The Research On Quality Control Of Cord Blood Bank

Umbilical cord blood is the blood left in the placenta and umbilical cord when the baby has delivered fetus, umbilical cord has legated and transected, Wherein the presence of the cord blood stem cells are often used for transplantation, To treat a variety of hematological disorders and immune system diseases. The establishment of cord blood stem cell bank in our country is a bit late, A lot of work needs to be done in the quality management of the blood bank, Urgent need to carry out related research.In This thesis, I accordance with the "AABB" which is a internationally accepted standards of Blood Bank Quality Management, Use the Beijing Umbilical cord blood stem cell bank as the background, Do a depth study of the quality control about Umbilical cord blood, Analysis of the quality control problems of the Umbilical cord blood and their causes, Proposed targeted quality control measures, Design the Quality control programs of the Umbilical cord blood systematically, Formed a complete quality control program of the Umbilical cord blood.The main research work carried out and the innovative achievements made in This thesis as followed.(1)Conducted an investigation and review for cord blood stem cell bank quality management and control relevant international standards and domestic laws and regulations relating to the industry, Comparative and analysis the quality control requirements related to the blood bank of the general ISO9001quality control system and the United States Association of Blood Banks AABB quality certification standards, Clearly the quality control requirements of Umbilical cord blood bank in this study.(2)Conducted an investigation and statistical analysis for the status and quality problems exist of the Quality Control for Beijing cord blood bank, Defined the core areas of quality control, Mainly due to quality problems easily lead to core aspects were analyzed, Presents various aspects of quality control, Formed a whole process quality control point system for the quality control’core part of the cord blood bank. (3)Proposed some quality control measures of the Umbilical cord blood quality control core aspects. These measures are well targeted, systematic and operational, Formed a system of quality control strategy of the whole process for the core part of Umbilical cord blood quality control, Can effectively avoid the quality problems for the core aspects of the Umbilical cord blood, Plays an important role for the quality of the Umbilical cord blood.(4)Conducted a system design for the quality control program of the cord blood bank, Including the target of quality control, planning, organizational structure, quality control requirements of the core aspects and control processes, material quality control requirements, document management, quality supervision, inspection, auditing evaluation mechanisms, personnel training, Proposed a complete quality control program, And the feasibility of the program were demonstrated.(5)Conducted a case applications and proven of the proposed improve measures for the quality control on the Umbilical cord blood. Proven results shows that, After Implemented the improvement measures, All aspects of quality have been guaranteed very well. Quality indicators have improved significantly. Demonstrate the effectiveness of the proposed quality control measures in This thesis.Results of this study have practical significance to improve quality control cord blood banks. Obtained various types of lists, tables and other tools during the study, Can be used as a template for the actual work.