Application of binomial distribution-based statistical process control method in blood quality control
Journal Title: Chinese Journal of Blood Transfusion - Year 2024, Vol 37, Issue 2
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.
Authors and Affiliations
Xingchen LIU, Huayou DAI, Junhong YANG, Danli CUI, Siqi WU, Pengwei YIN, Xia HUANG, Yongzhu XU
Keywords
Related Articles
- EP ID EP738766
- DOI 10.13303/j.cjbt.issn.1004549x.2024.02.012
- Views 41
- Downloads 0
Serological and genetic analysis of a Bel subtype caused by a novel 29insG mutation: a case report
Objective To investigate the serological characteristics and molecular mechanism of a case of Bel subtype. Methods Serological method was used to analyze the ABO blood group of the patient, absorption and elution test wa...
Study on mitochondrial respiratory function in stored apheresis platelets using real-time energy metabolism detection technology
Objective To explore the optimal parameters for detecting mitochondrial respiratory function (MRF) in apheresis platelets (AP) using real-time energy metabolism detection technology, and to study the change of MRF in AP...
Autologous blood transfusion during heart valve replacement surgery: a retrospective study
Objective To retrospectively analyze the indexes of autologous blood transfusion during heart valve replacement, in order to provide reference for allogeneic blood transfusion during heart valve replacement surgery under...
Perioperative transfusion strategies for patients with rare coagulation factor deficiency
Objective To discuss the perioperative blood transfusion strategy of patients with hereditary coagulation factor deficiency through the perioperative blood coagulation management of a patient with coagulation factor Ⅺ de...
The present situation and advance of red blood cell transfusion triggers
In clinical practice, red blood cell infusion needs to be based on the patient′s hemoglobin level. However, different guidelines recommend different thresholds for red blood cell infusion and the timing of blood transfus...