Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today the October 2021 launch of Caresphere XQC in Japan. This application works seamlessly with other applications currently available on the Caresphere platform to provide more reliable testing results and to bring more efficiency to laboratory operations.
Clinical laboratories in hospitals and other medical institutions are required to assure the reliability of their testing results and provide proven evidence of that reliability. To assure the quality of results, they need to assess measurement variability within their own labs ("internal quality control"),1 to assess measurement variability among other labs ("external quality assessment")2 and to provide and manage the proof/grounds for testing results ("traceability").
In 1999, Sysmex introduced SNCS,3 a network service that enables real-time external quality assessment and automatic monitoring, to hospitals and other medical institutions that use Sysmex’s testing instruments and reagents. A year later, Sysmex launched eQAP, an external quality assessment program, which performs external quality assessment for medical institutions that do not use Sysmex’s testing instruments and reagents. Since 2003, Sysmex has provided SNCS/eQAPi,4 an external quality assessment program combining both services.
In February 2014, Sysmex was accredited for ISO/IEC 17043 (Conformity assessment - General requirements for proficiency testing), which is recommended for participation in ISO 15189 (Medical laboratories - Requirements for quality and competence), for its SNCS/eQAPi.
In 2018, to continue an expansion of related products and services, Sysmex launched Caresphere, a safe, seamless, and globally standardized platform that links in real time a variety of information managed by testing instruments and laboratory information systems. As further integration and expansion of SNCS/eQAPi into Caresphere, Sysmex launched a new external quality assessment program in Japan in October 2021 under the name of Caresphere XQC. Seamlessly linked with other apps already available in the Caresphere platform, the introduction of this Caresphere XQC will not only make it possible to perform external quality assessment programs accredited for ISO/IEC 17043, but also increase the reliability of testing results and operational efficiency in laboratories.
Going forward, by leveraging the information and expertise accumulated in Caresphere, Sysmex will continue to launch new applications and services that contribute to enhancing the efficiency and quality of testing while meeting region-specific needs, thereby helping to resolve the issues faced by its global customers.
Overview of Caresphere XQC
Name: Caresphere XQC External Quality Assessment Application
Target fields: Hematology, Urinalysis, Hemostasis, Immunology and Clinical Chemistry
Target markets: All regions
Launch: Japan ― October 4, 2021
*Already launched in EMEA, China and AP regions (except Korea, Mongolia and Taiwan).
*To be launched in the Americas region in the future
References
April 5, 2018 news release: “Sysmex Launches Caresphere™, a New Network Solution -Supporting the Intelligent Use of Information for the Healthcare of the Future, Where the Use of Information is Accelerating-” https://www.sysmex.co.jp/en/news/2018/180405.html
March 18, 2019 news release: “Sysmex Launches Caresphere™ LWS, a Laboratory Information System -Further Enhancing Clinical Testing Efficiency through a New Caresphere™ Solution-” https://www.sysmex.co.jp/en/news/2019/190318.html
September 19, 2019 news release: “Sysmex Launches Caresphere™ QM, an Operational Support System for Testing Quality Management -Realizing the Operation of High-Quality Clinical Laboratories through our New Caresphere™ Solution-” https://www.sysmex.co.jp/en/news/2019/190919.html
Terminology
- Internal quality control: Control methods for ensuring the measurement results of analyzers within a laboratory. To check to make sure that laboratories’ analyzers are functioning correctly by measuring specific materials on a daily basis.
- External quality assessment: Quality assessment process that evaluates the quality of routine testing in clinical laboratories, by statistically comparing the results of same samples delivered to participating laboratories. The results are returned to the laboratories and are utilized for improvement.
- SNCS (Sysmex Network Communication Systems): SNCS is an online support program that connects the Customer Support Center and customers' instruments via Internet to provide real-time external quality assessment, scientific information, and monitoring instrument conditions.
- eQAPi: A large-scale real-time external quality assessment program for fields including hematology, immunology, and clinical chemistry. This service also involves analyzing the results of measurement data in real time, which contributes to improving the accuracy of everyday testing