Standards › Standard 2D › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · AI-SOP-002 · Version 1.1 · Approved by the ASF Expert Committee
Supports: 2D.6
At a glance
- Consult the staff who will use an AI system before the decision is final.
- Ask about practical impact, workload and training needs.
- Address the training needs before go-live.
- Record the consultation on AI-FRM-002.
- Stop and get help straight away if: an AI system goes live with no consultation record.
1. Purpose
To make sure staff who will deliver care with an AI system understand its practical effect, raise their concerns, and are trained before go-live [EC].
2. Scope
| Applies to | Clinical project lead, staff who will use the system, staff representatives |
| Locations | Each clinical area that will use the system |
| When | Before the decision is final, and before go-live |
| Does not apply to | Staff who never use the system |
3. Definitions
| Term | Meaning |
|---|---|
| Consultation | A two-way discussion in which concerns are heard and answered, recorded before the decision |
| Training need | A skill or knowledge gap identified before use |
4. Background
A system introduced without staff input often fails in practice, through workload, unclear use or lost trust. Criterion 2D.6 asks for consultation before introduction.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Clinical project lead | Runs the consultation and records it | Clinical |
| Staff representatives | Raise concerns on behalf of teams | Staff |
| Chief executive | Takes the final decision with the consultation record | Executive |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Consultation record (AI-FRM-002) | Current | Completed for each system |
| Briefing summary on the system | Plain language | Given to staff before the session |
7. Safety
- Staff concerns about patient safety must be recorded and answered before go-live, not after.
8. Before you start
- Prepare a plain-language summary of the system.
9. Procedure
Step 1. Brief staff.
- Explain the system, its purpose, what it does and does not do, and who uses it.
Key point: Plain language, not technical marketing.
Step 2. Consult.
- Hold sessions with each staff group who will use the system.
- Record each concern, question and response.
Key point: Record the concern even if it cannot be fixed. Explain why.
Step 3. Identify training needs.
- List the skills needed and the training method for each group.
Key point: Training is part of the consultation, not an add-on.
Step 4. Respond before go-live.
- Respond to each concern in writing before go-live.
- Address training before any staff use the system.
Key point: A concern without a response is a reason for staff to ignore the system.
Step 5. Ask after go-live.
- Ask staff about the system after three months, and record the result.
Key point: Only use reveals the real effect.
10. Decision points
- If a concern about patient safety is not resolved, go-live is delayed until the chief executive decides.
11. Special situations
| Situation | Action |
|---|---|
| Urgent introduction | Consult as far as possible in the time available, and complete the record afterwards within 14 days. |
12. Escalation
- Unresolved safety concerns go to the chief executive.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Systems with consultation record before go-live | 100% | Each system | Clinical project lead | Stop go-live |
| Training completed before use | 100% | Each system | Clinical project lead | Delay use |
| Staff who can describe the consultation (sample) | At least 80% (EC) | Yearly | Clinical lead | Re-brief |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| AI-FRM-002 Staff Consultation Record | Governance file | the period set by the facility’s records policy years |
15. Training
- Project leads are trained in consultation methods (EC).
16. Related documents
| ID | Title | Use |
|---|---|---|
| AI-FRM-002 | Staff Consultation Record | Used in steps 2 to 4 |
| AI-POL-001 | Responsible Use of AI in Care Policy | Parent policy |
| SOP-N29 | Learning, Training and Competence Policy (generic) | Training and competence |
17. Evidence
| Reference | Note |
|---|---|
| E-011 | WHO (2021), Ethics and governance of artificial intelligence for health. Used as the basis for AI governance. Link and wording to verify before publication. |
| E-009 | ASF Expert Committee consensus. Consultation method to be agreed. |
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
References
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)
- World Health Organization (2021). Ethics and governance of artificial intelligence for health: WHO guidance. Geneva: WHO. Open source (E-011)