FDA Final Rule on Regulation of LDTs, New ASCLS Volunteer Opportunities, Meet the ASCLS Candidates for National Office, Lab CE at 2024 Joint Annual Meeting, Call for CLEC 2025 Session Proposals, CLEC 2024 Sessions On Demand, and More!
Time to Renew Your ASCLS Membership
ASCLS has already begun the 2024-25 membership renewal season. Thank you to the over 500 members who have already signed up for the next Society year.
For those of you who have not yet renewed, notices will arrive by mail in the next few weeks. Renew your membership by July 31 to ensure access to your membership benefits, stay connected to your community of medical laboratory professionals, and to maintain your continued membership status. Thank you for your support of ASCLS, and we look forward to another year to educate, motivate, celebrate, and labvocate.
FDA Final Rule on Regulation of Laboratory Developed Tests (LDTs)
On May 6, 2024, the Food and Drug Administration (FDA) published the final rule defining how the agency will be changing enforcement discretion on LDTs.
The rule is substantially changed from the preliminary rule published late last year. The changes are directly responsive to many of the concerns raised by ASCLS and other laboratory groups, which universally told FDA the rule, as written, would harm patients.
Unchanged from the preliminary rule is FDA’s decision to not enforce requirements under the FD&C Act and FDA’s regulations for “1976-Type LDTs”; Human Leukocyte Antigen (HLA) tests that are designed, manufactured, and used within a single laboratory certified under CLIA that meets the requirements to perform high-complexity histocompatibility testing when used in connection with organ, stem cell, and tissue transplantation to perform HLA allele typing, for HLA antibody screening and monitoring, or for conducting real and “virtual” HLA crossmatch tests; and tests intended solely for forensic (law enforcement) purposes.
The final rule expands the areas where FDA will not be enforcing some or all of the regulations applied to other LDTs. FDA intends to continue enforcement discretion and not enforce most regulations for:
- LDTs manufactured and performed within the Veterans Health Administration (VHA) or the Department of Defense (DoD);
- LDTs approved by NYS CLEP15;
- LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system;
- Currently marketed IVDs offered as LDTs that were first marketed prior to the date of issuance of this rule and that are not modified, or that are modified in certain limited ways (grandfathering); and
- Non-molecular antisera LDTs for rare red blood cell (RBC) antigens where such tests are manufactured and performed in blood establishments, including transfusion services and immunohematology laboratories and where there is no alternative available to meet the patient’s need for a compatible blood transfusion.
The final rule is voluminous and detailed. Its effects are likely to be felt in most high complexity clinical laboratories.
ASCLS would strongly prefer the focused and risk-based approach to regulating LDTs found in the bipartisan Verifying Accurate Leading-edge IVCT Development Act (VALID), but Congress has failed to move this legislation forward. ASCLS plans to continue the Society’s advocacy for VALID or VALID-like legislative solutions.
As these regulations are now law, ASCLS is preparing educational opportunities for our members on how to implement these new regulations, if they are affected. Time has been reserved at the ASCLS, AGT & SAFMLS Joint Annual Meeting in July, and a potential webinar is in the works. It is likely to take some time to know exactly how this new rule will impact clinical laboratories, as experts digest and analyze its details.
Volunteer Opportunities
Apply by June 10
Associate Editors, Clinical Laboratory Science Journal
The Clinical Laboratory Science (CLS) Journal has multiple opportunities for associate editors in all of the disciplines—hematology/hemostasis, microbiology, chemistry, urinalysis, molecular, immunohematology, microbiology, research, education, and quality management/quality assurance. If you are interested in helping revitalize the journal and have editorial, authorship, or peer review experience, we are looking for volunteers. Learn more.
Scientific Assembly Coordinator and Vice Coordinator
ASCLS values the scientific knowledge of our members and wants to develop actively engaged communities in our organization that can share information, network, and grow. The Scientific Assemblies Coordinator and Vice Coordinator will oversee a Scientific Assemblies Leadership Community made up of the Chair/Vice Chair positions of all the SAs as well as the Coordinator Team. Other tools, as needed, may be provided to facilitate their work. The Vice Coordinator will move into the Coordinator position at the conclusion of the Vice Coordinator term. The Scientific Assemblies Coordinator will be an ex-officio member of the Virtual Learning Steering Committee. Learn more.
Scientific Assembly Chairs and Vice Chairs
The ASCLS Scientific Assemblies (SAs) play important roles aligned under the Knowledge pillar of the ASCLS Strategic Framework. Each SA will be led by a Chair and Vice Chair for one-year terms. The Vice Chair automatically moves into the Chair position at the conclusion of the Vice Chair term. In addition to the responsibility of leading the SA to achieve its purpose, each Chair and Vice Chair will be a member of the Scientific Assemblies Leadership Community made up of the Chair/Vice Chair positions of all the SAs as well as the Coordinator and Vice Coordinator. Learn more.
Meet the Candidates for ASCLS National Office
The ASCLS Nominations Committee is pleased to present the following candidates for office in the 2024-25 Society year. Candidates selected by the House of Delegates will take office during the 2024 ASCLS, AGT & SAFMLS Joint Annual Meeting. Delegates will elect one president-elect; four 3-year term directors; one 1-year term director; one 5-year term member for the Judicial Committee; and four 2-year term members for the Nominations Committee.
New this year, the candidate profiles include an expanded perspective of candidate information, along with a short video. Candidates were asked to answer the following question in a two-minute video: What is one unique skill, experience, and/or expertise that sets you apart to lead ASCLS and the profession in the future? See the videos and read about each candidate here.
In an effort to create more touch points between the candidates running for national positions and the members electing them to those positions, the ASCLS Nominations Committee has scheduled a virtual Meet and Greet and three Ask Me Anything (AMA) sessions to provide an opportunity for members to ask questions of the candidates running for national positions. There’s still time to sign up for the last AMA:
Ask Me Anything: Meet Your Director Candidates Session 2
Sunday, May 19, 7 pm ET
Panelists: Lindsey Davenport-Landry, Kelcey Harper, Heather Herrington, Emilia Marrero-Greene, and Stacey Lyn Robinson.
The AMA is free to all members, but registration is required. Members will submit a question with their registration to ask the candidates. The moderators will make efforts to ask the candidates as many questions as time allows. Recordings of the Meet and Greet and AMAs will be available next week.
If you have any questions, please contact Toula Castillo.
Developing and Ascending Professionals Forums Seek Officer Nominations
Deadline: June 7
Would you like to take on a leadership role in the Developing Professionals Forum (DPF) or the Ascending Professionals Forum (APF)? Or do you know someone who would make an excellent fit? The DPF is seeking its next chair, vice chair, and secretary, and the APF is seeking its next vice chair and secretary. All applicants must be ASCLS Developing or Ascending Professional members as of February 28, 2024.
Submit your applications by June 7, 2024.
Diversity Advocacy Council Call for Officer Nominations
Deadline: June 7
The ASCLS Diversity Advocacy Council (DAC) is seeking nominees for the position of secretary for a partial one-year term.
The secretary shall record and keep in permanent form the minutes of all meetings of the DAC; keeping records of board actions, including overseeing the taking of minutes at all board meetings, sending out meeting announcements, distributing copies of minutes and the agenda to each board member, and assuring that DAC records are maintained. This partial one-year term will expire in 2025.
Learn more and submit your nominations by June 7, 2024.
Upcoming Events
LabJAM Provides CE in all Facets of Medical Laboratory Science
July 8-12 | Pittsburgh, Pennsylvania, or Virtual
The 2024 ASCLS, AGT & SAFMLS Joint Annual Meeting (JAM) offers a broad educational program that brings together the scientific knowledge from three medical laboratory organizations and deep expertise in leadership. The educational program will provide you about 50 hours of P.A.C.E.®-approved continuing education. Scientific sessions span Chemistry/Urinalysis to Microbiology/Public Health, Hematology/Hemostasis to Molecular and Biochemical Genetics, Generalist/Interdisciplinary to Laboratory Administration Management, and much more. You’ll also benefit from the opportunities to socialize and learn informally from other laboratory professionals from across the country. Browse the educational sessions.
JAM also provides flexibility with two attendee options. Sign up by June 20 and save.
In-Person Attendance: JAM will be held at the Wyndham Grand Hotel in Pittsburgh, Pennsylvania. In addition to the educational program, poster presentations, industry partner exhibits, and networking activities, you’ll also receive access to all recorded JAM educational sessions for 30 days after the event, providing you with about 50 hours of P.A.C.E.®-approved credit.
Virtual Attendance: You will have access to the nearly 50 educational sessions, either streamed live or recorded; industry partner virtual activities; and virtual poster presentations. You will also have access to all recorded JAM educational sessions for 30 days after the event. You get to choose which sessions and events you want to attend live and which recordings you will view later when the time is right. Create a personalized JAM experience that fits your life.
Order Your Commemorative JAM T-shirt
The ASCLS Developing and Ascending Professionals Forums are proud to offer this unique fundraiser to remember your time in Pittsburgh for the 2024 JAM. Shirts can be shipped to your home for virtual attendees, or you can select to pick up onsite at JAM. Order by June 20.
Call for CLEC 2025 Session Proposals
The Clinical Laboratory Educators Conference (CLEC) Steering Committee is currently accepting session proposals for CLEC 2025. The submission deadline is June 15.
CLEC 2025 will be held March 6-8 in Atlanta at The Westin Peachtree Plaza. Share your knowledge, experiences, and perspectives on a variety of topics, including educational methodologies, teaching strategies, student centered issues, program management/administration, and faculty development. All educational sessions will be presented in-person.
Looking for inspiration? Here are a few topics suggested by 2024 CLEC attendees. Also, check out photos from CLEC 2024, held February 22-24 in Las Vegas.
CLEC 2024 On Demand
All educational sessions from the highly-rated CLEC 2024 were recorded and are now available to stream online via labucate.org. This library of on-demand courses includes content created by your peers and is focused on topics of relevance to today’s medical laboratory science educators. Individual sessions are $10 for ASCLS members/$15 for non-members.
The All Access CLEC 2024 On Demand bundle gives you 37 sessions and 37 hours of P.A.C.E.® credit ($250 for ASCLS Members/$375 for non-members).
The Best of CLEC 2024 bundle contains the top 10 rated sessions ($80 for ASCLS Members/$120 for non-members). Sessions included are:
- Developing Educational Resources to Increase Clinical Preceptor Effectiveness
- Focus on Learning Tools
- Focus on Recruitment
- From Trainer to Teacher: Supporting a Successful Transition
- Innovative Teaching Strategies that Inspire Creativity and Critical Thinking
- Integrating Generative Artificial Intelligence into the Classroom
- Reinventing the Blood Bank Student Laboratory
- The Student Toolbox: Classroom Strategies to Enhance Students’ Study Skills, Exam Preparation, and Self-Reflection
- The Ups and Downs of Program Directorship
- Unlocking the Power of Neurodiversity in the Higher Education Classroom: Debunking Myths and Boosting Learning for All!
Access to CLEC 2024 On Demand is good until March 2025.
ASCLS is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
CDC OneLabTM
OneLab Network Resources
CDC’s OneLab Network provides opportunities for education and training, as well as a space for collaboration between clinical, public health, individuals who perform or coordinate testing at non-laboratory sites, and CDC laboratory education and training professionals. Check out these new resources.
Risk Assessment in Clinical Laboratories – On March 27, 2024, Crystal Fortune, MPH, MLS(ASCP)CM, RBP(ABSA), biosafety and outreach specialist at the Montana Public Health Laboratory, presented on how to identify and assess for hazards and mitigate risk. The webinar recording is available.
Creating Next-Level Trainings for Clinical and Public Health Laboratory Professionals – This course is designed to help develop the knowledge, skills, and confidence of laboratory instructors to deliver more effective training. Participants will learn how to apply CDC’s Quality Training Standards and Training Developer Checklist to the training they develop for laboratory professionals. The strategies and practices discussed can be adapted to a variety of training types, such as in-person lectures; See-one, Do-one, Teach-one; or eLearning (on-demand). This course consists of five virtual two-hour sessions. All sessions are held virtually from 1-3 pm ET, August 5-16, 2024. Learn more and sign up by July 17.
OneLab REACH Resources
The OneLab Rapid Education and Capacity-building Hub (REACH) is a laboratory education and training learning management system specifically designed and tailored for the needs of clinical and public health laboratory professionals. OneLab REACHTM supports the laboratory community by providing relevant and timely education and training resources, including the following new course.
Routine Microscopy Procedures eLearning Course – This course is designed to explore the processes, procedures, and techniques necessary for completing routine microscopic examinations of laboratory specimens. This eLearning course will introduce laboratory professionals to microscopy procedures for smear preparation, as well as preparing and interpreting the results of a Gram stain, wet mount, potassium hydroxide (KOH), and India Ink procedures. This course is approved for 1.5 contact hour(s) of P.A.C.E.® credit.
The Centers for Disease Control and Prevention, Division of Laboratory Systems is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
OneLab™ and OneLab REACH™ are registered trademarks of the US Department of Health and Human Services (HHS).
New Episode of Off the Bench Podcast
Subscribe to the Off the Bench Podcast for discussions on scientific and not-so-scientific ideas in laboratory medicine. New episodes drop the last Friday of each month.
On the April 26 episode, host Sophia Chandrasekar talks with Professor Grace Leu-Burke of the University of Alaska in Anchorage (UAA). Professor Leu-Burke shares the challenges for a medical laboratory professional in Alaska and the research program she developed at UAA for the MLS program.
Subscribe to the podcast through Apple Podcasts, Spotify, or your favorite podcast app.
Local Events
ASCLS-New York Spring Seminar
June 7
Dobbs Ferry, New York
Welcome New Members
We’re happy to welcome 96 individuals who joined ASCLS in the past month.
Professional Members
Leitha Boutwell, AL
Michael Collins, IL
Michelle Herdman, WV
Kayala Jordan, WV
Ridgely Moore, VA
Esther Muitta, MO
Jeri Nurnberger, ND
Philip Joseph Pabalate, IL
Natalya Plotkina, NC
Evangelina Rocillo, CA
Sara Shaw, MA
Kenneth Smeal, PA
Jenny Tracy, FL
Ascending Professional Members
Haley Aufdemberge, KS
Cheyenne Child, WA
Jessica DeJoy, AL
Jonnathan Once, NY
Community Member
Amber Goachee, MI
Developing Professional Members
Thressia Alcendor
Hollie Apprill, MO
Catherine Bravo, NY
Jaclyn Briggs, NC
Katherine Ciambor, NC
Skylar Davenport, VA
Thi Ngoc Xoan Dinh, NC
Daniel Duran, MS
April Fortenberry, NC
Simone Gaskins, MD
Habtom Hagos, GA
Natalia Islam, MD
Annie Luong, NC
Kaylee Luther, NC
Erin Mansier, FL
Courtney Nevers, NC
Viviam Osuagwu, MD
Nadiya Patel, NC
Victoria Pedro, GA
Alyssa Peele, MS
Lauren Phillips, NC
Alexandra Raczek, NJ
Jessica Robbins, OK
Matthew Rodriguez, OK
Daniel Salinas, GA
Emily Shoemaker, NC
Megan Stewart, AL
Rachel Tompkins, FL
Stanley Washington Jr, GA
William Weissinger, MS
Terra Wineman, MO
Luzi Yan, NC
Connect: The Community Conversations
ASCLS Connect is an invaluable platform to ask questions, share feedback, and stay connected with your community of laboratorians. Here are some of the recent discussions you may have missed.
The Membership Committee posts “Membership Mondays” questions each week to spur discussion and get to know fellow ASCLS members. Recent questions were:
- Did you get to see the “Northern Lights” in your area?
- What gardening “zone” are you in, and what are you planting this season?
- Kudos and shout outs to new graduates and/or your alma mater.
In the Clinical Laboratory Educators Forum, members gave feedback on a prototype laboratory math challenge tool.
Also in the Clinical Laboratory Educators Forum, members shared attendance policies and clinical microbiology demonstration videos.
In the Immunology/Immunohematology Scientific Assembly, members gave advice on a control for AB pos blood type.