ASCP News - January 2025

ASCP Urges Trump Transition Team to Rescind FDA LDT Rule

ASCP has contacted the Trump transition team leaders to urge the incoming administration of President-elect Donald Trump to rescind the U.S. Food and Drug Administration’s (FDA) Final Rule claiming oversight authority over laboratory developed tests (LDTs).

In a letter to Linda McMahon and Howard Lutnick, co-chairs of the Trump transition team, ASCP President Greg Sossaman, MD, MASCP, noted that the previous Trump Administration ruled that the FDA should not regulate LDTs. In 2020, U.S. Health and Human Service Secretary Alex Azar blocked the FDA from exercising oversight over LDTs. Secretary Azar’s decision was based on a legal opinion drafted by the General Counsel of the U.S. Department of Health and Human Services, arguing that the FDA lacked sufficient statutory authority to provide oversight of LDTs. 

ASCP—which filed an amicus curiae brief in October in a lawsuit seeking to overturn the Final Rule and submitted congressional testimony opposing both the Final Rule and the Verifying Accurate and Leading-edge IVCT Development Act, or VALID Act—believes that both the FDA Final Rule and the VALID Act fundamentally undermine patient access to quality care by imposing expensive and duplicative oversight burdens on clinical laboratories without improving patient outcomes.

By rescinding FDA’s Final Rule, ASCP President Sossaman expressed hope that President Trump’s leadership would send a clear message to both the FDA and Congress that LDTs are currently regulated appropriately in a manner that is nimble and free of excessive bureaucracy. This is provided by the Clinical Laboratory Improvement Amendments of 1988. To maintain the highest quality patient care, we must never discourage accredited clinical laboratories from developing and providing innovative, cost effective, quality laboratory services. 

ASCP 2024 Effective Test Utilization Best Practice Recommendations Now Available 

In October, ASCP announced that its 2024 Effective Test Utilization (ETU) Best Practice Recommendations were available online. The list of six recommendations was curated by member experts of the ETU subgroup, part of the ASCP Quality and Patient Safety Steering Committee, from the many submissions we received—including some from colleagues at the American Society for Microbiology (ASM). The recommendations were reviewed and vetted by ASCP member experts and where appropriate, colleagues from sister societies such as the American College of Obstetricians and Gynecologists (ACOG).

As in years past, the tests selected for this list were those that:

• Are frequently performed;
• There is evidence that the test either offers no benefit or is harmful (either entirely or in specific clinical situations);
• The test is costly, and it does not provide higher quality patient care;
• Eliminating the test or changing to another test is within the control of the clinician.

By implementing these and other ETU best practices in the laboratory, we strive to see higher quality care, lower costs, and a more effective use of laboratory resources and personnel. Please share this list widely to raise awareness about effective test utilization best practices in the laboratory that impact the entire spectrum of patient care. ASCP continues to champion efforts to bring the right test to the right patient, at the right time.

Learn New Strategies at KnowledgeLab 2025

Registration is now open for KnowledgeLab 2025, which is scheduled for April 7-8 in Scottsdale, Arizona. KnowledgeLab is the premier destination for current and aspiring leaders in the medical laboratory, bringing together influential leaders and motivated colleagues who are tackling similar challenges. Participants will learn from the knowledge and experiences of one another, sharpening their own management and leadership skills, while making lasting connections. 

Education topics will include laboratory management, business and clinical operations, medical decision support, quality management for patient safety, human resources, compliance and risk management, information management and technology, financial management, and strategic planning. 

Come away energized and equipped with solutions that will make an immediate impact in the laboratory. Visit ascp.org and click on the ASCP Store.

ASCP Welcomed President Sossaman and New Board at ASCP 2024 

Gregory N. Sossaman, MD, MASCP, was installed as 2024-2025 President of ASCP during the Society’s Annual Meeting, Sept. 4-6, in Chicago, IL. Dr. Sossaman is System Chair of Clinical Pathology and Service Line Leader of the Department of Pathology and Laboratory Medicine at Ochsner Health in New Orleans, LA. 

Dr. Sossaman earned his medical degree from Louisiana State University (LSU) School of Medicine in New Orleans, LA. He completed his internship and residency in anatomic and clinical pathology at LSU Medical Center and served as Chief Resident. He then completed fellowship training at LSU Medical Center in Cytopathology.

A longtime member of ASCP, he has served on the ASCP Fellows Council, on various ASCP committees and commissions, and the Board of Directors. In addition to his position as ASCP President, he also serves on the ASCP Commission on Science Technology and Policy. 

Officers of the ASCP Board of Directors are Vice President Sui Zee, MD, FASCP; Treasurer Diana L. Kremitske, MHA, MS, MLS(ASCP); Secretary Walter M. Oliveira, MASCP, MLS(ASCP)^CMSI; and Immediate Past President Robert A. Goulart, MD, MASCP.

Board Members are Jonathan R. Genzen, MD, PhD, FASCP, Fellow At-Large Director; Cheryl A. Germain, MHS, MASCP, PA(ASCP)^CM, Member At-Large Director; Jeannette Guarner, MD, FASCP; Fellow At-Large Director; Susan M. Harrington, PhD, MASCP, MLS(ASCP)^CM, D(ABMM), Member At-Large Director; Kamran Mirza, MD, PhD, FASCP, Fellow At-Large Director; Jennifer Stall, MD, FASCP; Fellow At-Large Director; Christopher Tormey, MD, MASCP, Fellow At-Large Director; and Stephanie Whitehead, MBA, MPH, MLS(ASCP)^CM, Member At-Large Director.

Council chairs are Savanah Gisriel, MD, Chair, Resident Council; Deniz Peker Barclift, MD, FASCP, Chair, Pathologist Council; Laura Severs, MHA, MLS(ASCP)^CM, Chair, Council of Laboratory Professionals; and Melody Boudreaux Nelson, DCLS, NRCC-CC, MS, MLS(ASCP)^CM, Chair-elect, Council of Laboratory Professionals. 

Patient Champions Partner with Tribal Communities to Improve Health Literacy

ASCP Patient Champions recently collaborated on the 2024 Tribal Health Literacy Workshop as part of its ongoing partnership with the Arizona Advisory Council on Indian Health Care (AACIHC).

AACIHC serves as a resource for all Tribal governments and the State of Arizona by supporting prevention, training, education, workforce development, policy, and legislation to meet the unique healthcare needs of the American Indian and Alaska Native (AI/AN) population in Arizona. It seeks to educate and advocate for improved health outcomes.

ASCP Patient Champions brings together individuals who have personally experienced the impact of laboratory medicine and diagnostics. These passionate patient advocates share their stories, raise awareness and collaborate with healthcare professionals to improve patient care and outcomes.

At the Tribal Health Literacy Workshop, Patient Champions Project Manager Sophia Lewin Adams partnered with Patient Champion Deedee O’Brien to present to members of Arizona’s 22 tribal communities. Their presentation covered the importance of understanding pathology reports and laboratory results, strategies for using storytelling to explain complex topics, and the value of peer-to-peer advocacy and support.