Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT)

Transfusion
L J DumontH Brandwein

Abstract

The increased use of white (WBC)-reduced blood components has prompted many institutions to develop quality assurance programs directed to such component preparation processes. For consistent preparation of WBC-reduced blood components that meet clinical needs as well as national standards, a program of process validation and control should be instituted. This involves controlling key factors that affect WBC reduction as well as periodic monitoring of the residual cellular content of components. Practical guidelines for the implementation of such a program are provided. A program involving three phases of monitoring was developed by individuals belonging to an international working party of the International Society of Blood Transfusion. The first phase, process validation, evaluates a minimum of 20 consecutive units (a minimum of 60 units when nonparametric measurements are used) to document the successful local implementation of a new or substantially modified process. Ongoing process control employing Levey-Jennings type control charts is used to demonstrate that the process remains stable over time. Process capability assessment and conformance with standards are evaluated once residual WBCs are counted in a sufficient numb...Continue Reading

Citations

Nov 8, 2003·Fukushima Journal of Medical Science·Hitoshi OhtoYuichi Rokkaku
Jan 1, 1997·Journal of Clinical Apheresis·E A BurgstalerR Brown
Apr 20, 2001·Journal of Clinical Apheresis·J ZingsemR Eckstein
Dec 23, 2003·Transfusion Medicine Reviews·Neil BeckmanUNKNOWN BEST Working Party of the ISBT
Mar 1, 2003·Journal of Immunological Methods·Ruth L GilbertDerwood H Pamphilon
Apr 20, 2000·Transfusion Science·G Rowe
Feb 6, 1998·Transfusion Science·L J Dumont
Jun 3, 1999·Transfusion Science·R N PieterszM J Seghatchian
Apr 5, 2000·Transfusion Science·E A Burgstaler, A A Pineda
Aug 14, 2001·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·M Masse
May 13, 1998·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·J A Loos, J L Wautier
Jan 17, 2002·Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis·C CoffeJ J Huart
Feb 16, 2002·Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis·G Rowe
Sep 6, 2000·British Journal of Haematology·L M Williamson
Sep 6, 2000·Vox Sanguinis·P F van der MeerH W Reesink
Mar 22, 2002·Vox Sanguinis·A ChabanelP Hervé
Jul 9, 2002·Vox Sanguinis·A BontadiniR Conte
Mar 16, 2002·Transfusion·Jürgen ZingsemReinhold Eckstein
Jul 31, 2002·Transfusion·John R HessTibor J Greenwalt
Nov 15, 2002·Transfusion·W H DzikC P Stowell
Dec 25, 2003·Transfusion·José Luis BuenoEmma Castro
Aug 15, 1998·Vox Sanguinis·J E Menitove
Jun 6, 2008·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·A ChabanelUNKNOWN EFS group of blood component QC laboratory managers
Jun 16, 2007·Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis·Joan CidRamon Pau Pla
Apr 10, 2007·Journal of Cardiothoracic and Vascular Anesthesia·Leena CapraroVille Pettilä
Aug 5, 2005·Transfusion·José Luis BuenoRocío González
Jul 22, 2004·Transfusion·Dragica PaunovicJoachim Riggert

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.