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Date Published: 10/03/2021
Abstract Views: 1729
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DOI: https://doi.org/10.51298/vmj.v498i1.27
Issue
Vol. 498 No. 1 (2021)
Section
Các bài báo
How to Cite
Quang Huy, V., Thị Diễm Phúc, H., & Khánh Cường, N. (2021). PROCEDURE OF RED BLOOD CELL PRODUCTION UTILIZING IN BLOOD TRANSFUSION EXTERNAL QUALITY ASSESSMENT PROGRAM. Vietnam Medical Journal, 498(1). https://doi.org/10.51298/vmj.v498i1.27

PROCEDURE OF RED BLOOD CELL PRODUCTION UTILIZING IN BLOOD TRANSFUSION EXTERNAL QUALITY ASSESSMENT PROGRAM

Vũ Quang Huy1,, Huỳnh Thị Diễm Phúc2, Nguyễn Khánh Cường2
1 Đại học y dược TP. Hồ Chí Minh
2 Trung tâm Kiểm chuẩn chất lượng xét nghiệm Y học – Đại học Y Dược TP. Hồ Chí Minh

Main Article Content

Abstract

Objective: Development a procedure to produce red blood cell specimens and evaluate the homogeneity and stability of producing samples to meet the criteria for using in blood transfusion external quality assessment program. Methods: 4 lots of samples (50 samples / lot) corresponding to 4 ABO blood groups are produced, 10 samples / lot are used to evaluate the homogeneity, 9 samples / lot are used to evaluate stability. in storage condition (49 days) and 3 samples / lot were used to assess stability in shipping conditions (7 days). Antigen, red blood cell count (RBC), hematocrit (Hct), hemoglobin (Hb), Na+, K+, lactate, lactate dehydrogenase (LDH) were used to evaluate and monitor sample’s quality. Results: 4 sets of red blood cells were successfully produced and evaluated according to ISO 17043: 2010. The production samples are homogeneous, stable for 35 days and still ensure the standards of clinical practice until 49 days, sample quality is assured for 7 days under shipping conditions. Conclusion: The procedure of red blood cell production has successfully developed according to ISO 17043: 2010 standards. The producing samples meet the quality requirements of homogeneity and stability, and can be applied in the blood transfusion external quality assessment program.

Article Details

Keywords

external quality assessment, blood transfusion, stability, uniformity.

References

1. Quyết định số 316/TTg (2016). Phê duyệt đề án tăng cường năng lực quản lý chất lượng xét nghiệm y học giai đoạn 2016 – 2025.
2. Tiêu chuẩn quốc gia TCVN ISO/IEC 17043 (2011). Đánh giá sự phù hợp – Yêu cầu chung đối với thử nghiệm thành thạo. Nhà xuất bản Hà Nội, pp.9 – 10.
3. Hoàng Thị Hà Anh (2014). Xây dựng quy trình sản xuất mẫu ngoại kiểm đánh giá chất lượng phòng thí nghiệm huyết thanh học HIV, pp.48 – 53.
4. Tiêu chuẩn Việt Nam TCVN 7366:2011 (ISO GUIDE 34:2009) (2011). Yêu cầu chung về năng lực của nhà sản xuất mẫu chuẩn, tr 17 – 18.
5. Deom A, El Aouad R, Heuck CC, Kumari S, Lewis SM, Uldall A & World Health Organization (1999). Requirements and guidance for external quality assessment schemes for health laboratories.
6. World Health Organization (WHO) (2004). External quality assessment of transfusion laboratory practice. Guidelines on establishing an EQA scheme in blood group serology. Geneva, pp.27 – 33.
7. Yu Y, Ma C, Feng Q, Chen X, et al (2013). Establishment and performance assessment of preparation technology of internal quality control products for blood transfusion compatibility testing, pp.3-6.