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International Accreditation of Healthcare Facilities

Standards › Standard 33 › Policies

Policy · LBT-POL-002 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 33.5

At a glance

  • The laboratory takes part in an external scheme for each test where one exists.
  • Each unsatisfactory result is investigated and corrected (LBT-REG-004).
  • Results are reviewed at a set interval by the laboratory lead.
  • Tests with no scheme are listed with the reason.
  • Stop and get help straight away if: a test with an available scheme is run with no participation and no reason recorded.

1. Purpose

To check the laboratory’s results against other laboratories through external quality assessment (33.5).

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 laboratory that does not compare its results with others may have a problem it cannot see. External quality assessment shows how its results compare with peers.

5. Responsibilities

Role Responsibility Competence
Laboratory director Enrols the laboratory in the schemes Medical director
Senior scientist Investigates and reports each result Laboratory director

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. Enrol.

  • Enrol in an external scheme for each test where one exists.

Key point: Enrolled.

Step 2. Submit and review.

  • Submit each round and review the result on receipt (LBT-REG-004).

Key point: Reviewed.

Step 3. Investigate.

  • Investigate each unsatisfactory result and record the correction.

Key point: Investigated.

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
Tests with scheme participation 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

16. Related documents

ID Title Use
LBT-REG-004 External quality assessment results 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

References

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