6.8: Non-conforming components and biohazards

6.8.1: Discard of non-conforming components (including outdated components)

Procedures for the discard of non-conforming components should ensure that an appropriate record of discard is maintained. This includes:

• the donation number
• the component identity
• the reason for discard
• the date of discard
• the identity of the person effecting the discard.

If the discard process involves recording as a discard on computer software and physically discarding, then adequate records are required for both steps.

6.8.2: Biohazards

Components from donations that are repeatably reactive in mandatory microbiological screening tests or from donors whose records indicate their components should be destroyed because they are on a high-risk deferral registry or because of previous mandatory test results are classified as biohazards.

Secure and effective procedures are required to ensure that all components and samples from biohazard donations are retrieved for safe disposal in accordance with Blood Service policies and with the Department of Health’s Safe Management of Healthcare Waste.⁶ Procedures should include:

• a system which ensures all components prepared from any donation can be traced
• maintaining a record of the person who retrieves each biohazard component, including laboratory sample

When biohazard material (e.g. plasma) is retained for laboratory use, it must be appropriately labelled to prevent it ever being used for therapeutic purposes and must be stored in a secure freezer or other storage unit that is clearly labelled to prohibit the storage of material for therapeutic use. An inventory of freezer (or other storage unit) contents of such samples, record of ‘sample’ retention, reason for retention and fate should be maintained.