Update notice: Chapters 3, 4, 5, 6 have been redrafted. Please refer to Change Notification 12 - 2010.
5.4 Preparation of the venepuncture site
Blood must be drawn from a suitable vein in the antecubital fossa in an area that is free of skin lesions. The veins can be made more prominent by using appropriate means of venous occlusion.
Although it is not possible to guarantee sterility of the skin surface for venepuncture, a strict standardized and validated procedure for the preparation of the venepuncture site should be in operation to achieve surgical cleanliness and thus to provide maximum possible assurance of a sterile product.
The antiseptic solution used must be allowed to dry completely after application to the donor's skin, or the skin wiped dry with sterile gauze before venepuncture. Thereafter, the prepared area must not be touched with fingers before the needle is inserted.
5.5 Preparation of the blood pack
Whole Blood pack
The blood collection set must be in date and inspected for any defects. These are sometimes obscured by the label attached to the container, so careful inspection is required.
Moisture on the surface of a plastic pack after unpacking should arouse suspicion of a leak and if one or more packs in any packet is found to be abnormally damp, none of the packs in that container can be used. The solution in the set should be checked for clarity and must be clear before accepting the packs for use.
The blood pack is positioned below the level of the donor's arm and the blood collection tube must be clamped off.
The method used for monitoring the volume of blood removed shall be checked to be in working order and the pack placed in the correct position for the method to be effective.
The complete apheresis set and individual packaging must be thoroughly inspected for faults prior to use and during the setting up procedure. The set must be in date and a search made for set faults such as kinks, occlusions, points of weakness or leaks that may only become detectable during the setting up and priming procedure before the donor is attached to the set.
If an occlusive kink that cannot be remedied or a leak becomes apparent during a procedure then that procedure must be abandoned and any blood constituents remaining in the disposable must not be returned to the donor.
Any faults detected before or during a procedure must be recorded in accordance with local quality systems. Any defects must be reported (see Section 5.11).
If there is any doubt about the integrity of any set, it must not be used but retained for inspection and returned to the manufacturer if deemed necessary.
Labelling: whole blood and apheresis packs and donor sample tubes must be labelled in accordance with local SOPs.
All donors' records and labels should be checked for printing errors. Duplicate number sets shall not be used and these and missing numbers shall be reported via a designated senior manager to the printer concerned and to the Chairman of the National Working Party or equivalent on machine-readable labels.