Evaluation and improvement of blood station quality management system: based on external audit
Journal Title: Chinese Journal of Blood Transfusion - Year 2023, Vol 36, Issue 11
Abstract
Objective To identify the main unqualified items in the external audit of blood station quality management system (referred to as external audit), in order to take necessary measures to continuously improve the quality system. Methods Unqualified items(data) in the national and Shandong provincial blood safety technical audits (referred to as national and provincial audits) and four blood station blood safety technical joint audits (referred to as inter station mutual audits) from 2017 to 2019 were collected and analyzed by Excel and Pareto curves (graphs). Corresponding corrective and preventive measures were developed and implemented, and then tracked and evaluated by the quality management department three months after the external audit to verify their effectiveness. Results In a total of 7 external audits of blood station quality management system that our blood station has participated in over the past 3 years (including 2 national audits, 2 provincial audits, and 3 inter station mutual audits), the main unqualified terms were "12 monitoring and continuous improvement" 11.90% (15/126), "13 blood donation services" 11.90% (15/126), "06 equipment" 10.32% (13/126), "11 records" 10.32% (13/126), "03 organization and personnel" 8.73% (11/126), "15 blood preparation" 7.94% (10/126), "08 safety and health" 7.14% (9/126), and "14 blood testing" 7.14% (9/126). Among them, "monitoring and continuous improvement" ranked first in two national audits and two provincial audits, with 16.67% (5/30) and 14.71% (5/34), respectively, and was 8.06% (5/62) in inter station mutual audit, and the difference between the three kinds of audits was not statistically significant (P>0.05). "Records" accounted the highest proportion in inter station mutual review of 19.35% (12/62), while was respectively 0 and 2.94% (1/34) in national and provincial audits, with statistically significant difference between the three kinds of audits (P<0.05). Conclusion External audit against unqualified items is important for quality improvement. By analyzing the unqualified terms, taking corresponding measures to improve weak links, and evaluating the effectiveness of those measures, it can effectively ensure the effective operation of blood station quality management system.
Authors and Affiliations
Xuemei LI, Haizhong FU, Fei DONG, Lihua XU, Sheng WANG
Keywords
Related Articles
- EP ID EP738697
- DOI 10.13303/j.cjbt.issn.1004-549x.2023.11.017
- Views 8
- Downloads 0
Optimization of large-scale production process for human prothrombin complex concentrates
Objective To determine the optimal process conditions for efficiently extracting human prothrombin complex concentrates from human plasma. Methods Using human plasma as the materials and the yield of prothrombin complex...
Molecular genetics research of a Chinese family carrying triple HLA-A alleles
Objective To determine molecular basis of a rare HLA-A typing results carrying triple A alleles in potential allo-HSCT donor and her family. Methods HLA-A, -B, -C, -DRB1, -DQB1, -E, -F, -G of 5 members in the family were...
Experimental study of Genipin cross-linked hemoglobin isolated from fetal
Objective To achieve effective polymerization rate (molecular weight of 64-600 KD) ≥70% and average molecular weight of 100-300 KD across the way of Gennipin (Genipin, Gnp) crosslinked hemoglobin isolated from fetal (hem...
Establishment of human monoclonal hybridoma cell lines specific for PP1Pk antigens from peripheral B lymphocytes of a p[Tj(a-)] donor
Objective To establish lymphoblastoid cell line (LCL) and human monoclonal antibody cell lines against PP1Pk antigens from a donor with rare p[Tj(a-)] phenotype. Methods Peripheral blood mononuclear cells (PBMCs)of an O...
Effect and mechanism of extracorporeal photopheresis on preventing acute graft versus host disease in ice
Objective To investigate the preventive effects of early apoptotic splenic mononuclear cells induced by extracorporeal photopheresis (ECP) on acute graft versus host disease (aGVHD) in mice and explore the underlying mec...