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CLSI in the People’s Republic of China

Clinical and Laboratory Standards Institute (CLSI) Activities in the Peoples Republic of China (PRC): A Brief Report

Clinical and Laboratory Standards’ (CLSI) relationships in the People’s Republic of China (PRC) began almost 10 years ago, in 2012, at a time when China’s major national health care reform directives were created. The need was recognized at this time for China’s laboratory medicine services to be elevated to meet international standards. As the globally recognized leader in medical standards creation acting as technical assistance for the Chinese adoption, CLSI was a natural partner.

Key drivers for this continually maturing relationship included:

  • PRC central and provincial government’s increased focus on and mandates for health care reform.
  • PRC central government’s promotion and rapid implementation of internationally accepted best practice standards that could be readily adapted for local requirements.
  • Increasing acceptance in the PRC that the field of laboratory medicine is essential for the diagnosis and treatment of all communicable and most noncommunicable diseases.
  • Respected PRC academic experts and opinion leaders in  laboratory medicine  were markedly increasing their active engagement on the international standards development stage.
  • The complexities of the need for expedient training and implementation on many of the standards required significant support that could potentially be provided by CLSI.
  • Increased national and provincial requirements in PRC for medical laboratories to achieve accreditation aligned to internationally recognized standards.
  • The PRC’s recognition of CLSI as the most respected leader in global laboratory medicine standards development. CLSI’s portfolio of 200 standards, 1,700 organizational members in 60 countries, and major roles in the international Organization for Standardization (ISO) and World Health Organization (WHO) activities have contributed to this recognition.
  • It began in 2012, when CLSI’s president at the time, Dr. Mary Lou Gantzer, was invited to Beijing by Dr. Tony Chan, China State Standard Technical Committee for Clinical Laboratory Testing and In Vitro Diagnostic Test System (SAC/TC136) advisor, to provide the plenary session speech at the SAC/TC136 annual conference. Dr. Gantzer’s presentation and subsequent introductions to relevant leaders in China began a series of fruitful discussions and activities with members of academia, government, and the in vitro diagnostic industry.

In recent years, important successes between the PRC and CLSI include: 

  • Academia:
    • Meetings with the Board President, deans, and other academic leadership at Sun Yat-sen University (SYSU) and Zhongsan Medical school in Guangzhou to conduct strategy sessions, provide lectures by international experts, create a model community-based medicine program, and advance laboratory medicine curriculum at the university.
    • Providing lectures by international experts at Shenzhen University.
    • Coordination, expert advice, and ongoing support for the new four-year academic degree program at NanFang College of SYSU beginning in 2016, including dedicated academic professional support from CLSI.
    • CLSI’s provision of international expert speakers at national societies for the Chinese Medical Association and related conferences in various fields of laboratory medicine, including quality management systems and antimicrobial susceptibility testing and methods. 
  • Practicing Health Care Professions:
    • The most noteworthy efforts have been dedicated to the quality improvement in China’s tier 1 and 2 community health centers (CHC) and hospitals. These efforts were chosen to support China’s national health care reform initiatives to promote the increased confidence and use of community-based health care. The result was the creation of a sophisticated and coordinated program of community-based medicine. The leadership of committed Chinese partners was essential at provincial and district government ministries of health, largely in Guangdong province, as well as the private partner of Daan Health (now YunKang Health Group).
    • Accomplishments to date include:
      • Creation and implementation of the Community-Based Clinical Laboratory Quality Management Enrichment Program, which can be replicated on a larger scale.
      • Creation of a quality operations checklist based on the international standard ISO 15189 and CLSI’s quality management system checklist derived from its global training activities in 22 countries, and in alignment with the Chinese National Accreditation Service (CNAS) requirements.
      • Training of a core cadre of local experts to audit, assess, and improve the quality of operations at tier 1 and 2 hospitals and health care centers using a training-of-trainers model.
      • Coordination of local support by YunKang’ s laboratory experts and support for the CHC’s training for and implementation of a quality management system, logistics (couriers and specimen transport), reference testing, remote quality control monitoring, information technology support, equipment selection, personnel training, and accreditation preparedness.
      • Joining as affiliate members of CLSI with over 4,000 sites to provide access to CLSI standards, education, trainings, and related best practice tools.
      • Selective translation into Mandarin of essential standards, guidelines, and job aids.
      • Direct observation and gap assessments utilizing a locally adapted checklist form, with easily observable improvements of nonconformances after training and support.

CLSI is proud of its continuing role in supporting China’s steady improvement of the quality and capabilities of its medical laboratory infrastructure based on CLSI’s global standards. The CLSI/PRC relationship demonstrates the value of partnerships in  alignment with CLSI’s nonprofit mission to develop clinical and laboratory practices and promote their use worldwide.