From June 10th to 12th, China National Accreditation Service for Conformity Assessment (CNAS) appointed evaluation experts to conduct (ISO15189) on-site supervision and evaluation of medical laboratory quality and capability accreditation for the Laboratory Department of Sunshine Ronghe Hospital. After a three-day comprehensive review by the expert group, the inspection department successfully passed the on-site supervision and review with excellent results.
Professor Gong Yanwen from the Laboratory Medicine Center of the Second Hospital of Shandong University serves as the leader of the on-site supervision and evaluation team. Prof. Kequ Linlin and Prof. Li Wei from the Laboratory Department of Qilu Hospital of Shandong University were the members of the review team, and conducted a comprehensive review of the operation of the quality management system of the laboratory department of the hospital in accordance with the requirements of the guidelines.
First meeting
On the morning of June 10, evaluation experts, Dean Wang Mingxiao, Vice Dean Chen Dan, Vice Dean Liang Cunhe, heads of relevant clinical departments and functional departments, Director Ji Haisheng of Laboratory Department and the backbone of the department participated in the on-site supervision Review first meeting. Prof. Gong Yanwen, the head of the review team, gave a detailed introduction to the members of the expert team and their division of labor, the purpose, basis, schedule, principles, and methods of this review, and read out a statement of integrity and self-discipline. Director Ji Haisheng introduced the basic situation of the medical laboratory department and the operation of the department’s quality management system since the initial evaluation to the evaluation expert group. On behalf of the hospital, President Wang Mingxiao extended a warm welcome to the arrival of the expert group, introduced the development status of the hospital to the expert group, fully affirmed the positive effect of ISO 15189 laboratory accreditation on the improvement of the hospital’s inspection quality, and hoped that the evaluation experts would have a better understanding of the quality management of the laboratory. The continuous improvement of the system provides valuable opinions and continuously promotes the overall improvement of the hospital’s inspection quality.
Review expert comprehensive detailed inspection
Under the condition of strict compliance with the requirements of epidemic prevention and control, the evaluation experts, in accordance with the CNAS-CL02 “Medical Laboratory Quality and Competence Accreditation Guidelines” and its application requirements, adhere to the principles of objectivity and fairness, conformity evidence, equality and confidentiality, and pass the Reviewing documents, consulting materials, on-site inspections, on-site experiments, clinical visits and exchanges The system and other aspects have been carefully and meticulously checked one by one, and a full-process and full-coverage review has been carried out on the operation of the inspection department’s quality system and the compliance and validity of related documents, as well as the scope of the laboratory’s technical ability to maintain accreditation.
Close meeting
At the last meeting, Professor Gong Yanwen, on behalf of the evaluation expert group, fully affirmed the management level, technical ability and personnel quality of the medical laboratory department, and also put forward rectification requirements for the problems found in the evaluation. The expert group unanimously believed that the quality management system of the inspection department was in good operation, in line with the ISO 15189 accreditation criteria and technical requirements, and announced that the inspection department of Sunshine Ronghe Hospital passed the on-site supervision and review.
Director Ji Haisheng made a statement: The inspection department will take this review as an opportunity to take effective corrective measures in accordance with the requirements put forward by experts, rectify non-conformities in a timely manner, and further implement the “accurate and reliable, fast and timely, scientific management, high-quality Service” quality policy to ensure the continuous and effective operation of the quality management system.
President Wang Mingxiao expressed his gratitude to the evaluation experts for their hard work in the three-day on-site supervision and evaluation. He pointed out that ISO 15189 is an international standard for the accreditation of the quality and capability of medical laboratories, which is conducive to improving the quality of inspections and expanding the core competitiveness of the hospital. It is hoped that the laboratory will focus on the shortcomings of this supervision and review in the future, conscientiously implement the valuable opinions and suggestions put forward by experts, draw inferences from others, continue to improve, and escort the health of the general public with better services, and for the hospital Continued high-quality development to make greater contributions.
