Abstract

Background: These last 20 years, the activity of Italian blood banks and transfusion services has been modified and widened, following the evolution of transfusion medicine from the primary, prevailing interest for immunohematology towards new activities in diagnostic, clinical-therapeutic and research field. Notwithstanding this gradual transformation, blood collection activity and the production of hemocomponents in quantities proper to reach and/or keep a balance of self-sufficiency on a local and national level, keeps beeing a prior target, as it is the main task of National Health Department plans. The aim necessary to guarantee hemocomponent safety is very important also, as such as to meet public opinion expectations and law provisions in an efficient way. Blood safety can only be joined to adopting severe methodological criteria even upon donor’s selection stage, in order to avoid hemocomponents donation in the “window period” of HBV, HCV or HIV infections. Nevertheless the temporary donation suspension has a negative impact on subsequent donations by the deferred donors. Donors who do not meet any of the selection criteria in the screening process, may undergo quarantine plasmapheresis (QP) as an alternative to deferral, and QP units may be stocked, validated and released only if repeated donor’s screening tests are negative up to a maximum of 12 months after the risk event.

Methods: Since 01/01/98 we have been collecting 600 mL QP units from donors who should have been deferred for one of the following reasons: 1) minor dental surgery (DS); 2) major or minor surgery (MMS); 3) sexual risk behaviours (SRB) (with a limit to: change of sexual partner or more than one partner); 4) health care work risk (HW); 5) other risk events (OR) (with a limit to: tattoo application, skin or ear piercing, acupuncture); 6) endoscopic examination (EE). QP units were daily listed, labelled and physically located and quarantined in monthly dedicated containers within a specific freezer.

Results: From 01/01/98 to 06/30/04 we have been collecting 16,555 plasmapheresis units and 1,531 (9.25%) of these were QP donated by 1,053 donors. First time apheresis donors were 350 and 45% of them became repeat plasmapheresis donors. The causes for including donors into QP group have been in percentage respectively: 1) DS: 29.5; 2) MMS: 26; 3) SRB: 20.5; 4) OR: 19; 5) EE: 3; HW: 2. None of the QP units has been eliminated for seroconversion during or at the end of the quarantine period; QP units elimination percentages (0.69) for sanitary reasons (high ALT, HCV positive) soon after donation appear to be substantially superimposable in comparison to non-QP units (0.71).

Conclusions: Our data shows that the provisions of this strategy, with a limit to some specific exclusion causes and joined to a proper logistical organization: 1) Does not generate an increase of elimination sanitary causes of plasmapheresis soon after donation. 2) Is highly efficient in improving plasma production safely, without sacrificing whole blood donations. 3) Greatly increases repeat plasmapheresis donor’s recruitment. 4) Prevents the negative impact on subsequent donations by the deferred donors. 5) Is a donor’s recruitment and a retention strategy which contributes to raise plasma production safely, even though restrictive changes to donation selection criteria continue to increase deferrals.

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