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International Accreditation of Healthcare Facilities

Standards › Standard 5 › Policies

Policy · BLD-POL-001 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 5.8

At a glance

  • The blood bank has a written quality system for procedures, equipment, audit and training.
  • Each procedure has an owner and a review date.
  • Equipment is checked and calibrated on schedule.
  • The quality system is audited each year and reported to the governing body.
  • Stop and get help straight away if: a procedure is in use with no owner or past its review date, or an audit finding is open past its due date.

1. Purpose

To make sure the blood bank works the same way every day, and that its quality is checked (5.8).

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 blood bank without a quality system depends on the memory of its people. A written system covering procedures, equipment, audit and training keeps the service the same from one shift to the next.

5. Responsibilities

Role Responsibility Competence
Blood bank director Owns the quality system Clinician
Quality manager Runs the audit and training plan Quality

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. Write.

  • Keep the procedures, equipment list and training plan written and current.

Key point: Written, owned, dated.

Step 2. Audit.

  • Audit each procedure each year against its written standard (BLD-FRM-004 for the emergency release audit, and others as set).

Key point: Audit finds the gap before the patient does.

Step 3. Act.

  • Close each finding by its due date and report the status to the governing body.

Key point: Findings close.

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
Procedures in date 100% Quarterly Quality manager Escalate to governing body
Audit findings closed by due date At least 90% Quarterly Quality manager Escalate to governing body

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
STF-SOP-001 Staff credential verification and recheck Staff
GOV-PLN-002 Quality improvement plan Plan

17. Evidence

Reference Note
E-009 Based on ISO 15189:2022 for medical laboratories.
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

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