CNAS, authorized by the National Certification and Accreditation Administration, is a national accreditation body that follows international standards and regulations. The ISO15189 accreditation is currently recognized as the most authoritative laboratory quality management system worldwide. Projects accredited under ISO15189 are recognized internationally among thousands of laboratories, providing superior and safer diagnostic services for both clinical settings and patients.
The on-site assessment was led by Professor Du Xiang, former Vice President and Director of the Pathology Department at Fudan University Affiliated Cancer Hospital. Other assessors included Professor Yin Weihua from the Pathology Department at Peking University Shenzhen Hospital, Professor Yang Li from the Pathology Department at Xijing Hospital of Air Force Medical University, Professor Zheng Bo from the Pathology Department at Cancer Hospital of the Chinese Academy of Medical Sciences, and Professor Yang Jun from the Pathology Department at Gulou Hospital, Nanjing University Medical School.
At the initial meeting on October 11, Professor Du Xiang, the lead assessor, outlined the purpose, scope, methodology, schedule, and division of labor for the assessment, stressing the fairness and objectivity of the review.
Xu Xianhua, Director of the Pathology Department at Hainan Cancer Hospital and head of the laboratory, delivered a detailed report covering the hospital’s overview, the development history of the Pathology Department, and the operation of the ISO15189 quality management system.
(Shi Yaohui, Secretary)
Shi Yaohui, Secretary of the Party Committee and Executive President of Hainan Cancer Hospital, extended a warm welcome and sincere thanks to the panel of assessors on behalf of the hospital. He emphasized that the continuous high-quality development of the pathology discipline is a key aspect of building a specialized cancer hospital. The hospital has always placed great importance on the internal construction and academic advancement of the Pathology Department. He expressed hope that the assessors would provide valuable suggestions to further improve the department’s quality management system, elevating the quality of work and technical capabilities, thereby better serving cancer patients from Hainan and beyond.
(On-Site Assessment by the Expert Group)
During the three-day on-site evaluation, the expert group strictly followed the latest version of the "Standards for Accreditation of Medical Laboratories - Quality and Competence." They conducted an in-depth review of various aspects, including histopathology, cytopathology, molecular pathology, immunohistochemistry, reagents and consumables, equipment, personnel management, and quality management. The experts meticulously examined the documentation, SOPs, and record forms of each department within the laboratory, assessed the full operational workflow, and conducted a comprehensive evaluation of the conformity and effectiveness of the laboratory’s quality management system and related documents. Additionally, they solicited feedback from clinical departments, evaluating whether the pathology department’s testing projects and service quality met clinical needs, whether pathology reports were timely, and whether diagnoses were accurate, to assess the overall clinical service capabilities of the department.
(Professor Du Xiang)
At the closing meeting on October 13, Professor Du Xiang provided a comprehensive summary of the evaluation results. The expert panel unanimously concluded that the quality management system of the Pathology Department at Hainan Cancer Hospital operates effectively, with well-documented systems, a clear organizational structure, and reasonable allocation of responsibilities. The laboratory’s comprehensive service capabilities fully meet clinical and patient needs, and the current quality management system and technical competence comply with CNAS accreditation requirements. He officially announced that the on-site assessment was successfully passed.
(Liu Yuehong, Vice President)
On behalf of the hospital, Vice President Liu Yuehong expressed her gratitude to the expert team for their meticulous and professional work during the assessment. She noted that passing the on-site ISO15189 accreditation marks another step forward in the standardization of the pathology departments quality management, ensuring that reports issued are internationally recognized and accurate. The hospital will continue to support the Pathology Department in its efforts toward continuous improvement, further enhancing diagnostic capabilities and service quality to better serve cancer patients.
Editor | Huang Fei
Images | Yang Enhao, Li Hongyi