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 observe the effect of deglycerolized red blood cells suspended in MAP on preservation and explore the most effective preservation method. 【Methods】 Concentrated red blood cells were prepared by centrifuging 400 mL of whole blood on the third day after collection. 40% compound glycerol solution was added using the ACP 215 automatic blood cell analyzer, and the resulting mixture was stored in an ultra-low temperature refrigerator at -65℃ for 30 days. After thawing and washing, it was equally separated into two bags. The control group received 0.9% sodium chloride solution, while the experimental group received MAP. Both groups were stored at 2-6℃. Hematological parameters, hemolysis indexes and cell metabolism indexes were measured on day 0, 1, 3, 5, 7 and 14 after storage. The quality changes of both groups were observed during the 14-day storage period. 【Results】 The quality of red blood cells in both groups was assessed through a panel of quality tests, including volume, hemoglobin content, free hemoglobin content, white blood cell residue, glycerin residue and sterility. These results met the Quality Requirements outlined in the "Quality Requirements of Whole Blood and Component Blood" (GB18469-2012), Hematocrit, red blood cell count, Hb recovery rate after washing and MCV meet the detection limit outlined in the "Expert Consensus on Quality Evaluation Indicators for Frozen Red Blood Cells", and the residual amount of platelets exceeds the detection limit(≤1%). There were no significant differences in RBC, Hct, MCV and hemoglobin between the two groups during the 14 day storage period. The level of free hemoglobin, hemolysis rate and K+ value increased in both groups over time. Significant differences in free hemoglobin were found on day 3, 5, 7 and 14 between the two groups(P<0.05). Hemolysis rate was significantly different on days 3, 5, 7 and 14, while K+ value was significantly different only on day 14(P<0.05). On day 14, the osmotic fragility of red blood cells was higher in the control group than in the experimental group(P<0.05); The ATP and pH values of both groups decreased as storage time increased, and significant differences in ATP and pH value were found on day 3, 5, 7 and on day 1, 3, 5, 7 and 14, respectively(P<0.05). 【Conclusion】 Deglycerolized red blood cells suspended in MAP additive solution can extend the storage period of blood to 7 days. This study provides a reference for the formulation of relevant standards.
ABSTRACT
【Objective】 To investigate the status quo and existing problems of quality control laboratory of blood stations in Hebei province, and to provide reference for the capacity building of quality control laboratory in the future. 【Methods】 The data of routine blood collection and supply, blood component preparation, blood sampling ratio/frequency, and sampling results among 12 blood stations in Hebei in 2020 were collected. The monitoring effect of blood component quality in Hebei province, combined with the indicator changes of main blood components, were analyzed. 【Results】 Blood component preparation from blood stations in Hebei are different. The requirements for the number and frequency of routine sampling in each apartment are not standardized, and retrospective analysis was not conducted basically. Although the frequency and sampling of blood component quality monitoring can meet the minimum requirements of the Quality Monitoring Guidelines of Whole Blood and Blood Components 2017 and Technical Operating Regulations of Blood Stations (2019 Edition), but does not match the actual collection and preparation units. The qualification rate and reliability are unstable due to the small sample size. Monthly quality inspection can result in judgment errors, which is not conducive to systematic analysis and continuous improvement of blood collection and supply process. 【Conclusion】 In the context of continuous enhancement of blood collection and supply standardization in Hebei Province, the blood quality monitoring mechanism based on intra-province consistency can be further studied to standardize intra-province homogenization of blood quality monitoring in multiple links including sampling rules, statistical analysis and data comparison calibers.
ABSTRACT
The blood donation, component preparation and manufacturing, laboratory, issuing and quality control were studied and compared between the UK and China, in order to learn British experience in the clinical practice and blood services. The age limits of blood donors, blood collection units, donation times per year, laboratory items, and the types(volumes) of component preparation and manufacturing in the UK are more superior than those in China. In addition, the blood quality monitoring and regarding indicators are more scientific and reasonable in the UK. The full reimbursement of clinical blood expenses for patients has been realized in the UK. The British experience in continuous safeguard of the blood safety and balance of requirement and availability contributes to the constant and scientific development of British blood services over the years, and is worthy of references.
ABSTRACT
Objective To explore the management mode of regional clinical blood ,as well as the role of Regional Medical Center in the blood management ,and have a comprehensive understanding of Daxing district clinical blood using present situation .Methods Organized Daxing district clinical blood using quality control center experts to do a research of 18 medical institutions in the blood management status of clinical blood demand within the jurisdiction ,and analyzed the statistics related to clinical use of blood in vari‐ous medical institutions from January to December in 2014 ,according to Beijing Wei Yi [2008]189 words in medical institutions of Beijing City ,the department of transfusion(blood bank) in the relevant provisions of the basic standard.Results Through the sur‐vey ,only regional medical center established the department of transfusion in 18 medical institutions ,other medical institutions have set up blood bank .Practitioners of department of transfusion (blood bank) in the number full‐time staff ,with post qualification num‐ber and degree of structure ,difference between regional medical center and other kind hospitals was significant (P0 .05) .Three grade hospitals in biological safety and continuous im‐provement of quality ,could be carried out in accordance with the PDCA cycle ,and have obvious advantages compared with the other one or two grade hospitals .Conclusion Fifteen medical institutions do not have the clinical blood transfusion compatibility testing conditions .To ensure the safety of blood for clinical use ,blood need to be tested by the department of transfusion regional medical center .