Standards › Standard 33 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · LBT-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 33.3
At a glance
- Every method is validated for its intended use before the first patient result (LBT-REG-002).
- Validation covers precision, accuracy, reportable range and reference interval.
- A change to a method triggers revalidation.
- No method is used on patients on the manufacturer’s claims alone.
- Stop and get help straight away if: a method is used on patients before it is validated.
1. Purpose
To make sure each test method is shown to be fit for its clinical use before patients depend on it (33.3).
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 |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
A method used for patient results must first be shown to work for this laboratory. Validation or verification before clinical use prevents results from an unproven method.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Laboratory director | Approves each validation | Medical director |
| Senior scientist | Designs and reports the validation | Laboratory director |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Design.
- Plan the validation for precision, accuracy, reportable range and reference interval.
Key point: Designed.
Step 2. Validate.
- Run the validation and write the report.
Key point: Validated.
Step 3. Approve and release.
- The laboratory director approves the report and the method is released for patient use (LBT-REG-002).
Key point: Released.
10. Decision points
- No decision points in this procedure.
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
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Methods validated before first patient use | 100% | Annual | Laboratory director | Escalate to the medical director |
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
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| LBT-REG-002 | Method validation register | Register |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on ISO 15189:2022 Medical laboratories: requirements for quality and competence, ISO 9001:2015 for supplier control, and the Global Patient Safety Action Plan 2021–2030 for critical results. |
| 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 |
E-learning for this document
- Equipment, Reagents & Traceability (LAB-04)
References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)