Quality and Safety of Blood Products
1Canadian Blood Services, Ottawa, Canada
2Australian Red Cross Blood Service, Sydney, Australia
3University of Alberta, Edmonton, Canada
4Canadian Blood Services, Hamilton, Canada
Quality and Safety of Blood Products
Description
Blood products, including platelet concentrates, red blood cell concentrates, and plasma, are biological pharmaceuticals which should meet the highest quality and safety standards. Good Manufacturing Practices (GMP) have been broadly adopted as the main tool for quality assurance of blood products. Similarly, several strategies including donor screening, skin disinfection methods, first aliquot diversion, and bacterial detection methods have been implemented to decrease the incidence of transfusion-associated septic events. Although there is a consensus that some or all of these measures are in operation worldwide, uncertainty still exists about variation of practice in different blood suppliers. Major considerations that challenge the consistency in quality and safety of blood products are the biological nature of raw material, differences in manufacturing processes, and variation in testing methods.
We invite original and review manuscripts describing current and under-development practices related to improving the quality and safety of blood products.
Potential topics include, but are not limited to:
- Quality assurance practices for platelet concentrates, red blood cell concentrates, and plasma
- New approaches and technologies to improve the quality of blood products
- Understanding the biological characteristics of each of the blood products (“what is in the bag”)
- Blood product quality markers associated with international standards
- Blood product quality markers associated with quality monitoring programs
- Safety practices for platelet concentrates, red blood cell concentrates, and plasma:
- Donor screening and deferrals
- Skin disinfection
- First aliquot diversion
- Testing for viral, bacterial, and parasitic infections: current and under-development methods
- Pathogen reduction technologies
- Practices to manage blood product safety including approaches when screening assays are not available or have not been implemented
- Emerging pathogens