The Clinical and Laboratory Standards Institute (CLSI) was founded nearly 50 years ago by clinicians and laboratory scientists as a not-for-profit standards development organization with the intention to work collaboratively on ways to ensure the quality of laboratory testing, improve patient care, and develop a formal consensus process for standardization in the field of laboratory medicine. CLSI's work is closely aligned with the goals of The Journal of Applied Laboratory Medicine.
CLSI's mission continues to be to “develop clinical and laboratory practices and promote their use worldwide.” CLSI supports a global community of more than 1700 institutional and organizational members from 68 countries, including hospitals, universities, professional societies, diagnostic companies, and government agencies, as well as individual members. More than 2000 active volunteers help in developing our standards and guidelines. Working alongside colleagues and experts to improve the quality of laboratory testing, CLSI offers an opportunity for volunteers to maximize their voice in the global laboratory community.
CLSI actively promotes global harmonization of standards through its own initiatives and through communication and cooperation with many organizations around the world, such as WHO, the College of American Pathologists (CAP), the CDC, the US Food and Drug Administration (FDA), the International Organization for Standardization (ISO),2 the Kenya Accreditation Service (KENAS), the South African National Accreditation System (SANAS), and others. CLSI's active collaboration with such organizations results in laboratory standards recognized by these organizations and broadly accepted in the international clinical laboratory community.
CLSI's focus on quality is both timely and vital. The increasing awareness of the costly personal and economic impact of medical errors has focused a spotlight on quality management in the healthcare arena. In the present environment of limited resources, quality cannot be taken for granted by those who fund, receive, and provide laboratory services in any part of the world.
CLSI's relationships with its many partners have contributed to its growth and expansion from a standards development organization to that of a global leader in support of laboratory quality and accreditation. CLSI provides training and outreach educational services throughout the world to help laboratories achieve sustainable quality and implement quality management systems (QMSs) to better diagnose and treat patients.
Special mention should be made of CLSI's Global Health Partnerships program. This grant-funded program focuses on the improvement of laboratory medicine practices in developing countries around the world, as evidenced by their achieving accreditation. Most importantly, the program strives to produce test results that local doctors, healthcare professionals, and the public can trust. CLSI staff works to inspire quality management, not only in the laboratory, but throughout the entire healthcare system, to promote a culture of quality and to improve quality patient care worldwide.
This work has already occurred in 34 countries in Africa, Central Asia, Southeast Asia, and elsewhere. More Global Health Partnership programs are being planne. Laboratories that envisioned accreditation as a mere dream are now ISO 15189 accredited because, in part, of these programs. They are now contributing to healthcare in their countries in ways that could not have been done before. With CLSI's support, more laboratories continue working toward accreditation through internationally recognized accreditation organizations.
CLSI staff and laboratory volunteers provide the resources and support that laboratories need to implement a trusted QMS, using reliable standards such as CLSI documents QMS01, QMS06, The Key to Quality™, and ISO 15189.
CLSI has been doing important work with ISO Technical Committee 212 on in vitro diagnostic test systems. Over the last 22 years, under CLSI's guidance as the ISO-selected secretariat, the ISO group has published a series of internationally accepted standards for laboratory quality management, laboratory accreditation (including the widely used ISO 15189), traceability of laboratory results to standardized reference methods, and more.
CLSI applauds AACC's launch of The Journal of Applied Laboratory Medicine. The journal fills a great need in our field for practical applied research on current challenges in the laboratory. We look forward to even further aligning the principles of CLSI with those of practical experiences toward applied laboratory medicine. Our common goal has always been improved patient outcomes. We at CLSI are excited to see the new The Journal of Applied Laboratory Medicine taking a major step in this direction. Indeed, all best practices only achieve their potential when they are implemented in a manner that achieves results with global impact and improved patient care.
↵2 Nonstandard abbreviations:
- International Organization for Standardization
- quality management system.
Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form.
Employment or Leadership: J. Zakowski, CLSI and Beckman Coulter.
Consultant or Advisory Role: None declared.
Stock Ownership: None declared.
Honoraria: None declared.
Research Funding: None declared.
Expert Testimony: None declared.
Patents: None declared.
- Received April 26, 2016.
- Accepted May 10, 2016.
- © 2016 by American Association for Clinical Chemistry