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  • Contains 3 Component(s), Includes Credits Includes a Live Web Event on 05/04/2023 at 2:00 PM (EDT)

    Current methods for AST of Mycobacterium tuberculosis complex (MTBC), as well as new and evolving standards for non-tuberculous Mycobacterium spp. will be discussed.

    Susceptibility testing of mycobacteria will be discussed in this upcoming webinar. Speakers will: 

    • Discuss current methods for phenotypic and genotypic antimicrobial susceptibility testing (AST) of Mycobacterium tuberculosis complex (MTBC).
    • Review new and evolving standards for non-tuberculous Mycobacterium spp.
    • Evaluate updated guidance from the forthcoming CLSI Standard M24.
    • Review recent changes that impact AST for MTBC.


    ​Barbara A. Brown-Elliott MS, MT(ASCP), SM

    Professor of Microbiology and Associate Director of the Mycobacteria/Nocardia Laboratory at the University of Texas Health Science Center at Tyler (UTHSCT)

    University of Texas Health Science Center at Tyler (UTHSCT)

    Barbara A. Brown-Elliott MS, MT(ASCP), SM is currently a Professor of Microbiology and Associate Director of the Mycobacteria/Nocardia Laboratory at the University of Texas Health Science Center at Tyler (UTHSCT). She has supervised the UTHSCT laboratory since 1988. Before coming to the UTHSCT, she served as a clinical microbiology supervisor, a consultant for a clinical microbiology reference laboratory, and a microbiology Adjunct Professor in medical technology. She is the author and/or co-author of more than 300 peer-reviewed articles and chapters on nontuberculous mycobacteria (NTM), Nocardia and other aerobic actinomycetes, with over 100 publications on antimicrobial susceptibility testing and resistance mechanisms. She has been a member of the American Society for Microbiology (ASM) since 1978 and is a frequent speaker at local, national, and international meetings. She is a member of the Clinical and Laboratory Standards Institute (CLSI) Antimycobacterial Susceptibility Subcommittee (Currently revised as the Antimycobacterial Susceptibility Working Group). She is a 2009 recipient of the Becton Dickinson Gardner Middlebrook Award for Outstanding Work in Mycobacteriology, the ASM Scherago-Rubin Award for outstanding clinical microbiologist in 2013, and an ASM Distinguished Lecturer from 2019-2020. 

    Marie-Claire Rowlinson, PhD, D(ABMM)

    Chief of Bacterial Diseases at the Wadsworth Center, New York State Department of Health

    Wadsworth Center, New York State Department of Health

    Dr. Marie-Claire Rowlinson received her undergraduate and doctoral degrees in Medical Microbiology in the UK and then completed a post-doctoral fellowship in Medical and Public Health Laboratory Microbiology at University of California, Los Angeles. Following the fellowship, Dr. Rowlinson worked with the Association of Public Health Laboratories (APHL) in their Global Health program, building laboratory capacity in Eastern Europe, Africa, and the Caribbean. From 2012 to 2021, she held the position of Assistant Laboratory Director and CLIA Laboratory Director at the Florida Department of Health, Bureau of Public Health Laboratories in Jacksonville. Since September 2021, Dr. Rowlinson is the Chief of Bacterial Diseases at the Wadsworth Center, New York State Department of Health. Dr. Rowlinson’s expertise is in infectious disease diagnostics, in particular molecular diagnostics, tuberculosis, and global health. She continues to work closely with the Association of Public Health Laboratories and is the Chair of the APHL Infectious Diseases Committee and a Member of the TB Subcommittee. She also continues to work with APHL on an international level, consulting with the Global Health program, most recently working with the Ukraine Ministry of Health. Dr. Rowlinson is a Member of the College of American Pathologists Microbiology Committee.

    ​Romney Humphries, PhD D(ABMM) (Moderator)

    Director of Infectious Diseases Laboratories and Director of the Division of Laboratory Medicine, Vanderbilt University Medical Center

    Vanderbilt University Medical Center

    Romney Humphries, PhD D(ABMM) is a Professor in the Department of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, where she is the Director of Infectious Diseases Laboratories and the Director of the Division of Laboratory Medicine.

    Romney received her PhD in bacteriology from the University of Calgary, Canada and a clinical and public health microbiology CPEP fellowship at UCLA.

    She worked at UCLA as an assistant professor in Pathology and laboratory medicine from 2010–2017 and was the section chief for clinical microbiology from 2012–2017. She then took on the role of Chief Scientific Officer at Accelerate Diagnostics from 2017–2020 before returning to academia in 2020, at VUMC.

    Dr. Humphries is passionate about clinical microbiology and antimicrobial resistance in particular. She is a champion for the development of novel diagnostic tests for infectious diseases to transform how patients with infections are managed.

    Dr. Humphries is an editor for the Journal of Clinical Microbiology and Clinical Infectious Diseases. She is a member of the Clinical and Laboratory Standards Institute (CLSI) Antibiotic Susceptibility Testing (AST) Subcommittee, the College of American Pathologists (CAP) Microbiology Committee, the American Society for Microbiology (ASM) Professional Practices Committee, and vice-chair of the Infectious Diseases Society of America Diagnostics Committee.

    She is the author of over 150 peer-reviewed articles, numerous book chapters, and has lectured globally on the topics of antimicrobial resistance and diagnostic microbiology. Dr. Humphries is the 2022 ASM awardee for Leadership and Research in Clinical Microbiology. She is a fellow of the American Academy of Microbiology, and the Infectious Diseases Society of America.


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      • Non-member - $30
      • Individual Student - $30
      • Individual Associate - $30
      • Individual Full Member - $30
      • Industry Level III - $30
      • Industry Level II - $30
      • Industry Level I - $30
      • HCPGOV Level III - $30
      • HCPGOV Level II - $30
      • HCPGOV Level I - $30
      • Health System - $30
      • CLSI Staff - Free!
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  • Contains 3 Component(s), Includes Credits

    Learn about improving antimicrobial stewardship with new approaches in thoughtful antimicrobial reporting. Speakers: Nicole Scangarella-Oman, MS April M. Bobenchik, PhD, D(ABMM), MT(ASCP) Patricia (Trish) Simner, PhD, D(ABMM) Nathan P. Wiederhold, PharmD Stephen Cole, VMD, MS, DACVM

    Learn about improving antimicrobial stewardship with new approaches in thoughtful antimicrobial reporting.

    By participating in this program, you will learn about: 

    • The changes in the 33rd edition of M100, including those to Tables 1. 
    • Tables/information with CLSI Antifungal Susceptibility documents similar to Table 1 in M100.
    • The work of the Antifungal Susceptibility Testing subcommittee WG on intrinsic resistance with examples of intrinsic antifungal resistance.
    • Examples where definition of intrinsic resistance is not met but antifungal susceptibility testing is still not recommended.
    • Selecting antimicrobials to test and report for veterinary specimens.
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      • Non-member - Free!
      • Individual Student - Free!
      • Individual Associate - Free!
      • Individual Full Member - Free!
      • Industry Level III - Free!
      • Industry Level II - Free!
      • Industry Level I - Free!
      • HCPGOV Level III - Free!
      • HCPGOV Level II - Free!
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 2 Component(s), Includes Credits

    CLSI 2023 AST Webinar: M100-Ed33 Updates

    Presented on April 6, 2023

    Moderator:
    Janet Hindler, MCLS, MT(ASCP), F(AAM), Consultant, Clinical Microbiology, Los Angeles, CA

    Speakers:
    Romney M. Humphries, PhD, D(ABMM), Medical Director, Clinical Microbiology and Professor, Vanderbilt University Medical Center, Nashville, TN
    April M. Bobenchik, PhD, D(ABMM), MT(ASCP), Medical Director Microbiology, Associate Professor Pathology & Laboratory Medicine, Penn State Health, Milton S. Hershey Medical Center, Hershey, PA

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      • Non-member - $99
      • Individual Student - $74.25
      • Individual Associate - $84.15
      • Individual Full Member - $74.25
      • Industry Level III - $49.50
      • Industry Level II - $59.40
      • Industry Level I - Free!
      • HCPGOV Level III - $49.50
      • HCPGOV Level II - $59.40
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 2 Component(s), Includes Credits

    Summary: CLSI 2023 AST Webinar: M100-Ed33 Updates

    Presented on April 5, 2023

    Moderator:
    Janet Hindler, MCLS, MT(ASCP), F(AAM), Consultant, Clinical Microbiology, Los Angeles, CA 

    Speakers: 

    Romney M. Humphries, PhD, D(ABMM), Medical Director, Clinical Microbiology and Professor, Vanderbilt University Medical Center, Nashville, TN

    April M. Bobenchik, PhD, D(ABMM), MT(ASCP), Medical Director Microbiology, Associate Professor Pathology & Laboratory Medicine, Penn State Health, Milton S. Hershey Medical Center, Hershey, PA

    • You must log in to register
      • Non-member - $99
      • Individual Student - $74.25
      • Individual Associate - $84.15
      • Individual Full Member - $74.25
      • Industry Level III - $49.50
      • Industry Level II - $59.40
      • Industry Level I - Free!
      • HCPGOV Level III - $49.50
      • HCPGOV Level II - $59.40
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
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  • Contains 2 Component(s) Recorded On: 11/08/2022

    Helpful information about your CLSI membership will be presented in this Webinar for delegates and alternate delegates.

    Helpful information about your CLSI membership will be presented in this Webinar for active CLSI Delegates and Alternate Delegates, including: 

    • Who CLSI is, how we make a difference, and who our members are.
    • An introduction to our new CEO, Barb Jones, PhD.
    • Your role as a Delegate.
    • A volunteering general overview.
    • A high-level membership benefits review.
    • A step-by-step walkthrough of “My CLSI.”
    • A demo of our online library, eCLIPSE.
    • Accreditation resources.
    • New CLSI documents and products.
    • Upcoming publications and products. 

    Barb Jones, PhD

    CEO, CLSI

    Clinical and Laboratory Standards Institute

    Dr. Barb Jones was appointed as Chief Executive Officer of CLSI on May 15, 2022. She is the third CEO in CLSI's 54-year history. Dr. Jones’ experience includes operations leadership, laboratory management, pharmaceutical and quality standards development, regulatory policy, and business development at both the national and international levels. Prior to her role as CLSI’s CEO, Barb was Senior Vice President, Scientific Operations and Regulatory Affairs at Vyant Bio in San Diego, California.

    In her role as Vice President at the United States Pharmacopeia (USP), Dr. Jones directed the work of more than 200 global scientists and oversaw the “Gold Standard” for reference materials for the US and more than 150 countries worldwide. As a scientist and researcher for the National Institute of Standards and Technology (NIST), she served as Science Advisor for the Biochemical Sciences Division, and was appointed by the NIST Director as Advisor to the US House of Representatives Committee on Science and Technology. In this role, she developed analytical techniques for lab-on-a-chip technology and coordinated the expansion of chemical and biological weapons counterterrorism standards for the US Department of Homeland Security.

    Additionally, she has provided critical advisement on the viability of acquisitions and technologies, particularly in pharmaceutical and medical device and diagnostic development. She also has advised international policy makers, key scientists, and business leaders around the world on pharmaceutical standards, laboratory practices, proficiency, and regulatory compliance.

    Dr. Jones received her Doctorate in Analytical Chemistry from Arizona State University and was awarded a prestigious National Research Council postdoctoral fellowship at NIST.

    Katie Barnett

    Director, Membership and User Experience, CLSI

    Clinical and Laboratory Standards Institute

    Katie Barnett is CLSI's Director of Membership and User Experience and has been with CLSI for the past 14 years. She previously held the positions of Membership Director and Manager of Membership and Marketing.

    Jessica (Chumaceiro) Tredway

    Customer Relationship Manager, CLSI

    Clinical and Laboratory Standards Institute

    Jessica Tredway is CLSI's Customer Relationship Manager. Her responsibilities include building, retaining, maintaining, and fostering relationships between CLSI and its stakeholders, including members, customers, volunteers and vendors.

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      • Non-member - Free!
      • Individual Student - Free!
      • Individual Associate - Free!
      • Individual Full Member - Free!
      • Industry Level III - Free!
      • Industry Level II - Free!
      • Industry Level I - Free!
      • HCPGOV Level III - Free!
      • HCPGOV Level II - Free!
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
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  • Contains 3 Component(s), Includes Credits Recorded On: 09/27/2022

    Learn how to use the 4th edition of EP14--Evaluation of Commutability of Processed Samples. EP14 provides guidance for evaluating the commutability of processed samples for determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.

    Using EP14: Evaluation of Commutability of Processed Samples

    September 27, 1:00 PM US Eastern time

    Learn how to use the 4th edition of EP14--Evaluation of Commutability of Processed Samples. EP14 provides guidance for evaluating the commutability of processed samples for determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.

    Learning Objectives:

    • Understanding commutability
    • Determine which type of processed samples may need to be evaluated for commutability
    • How to design the commutability evaluation study, including acceptance criteria
    • Running the study, then reviewing the results to see if data transformations are needed
    • Analyzing the data and evaluating commutability

    Speaker: Jeffrey R. Budd, PhD

    Jeffrey R. Budd, PhD

    Dr. Budd received his PhD in Biometry and Health Information Systems from the University of Minnesota. His entire career has been directed toward improving clinical diagnostics in lung function, cardiac electrophysiology, home health monitoring and finally in vitro diagnostics (IVD). He was Principal Biostatistician at Beckman Coulter for 20 years from which he retired 2 years ago.

    Besides an IVD biostatistical consulting practice, Dr. Budd actively participates in developing IVD international guidelines. This includes membership in the ISO TC212 working group 2 which published 17511 on metrological traceability and the IFCC working group on reference material commutability which published a series of papers on this topic. He also plays active roles in CLSI including as a member of the EP Expert Panel; as chair of the document development committees (DDC) for EP09 on measurement procedure comparison, EP12 on qualitative examinations and EP30 on commutable reference material; and as member of the DDCs for EP14 on processed sample commutability and for EP32 on metrological traceability.


    • You must log in to register
      • Non-member - $30
      • Individual Student - $22.50
      • Individual Associate - $22.50
      • Individual Full Member - $22.50
      • Industry Level III - $15
      • Industry Level II - $12
      • Industry Level I - Free!
      • HCPGOV Level III - $15
      • HCPGOV Level II - $12
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
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  • Contains 2 Component(s) Recorded On: 08/23/2022

    Learn more about how CLSI's new product, Method Navigator, can help you to establish and implement laboratory test methods.

    In this free webinar, you will be able to:

    • Understand the purpose of CLSI's new product, Method Navigator.
    • List the 8 phases of the CLSI Test Life Phases Model.
    • Describe how to use Method Navigator when establishing or implementing a new test method.

    Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE

    Laboratories Made Better!

    Ms. Berte has a bachelor’s degree in Medical Technology and a master’s degree in Health Care Administration. In addition to being an ASCP-certified Medical Technologist, Specialist in Blood Banking, and Diplomate in Laboratory Management, she is also certified as a Quality Manager and Quality Auditor by the American Society for Quality.

    Ms. Berte has been the author of numerous articles, chapters, and books and continues to provide learning programs on various aspects of laboratory quality management. She has volunteered for CLSI for 30 years and has served as chairholder and member of past and current CLSI document development committees and was one of the developers of the Method Navigator product you will see today.


    Tabitha Kern, MS, MLS (ASCP)CM

    CLSI

    Ms. Kern is a director of Standards Development and Project Administration at CLSI and has been apart of the organization for over three years. She has her Master’s degree in Medical Laboratory science and is an ASCP-certified Medical Laboratory Scientist. Prior to CLSI she spent 12 years working in an Immunology and Flow Cytometry medical laboratory. Her project focus has been on documents in Method Evaluation area. Ms. Kern has helped with the development and implementation of this novel product.

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      • Non-member - Free!
      • Individual Student - Free!
      • Individual Associate - Free!
      • Individual Full Member - Free!
      • Industry Level III - Free!
      • Industry Level II - Free!
      • Industry Level I - Free!
      • HCPGOV Level III - Free!
      • HCPGOV Level II - Free!
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
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  • Contains 3 Component(s), Includes Credits

    This comprehensive document covers all aspects for flow cytometry testing from the installation of the instrument to archiving the results. The target audience is anyone who touches a flow cytometer.

    CLSI H62, Validation of Assays Performed by Flow Cytometry

    Recorded on: August 18th, 1:00 PM US Eastern time

    The Clinical and Laboratory Standards Institute (CLSI) recently released the first edition of CLSI H62, Validation of Assays Performed by Flow Cytometry. This comprehensive document covers all aspects for flow cytometry testing from the installation of the instrument to archiving the results.  The target audience is anyone who touches a flow cytometer.

    The objective of this webinar is to provide guidance on how to distill the vast amount of information contained in this 234-page document into practice in the laboratory. Real-life examples of applying the document and practical suggestions will be provided.

    In this webinar, you will learn:

    • How to navigate the document;
    • How to plan an analytical method validation and create an assay validation protocol;
    • How to execute an analytical method validation;
    • How to streamline data analysis and report creation;
    • What to do when you have questions about CLSI H62

    Speakers:

    Dr. Virginia Litwin, PhD
    Charles River Laboratories

    Dr. Nithianandan Selliah, PhD
    Cerba Research

    Dr. Virginia Litwin, PhD

    Charles River Laboratories

    Virginia Litwin is a thought-leader in validation and standardization for flow cytometry. Bringing “Cytometry from Bench-to-Bedside” has been the focus of her professional activities since 1999 when she started working in translational medicine at Bristol-Myers Squibb. 

    She co-founded the Flow Cytometry Community within the AAPS. This group published the first papers on flow cytometry method and instrument validation. She was a councilor for the International Society for the Advancement of Cytometry (ISAC) and the International Clinical Cytometry Society (ICCS). She serves on the ICCS Advocacy Committee whose mission is to interface with regulatory agencies and has been an invited speaker at FDA/NIST on many occasions.

    Virginia is the chair of the Document Development Committee for the CLSI H62. She edited the book, Flow Cytometry in Drug Discovery and Development, as well as journal special issues: JIM- Flow Cytometry Biomarkers and Translational Medicine (2011); Cytometry Part B- Receptor Occupancy (2015); Cytometry Part B- Cytometry Advancing Next Generation Drug Development (2021).

    After obtaining a Ph.D. in Virology/Immunology from the University of Iowa, Virginia joined Lewis Lanier at DNAX as a post-doctoral fellow where she identified the KIR receptor, KIR3DL1 (CD158E1). She has held leadership roles in several contract research organizations. Currently she is a Research Scientist at Charles River Laboratories in Québec, Canada.

    https://www.linkedin.com/in/virginia-litwin-99869511

    https://twitter.com/VirginiaLi...

    Dr. Nithianandan Selliah, PhD

    Global Head of Flow Cytometry

    Cerba Research

    Nithianandan Selliah’s professional work spans academia, the biotech/pharma sector and most recently CROs. His Ph.D. research at the University of Kentucky focused on the effect of epinephrine in the modulation of T cell activation. After his PhD, he joined Dr. Terri Finkel’s lab at National Jewish Medical center to study the mechanism of by stander killing of CD4 T cells by HIV. This worked continued at the Children’s Hospital of Philadelphia. Later he conducted pioneering research in CAR T-cells for HIV therapy under the mentorship of Dr. Richard Junghans at Roger Williams Medical Center in Providence, RI. He then moved to a Biotech company to identify biomarkers for lupus disease utilizing flow cytometry. He joined Celgene to work on a specific project to explore therapeutic potential of red blood cells derived from in vitro differentiation of HSCs.

    In 2015, Dr. Selliah joined LabCorp drug development (formerly Covance) to help facilitate their expansion of flow cytometry supporting clinical drug development. He has developed and validated more than 10 flow cytometric methods which were deployed in numerous global clinical trials. His work has been represented at the International Clinical Cytometry Society (ICCS) Annual Course and the International Society for the Advancement of Cytometry’s annual meeting, CYTO. He has contributed to recommendation papers in Cytometry B and Current Protocols in Cytometry, and a chapter on receptor occupancy assays.

    He is an active member of the ICCS Quality and Standards committee whose mission is to create educational modules for the international flow cytometry community on standardizing processes for flow cytometry assays, including reagent quality testing and instrument standardization.

    Currently Dr. Selliah is the Global Head of Flow Cytometry at Cerba Research, where he leads a team of 12 scientists in developing and validating Flow cytometry assays for global clinical trials. 

    • You must log in to register
      • Non-member - $30
      • Individual Student - $22.50
      • Individual Associate - $25.50
      • Individual Full Member - $22.50
      • Industry Level III - $15
      • Industry Level II - $12
      • Industry Level I - Free!
      • HCPGOV Level III - $15
      • HCPGOV Level II - $12
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
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  • Contains 3 Component(s), Includes Credits

    Organized by the CLSI Outreach Working Group, this session discusses the challenges and solutions for AST testing faced by various stakeholders. It includes a panel discussion with participation by FDA.

    Organized by the CLSI Outreach Working Group, this session discusses the challenges and solutions for AST testing faced by various stakeholders. It includes a panel discussion with participation by FDA.

    Moderator:
    Janet Hindler, MCLS MT(ASCP)F(AAM), Los Angeles County Department of Health

    Speakers include:
    Romney Humphries, PhD, D(ABMM), Medical Director, Clinical MIcrobiology, Vanderbilt University Medical Center
    Jean B. Patel, PhD, D(ABMM), Principal Scientist, Microbiology, Beckman Coulter
    Dmitri Iarikov, MD, PhD, Deputy Division Director, FDA Center for Drug Evaluation and Research
    Natasha Griffin, PhD, Lead Biologist, FDA Center for Devices and Radiological Health


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      • Non-member - Free!
      • Individual Student - Free!
      • Individual Associate - Free!
      • Individual Full Member - Free!
      • Industry Level III - Free!
      • Industry Level II - Free!
      • Industry Level I - Free!
      • HCPGOV Level III - Free!
      • HCPGOV Level II - Free!
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
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  • Contains 3 Component(s), Includes Credits

    Based on CLSI document NBS01, Dried Blood Spot Specimen Collection for Newborn Screening, 7th edition, this video demonstrates how to: • Prepare for specimen collection. • Collect blood specimens using the recommended heelstick technique. • Handle specimens properly and maintain appropriate records. • Transfer specimens to the screening lab in a timely manner. • Prevent testing problems that can delay the newborn’s diagnosis and treatment.

    Based on CLSI document NBS01, this video demonstrates how to:

    • Prepare for specimen collection.
    • Collect blood specimens using the recommended heelstick technique.
    • Handle specimens properly and maintain appropriate records.
    • Transfer specimens to the screening lab in a timely manner.
    • Prevent testing problems that can delay the newborn’s diagnosis and treatment.

    0.5 P.A.C.E. credits are available for this course.

    CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

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      • Non-member - $100
      • Individual Student - $75
      • Individual Associate - $85
      • Individual Full Member - $75
      • Industry Level III - $50
      • Industry Level II - $40
      • Industry Level I - $30
      • HCPGOV Level III - $50
      • HCPGOV Level II - $40
      • HCPGOV Level I - $30
      • Health System - $30
      • CLSI Staff - Free!
    • More Information