Proposed Topic (Most preferred): :
Clinical Safety and Quality Service II (Projects aiming to enhance clinical safety and outcomes, clinical governance / risk management)
Authors (including presenting author) :
Chan KH, Liu CL, Yu MY, Wong KH, Lee CK
Affiliation :
Quality Department, Hong Kong Red Cross Blood Transfusion Service
Introduction :
Blood Safety is a key objective in clinical blood transfusion which is achieved via a number of measures. These include donor eligibility, infectious diseases screening, judicious transfusion indications. However, emerging infectious disease remains a threat to our blood supply. Pathogen Reduction Technology (PRT), INTERCEPT treatment was introduced into Hong Kong Red Cross Blood Transfusion Service (BTS) since December 2020 for platelet blood products and June 2023 for plasma blood products. The mechanism of INTERCEPT-PRT is irreversibly cross-linking the nucleic acids of pathogens by exposure of platelet and plasma blood products to chemical reagent, amotosalen and UVA light, resulting in inactivation of broad spectrum of viruses, bacteria, parasites and leukocytes. Inactivation of pathogens is able to reduce the risk of transfusion transmitted pathogens, such as cytomegalovirus. Reduction of pathogens and leukocytes are also able to prevent the transfusion-associated graft-versus-host disease. Quality Department plays an important role in monitoring the quality of PRT blood products.
Objectives :
Quality Department aims to monitor PRT platelet and plasma blood products to ensure all prepared products fulfilling the requirements of Council of Europe and Association for the Advancement of Blood and Biotherapies, with utilization of validated sampling methods and statistical analysis.
Methodology :
Sampling of PRT platelet blood products is conducted on a monthly basis with determination of absolute platelet count, residual white cell count and pH at the end of shelf life. Similarly for PRT plasma blood products, sampling is conducted with determination of Factor VIII activity, fibrinogen content, residual white blood cell count, red blood cell count and platelet count.
Result & Outcome :
A total of 11,552 units PRT platelets and 759 units of PRT plasma products were produced at BTS since its implementation. 370 units of PRT platelets and 31 units of PRT plasma were sampled for quality control. All sampled PRT platelets fulfilled the requirements of greater than 200 x 10^9 per unit for absolute platelet count, less than 1 x 10^6 per unit for residual white cell count and pH of greater than 6.2 at the end of shelf life. Besides, all sampled PRT plasma units fulfilled the requirements of greater than 50 IU per 100 mL of Factor VIII, greater than 60% of potency after freezing and thawing of freshly collected plasma unit for fibrinogen, less than 1 x 10^8 per litre for residual white blood cell count, less than 6 x 10^9 per litre for red blood cell count and less than 50 x 10^9 per litre for platelet count. The PRT blood products fulfilled the requirements of Council of Europe and Association for the Advancement of Blood and Biotherapies. Our Quality Department actively monitors the quality of various blood products to ensure transfusion safety and pursue for better health of patients.
