Laboratory developed test rule comment deadline Dec 4, ASCLS members labvocate on Capitol Hill, breaking news on PAMA cuts, registration open for CLEC 2024 and ELMC2 2024, upcoming ASCLS Education & Research Fund Handmade for the Holidays fundraiser, and more.
Laboratory Developed Test Rule Comment Deadline is December 4
The deadline to comment on a U.S. Food & Drug Administration (FDA) proposed rule to begin regulating Laboratory Developed Tests (LDTs) is December 4. ASCLS encourages all members of our community to read the proposal and provide input.
The proposed rule would amend the FDA’s regulations to make explicit that LDTs (defined by FDA as in vitro diagnostic products (IVDs)) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a phaseout of its “general enforcement discretion approach to LDTs” that has been in place in place since the 1970s.
The ASCLS Government Affairs Committee and the ASCLS Board of Directors are reviewing the proposed rule and will provide comments. ASCLS currently has no position on this proposed rule but will share the Society’s written comments in the ASCLS Open Forum when complete. ASCLS has been a supporter of the most recent iteration of the VALID Act in Congress, which would create a more modern framework for regulation of LDTs. ASCLS been in favor of some regulation of LDTs as long as that regulation is narrowly focused and risk-based. It is yet unclear if this proposed rule meets those criteria, but the Society is concerned that, as written, the change would negatively impact the clinical laboratories community to continue to provide the same level of testing for patients.
The rule is very detailed in the legislative and regulatory history of this issue and enumerates areas where the FDA will continue to apply “enforcement discretion” (i.e., will not regulate). There are a number of examples FDA provides, but in particular the following: “FDA is proposing to continue to apply the current general enforcement discretion approach going forward. One such category of tests is referred to in this preamble as ‘1976-Type LDTs.’ Such tests have the following characteristics common among LDTs offered in 1976: use of manual techniques (without automation) performed by laboratory personnel with specialized expertise; use of components legally marketed for clinical use; and design, manufacture, and use within a single CLIA-certified laboratory that meets the requirements under CLIA for high complexity testing.”
It is clear that FDA intends to publish a final rule (which has the effect of making it federal law) no later than summer of 2024. It appears, though, that the final form of that rule may change substantially based on feedback from the clinical laboratory community.
All laboratory professionals that have LDTs in their laboratories should provide comments to the FDA, providing specifics around their tests, their impact on patients care, and the negative effects should an overly broad rule be put in place. FDA needs to be aware of the full scope of how broadly LDTs are used and the variety of approaches.
ASCLS Members Labvocate for SALSA and the Clinical Laboratory Workforce
2023 Laboratory Legislative Symposium
On October 23, nearly 100 medical laboratory professionals from six organizations joined together in Alexandria, Virginia, and virtually for the 2023 Laboratory Legislative Symposium. Members from ASCLS, the American Society for Clinical Pathology (ASCP), Association of Genetic Technologists (AGT), American Medical Technologists (AMT), National Society for Histotechnology (NSH), and the Philippine Association of Medical Technologists-USA (PAMET-USA) learned about the legislative issues impacting medical laboratories and how to be labvocates and make their voices heard on Capitol Hill.
The day-long program included presentations, special guest speakers, and tips on how to speak with members of Congress. On October 24, attendees met with their respective members of Congress to advocate for bills and issues discussed the day before.
The Symposium covered:
- The history of PAMA, its affect on laboratory reimbursements, and the importance of passing the Saving Access to Laboratory Services Act (SALSA).
- Medical laboratory workforce issues, including advocating Congress to allocate funding to alleviate the clinical laboratory personnel shortage.
- Newly proposed FDA regulation of laboratory-developed tests and how to submit comments.
Breaking Legislative News: Additional One Year Delay on PAMA Cuts Passes Congress
This week the House of Representatives and Senate passed approving a continuing resolution (CR) that includes a one-year delay of implementation of the PAMA Medicare payment cuts to clinical laboratory services and data reporting, until January 2025. President Biden signed it into law yesterday.
Thank you to all who participated in some form of the Stop Lab Cuts campaign, especially those who made Hill visits at the Symposium. Awareness of the problem by Congress continues to increase.
Without this action, clinical laboratories would have faced a fourth round of cuts of up to 15 percent to 800 tests next year. Resumption of year-over-year cuts would threaten patient access to quality clinical laboratory services, reduce investment in innovation for the next generation of diagnostics, and weaken the nation’s clinical laboratory infrastructure.
We will continue to work with our coalition partners to pass SALSA next year so we have a permanent solution.
Fall Board of Directors Meeting
The ASCLS Board of Directors met on October 22 in Alexandria, Virginia, for its fall meeting. Board members engaged in strategic discussions centered on diversity, equity, inclusion, and belonging (DEIB) at the core of ASCLS’ purpose; the clinical laboratory’s role in building a more equitable healthcare system; ASCLS’ position on regulation of laboratory-developed tests; and re-examining the CLS Journal.
The meeting included the following actions.
- The Board will create a Diversity, Equity, Inclusion, and Belonging (DEIB) Position Paper Taskforce, which will submit an ASCLS DEIB Position Paper on the definition, role, direction, challenges, and opportunities for DEIB in ASCLS.
- The Board sunset the Leadership Academy Committee.
- The Board will establish an Expert/Speaker Directory with names of speakers who are willing to speak at events sponsored by ASCLS constituent societies.
- The Board will conclude its work to re-establish the Clinical Laboratory Science Journal.
- The Board approved the Articles of Incorporation and Provisional Bylaws for the Association of Medical Laboratory Educational Programs (AMLEP) and approved the inaugural AMLEP Board of Directors.
- The Board approved the Hyatt Regency Bellevue, Washington, as the site for the 2026 Clinical Laboratory Educators Conference.
- The Board approved the merger of the Society’s Capital Area, Maryland, and Delaware Constituent Societies.
Registration Open for the 2024 Clinical Laboratory Educators Conference in Las Vegas
Save your seat for the 2024 Clinical Laboratory Educators Conference (CLEC), which will be held February 22-24 in Las Vegas. A discounted early bird registration rate is available through December 20.
CLEC is the event of the year for faculty, administrators, directors, advisers, and anyone in medical laboratory education. Reconnect with friends, make new ones, and learn from educators with the same goal to provide excellent medical laboratory education. Browse a preview of the educational sessions that will be offered at CLEC 2024.
To provide you flexibility to participate in CLEC in the format that best fits your personal circumstances, you have the option to attend CLEC either in-person at the Westgate Las Vegas or virtually through the streaming device of your choice, wherever you are.
All educational sessions will be streamed live and recorded. Both in-person and virtual registrants will have access to all session recordings for 30 days after the event—about 40 hours of P.A.C.E.®-approved credit—as well as additional virtual content provided in the conference app. 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. Design a CLEC schedule that fits your work and personal life.
Thrive in Management – Attend the Emerging Laboratory Managers Collaborative Conference
The Emerging Laboratory Managers Collaborative Conference (ELMC2) is designed specifically for laboratory professionals to help you transition into and thrive in management roles. Register by December 23 and save with the Early Bird Rate.
ELMC2 provides two days of virtual programming (live and streamed for up to 30 days after the live event), up to 20 hours of P.A.C.E.® credit, networking events, access to an attendees-only online community, and follow up programming expected to take place 6-12 weeks after the conclusion of the virtual conference, as well as special meet-ups at the ASCLS, AGT & SAFMLS Joint Annual Meeting in July.
Get real-world advice from experienced medical laboratory leaders to help you solve your stickiest problems. Discounted group registration rates are available, $170 and under. For group registration, complete this form.
ASCLS Education & Research Fund Handmade for the Holidays Fundraiser
Place Your Bids November 20-December 1
Raise money for medical laboratory science scholarships and research grants and start your holiday shopping with the ASCLS E&R Fund’s 2023 Handmade for the Holidays annual fundraiser. Win unique and lab-themed items while raising money for an important cause.
All money raised through Handmade for the Holidays goes to the ASCLS Education & Research Fund, Inc., which provides scholarships, research grants, and professional awards that assist in the growth of the medical laboratory science profession and enhances the essential services provided by laboratory professionals. Thank you for your support!
This #GivingTuesday you can help build a strong future for clinical laboratory science. By donating to the ASCLS E&R Fund, you will support clinical laboratory science students at the associate, bachelor, master, and doctoral levels; fund critical research in laboratory science; and raise the visibility of the profession.
You can donate directly to the E&R Fund through the Handmade for the Holidays Fundraiser by using the “Donate” button.
ASCLS Leaders Training: The Ins and Outs of ASCLS Connect
If you are an ASCLS constituent society leader or national committee chair or vice chair, ASCLS Connect is one of your most valuable tools to communicate and collaborate. Join us for a virtual training on Monday, December 11, at 8 pm ET, as we walk you through how to effectively use ASCLS Connect to start discussions, send emails, share files, find members, and more. Sign up today.
Save the Dates for 2024 Events
Mid-Year ASCLS House of Delegates Meeting
January 14, 2024 | Virtual
ASCLS will hold its fourth annual mid-year virtual meeting of the House of Delegates on Sunday, January 14. The ASCLS House of Delegates has authority within the Society regarding the approval of professional practice standards, position papers, and the scope and direction for the Society and the profession.
Delegates who began their term with the first session of the 2023-2024 House of Delegates on June 30 will receive information about how to attend the mid-year meeting.
PRISM: Pride · Respect · Inclusion · Support · Momentum
The ASCLS Diversity Advocacy Council (DAC) invites you to participate in the fourth annual PRISM: Pride · Respect · Inclusion · Support · Momentum. Join medical laboratory friends and colleagues as we celebrate and ignite discussions regarding diversity in the profession and the inequities in our healthcare system.
PRISM features a series of virtual discussions. Plan to join us for the following events:
- Candid Conversation with Letycia C. Nuñez Argote, PhD, CPH, MLS(ASCP)CM, ASCLS Diversity Advocacy Council Past Chair, on Monday, January 15
- Dynamic Discussion with the eLABorate Topics podcast hosts, Lona Gordon Small, MBA, PMP, CPBPM, MLS(ASCP); Stephanie Whitehead, MBA, MPH, MLS(ASCP); and Tywauna Wilson, MBA, MLS(ASCP), on Tuesday, January 16
- Glenda Price Diversity in Leadership Award Online Fundraiser, January 12-17
All events are held virtually through Zoom and are free to attend. Stay tuned for more details on how to sign up.
April 14-20 | Virtual
Step out of your labs and into your communities to help spread the word about the medical laboratory profession by participating in the ASCLS Lab Week Virtual Run.
This virtual race can be run at any time during Medical Laboratory Professionals Week (April 14-20, 2024) and can be run anywhere. Participants can walk, use a treadmill, run outside, or even ride a bike to complete the 5K distance (or 3.1 miles).
Race packets will go on sale January 1 with Early Bird Pricing available through February 15. All proceeds go to scholarships that help medical laboratory professionals attend ASCLS meetings, lobby representatives for the profession, and become future leaders in the field.
Race organizers are currently looking for sponsors. If you or someone you know is interested in reaching thousands of laboratory professionals, please contact email@example.com.
Lab Week Date Change for 2024
Historically, Medical Laboratory Professionals Week is celebrated the last full week of April. ASCLS is part of a coalition of laboratory organizations that celebrate Medical Laboratory Professionals Week. Some members of the coalition noted that Passover will be celebrated during the last week of April next year, so the coalition voted to change Lab Week to the third week, April 14-20, for 2024.
The CDC’s OneLab Network provides opportunities for education and training, as well as a space for collaboration between clinical, public health, and CDC laboratory education and training professionals. Access recent webinar recordings and online courses.
- Empowering Healthcare: Bridging Gaps, Building Futures with the Clinical Laboratory Development Program – October 24 webinar recording with Rhiannon Clifton, Senior Director, Clinical Laboratory Development Program, University of Illinois System
- Developing and Implementing an Individualized Quality Control Plan – August 30 webinar with James H. Nichols, PhD, DABCC, FAACC, Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing, Medical Director of Special Testing at Vanderbilt University Medical Center in Nashville
- Clinical Laboratory Improvement Amendments (CLIA) and Provider Performed Microscopy (PPM) Procedures: An Introduction – This basic-level course provides information on selected topics, including: background of PPM procedures, overview of criteria, examinations, and regulations, how to apply for a CLIA Certificate for PPM Procedures, requirements for PPM personnel, and additional CLIA requirements and quality practices
- Introduction to Clinical Laboratory Improvement Amendments (CLIA) of 1988 – This course equips learners with foundational information about CLIA, including the history, its importance, and implications for clinical laboratories and facilities that perform testing that are subject to the regulations
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.
ASCLS Seeking Paid Data Input Contractors
Certified medical laboratory professionals will have the opportunity to begin work on a new ASCLS project in early December and will be compensated at $40 per hour. As part of the Society’s partnership with the Centers for Disease Control and Prevention (CDC) to support the CDC’s OneLab initiative, ASCLS is compiling and analyzing a database of more than 6,000 P.A.C.E.®-accredited CE programs to identify gaps and provide a foundation for areas of future CE development.
The Society is looking for individuals to serve as P.A.C.E.® Data Input Contractors to work on this project. These are paid positions, and ongoing tenure in the project is at the sole discretion of ASCLS. Though the exact timeframe is unknown, it is anticipated that the work will be completed within three months. Both parties may agree to additional time as necessary. Learn more.
ASCLS is seeking an editor-in-chief for Clinical Laboratory Science (CLS) journal. The editor-in-chief provides leadership and direction that results in the publishing of a well-respected, peer-reviewed, scientific journal. This is a prestigious appointment with the editor-in-chief having the opportunity to lead a high-quality, growth-focused journal through a transformative period and will help assure a higher level of impact in the years to come. The editor(s)-in-chief plans editorial content, develops and reviews manuscripts, organizes journal functions to maintain editorial integrity, and evaluates and makes adjustments to the journal as appropriate.
The term of the editor-in-chief is three years, and may serve no more than two consecutive terms. Learn more.
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.
In the October 27 Halloween episode, Brandy Gunsolus, DCLS, MLS(ASCP)CM, shares her creepiest, most disgusting, and “more unusual” stories that happened while working in medical laboratories. Beware: This episode is not for the squeamish! Special thanks go out to our episode sponsor, the University of Cincinnati Online.
Voices Under 40
Kate currently works as a medical laboratory scientist at St. Luke’s Magic Valley in Twin Falls where she was recently announced as a St. Luke’s Safety Hero Award Recipient. There she serves as a night shift generalist, performing patient testing, quality control, and maintenance in all departments throughout the night.
Kate has been very active in ASCLS, serving as ASCLS-Idaho’s and Region VIII’s Ascending Professional representative for multiple years, an Idaho Board of Directors member for three years, and a national Awards Committee Member for five years. She is also a 2019 graduate of the Region VIII Leadership Academy and has worked with ASCLS-Idaho’s Leadership Academy for two years. Read more.
ASCLS Voices Under 40 honors ASCLS members who have shown exceptional commitment to the Society, the laboratory profession, and their community at large at a younger age in their professional career. Each month we spotlight one of the shining voices who were selected from many nominations across the country. Do you know an individual that should be recognized as a 2024 Voices Under 40 recipient? Submit their name by March 1.
Welcome New Member
In the #IamASCLS-Introduce Yourself Community, Carly recently introduced herself:
“My name is Carly, and I have been an MLS for almost 10 years now. I was active with ASCLS as a student/new professional and then became inactive as I had babies and traveled the country. My babies are a little older now, and I am in a permanent position, so I wanted to plug back in with ASCLS. I am originally from South Dakota but currently work in Louisiana and would be especially interested in connecting with other people in the region, as I don’t have many contacts here.” Connect with Carly.
Check out events happening in ASCLS constituent societies.
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:
- What motivates you at work and gives you job satisfaction, despite the routine challenges in the medical lab?
- What was your favorite Halloween costume as a kid? Or your most creative costume as an adult? What is your least favorite Halloween candy?
- What do you think is the most significant future trend in MLS?
In the Open Forum, the ASCLS Leadership Development Committee asked members to share their favorite leadership author, or leadership life lesson.
Also in the Open Forum, ASCLS taskforces have shared draft position papers and asked for feedback from members:
- Scope of Practice and Personnel Standards Position Paper – feedback due today, November 17
- Advanced Practice: Doctorate in Clinical Laboratory Science Position Paper – feedback due November 30