Clinical and Laboratory Standards Institute The Highest Standards
Clinical and Laboratory Standards Institute The Highest Standards for Global Health Care Overview for Industry Members
Who We Are The Clinical and Laboratory Standards Institute (CLSI) is the global leader for standardizing laboratory best practices that deliver more accurate results and improved testing. The Highest Standards for Global Health Care 2
Who We Are Our Mission Setting the standard in laboratory medicine for a healthier world. The Highest Standards for Global Health Care Our Vision Develop clinical and laboratory practices and promote their use worldwide. 3
Who We Are Our Members 1, 400+ Members From 80+ Different Countries 100+ Industry Organizations The Highest Standards for Global Health Care 55+ 45+ Health Systems Regulators 1, 100+ Hospitals and Independent Laboratories 2, 600+ Volunteers 400+ Individuals 4
Who We Are Professions • Hospitals • Physicians • Medical Laboratories The Highest Standards for Global Health Care Industry • • Microbiology Pharmaceutical Manufacturers IVD Manufacturers Regulators • Public Health • Governments • Accreditors 5
Who We Are Board of Directors Consensus Council Expert Panels for Each Specialty Area Document Development Committees, Subcommittees, and Working Groups The Highest Standards for Global Health Care 6
Why to Trust Us Our standards are recognized by laboratories, accreditors, and regulators as the way to improve medical laboratory testing around the globe. The Highest Standards for Global Health Care 7
How We Do It • We bring together industry, professions, and government experts to share their knowledge, experience, and best practices. • Through a truly neutral consensus-based process, we create standards that enable laboratory scientists to meet regulatory requirements, obtain accreditation, and improve the outcomes of their testing. Professions Regulators Industry The Highest Standards for Global Health Care 8
Why We Exist Collaborating to create higher standards. We document, aggregate, and disperse the broadest base of laboratory standards that elevate the quality of patient care through improved testing and more accurate test results, leading to fewer mistakes. The Highest Standards for Global Health Care 9
Why We Exist Collaborating to create higher standards. • With our 250+ resources, we provide the first-hand access you need to increase the likelihood that your products meet regulatory requirements. • When lab testing is standardized, health care providers receive more accurate results. • Standardization helps improve laboratory testing worldwide. The Highest Standards for Global Health Care 10
What We Offer 250+ Standards and Companion Products. Specialty Areas: • Automation and Informatics • Newborn Screening • Clinical Chemistry and Toxicology • Point-of-Care Testing • Quality Management Systems and General Practices • Veterinary Medicine • Hematology • Immunology and Ligand Assay • Method Evaluation • Microbiology • Molecular Methods The Highest Standards for Global Health Care 11
Why Join? Our members get better results. For companies in the diagnostics and pharmaceutical fields, the time and cost involved in overcoming regulatory hurdles can greatly delay or even end the chance to get important innovations into practice. CLSI membership allows your industry organization or large commercial laboratory to collaborate with regulators, peers, and customers on developing and implementing standards that are widely recognized to facilitate regulatory review for IVD devices, tests, and other diagnostic products. The Highest Standards for Global Health Care 12
Why Get Involved? Have a seat at the table. Become a volunteer. • You can directly impact the standards used each day to improve patient care worldwide. • Collaborate with industry influencers, government representatives, and laboratory experts to shape standards used to improve the quality of test results, obtain and maintain laboratory accreditation, and meet regulatory requirements. • Contribute your first-hand insights to help improve quality by creating standards that are relevant, timely, and efficiently implemented. • Advance your career, receive recognition, and stand out as a thought leader among your peers. • Have an active voice, and a visible and influential role in shaping the standards that impact patient care. The Highest Standards for Global Health Care 13
Industry Member Benefits All members receive: • Discounts and additional access to products for their organization. • Recognition alongside many of the top health care organizations and industry leaders in the world. • Access to volunteer opportunities to help create standards. • Invaluable networking opportunities and exclusive career advantages. • A seat at the table to vote on our standards. The Highest Standards for Global Health Care 14
Bronze Level III $3, 500 per year Starter access for one site in your organization. • 50% discount on products and programs. • Access to CLSI’s full library of documents for one user. The Highest Standards for Global Health Care 15
Silver Level II $11, 000 per year High-level access for one site in your organization • Access to e. CLIPSE, CLSI’s online library of documents, for two concurrent users. • 60% discount on products and programs. • Free shipping within the US. The Highest Standards for Global Health Care 16
Gold Level I $27, 500 per year Premium access for all sites in your organization • Access to e. CLIPSE, CLSI’s online library of documents, for all of your employees. • 70% discount on products and programs. • Free shipping within the US. • Benefits extend to all sites. The Highest Standards for Global Health Care 17
Membership In Action Membership dues support the creation of standards and their implementation—improving patient care worldwide. Membership dues support: • Document development—allowing us to bring together experts in the field to create the highest standards. • Neutral standards—ensuring a consensus-based process where no one voice is represented above another. • A collaborative forum—where laboratory professionals can come together to address the needs of the ever-changing laboratory landscape. The Highest Standards for Global Health Care 18
Summary CLSI is a standards development organization with 250+ standards and related products. The Highest Standards for Global Health Care We are a global organization that provides consensus based medical laboratory standards built around a balance of professional, industry, and government expertise. We offer membership and volunteering opportunities to help set the standard in laboratory medicine for a healthier world. 19
Represent your organization’s voice in creating standards that influence regulatory requirements. Follow us on social media: @CLSI_Lab. News Join today at: clsi. org/industry-membership. For membership inquiries: membership@clsi. org 20
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