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Membership Emails
Below is a sample of the emails you can expect to receive when signed up to Clinical and Laboratory Standards Institute.
Featuring new QMS documents, a free rationale document and webinar, ways to get involved, and more!
June 2019
In This Issue
· Featured This Month
· Members Get More
· CLSI Case Studies
· ASM/APHL/CDC Webinar
· Global Training Updates
· Meeting Information
· Get Involved
Featured This Month
QMS12| Developing and Using Quality Indicators for Laboratory Improvement, 2nd Edition
QMS01| A Quality Management System Model for Laboratory Services, 5th Edition
MR04| Azithromycin Breakpoint for Neisseria gonorrhoeae, 1st Edition
Shop Now
Wanted: CLSI Case Studies
Have you implemented a CLSI standard in your laboratory or company? We'd like to hear about your experience!
CLSI would like to share your experience with others who are using or thinking about using CLSI standards. We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard. Case studies will be reviewed, and if selected, the case studies may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
Global Training Updates
CLSI's Global Health Partnerships (GHP) has recently been working in Kenya. Their activities include:
Conducting viral load scorecard assessments for viral load labs.
Hosting a five-day workshop for local mentors and laboratorians, on topics including:
- Mentor effectiveness
- Method validation/verification
- Quality control interpretation
- Uncertainty of measurement
Learn More
Get Involved With CLSI
CLSI's volunteer program offers you the opportunity to maximize your voice in the global laboratory and health care community.
We are currently looking for volunteers to serve on CLSI's Consensus Council and three Board of Directorsgovernance committees: the Awards, Finance, and Nominating Committees.
CLSI also requests nominations for volunteers to serve as members and contributors on document development committees on:
EP27: How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 2nd Edition
AUTO17: Semantic Interoperability for In Vitro Diagnostic Systems, 1st Edition
We are also looking for a volunteer to serve as a mentor for a GHP program in the Democratic Republic of Congo.
Learn More
ASM/APHL/CDC Free Training Webinar
A free training webinar, "Best Practices for Identification of Carbapenem Resistant
Pseudomonas aeruginosa," sponsored by the American Society for Microbiology (ASM), the Association of Public Health Laboratories (APHL), and the Centers for Disease Control and Prevention (CDC) has been scheduled for Tuesday, July 9, 2019 at 2:00 PM Eastern (US) Time. This webinar will discuss best practices for the laboratory identification of carbapenem resistant
P. aeruginosa
(CRPA) and the importance of communication between clinical labs and public health labs about their test methods and results.
Join CLSI volunteer Patricia J. Simner, MSc, PhD, D(ABMM), of Johns Hopkins Medicine for this free webinar and receive 1.0 P.A.C.E.® CE credit.
Register Today
Meeting Information
Visit CLSI staff at the American Society for Clinical Laboratory Science (ASCLS) and Association of Genetic Technologists (AGT) Joint Annual Meeting, June 23-27, in Charlotte, NC | Location 11 to see what's new and coming soon.
Members Get More
Want to connect with your colleagues around the world and keep up to date with the latest in laboratory technology and quality? Consider a CLSI membership.
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This guideline provides a structured approach for developing effective laboratory personnel training and competence assessment programs.
QMS03-Ed4 Training and Competence Assessment, 4th Edition Published: November 1, 2016
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Document Highlights
An effective training program sets the expectation that personnel need to learn and apply the laboratory and organization's processes and procedures.
CLSI guideline QMS03:
Provides the necessary background information and processes to develop training and competence assessment programs.
Helps the laboratory meet regulatory and accreditation requirements.
Helps the laboratory ensure knowledgeable and competent personnel in all laboratory disciplines.
Ensure your staff has the training and competence assessment resources they need with QMS03.
Order Today
Click here for a document preview
You May Also Be Interested In...
QMS25-Ed1 Handbook for Developing a Laboratory Quality Manual, 1st Edition
This handbook assists laboratories in developing a quality manual— a vital component of implementing and maintaining a complete laboratory quality management system.
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Featuring new QMS and VET documents, ways to get involved, and more!
July 2019
In This Issue
· Featured This Month
· Members Get More
· CLSI Case Studies
· On Demand: VET09 Webinar
· Global Training Updates
· Visit CLSI at AACC
· Get Involved
Featured This Month
QMS01| A Quality Management System Model for Laboratory Services, 5th Edition
VET09| Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings, 1st Edition
NBS03 - Preorder| Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition
Shop Now
Wanted: CLSI Case Studies
Have you implemented a CLSI standard in your laboratory or company? We'd like to hear about your experience!
CLSI would like to share your experience with others who are using or thinking about using CLSI standards. We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard. Case studies will be reviewed, and if selected, the case studies may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
Global Training Updates
CLSI's Global Health Partnerships (GHP) staff has been hard at work partnering with a lab in Kenya to help with final preparations before their first visit by the Kenya Accreditation Service.
GHP staff has also been mentoring 15 laboratories in Tanzania, some of which are nearing important milestones. We'll be providing more information on individual labs in the region in the coming months!
Learn More
Get Involved With CLSI
CLSI's volunteer program offers you the opportunity to maximize your voice in the global laboratory and health care community.
CLSI requests nominations for volunteers to serve as members and contributors on document development committees for:
MM25: Sequencing Bioinformatics for Human Genetics and Oncology, 1st Edition
NBS11: Newborn Screening for Congenital Adrenal Hyperplasia, 1st Edition
It's also time to nominate individuals to serve on the CLSI Board of Directors for the 2019 election cycle. Nominate an individualhere.
Learn More
Upcoming Webinar: VET09
Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings
Tuesday, September 17, 2019 | 1:00 PM Eastern (US) Time
At the completion of this webinar, you'll be able to:
Understand available CLSI resources.
Know the rationale for the VET09 document creation.
Understand the organization of the document.
Know when and how VET09 can be useful to veterinarians.
Nonmember cost:
$25.00
Member discounts apply.
Earn 1.0 P.A.C.E. ® Continuing Education credit for completion of this live webinar.
Register Today
Visit CLSI at AACC
Are you attending the American Association for Clinical Chemistry's (AACC) 71st Annual Scientific Meeting and Clinical Lab Expo in Anaheim, California, USA from August 4-8? We'd love to see you!
Visit us at booth #1918 and be sure to register for our free Member Open House scheduled for Monday, August 5, 2019 from 5:30–7:00 PM Pacific (US) Time.Learn more and register.
Members Get More
Keep up with the latest information in laboratory technology and ensure that your organization can contribute to the development of fair and balanced laboratory standards that improve quality in your lab and around the world.
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This report provides veterinarians with the information needed to successfully acquire and interpret antimicrobial susceptibility test results. It promotes common understanding between the veterinarian and the veterinary microbiology laboratory by providing example culture and susceptibility reports and animal species-specific guidance on applying breakpoints to interpret susceptibility test results.
VET09-Ed1 Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings, 1st Edition Published: July 23, 2019
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Document Highlights
VET09 promotes common understanding in:
Laboratory processes including:
How AST is performed.
Reasons for AST not being performed.
How AST results are assessed by the laboratory.
Factors that affect antimicrobial drug selection in animals including:
Principles of antimicrobial pharmacology.
How bacterial species identification affects AST results interpretation.
The veterinarian's role in ensuring AST results are accurate and useful.
Successfully acquire and interpret AST results in your lab with CLSI's document VET09-Ed1.
Order Today
Click here for a document preview
Related Webinar...
VET09 Webinar Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings
Tuesday, September 17, 2019 | 1:00 PM Eastern (US) Time
At the conclusion of this program, the participant will be able to:
Understand available CLSI resources.
Know the rationale for the VET09 document creation.
Understand the organization of the document.
Know when and how VET09 can be useful to veterinarians.
Earn 1.0 P.A.C.E.®
Continuing Education credit for completion of this live webinar.
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This guideline describes the recommended protocols for screening preterm, low birth weight, and sick newborns for hearing loss, critical congenital heart defects, and diseases detectable through newborn dried blood spot screening.
NBS03-Ed2 Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition Published: August 12, 2019
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Document Highlights
NBS03:
Focuses on unique issues affecting newborn screening (NBS) for the population of preterm, low birth weight (LBW), or sick newborns.
Describes newborn screening for of preterm, low birth weight (LBW), or sick newborns worldwide to detect treatable diseases before physical damage can occur.
Ensure your staff has the newborn screening resource they need for preterm, low birth weight, and sick newborns with CLSI document NBS03.
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Featuring new documents, webinars, and volunteer opportunities.
August 2019
In This Issue
· Featured This Month
· CLSI Case Studies
· Global Training Updates
· Free CLSI and APHL Webinar
· Get Involved
· Members Get More
Featured This Month
NBS03| Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition
VET09| Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings, 1st Edition
Webinar: Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings| September 17, 2019 |1:00 PM
Eastern (US) Time
Shop Now
Global Training Updates
After another round of mentorships were completed in Tanzania, seven laboratories, which received mentorship support from CLSI, were assessed and recommended for international accreditation. We are expecting a few more labs to be assessed in the upcoming months. These are significant achievements made possible by partnerships withthe Management and Development for Health (MDH) organization; the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC); and the Centers for Disease Control and Prevention (CDC). In Kenya, our mentors have been busy conducting ongoing trainings and mentorships to prepare labs for upcoming accreditation assessments.
Learn More
Get Involved With CLSI
CLSI's volunteer program offers you the opportunity to maximize your voice in the global laboratory and health care community.
CLSI requests nominations for volunteers to serve on:
10 Expert Panels in various technical areas
A Document Development Committee on NBS11: Newborn Screening for Congenital Adrenal Hyperplasia, 1st Edition
View Opportunities*
* Login is required. Not registered? Sign-up here.
It's also time to nominate individuals to serve on the CLSI Board of Directors for the 2019 election cycle.
Nominate an Individual
Wanted: CLSI Case Studies
Tell us how CLSI documents have helped you.
For example, have you used CLSI standards to help you implement a QMS, pass an inspection, or achieve regulatory approval? Have you used CLSI standards to improve a process, validate new instruments, or implement a new test? Please share your experience so others can learn from you! We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard. Case studies will be reviewed, and if selected, may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
Free Webinar From CLSI and APHL
CLSI and APHL will be hosting a free webinar, "MDRO" and "nMDRO": A Briefing for Clinical and Public Health Microbiologists, on Thursday, September 19, 2019 from 2:00-3:00 PM (Eastern) US Time.
At the conclusion of the program, the participant will be able to:
List MDRO and novel MDRO (nMDRO) that present the greatest challenges to clinical and public health microbiologists.
Describe reliable methods for detection of MDRO and nMDRO.
Discuss strategies for communicating results for MDRO and nMDRO to clinical and public health professionals.
Speaker:
Janet Hindler, MCLS, MT(ASCP), F(AAM), Clinical Microbiologist, UCLA Medical Center, Los Angeles, CA
Register Now
Members Get More
Did you know that a CLSI membership offers you and your organization significant benefits such as:
Discounts on products.
Opportunities to network with colleagues and experts in the field.
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2020 CLSI Excellence Awards
Call for Nominations
Submit Your Nomination Today!
A CLSI Excellence Award is one of the highest honors CLSI can bestow upon one of its volunteers. You can nominate a colleague for a CLSI Excellence Award in your choice of four categories. Please view the award descriptions here.
Submitting an Excellence Award nomination is easy. Any individual may submit a nomination for a CLSI award recipient. The nominee must be a CLSI member in good standing. There is no limit to the number of nominations one may submit. However, award recipients may only receive a particular award once every 7 years. Please view our list of past award recipients here.
Submit your official nomination via the form below. Please remember to include all the required information. The deadline is October 15, 2019, 11:59 PM Eastern (US) Time.
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Call for Volunteers: Expert Panels and Document Development Committee
Don't Just Use the Standards—Raise the Standards.
To view volunteer opportunities, you must log in to the CLSI website. Don't have a CLSI login? Sign up here for free.
CLSI is seeking nominations for expert panels on:
Automation and Informatics
Clinical Chemistry and Toxicology
Evaluation Protocols
Hematology and Immunology and Ligand Assay
Microbiology
Molecular Methods
Newborn Screening
Point-of-Care Testing
Preexamination Processes
Quality Management Systems
View This Opportunity >
Learn More About Expert Panels >
NBS11: Newborn Screening for Congenital Adrenal Hyperplasia, 1st Edition
This document development committee is looking for volunteers with:
Expertise in all phases of the NBS process, with emphasis on CAH screening.
Expertise in international NBS programs and processes.
Expertise in health care professions (eg, pediatrics, genetic counseling, family practice, nursing) involved in the newborn CAH screening follow-up processes.
Expertise in evaluating the influence of preterm birth, newborn illness, and maternal steroid treatment on CAH NBS results.
Expertise in instrumentation and reagents for newborn CAH screening.
Experience in and knowledge of NBS regulatory aspects.
View This Opportunity >
Learn More About Document Development Committees >
Not interested in our current openings?
Complete your Volunteer Profile to be notified directly of future volunteer opportunities in your area of interest.
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This guideline includes detailed information for design, testing, validation, implementation, and ongoing support of an autoverification algorithm system for use in the medical laboratory.
AUTO15-Ed1 Autoverification of Medical Laboratory Results for Specific Disciplines, 1st Edition Published: September 11, 2019
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Document Highlights
AUTO15:
Provides recommendations for designing autoverification algorithms for specific disciplines and types of testing in the medical laboratory.
Includes guidance for human intervention, whether results are generated from an automated system or manual result entry.
Gives recommendations for the creation of scalable algorithms that provide levels of adaptation from simple to more complex criteria and the actionable implementation of autoverification in the laboratory.
Is intended for use by laboratorians, personnel responsible for information systems, and vendors for medical informatics and
in vitro
diagnostics.
"AUTO15 provides a granular framework that can be used as a cornerstone for laboratorians, regulating agencies, instrumentation and automation vendors, and information systems providers alike to provide direction on exactly how a robust autoverification system should function so that high levels of autoverification can be achieved."
—William Marquardt, C(ASCP), MBA
VP Lab Intelligence/Connectivity at Data Innovations LLC
and Chairholder of AUTO15
Ensure your staff has the support it needs for designing autoverification algorithms.
Order Today
Click here for a document preview
You May Also Be Interested In...
AUTO10-Ed1 Autoverification of Clinical Laboratory Test Results, 1st Edition
This document provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population.
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Featuring new documents, webinars, volunteer opportunities, and more!
September 2019
In This Issue
· Featured This Month
· Upcoming Events
· Global Training Updates
· CLSI Case Studies
· Get Involved
· Members Get More
Featured This Month
AUTO15| Autoverification of Medical Laboratory Results for Specific Disciplines, 1st Edition
MR03| Meropenem Breakpoints for Acinetobacter spp., 1st Edition
MR06 |
Daptomycin Breakpoints for Enterococci, 1st Edition
Earn 1.0® PACE CE credit while attending one of our upcoming webinars:
QMS01: What's Changed and New
Tuesday, October 22, 2019 | 2:00–3:00 PM Eastern (US) Time
Speakers: Anne T. Daley, MS, MT(ASCP)DLM, CMQ/OE(ASQ)CSBB, CLC(AMT) and
Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE
An Introduction to CLIA Regulations: What You Need to Know and Document Tuesday, October 29, 2019 | 1:00–2:00 PM Eastern (US) Time
Speaker: James Nichols, PhD, DABCC, FAACB
Sponsored by
Accuracy in Patient and Specimen Identification: What's New in GP33?
Tuesday, November 5, 2019 | 1:00–2:00 PM Eastern (US) Time
Speaker: Eric Stanford, MHA, MLS(ASCP)
Starting at $99 for nonmembers. Member discounts apply.
Shop Now
Global Training Updates
CLSI's Global Health Partnerships (GHP) team recently finished a gap assessment activity in Zambia to measure how the labs undergoing mentorship from CLSI mentors are doing. The quality management system is progressing well.
In Kenya, the 12th laboratory mentored by CLSI's team has been recommended for accreditation—a milestone for the team. In addition, two other labs in Kenya passed their surveillance assessments that were conducted by the accrediting body.
The GHP team will be traveling to Tanzania for MeSLAT's Scientific Conference and Annual Meeting (October 2–4) and Kenya for the AKMLSO Scientific & Exhibition Conference (October 9–12).
Learn More
Get Involved With CLSI
Share your experience and expertise to improve laboratory testing around the world by becoming a CLSI volunteer.
We're currently requesting nominations for volunteers to serve on several expert panels in various technical areas and a new document development committee on EP40: Evaluation of Sample and Reagent Carryover, 1st Edition.
View Opportunities*
* Login is required. Not registered? Sign up here.
Upcoming Events
CLSI will be represented at the following upcoming events:
Medical Laboratory Scientists Association of Tanzania's Scientific Conference and Annual Meeting | October 2–4, 2019 | Tanzania
Association of Kenya Medical Laboratory Scientific Officers's Scientific & Exhibition Conference | October 9–12, 2019 | Kenya
Wanted: CLSI Case Studies
How have CLSI documents or products helped your lab or organization?
For example, have you used a particular CLSI standard or product to help you implement a quality management system (QMS) or pass an inspection? Did using a CLSI standard or product help you improve a process, validate new instruments, or implement a new test?
Share your experience so others can learn from you! We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard or product. Case studies will be reviewed, and if selected, may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
Members Get More
Did you know that a CLSI membership offers you and your organization significant benefits such as:
Discounts on products
Opportunities to network with colleagues and experts in the field
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Call for Volunteers: Method Evaluation and Microbiology Document Development Committees
Don't Just Use the Standards—Raise the Standards.
To view volunteer opportunities, you must log in to the CLSI website. Don't have a CLSI login? Sign up here for free.
EP40:
Evaluation of Sample and Reagent Carryover, 1st Edition
This document development committee is looking for volunteers with:
Expertise in statistical protocols and measurement procedures for evaluation development.
Experience in medical laboratory practice (eg, laboratorians, laboratory managers, and laboratory directors).
Experience in and knowledge about assay development, system engineering, or
in vitro
manufacturing.
Experience in and knowledge about laboratory regulations and accreditation processes.
Experience in analytical validation studies.
View This Opportunity >
Learn More About Document Development Committees >
Signup Deadline: October 25, 2019
M63:
Principles and Procedures for the Gram Stain, 1st Edition
This document development committee is looking for volunteers with:
Expertise in specimen manipulation and smear preparation.
Expertise in laboratory staining techniques and microscopy in the medical laboratory, government, or industry.
Experience in microscopic microbial morphology and Gram stain use in patient care.
View This Opportunity >
Learn More About Document Development Committees >
Signup Deadline: October 28, 2019
Document Development Committee on Two EP19-related workbooks:
EP42:
Laboratory-Developed Tests: A Workbook for Establishment and Implementation
EP41:
A Workbook for Laboratory Implementation of Unchanged Manufacturer Test Methods
This document development committee is looking for volunteers with:
Expertise in developing LDT method details in a medical laboratory.
Knowledge of and experience using FDA 21 CFR Part 820 QSReg, CLIA regulations, and ISO standards 9001, 13485, 14971, 17025, and 15189.
Experience in the medical laboratory environment involving requirements for implementing test methods developed by manufacturers that are unchanged from the manufacturer's instructions.
Expertise in establishing the instrumentation, reagents, controls, and performance specifications needed for one or more LDTs.
Knowledge of and experience in test method implementation in a medical laboratory.
Experience using CLSI document EP19.
Experience using CLSI evaluation protocols for validating test methods and verification of test method performance specifications.
View This Opportunity >
Learn More About Document Development Committees >
Signup Deadline: November 8, 2019
Not interested in our current openings?
Complete your Volunteer Profile to be notified directly of future volunteer opportunities in your area of interest.
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October 2019
In This Issue
· Featured This Month
· Upcoming Events
· Global Training Updates
· CLSI Case Studies
· Get Involved
· Members Get More
Featured This Month
QMS01CL| Gap Analysis Checklists, 1st Edition
NBS08 - Preorder| Newborn Screening for Hemoglobinopathies, 1st Edition
EP35 - Preorder |
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition
Earn 1.0 PACE® CE credit while attending one of our upcoming webinars:
An Introduction to CLIA Regulations: What You Need to Know and Document Tuesday, October 29, 2019 | 1:00–2:00 PM Eastern (US) Time
Speaker: James Nichols, PhD, DABCC, FAACB
Sponsored by
Accuracy in Patient and Specimen Identification: What's New in GP33?
Tuesday, November 5, 2019 | 1:00–2:00 PM Eastern (US) Time
Speaker: Eric Stanford, MHA, MLS(ASCP)
Rational Approach to Antibacterial and Antifungal Breakpoints
Wednesday, November 20, 2019 | 1:00-2:00 PM Eastern (US) Time
Speakers: Patricia Simner PhD, D(ABMM) and Stephanie Mitchell, PhD, D(ABMM)
In partnership with
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Global Training Updates
Global Health Partnerships (GHP) Vice President, Patrick Mateta, and Project Manager, Emily Anderson, have just returned from exhibiting at two conferences for medical technologists and laboratorians.
In Tanzania, Patrick and Emily, joined by Regional Contract Manager, Wilson Mtotela, attended the Medical Laboratory Scientists Association of Tanzania (MeLSAT) conference held in Bagamoyo. Afterward, they traveled to Kenya where they attended the Association of Kenya Medical Laboratory Scientific Officers (AKMLSO) conference in Kisumu with some of CLSI's regional contractors.
Each conference focused on quality improvement, safety, infection prevention, and surveillance. Patrick and Emily were thrilled to have so many conference participants visit the CLSI booth and to see professionals of all ages invigorated and excited about the profession.
Learn More About GHP
Get Involved With CLSI
Share your experience and expertise to improve laboratory testing around the world by becoming a CLSI volunteer.
We're currently requesting nominations for volunteers to serve on document development committees for:
EP40: Evaluation of Sample and Reagent Carryover, 1st Edition
Sign-up Deadline: October 25, 2019
M63:
Principles and Procedures for the Gram Stain, 1st Edition
Sign-up Deadline: October 28, 2019
Two EP19-related workbooks: EP41 and EP42 Sign-upDeadline: November 8, 2019
View Opportunities*
* Login is required. Not registered? Sign up here.
Upcoming Events
We're looking forward to seeing some of our volunteers at our upcoming January 2020 Committees Week in Tempe, Arizona. Registration is now open. A schedule-at-a-glance and hotel information are available for your convenience.
Register Now
Wanted: CLSI Case Studies
How have CLSI documents or products helped your lab or organization?
For example, have you used a particular CLSI standard or product to help you implement a quality management system (QMS) or pass an inspection? Did using a CLSI standard or product help you improve a process, validate new instruments, or implement a new test?
Share your experience so others can learn from you! We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard or product. Case studies will be reviewed, and if selected, may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
Members Get More
Did you know that a CLSI membership offers you and your organization significant benefits such as:
Discounts on products.
Opportunities to network with colleagues and experts in the field.
December 17, 2019 | 1:00-2:00 PM Eastern (US) Time
Learn about the FDA's role in increasing the availability and reliability of antimicrobial susceptibility tests, then learn more about CLSI's Rationale Documents. What are they? How can you use them?
Speakers:
John Farley, MD, MPH
Romney Humphries, PhD, D(ABMM)
Earn 1.0 PACE® CE Credit. Free registration required. Space is limited.
AST Annual Update Webinars
Wednesday, February 26, 2020 | 1:00-2:30 Eastern (US) Time
or
Thursday, February 27, 2020 | 3:00-4:30 Eastern (US) Time
Identify the major changes found in the updated edition of CLSI document M100-Ed30. Learn to design a strategy for implementing the new standard into laboratory practices and get communication strategies for informing clinical staff of significant AST and reporting changes.
This month, seven CLSI staff members attended the International Organization for Standardization (ISO) Technical Committee 212 (ISO/TC 212) Plenary Meeting in Mexico City. CLSI serves as the Secretariat for TC 212, which is responsible for international standardization and guidance in the field of laboratory medicine and
in vitro
diagnostic test systems.
As Secretariat, CLSI is responsible for ensuring that meetings are conducted according to ISO Directives. For more updates from the recent ISO meetings, visit our blog in the coming weeks.
Learn More About ISO
Get Involved With CLSI
Help us improve laboratory testing around the world by becoming aCLSI volunteer!
We're currently looking for volunteers to serve on a document development committee for AUTO11: Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition.
View Opportunities*
* Login is required. Not registered? Sign up here.
Upcoming Events
We're looking forward to seeing volunteers at our upcoming January 2020 Committees Week in Tempe, Arizona. Registration is now open. A schedule-at-a-glance and hotel information are available for your convenience.
Register Now
Wanted: CLSI Case Studies
Has a CLSI standard or product helped your lab overcome a challenge? We'd love to hear your story!
For example, have you used a particular CLSI standard or product to help you implement a quality management system (QMS) or pass an inspection? Did using a CLSI standard or product help you improve a process, validate new instruments, or implement a new test?
Share your experience so others can learn from you! We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard or product. Case studies will be reviewed, and if selected, may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
Members Get More
CLSI membership is the best way for you and your organization to:
Access to the latest CLSI products and programs.
Contribute to the development of the standards you use every day.
Strengthen your CV and network with colleagues from around the globe.
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See what's publishing soon, upcoming webinars, and more.
December 2019
In This Issue
· Featured This Month
· Upcoming Events
· Global Training Updates
· CLSI Case Studies
· Get Involved
· CDC International Biosafety Symposium
Featured This Month
M100 - Preorder|
Performance Standards for Antimicrobial Susceptibility Testing, 30th Edition
NBS05 - Preorder|
Newborn Screening for Cystic Fibrosis, 2nd Edition
EP35 - Preorder|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition
Shop Now
Upcoming Webinars
AST Annual Update Webinars
Wednesday, February 26, 2020 | 1:00-2:30 PM Eastern (US) Time
or
Thursday, February 27, 2020 | 3:00-4:30 PM Eastern (US) Time
Identify the major changes found in the updated 30th Edition of CLSI document M100. Learn how to design a strategy for implementing the new standard into laboratory practices and get communication strategies for informing clinical staff of significant antimicrobial susceptibility testing and reporting changes.
During the first week of December, together with the Ministry of Health and MDH, Global Health Partnerships staff conducted training for new members of the mentor pool in Tanzania. Participants selected for this course were primarily quality officers who work in laboratories that have achieved accreditation aligned with ISO 15189.
During the week of December 8, the new mentors were joined by the existing pool of mentors at a workshop to review standardized QMS documents. These documents, which describe aspects of management and technical accreditation requirements, will facilitate QMS implementation in laboratories seeking accreditation.
Learn More About GHP
Get Involved With CLSI
CLSI volunteers directly impact and improve quality in laboratory medicine by sharing their expertise to help develop the standards and guidelines laboratorians use every day. Learn more about the work CLSI volunteers do and how you can join them to help enhance laboratory testing and patient care.
We're currently requesting nominations for volunteers to serve on a document development committee for:
AUTO11:Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition
Signup Deadline: December 23, 2019
View Opportunities*
* Login is required. Not registered? Sign up here.
Upcoming Events
We're looking forward to seeing volunteers at our upcoming January 2020 Committees Week in Tempe, Arizona. Registration is now open. A schedule-at-a-glance and hotel information are available for your convenience.
Register Now
Wanted: CLSI Case Studies
Has a CLSI standard or product helped your lab overcome a challenge? We'd love to hear your story!
For example, have you used a particular CLSI standard or product to help you implement a quality management system (QMS) or pass an inspection? Did using a CLSI standard or product help you improve a process, validate new instruments, or implement a new test?
Share your experience so others can learn from you! We are seeking case studies for all areas of the clinical laboratory, for any CLSI standard or product. Case studies will be reviewed, and if selected, may be shared on CLSI's website and on social media sites. Plus, by submitting a case study, you'll be entered for a chance to win a free document of your choice.
Share Your Case Study
16th CDC International Biosafety Symposium
Save the date for the 16th CDC International Biosafety Symposium on February 29 to March 4, 2020 at the Westin Perimeter North Hotel in Atlanta, GA. This year's theme is The Power of Risk Assessment: Laboratory Safety and Security for Clinical, Public Health, Research, and Animal Care.
The deadline to submit a poster abstract for the symposium is January 15, 2020. To submit a poster, please complete the poster abstract form. If you have questions about poster abstract submission, please contact Laura Girr by email at the Eagleson Institute (lgirr@eagleson). For the agenda and more details, please visit www.eagleson.org/cdc.
The last day for early bird registration is January 30, 2020.
Members Get More
CLSI membership is the best way for you and your organization to:
Stay up to date with the latest in testing methodologies and QC.
Contribute to the development of the standards you use every day.
Strengthen your CV and network with colleagues from around the globe.
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Learn about CLSI's featured products, webinars, and more.
January 2020
In This Issue
· New Documents
· Upcoming Events
· Global Training Updates
· CLSI Case Studies
· Get Involved
· Members Get More
New Documents
M100|
Performance Standards for Antimicrobial Susceptibility Testing, 30th Edition
POCT15|
Point-of-Care Testing for Infectious Diseases, 1st Edition
EP35|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition
Shop Now
Upcoming Webinars
AST Annual Updates Webinars
Wednesday, February 26, 2020 | 1:00-2:30 PM Eastern (US) Time
or
Thursday, February 27, 2020 | 3:00-4:30 PM Eastern (US) Time
Identify the major changes found in the updated 30th edition of CLSI document M100. Learn how to design a strategy for implementing the new standard into laboratory practices and get communication strategies for informing clinical staff of significant antimicrobial susceptibility testing and reporting changes.
Moderator:
Janet Hindler, MCLS, MT(ASCP), F(AAM)
Speakers:
Romney M. Humphries, PhD, D(ABMM) and Audrey Schuetz, MD, MPH, FCAP
Earn 1.5 PACE®
CE credits. Registration required.
POCT15 Webinar
Point-of-Care Testing for Infectious Diseases Webinar
Tuesday, March 10, 2020 | 1:00-2:00 PM Eastern (US) Time
Learn about CLSI's POCT15 report that provides recommendations for assisting providers, laboratories, public health agencies, and policymakers in assessing, deploying, performing, and utilizing point-of-care testing to improve the management of infectious diseases. Also learn about recommendations for indications, limitations, appropriate use, and result reporting and interpretation.
Speakers:
Sheldon M. Campbell, MD, PhD, FCAP and Robert L. Sautter, PhD, HCLD/CC ABB
Earn 1.0 PACE®
CE credits. Registration required.
Register Today
Global Training Updates
CLSI is excited to announce a new relationship in Zambia with the Centre for Infectious Disease Research in Zambia Lab Innovation for Excellence (CIDRZ LIFE) program. The Global Health Partnerships staff is collaborating with this program to implement quality management systems and mentorship strategies. Currently in Zambia, three CLSI mentors are working with the laboratory technologists and biomedical scientists in selected laboratories in preparation for accreditation aligned with
ISO.
Learn More About GHP
Get Involved With CLSI
Want to directly impact the standards you and your colleagues use every day? Become a CLSI volunteer to use your expertise to improve the quality of laboratory testing throughout the world, network with other like-minded professionals, and enhance your career.
We're currently requesting nominations for volunteers to serve on a document development committee for:
M64:
Implementation of Taxonomy Changes, 1st Edition
Signup Deadline: February 5, 2020
View Opportunities*
* Login is required. Not registered? Sign up here.
Win a Free Document: Submit a Case Study
Submit a case study and be entered for a chance to win a free document of your choice! Has a CLSI standard or product helped your lab overcome a challenge? We'd love to hear your story! Case studies will be reviewed, and if selected, may be shared on CLSI's website and on social media sites.
Share Your Case Study
Upcoming Events
January Committees Week
We're looking forward to seeing our volunteers in Tempe, Arizona. Registration has closed, but meeting details and information can be found on our website.
Learn More
March Committees Week
Registration for CLSI's March 2020 Committees Week in Dallas, Texas is open. A schedule-at-a-glance and hotel information are available on our website.
Register Now
Medlab Middle East
The Annual Medlab Middle East (formerly Medlab Dubai) exhibition will be held February 3–6, 2020 at the Dubai World Trade Centre in Dubai, UAE. Long established as the "must attend event in the region," Medlab Middle East is where the world of laboratory medicine meets.
Attending Medlab Middle East? Stop by and say hello to CLSI at booth Z3-C49.
Members Get More
CLSI membership is the best way for you and your organization to:
Stay up to date with the latest in testing methodologies and QC.
Contribute to the development of the standards you use every day.
Strengthen your CV and network with colleagues from around the globe.
950 West Valley Road | Suite 2500
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February 2020
In This Issue
· Featured Products
· Governance Updates
· Global Training Updates
· Upcoming Events
· Get Involved
· Members Get More
Featured Products
M100|
Performance Standards for Antimicrobial Susceptibility Testing, 30th Edition
POCT15|
Point-of-Care Testing for Infectious Diseases, 1st Edition
EP35|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition
Shop Now
Upcoming Webinars
AST Annual Update Webinars
Wednesday, February 26, 2020 | 1:00-2:30 PM Eastern (US) Time
or
Thursday, February 27, 2020 | 3:00-4:30 PM Eastern (US) Time
Identify the major changes found in the updated 30th edition of CLSI document M100. Learn how to design a strategy for implementing the new standard into laboratory practices and get communication strategies for informing clinical staff of significant antimicrobial susceptibility testing and reporting changes.
Moderator:
Janet Hindler, MCLS, MT(ASCP), F(AAM)
Speakers:
Romney M. Humphries, PhD, D(ABMM) and Audrey Schuetz, MD, MPH, D(ABMM)
Earn 1.5 PACE®
CE credits. Registration required.
Register Today
Global Training Updates
Members of CLSI's Global Health Partnerships (GHP) staff were recently in Dubai, UAE attending the the Medlab Middle East exhibition.
Following the exhibition, GHP's Vice President, Patrick Mateta, led an Internal Audit training session in partnership with the CLSI MENA office and Prime Healthcare Group.
GHP staff also traveled to South Africa for the regional stakeholders workshop on Antimicrobial Resistance External Quality Control (AMR EQA).
GHP activities in Zambia are ongoing, where assessments in four new labs that were selected to be mentored for accreditation will be conducted.
Learn More About GHP
Get Involved With CLSI
Enhance your career path by collaborating with like-minded professionals to improve laboratory medicine. Our volunteers work with leading experts to develop the most trusted medical laboratory standards in the world. Learn more about the many benefits of becoming a CLSI volunteer.
Open Opportunities:
MM22: Microarrays for Diagnosis and Monitoring of Microbial Infections, 2nd Edition
PRE01:Preexamination Processes for Identification, Collection, Transport, and Handling of Medical Laboratory Specimens, 1st Edition
QMS28:Laboratory Safety Management, 1st Edition
View Opportunities*
* Login is required. Not registered? Sign up here.
CLSI Governance Updates
In January 2020, CLSI welcomed new members to the Board of Directors. View the profiles of the current Board of Directorshere.
Upcoming Events
March Committees Week
CLSI's March 2020 Committees Week will take place from March 23 to March 26 in Dallas, Texas. A schedule-at-a-glance and hotel information are available on our website. Registration for the March meeting will end on March 6, 2020.
Register Now
Members Get More
Get valuable discounts on standards and related products while staying up to date with the latest testing methodologies and QA practices. Find out more about which membership level is right for your organization.
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Upcoming Webinars
Register today for these upcoming webinars!
GP42 Webinar | 20/20 Vision of Change for the Collection of Capillary Blood Specimens
Tuesday, September 22, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Nancy Glasgow-Roberts PBT (ASCP)
In this webinar you''ll learn:
.
Why it is essential to follow the updated capillary blood collection standards.
.
How the standards changed in the new document revision and why.
.
What your laboratory may need to change to adhere to the new standards.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
Passing-Bablok Regression Webinar | Robust Regression Techniques for Method Comparison
Tuesday, October 6, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Florian Dufey, PhD
In this webinar you''ll learn:
.
How robust regression techniques (Theil-Sen and Passing-Bablok regression) for method comparison are derived and how they work.
.
The assumptions underlying the different methods.
.
How these methods compare to non-robust methods like linear or Deming regression.
Cost: $99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
View All Webinars
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CLSI
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Annapolis Junction, MD 20701 USA
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Do you have the latest version?
Every time work is redone, the cost of laboratory services, as well as the cost of quality, increases.
QMS20-Ed2
This guideline helps laboratories understand, apply, track, and manage the different types of quality costs that affect their processes, services, and financial well-being. QMS20 discusses types of quality costs, applying the cost of quality to laboratory operations, monitoring and evaluating the effectiveness of a cost of quality program, and transitioning to a cost of quality culture.
The concepts and applications presented in QMS20 can be used to identify and promote the principles of quality cost management for detecting and removing the costs of waste and errors.
Buy QMS20
QMS20 Blog
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Learn about CLSI''s featured products, webinars, and more.
April 2020
In This Issue
? COVID-19 Resources
? Get Involved
? Featured Products
? Documents for Public Review
? The Latest News From CLSI
? Members Get More
COVID-19 Resources
With a global pandemic underway, CLSI''s mission to "develop clinical and laboratory practices and promote their use worldwide" is more relevant than ever before. CLSI recognizes the important contributions of laboratory professionals and the health care community and applauds their efforts in the global fight against COVID-19.
We''ve compiled a list of documents and other helpful resources for the laboratory community and made some additional documents free for a limited time.
View List
Featured Products
MR08 |
Cefazolin Breakpoints for Enterobacterales (Uncomplicated Urinary Tract Infections), 1st Edition
M29 |
Protection of Laboratory Workers From Occupationally Acquired Infections, 4th Edition
GP36 |
Planning for Laboratory Operations During a Disaster, 1st Edition
Shop Now
Read the Latest From CLSI
On the CLSI blog you can learn about newsworthy laboratory topics and how we help make the world a healthier place. Our latest blog posts include:
Standardization in Molecular Diagnostics: More Critical Now Than Ever
Antimicrobial Resistance and the COVID-19 Pandemic
COVID-19 Testing Information and Resources for Laboratories
View Articles
Get Involved With CLSI
We''re currently requesting nominations for volunteers to serve on a document development committee for:
C38: Control of Preexamination Variation in Trace Element Determinations, 2nd Edition
Signup Deadline: May 22, 2020
Learn More
* Login is required. Not registered? Sign up here.
Documents for Public Review
Help shape the standards that affect your day-to-day work. To preserve the integrity of standards developed through the CLSI consensus process, we seek input from the public on our in-process draft documents before they are approved for publication. Opening the dialogue to CLSI members and nonmembers alike, we encourage your involvement in shaping our documents to ensure all interested parties are given a voice.
View Documents
Members Get More
CLSI membership is the best way for you and your organization to:
Stay up to date with the latest in testing methodologies and QC.
Contribute to the development of the standards you use every day.
Strengthen your CV and network with colleagues from around the globe.
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Wayne, PA 19087 USA
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2020 Call for Nominations
Dear CLSI Members, Customers, and Colleagues:
It is time to nominate individuals to serve on the CLSI Board of Directors for the 2020 election cycle. Please propose the names of individuals for Nominating Committee consideration.
Open positions include:
.
1 Officer - Treasurer (2-year term beginning January 1, 2021)
.
1 Director - Professions Constituency (3-year term beginning January 1, 2021)
.
1 Director - Industry Constituency (3-year term beginning January 1, 2021)
.
1 Director - Government Constituency (3-year term beginning January 1, 2021)
The Call for Nominations is now open through August 26, 2020.
Nominate a Candidate
Sincerely,
Victor Waddell, PhD, MS
Chair, CLSI Nominating Committee
Clinical and Laboratory Standards Institute
PO Box 633, Annapolis Junction, MD 20701 USA
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New From CLSI
VET03 and Its Supplement (VET04)
Find methods for broth dilution and disk diffusion (VET03) and corresponding data tables (VET04) for testing aquatic bacteria.
Together, these documents contain best practices from scientists in the veterinary laboratory medicine field and their recommendations for conducting antimicrobial susceptibility testing (AST) on bacteria isolated from aquatic animals.
These documents discuss:
.
Major revisions and updated breakpoint data.
.
Indications for performing antimicrobial susceptibility tests.
.
Special considerations for testing fastidious, atypical, and psychrophilic isolates.
"These documents have been updated and reorganized with the end-user in mind, with input from global experts in aquatic medicine. CLSI VET03 and VET04 are must-have documents for any laboratory supporting clinical diagnostics or antimicrobial resistance surveillance efforts in aquaculture."
- Brian V. Lubbers, DVM, PhD, DACVCP, Chairholder of VET03 and VET04
Buy Today
Clinical and Laboratory Standards Institute
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Suite 2500, Wayne, PA 19087 USA
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September 2020
In this edition:
.
New Products
.
COVID-19 Testing Resources
.
Latest Insights
.
Volunteer Opportunities
.
Global Training Updates
.
Membership Highlights
New Products
MM13
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd Edition
This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.
POCT14
Point-of-Care Coagulation Testing and Anticoagulation Monitoring, 2nd Edition
POCT14 contains critical information for users and manufacturers of point-of-care coagulation testing devices for monitoring heparin and vitamin K antagonist therapy.
GP42 - Preorder
Collection of Capillary Blood Specimens, 7th Edition
This standard provides procedures for collection of capillary blood specimens. Specifications for collection sites, puncture depth, and disposable devices used to collect, process, and transfer capillary blood specimens are also included.
Shop Now
Upcoming Live Webinars
.
GP42 Webinar - 20/20 Vision of Change for the Collection of Capillary Blood Specimens
Tuesday, September 22, 2020 | 1:00 PM Eastern (US) Time
Speaker: Nancy Glasgow-Roberts, PBT(ASCP)
.
Passing-Bablok Regression Webinar - Robust Regression Techniques for Method Comparison
Tuesday, October 6, 2020 | 1:00 PM Eastern (US) Time
Speaker: Florian Dufey, PhD
Register Today
COVID-19 Testing Resources
We have compiled a list of helpful CLSI documents for the laboratory community's use during the COVID-19 pandemic.
You can view the related documents, learn how they help with COVID-19 testing, and access sample pages. Plus, some CLSI documents are free for a limited time! We''ve also added a handful of free overview webinars for you to learn more about how these documents can help your laboratory.
View Resources
Latest Insights
Read our blog to learn more about susceptibility interpretation of the Candida parapsilosis species complex, veterinary antimicrobial susceptibility testing, and selecting a referral laboratory.
Read the Latest
Volunteer Opportunities
Applications for volunteer positions are now being accepted for:
.
A document development committee for a new document: POCT18-Test Selection Process for CLIA-Waived Complexity Testing for SARS-CoV-2, Respiratory Syncytial Virus, and Influenza, 1st ed.
.
A document development committee for a new document: NBS12-Newborn Screening for Galactosemia, 1st ed.
.
A document development committee for a document revision: MM23-Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 2nd ed.
.
A document development committee for a document revision: EP23-Laboratory Quality Control Based on Risk Management, 2nd ed.
.
Voting members on Consensus Council
.
Volunteers on Expert Panels
.
Volunteers to serve as reviewers for the Subcommittee on Veterinary Antimicrobial Susceptibility Testing.
.
A document development committee for a new document: PRE05-Urine Specimen Collection, 1st ed.
Learn More
Global Training Updates
As the COVID-19 pandemic continues, our Global Health Partnerships team has pivoted from its normal programming in our global health security agenda portfolio to support a request for biosafety, QMS, and molecular training of COVID-19 testing. This support effort is currently underway with our colleagues in Zanzibar through a series of virtual trainings.
Learn More
Members Get More
As a CLSI member, you have access to the most up-to-date laboratory standards. Using CLSI products is crucial to ensuring that patients receive the best care based on the most accurate test results.
Learn how CLSI membership can help improve your lab.
Part of a laboratory system? CLSI also offers a Health System Membership to cover multiple sites. Learn more here.
Current Member Login
Learn About Membership
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701
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Upcoming Webinars
Register today for these upcoming webinars!
POCT14 Webinar | Coagulation Testing at the Point-of-Care
Thursday, September 10, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Marcia L. Zucker, PhD, FAACC
At the end of this webinar, participants will be able to:
.
Discuss how differing point-of-care (POC) technologies may impact coagulation test results.
.
Discuss the appropriate ways to compare POC and laboratory coagulation assays for both monitoring anticoagulation therapy and evaluating hemostatic function.
.
Describe the different clinical applications for ACT and APTT.
.
Manage clinician expectations when implementing POC coagulation testing.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
GP42 Webinar | 20/20 Vision of Change for the Collection of Capillary Blood Specimens
Tuesday, September 22, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Nancy Glasgow-Roberts PBT (ASCP)
In this webinar you''ll learn:
.
Why it is essential to follow the updated capillary blood collection standards.
.
How the standards changed in the new document revision and why.
.
What your laboratory may need to change to adhere to the new standards.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
Passing-Bablok Regression Webinar | Robust Regression Techniques for Method Comparison
Tuesday, October 6, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Florian Dufey, PhD
In this webinar you''ll learn:
.
How robust regression techniques (Theil-Sen and Passing-Bablok regression) for method comparison are derived and how they work.
.
The assumptions underlying the different methods.
.
How these methods compare to non-robust methods like linear or Deming regression.
Cost: $99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
View All Webinars
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701 USA
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CLSI Excellence Awards
Call for Nominations
Submit Your Nomination Today!
A CLSI Excellence Award is one of the highest honors CLSI can bestow upon a volunteer. You can nominate a colleague for a CLSI Excellence Award in your choice of three categories. Please view the award descriptions here.
Submitting an Excellence Award nomination is easy. Any individual may submit a nomination for a CLSI award recipient. The nominee must be a CLSI member in good standing. There is no limit to the number of nominations one may submit. However, award recipients may only receive a particular award once every seven years. Please view our list of past award recipients here.
Submit your official nomination via the form below. Please remember to include all the required information.
The deadline for submissions is October 15, 2020, 11:59 PM Eastern (US) Time.
Nominate a Colleague
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Download CLSI''s 2020 Catalog!
The Clinical and Laboratory Standards Institute (CLSI) is the global leader in the standardization of medical laboratory best practices that can help you deliver more accurate results and improved patient outcomes. Use our catalog to ensure your organization has the most recent editions of our documents.
2020 Catalog
In this catalog, you'll find our full listing of truly neutral consensus-based guidelines that are easy to access, easy to use, and enable everyone from medical technologists to quality control managers to improve the outcomes of their laboratory testing. CLSI documents are offered in PDF, print, and/or subscription format.
View the Catalog
Clinical and Laboratory Standards Institute (CLSI)
PO Box 633, Annapolis Junction, MD 20701 USA
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Current Openings:
A document development committee for a document revision: MM23-Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 2nd ed.
Apply on or before 25 September 2020.
View and Apply
A document development committee for a document revision: EP23-Laboratory Quality Control Based on Risk Management, 2nd ed.
Apply on or before 28 September 2020.
View and Apply
Voting members on CLSI''s Consensus Council
Apply on or before 30 September 2020.
View and Apply
Volunteers on CLSI''s Expert Panels
Apply on or before 30 September 2020.
View and Apply
Volunteers to serve as reviewers for the Subcommittee on Veterinary Antimicrobial Susceptibility Testing.
Apply on or before 30 September 2020.
View and Apply
A document development committee for a new document: PRE05-Urine Specimen Collection, 1st ed.
Apply on or before 1 October 2020.
View and Apply
A document development committee for a new document: NBS12-Newborn Screening for Galactosemia, 1st ed.
Apply on or before 23 October 2020.
View and Apply
View All Opportunities
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701 USA
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New Free Webinars for COVID-19
Testing Documents
Access over 10 overview webinars about our key COVID-19-related documents.
Learn about why these documents were created, how you can implement them, and why they are more important now than ever during the COVID-19 pandemic.
M40 Free Overview Webinar
M40 Overview: Quality Control of Microbiological Transport Systems
Ensuring your staff has the knowledge they need to properly prepare specimens for transport is critical to the safety of your staff. The M40 webinar can help your lab use M40, which includes information on considerations for selecting microbiological transport devices, quality control (QC) of microbiological transport devices, and more.
M29 Free Overview Webinar
M29 Overview: Protection of Laboratory Workers From Occupationally Acquired Infection
Keep your staff safe from the threat of infection with this overview webinar that covers the use of M29 for biological risk assessment, implementing standard laboratory practices, and more.
MM06 Free Overview Webinar
MM06 Overview: Quantitative Molecular Methods for Infectious Diseases
Molecular assay testing is used to identify COVID-19 positive patients. The MM06 webinar can help you use MM06 to learn about specimen collection issues affecting molecular quantification, guidance for verification and validation, and more.
View All Webinars
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701 USA
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July 2020
In this edition:
.
New Products
.
COVID-19 Testing Resources
.
Latest Insights
.
Volunteer Opportunities
.
Global Training Updates
.
Membership Highlights
New Products
M59
Epidemiological Cutoff Values for Antifungal Susceptibility Testing, 3rd Edition
Get the latest epidemiological cutoff values generated using the reference broth dilution methods described in CLSI microbiology standards M27 and M38.
M60
Performance Standards for Antifungal Susceptibility Testing of Yeasts, 2nd Edition
This document provides updated minimal inhibitory concentration, zone diameter, and quality control tables for the CLSI antifungal susceptibility testing documents M27 and M44.
M61
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi, 2nd Edition
M61 provides minimal inhibitory concentration breakpoints and quality control tables for the CLSI antifungal susceptibility testing documents M38 and M51.
Shop Now
COVID-19 Testing Resources
We have compiled a list of helpful CLSI documents for the laboratory community's use during the current COVID-19 pandemic.
You can view the related documents, learn how they help with COVID-19 testing, and access sample pages. Plus, some CLSI documents are free for a limited time!
View Resources
Latest Insights
Learn about validation and verification of molecular diagnostics testing and keep up with the latest laboratory news by checking out our blog.
Read the Latest
Volunteer Opportunities
Apply to volunteer on a document development committee for:
EP19-A Framework for Using CLSI Documents to Evaluate Medical Laboratory Measurement Procedures, 3rd ed.
Apply on or before 20 July 2020.
M66-Methods for Active Surveillance of Multidrug-Resistant Organisms, 1st ed.
Apply on or before 6 August 2020.
Learn More
Global Training Updates
CLSI's Global Health Partnerships (GHP) team continues working to convert face-to-face training and mentorship into virtual programs where trainees can maintain their access to the technical support needed to meet their laboratory quality goals.
CLSI recently signed a contract to develop and implement an antimicrobial resistance (AMR) external quality assessment (EQA) qualification program in collaboration with the African Society for Laboratory Medicine (ASLM) and its consortium partners under a Fleming Fund EQA grant for Africa (EQUAFRICA).
In further support of building and strengthening local capacity for equipment maintenance and calibration, CLSI signed a second contract with The Institute for Health Research, Epidemiological Surveillance and Training (IRESSEF) to continue work with partners to assist regional calibration centers to implement quality management systems and prepare for ISO 17025 accreditation
Learn More
Members Get More
As a CLSI member, you have access to the latest laboratory standards. CLSI documents and products are crucial to ensuring that patients receive the best care based on the most accurate test results.
Learn how CLSI membership can help improve your lab.
Part of a laboratory system? CLSI also offers a Health System Membership to cover multiple sites. Learn more here.
Current Member Login
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Clinical and Laboratory Standards Institute
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New From CLSI
M59, M60, M61
Find the most up-to-date antifungal susceptibility testing data with these new editions of CLSI's M59, M60, and M61. Using the most current data available is crucial to the accurate reporting that leads to the best patient care and outcomes.
Now more than ever, with the increased spread of antimicrobial resistance, health care providers rely on the lab to provide them with accurate results that inform treatment decisions.
These documents discuss:
.
Epidemiological cutoff values for antifungal testing.
.
MIC, zone diameter, and quality control tables.
.
Susceptibility testing for filamentous fungi.
Buy Today
Learn about antimicrobial resistance during the COVID-19 pandemic in our blog post.
Read Today
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Upcoming Webinar
Register today for this upcoming webinar!
Passing-Bablok Regression Webinar | Robust Regression Techniques for Method Comparison
Tuesday, October 6, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Florian Dufey, PhD
In this webinar you''ll learn:
.
How robust regression techniques (Theil-Sen and Passing-Bablok regression) for method comparison are derived and how they work.
.
The assumptions underlying the different methods.
.
How these methods compare to non-robust methods like linear or Deming regression.
Cost: $99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
View All Webinars
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Download CLSI''s 2020 Catalog!
The Clinical and Laboratory Standards Institute (CLSI) is the global leader in the standardization of medical laboratory best practices that can help you deliver more accurate results and improved patient outcomes.
2020 Catalog
In this catalog, you'll find our full listing of truly neutral consensus-based guidelines that are easy to access, easy to use, and enable everyone from medical technologists to quality control managers to improve the outcomes of their laboratory testing. CLSI documents are offered in PDF, print, and/or subscription format.
Download for Free
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Upcoming Webinars
Register today for these upcoming webinars!
POCT14 Webinar | Coagulation Testing at the Point-of-Care
Thursday, September 10, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Marcia L. Zucker, PhD, FAACC
At the end of this webinar, participants will be able to:
.
Discuss how differing point-of-care (POC) technologies may impact coagulation test results.
.
Discuss the appropriate ways to compare POC and laboratory coagulation assays for both monitoring anticoagulation therapy and evaluating hemostatic function.
.
Describe the different clinical applications for ACT and APTT.
.
Manage clinician expectations when implementing POC coagulation testing.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
GP42 Webinar | 20/20 Vision of Change for the Collection of Capillary Blood Specimens
Tuesday, September 22, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Nancy Glasgow-Erickson, PBT (ASCP)
In this webinar you''ll learn:
.
Why it is essential to follow the updated capillary blood collection standards.
.
How the standards changed in the new document revision and why.
.
What your laboratory may need to change to adhere to the new standards.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
Passing-Bablok Regression Webinar | Robust Regression Techniques for Method Comparison
Tuesday, October 6, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Florian Dufey, PhD
In this webinar you''ll learn:
.
How robust regression techniques (Theil-Sen and Passing-Bablok regression) for method comparison are derived and how they work.
.
The assumptions underlying the different methods.
.
How these methods compare to non-robust methods like linear or Deming regression.
Cost: $99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
View All Webinars
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Do you have the latest version?
Proper collection and storage techniques are essential to molecular specimen integrity.
MM13-Ed2
This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.
Buy Today
Ensure your lab has the knowledge and tools needed to perform accurate COVID-19 and other molecular testing. To learn more about how MM13 can help your lab, read the MM13 press release.
MM13 Press Release
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Resources Helpful for COVID-19 Testing
CLSI Documents Related to COVID-19 Testing
We''ve compiled a list of documents identified as helpful for the laboratory community's use during the current pandemic.
Learn about these documents, how they help with COVID-19 testing, and access their sample pages.
View Document List
New Free Documents
For a limited time, we''re offering additional documents for free. Find these products on our website and check-out through the online store (no credit card required).
Or, use our new online portal that provides easy access to our free COVID-19 related documents. Simply enter your e-mail address to gain digital access to these documents.
Access Free Documents
Additional Resources
Our member organizations are doing some amazing work during this time. To share some of this work, we have compiled a list of resources that we have found useful lately.
Learn what you need to know, map the virus, find a testing directory, add a new podcast to your queue, and more.
See Additional Resources
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Just Published From CLSI
In these document revisions, the methods for broth dilution and disk diffusion (VET03) and corresponding data tables (VET04) for testing aquatic bacteria were updated. They contain the current best practices from scientists in the field and their recommendations for conducting antimicrobial susceptibility testing (AST) on bacteria isolated from aquatic animals.
Used together, the tables presented in VET04 represent the most current information for drug selection, interpretation, and quality control using the procedures standardized in VET03.
VET03
Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 2nd Edition
This guideline provides the most up-to-date techniques for the determination of minimal inhibitory concentrations and zones of inhibition of aquatic bacteria and criteria for data interpretation and quality control testing.
Date of Publication: May 20, 2020
Learn More
VET03 Supplement (VET04)
Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 3rd Edition
This document includes updated tables for the Clinical and Laboratory Standards Institute veterinary antimicrobial susceptibility testing guideline VET03.
Date of Publication: May 20, 2020
Learn More
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Why are these documents important?
One Health, or the idea that the health and wellness of all living things on this planet is interconnected, makes veterinary AST just as important as human AST. Learn about how CLSI has promoted the values of the One Health Initiative through its AST subcommittees that establish testing standards for the human and veterinary laboratory sectors.
Read Now
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Current Openings:
A document development committee for a document revision: M56-Principles and Procedures for Detection of Anaerobes in Clinical Specimens, 2nd ed.
Apply on or before 31 August 2020.
View and Apply
Reviewers for the Subcommittee on Antifungal Susceptibility Tests. Representatives of industry (nonpharmaceutical) and government are especially needed.
Apply on or before 31 August 2020.
View and Apply
Reviewers for the Subcommittee on Antimicrobial Susceptibility Testing (AST). Representatives of industry (nonpharmaceutical) and government are especially needed.
Apply on or before 31 August 2020.
View and Apply
A document development committee for a new document: POCT18-Test Selection Process for CLIA-Waived Complexity Testing for SARS-CoV-2, Respiratory Syncytial Virus, and Influenza, 1st ed.
Apply on or before 14 September 2020.
View and Apply
A document development committee for a new document: NBS12-Newborn Screening for Galactosemia, 1st ed.
Apply on or before 25 September 2020.
View and Apply
A document development committee for a document revision: MM23-Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 2nd ed.
Apply on or before 25 September 2020.
View and Apply
A document development committee for a document revision: EP23-Laboratory Quality Control Based on Risk Management, 2nd ed.
Apply on or before 28 September 2020.
View and Apply
View All Opportunities
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CLSI Excellence Awards
Call for Nominations
Submit Your Nomination Today!
A CLSI Excellence Award is one of the highest honors CLSI can bestow upon a volunteer. You can nominate a colleague for a CLSI Excellence Award in your choice of three categories. Please view the award descriptions here.
Submitting an Excellence Award nomination is easy. Any individual may submit a nomination for a CLSI award recipient. The nominee must be a CLSI member in good standing. There is no limit to the number of nominations one may submit. However, award recipients may only receive a particular award once every seven years. Please view our list of past award recipients here.
Submit your official nomination via the form below. Please remember to include all the required information.
The deadline for submissions is October 15, 2020, 11:59 PM Eastern (US) Time.
Nominate a Colleague
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Let CLSI Document QMS05-Ed3 Be Your Guide!
Qualifying, Selecting, and Evaluating a Referral Laboratory
This guideline provides recommended criteria and easily implemented processes to qualify, select, and evaluate a referral laboratory.
The recommendations in this guideline include activities necessary to meet international and national published requirements for referral laboratories.
Document Highlights
QMS05 provides information on:
.
Identifying expectations for service.
.
Developing an agreement with a referral laboratory.
.
Applying service metrics.
Shop Now
Learn More
For more information on selecting a referral laboratory, check out our new blog post.
QMS05 Blog
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Laboratory Quality Management System (LQMS) Certificate Program
Updated Online Course
Our self-paced Laboratory Quality Management System (LQMS) Certificate Program has been updated!
New Version Released: November 2020
This online learning program provides the most up-to-date information for the implementation and sustainment of a quality management system (QMS) in your laboratory. Based on the latest edition of QMS01-A Quality Management System Model for Laboratory Services, this program provides a process-oriented approach to meeting quality objectives.
The new LQMS includes:
.
Access to the latest edition of QMS01.
.
13 self-paced online learning modules taught by quality experts.
.
The ability to earn 13 P.A.C.E.? CE credits.*
Learn to deliver consistent, high-quality, and cost-effective laboratory services with CLSI''s LQMS Certificate Program.
Early bird special! For a limited time, take 20% off $750 and get access for $600 (nonmember rate, member discounts apply).
Learn More
*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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Do you have the latest version?
EP06 provides manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval.
EP06-Ed2
This guideline provides information for characterizing the linearity interval of a measurement procedure, validating a linearity interval claim (to be performed by the manufacturer), and verifying an established linearity interval claim (to be performed by the end user).
Robert McEnroe, PhD, Chairholder of EP said, "EP06 2nd Edition provides guidance during validation and verification processes end to end. Enhancement of graphical representations and understandable worked examples allow the reader to better interpret robustness and potential limitations of an assay's linearity."
Buy EP06
Read More on EP06
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Laboratory Quality Management System (LQMS) Certificate Program
Updated Online Course
Our self-paced Laboratory Quality Management System (LQMS) Certificate Program has been updated!
New Version Released: November 2020
This online learning program provides the most up-to-date information for the implementation and sustainment of a quality management system (QMS) in your laboratory. Based on the latest edition of QMS01-A Quality Management System Model for Laboratory Services, this program provides a process-oriented approach to meeting quality objectives.
Product Highlights
The new LQMS includes:
.
Access to the latest edition of QMS01.
.
13 self-paced online learning modules taught by quality experts.
.
The ability to earn 13 P.A.C.E.? CE credits.*
Learn to deliver consistent, high-quality, and cost-effective laboratory services with CLSI''s LQMS Certificate Program.
Early bird special! For a limited time, take 20% off $750 and get access for $600 (nonmember rate, member discounts apply).
Learn More
* 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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New From CLSI
MM13-Ed2
This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.
Elizabeth Sheppard, MBA, HT(ASCP), Chairholder of MM13, said, "Bringing together a group of subject matter experts, we were able to update the CLSI MM13 document to include mainstream advancements in molecular methods and various specimen types."
MM13 discusses:
.
Selecting commercial sample preparation methods.
.
Enriching and selecting cells.
.
DNA and RNA Storage.
MM13 has been identified as a document helpful for laboratories performing COVID-19 testing. For more useful COVID-19 resources, visit our website.
Buy Today
MM13 Press Release
COVID-19 Resources
Clinical and Laboratory Standards Institute
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QMS20
The Cost of Quality in Medical Laboratories, 2nd Edition
This guideline helps laboratories understand, apply, track, and manage the different types of quality costs that affect their processes, services, and financial well-being.
Corrections needed for improperly ordered examinations, unacceptable specimens, QC failures, lost reports, and erroneous results increase laboratory and organizational costs and can adversely affect patient care.
DATE OF PUBLICATION: November 9, 2020
Learn more about how QMS20 can help you manage costs and reduce nonconformances by reading our blog post.
Shop Now
QMS20 Blog Post
Upcoming Related Webinar
QMS20-Ed2 Webinar | The Cost of Quality in Medical Laboratories
Time: Thursday, December 17, 2020 | 1:00-2:00 PM Eastern (US) Time Speaker: Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE Cost per attendee: $50.00. Member discounts apply; Free for Level I and Health System members.
1 P.A.C.E.? CE Credit will be provided. CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.? Program.
In this webinar you will learn:
.
What''s new in the updated edition of QMS20.
.
How to list, describe, and provide laboratory examples of the types of quality costs.
.
Ways to distinguish between costs that support good quality and those that result from poor quality.
.
How to use basic tools to quantify laboratory failure quality costs.
Register Here
Clinical and Laboratory Standards Institute
CLSI
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EP06
Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition
This recently updated guideline provides information for characterizing the linearity interval of a measurement procedure, validating a linearity interval claim (to be performed by the manufacturer), and verifying an established linearity interval claim (to be performed by the end user).
DATE OF PUBLICATION: November 24, 2020
EP06 provides manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval.
Document Highlights
EP06 provides the most recent information on:
.
Validating and verifying the measurement procedure linearity interval.
.
Preparing and testing linearity panel samples.
.
Matrix effects.
Shop Now
Learn More
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QMS01-Ed5
A Quality Management System Model for Laboratory Services
Reduce nonconformances and help your lab pass and maintain accreditation with QMS01. This document will show you how to develop and implement a quality management system that fits your lab's unique needs.
QMS01 provides a structure for a comprehensive, systematic approach to building quality into the laboratory's processes, assessing the laboratory's performance, implementing quality improvements, and more.
Document Highlights
QMS01 provides information on:
.
The quality management essentials.
.
The laboratory's path of workflow.
.
Implementing a quality management system.
Get QMS01 Today
QMS01CL | Gap Analysis Checklists, 1st Edition
These 12 checklists provide a model for medical laboratories to organize the implementation and maintenance of an effective quality management system.
These checklists are available in electronic form only.
The QMS01 Gap Analysis Checklists cover topics such as:
.
Facilities and safety management.
.
Organizational leadership.
.
Continual improvement.
Learn More
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New From CLSI
QMS05-Ed3
Learn how to find a qualified referral lab for backup service, consultation services, or esoteric examinations not regularly performed in your lab. Easy-to-follow step-by-step processes to qualify, select, and evaluate a referral lab can be found in this updated edition of QMS05.
The document includes flowcharts and appendixes with helpful worksheets and an approved referral laboratory list to assist you in finding a provider that will meet your lab's unique needs.
This document discusses:
.
Identifying expectations for service.
.
Developing an agreement with the referral lab.
.
Evaluating performance of the referral lab.
Buy Today
CLSI''s Quality Systems Essentials are the backbone of all of our Quality Management System documents. Learn about them here in our Blog Post.
Blog Post
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QMS20
The Cost of Quality in Medical Laboratories, 2nd Edition
This guideline helps laboratories understand, apply, track, and manage the different types of quality costs that affect their processes, services, and financial well-being.
DATE OF PUBLICATION: November 9, 2020
Corrections needed for improperly ordered examinations, unacceptable specimens, QC failures, lost reports, and erroneous results increase laboratory and organizational costs and can adversely affect patient care.
Document Highlights
QMS20 provides information on:
.
Nonconforming events costs.
.
Important relationships between quality and cost.
.
Using failure costs to identify improvement projects.
Shop Now
Learn More
QMS20-Ed2 Webinar | The Cost of Quality in Medical Laboratories
Time: Thursday, December 17, 2020 | 1:00-2:00 PM Eastern (US) Time Speaker: Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE Cost per attendee: $50.00. Member discounts apply; Free for Level I and Health System members.
1 P.A.C.E.? CE Credit will be provided. CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.? Program.
In this webinar you will learn:
.
What''s new in the updated edition of QMS20.
.
How to list, describe, and provide laboratory examples of the types of quality costs.
.
Ways to distinguish between costs that support good quality and those that result from poor quality.
.
How to use basic tools to quantify laboratory failure quality costs.
Register
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701 USA
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Do you have the latest version?
For the information you need to properly collect capillary blood specimens, get the newest edition of our trusted standard. GP42 is intended for health care professionals as well as manufacturers of capillary puncture and incision devices and microcollection containers.
GP42-Ed7
This standard provides procedures for collection of capillary blood specimens. Specifications for collection sites, puncture depth, and disposable devices used to collect, process, and transfer capillary blood specimens are also included.
Nancy Glasgow-Roberts, PBT(ASCP), Chairholder of GP42, said, "GP42 was written to help instill the confidence and expertise needed to obtain suitable capillary blood specimens the first time around. The difference between good and great in capillary collections is in the details. The GP42 document development committee was committed to these details. Every health care provider collecting capillary specimens can firmly rely on the information in GP42, and laboratories can implement the information in GP42 into their standard operating procedures with confidence."
Buy Today
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March 2020
In This Issue
? Newsworthy From the CDC
? Get Involved
? Featured Products
? Documents for Public Review
? Global Training Updates
? Members Get More
Newsworthy From the CDC
Today, Monday, March 23, at 3:00 PM Eastern (US) Time, the CDC''s Division of Laboratory Systems will convene a weekly call with clinical laboratories to discuss the nation''s clinical laboratory response to coronavirus disease (COVID-19). This call is the first of a series of weekly calls the division will host to discuss hot topics and to solicit the laboratory community''s questions about the national response to the COVID-19 pandemic. These Clinical Laboratory COVID-19 Response Calls will take
place every Monday at 3:00 PM ET.
CDC encourages you to invite colleagues to join the call as well as share this message. Join online or dial in using the Zoom information:
For higher quality, dial the number closest to your current location:
+1 312 626 6799/Passcode 327712608#
+1 929 205 6099/Passcode 327712608#
+1 253 215 8782/Passcode 327712608#
+1 301 715 8592/Passcode 327712608#
+1 346 248 7799/Passcode 327712608#
+1 669 900 6833/Passcode 327712608#
International numbers available: https://zoom.us/u/aekABTPTfG
Featured Products
M100|
Performance Standards for Antimicrobial Susceptibility Testing, 30th Edition
EP19-Ed2 Free|
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition
EP35|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition
Shop Now
Upcoming Webinars
Free EP19 Webinar:
Help Validate and Verify Laboratory Developed Tests: Using EP19, A Framework for Using CLSI Documents
Tuesday, April 7, 2020 | 1:00-2:00 PM Eastern (US) Time
Speaker:
Marcia L. Zucker, PhD, FAACC
President, ZIVD LLC
Earn 1 PACE?
CE credit. FREE. Registration required.
CLIA Webinar
Setting up the Clinical Laboratory: What to Think About Before You Start
Thursday, April 30, 2020 | 1:00-2:00 PM Eastern (US) Time
Speaker:
Mark D. Kellogg, PhD, MT(ASCP), DABCC
Director of Quality Programs and Associate Director of Chemistry, Deptartment of Laboratory Medicine, Boston Children''s Hospital, Assistant Professor of Pathology, Harvard Medical School
Earn 1 PACE?
CE credit. Registration required.
Register Today
Global Training Updates
Earlier this month CLSI''s Global Health Partnerships (GHP) team was in Tanzania facilitating two workshops. One workshop covered method validation and QC, and the other discussed root cause analysis and corrective action. Participants will apply the knowledge gained in these quality management system workshops to prepare their laboratories for international accreditation.
Learn more about what CLSI''s GHP does around the world to help laboratories improve testing and pass and maintain accreditation.
Learn More About GHP
Get Involved With CLSI
Enhance your career path by collaborating with like-minded professionals to improve laboratory medicine. Our volunteers work with leading experts to develop the most trusted medical laboratory standards in the world. Learn more about the many benefits of becoming a CLSI volunteer.
Learn More
* Login is required. Not registered? Sign up here.
Documents for Public Review
Help shape the standards that affect your day-to-day work. To preserve the integrity of standards developed through the CLSI consensus process, we seek input from the public on our in-process draft documents before they are approved for publication. Opening the dialogue to CLSI members and nonmembers alike, we encourage your involvement in shaping our documents to ensure all interested parties are given a voice.
View Documents
Members Get More
CLSI membership offers you and your organization significant discounts on CLSI standards and products and gives you access to career-enhancing opportunities like networking and volunteering alongside some of the leading experts in your field.
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New Free Webinars for COVID-19 Testing Documents
Free Webinars
Access overview webinars of our key COVID-19-related documents.
Learn about why these documents were created, how you can implement them, and why they are more important now than ever during the COVID-19 pandemic.
Download for Free
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New From CLSI
M23S
This document describes the necessary technical steps for establishing the optimal disk content (potency) for single antimicrobial agents without the addition of enhancing or inhibiting substances.
This document is available in electronic format only.
M23 describes the data used to establish breakpoints and QC ranges for antimicrobial agents, including:
.
Microbiological data.
.
PK and PD characteristics.
.
Clinical data.
Get it For Free Today
Learn more about the interplay of pharmacokinetics and pharmacodynamics of antimicrobial agents by reading an article by Patricia J. Simner and Linda Miller here.
Read Article
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New Free Resources for COVID-19 Testing
New - Free Webinars
Free overview webinars of our key COVID-19 documents are now available.
Learn about why these documents were created, how you can implement them, and why they are more important now than ever during the COVID-19 pandemic.
Download for Free
CLSI Documents Related to COVID-19 Testing
We''ve compiled a list of documents identified as helpful for the laboratory community's use during the current pandemic.
Learn about these documents, how they help with COVID-19 testing, and access their sample pages.
View Document List
Free Documents
For a limited time, we''re offering additional documents for free. Find these products on our website and check out through the online store (no credit card required).
Or, use our new online portal that provides easy access to our free COVID-19 related documents. Simply enter your e-mail address to gain digital access to these documents.
Access Free Documents
Additional Resources
Our member organizations are doing some amazing work during this time. To share some of this work, we have compiled a list of resources that we have found useful lately.
Learn what you need to know, map the virus, find a testing directory, add a new podcast to your queue, and more.
See Additional Resources
Clinical and Laboratory Standards Institute
950 West Valley Road
Suite 2500, Wayne, PA 19087 USA
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Upcoming Webinars
Register today for these upcoming webinars!
POCT14 Webinar | Coagulation Testing at the Point-of-Care
Thursday, September 10, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Marcia L. Zucker, PhD, FAACC
At the end of this webinar, participants will be able to:
.
Discuss how differing point-of-care (POC) technologies may impact coagulation test results.
.
Discuss the appropriate ways to compare POC and laboratory coagulation assays for both monitoring anticoagulation therapy and evaluating hemostatic function.
.
Describe the different clinical applications for ACT and aPTT.
.
Manage clinician expectations when implementing POC coagulation testing.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
Register
GP42 Webinar | 20/20 Vision of Change for the Collection of Capillary Blood Specimens
Tuesday, September 22, 2020 | 1:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speaker: Nancy Glasgow-Erickson, PBT (ASCP)
In this webinar you''ll learn:
.
Why it is essential to follow the updated capillary blood collection standards.
.
How the standards changed in the new document revision and why.
.
What your laboratory may need to change to adhere to the new standards.
$99.00. Member discounts apply.
1 P.A.C.E.? CE Credit will be provided.
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Clinical and Laboratory Standards Institute
CLSI
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Annapolis Junction, MD 20701 USA
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New From CLSI
GP42-Ed7
This standard provides procedures for collection of capillary blood specimens. Specifications for collection sites, puncture depth, and disposable devices used to collect, process, and transfer capillary blood specimens are also included.
Proper capillary blood collection and handling procedures are critical to accurately reflect patient physiology. GP42 provides essential guidance to help health care workers safely collect quality capillary specimens.
GP42 discusses:
.
Patient assessment and positioning.
.
Specimen collection and labeling.
.
Special considerations.
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Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701 USA
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2020 Call for Nominations
Dear CLSI Members, Customers, and Colleagues:
It is time to nominate individuals to serve on the CLSI Board of Directors for the 2020 election cycle. Please propose the names of individuals for Nominating Committee consideration.
Open positions include:
.
1 Officer - Treasurer (2-year term beginning January 1, 2021)
.
1 Director - Professions Constituency (3-year term beginning January 1, 2021)
.
1 Director - Industry Constituency (3-year term beginning January 1, 2021)
.
1 Director - Government Constituency (3-year term beginning January 1, 2021)
The Call for Nominations is now open through August 26, 2020.
Nominate a Candidate
Sincerely,
Victor Waddell, PhD, MS
Chair, CLSI Nominating Committee
Clinical and Laboratory Standards Institute
PO Box 633, Annapolis Junction, MD 20701 USA
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Do you have the latest version?
The tables presented in VET01S represent the most current information for drug selection, interpretation, and quality control using the procedures standardized in VET01.
VET01S-Ed5
This document includes updated tables for the Clinical and Laboratory Standards Institute veterinary antimicrobial susceptibility testing standard VET01, which includes the most current recommended methods for disk diffusion susceptibility testing of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution for veterinary use.
Zone diameters and MIC breakpoints for various organisms, including Pseudomonas aeruginosa, Staphylococcus spp., and Actinobacillus pleuropneumoniae, as well as MIC QC ranges and an MIC troubleshooting guide are included.
Get VET01S
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701 USA
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October 2020
In this edition:
.
New Products
.
COVID-19 Testing Resources
.
Latest Insights
.
Volunteer Opportunities
.
Global Training Updates
.
Membership Highlights
New Products
GP42
Collection of Capillary Blood Specimens, 7th Edition
This standard provides procedures for collection of capillary blood specimens. Specifications for collection sites, puncture depth, and disposable devices used to collect, process, and transfer capillary blood specimens are also included.
QMS20 - Preorder
The Cost of Quality in Medical Laboratories, 2nd Edition
This guideline helps laboratories understand, apply, track, and manage the different types of quality costs that affect their processes, services, and financial well-being.
VET01S - Preorder
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals, 5th Edition
This document includes updated tables for the Clinical and Laboratory Standards Institute veterinary antimicrobial susceptibility testing standard VET01.
Shop Now
COVID-19 Testing Resources
We have compiled a list of helpful CLSI documents for the laboratory community's use during the COVID-19 pandemic.
You can view the related documents, learn how they help with COVID-19 testing, and access sample pages. Plus, some CLSI documents are free for a limited time! We''ve also added a handful of free overview webinars for you to learn more about how these documents can help your laboratory.
View Resources
Latest Insights
Read our blog to learn more about World Standards Day 2020, Newborn Screening Awareness Month, and World Patient Safety Day 2020.
Read the Latest
Volunteer Opportunities
Applications for volunteer positions are now being accepted for:
.
CLSI''s Expert Panels (various specialty areas needed)
.
A document development committee for a new document: NBS12-Newborn Screening for Galactosemia, 1st ed.
Learn More
Global Training Updates
Together with Zambia's Ministry of Health and the US CDC, through CLSI''s partnership with Centre for Infectious Disease Research in Zambia-Lab Innovation for Excellence (CIDRZ LIFE), two laboratories recently underwent initial accreditation assessments. Both laboratories were recommended for accreditation aligned with ISO 15189. A third laboratory had a surveillance visit and added two of its specialized laboratories to the accreditation scope. CLSI mentors are now working with these laboratories to develop a corrective action plan that will address the few nonconformances identified during the assessments.
Learn More
Members Get More
As a CLSI member, you have access to the most up-to-date laboratory standards. Using CLSI products is crucial to ensure patients receive the best care based on the most accurate test results.
Learn how CLSI membership can help improve your lab.
Part of a laboratory system? CLSI also offers a Health System Membership to cover multiple sites. Learn more here.
Current Member Login
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Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701
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New From CLSI
POCT14-Ed2
This guideline provides recommendations to users and manufacturers of point-of-care coagulation testing devices for monitoring heparin and vitamin K antagonist therapy and for the evaluation of hemostasis, as well as to ensure reliable results comparable with those obtained by routine medical laboratory testing.
POCT testing provides examination results more rapidly than can be achieved in hospital or reference laboratory settings. This availability is important in intensive care units, emergency departments, operating rooms, and outpatient clinics, in which immediate diagnostic information may help expedite treatment decisions.
POCT14 discusses:
.
Vitamin K antagonists such as PT and INR.
.
Heparin (eg, APTT and ACT).
Information on potential assay interferences, including direct oral anticoagulants are also discussed.
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Clinical and Laboratory Standards Institute
CLSI
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Annapolis Junction, MD 20701 USA
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Do you have the latest version?
Laboratories need a defined process to identify candidate referral laboratories and consultants and qualify them for additional consideration. There are important criteria the lab should consider when undertaking this process. QMS05 walks you through a clear step-by-step process for qualifying the best referral lab or consultant for your needs.
QMS05-Ed3
QMS05 provides invaluable guidance for referral laboratory selection with practical examples of the forms and checklists you'll need for evaluation. Information on using service metrics to perform ongoing performance evaluation once the referral laboratory is selected is also included.
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Clinical and Laboratory Standards Institute
950 West Valley Road
Suite 2500, Wayne, PA 19087 USA
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August 2020
In this edition:
.
New Products
.
COVID-19 Testing Resources
.
Latest Insights
.
Volunteer Opportunities
.
Global Training Updates
.
Membership Highlights
New Products
POCT14
Point-of-Care Coagulation Testing and Anticoagulation Monitoring, 2nd Edition
POCT14 contains critical information for users and manufacturers of point-of-care coagulation testing devices for monitoring heparin and vitamin K antagonist therapy.
GP42 - Preorder
Collection of Capillary Blood Specimens, 7th Edition
This standard provides procedures for collection of capillary blood specimens. Specifications for collection sites, puncture depth, and disposable devices used to collect, process, and transfer capillary blood specimens are also included.
MM13 - Preorder
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd Edition
This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.
Upcoming Live Webinars
.
POCT14 Webinar - Coagulation Testing at the Point-of-Care
Thursday, September 10, 2020 | 1:00 PM Eastern (US) Time
Speaker: Marcia L. Zucker, PhD, FAACC
.
GP42 Webinar - 20/20 Vision of Change for the Collection of Capillary Blood Specimens
Tuesday, September 22, 2020 | 1:00 PM Eastern (US) Time
Speaker: Nancy Glasgow-Erickson, PBT (ASCP)
Shop Now
COVID-19 Testing Resources
We have compiled a list of helpful CLSI documents for the laboratory community's use during the COVID-19 pandemic.
You can view the related documents, learn how they help with COVID-19 testing, and access sample pages. Plus, some CLSI documents are free for a limited time! We''ve also added a handful of free overview webinars for you to learn more about how these documents can help your laboratory.
View Resources
Latest Insights
Read our blog to learn more about the ongoing antimicrobial resistance crisis amidst the COVID-19 pandemic, CLSI''s work in Zambia, and the new edition of POCT14.
Read the Latest
Volunteer Opportunities
Applications for volunteer positions are now being accepted for:
A document development committee for a document revision of M56-Principles and Procedures for Detection of Anaerobes in Clinical Specimens, 2nd ed.
Reviewers on the Subcommittees on Antifungal Susceptibility Tests and Antimicrobial Susceptibility Testing. Representatives of industry (nonpharmaceutical) and government are especially needed.
Apply on or before 31 August 2020.
Learn More
Global Training Updates
CLSI's Global Health Partnerships (GHP) team is pleased to report that two of the laboratories they been working with through the quality management system program in Zambia recently underwent annual surveillance assessments by the accrediting organization, and both laboratories were successful. These assessments were unique because of COVID-19; the accrediting organization used virtual platforms to conduct them.
Learn More
Members Get More
As a CLSI member, you have access to the most up-to-date laboratory standards. Using CLSI products is crucial to ensure that patients receive the best care based on the most accurate test results.
Learn how CLSI membership can help improve your lab.
Part of a laboratory system? CLSI also offers a Health System Membership to cover multiple sites. Learn more here.
Current Member Login
Learn About Membership
Clinical and Laboratory Standards Institute
CLSI
PO Box 633
Annapolis Junction, MD 20701
Manage Preferences | Unsubscribe | View Online
June 2020
In this edition:
.
New Products
.
COVID-19 Testing Resources
.
Latest Insights
.
Volunteer Opportunities
.
Global Training Updates
.
Membership Highlights
New Products
VET03
Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 2nd Edition
Use this essential document for the most up-to date methods in veterinary lab medicine.
VET03 Supplement (VET04)
Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals, 3rd Edition
This document provides corresponding data tables for testing aquatic bacteria and is intended for use with VET03.
QMS05
Qualifying, Selecting, and Evaluating a Referral Laboratory, 3rd Edition
This document provides invaluable guidance for referral laboratory selection with practical examples of the forms and checklists you'll need for evaluation.
Shop Now
COVID-19 Testing Resources
We have compiled a list of helpful CLSI documents for the laboratory community's use during the current COVID-19 pandemic.
You can view the related documents, learn how they help with COVID-19 testing, and access sample pages. Plus, some CLSI documents are free for a limited time!
View Resources
Latest Insights
Learn about validation and verification of molecular diagnostics testing and keep up with the latest laboratory news by checking out our blog.
Read the Latest
Volunteer Opportunities
Apply to volunteer on a Document Development Committee for:
EP19-A Framework for Using CLSI Documents to Evaluate Medical Laboratory Measurement Procedures, 3rd ed.
Apply on or before 20 July 2020.
M66-Methods for Active Surveillance of Multidrug-Resistant Organisms, 1st ed.
Apply on or before 6 August 2020.
Learn More
Global Training Updates
As laboratories in Zambia prepare for accreditation, CLSI mentors and mentor trainees continue to work very closely with the laboratory quality teams to establish their quality management systems. Several of the laboratories have submitted applications for international accreditation and are awaiting their assessments, while others are advancing into the implementation phase of the mentorship.
Learn more about how CLSI's partnerships can provide international outreach services and hands-on support to help your lab achieve sustainable quality with systems designed to better diagnose and treat patients.
Learn More
Members Get More
As a CLSI member, you have access to the latest laboratory standards. CLSI documents and products are crucial to ensuring that patients receive the best care based on the most accurate test results.
Learn how CLSI membership can help improve your lab.
Part of a laboratory system? CLSI also offers a Health System Membership to cover multiple sites. Learn more here.
Current Member Login
Join Today
Clinical and Laboratory Standards Institute
950 West Valley Road
Suite 2500, Wayne, PA 19087 USA
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Upcoming Webinars
Register today for these upcoming webinars!
EP06-Ed2 Webinar | Evaluation of Linearity
Thursday, January 14, 2021 | 1:00-2:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Speakers:
.
Robert J. McEnroe, PhD, Chairholder of EP06 revision
.
Marina V. Kondratovich, PhD, US Food and Drug Administration (FDA)
.
Rhona J. Souers, MS, College of American Pathologists (CAP)
In this webinar you will learn:
.
What''s new in the updated edition of EP06.
.
A simpler method for establishing a linearity interval.
.
A simpler method for verifying an already established linearity interval.
.
How to interpret linearity interval data.
Cost: $50.00 per person. Member discounts apply; free for Level I & Health System members.
1 P.A.C.E.? CE Credit will be provided. CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.? Program.
Register Now
CLSI and CAP 2021 Webinar | Ensuring Quality Beyond the Test: Reporting Antimicrobial Susceptibility Results
Thursday, January 21, 2021 | 1:00-2:00 PM Eastern (US) Time This webinar will be available on-demand following live recording.
Moderator: Romney M. Humphries, PhD, (D)ABMM Speakers: Tanis Dingle, PhD, FCCM, D(ABMM) and Carol Ann Rauch, MD, PhD, FCAP
After this program, participants will be able to:
.
Evaluate how to best report AST results on isolates recovered from the CSF.
.
Describe best practices on reporting AST results for pan-susceptible isolates.
.
Discuss strategies on how to best report results for antimicrobials with no breakpoints.
.
Review impact of taxonomy changes on AST results.
Cost: $30.00 per site. Member discounts do not apply.
Earn 1.0 PACE CE? Credit. 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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