In Focus
Management of donors and donations when recurrent quality management failures occur
Are recurring QMS failures preventable?
Blood Collection Agencies (BCAs) are responsible for managing donations that do not meet Quality Monitoring System (QMS) standards.
QMS failures
Recurrent QMS failures and avoidable component discards may affect the safety, efficiency, and sustainability of BCAs. Whole blood and blood component donations undergo rigorous Quality Control (QC) measures to ensure that any blood product received by a recipient is safe and of high quality. These QMS failures not only identify products that do not meet the established standards but can also result from technical issues or health conditions related to the donor. As such, addressing the issue of recurrent failures is vital for maintaining high standards of donor care and product quality.
Some of the main reasons for QMS failure include:
- Positive results from the Direct Antiglobulin Test (DAT).
- High residual white blood cell (WBC) counts.
- Blockages in the leucodepletion filter.
- Lipemic plasma.
- A high titre of irregular red cell antibodies.
Several advisory boards, including the Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC)1 and Association for the Advancement of Blood and Biotherapies (AABB)2, have established standards and guidelines for quality control in blood donation screening. However, there is no guidance on managing donors whose donations are repeatedly discarded. Different BCAs have varying donor management guidelines.
The Scottish National Blood Transfusion Service (SNBTS) approach
In Scotland, if a donation fails to meet standards in the QC process (i.e. considered a QMS failure), the donation is discarded by the manufacturing laboratory. If the QMS failure is recurrent, the donor medical team is notified to decide on donor management and future blood donation acceptance.
1. Positive direct antiglobulin test (DAT)
A positive direct antiglobulin test (DAT) is a recognised occurrence in blood donors. A positive DAT may be caused by minor infections, some medications or inflammation but it can also be found in otherwise fit and healthy individuals. The JAPC guidelines do not prevent the issue of DAT-positive blood. The SNBTS discard all red cells and platelets from DAT donations due to operational reasons SNBTS does not currently release red cells or platelets for transfusion from donations which show positive DAT reactions. As red cells and platelets from DAT-positive donations are discarded, it is necessary to identify and manage donors at risk of recurrent discards. If there are three or more positive DAT results within the last five years, the active donors will be informed of their results. The donor is informed that if they are in good health, there are no clinical concerns regarding this result; we do not recommend further tests or a General Practitioner review. If donors test negative for Irregular Antibody Status, they may be eligible to donate plasma. If they test positive for Irregular Antibody Status, the donor would be placed off service.
2. High residual WBC counts
With the exception of granulocytes, since November 1999, allogeneic blood components in the United Kingdom (UK) have undergone leucocyte depletion (LD). This process reduces the risk of transfusion-related reactions and complications. These include the potential transmission of Variant Creutzfeldt–Jakob disease (vCJD), Cytomegalovirus (CMV), febrile non-haemolytic transfusion reactions, and HLA alloimmunisation. The UK Blood Services issues universal leukocyte-depleted red cell units, with 1% of these products undergoing quality control checks for residual white blood cells (WBCs). The failure rate for these checks is extremely low due to the manufacturer-provided inline leukocyte filters. According to JPAC standards, leukocyte-depleted blood should contain fewer than 5×106 WBCs per unit. However, there are instances where donations fail to meet QC standards. In Scotland, if two consecutive high residual WBCs are detected, these donors are deferred and referred to a General Practitioner.
3. Blockages in the leucodepletion filter
Filter blocks which require investigation do not necessarily reflect a medical concern with the donor's health. However, in some cases, a blocked filter may be associated with a haemoglobin variant, such as sickle cell trait. Less commonly, it may also be associated with red cell autoantibodies, abnormalities on the full blood count, or paraproteins. Therefore, filter blockages could indicate potential health concerns for the donor. If two consecutive filter blocks exist, these donors are deferred and referred to a General Practitioner in Scotland for review and investigation.
4. Lipemic plasma
Lipemic blood donations remain an essential quality and safety issue in BCAs. Although occasional lipemia in blood donations is not uncommon, a pattern of recurrent lipemic discards can significantly affect component yield, laboratory processing, and overall supply.
Lipemic plasma appears cloudy due to elevated lipid (fat) levels in the blood. This can occur after consuming a high-fat meal and may not indicate any health problems. However, it can also suggest an underlying health condition, such as high cholesterol, in blood donors.
Recurrent lipemia may indicate an underlying metabolic condition in donors. BCAs may carefully evaluate the medical management of any donor with this condition and should focus on the medical management of donors who repeatedly present with lipemic donations. This includes understanding the underlying causes, providing lifestyle guidance, identifying donors at risk, applying evidence-based counselling, implementing appropriate deferral policies, and developing clear pathways for clinical referral. Considering these factors can improve both donor outcomes and operational efficiency.
BCAs should also prioritise safeguarding blood component quality, minimising preventable discards, and ensuring the optimal use of donor contributions. The recurrence of lipemic blood donations has direct implications for component preparation and safety.
In SNBTS, lipemic plasma is identified in components obtained through apheresis or separated from whole blood. One or more components separated from whole blood during a donation may be discarded, with this most often applying to plasma components.
Donors with lipemic plasma who are repeatedly discarded are deferred and referred to a General Practitioner.
Normal (left) and Lipemic (right) plasma
5. A high titre of irregular red cell antibodies
Donations from donors with high levels of red cell antibodies cannot be used for patient transfusions. Red cell antibodies can develop in healthy individuals, often following pregnancy or blood transfusions, or can be naturally occurring. While elevated red cell antibodies do not harm the donor or indicate any underlying health issues, in Scotland if the antibody titre exceeds the accepted limit of 1:50, the SNBTS must discard the donation and inform the donor that they are no longer eligible to donate. If the red cell antibody titre level is below 1:50, then the plasma components are discarded, but the red cells can be used.
Why is it important to pay attention to recurrent QMS failures?
BCAs should proactively identify, analyse, and resolve recurring QMS failures, and their broader impact on regulatory compliance, operational performance, and the benefit of donors and patients. The most compelling reason to address recurrent QMS failures is their potential impact on recipient safety. Other reasons why BCAs should address these failures include:
- Operational Efficiency and Resource Protection Preventable discards directly affect the availability of red cells, platelets, and plasma. Beyond the clinical impact, recurrent failures carry a significant operational burden, including additional investigation, wasted consumables, and implications for blood stocks.
- Driving Continuous Quality Improvement Managing recurrent failures is central to the culture of continuous improvement in BCAs. Effective systems integrate root cause analysis, trend monitoring, targeted training, SOP refinement, and verification of effectiveness.
- Donor Experience and Retention Donors give blood to help others and contribute to a resource that they may need in the future. They trust the BCA to manage their donation in a safe and effective way. Recurrent discards can lead to donor frustration and reduce donor return. Addressing systemic causes protects donor confidence and helps maintain a stable donor base.
- Organisational Reputation and Public Trust BCAs must ensure the public's confidence that donated blood is managed with the highest level of professionalism. Failure of the continuous quality management system can lead to reputational risk, regulatory scrutiny, and decreased public confidence.
Conclusions
Recurring QMS failures and preventable discards may indicate deeper systemic issues. A strong, data-driven approach, process review, and continuous improvement ensure product safety, regulatory compliance, and optimal utilisation of donor contributions.
While the issue of recurrent QMS failures is important, the topic remains understudied. As such, the ISBT Donors and Donation Working Party established a working group on this topic. We are currently in the process of conducting a Vox Sanguinis International Forum survey to describe how BCAs around the world manage donations and donors with recurrent discards. We look forward to publishing these results in an upcoming Vox Sanguinis issue.
References
- Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC) https://www.transfusionguidelines.org/
- Association for the Advancement of Blood and Biotherapies (AABB) https://www.aabb.org/news-resources/resources/clinical-practice-resources
