The clinical laboratory is critical to promoting and managing the delivery and use of healthcare resources. ASCP—a proponent of patient-centered care and evidence-based medicine—will host a Choosing Wisely Champions session during the ASCP 2024 Annual Meeting on September 6, at 2:30 p.m. (CT) to showcase successful efforts to carefully steward laboratory resources. Elise Occhipinti, MD, FASCP chair of ASCP’s Quality and Patient Safety Steering Committee, will introduce the two 2024 Choosing Wisely Champions and discuss the transition of the Choosing Wisely program from the American Board of Internal Medicine to ASCP. 

Choosing Wisely Champions

Kathryn Golab, DCLS, MLS(ACSP)^CMSH^CM is the clinical specialist in hematology, coagulation and urinalysis with Sentara Healthcare. She is recently finished her studies as a Doctor of Clinical Laboratory Science through Rutgers School of Health Professions at Froedtert and the Medical College of Wisconsin (F&MCW) and worked with multiple interdisciplinary teams throughout her final academic year to improve laboratory ordering and utilization at the point of impact on patient care teams. Choosing Wisely guidelines, as well as other nationally recognized consensus guidelines, provided the backbone of her utilization recommendations to clinicians on patient care rounds.

Dr. Golab participated in the Enterprise Laboratory Stewardship Committee at F&MCW as a laboratory representative and led the development of an initiative to reduce over-ordering of heavy metal blood screening panels in collaboration with the enterprise medical toxicology division. As part of her final academic year, she also performed utilization-based research focused on the ordering and use of peripheral blood flow cytometry.

Using the ASCP Choosing Wisely Guideline related to peripheral blood flow cytometry, she developed a clinical decision support tool within the electronic medical record system that led to a 47-percent reduction in unnecessary peripheral blood flow cytometry requests for patients without a history of hematolymphoid malignancy and increased appropriate utilization from 47 percent to 80 percent. This work was presented as a poster presentation at the ASCP national meeting in September 2024, with plans to publish a journal manuscript with these and additional findings in the near future.

The second Choosing Wisely Champion is the PLUGS^® (Patient-centered Laboratory Utilization Guidance Services) Informatics Committee. It is a laboratory stewardship collaborative whose mission is to improve laboratory test access, ordering, retrieval, interpretation and reimbursement. PLUGS^® is led by a team of experts within Seattle Children’s Hospital & University of Washington who serve as the leaders for the collaborative. PLUGS’s membership comprises a diverse group of laboratory stewardship stakeholders representing hospitals, health systems, laboratories, patient advocacy groups, health and biotechnology companies, and payers.

Allison Chambliss, PhD, DABCC, FADLM will present on behalf of the PLUGS Informatics Committee, which has focused on two important considerations related to practical application of benchmarking: accounting for patient population differences and resource requirements for gathering, collating, and sharing laboratory utilization data across different institutions. Criteria for selecting metrics were defined and three initial benchmarks were developed: vitamin D, thyroid testing, and iron deficiency workups. Practical guidance on retrieving data and calculating the actual metric was included.

A pilot study using these benchmarks revealed significant variations in performance across participating institutions. Institutions with established interventions showed better outcomes against the relevant metrics, highlighting the effectiveness of targeted interventions in improving stewardship. Using these metrics, individual institutions can compare their calculated metrics to the proposed benchmark goals to assess the potential for improvement. The approach and findings were disseminated to the PLUGS® membership at the 2023 and 2024 PLUGS® Summits. They have also spread awareness beyond PLUGS® members through the Clinical Laboratory News Quarterly Focus on Laboratory Stewardship. 

Be sure to add this important session to your schedule. Learn more by clicking here.

 

ASCP 2024 will host several renowned thought leaders at the named lecture series who will share their knowledge to help advance pathology and laboratory medicine and inspire you to make a difference in serving your profession. Here is a list of the guest speakers for the 2024 named lectures:

Cindy S. Johns Lecture

Speaker Patricia Ellinger will present “Cindy’s Work is Never Done” on Friday, Sept. 6 from 9:15-10:15 a.m. This lecture pays tribute to the memory of longtime ASCP member Cindy Johns who passed away in December 2017 after a lengthy battle with cancer. A champion for laboratory medicine, Ms. Johns worked tirelessly as an ASCP volunteer for more than 30 years.  

Ms. Ellinger, a tireless leader for more than 50 years, has forged new pathways in the education and certification of medical laboratory professionals, elevating the stature of the profession. A nationally recognized medical laboratory leader, she exemplifies a commitment to service—as an educator, supervisor of a major blood bank laboratory; and as a 35-year ASCP volunteer.

Even after she retired more than a decade ago, she returned to full-time work developing an innovative new program—the Medical Laboratory Technician-to-Medical Laboratory Scientist degree at St. Cloud State University, in St. Cloud, Minnesota—to address the workforce shortage. Now retired, Ms. Ellinger advises colleague to “get outside our comfort zone and share our talents in our communities.” 

Michele D. Raible Lecture for Residents

Speaker Kurt Schaberg, MD, associate clinical professor at UC Davis Health, will present “Learning Anatomic Pathology and Preparing for the Boards” on Thursday, September 5, from 9:15 to 10:15 a.m. The Michele D. Raible Lecture honors Dr. Raible’s commitment to delivering superior medical education and creating a lasting impact on the lives of medical students during her career.

In his presentation, Dr. Schaberg will discuss methods for learning anatomic pathology, with an emphasis on list learning, effortful study, and the importance of clinical knowledge. The faculty will discuss studying strategies for residency, the boards, and for practice.

Dr. Schaberg, who is also director of the Pathology Residency Program at UC Davis Health, is an anatomic pathologist with specialized training in surgical pathology of the gastrointestinal tract. He also practices general cytopathology and performs ultrasound-guided fine needle aspirations, and has a special clinical interest in inflammatory diseases of the gastrointestinal tract, particularly ulcerative colitis and Crohn's disease. Dr. Schaberg's research focuses on gastrointestinal surgical pathology and cytopathology, particularly of the liver and pancreas.

Castleberry: it is about a voyage with her work, focus on indigenous population, culturally signif, underserved population. Learn how her voyage thru has allowed her to bring health to underserved population. Very unique and how it has informed her perspective on the lab profession in a way to support underserved populations.

Barbara M. Castleberry Lecture for Laboratory Professionals

Speaker Susan Johnson, MSTM, MLS(ASCP)SBB^CM will present Oh! The Places You May Go! on Wednesday, September 4, from 3:00 to 4:00 p.m. This lecture is named in honor of Dr. Barbara Castleberry, who served for 18 years as vice president of the Board of Registry (now known as the ASCP Board of Certification). Through her innovative leadership, Dr. Castleberry strategically positioned the BOC for the competitiveness of the 21st century.

Ms. Johnson is the director of Clinical Education at Versiti as well as the director of the Transfusion Medicine Program at Marquette University and associate director of the Indian Immunohematology Initiative. Prior to this, Sue worked in an immunohematology reference laboratory for 25 years, developing a special interest in autoimmune hemolytic anemia, particularly drug-induced immune hemolytic anemia. In her presentation, she will share her journey because of her involvement with professional societies and talk about how attendees may become involved in their own professional societies. .

Ms. Johnson has a lengthy history of volunteer services, including active involvement with the ASCP Board of Certification. From 2014 to 2023, she has served on the ASCP Board of Certification Board of Governors, including as Chair from 2019 to 2021. More recently, she has taken the lead on the BOC’s Nomenclature Task Force. She continues in her role as Task Force Chair and leads the campaign to encourage everyone to use MLS(ASCP) credential instead of MT(ASCP), as well as working to heighten awareness that we should be using the terms cytology and cytologist instead of cytotechnologist and cytotechnology.

Arthur Purdy Stout Lecture for Pathologists 

Speaker John Hart, MD, will present “Steatohepatitis Diagnosis for the Surgical Pathologist: New Developments in 2024” on Wednesday, Sept. 5, from 10:30 to 11:30 a.m. Dr. Hart is a professor of pathology and professor of medicine at the University of Chicago, Department of Pathology. He is a gastrointestinal and hepatic pathologist with expertise in the full range of neoplastic and non-neoplastic diseases of the gastrointestinal tract and liver. His clinical interests include Barrett’s esophagus, IBD-related cancer, liver cancer, pancreatic cancer and stomach cancer.

Please mark your calendar for these informative lectures! For more information, visit https://www.ascp.org/annualmeeting/2024

Skateboarding and medicine are two passions for Viharkumar Patel, MD, FASCP, a surgical neuropathologist and a Top Five honoree for ASCP’s 2024 40 Under Forty program. So much so that skateboarding was his inspiration to pursue neuroscience and neuropathology, and he co-founded the Skaters Advancing Brain Education and Research Foundation, a non-profit organization dedicated to raising awareness of brain health and disease and advocating for the youth.

Dr. Patel is one of five high-achieving pathologists, pathology residents, and medical laboratory professionals under age 40 who have been named to the prestigious ASCP 2024 40 Under Forty Top Five list. 

ASCP's 40 Under Forty program shines a spotlight on 40 highly accomplished pathologists, pathology residents, and laboratory professionals under age 40 who have made significant contributions to the profession and stand out as the future of laboratory leadership. 

The pathologists, pathology residents, and laboratory professionals who applied for the 2024 ASCP 40 Under Forty program were asked to submit a resume and write a personal statement addressing how they see themselves as a leader or becoming a leader within the profession.

The ASCP 40 Under Forty Top Five honorees were selected through a combination of public voting and committee selection. Each of the five will receive a stipend to attend the ASCP 2024 Annual Meeting, to be held Sept. 3-6, in Chicago. The Top Five also receive recognition at ASCP 2024. Here’s a look at this year’s Top Five honorees:

Kaleel al-Obaidy, MD, FASCP, MBBS, D-ABP

Dr. al-Obaidy is a senior staff pathologist specializing in genitourinary, head and neck, and molecular pathology at Henry Ford Health in Detroit, MI, and a clinical assistant professor at Michigan State University. He earned his medical degree from the University of Dammam, Saudi Arabia, in 2012 and soon began an anatomic pathology residency. In 2015, he moved to the United States for pathology residency training, followed by head and neck focused-surgical pathology and genitourinary pathology fellowships at Indiana University, and a molecular genetics pathology fellowship at the Cleveland Clinic. His focus is on genitourinary tumor diagnosis and research, particularly renal neoplasm classification. During his residency, under the guidance of his mentors, Dr. Al-Obaidy identified the first renal tumor with a novel recurrent KRAS mutation, they named "papillary renal neoplasm with reverse polarity," and discovered a novel molecular alteration in thyroid-like follicular renal cell carcinoma, EWSR1:PATZ1 fusion."

Brittany Bell, MS, MBA, MLS(ASCP)^CM, MB^CM

Ms. Bell is the vice president of the Commercial Pharma Services division at NeoGenomics Laboratories. She oversees the Pharma Services Business Development, Scientific Affairs, and Alliance Management teams, encompassing her commercial responsibilities. In her role, she emphasizes the critical role of laboratories in supporting clinical trials for drug development, particularly in oncology. She is enthusiastic about promoting the laboratory field and has mentored young professionals, helping them launch their careers in laboratory science. Ms. Bell’s passion is to elevate the visibility of laboratory professionals. She has served on the ASCP Council of Laboratory Professionals and led initiatives that significantly enhanced NeoGenomics' commercial engagement and operational efficiencies. Ms. Bell holds a bachelor's degree from the University of Pittsburgh, a master's degree in Medical Laboratory Science from Thomas Jefferson University, and an MBA from Temple Fox School of Business.

Kimberly Flock, PhD, QBRS^CM

Dr. Fiock is the founder and director of the Iowa Neuropathology Resource Laboratory, a human brain tissue biorepository and histology core at the University of Iowa. She is also the technical director of the Histology Research Laboratory at the same institution. Dr. Fiock holds a Bachelor of Science in Neuroscience and Psychology from the University of Texas, Dallas, and a Master of Science and PhD in Pathology from the University of Iowa. Her research interests center on the tau protein in neurodegeneration, focusing on the role of astrocytes in determining disease patterns. An active member of ASCP, Dr. Fiock works to promote diverse role models in science and supporting equitable science education through her partnership with Reinvented Magazine, a non-profit dedicated to reinventing the perception of women in STEM, and her outreach to schools in rural Iowa. Through her social media platform, ThePathPhD, Dr. Fiock educates more than 28,000 followers about research and careers in neuropathology and reaches more than 2,000,000 people.  

Viharkumar Patel, MD, FASCP, is an assistant professor at the University of California, Davis, and is a surgical neuropathologist who enjoys teaching. He holds a unique appointment as the biochemistry co-discipline lead for the UC Davis Medical School. He completed his pathology residency at the University of Wisconsin, Hospital and Clinics and neuropathology fellowship at Brigham & Women’s Hospital, in Boston. He received his bachelor’s degree in biological sciences at University of California, Davis, and is a graduate of St. George’s University, School of Medicine. Dr. Patel serves on the ASCP Pathologist Council, is involved in ASCP’s Mentorship Program and is a Pathology Ambassador.  

Steven Springer, MLS(ASCP)^CM, PA^CM, MB^CM is the senior director of laboratory operations and the site head at Foundation Medicine in San Diego, CA. He holds a BS in Clinical Laboratory Sciences from the University of Iowa and dual master’s degrees Pathologists’ Assistant Studies and Healthcare Administration from Rosalind Franklin University, in North Chicago, IL. He has demonstrated a passion for innovation and entrepreneurship within the medical laboratory field. His contributions include participating in focus panels for early-stage companies developing cutting-edge pathology devices, running a consulting firm that advises innovative biotech companies, mentoring students transitioning into the workplace, and guest lecturing at universities on business aspects of laboratory medicine. He is vice chair of the American Association of Pathologists’ Assistants Legislative Committee and a member of ASCP’s Council of Laboratory Management and Administration. 

Urge Congress to Fix Medicare Fee Schedules
The Centers for Medicare and Medicaid Services proposes to cut payment rates for physician services, including pathology services, by almost 3 percent, and additional cuts to hundreds of clinical laboratory services. Also, the Medicare Economic Index, which measures medical practice cost inflation, is expected to increase in 2025. ASCP urges our members to contact Congress and demand that they fix Medicare payment rates. Read more.

Resources for Imminent BD Blood Culture Media Bottle Shortage
BD Life Sciences, a leading manufacturer of blood culture media bottles (BD BACTECTM blood culture vials), has notified customers to expect an impending shortage in blood culture media bottles. BD has said the supply disruption associated with BD’s plastic bottle supplier, is more complex than initially predicted and will affect its ability to keep up with global demands. The impact of this shortage is expected to affect patient care and the ability to diagnose and treat bloodstream infections. Read more.

CMS Recognizes Specialist in Cytology Certification as CLIA Compliant
The ASCP and ASCP Board of Certification (BOC) are pleased to announce a significant milestone that underscores the value of ASCP BOC credentials in enhancing the professional landscape for laboratory professionals while elevating patient safety. The ASCP BOC developed an eligibility route for the SCT(ASCP) certification exam, specifically for graduates of master's level CAAHEP-accredited Cytology Programs within the past five years. The Center for Medicare and Medicaid Services (CMS) and the Center for Disease Control and Prevention recognize the ASCP BOC Specialist in Cytology certification, SCT(ASCP), as CLIA compliant. Read more.

ASCP and Board of Certification Urge University of Maryland to Reconsider MLS Program Closure
The University of Maryland School of Medicine has announced it will not accept students into its medical laboratory scientist (MLS) training program this fall, and it will cease operations entirely in 2027. ASCP and the ASCP Board of Certification have written to the Dean of the Medical School highlighting the critical importance of the laboratory workforce and urged the school to reconsider its plans. Read more.

ASCP, BOC Support Veterans Affairs Proposal on MLS’s Scope of Practice
ASCP and the ASCP Board of Certification (BOC) urged the U.S. Department of Veterans Affairs (VA) to finalize a proposal to adopt the ASCP BOC’s scope of practice for medical laboratory scientists. The VA’s proposal would set a national standard of practice for medical laboratory scientists, which means medical laboratory scientists at VA locations could have the same scope of practice, regardless of state licensure laws. Read more.

Help ASCP Understand the Financial Realities of Laboratory Education. Your Insights Matter!
ASCP members are encouraged to participate in a new survey, set to launch on Sept. 9, to study the costs associated with laboratory education and training for professionals in medical and public health laboratories. The study is conducted by ASCP and the ASCP Board of Certification. Read more.

ASCP 2024: Discover How the LDT Ruling May Affect Your Practice
The Food and Drug Administration’s claim it has authority to regulate laboratory developed tests has been a hot topic for more than a year. ASCP will devote three hours of education to this topic, and how it may affect laboratory medicine and patient care, during a special three-part series on Sept. 5 and 6 at the ASCP 2024 Annual Meeting in Chicago. Read more.

CDC Virtual Reality Laboratory Expands Access to Training on Biosafety and Preparedness
A new Virtuality Reality Laboratory, from the Centers for Disease Control and Prevention’s OneLab program, offers access to free training in biosafety, specimen handling, and preparedness. Read more.

ASCP 2024 Policy Session Puts Spotlight on ASCP’s Massive CLIA Win, the LDT Lawsuit, and More
Jonathan Genzen, MD, PhD, FASCP, clinical pathology professor at the University of Utah and chief medical officer and senior director of government affairs at ARUP Laboratories, and ASCP President-Elect Gregory N. Sossaman, MD, MASCP, clinical pathologist and service line lead for pathology and laboratory medicine at Ochsner Health, New Orleans, will lead a session, “Public Policies Impacting the Practice of Pathology and Laboratory Medicine, on Friday, Sept. 6, at the ASCP 2024 Annual Meeting. The session will be moderated by Greg Davis, MD, FASCP, a member of the ASCP Board of Directors. Read more.

Medical Lab Directors, Residents, Fellows--This Test Utilization Course is Designed for You
ASCP’s long involvement and leadership in Effective Test Utilization (ETU) has led to the development of best practices to reduce unnecessary testing and waste, improve cost-effectiveness, and benefit patient outcomes using evidence-based testing. Now ASCP, through a cooperative agreement with the Centers for Disease Control and Prevention (CDC), has developed an eLearning course, “Case-Based Best Practices in Effective Test Utilization for Clinical Laboratories,” freely available through the ASCP Store. Read more.

To learn more about ePolicy News and access past newsletters and articles, click here.

ASCP and ASCP Board of Certification (BOC) are conducting a study related to the costs associated with laboratory education and training for professionals in medical and public health laboratories, including students and program directors. This study aims to (1) identify deficiencies in existing student debt-reduction programs at federal and state levels and advocate for better support for laboratory professionals, and (2) propose solutions to address the educational and training needs of the laboratory workforce. By recognizing financial obstacles, the study will highlight the necessity of affordable education and provide insights into issues impacting career progression and job satisfaction.

We encourage you to participate in this survey, set to launch on September 9, 2024!

For more information on our workforce resources, please visit our workforce webpage.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

In a formal comment letter to the U.S. Department of Veterans Affairs (VA), ASCP and the ASCP Board of Certification (BOC) urged the agency to finalize a proposal to adopt the ASCP BOC’s scope of practice for medical laboratory scientists. The VA’s proposal would set a national standard of practice for medical laboratory scientists means that medical laboratory scientists at VA locations could have the same scope of practice, regardless of state licensure laws. In addition to commenting on the VA’s scope of practice proposal, the ASCP and ASCP BOC urged the VA to update the professional terminology it uses for baccalaureate-level medical laboratory professionals. We also urged the VA to update its professional nomenclature for this position and use the term, “medical laboratory scientists,” instead of the term, “medical technologist.”

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

ASCP recently learned that the University of Maryland School of Medicine was planning to close its medical laboratory scientist (MLS) training program, the oldest and largest in the state. The University announced it will not accept students into its program this fall and will cease operations in 2027. In response, the ASCP and ASCP Board of Certification wrote to the Dean of the Medical School highlighting the critical importance of the laboratory workforce and urged the school to reconsider its plans. ASCP also noted that the loss of this program would adversely impact the ability of area medical laboratories to recruit and train staff to fill their needs for laboratory professionals, which in turn would impact patient care.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

The ASCP and ASCP Board of Certification (BOC) are pleased to announce a significant milestone that underscores the value of ASCP BOC credentials in enhancing the professional landscape for laboratory professionals while elevating patient safety. The ASCP BOC developed an eligibility route for the SCT(ASCP) certification exam, specifically for graduates of master's level CAAHEP-accredited Cytology Programs within the past five years. 

This initiative, alongside a recent advocacy win with the Center for Medicare and Medicaid Services (CMS) and the Center for Disease Control and Prevention (CDC), highlights the BOC's commitment to advancing the cytology field. As of July 2024, CMS and the CDC have recognized the ASCP BOC Specialist in Cytology certification, SCT(ASCP), as an approved board examination for meeting the CLIA personnel qualifications of 42 CFR 493.1483.

This approval includes all SCT(ASCP) credential holders, including those who tested under Route 3 before July 2024, ensuring that all CT(ASCP) and SCT(ASCP) credential holders are recognized under the CLIA personnel qualifications. This significant achievement benefits all ASCP BOC credentialed cytologists and the patients they serve. 

For complete information on the CT(ASCP) and SCT(ASCP) credentials, eligibility requirements, and application instructions, visit the BOC website at www.ascp.org/boc/ct and www.ascp.org/boc/sct. We extend our gratitude to everyone who contributed to this advocacy win and to our community of cytology laboratory professionals for their dedication to excellence.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

The Centers for Medicare and Medicaid Services (CMS) recently published its CY 2025 Medicare Physician Fee Schedule (PFS) Proposed Rule on the in the Federal Register. The bottom line: CMS is proposing to cut payment rates for physician services, including pathology services, by almost 3 percent. In addition, CMS is proposing cuts of up to 15 percent for hundreds of clinical laboratory services. These cuts coincide with CMS projecting a 3.6-percent increase in the Medicare Economic Index, a measure of medical practice cost inflation, for 2025. In the face of these fiscal challenges, ASCP is urging individuals to contact Congress and demand that they fix Medicare payment rates.

CMS proposes to cut the Medicare conversion factor, used to make annual adjustments to physician payment rates, by 2.8 percent. This cut is the result of the expiration of a 2.93-percent payment increase provided by Congress for 2024, coupled with the lack of a positive conversion factor update from Congress for 2025 and a mandatory -0.05 percent budget neutrality adjustment. This means that unless CMS makes specific policy changes increasing or decreasing payment rates for pathology services, the overall cut in payment rates for pathology practices and independent clinical laboratories is approximately 2.8 percent.

As it turns out, CMS did NOT propose policy changes that impact the overall calculus for pathology. In the PFS impact table, CMS outlined that the overall impact for pathology and independent laboratories is 0.0 percent. As is often the case, however, CMS will make changes in payment rates for specific services, so depending on the mix of services provided, pathologists and laboratories may find that the overall impact differs from these broad brushstrokes.

Interestingly, one of the factors that has helped pathology in recent years is the increases CMS made to the clinical labor rates for certain anatomic pathology services. Based on data from ASCP’s biennial Wage Survey, CMS increased the technical component rates to reflect increased labor costs for certain laboratory professionals—histotechnologists and cytotechnologists. For histotechnologists, CMS increased the per minute labor rate from $0.55 to $0.63, a 15-percent increase in the allowed labor rate. It also increased the clinical labor rate for services performed by cytotechnologists from $0.76 to $0.85, a 12-percent increase. These increases have helped protect pathology services from policy changes that could lower payment rates.

ASCP believes that the cuts CMS proposes are inappropriate and adversely impact patient care. Medicare’s PFS rates have been declining for years and Congress needs to address low PFS payment rates before more economic harm is imposed on pathology and other physician practices, clinical laboratories, and other entities that provide patient care. As a result, ASCP is working with the American Medical Association to lobby Congress to Fix Medicare Payment Rates. Below we will be asking you to participate in a grassroots advocacy campaign to urge Congress to fix this mess. ASCP is supporting H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which would provide the PFS with regular reimbursement update tied to the MEI.

CMS Plans Cuts to CLFS
In addition to cutting pay for pathology services, CMS plans to impose cuts on the Clinical Laboratory Fee Schedule (CLFS). As part of the Protecting Access to Medicare Act, Congress tasked CMS with creating a new payment scheme for laboratory services. When CMS did so, it adopted a flawed approach, relying heavily on payment rate data from large reference laboratories. This resulted in CMS calling for massive cuts in payment rates. These payment rates were then quickly adopted by private insurers, causing a significant drop in revenues for clinical laboratories and forcing some laboratories out of the market. This negatively impacts patient access to care.

In response, ASCP and other organizations concerned about CLFS payment rates lobbied Congress to pause the new CMS payment system and fix it. While we have been successful in blocking CMS from imposing more cuts, Congress’s most recent moratorium on cutting laboratory payment rates only extends through the rest of 2024. Thus, CMS is proposing that hundreds of common laboratory services be cut by up to 15 percent next year.

ASCP has been stalwart supporter of the Saving Access to Laboratory Medicine Act, or SALSA, which is legislation intended to fix the flaws in the way CMS crafted the current CLFS payment rate system. ASCP is urging EVERYONE concerned about quality patient care and the future of pathology and laboratory medicine is encouraged to contact their legislators and urge them to support SALSA. This measure is needed not only to avoid draconian payment rate cuts for 2025, but also to help prevent these problems from happening on an annual basis.

Here's How You Can Help
ASCP has released a grassroots lobbying campaign so you can quickly urge Congress to fix Medicare payment rates. Please click on this link to use ASCP’s eAdvocacy Center to protect patient access to quality pathology and laboratory medicine services. Your actions should only take a few short minutes. Thank you.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

 

 

Stop by the ASCP Workforce Lounge during the ASCP 2024 Annual Meeting to connect with fellow attendees and discover tools, resources, and practical knowledge for pathologists and laboratory professionals who are looking to expand their organizational development, recruit new employees or retain existing staff, or seek new employment.

You will find the ASCP Workforce Lounge located by the registration desk. Here are a few things you can learn about at the Workforce Lounge:
• Stay informed of job marketplace & industry trend updates, view industry occupation roles/titles
• See a CDC OneLab VR (Virtual Reality Laboratory) Demo
• View wage/vacancy rates
• View Workforce Maps on Tableau and Workforce Survey Reports
• Get up-to-date on ASCP’s collaboration in support of the CDC OneLabTM Initiative
• Learn about new, free training resources for laboratory professionals through ASCP’s CDC OneLabTM grant
• Dig into the ASCP Negotiation & Advocacy Toolbox and win a chance at a daily prize
• Chat with ASCP volunteer mentors who can offer attendees professional guidance and support
• Discuss continuing education opportunities
• Review career advancement opportunities including Career Exploration Tools and job search resources

Session Offering
This year, the Workforce Lounge is organizing a session on the challenges the field is facing in recruiting the next generation of laboratory professionals and proposed solutions. Please make sure to watch our session before the Annual Meeting during the "Path to Chicago" available on-demand:

Non-traditional Recruitment Methods for the Next Generation of Laboratory Professionals
This course will address the need to improve entry of the laboratory professionals into the field, through examining creative recruitment strategies both in employment and academic settings that the presenters have implemented in their institutions with success.

Register here for the ASCP 2024 Annual Meeting!

Meeting up with longtime friends and making new friends at the ASCP 2024 Annual Meeting is a great way to expand your professional network. Two events you Annual Meeting attendees won’t want to miss are a Sept. 3 wine tasting led by Bruce Smoller, pathologist and wine connoisseur, and our second annual 5k walk/run on Sept. 4 along Chicago’s iconic lakefront!

Back by popular demand, Bruce Smoller, MD, FASCP, pathologist and wine connoisseur, will join ASCP in Chicago to host a spectacular wine tasting event. Join Dr. Smoller and fellow attendees at 6 p.m. Central time on Tuesday, September 3 at ASCP headquarters, 33 W. Monroe St., for a guided tasting with discussion on how to evaluate, experience, and select wine. Registration is $35. The Wine Tasting Mixer can be added to your 2024 Annual Meeting Registration.

Meanwhile, the Petri Dash 5k Run/Walk will provide an invigorating, not to mention spectacular, morning run along 3.1 miles of Chicago’s iconic lakefront on Wednesday, September 4, from 6:15 a.m.-8 a.m. You’ll experience the city’s picturesque Riverwalk and famous architecture, a magnificent sunrise over Lake Michigan as you follow the uninterrupted Lakefront Trail, and finally, the stately Buckingham Fountain, your turn-around point, where you’ll be amazed by Chicago's downtown, with glimpses of the Shedd Aquarium, Adler Planetarium, and more! Registration is $30. Proceeds will support the ASCP Foundation. Register by August 11th to receive an official race t-shirt! Registration for the 5k can be added to your ASCP 2024 registration.

Jonathan Genzen, MD, PhD, FASCP, clinical pathology professor at the University of Utah and chief medical officer and senior director of government affairs at ARUP Laboratories, and ASCP President-Elect Gregory N. Sossaman, MD, MASCP, clinical pathologist and service line lead for pathology and laboratory medicine at Ochsner Health, New Orleans, will lead a session, “Public Policies Impacting the Practice of Pathology and Laboratory Medicine, on Friday, Sept. 6, at the ASCP 2024 Annual Meeting. The session will be moderated by Greg Davis, MD, FASCP, a member of the ASCP Board of Directors.

Dr. Genzen’s presentation will focus on laboratory developed tests, which the Food and Drug Administration has claimed it has authority to regulate. He will provide an update on a lawsuit challenging the FDA’s authority over LDTs. He’ll also discuss ASCP’s efforts to support the lawsuit and possible legislative options Congress might consider to supersede the FDA rule. 

Following the discussion on LDTs, Dr. Sossaman will give an overview of ASCP’s advocacy wins on the recent Clinical Laboratory Improvement Amendments (CLIA) final rule.  ASCP succeeded in reversing a policy recognize nursing degrees for high complexity testing. He will also provide an update on the Medicare Physician and Clinical Laboratory Fee Schedules, which have suffered numerous cuts over the years. These fee schedules have not kept pace with inflation over the years. Since they are often used as benchmarks by private insurance companies to determine what they pay, fixing the Medicare payment rates is crucial to improving the bottom line for clinical laboratory and pathology services, which influences everyone’s salaries.

At the end of this policy session, attendees will be encouraged to contact federal policymakers urging then to fix Medicare payment rates.
To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

The Centers for Disease Control and Prevention’s (CDC) new Virtual Reality (VR) Laboratory gives access to free training in key areas of biosafety, specimen handling, and preparedness, available through its OneLab VR program. The VR environment includes 12 separate laboratory areas (with more than 100 custom-built pieces of laboratory equipment) in a 50,000-square-foot virtual facility designed for clinical and public health laboratory training.

Stop by the Workforce Lounge at the ASCP 2024 Annual Meeting, September 4-6 to check out daily live demonstrations of the CDC OneLab VR laboratory environment.

The VR program empowers laboratory professionals by providing them with a safe and controlled learning environment where they can apply, assess, and improve their laboratory skills. Learners can take on-demand VR training or use the multi-player, open format to deliver live training to learners and communicate with them from anywhere. The VR-based laboratory scenarios are freely available through OneLab REACH, and OneLab VR is designed for the Meta Quest 2 headset – download OneLab VR from the Meta Quest Store.

Of interest to ASCP members, CDC is also offering a limited number of free VR headsets to eligible clinical laboratories, academic laboratories, and medical laboratory science training programs in need through their OneLab VR-Ready Laboratories Program. VR-based laboratory education could be especially powerful in helping strengthen laboratory biosafety programs, expanding the interactivity and engagement in laboratory training or refresher trainings, or supporting training in clinical laboratories suffering from understaffing.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

The Food and Drug Administration’s claim it has authority to regulate laboratory developed tests has been a hot topic for more than a year. ASCP will devote three hours of education to this topic, and how it may affect laboratory medicine and patient care, during a special three-part series on Sept. 5 and 6 at the ASCP 2024 Annual Meeting in Chicago.

Panel Discussion on Regulatory Oversight of Laboratory Developed Tests (LDTs)
Thursday, Sept. 5, 8–9 a.m.
Jonathan Genzen, MD, PhD, FASCP, Chief Medical Officer and Professor of Clinical Pathology at ARUP Laboratories, University of Utah, and Michelle Campbell, MLS(ASCP)CMMBCMSCCM, will lead this first panel discussion and present an outline of the five stages of the requirements established by the FDA, potential strategies to comply with the final rule, and recent updates on litigation and potential future legislation.

In May, the FDA officially released its final rule on oversight of laboratory developed tests (LDTs), describing the phaseout of its general enforcement discretion approach for LDTs. The release of this final rule has raised many questions and concerns, specifically regarding how clinical laboratories may be impacted by the final rule, what the specific requirements of the rule are, and how laboratories should best prepare to comply with these requirements in advance of the respective deadlines for compliance. In this “Meet the Experts” session, Dr. Genzen and Ms. Campbell will moderate an interactive Q&A discussion involving attendees, laboratory leaders, and regulatory colleagues to walk through some of the more challenging aspects of the final rule.

Please join us for this timely, open, and engaging discussion on an issue that impacts all clinical laboratories that perform LDTs. This session offers 1.0 CME/CMLE credit.

Practical Approaches to FDA Stage 1 Requirements to Laboratory Developed Tests
Friday, Sept. 6, 10:45–11:45 a.m.
The final rule on laboratory developed tests (LDTs) released by the U.S. Food and Drug Administration (FDA) in May outlines five “phase out” stages occurring over a 4-year period.  Stage 1 includes the first set of requirements that high-complexity CLIA laboratories will be required to adhere to if they are offering LDTs.  These requirements include 1) medical device reporting, 2) corrections and removals reporting, and 3) quality system requirements specific for handling compliant files.  As the deadline for meeting these requirements – May 6, 2025 – is now less than a year away, it is critically important for clinical laboratories to understand what these requirements are, and more importantly, how they can begin to prepare for them in compliance with the final rule. 

In this session, presenters Dr. Genzen and Ms. Campbell will begin by providing an easy-to-understand outline of the requirements underlying stage 1. They will also share with attendees the specific FDA regulations that define these requirements for additional reference.  Important definitions related to adverse events and medical device reporting will be reviewed, emphasizing areas where specific policies are required under the law.  The speakers will review example medical device reports so that attendees can better understand events where reporting to the FDA will be expected. Lastly, the session will conclude with a brief overview of what to anticipate in preparation for stage 2 of the final rule and beyond. This session offers 1.0 CME/CMLE credit.

Interpreting Laboratory Developed Tests FDA Language
Friday, Sept. 6, 1:15–2:15 p.m.
The presenter will be Prithul Bom, President and CEO of Regulatory Technology Services, the FDA accredited Third Party Review Organization. Check back for more details on this session!

Register for the ASCP 2024 Annual Meeting here.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

On June 11, BD Life Sciences, one of the leading manufacturers of blood culture media bottles (BD BACTECTM blood culture vials), notified customers to expect an impending shortage in blood culture media bottles. BD has recently relayed that the supply disruption associated with BD’s plastic bottle supplier, is more complex than initially predicted and will affect its ability to keep up with global demands. The impact of this shortage is expected to affect patient care and the ability to diagnose and treat bloodstream infections, including bacterial and fungal sepsis.

BD will be providing updates on the status of the shortage here as they become available. BD expects to relay another update by September 2024. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are both working closely with BD and have released communications about the shortage, including the FDA’s recommendations on best practices for utilization of BD BACTEC blood culture media bottles. The FDA has further added blood culture media to the medical device shortage list.

The BD Life Sciences Microbiology division, as well as representatives from the CDC and blood culture utilization experts from Johns Hopkins Hospital, presented at the July 15 CDC Laboratory Outreach Communication System (LOCS) call, which focused on responses to this emerging disruption. A transcript of the call will be available on the CDC LOCS website soon. The LOCS meeting presenters, as well as a few additional experts, will also present on this topic at an upcoming Infectious Disease Society of America (IDSA)-CDC clinician call on July 23. Registration for the call is available here.

In the meantime, ASCP members are encouraged to review best practices on utilization of blood culture media bottles and monitor processes to ensure both routine disinfection practices to minimize the risk of blood culture contamination, and proper blood collection volumes to avoid the risk of requiring re-collection. ASCP will also be releasing a free “Blood Culture Collection Best Practices for Laboratory Professionals” eLearning course in the coming weeks. This eLearning course can be shared to phlebotomy teams and other members of the laboratory team who conduct and monitor blood culture collection processes. Enrollment details for this course will be posted here when the course launches.

ASCP member concerns on this topic can be directed to the CDC’s Division of Laboratory Systems at DLSinquiries@cdc.gov.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

ASCP’s AMA Delegates Represent Pathologists’ Interests at AMA Meeting … and Receive a Surprise 
ASCP delegates exemplified leadership and supported the interests of the pathology and laboratory medicine profession at the American Medical Association 2024 Annual Meeting of the House of Delegates. In recognition of their successful advocacy efforts, they were awarded the 2024 ASCP President’s Award. Learn about the issues they addressed. Read more.

ASCP, GME Coalition Weigh in on Congressional Graduate Medical Education Initiative
ASCP and 50 other medical societies are supporting a Congressional bipartisan initiative to invest in training more physicians. This effort is desperately needed as the demand for physicians outpaces supply and the patient population and physician workforce age. Read more.

National Academies’ Report Examines Racial and Ethnic Disparities in Health Care
The National Academies of Sciences, Engineering, and Medicine has convened an expert committee to review major drivers of healthcare disparities, examine successful and unsuccessful interventions, and make recommendations to advance health equity. The report aligns with ASCP’s diversity, equity, and inclusion goals and is supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Read more.

 ASCP Endorses Legislation to Address Public Health Infrastructure
ASCP has endorsed the Public Health Infrastructure Saves Lives Act, which seeks to address chronic underfunding of the state, local, tribal and territorial public health infrastructure. If approved, the program would award grants to state and territorial health departments, and to local health departments serving over 500,000 people, based on a formula determined by factors including population size, burden of preventable disease and disability, and poverty rate. Read more.

Take Action! Help Improve Medicare Payments
ASCP is asking ASCP members and nonmembers alike to urge Congress to fix the Medicare Physician and Clinical Laboratory Fee Schedules. Payment cuts and the lack of an inflationary adjustment means payment rates for pathology and laboratory services have declined significantly over the last two decades. With insurers benchmarking their rates to these fee schedules, reforming these fee schedules is essential. Discover how you can help! Read more.

To learn more about ePolicy News and access past newsletters and articles, click here.

ASCP is asking ASCP members and nonmembers alike to urge Congress to fix the Medicare Physician and Clinical Laboratory Fee Schedules (PFS and CLFS, respectively). Payment cuts and the lack of an inflationary adjustment means that payment rates for pathology and laboratory services have declined significantly over the last two decades. With insurers benchmarking their rates to these fee schedules, reforming these fee schedules is essential. Click here to use ASCP’s eAdvocacy Center.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

ASCP has endorsed the Public Health Infrastructure Saves Lives Act, which is intended to address chronic underfunding of the state, local, tribal and territorial public health infrastructure. The legislation seeks to ensure a dedicated investment in foundational public health capabilities and workforce.

The program would award grants to state and territorial health departments, and to local health departments serving over 500,000 people, based on a formula determined by factors including population size, burden of preventable disease and disability, and poverty rate.

The measure, introduced by Senator Patty Murray (D-WA), would also help address shortages in the public health workforce, which saw the loss of almost half of its workforce between 2017 and 2021.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

With support from the Agency for Healthcare Research and Quality and the National Institutes of Health, the National Academies of Sciences, Engineering, and Medicine convened an expert committee to review the major drivers of health care disparities, provide insight into successful and unsuccessful interventions, identify gaps in the evidence base, and make recommendations to advance health equity. From these workshops, four key topics were developed–establishing productive partnerships with communities, diversifying the health care workforce, addressing factors that perpetuate health care inequities, and improving data and measures.

The overall perspectives from the report align with ASCP’s goals and focus areas as outlined in the Society’s Blueprint for Action. Through its Diversity, Equity & Inclusion (DEI) initiative, ASCP seeks to cultivate a pathology and laboratory medicine profession in which all individuals thrive through appreciation, respect, and engagement. To achieve this goal, ASCP has been working to empower women and underrepresented minorities using DEI strategies to improve awareness, recruitment, talent development, and the development of inclusive and equitable workplaces. ASCP continues to incorporate DEI in all aspects of its work and activities.

Check out the report, including an interactive webpage, an animated video, policy briefs for Congress and federal agencies, and an action guide for researchers and research funders, here.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

ASCP, a member of the Graduate Medical Education Advocacy Coalition (GMEAC), has joined 50 other medical societies in responding to a recent initiative from the Congressional Bipartisan Medicare Graduate Medical Education (GME) Working Group. The Working Group recently released a draft framework for Congress’s review and revision of current federal GME policies.

In its outline, the Working Group states, “It has become clear that there are not enough physicians to meet the health care needs of Americans.”  The federal Health Resources and Services Administration, it notes, states that “there will be a shortage of 139,940 physicians across all specialties by 2036.”  “Congress can act to address these shortages by increasing the number of Medicare-supported residency positions in teaching hospitals,” targeting key specialties, the proposal reports.

The Coalition’s letter provided support for increasing the number of Medicare GME slots to address projected physician shortages. ASCP and others wrote, “While numerous policy solutions are needed to sustain and bolster the physician workforce, increased Medicare support for GME is a key component to stabilizing the workforce expansion. With demand for physicians continuing to outpace supply as both the patient population and physician workforce age, it is critical now more than ever that Congress build on recent bipartisan efforts and invest in training more physicians.”

In addition, the Coalition letter urged Congress to make changes to the distribution formula used by the Centers for Medicare and Medicaid Services for future distributions, targeting slots to specific specialties and/or regions of need, and improving outreach and technical assistance for rural teaching hospitals to ensure all facilities have sufficient lead-time to apply for GME-funded slots. A copy of the Coalition letter is available here.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.