Standards › Standard 33 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · LBT-SOP-009 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 33.14
At a glance
- A change to a released result is recorded as an amendment, linked to the original (LBT-REG-008).
- The amendment states its reason, date and person.
- The original value stays visible in the record.
- The amended result is reported to the requester.
- Stop and get help straight away if: a released result is changed with no record of the original value.
1. Purpose
To make sure any change to a released result can be traced back to the original (33.14).
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 result that is changed after release must show what it was and what it became, and why. Without that, the change cannot be trusted or reviewed.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Senior scientist | Authorises and records each amendment | Laboratory director |
| Reporting staff | Send the amended report to the requester | Senior scientist |
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. Record.
- Record the amendment, its reason, the date and the person (LBT-REG-008).
Key point: Recorded.
Step 2. Keep the original.
- Keep the original value visible and linked in the record.
Key point: Linked.
Step 3. Report.
- Send the amended report to the requester.
Key point: Reported.
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 |
|---|---|---|---|---|
| Amendments with original and reason recorded | 100% | Quarterly | 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-008 | Result amendment 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)