Standards › Standard 33 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · LBT-SOP-002 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 33.4
At a glance
- Quality control material is run at the set interval and with each analytical run (LBT-REG-003).
- Results are reviewed against the defined rules before patient results are released.
- An out-of-control run is held, not released.
- Every corrective action is recorded.
- Stop and get help straight away if: patient results are released from a run whose control is out of limit.
1. Purpose
To make sure each analytical run is in control before patient results leave the laboratory (33.4).
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
Quality control shows whether a test is working on the day. A result released before the control has been run and accepted may be wrong.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Laboratory technician | Runs and reviews quality control for each run | Senior scientist |
| Senior scientist | Investigates out-of-control runs | 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. Run.
- Run the control material with the patient samples at the set interval.
Key point: Run.
Step 2. Review.
- Review the control results against the rules before release (LBT-REG-003).
Key point: Reviewed.
Step 3. Hold and correct.
- Hold any out-of-control run, correct it and repeat before release.
Key point: Corrected.
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 |
|---|---|---|---|---|
| Runs with quality control reviewed before release | 100% | Monthly | Senior scientist | Escalate to the laboratory 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-003 | Internal quality control log | 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
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)