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Standards › Standard 53 › Standard operating procedures (SOPs)

SOP · ALR-SOP-003 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 53.3

At a glance

  • Skin and blood allergy tests are performed with validated methods and reagents (LBT-REG-004 for external assessment).
  • Each test run includes positive and negative controls, checked before results are reported (LBT-SOP-002).
  • Results are interpreted by a qualified clinician with the clinical history (ALR-FRM-002).
  • Results are reported with the clinical context and the limits of the test.
  • Stop and get help straight away if: a result is reported from a test run whose controls failed.

1. Purpose

To make sure allergen tests are reliable and their results are interpreted with the clinical picture (53.3).

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

To make sure allergen tests are reliable and their results are interpreted with the clinical picture (53.3).

5. Responsibilities

Role Responsibility Competence
Allergologist Interprets results with the clinical history and signs the report Clinical lead
Laboratory lead Runs quality control and the external assessment Clinical lead

6. Materials and equipment

Item Requirement Condition
Records and forms named in this document Current version Checked before use

7. Safety

8. Before you start

9. Procedure

Step 1. Control.

  • Run the positive and negative controls with each test run, and check them before reporting.

Key point: Controlled.

Step 2. Interpret.

  • Interpret each result with the clinical history and record it (ALR-FRM-002).

Key point: Interpreted.

Step 3. Report.

  • Report with the clinical context and the limits of the test (LBT-SOP-008).

Key point: Reported.

10. Decision points

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

13. Monitoring

Measure Target Frequency Owner If not met
Test runs with controls passing before reporting 100% Each run Laboratory lead Withhold the result and repeat the run
Results signed by a qualified clinician 100% Each result Allergologist Escalate to the clinical lead

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

16. Related documents

ID Title Use
ALR-FRM-002 Allergy test result and interpretation record Record
LBT-SOP-002 Internal quality control (existing, reused) SOP

17. Evidence

Reference Note
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

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