CLSI creates standards and guidelines for the clinical laboratory community

The Clinical and Laboratory Standards Institute creates best practice standards and guidelines for clinical laboratory professionals. In its most basic form, CLSI is a membership organization that provides a forum where the best minds in the clinical laboratory world come together and create best practice standards and guidelines for use by the clinical laboratory community. CLSI's portfolio of more than 200 standards, guidelines, and implementation tools is seen as authoritative because our voluntary consensus process carefully balances the viewpoints of industry, government, and the healthcare professions in the creation of our materials. Also, many of CLSI's standards and guidelines are recognized by the U.S. Food and Drug Administration (FDA) and many of the world's laboratory accrediting agencies.

Initiatives CLSI is promoting to advance its mission. Some of our bigger initiatives include the creation of a number of companion job aids and other tools to help laboratory professionals implement the standards and guidelines, as well as the development of sophisticated electronic delivery and search tools. We also offer easy-to-use software for method evaluations and related requirements, and provide training and education of laboratorians on many of CLSI's documents, including the new EP23, which focuses on quality control based on risk management. One of the recurring customer concerns we hear at CLSI is something to the effect of, “We enjoy and trust your standards…but can you make them easier to understand and implement for everyday lab use?” Our mantra is to move CLSI in this direction in all we do, but to do so without diluting the value of the content of the full standards and guidelines as the source documents.

Why acceptance of consensus standards and guidelines within the healthcare community is important. The acceptance of consensus standards and guidelines within the healthcare community is important to healthcare, and to the physical and social health of the world—not just the United States. The clinical laboratory is one of the healthcare fields of practice with a high degree of commonality from site to site. Regardless of geography, size, and complexity, all laboratories have a common path of workflow with which all policies, processes, and procedures align. I have never met anyone in the lab field who didn't want to provide the highest quality test results so that physicians and patients benefit. Why keep recreating the wheel? CLSI certainly helps in this regard.

Second, and importantly, the U.S. government and many other countries' governments encourage their agencies not to create standards where a private organization's standards exist and meet internationally accepted principles of open and transparent processes. CLSI is the only membership organization in the world solely focused on the creation of such standards for the clinical laboratory field. Our documents are used by industry (producers) and the healthcare professions (users) and are recognized as voluntary consensus standards by various government agencies. In short, CLSI exists because we provide a very clear win-win-win arrangement for all key stakeholders.

How evolving regulatory and legal contexts are changing the work of CLSI and its value to labs. Clinical laboratories are undoubtedly one of the most regulated areas of healthcare. While regulations outline “what” must be done, they typically do not advise “how” to do it. This is where CLSI comes in. Many of our standards, guidelines, and companion products are typically “how-to” approaches to meeting accreditation and regulatory requirements. Although they are not required by law, the fact that government officials from such agencies as the Centers for Medicare & Medicaid Services (CMS)/Clinical Laboratory Improvement Amendments (CLIA), the FDA, the Centers for Disease Control and Prevention (CDC), and state public health agencies not only recognize CLSI's standards and guidelines but are also active authors and members allows CLSI documents to be used as authoritative sources for best practices in the clinical laboratory.

Important new guidelines have been published. CLSI produces between 20 and 40 new standards or guidelines each year and updates many more. All of them affect the laboratory or the IVD manufacturer in some way. Laboratories that perform newborn screening testing will definitely want to be aware of I/LA35-A, Newborn Screening for Cystic Fibrosis. Microbiology labs should be aware of the latest version of M100, Performance Standards for Antimicrobial Susceptibility Testing (M100-S22). New chemistry guidelines have also been published, including Expression of Measurement Uncertainty in Laboratory Medicine (C51-A), and Assessment of Fetal Lung Maturity by the Lamellar Body Count (C58-A). Finally, as previously mentioned, EP23-A, Laboratory Quality Control Based on Risk Management, promises to change the way laboratories think about quality control, formalizing all that the lab does to identify and prevent test errors.

CLSI nurtures the development of global lab standards. We are very proud of CLSI's global efforts, supported by grant funding, to work with talented, eager local staff to implement best laboratory practices. CLSI is now active in 17 countries, largely in sub-Saharan Africa. We have also launched a new educational program in Vietnam, introducing Quality Management Systems to laboratory policy and decision makers. CLSI's mission is to both develop and promote our best practices. We now have a far deeper appreciation that good laboratory practices, using CLSI's Quality Management System as a foundation, are universally applicable in any setting. Our global efforts to strengthen laboratory capacity in resource-poor regions have truly been one of the most personally rewarding aspects of my career.