A retrospective study of Quality Control of Fresh Frozen Plasma (FFP) using Factor VIII levels in Central Blood Transfusion Services Indonesian Red Cross

Background: According to a report from the Ministry of Health of the Republic of Indonesia, there are 470 blood transfusion units in Indonesia (235 units managed by PMI, 220 units managed by the government, four units of health services provinces, nine units of vertical hospital BTUs, two unit’s Indonesian police and army hospital) distributed in 38 provinces. With so many BTUs spread throughout Indonesia, each BTU must have the same quality standards to maintain and improve blood services. Therefore, it is necessary to carry out Quality Control of the blood component products produced. Quality control is critical in safely and effectively processing blood and other components. A quality concept comprises quality control, assurance, and management. The laboratory service should have a quality control system. Quality testing and monitoring of blood components for transfusion have led to manufacturing or development. Factor VIII levels are internal quality control parameters required for quality analysis of Fresh Frozen plasma (FFP). As per international standard guidelines and government national regulations (PMK 91/2015) for quality assurance of FFP, 1% of all the units prepared, or four units per month, are tested for stable coagulation factors, including Factor VIII levels.
Objective: This study aims to evaluate factor VIII levels in each units FFP to ensure the availability of high-quality products with maximum therapeutic and minimal risk to recipients.
Methods: The retrospective data were collected from Research and Development CBTS Indonesian Red Cross archives from 1 January 2019 to 30 April 2023. Out of total 284 units FFP collected from Blood Transfusion Unit Indonesian Red Cross from Sumatera Island (Lampung Province, Palembang City, Pekanbaru City), DKI Jakarta Province (CBTS IRC), Jawa Barat Province (Depok City, District of Bekasi City, District of Bogor City), Banten Province (Tangerang City, District South of Tangerang City), Government Hospital (Fatmawati Hospital BTU), Army Hospital (RSPAD Gatot Soebroto BTU) were tested Quality Control with semi-automated Sysmex CA50 and automated Sysmex CA620 to determine of factor VIII levels in each unit FFP.
Results: A total of 284 units of FFP were tested, and mean factor VIII levels were 1,2 IU/mL with a range of 0,3 IU/mL-5,3 IU/mL, the normal range measure being > 0,7 IU/mL. Only 4,9 % (14/284) FFP units were inappropriate from the standard, while 95,1 % (270/284) FFP units could be accepted criteria standard.
Conclusion:  We conclude that there are still those below-standard Quality FFP products from blood transfusion units; it is necessary to increase the processing of blood components so that the coagulation factors are maintained. From taking blood collecting, transporting, and shipping, it is required to carry out quality control to produce products that meet national and international standards.