山东省血站献血服务、成分制备及血液供应过程质量监测指标体系的应用OACSTPCD

Objective To establish an effective quality indicator monitoring system,scientifically and objectively evalu-ate the quality management level of blood banks,and achieve continuous improvement of quality management in blood bank.Methods A quality monitoring indicator system that covers the whole process of blood collection and supply was estab-lished,the questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of in-dicators and calculation formulas was distributed to 17 blood banks in Shandong.Statistical analysis of 21 quality monitoring indicators in terms of blood donation service(10 indicators),blood component preparation(7 indicators),and blood sup-ply(4 indicators)from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed.Results The average values of quality monitoring indicators for blood donation service processof17 blood bankswere asfollows:44.66％(2 233/5 000)of regular donors proportion,0.22％(11/50)of adverse reactions incidence,0.46％(23/5 000)of non-standard whole blood collection rate,0.052％(13/25 000)of missed HBsAg screening rate,99.42％(4 971/5 000)of first,puncture success-ful rate,86.49％(173/200)of double platelet collection rate,66.50％(133/200)of 400 mL whole blood collection rate,99.25％(397/400)of donor satisfaction rate,82.68％(2 067/2 500)of use rate of whole blood collection bags with by-pass system with sample tube,and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood(P<0.05).The platelet collec-tion rate,incidence of adverse reactions to blood donation,and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks(P<0.05).The average quality monitoring indi-cators for blood component preparation process of 17 blood banks were as follows:the leakage rate of blood component prepa-ration bags was 0.03％(3/10 000),the discarding rate of lipemic blood was3.05％(61/2 000),the discarding rate of he-molysis blood was 0.13％(13/10 000).0.06 case had labeling errors,8 bags had blood catheter leaks,2.76 bags had blood puncture/connection leaks,and 0.59 cases had non-conforming consumables.The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks(P<0.05),and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks(P<0.05).The aver-age values of quality monitoring indicators for blood supply process of 17 blood banks were as follows:the discarding rate of expired blood was 0.023％(23/100 000),the leakage rate during storage and distribution was of 0.009％(9/100 000),the discarding rate of returned blood was 0.106％(53/50 000),the service satisfaction of hospitals was 99.16％(2 479/2 500).The leakage rate of blood components during storage and distribution was statistically different with that of blood com-ponent preparation bags between different blood banks(P<0.05).There were statistically significant differences in the pro-portion of regular blood donors,incidence of adverse reactions,non-standard whole blood collection rate,400 mL whole blood collection rate,double platelet collection rate,the blood bag leakage rate during preparation process,the blood com-ponents leakage rate during storage and distribution as well as the discarding rate of lipemic blood,hemolysis blood,expired blood and returned blood among large,medium and small blood banks(all P<0.05).Conclusion The establishment of a quality monitoring indicator system for blood donation services,blood component preparation and blood supply processes in Shandong has good applicability,feasibility and effectiveness.It can objectively evaluate the quality management level,fa-cilitate the continuous improvement of the quality management system,promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.