classify and register the incident.

  • Within 2 working days, the chief executive or delegate classifies the event as serious or not.
  • Enter it on the incident log with the date, the classification and the reviewer.

Key point: Classification decides the level of review. Make it early.

Step 2. Form the review team.

  • Include a clinician, a manager from another service, a quality lead and, where possible, a patient representative.
  • No one directly involved may lead the review.

Key point: Independence is what makes the findings believable.

Step 3. Gather the facts.

  • Collect the records, timeline, equipment logs, rotas and communications.
  • Interview the people involved, one at a time, in a neutral setting, and record what each person says.
  • Build a timeline of events with times.

Key point: A timeline shows what happened in order. Gaps in it are questions to answer.

Step 4. Find the root causes.

  • Use the five whys or a fishbone diagram to move from what happened to why.
  • Ask whether the system allowed the error, made it likely, or failed to catch it.
  • Agree the root causes as a team and record them on INC-FRM-001.

Key point: Stop when you reach a system cause. Blaming a person is the end of the analysis, not the start of the fix.

Step 5. Write actions.

  • For each root cause, write one or more actions that change the system: a checklist, a redesign, training with a check, a change of equipment or staffing.
  • Give each action an owner, a due date and a measure of success.
  • Rank actions by strength. Prefer changes that remove the hazard over warnings and training alone (EC).

Key point: Training alone is the weakest action. Make the safe choice the easy choice.

Step 6. Track and close actions.

  • Enter each action on the tracker (INC-REG-001).
  • Review overdue actions monthly with the governing body.
  • Close an action only when the measure of success is shown.

Key point: An action is complete when it works, not when it is written.

Step 7. Share and report.

  • Share the findings and lessons with staff in the affected service.
  • Report the outcome to the governing body and, where appropriate, to the patient or family.

Key point: The lessons only help if people hear them.

10. Decision points

11. Special situations

Situation Action
Death of a patient Notify the coroner or prosecutor where the law requires; follow the legal procedure (EC).

12. Escalation

13. Monitoring

Measure Target Frequency Owner If not met
Serious incidents with a completed root-cause review within 45 days 100% Monthly Quality lead Escalate to governing body
Actions completed by due date 90% (EC) Monthly Quality lead Escalate to owner’s manager
Actions verified as effective 100% of closed actions Quarterly Quality lead Re-open action

14. Records

Record Kept in Retention
RCA record (INC-FRM-001) Quality file the period set by the facility’s records policy years
Action tracker (INC-REG-001) Quality file the period set by the facility’s records policy years

15. Training

16. Related documents

ID Title Use
INC-FRM-001 Root Cause Analysis Record Used in steps 3 to 5
INC-REG-001 Incident Action Tracker Used in step 6
INC-POL-001 Incident Reporting and Management Incident classification
GOV-PLN-002 Quality Improvement Plan Actions feed the plan

17. Evidence

Reference Note
E-009 ASF Expert Committee consensus. Timeframes (2 days, 45 days, 24 hours) are EC decisions.

18. Change history

Version Date What changed Approval
1.0 the date of approval First version Approved by the ASF Expert Committee
1.1 the date of approval Internal quality review: corrected cross-references, status wording and document control Approved by the ASF Expert Committee

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