From July 22 to 25, (CNAS) ISO15189 accredited expert team was assigned to Department of Blood Transfusion of the First Affiliated Hospital of Xi 'an Jiaotong University (XJTU) for on-the-spot assessment.
The expert group carefully examined the quality management process of Department of Blood Transfusion by reviewing the system documents, laboratory experiments and personnel capability assessment. Through holding meetings with medical staff from relevant clinical departments and visiting clinical departments, the expert team can evaluate the communication effectiveness between Department of Blood Transfusion and clinical departments and assess the ability to provide technical services, and comprehensively evaluate the connotation construction of quality system and technical service capability of this department. The experts unanimously agreed that the establishment and operation of quality management system, testing quality and service ability of Department of Blood Transfusion can meet the basic requirements of ISO15189:2012 Medical Laboratory Quality and Competence Accreditation Criteria,CNAS-CL02-A006: 2018 Application Instructions of Accreditation Criteria of Medical Laboratory Quality and Competence in Blood Transfusion Medicine and CNAS-CL02-A010: 2018 Application Instructions of Accreditation Criteria for Quality and Competence of Medical Laboratory in Laboratory Information System. The expert team declared that all the registered items passed on-the-spot assessment and highly recognized the establishment and operation of the laboratory quality management system. This marks a leap forward in the disciplinary construction of Department of Blood Transfusion in our hospital and turns a new page for the establishment of second-grade discipline of blood transfusion medicine.
During the process of establishment and approval of ISO15189 medical laboratory, Department of Blood Transfusion constantly infused extensive efforts to make improvement strictly according to the accreditation criteria. After more than two-year full preparation, a series of document specifications have been revised and modified in the aspects of system document formulation, project quality control, personnel training and assessment, reagent and consumable management and hardware facility transformation,etc. The established quality system has high adaptability, which can guarantee that problems can be detected and continually improved during the laboratory operation, and the quality policy and objectives of the laboratory can be effectively realized during the operation.
ISO15189 medical laboratory accreditation is a process in which international authorities recognize the quality and ability of laboratories, which is a critical pathway to strengthen the standardization of medical laboratories and improve the overall management level and quality service capability of hospitals. It can not only elevate the laboratory level in line with international standards, but also promote persistent improvement of laboratory quality management, enhance the core competitiveness of disciplines and strengthen the influence of the industry. Test reports issued by CNAS accredited laboratories can be mutually recognized by CNAS accredited medical institutions in over 100 countries and regions worldwide, indicating that the test results are mutually recognized around the globe.
Up to now, nearly 500 medical laboratories have been accredited including only 4 Department of Blood Transfusion. Department of Blood Transfusion of our hospital becomes the first laboratory in the northwest China to pass on-the-spot assessment of (CNAS) ISO15189.
