Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 13 views

    ISBTABS 369 Preview 6

    Uploaded by

    arfat lusinanto
    1) This study evaluated the factor VIII levels in 272 units of fresh frozen plasma (FFP) produced between 2019-2023 at 13 blood transfusion units in Indonesia to assess quality. 2) The average factor VIII level was 1.2 IU/mL, within the normal range of >0.7 IU/mL. Only 2 units (0.73%) did not meet standards, originating from non-GMP certified units. 3) Most FFP units (99.27%) met quality standards, originating from GMP-certified blood transfusion units, demonstrating the importance of GMP implementation for producing quality blood products.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    ISBTABS 369 Preview 6

    Uploaded by

    arfat lusinanto
    13 views1 page
    1) This study evaluated the factor VIII levels in 272 units of fresh frozen plasma (FFP) produced between 2019-2023 at 13 blood transfusion units in Indonesia to assess quality. 2) The average factor VIII level was 1.2 IU/mL, within the normal range of >0.7 IU/mL. Only 2 units (0.73%) did not meet standards, originating from non-GMP certified units. 3) Most FFP units (99.27%) met quality standards, originating from GMP-certified blood transfusion units, demonstrating the importance of GMP implementation for producing quality blood products.

    Original Title

    ISBTABS-369-preview-6 (1)

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    1) This study evaluated the factor VIII levels in 272 units of fresh frozen plasma (FFP) produced between 2019-2023 at 13 blood transfusion units in Indonesia to assess quality. 2) The average factor VIII level was 1.2 IU/mL, within the normal range of >0.7 IU/mL. Only 2 units (0.73%) did not meet standards, originating from non-GMP certified units. 3) Most FFP units (99.27%) met quality standards, originating from GMP-certified blood transfusion units, demonstrating the importance of GMP implementation for producing quality blood products.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    13 views1 page

    ISBTABS 369 Preview 6

    Uploaded by

    arfat lusinanto
    1) This study evaluated the factor VIII levels in 272 units of fresh frozen plasma (FFP) produced between 2019-2023 at 13 blood transfusion units in Indonesia to assess quality. 2) The average factor VIII level was 1.2 IU/mL, within the normal range of >0.7 IU/mL. Only 2 units (0.73%) did not meet standards, originating from non-GMP certified units. 3) Most FFP units (99.27%) met quality standards, originating from GMP-certified blood transfusion units, demonstrating the importance of GMP implementation for producing quality blood products.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Abstract Submission

    3.0 Blood products / components


    3.2 Blood components
    ISBTABS-369
    A retrospective study of Quality Control of Fresh Frozen Plasma (FFP) using Factor VIII levels in CBTS Indonesian
    Red Cross from periode 2019-2023
    A Lusinanto* 1, A Nuryadin2, S Srihartaty2, S Chunaeni3, R Syafitri Evi Gantini4
    1National Reference, 2Research Development, 3Quality Manager, 4Director, Central Blood Transfusion Service

    Indonesian Red Cross, South of Jakarta, Indonesia

    Backgroud: Based on data reports from the Ministry of Health of the Republic of Indonesia, there are 470 blood
    transfusion units in Indonesia (235 units managed by the Indonesian Red Cross, 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 is carried out during the
    manufacturing or production development process. Factor VIII levels are internal quality control parameters required for
    quality analysis of Fresh Frozen plasma (FFP). According to international standard guidelines and national government
    regulations (PMK 91/2015), coagulation factors are tested to ensure the quality of FFP products, including Factor VIII
    levels as much as 1% of all units produced, or four units of blood per month.
    Aims: This study aims to evaluate factor VIII levels in each FFP unit to ensure the availability of a standard quality
    product with maximum therapeutic effects and minimum risks for 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 272 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: From a total of 13 BTUs tested for quality, 272 FFP units tested for factor VIII had an average factor VIII content
    of 1.2 IU/mL with a range of 0.5 IU/mL to 5.3 IU/mL, which is normal, should be >0.7IU/mL. Only 0.73% (2/272) of FFP
    units that do not meet the standards of the BTU have yet to implement GMP. Meanwhile, 99.27% (270/272) of FFP units
    were according to standards, originating from BTUs receiving GMP certification.
    Summary / Conclusions: 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 to maintain the coagulation factors by
    implementing GMP by taking blood, collecting, transporting, and shipping. It is required to carry out quality control to
    produce products that meet national and international standards.

    You might also like