The international standard ISO 15189, which specifies quality and competence requirements for clinical laboratories, is taking on increased importance as it is now regarded as a requirement by the Ministry of Health, Labour and Welfare for approval to operate as a core clinical research hospital or as a core hospital for cancer genomic medicine, as well as to qualify for additional medical service fee points under the international standard test management category. In addition, needs for the operation of clinical laboratories that are compliant with international standards and support services for such operation are expected to further increase, driven by plans to make ISO 15189 certification a legal requirement for the operation of clinical laboratories overseas.2
At the same time, the adoption and maintenance of ISO 15189 certification entail a large amount of work starting with the preparation of management documents and implementation records, making it a challenge to combine clinical testing and ISO 15189-related work.3
In 2018, Sysmex started providing Caresphere™ as a network solution that supports the resolution—from a new dimension—of issues associated with improving operational efficiency and quality in various areas related to testing and healthcare. With increasing customer satisfaction, this service has continued to enhance and expand related products and services since.
In September 2019, Sysmex launches the Caresphere™ QM operational support system for testing quality management. The new application supports the operation of clinical laboratories that comply with ISO 15189. By facilitating the combination of clinical testing and ISO 15189-related work through the provision of Caresphere™ QM, Sysmex will help realize the operation of high-quality clinical laboratories.
With the aim of supporting the operation of ISO 15189-compliant clinical laboratories, Caresphere™ QM looks to reduce the work burden associated with, and to continually improve, ISO 15189 compliance by digitalizing approval and notification processes that hitherto were conducted using paper records (e.g., management of documents, workflow, corrective actions, and schedules) as well as consulting procedural manuals during clinical testing work. The new application concurrently supports the cultivation of clinical laboratory staff by making the training status and skills required from such staff visible (e.g., track record management functions that cover skill management, acquisition and renewal of qualifications, and participation in academic conferences). In addition, Caresphere™ QM links up with Sysmex consulting service to acquire ISO 15189 certification, thus combining into a broader service for clinical laboratories that ranges from certification acquisition to post-acquisition maintenance management.
By leveraging the information and expertise it has accumulated in Caresphere™, going forward Sysmex will continue to launch new applications and services that contribute to more efficient and higher-quality testing that meets the needs of specific regions. As a result, we aim to help resolve the issues our customers face around the world.