Participate in CLSI's webinar to gain knowledge on the latest method evaluation standards, get a sneak peek of EP47, and engage in a Q&A session addressing important topics in the industry.

Tuesday, November 12, 2024, 1:00 PM ET

Agenda
Introduction | Tabby Kern, MS, MLS(ASCP)CM and Mark Kellogg, PhD, MT(ASCP), DABCC
Framework of EP | Paula Ladwig, MS, MLS(ASCP)
Overview of EP10: Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures| Michelle Campbell, MS, MLS(ASCP)CMMBCM, SCCM
Preview of EP47: Evaluation of Reagent Carryover | Marvin Berman, PhD
Q&A Discussion | Mark Kellogg, MT(ASCP), DABCC, Moderator

Earn 1.0 P.A.C.E. Credits. 

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

The appropriate use of consensus standards can greatly streamline FDA medical device submissions and reduce the burden for the conformity assessment elements. With appropriate use of FDA-recognized consensus standards, developers of devices and LDTs can submit declarations of conformity (DOC) to meet some premarket requirements and reduce the amount of supporting data and information that are submitted to FDA. This webinar will feature a live Q&A discussion.

Speakers from each area will each present information on development and/or use of standards from their perspective:

• Clinical and Laboratory Standards Institute (CLSI), for standards development process and standards available to industry.
• FDA, for the appropriate use of standards.
• Abbott, for the industry perspective on participation in standards development.

Wednesday, August 28, 2024 | 1:00 PM ET

Earn 1.0 P.A.C.E.®️ credits.

Learning Objectives:

1. Identify how the use of FDA-Recognized Standards can reduce the documentation burden of regulatory submissions.
2. Determine how to use consensus standards effectively, including the submission of a Declaration of Conformity to the FDA.
3. Summarize how participation in standards development is essential to ensuring that consensus standards incorporate regulatory needs. 

Agenda
Introduction and CLSI’s Standards Development Process, Barb Jones, PhD 

FDA-Recognized Standards and Declaration of Conformity, Terry Woods, PhD 

Participation in Standards Development, Vicki Petrides, MS 

Q&A Discussion | All Panelists, Moderated by Barb Jones, PhD 

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

Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register for this first webinar and receive access to the entire series that will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, topics, and other LDT resources.

The first webinar is a panel discussion and overview of the FDA's Final Rule on LDTs, including practical resources for your laboratory to implement into practice. 

Webinar 1: FDA's Final Rule on LDTs | Thursday, August 15, 1:00 PM ET

Webinar Agenda

Overview of the Ruling | Shannon Bennett, MS, MBA, CMQOE(ASQ)

Q&A Discussion | Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM; Jonathan Genzen, MD, PhD, MBA; Shannon Bennett, MS, MBA, CMQOE(ASQ)

Method Navigator as a LDT Resource | Tabitha Kern, MS, MLS(ASCP)CM

Webinar 1 Learning Objectives 

1. Describe three main takeaways from the FDA's Final Rule on Laboratory Developed Tests (LDTs). 
2. Identify two resources that your laboratory can use to prepare for the ruling. 

Earn 1.0 P.A.C.E. credits for the first webinar. 

Upcoming Webinars

Webinar 2 | Quality Management for Complaint Files| TBD, Fall 2024

Webinar 3 | Medical Device Reporting | TBD, Winter 2025

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

This annual webinar is a collaboration between CLSI, Society of Infectious Disease Pharamcists (SIDP), and the American College of Clinical Pharmists (ACCP). It will provide updates on the latest breakpoint recommendations from CLSI from M100 | Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition, and offers practical strategies on incorporating those changes into clinical practice. Speakers will address the importance of partnerships between pharmacists and laboratory professionals on effective implementation of updates to enhance clinical practice. Audience polling will be included throughout, with an opportunity for Q&A at the end.

CLSI members can register for free by signing into their CLSI account. Society of Infectious Disease Pharamcists SIDP and ACCP ID PRN members, please register on SIDP's website. 

Live Date: Wednesday, August 7, 2024
1:00 PM – 2:30 PM ET / 12:00 PM – 1:30 PM CT

Earn 1.5 P.A.C.E.®️ credits. 

Target Audience:
This activity was planned to meet the educational needs of Pharmacists and Laboratory Professionals.

Learning Objectives:

·       Summarize highlights from the M100—Performance Standards for Antimicrobial Susceptibility Testing, 34^th Edition standards for antimicrobial susceptibility testing and reporting

·       Examine nuances that may be encountered when performing antimicrobial susceptibility testing (AST) for carbapenem-resistant bacteria.

·       Evaluate species-specific guidance for AST of Staphylococcus sp. and ceftriaxone dosing guidance for methicillin-susceptible Staphylococcus aureus

·       Discuss the revised breakpoints, reporting, and treatment recommendations for Stenotrophomonas maltophilia

Clinical and Laboratory Standards Institute is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. Program.

Please register for this course to claim P.A.C.E. credits from the June Education Session and access the on-demand recording. 

Explore the challenges and successes of using beta-lactam combination agents from three different perspectives, including the pharmaceutical industry, the laboratory, and clinical practice. This session will delve into the development process of beta-lactam combination agents and laboratory requests and QC issues. The successes and failures of using beta-lactam combination agents in clinical practice will also be discussed.

Learning Objectives

• Describe the process in development of beta-lactam combination agents. 
• Recognize requests that laboratories receive for testing these agents. 
• Identify challenges laboratories face with QC issues when testing beta-lactam combination agents. 
• Summarize the success and failures of using beta-lactam combination agents in clinical practice. 

Clinical and Laboratory Standards Institute is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. Program.

Join CLSI on April 17 at 1:00 ET for a webinar on the latest in Antimicrobial Susceptibility Testing (AST) with the release of the 34th edition of the CLSI M100 document. Receive the latest guidance for implementing new breakpoints and standards into your laboratory practices. Some of the major changes that will be discussed during the webinar include a significant reorganization of dosage recommendations, addition of sulbactam-durlobactam to breakpoints, a new Table 2A-2 for Salmonella and Shigella, and many more. A few substantive changes to the upcoming CLSI M02 and M07 will also be discussed.

Learning Objectives:

1. Identify the major changes found in the updated 34th edition of the CLSI M100 document.
2. Design a strategy for implementing the new standard into laboratory practices.
3. Develop a communication strategy for informing clinical staff of significant AST and reporting changes

Register for the webinar to watch live on April 17, 2024 at 1 PM ET | 12 PM CT | 11 AM MT | 10 AM PT
Or watch the webinar on-demand anytime. The on-demand recording will be available on April 19, 2024. 

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

Este programa de LQMS, recientemente rediseñado y optimizado, presenta elementos atractivos e interactivos, además de instrucciones detalladas paso a paso que le ayudarán a navegar sin problemas los requisitos regulatorios y de acreditación. El programa incluye lecciones fáciles de navegar para cada uno de los 12 elementos esenciales del sistema de la calidad que aparecen en el modelo de sistema de gestión de la calidad (QMS) presentado en la directriz QMS01 del CLSI: un modelo de sistema de gestión de la calidad para servicios de laboratorio. Este paquete de descuento incluye el PDF del QMS01 del CLSI y acceso al programa de LQMS. Las características nuevas y dinámicas del curso incluyen:

Comprobaciones de conocimiento regulares.

• Gráficas interactivas.
• Actividades divertidas de emparejamiento y clasificación.
• Líneas de tiempo interactivas.
• Interesantes lecciones en video.
• Capacidad de búsqueda avanzada.

 Objetivos del programa:
Al concluir el curso, usted podrá:

1. Demostrar un conocimiento básico sobre los procesos que su laboratorio necesita para implementar y mantener un sistema de gestión de la calidad efectivo.
2. Determinar su nivel personal de conocimientos sobre QMS y resolver cualquier deficiencia.
3. Desarrollar una base sólida antes de obtener una certificación de calidad más avanzada.

Reciba 13 créditos P.A.C.E. CE por su participación en el curso, después de completar el examen final.

El CLSI es un proveedor de programas de educación continua en ciencias de laboratorio clínico del Programa ASCLS P.A.C.E.

This newly redesigned and streamlined LQMS program features engaging interactive elements and specific step-by-step instructions to help you smoothly navigate regulatory and accreditation requirements. The program includes easy-to-navigate lessons for each of the 12 Quality System Essentials in the Quality Management System (QMS) model presented in CLSI guideline QMS01—A Quality Management System Model for Laboratory Services. The course's dynamic new features include: 

• Regular knowledge checks.
• Interactive graphics.
• Fun matching and sorting activities.
• Interactive timelines.
• Engaging video lessons.
• Searchability.

At the conclusion of this course, you will be able to:  

• Demonstrate a basic understanding of the processes your laboratory needs to implement and maintain an effective Quality Management System. 
• Determine your personal level of QMS knowledge and address any gaps. 
• Develop a foundation for pursuing more advanced quality certification.  

Receive 13 P.A.C.E.® CE credits for your participation in the course, upon completion of the final exam.  

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

All materials in this course are copyrighted.

©2024 Clinical and Laboratory Standards Institute. All rights reserved.

Register for this free course to claim 1.5 P.A.C.E. credits from the January 2024 education session and receive access to the on-demand recording and slides.

Intended for clinical, veterinary, and public health laboratories, review the gaps associated with defining, detecting, and reporting MDRO. 

Learning Objectives:

1. Describe gaps that are impacting the definition, detection, and reporting MDRO in clinical, veterinary, and public health laboratories.
2. Discuss processes that can be implemented to fill the gaps.
3. Identify current resources that may help fill the gaps.

The on-demand recording will be available to view on January 26th. 

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

Objectives:

-Discuss the updated College of American Pathologists (CAP) checklist items and how the 2023 Breakpoint Implementation Toolkit (BIT) can be used to meet regulatory needs.
-Understand antimicrobial susceptibility testing (AST) system-specific steps to complete the 2023 BIT.
-Develop a strategy for updating to current minimum inhibitory concentration (MIC) breakpoints.

Earn 1.0 P.A.C.E.®️ credits.

Review the BIT Toolkit. 

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