ABSTRACT
【Objective】 This study endeavors to introduce the statistical process control (SPC) method to analyze the quality control index concerning red blood cells in additive solution with leukocytes reduced, with the aspiration to advance the effective utilization of blood quality control data, thereby providing empirical foundations for the continual enhancement of blood quality. 【Methods】 Between 2020 and 2022, test data pertaining to the quality control index of red blood cells in additive solution with leukocytes reduced were amassed from six blood stations in Chongqing area. Utilizing Minitab software, the SPC analysis was carried out, p-control charts were delineated, the non-conformance rates of each quality control index along with their 95% confidence intervals were computed, as well as the Process Capability Index (Z value). 【Results】 In accordance with the Whole Blood and Blood Components Quality Requirements, the appraisal of the quality control indexes for red blood cells in additive solution with leukocytes reduced manifested a conformity rate of 100% for appearance, end-of-storage hemolysis rate and sterility test. Nonetheless, the conformity rates for volume, hemoglobin, hematocrit and residual leukocytes did not attain 100%, albeit all were ≥75%. Through the employment of binomial distribution-based p-control charts, the controlled state of the production process was discerned. Although the overarching conformity rate satisfied the national standard stipulations, it was discerned that there were out-of-control points concerning volume, hemoglobin, hematocrit, and residual leukocytes across different institutions, exhibiting palpable trends. The non-conformance rates of all quality control indexes were less than 25%, yet at a 95% confidence level, the residual leukocyte counts from institutions B, C, E, and F did not adhere to the stipulations (exceeding 25%). By architecting the ability evaluation index Z value for count data process capability analysis, it was unveiled that the volume of institution E, the hematocrit of institutions B, C, and F, and the residual leukocytes Z values of all six blood collection and supply institutions were below 2, hinting at avenues for amelioration. 【Conclusion】 The SPC method anchored in binomial distribution exhibits substantial application merit in blood component quality management, facilitating real-time surveillance of blood collection, preparation, and storage procedures.
ABSTRACT
【Objective】 To provide data reference for the implementation of the homogenization of pre-donation blood testing by investigating the relevant situation of pre-donation blood testing in various blood services in Chongqing and analyzing their differences. 【Methods】 A questionnaire covering the basic information of pre-donation blood testing items, quality control and the management of deferral donors was developed, and issued to 19 blood services in Chongqing through E-mails by Chongqing Society of Blood Transfusion. The data collected were sorted, revised and analyzed. 【Results】 A total of 19 questionnaires from 19 blood services(including 1 blood center, 1 sub-center, 6 central blood stations and 11 central blood banks) were collected. All of the pre-donation blood test items of 19 blood services met the Blood Donor Health Test Requirements. Hemoglobin, blood group, ALT and HBsAg testing were carried out by 19 blood services, anti-TP testing by 15, and lipid blood testing by 11, using different detection methods and reagents. Significant differences were found in the frequency and rules of internal quality control for quantitative testing items. In addition, the deferral time and re-recruitment strategy of deferral blood donors were also significantly different. 【Conclusion】 There were differences in the management of pre-donation blood testing and blood donor management after blood donation among blood services in Chongqing. Further standardization was needed to realize regional homogenization and guarantee blood safety and the safety of blood donors.
ABSTRACT
Objective To evaluate the quality of pooled platelets leukocytes reduced after filtering out leukocytes using two man-ufacturers of leucocyte filters for pooled platelets and improving the preparation method.Methods Pooled platelets was prepared from 400 mL fresh whole blood by buffy coats(BC)method,after 1 6 h,(22±2)℃ holding period,pooled six bags of ABO-matched buffy coats.and then filtered with two manufacturers of leucocyte filter,divided into the control group and the experimental group. Before and after filtering,the numbers of platelet and leukocyte,pH,hypotonic shock response(HSR),platelet aggregation and CD62p expression were detected.Results Before filtering leukocytes,the platelet quality of two groups achieved the requirements of Chinese standards.The numbers of platelet and leukocyte,pH,CD62p expression(%)and platelet aggregation showed no signifi-cant difference between two groups(P >0.05).However,After filtering,the pH,platelet aggregation and the platelet recovery,the experimental group and the control group,were (6.53±0.60)vs(7.00±0.06)、(5.5±3.8)% vs (77.4±14.7)%,(86.8±4.3)%vs (90.6±2.7)%,showed significant differences (P 0.05).Conclusion The quality of pooled platelets leukocytes is reduced,after filte-ring out leukocytes with two manufacturers of leucocyte filters and improving the preparation method,achieves the requirements of Chinese standards.However,the leukocyte filters of experimental group might have influence on platelet aggregation and pH.