7.7 Non-conforming components and biohazards
Discard of non-conforming 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.
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 Safe Disposal of Clinical Waste, Second Edition, 1999, Health Services Advisory Committee, Health and Safety Commission.(2) Procedures should include
a system which ensures all components prepared from any donation can be traced
maintaining a record of the person whom retrieves each biohazard component, including laboratory samples.
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.