CLSI Annual Report - FY2022

Learn more about CLSI's fiscal year 2022 with our Annual Report.

Setting Global Standards

for a Healthier World

2022 Annual Report


Setting the standard in laboratory medicine for a healthier world.

A Message From the CEO Barb Jones, PhD Chief Executive Officer, CLSI


Develop clinical and laboratory practices and promote their use worldwide.

“Our patients’ treatment is a journey - not a destination!” I heard those words spoken by a legendary physician when I was 22 years old—and they have remained perhaps the defining principle of my 30-year career, prompting me to make a positive impact on the patient experience whenever and wherever I could. When I was presented in May with the privilege of leading CLSI, I knew I had finally found a way to profoundly affect the experience of every single patient on the planet. Regardless of treatment path, every patient’s journey begins with the same critical first step: the diagnosis. Over the course of CLSI’s last fiscal year, our volunteer experts and staff have meaningfully touched the lives of countless patients and their families. Whether it’s the development of vital clinical laboratory and point-of-care testing standards and guidelines, or the delivery of rigorous education, training courses, and webinars—our work ensures the integrity and reliability of the tests that inform the diagnosis. With our help, every patient begins their journey knowing their path has been built on the strongest of foundations. We are proud to release our 2022 Annual Report, which provides an overview of this work, as well as the organization’s significant accomplishments over the last fiscal year. With the strides we’ve made in areas like document development, membership renewal and expansion, grant funding, and educational programs, CLSI has continued to set the standard for excellence—literally—in the global medical laboratory community. And we’re only getting started. Looking ahead to 2023, CLSI remains focused on its mission to develop and implement the highest quality laboratory standards and guidelines around the world. We’ll be keeping our eyes on the dynamic changes in our industry brought about by a global pandemic and will continue shaping our processes to respond more quickly to the needs of our communities around the world. While we remain expansive in our reach, we will always be focused on the needs of each individual patient. It has been a privilege to do this work together. With our collective expertise, knowledge, and great compassion, we will continue to set the standard in laboratory medicine for a healthier world, one patient at time.


CLSI is the leading global non-profit laboratory medicine standards development organization, with over 24,000 individuals with membership access, 2,000 volunteers, and 250 products. CLSI standards are recognized by laboratories, accreditors, and government agencies worldwide as the best way to improve medical laboratory testing. Organizations use CLSI standards to improve their testing outcomes, maintain accreditation, bring products to market faster, and navigate regulatory hurdles. superior quality. Responsiveness We proactively identify and respond to the needs of our stakeholders in an open and timely manner. Integrity We act ethically and with fairness, trust, respect, and openness. Teamwork We are committed to effective collaboration among members, volunteers, staff, and other partners. Inclusiveness We include the viewpoints of industry, government, and the health care professions in a consensus-driven process. Excellence We continuously improve upon our tradition of technical excellence and


Barb Jones, PhD

CLSI in 2022

The Global Leader in Setting Clinical Laboratory Standards CLSI is a not-for-profit organization that develops laboratory standards worldwide. Our standards are recognized by laboratories, accreditors, and government agencies as the best way to improve medical laboratory testing.

CLSI brings together the worldwide laboratory community to advance a common cause.


Health Care: • Hospitals

• Public Health Organizations • Governments • Accreditors

• Health Care Providers • Medical Laboratories

24,000+ Individuals With Membership Access

250+ Products, standards, and guidelines

75+ Countries with CLSI members

Industry/Manufacturers: • Medical Devices • Pharmaceutical Microbiology • In Vitro Diagnostics

Our specialty areas include:

Automation and Informatics


Clinical Chemistry and Toxicology

Molecular Methods

CLSI & ISO CLSI serves as the American National Standards Institute (ANSI)-appointed Secretariat for the International Organization for Standardization (ISO) Technical Committee 212 (ISO/TC 212), Clinical

General Laboratory/Preexamination

Newborn Screening


Point-of-Care Testing

laboratory testing and in vitro diagnostic test systems. ISO/TC 212 is responsible for international standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems.

Immunology and Ligand Assay

Quality Management Systems

Method Evaluation

Veterinary Medicine

President’s Update Victor Waddell, PhD President, CLSI Bureau Chief, Arizona State Public Health Laboratory


2022 Board of Directors Composed of a balanced representation from government, industry, and the health care professions, the CLSI Board of Directors is dedicated to maintaining the integrity of the voluntary consensus process, promoting quality medical testing and health care services, and fulfilling the CLSI mission.

As I reflect on CLSI’s 2022 fiscal year, it’s hard to not mention one word—transition. When the fiscal year kicked off, the Omicron variant of the SARS-CoV-2 virus was sweeping the world. Then, as the fiscal year came to a close in June, we held our first ever hybrid meeting—a transition to a new way of gathering. CLSI has also gone through a leadership transition this year. Glen Fine retired from his role as CLSI’s CEO after 17 years. Under Glen’s leadership, CLSI dramatically increased its global relevance and significantly improved the quality of laboratory medicine for laboratorians and patients around the world. Glen’s dedication and commitment has made CLSI a highly respected organization globally. However, as they say, with great change comes great opportunity. At the end of this fiscal year, CLSI ushered in a new era under the leadership of Barb Jones, PhD. Barb is well positioned to build on our mission and lead CLSI successfully into the future. She has an excellent track record of success as a consensus builder, with leadership experience in government, industry, and health care. I look forward to working with her to continue to move CLSI forward. During the 2022 fiscal year, membership remained a strong contributor to our mission. Over 24,000 individuals from 75 different countries have access to CLSI standards and products through their memberships. Our members not only support document development in the short term, but their membership ensures that CLSI has the means and infrastructure for standards development in the future. Our standards development and promotional efforts continued to drive our mission— last year CLSI published more than 25 standards and related products. In addition, more than 10,000 people participated in expert-led webinars and online learning courses. Working together with our CLSI volunteer experts, CLSI staff are supporting 96 products currently in development, fulfilling our mission to develop critical standards for the medical laboratory community. In addition to these development efforts, CLSI worked to successfully promote standards and laboratory quality worldwide, with programs in Tanzania, Zambia, Zimbabwe, and the Caribbean, and has recently been designated a non-state actor by WHO’s Pan-Americas Region. This designation allows us to bring our mission to Latin America as never before. Given all that we have accomplished in fiscal year 2022, The Board of Directors and I are excited for the year ahead and will be working closely with Barb and her leadership team to secure the legacy of CLSI for generations to come.


Victor Waddell, PhD President Arizona State Public Health Laboratory James H. Nichols, PhD, DABCC, FAACC President-Elect Vanderbilt University School of Medicine

Joseph Passarelli Secretary Roche Diagnostics

Carl D. Mottram Immediate Past President Independent Consultant Barb Jones, PhD Chief Executive Officer CLSI

Rick Panning, MBA, MLS(ASCP) CM Treasurer ARUP Laboratories


Leonthena R. Carrington, MBA, MT(ASCP) FDA Center for Devices and Radiological Health

Gary W. Procop, MD, MS American Board of Pathology

Dennis J. Ernst, MT(ASCP) Independent Consultant

Andrew Quintenz Bio-Rad Laboratories, Inc.

Collette Fitzgerald, PhD Centers for Disease Control and Prevention

Susan Sharp, PhD, D(ABMM), F(AMM) Copan Diagnostics, Inc. Paula M. Snippes Vagnone, MT(ASCP) Minnesota Department of Health

Randall T. Hayden, MD St. Jude Children’s Research Hospital

Loralie J. Langman, PhD, DABCC, FACB, F-ABFT Mayo Clinic

Barbara L. Zimmer, PhD Beckman Coulter, Inc.

Tania Motschman, MS, MT(ASCP)SBB Independent Consultant

2022 Award Winners

Excellence in Standards Development Award This award is given to the volunteer(s) who make significant contributions in developing and/or managing one or more consensus standard, guideline, or other work product. Such an individual (or group) is dedicated and committed to CLSI consensus development, and an enthusiastic participant.

Russell J. Eilers Memorial Award CLSI’s highest award is the Russell J. Eilers Memorial Award. One award is given annually to a volunteer or group of volunteers selected by the CLSI President as having made exceptional contributions to CLSI’s success over extended periods of time.

Virginia R. Fajt, DVM, PhD, DACVCP Dr. Fajt led the multi-year effort to develop the CLSI document VET09, Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings, 1st Edition. She then recruited a team of veterinarians, pharmacologists, epidemiologists, and microbiologists to contribute to the document. Dr. Fajt is a veterinarian and clinical pharmacologist who has been active in CLSI through the Veterinary Antimicrobial Susceptibility Testing Subcommittee (VAST) as an observer, advisor, and previous voting member.

Paula Ladwig, MS, MT(ASCP) Ms. Ladwig’s has used her strong leadership and organizational skills to help manage the completion of evaluation protocol documents. In addition, she has expressed the need for mentorship for new evaluation protocol volunteers, and has stepped up as a mentor herself. Recently, on her recommendation, the Consensus Council approved expansion of this important committee to enable more efficient management of the document library.

Barbara L. Zimmer, PhD Dr. Zimmer has served as an appointed voting member and an appointed advisor to the CLSI AST Subcommittee representing industry, and has participated in many working groups. In addition, Dr. Zimmer was appointed by CLSI to serve as a delegate to the CEN/ISO/TC WG 212-4 for Antimicrobial Susceptibility Testing and remained on this committee from 2004–2012. She participated in ISO 20776-1 and 20776-2 Working Groups, and also served as Chair of the Writing Group for Standardization of Mueller-Hinton Medium, ISO/CD 16782.

Nancy L. Anderson, MMSc, MT(ASCP) Nancy Anderson’s sustained and meaningful contributions to CLSI standards development span more than 20 years. Through her tenure at the US Centers for Disease Control and Prevention (CDC), she has been a steady guiding advocate for the full breadth of laboratory best practices. Ms. Anderson has held positions at the CDC Division of Laboratory Systems, The Clinical Laboratory Improvement Advisory Committee (CLIAC), and inter-governmental agencies.

John V. Bergen Excellence Award The John V. Bergen Excellence Award is presented annually to an outstanding volunteer or group of volunteers in recognition of advances in CLSI organizational directives and objectives, through unique and significant contributions.

Barbara Zehnbauer, PhD, FACB, FACMG Dr. Barbara Zehnbauer’s clinical laboratory career spans over three decades, most notably in the field of molecular diagnostics testing, oncology, and human genetics and genomics. She has been active with CLSI for over 14 years, playing a significant role in the development of the organization’s molecular diagnostics documents through her involvement with the Expert Panel on Molecular Diagnostics, the former Consensus Committee on Molecular Methods, and various document development committees.

Excellence in Member Organization Leadership This award is presented to the member organization that offers exemplary support to CLSI and its mission to maintain leadership in the domain of document development.

University of Washington Medical Center Mayo Clinic Health System

Membership Highlights

Sustaining and top-level industry member organizations provide a significant commitment to CLSI. The generous support of our members helps CLSI develop consensus documents that address critical issues of quality in medical and health care testing.. CLSI acknowledges these sustaining and top- level industry members for their high level of support not only through membership dues, but also

the contributions their volunteers provide to the organization. CLSI is grateful for the following organizations’ generous support:


Individuals With Membership Access From 75+ Different Countries

45+ Government Members

96 Health Systems

400+ Individual Members

100+ Industry Organizational Members

Level I Industry Members CLSI is grateful for the following organizations’ generous support as Level I Industry Members:

Abbott Services LLC ARUP Laboratories BD Beckman Coulter Bio-Rad Laboratories, Inc. BioMérieux, Inc. Cepheid Data Innovations LLC Illumina, Inc. Laboratory Corporation of America Medical & Biological Laboratories Co., Ltd. Ortho-Clinical Diagnostics, Inc.

PerkinElmer, Inc. Pfizer Inc. Radiometer Medical ApS Roche Diagnostics Siemens Healthcare Diagnostics, Inc. Sonic Healthcare USA Sysmex America, Inc. Sysmex Corporation - Japan Thermo Fisher Scientific Veracyte, Inc. Werfen YunKang Group of Sun Yat-sen University

1,200+ Hospital and Independent Laboratory Members 15,000+ Documents Accessed by Members through eCLIPSE Ultimate Access™

I use CLSI documents to ensure our lab performs at the highest standard and engages in good standard practices. As a member, I enjoy providing input on the development of new documents. — Sean Dill, Highline Labs ”

Health Systems Health System Members are empowered with access to CLSI’s most up-to-date, globally recognized standards, allowing organizations to implement the highest-quality care across their organization.

Volunteering Highlights

I was fortunate to be included as a volunteer, which has allowed me to expand my network connections of respected laboratory peers for additional growth of not only my own institution, but to help improve quality for all laboratory professionals. — Kyle Nevins, Northwell Health ”

1,400+ Volunteers

1844 Sites Covered by Health System Membership 244 Organizations have merged and upgraded to health system membership.

96 Health Systems

97,000+ Hours Spent by CLSI Volunteers to Create Standards 431 Volunteer Applicants in FY2022 93 New Volunteers in FY2022

7868 Individuals Covered by Health System Membership

Susceptibility Testing Meetings Winter Virtual Meetings 260 Attendees Summer Hybrid Meetings

93 In-person Attendees 198 Virtual Attendees

"For over fifteen years, laboratories globally have used CLSI standards and guidelines to achieve and maintain international accreditation aligned to ISO 15189 and ISO 17025 standards. Accreditation builds customer confidence, facilitates trusted diagnostic test results, and reduces errors. If a laboratory is accredited, patients receive trusted care as clinicians manage patients based on accurate, timely, and reliable results." –Patrick Mateta, DHA, CQA (ASQ) Vice President, Global Health Partnerships, CLSI

Global Health Partnerships Highlights

Our Partnerships Program: Global Laboratory Standards

7 Labs Newly Accredited or Recommended for Accreditation

for a Healthier World Currently Working In: Barbados Guyana Jamaica Tanzania Trinidad & Tobago Zambia Zimbabwe

11 In-Person Trainings Held

237 Live Participants Trained

13 Virtual Trainings Held

330 Virtual Participants Trained

6 Workshops Held

124 Participants From 30+ Countries Trained

New collaborations: •Center for Integrated Health Programs (Nigeria)

•Foundation Quality India •Georgetown University •Pan American Health Organization (PAHO) Non-State Actor

The Impact of GHP

Standards Development Highlights

FY2022 Documents Published

CLSI mentors returned for one week to evaluate progress of laboratories in Tanzania. They reviewed their action plans from previous gap assessments and provided additional mentorship and training where gaps persisted. Laboratories have been working hard between the mentor visits to address the gaps identified, and many are on track to submit applications for international accreditation in the upcoming months.

Aug. 2021






Sept. 2021

CLSI congratulated 23 laboratories in Tanzania that have been recommended for accreditation aligned with ISO 15189:2012. These laboratories are among the laboratories the CLSI mentors started working with in early 2020.

12 Standards, Guidelines, and Supplements Published



Laboratories in Zambia that recently underwent a periodic assessment by the accreditation body continue to work hard to maintain their accreditation aligned with ISO 15189. A few of the laboratories have expanded their scopes of accreditation to include SARS-CoV-2 testing and other technical areas.

Nov. 2021

13 Derivative Products Published

Molecular Diagnostics Microbiology

Method Evaluation


Quality Management Systems Chemistry

Newborn Screening

16 Standards, Guidelines, and Supplements Authorized

CLSI recognized the 25 laboratories that received CLSI mentorship and were recommended for accreditation aligned with ISO 15189 in 2021 and the 15 laboratories that have submitted or are preparing to submit applications to the accreditation body. GHP mentors worked together with Tanzanian mentors to support QMS implementation in 22 laboratories that were added to the accreditation preparatory program. In addition, mentors provided ISO 17043 QMS implementation support to laboratories in Tanzania that provide proficiency testing panels.

Jan. 2022

FY2022 Documents Authorized

96 Products in Development

Another laboratory in Zambia has been accredited. Together with our Zambian colleagues in the Ministry of Health, CDC, and CIDRZ LIFE, CLSI congratulates the Levy Mwanawasa University Teaching Hospital Laboratory in Zambia on its achievement of international accreditation aligned with the ISO 15189 standard for medical laboratories. Over the last several years, CLSI mentors have been working together with the laboratory team to establish and strengthen the laboratory’s quality management system.

9863 Individuals Participated in Webinars

Apr. 2022

2047 Individuals Participated in Online Learning Courses

The CLSI team continued its support of capacity building efforts in the Caribbean Region through the facilitation of a virtual training workshop on Laboratory Measurement Uncertainty to provide laboratory management and staff with the essential knowledge and skills to comply with the requirements of the ISO 15189:2012 standard. CLSI worked in partnership with the CDC-Caribbean and Global Laboratory & Epidemiology Systems Strengthening Network (GLESSN) to deliver this training, along with trainings in the areas of Laboratory Risk Management & Quality Control and Laboratory Quality Control & Method Evaluation–Molecular COVID-19 PCR Testing.

Jun. 2022

Product Highlights

Gap Analysis Tool CLSI’s new Gap Analysis Tool can help personnel quickly and easily assess whether their laboratory is in compliance with QMS requirements and can track progress toward achieving complete compliance.

Method Navigator CLSI’s new Method Navigator subscription pulls together specific guidance from CLSI documents that will help laboratories fulfill FDA, CLIA, ISO, and other requirements, quickly and easily. Learn to identify, understand, and meet requirements and gain guidance to help document your efforts. Applicable to any test developer, including manufacturers, laboratories, research labs, and manufacturers of medical devices for humans.

Where to?

Meeting regulatory requirements

Guidance This Way Identify, understand, and meet regulatory requirements with CLSI’s new resource, Method Navigator.

Implementation Guides Our new Implementation Guides are intended for laboratory scientists to learn how to use CLSI’s Evaluation Protocol Standards. Customers can properly implement our EP standards ensuring quality test results, regulatory requirement readiness, and preparedness for accreditation.

Improving Participation

User Verification of Precision Implementation Guide

Implementation Guide EP15-Ed3-IG1

A New Way to Vote and Comment This year we introduced a new voting and commenting platform for volunteers. This new system allows users to make edits directly within the document and collaborate to vote on documents, streamlining the development process and speeding up the voting and commenting process for volunteers.

Evaluation of Detection Capability Implementation Guide Implementation Guide EP17-Ed2-IG

User Verification of Bias (Trueness) Implementation Guide Implementation Guide EP15-Ed3-IG2

Introduction This implementation guide describes the minimum procedures necessary for a medical laboratory to verify a manufacturer’s or laboratory-developed test’s precision claims. For additional information on verifying precision, see CLSI document EP15. 1 NOTE: The study described in this implementation guide for verifying precision can also be used to estimate bias (trueness). See CLSI document EP15-Ed3-IG2. 2 IMPORTANT NOTE: The study described in CLSI document EP15 1 is not intended for use by a test developer to establish precision for a new commercial or laboratory-developed test. Instead, test developers should use CLSI document EP05 3 for guidance on establishing or validating precision. Laboratories and commercial manufacturers are collectively referred to as “developers” in this implementation guide. Accuracy: A Combination of Precision and Bias It is important that measurement procedures provide accurate results. In order to do so, they must both be precise and have low bias as shown in the figure below.

Introduction This implementation guide describes the minimum procedures necessary for a medical laboratory to verify that a measurement procedure’s detection capability is consistent with the claims established by the developer. Detection capability includes (as shown in the figure below): • Upper boundary on blank sample measurements (ie, limit of blank [LoB]) • “Yes/no” detection of measurand presence (ie, limit of detection [LoD]) • Minimum amount of measurand that can be quantitated reliably with respect to a defined accuracy goal (ie, limit of quantitation [LoQ]) These values are especially critical to detecting extremely small amounts of a measurand. It is always the case that LoB < LoD ≤ LoQ. Knowledge of the detection capability helps determine the lower limit of the measuring interval, which is the lowest measurand concentration at which all defined performance characteristics of the measurement procedure are met (eg, acceptable bias, imprecision, linearity). Each measurement procedure also has an upper limit of quantitation, but determining this value is not within the scope of CLSI document EP17. 1

Introduction This implementation guide describes the minimum procedures necessary for a medical laboratory to estimate bias (trueness) of a laboratory measurement procedure. For additional information on estimating bias, see CLSI document EP15. 1 NOTE: The study described in this implementation guide uses the data and statistics generated from the precision study described in CLSI document EP15. 1 The instructions provided in CLSI document EP15-Ed3-IG1 2 should be used for running the precision study. IMPORTANT NOTE: The study described in CLSI document EP15 1 is not intended for use by a test developer to establish or validate bias claims for a new commercial or laboratory-developed test. Instead, test developers should use CLSI document EP09 3 for guidance on establishing bias claims. Laboratories and commercial manufacturers are collectively referred to as “developers” in this implementation guide. Accuracy: A Combination of Precision and Bias It is important that measurement procedures provide accurate results. In order to do so, they must both be precise and have low bias as shown in the figure below.

Risk Management Techniques to Identify and Control Laboratory Error Sources Implementation Guide Implementation Guide EP18-Ed2-IG

Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures Implementation Guide


Introduction This implementation guide describes the minimum procedures necessary for a medical laboratory to determine total analytical error (TAE) for quantitative measurement procedures. For additional information on evaluating TAE, see CLSI document EP21. 1 Several terms and abbreviations used in this implementation guide—and other CLSI documents—deserve careful attention and understanding because of their similarity and the way in which they are represented in other sources. They include: • Total analytical error (TAE): a measured and calculated quantity that includes errors associated with the examination (analytical) phase of testing. • Allowable total error (ATE): an error goal set by the laboratory. In other publications, ATE might be abbreviated as TEa (ie, total error allowable). • Total error (TE): includes errors from preexamination, examination, and postexamination sources. NOTE: Laboratories and commercial manufacturers are collectively referred to as “developers” in this implementation guide. What Is Total Analytical Error? TAE is an estimate of error in the results for patient samples, including imprecision, bias, nonlinearity, interferences, matrix differences, and other sources of analytical testing error. TAE can be measured over the entire analytical measuring interval (AMI) or at specific subintervals. The TAE calculation is compared with user-selected limits based on clinical need. Knowledge of the TAE is important when the laboratory is deciding whether differences in results for a patient are meaningful, as well as in answering the questions “How accurate are these results?” or “Does the measurement procedure meet clinical performance needs?” Accuracy: A Combination of Precision, Bias, and Other Sources of Error It is important that measurement procedures provide accurate results. In order to do so, they must both be precise and have low bias as shown in the figure below. Less bias, more precise

Introduction This implementation guide describes the minimum procedures necessary for a medical laboratory to identify and control laboratory error sources using risk management techniques. These instructions focus on the failure modes and effects analysis (FMEA) technique. Other options are included in CLSI documents EP18 1 and EP23™. 2 IMPORTANT NOTE: This implementation guide is not intended for use by a test developer to determine error sources for a new commercial or laboratory-developed test. Instead, test developers should use CLSI document EP18 1 for guidance on determining error sources. Laboratories and commercial manufacturers are collectively referred to as “developers” in this implementation guide. Overview of the Risk Management Process Diagnostic devices are extremely diverse in their technology, design, and function. Every test system is subject to hazards or hazardous situations during the preexamination, examination, and postexamination testing stages. The relative importance and likelihood of these failures vary with the device, the sample, the user, and the environment. In addition, a high level of variability exists in terms of skill and knowledge level among end users. The number of potential and observed failures can be large, making it important to prioritize efforts to reduce risk. Some failures are almost certain to cause patient harm, whereas a result that must be repeated but is not time sensitive only raises cost. With the classification of severity of harm and probability (or frequency) of occurrence, the importance of failures can be prioritized. The risk management process can help identify possible failures, their severity, and the likelihood they will occur. With this information, their importance can be prioritized, and measures to reduce the risk can be implemented. The risk management process asks the following questions: ULoQ N



Reportable Interval

Analytical Measuring Interval

Less bias, more precise

More bias, more precise

Less bias, less precise

Leveraging Volunteer Profiles We have continued to use CLSI Exchange’s volunteer pool, with 850 individuals updating their volunteer profiles. This helps us find qualified individuals for volunteer positions.

Sharing Useful Data Expert Panels now have dashboards built into CLSI Exchange that surface data relevant to their technical area, helping them make more informed decisions for the future of CLSI.


While CLSI document EP15 1 contains instructions for studying both precision and bias, this implementation guide focuses only on precision. CLSI document EP15-Ed3-IG2 2 focuses on bias.

Abbreviations: LoB, limit of blank; LoD, limit of detection; LoQ, limit of quantitation; ULoQ, upper limit of quantitation.

More bias, more precise

Less bias, less precise

NOTE: For additional information, see CLSI document EP17. 1 IMPORTANT NOTE: The study outlined in this implementation guide is not intended for use by a test developer to establish or validate detection capability for a new commercial or laboratory-developed test. Instead, test developers should use CLSI document EP17 1 for guidance on establishing or validating detection capability. Laboratories and commercial manufacturers are collectively referred to as “developers” in this implementation guide.

New Online Courses High precision (low coefficient of variation expressed as a percentage [% CV]) means that when a sample is run repeatedly, the results are very close to each other. Precision can be broken into various components. When the precision of a single run is considered, it is called “within-run precision.” “Repeatability” is measured when all components are held essentially the same (single run, operator, lot, calibration, etc.). “Reproducibility” is measured when all components are varied (multiple runs, days, operators, lots, etc.).

While CLSI document EP15 1 contains instructions for studying both precision and bias, this implementation guide focuses only on bias. CLSI document EP15-Ed3-IG1 2 focuses on precision. Having low or no bias means that when a sample is run, its results are very close to the true value (actual concentration or activity) for the sample.

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1 2.7 %

Education and other


Marketing and membership

Financial Highlights

1 4.7 %

Standards and guidelines

The Statement of Financial Position at the close of fiscal year 2022 indicated that CLSI had total assets of $16.6 million. The majority of those assets were in investments. CLSI’s largest liabilities were deferred membership dues and subscriptions of approximately $2.2 million. Deferred membership dues and subscriptions will be earned and recognized as revenue over the upcoming year. CLSI’s unrestricted net assets, also known as the organization’s reserves, were $13.3 million in, of which $12 million represent liquid reserves with horizons less than one year. CLSI’s operations generated $1.3 million in income during FY2022, but investment losses caused net assets to decrease by $372 thousand for the year. The change in net assets represented approximately $11 million in revenues, $10 million in expenses, and $1.7 million in investment losses. CLSI has three primary revenue streams: sales of standards, membership dues, and grants revenue. CLSI’s primary expense categories are: standards and product development, global health partnerships, marketing, information technology, and general and administrative.


Management and general


Standards and product development

Membership dues



4 0.6 %

Global health program

Grants and contracts Email: Phone: +1.610.688.0100 | Toll Free (US): +1.877.447.1888

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