with SCD instructions
assess packaging of frozen packs
inspection of packs after overnight storage at 4°C.
Component quality monitoring
A minimum of 1% of components produced for whole blood collection processes or 300 of each component (one of each relevant component per procedure) for apheresis collection will be subjected to routine quality monitoring for parameters specified in this book.
End users
Set up a process by which users will feedback information on acceptability of the packs for use. This would involve blood bank and ward/theatre staff. Obtain details on:
Blood bank issues:
acceptability to end users
acceptability of number and condition of bleed line samples
crossmatch/other label adherence
leak and breakage rates.
End user issues:
general acceptability
accessibility of ports for giving sets
leak and breakage rates.
On completion, the individual or group responsible for the trial will prepare and submit a Phase 2 report on the suitability for use of the blood pack system within the Service undertaking the trial. Deviations from this number must be agreed in accordance with local procedures.
References
1. Murphy, S, Rebulla, P, Bertolini, F, Holme, S, Moroff, G, Snyder, E, Stromberg, R (1994). In vitro assessment of the quality of stored platelet concentrates. The Biomedical Excellence for Safer Transfusion (BEST) Task Force of the International Society of Blood Transfusion. Transfusion Medicine Review, 8(1), pp29–36.
2. Recommended methods for radioisotope platelet survival studies: by the panel on Diagnostic Application of Radioisotopes in Hematology, International Committee for Standardization in Hematology (1977). Blood, 50(6), pp1137–1144.