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
- Protect the confidentiality of staff and patients in the review. Share findings in anonymised form.
- Staff involved must be supported, not punished for honest reporting.
8. Before you start
- Preserve records, equipment and logs related to the event.
- Inform the patient or family of the review (see the disclosure procedure).
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
- If the review finds a possible criminal or professional misconduct, refer it to the relevant authority through the chief executive, separately from the learning review (EC).
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
- Serious incidents are reported to the governing body within 24 hours of classification.
- Overdue actions are escalated to the chief executive after 30 days.
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
- Quality leads and senior managers are trained in root-cause methods before leading a review (EC).
- Staff involved in a review receive feedback on the findings.
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 |
E-learning for this document
- Incident Reporting, Just Culture and Open Disclosure (T-09)
- Nonconformity, Corrective Action and Risk (T-04)
References
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)