Volunteer
Volunteer to help shape laboratory standards.
Your expertise is in demand. Grab a seat at the table with your colleagues in the health care community and help develop the next generation of medical laboratory testing standards.
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Our step-by-step guide to getting involved.
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Why Volunteer?
Share Your Expertise
Take part in developing the best practice standards that affect the work you do every day.
Enhance Your Career
Grow your professional experience and résumé.
Gain Recognition
Get noticed by CLSI, your organization, your colleagues, and your community.
Network & Connect
Meet people who will be great contacts forever.
How CLSI Standards Are Developed
Our volunteers bring to our standards development process diverse skills, deep experience, and vast knowledge.
"If you're a person who cares about laboratory medicine, about the quality of the results that get to the patient...you really need to volunteer."
Andrew Quintenz
Board of Directors Member, CLSI
Global Scientific & Professional Affairs Manager, Bio-Rad Laboratories, Inc.
Current Opportunities
Don’t see an opportunity in your area of expertise? Complete your volunteer profile to get updates about new opportunities when they’re posted.
Working Group for EP Reviewers
Are you passionate about advancing medical laboratory guidelines for evaluation protocols? Do you possess expertise in any of the following areas:
- Linearity
- Establishment of reference intervals
- ROC curves
- Surrogate samples
- Interference testing
- Lot-to-lot variation
- Qualitative tests
- Reagent stability
- Delta checks
- Extended measuring intervals
- Commutability
- Precision
- Sample stability
If so, the CLSI Expert Panel on Evaluation Protocols (EP) invites you to join our EP Reviewer working group.
Apply on or before 2 August 2024.
As a member of this group, you will play a vital role in supporting various review processes within the expert panel. Your responsibilities may include:
- Conducting periodic reviews of the document library for relevance
- Reviewing proposed draft reviews
- Participating in expert panel reviews
- Assisting in project proposal development and review
- Reviewing documents to ensure mathematical calculations are accurate
This volunteer opportunity offers flexibility as reviewers will not be required to attend meetings. Most of the work can be completed independently and submitted to the CLSI Program Manager. Reviewers can serve up to four years on this panel.
If you have experience in any of the mentioned topics or are eager to become more involved with CLSI, we encourage you to apply! Click the link below to submit your application. For further inquiries or information, please contact Tabby Kern at tkern@clsi.org.
Join us in shaping the future of method evaluation!
Method Navigator Reviewer Group
Seeking volunteers who are well-versed in FDA quality system regulations and CLIA requirements. Your expertise is invaluable and could help us maintain and enhance our comprehensive EP navigation tool, Method Navigator.
Apply on or before 2 August 2024.
The tool guides users through the life of a test, detailing FDA QSRs; CLIA requirements; New York State requirements, and ISO standards. It also connects these requirements with relevant CLSI documents to facilitate successful compliance. This MN Reviewer working group will be responsible for reviewing existing Method Navigator content and making recommendations for new updates and edits. We are looking for individuals in the QMS and EP areas that are familiar with the regulations and requirements, as well as with CLSI documents. Your contributions and expertise will be immensely appreciated, as it will help provide better guidance for LDT developers, manufacturers, and medical laboratories as they establish and implement laboratory tests.
If you have experience in any of the mentioned topics or are eager to become more involved with CLSI, we encourage you to apply! Click the link below to submit your application. For further inquiries or information, please contact Tabby Kern at tkern@clsi.org.
Join us in shaping the future of method evaluation!
Laboratory-Developed Test (LDT) Final Rule Advisory Group
The FDA released the LDT Final Rule on 29 April 2024 and officially published it on 6 May 2024. The Final Rule asserts FDA’s legal authority to regulate LDTs and clarifies that laboratories that manufacture LDTs are subject to the same requirements as IVD manufacturers (ie, premarket review, QSRs, adverse event reporting, establishment registration and device listing, labeling standards, and investigational use requirements). Until this time, FDA has exercised general enforcement discretion over LDTs, opting not to enforce these applicable requirements. The FDA is phasing out its general enforcement discretion of LDTs in five stages over a four-year period (2024–2028). However, there is also a targeted enforcement policy in the final rule that provides limited and provisional enforcement discretion for certain types of LDTs.
In response to the final rule, laboratories are faced with how to navigate an unfamiliar FDA medical device regulatory environment, uncertainty regarding how to meet the new regulations, and tight deadlines associated with the phaseout stages. CLSI is committed to serving as a trusted resource for guidance, tools, and education to assist laboratories with preparing and meeting the new requirements.
Based on this commitment, CLSI is forming the LDT Final Rule Advisory Group to leverage the expertise of our laboratory, industry, and government subject matter experts.
Advisory Group Charge:
The CLSI LDT Final Rule Advisory Group is responsible for providing CLSI with insight and feedback on:
- CLSI’s overall organizational strategy in response to the FDA’s Final Rule: Medical Devices; Laboratory Developed Tests (Final Rule)
- CLSI product development needs to assist laboratories with implementation of the Final Rule
- Communications and communications strategy for content, products, and services related to the FDA Final Rule (eg, surveys, “White papers,” guidances, toolkits, checklists, educational opportunities)
- Identification of issues, challenges, questions, and concerns identified within the laboratory community in response to the Final Rule
- Collaboration opportunities (eg, joint education programs, seeking clarity on regulations from the FDA) with other professional societies or government agencies
- FDA guidances issued after the Final Rule
- Other related needs as they arise
NOTE: The duties and powers of this group are in an advisory capacity only.
Apply on or before 08 August 2024.
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Expertise in laboratory-developed tests and experience with modifying them
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Experience with developing laboratory regulations (ie, government agency representation)
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Experience with implementing government regulations
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Expertise in developing IVDs from a device manufacturer’s perspective
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Expertise from each laboratory area affected by the Final Rule, including but not limited to molecular diagnostics, microbiology and virology, drug testing, and chemistry
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Expertise with common applications of LDTs (eg, oncology, inherited diseases, toxicology, blood coagulation, biomarkers, antimicrobial susceptibility testing, public health surveillance and outbreaks)
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Experience working in various laboratory settings including academic medical centers, urban and rural hospital laboratories (large and small); large and small commercial laboratories, public health laboratories, and specialized settings.
Term of service:
Each Advisor will serve a minimum one-year term. CLSI anticipates that the Advisory Group will remain in operation throughout the FDA LDT enforcement discretion phase-out period until 2028.
Time commitment:
Approximately 10–20 hours annually. Attendance at initial kick-off web conference is required. Additional web conferences will be scheduled, if needed.
CLSI C66-Ed1 | Vitamin D Testing in the Medical Laboratory, 1st Edition
CLSI C66 will provide an overview of vitamin D tests currently performed in patient care, including tests for vitamin D metabolites. C66 will also be useful in the development of commercial vitamin D assays and appropriate laboratory developed tests (LDTs). In addition, this guideline will provide information for using vitamin D tests in patient care settings and for test utilization. Intended users of this guideline are clinicians, end-user laboratorians, manufacturers, and regulatory agencies. Guidance will be provided for verification of performance claims by end-user laboratories.
January 2025: Virtual inaugural meetings
January 2025 to November 2025: Drafting of document (higher-intensity volunteer time period)
June 2026 to July 2026: Voting period for draft document
August 2026 to October 2026: Revision of draft based on comments received during voting
April 2027: Expected publication date
Apply on or before 16 August 2024.
This group is looking for:
- Experience in developing and conducting immunoassays and mass spectrometry-based assays in the clinical laboratory.
- Experts in reviewing regulatory submissions from manufacturers.
- Representation from the CDC supporting the Vitamin D Standardization Program.
- Representation from clinician groups using vitamin D tests such as the Institute of Medicine, American Society for Bone and Mineral Research, and IFCC Committee on Bone Metabolism.
How to Volunteer
Create an Online Account or Log in
It’s easy, free, and takes only a few minutes. Already have an account? You can login here too.
Complete Your Profile
Once you complete your profile, you’ll receive updates about opportunities in your area of interest.
Apply for Current Opportunities
CLSI sends new volunteer opportunities every month via e-mail. You can also check back here to view opportunities.
Get Notified About Your Application
If selected, you’ll be notified about your committee position and start date via e-mail. You can learn more about the volunteer process at our Standards Development Process page.
Qualifications
Our volunteers come from diverse professional backgrounds and include health care, government, and industry professionals with the common goal of improving the quality of medical laboratory testing.
- Familiarity with CLSI’s standards.
- Experience in that area of laboratory science (varies by opportunity).
- Ability to work well in a group setting during the time frames listed on the opportunity.
- You don’t need an advanced degree to participate.
Payment of an annual administrative fee is required for participation on CLSI committees. If you or your organization is a member of CLSI, the annual fee is included in your membership dues and no additional payment is required. More information on CLSI membership can be found here.
What to Expect
On average, it takes 18-24 months to complete a CLSI document. As a committee volunteer, you are asked to commit to participating for the duration of the project.
Volunteers meet regularly—in person and via conference call—throughout the development process to review the draft document, discuss and resolve issues related to the document's content, and to make sure the committee is on schedule with respect to the document development timeline.
Groups & Committees
Working Groups
CLSI's working groups focus on tasks that support the work of a subcommittee. A working group's assignment is usually limited in scope. They can include writing a document, a section of a document, or conducting a technical study.
Subcommittees
Subcommittees are responsible for documents in a topic area. They write draft documents, evaluate and respond to comments on content throughout the document development process, conduct scheduled document reviews, and may be responsible for continual revision of certain documents.
Document Development Committees
Comprised of a balanced representation from government, industry, and the health care professions, a CLSI document development committee is a group of technical experts who work together to develop a CLSI document.
Expert Panels
Expert panels are responsible for identifying and proposing projects and advising the Consensus Council on their suitability. Their focus is on reviewing, commenting on, and voting on documents within their area of expertise.
Consensus Council
The Consensus Council sets priorities for and manages CLSI standards development and identifies continual improvement opportunities for standards development-related processes. The Consensus Council also votes on Final Draft documents to confirm adherence to process requirements.
Board of Directors
The CLSI Board of Directors fulfills CLSI's mission by supervising, controlling, and directing CLSI's affairs; assuring the integrity of the voluntary consensus process.
