From July 17 to 19, five experts from China National Accreditation Service for Conformity Assessment (CNAS) delivered 3-day re-assessment of Clinical Laboratory of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU). The expert group assessed the quality system of Clinical Laboratory in all aspects by reviewing documents, records, on-spot testing and staff assessment. The expert group highly recognized the establishment and operation maintenance of the quality system of Clinical Laboratory, confirmed the technological capability for application, and proposed valuable opinions and suggestions on the quality system.
In 2014, Clinical Laboratory passed the first assessment of Medical Laboratory Standard ISO15189 Accreditation, the supervision assessment in 2016, the renewal re-assessment in 2018, and the re-assessment of medical laboratory this year.
During the first meeting, Wang Lixin, Leader of the expert group and Director of Medical Experiment Center of General Hospital of Ningxia Medical University, introduced the purpose, scope, basis, posts and staff involved with the re-assessment, confirmed the schedule and task assignment, illustrated the assessment methods and procedure requirements, emphasized the principle of fairness, and announced the Statement of Justice, Confidentiality, Integrity and Self-discipline of On-spot Assessment. Subsequently, Du Qiong, Director of Sichuan Provincial People's Hospital, Chang Shiqing, Director of Luoyang Orthopedic-Traumatological Hospital of Henan Province, Zhang Jinyan, Director of the Fourth Hospital of Hebei Medical University, and Zhou Ting, Director of the Second Affiliated Hospital of XJTU, visited Clinical Laboratory accompanied by the team leader, and initiated on-spot assessment. In the afternoon, a communication meeting was held among medical staff from different departments and Clinical Research Center in the study room. They delivered interview with the ability and quality of service in Clinical Laboratory. At 6:30 a.m. on July 18, experts visited the clinical wards for specimen collection, tracing and clinical follow-up. At 13:00 p.m., body gesture assessment was delivered for staff from Clinical Laboratory. On July 19, five experts, Deputy Secretary Feng Guanglin, Yun Hui from Medical Department, Xin Aili from Nursing Department and all staff from Clinical Laboratory attended the final meeting. During the meeting, Director Wang Lixin reported the assessment results and announced that Clinical Laboratory passed the on-spot re-assessment. He also put forward specific requirement and timetable of further corrections. On behalf of our hospital, Deputy Secretary Feng Guanglin expressed gratitude to the experts for their hard work, highly recognized the work of Clinical Laboratory in recent years, and proposed higher requirement for the development of Clinical Laboratory. Finally, Chen Wei, Director of Clinical Laboratory, appreciated the experts for their on-spot guidance and experience, and promised that Clinical Laboratory will complete the correction task on schedule.
Medical laboratory accreditation is conducted based on the international standard ISO15189 "Medical Laboratory-Special Requirement for Quality and Ability", which is a universal and authoritative standard around the globe. The quality and ability of laboratory tests passing the international standard ISO15189 are in line with international standards, and the corresponding test reports issued by relevant laboratories are reliably guaranteed and accepted internationally. Successful pass of medical laboratory accreditation signifies that Clinical Laboratory can possess the technological capability to carry out laboratory tests complying with ISO15189 standard, generate reliable test reports for patients and clinical purposes, utilize CNAS National Laboratory Accreditation Mark and ILAC Mutual Recognition Arrangement Marks within the scope of certification and accreditation,building up a bridge for future communication with international counterparts.