A policy informing qualitative study to improve the process of blood product recalls and withdrawals

BACKGROUND: Challenges associated with blood product recalls and/or withdrawals in Canada identified a need to understand the process and identify ways in which it could be improved. With the use of qualitative techniques and a modified grounded theory approach, the current process was mapped, issues were identified, and recommendations to improve the system were developed. STUDY DESIGN AND METHODS: Potential participants were identified using a sampling strategy that included key stakeholder groups. After consenting, participants were interviewed using a semistructured interview guide. Interviews were audiotaped, transcribed, and coded using a coding scheme developed from the content of the interviews. A team approach to analysis identified relevant emergent themes and led to the development of recommendations. Draft recommendations were presented at a consensus meeting, and feedback was incorporated into the final set of recommendations. RESULTS: Forty‐five interviews were conducted. Major themes arising from the data were communication, timeliness of follow‐up information, and challenges related to patient notification. The current recall and/or withdrawal process was described and a new model for the recall and/or withdrawal process was developed. Nineteen recommendations were formulated: 12 general and 7 hospital‐specific. CONCLUSION: Large‐scale recalls and/or withdrawals involving unknown or uncertain risks can be challenging both for hospitals and for the blood supplier. However, using a qualitative research approach, recommendations and a model for improving the system were developed. Key recommendations include the development of national guidelines for notification and the use of a group of resource experts to assess risk and assist with notification decision making.     

Safe transfusion of blood and blood components

Nurses are integral to the blood transfusion process. This article, which forms part of Nursing Standards clinical skills series, outlines the role of the nurse in evidence-based transfusion practice. Patient assessment, preparation, pre-transfusion checks, documentation and adverse reactions are discussed.     

Guidelines for administering blood and blood components

The Serious Hazards of Transfusion (SHOT) scheme has revealed that many patients have received incorrect blood or blood component. This article reports new national guidelines for ordering, administering and managing blood, blood components and blood transfusion.     

Donation of blood components

The donation of blood by means of aphaeresis by means of a cellular separator is a procedure through which one obtains blood components in the most efficient manner, yielding the best quality in the final product although this procedure requires special characteristics on behalf of the donor and consequently has a higher cost. The authors have analyzed the characteristics of 81 donors who used this procedure and who voluntarily came to our blood bank over a 17 month period from January 2002 until May 2003; 287 such procedures were carried out. The quality of the product obtained, as a benefit for the possible receptor, compensates the greater dedication by the donor and the high cost of this technique.     

An aseptic fluid transfer system for blood and blood components

A device is described which can be attached to all blood bags. Two of these devices are heat-sealed together aseptically at any time during the storage life of the blood unit, and an opening connecting the two is created. In vitro and in vivo studies show that ten passes of a unit of blood through these devices produces no cytological changes and does not alter the in vivo survival of the unit when transfused. Further, if the unit is frozen, then thawed, and even stored at 4 C for five days after thawing, the in vivo survival is still unaffected.     

Bacterial contamination of blood components.

Despite considerable advances in the safety of blood components, transfusion associated bacterial infection (TABI) remains an unresolved problem. As yet there are no perfect preventative, screening and/or detection methodologies for eliminating contaminated units. Until a practical, rapid, cost-effective and logistically acceptable test becomes available, we should be satisfied with the choice of various limited solutions that at least partially improve the bacterial safety of blood components. It is also necessary to establish standardised guidelines and agreed upon systematic procedures for the recognition and reporting of the laboratory and clinical evaluation of adverse reactions in recipients of contaminated blood components.