Wonder, Excitement, and Preparing for the Future Capture the Spirit of ASCP 2024!

October 09, 2024

The ASCP 2024 Annual Meeting had an atmosphere full of wonder, excitement, and purpose for the laboratory. Attendees were eager to take part in collaborative sessions, mingle with fellow colleagues, and be part of ASCP’s mission to elevate pathology and laboratory medicine to meet the challenges of tomorrow.

ASCP was honored to host Martin Luther King III as the keynote speaker at the Grand Opening Session and Ambassador Dr. John Nkengasong as the keynote for the Scientific General Session. Mr. King has been a leading voice for peace, justice, and equity in the U.S. and globally. His work has had a transformative impact, and his keynote address will celebrate unity, equity, and inclusion that will inspire conversations and actions that will bring us a better tomorrow and help shape a more just society for all. Listen to his presentation here.

Longtime friend and member of ASCP, Ambassador Dr. John Nkengasong serves as the U.S. Global AIDS Coordinator and Senior Bureau Official for Global Health Security and Diplomacy. His leadership in overseeing the Presidents Emergency Plan for AIDS Relief (PEPFAR), which has made historic strides in addressing HIV/AIDS, highlights the power of strategic intervention in global public health, and his tenure as the first director of the Africa Centres for Disease Control and Prevention further underscores his ability to drive transformative change. His presentation can be accessed here. 

Meanwhile, if attendees missed any sessions at the Annual Meeting, they can purchase the On Demand package and still add it to their registration. For more about the On Demand package, click here.

Mark your calendars for the ASCP 2025 Annual Meeting, which will be held on November 17-20, 2025, at the Hyatt Regency Atlanta. Register early for the best available rates, up to 58% off. Click here to register. 

Hot Topics: What are the Work Concerns that Keep Pathologists Up at Night?

October 09, 2024

Staying current with advancements in pathology, increasing visibility of the profession among medical students, and bolstering appreciation of the value of pathologists in patient care are among the top 10 topics that weigh heavily on the minds of laboratory professionals, according to the results of an ASCP survey conducted this past summer.

 

Every summer, ASCP conducts a member survey to find out the topics that weigh on members’ thoughts. The chairs of ASCP’s four member councils—Council of Laboratory Professionals, Resident Council, Pathologist Council, and Council of Laboratory Management and Administrators.

 

“The Pathologist Council has opportunities to address these hot topics through ASCP’s roundtables and also by creating an online library that is open to all members when they want to learn more about certain areas,” says Pathologist Council Chair Deniz Peker Barclift, MD, FASCP.

“A number of our members are in academic medical centers where we have access to medical students. We need to promote pathology more among medical students,” she adds. “According to data, the number of American Medical School Graduates who choose pathology as a profession has been decreasing.”

She suggested that one way to encourage awareness of the profession among medical students is for pathologists to serve as mentors to help them learn about the profession and the various professional opportunities it offers. Another way could be to explore providing seed funds to start pathology interest groups in medical schools so students can learn about the profession.

“As for boosting awareness of our profession among patients, there is a new trend nationwide which might benefit pathologists: every time you finalize a patient report, it becomes available to the patient (via MyChart or other electronic platforms) at that moment,” Dr. Peker says. “So, we can create a culture among pathologists to write reports that are tailored to the patients, as if you are talking to them. The report would also display pathologists’ names and contact information, so patients can reach pathologists to discuss their reports.”  

Other topics of concern to pathologists were leadership training and managing workload. Dr. Peker pointed out that ASCP offers courses on leadership training and said the Pathologist Council will help to promote them.

“The workload concern is quite a big topic, especially in the current era where all have shortages of staff,” she adds. “This is an area that ASCP needs to focus on. The first step is to collect the data, analyze it, and come up with a response. Since we have members from all subspecialties in pathology, maybe ASCP, with our council’s help, can come up with some workload guidelines for the pathologists.”

Another facet of addressing the workforce and heightening awareness of the profession is to work at fostering relationships and nurturing leadership skills. “It is crucial to create a balanced atmosphere in every pathology practice,” says Dr. Peker. “One way to address this is to provide enough resources for pathologists to develop better interpersonal and communication skills. We need to help our pathologists find common ground with colleagues in other departments and help them to understand and appreciate each other’s work.  

“Pathologists often work behind the scenes, but their expertise is essential for diagnosis and patient care. Improving communication can enhance collaboration with other healthcare professionals. Since many interactions occur digitally, offering pathologists training on how to write clear, considerate, and professional emails or reports is important. This might include being mindful of phrasing, avoiding abrupt language, and considering how messages may be perceived by colleagues, other healthcare professionals, and patients” Dr. Peker adds.

Lastly, the survey results indicated that advocating for their patients is an important topic. The work of ASCP’s Effective Test Utilization Committee is one way in which to advocate on behalf of patients’ needs.

Members can expect to see the Pathologist Council roll some of these initiatives out in the coming year. Meantime, Dr. Peker encourages members to check into the ASCP Online Communities to help keep the conversation going about issues of concern that need to be addressed going forward.

“We want our members to know that we have heard their concerns, and we are doing our best to develop thoughtful programming or initiatives to respond to their needs,” she says.

 

 

Hot Topics: What are the Work Concerns that Keep Laboratory Professionals Up at Night?

October 09, 2024

Advocating for work conditions and commensurate compensation in the medical laboratory, demonstrating the value of laboratory professionals in health care are among the top 10 topics that weigh heavily on the minds of laboratory professionals, according to the results of an ASCP survey conducted this past summer.

 

Every summer, ASCP conducts a member survey to find out what are the topics that weigh on members’ thoughts. The chairs of ASCP’s four member councils—Council of Laboratory Professionals, Resident Council, Pathologist Council, and Council of Laboratory Management and Administrators.

 

CLP Council Chair Laura Severs, MHA, MLS(ASCP)CM addressed the compensation issue, saying, “In general, laboratory medicine professionals feel undercompensated for the complexity of our work. A contributing factor to the compensation issue is the perception we are not patient-facing professionals. However, our higher purpose as laboratory professionals is to care for our patients. Together, we are working to change and challenge these misconceptions.”

Compensation is also tied into another top concern—demonstrating the value of laboratory professionals as part of the healthcare team.

“Based on these and other concerns, the CLP is formulating content for our member roundtables as well as opening some key roundtables to non-members,” Ms. Severs says.

Four other key topics that are all related are the workforce shortage, staff recruitment and retention, and improving workplace culture.

“A lot of these hot topics tie in together,” Ms. Severs says. “We try to address them at a broad level. On staff retention and dealing with staff shortages, our council is really committed to providing support for our members to speak about their careers in the medical laboratory. Our Career Ambassadors program is a significant grassroots effort that equips our members with the tools, resources, and support to go into their communities and engage with people so they can learn about the wonderful and impactful careers in laboratory medicine.”

Building awareness of the key role that laboratory professionals play in patient care also ties in with another topic—conveying the importance of the laboratory to leaders of other departments in a healthcare system.

Another resource that the CLP is tapping into is the Negotiation and Advocacy Toolkit, which has a wide array of assets to equip laboratory professionals and leaders with the confidence to advocate for the laboratory when speaking with other department leaders and colleagues. As an example, many CLP members participated an interactive session, The Amazing Lab Race, during the ASCP 2024 Annual Meeting in September. Participants were divided into several teams comprising many different members of the laboratory as they worked together to solve problems and face challenges many of us experience. In January, the CLP will host a session on how to be an effective and engaged trainer in the laboratory. This will address making sure that the individuals who may work with laboratory students and new in practice professionals during a rotation are equipped to properly teach and train.

Meanwhile, the CLP continues to brainstorm ideas for member roundtables that are focusing on a mix of scientific content that pertains to emerging technologies in the laboratory field, such as artificial intelligence (AI) and machine learning and what kind of implications that has on laboratory professionals’ work. Other potential topics the CLP wants to address include advanced techniques in genomics, data science in the laboratory, and maximizing impact in resource constrained laboratories.

Members can expect to see the CLP roll some of these initiatives out in the coming year. Meantime, Ms. Severs encourages members to check into the ASCP Online Communities to help keep the conversation going about issues of concern that need to be addressed going forward. The diverse perspectives in our membership is displayed by the unique problem solving and open communication you will find in the ASCP Online Communities.

“We want our members to know that we have heard their concerns, and we are doing our best to develop thoughtful programming and initiatives to respond to their needs,” she says.

 

ePolicy News October 2024

October 08, 2024

ASCP Files Amicus Brief Urging Court to Overturn FDA Final Rule on LDTs

ASCP has filed an amicus curiae brief in a lawsuit urging the court to overturn the U.S. Food and Drug Administration Final Rule claiming authority to regulate laboratory developed tests. ASCP and four other medical specialty societies have joined together to bolster the lawsuits filed by the American Clinical Laboratory Association and the Association of Molecular Pathology. Read more.

Biden Signs Bill Blocking Laboratory Payment Rate Cuts

President Biden has signed a key temporary funding bill, which would block a series of massive cuts in the Medicare Clinical Laboratory Fee Schedule for 2025. Blocking cuts in laboratory payment rates for 2025 is a significant legislative victory for the laboratory community. Read more.

President’s Cancer Panel Invites ASCP to Workforce Meeting

ASCP Chief Medical Officer, Ali Brown, MD, FASCP was invited to a Sept. 12th meeting of President Biden’s National Cancer Panel, on Developing and Retaining a Robust and Diverse Cancer Workforce. The panel, housed at the National Institutes of Health, is responsible for overseeing implementation of the National Cancer Plan. Read more.

ASCP 2024 Effective Test Utilizations Best Practice Recommendations Now Available

ASCP has released its 2024 Effective Test Utilization (ETU) Best Practice recommendations. The six recommendations were curated by member experts of the ETU subgroup, part of the ASCP Quality and Patient Safety Steering Committee. By implementing these and other ETU best practices in the laboratory, ASCP is striving to see higher quality care, lower costs, and a more effective use of laboratory resources and personnel. Read more.

New Forensic Pathology Scholarship Open to Medical Students and Residents. Apply by October 11

ASCP is looking for medical students and pathology residents interested in gaining experience in forensic pathology through the transformative ASCP Forensic Pathology Rotation Scholarship Award, funded through a grant supported by the National Institute of Justice and George Mason University. Applications are due by Friday, October 11, 2024. Read more.

Help ASCP Better Understand the Financial Realities of Laboratory Education

ASCP and ASCP BOC are conducting a survey related to the costs associated with laboratory education and training for professionals in medical and public health laboratories, including students and program directors. The goal is to identify deficiencies in existing student debt-reduction programs at federal and state levels and advocate for better support for laboratory professionals and propose solutions to address the educational and training needs of the laboratory workforce. The survey closes October 21. Read more.

Calling All Pathology Residents Interested in Global Health!

Are you an ASCP member resident or fellow, currently training in pathology in the US or Canada, who is interested in expanding your experience, knowledge, and exposure to pathology in a low- to middle-income country setting? If so, we encourage you to apply for the prestigious ASCP Resident Global Health Fellowship. The application deadline for this opportunity is November 1, 2024. Read more.

 

ASCP Files Amicus Brief Urging Court to Overturn FDA Final Rule on LDTs

October 07, 2024

ASCP has filed an amicus curiae brief in a lawsuit seeking to overturn the U.S. Food and Drug Administration (FDA) Final Rule claiming authority to regulate laboratory developed tests (LDTs). ASCP and four other medical specialty societies (hereafter referred to as "the Amici Group," or "the Group")--representing the largest collection of pathology and laboratory organizations submitting an amicus brief urging the court to overturn FA's misguided LDT oversight scheme--have joined together to bolster the lawsuits filed by both the American Clinical Laboratory Association (ACLA) and the Association of Molecular Pathology (AMP). Besides ASCP, the American Association of Bioanalysts, the American Society for Microbiology, the Assocation for Diagnostics & Laboratory Medicine, and the Infectious Disease Society of America are united in their opposition to the FDA rule.  

In joining with other key stakeholders on the amicus, ASCP President Gregory N. Sossaman, MD, MASCP, said, “ASCP has heard loud and clear from our members that they are very concerned that FDA’s Final Rule will undermine their ability to provide appropriate care for their patients. FDA’s approach to oversight is too slow, cumbersome, and expensive to allow clinical laboratories to continue providing these critical diagnostic services. This flawed rule will massively scale back what LDTs services patients will be able to access, including when no commercial diagnostic is available. Given ASCP’s focus on ensuring quality care, submitting this amicus brief is essential to our mission of caring for patients.”

In submitting the amicus brief, ASCP and its partners concur with plaintiffs ACLA and AMP that the FDA does not have the authority to regulate laboratory developed tests. The Amici Group argues that the Final Rule has already had “serious detrimental effects on the clinical laboratories that perform these tests, and, ultimately, on the provision of medical care to patients who rely on these testing services for prompt diagnosis and treatment.”

In the brief, the Amici Group rejects FDA’s position that clinical laboratories offering LDT services are violating federal law, citing the Clinical Laboratory Improvement Amendments (CLIA), which specifically outlines federal legal requirement clinical laboratories must satisfy to provide testing services not approved by the FDA. The Group argues that FDA’s enforcement discretion policy allowing certain CLIA-certified laboratories to continue offering a limited subset of LDT services is so narrow that it fails to achieve its stated purpose of ensuring patient access to critical testing services. Additionally, FDA’s Final Rule infringes upon the practice of medicine by experienced, educated, and dedicated medical professionals.

Representing ASCP in developing the amicus brief is Jane Pine Wood, of McDonald Hopkins, an attorney well known for her work with the pathology and laboratory medicine community.

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.

 


Calling All Pathology Residents Interested in Global Health!

October 03, 2024

Are you an ASCP member resident or fellow, currently training in pathology in the US or Canada, who is interested in expanding your experience, knowledge, and exposure to pathology in a low- to middle-income country setting? If so, we encourage you to apply for the prestigious ASCP Resident Global Health Fellowship here. The application deadline for this opportunity is November 1, 2024 and the selected awardee will be notified by Friday, December 6, 2024.

The fellowship offers $5,000 in travel and stipend support to participate in an ongoing research project on prostate cancer awareness, barriers to screening, and correlations with PSA levels among men in Northern Tanzania. This fellowship includes a 1-month visit to the Kilimanjaro Christian Medical Center (KCMC) in Moshi, Tanzania, as well as virtual support to the site, carried out between January – June 2025. Scheduling of the in-person visit is flexible to the resident’s availability (with on-site mentor’s approval).

Don’t miss this unique opportunity to gain invaluable global health experience and contribute to global pathology efforts!

To access the full application, eligibility criteria, expectations for the resident, and more information about the project, click 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.

Help ASCP Better Understand the Financial Realities of Laboratory Education

October 03, 2024

ASCP and ASCP 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 invite you to take part in this important survey between September 23, 2024, and October 21,2024 by clicking here.  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.

Forensic Pathology Scholarship Open to Medical Students and Residents. Apply by October 11

October 03, 2024

ASCP is looking for medical students and pathology residents interested in gaining experience in forensic pathology through the transformative ASCP Forensic Pathology Rotation Scholarship Award, funded through a grant supported by the National Institute of Justice and George Mason University.

ASCP has previously awarded 19 scholarships to pathology residents through this unique opportunity and, in its final round of this scholarship program, ASCP is expanding eligibility to include medical students alongside pathology residents. Applications are due by Friday, October 11, 2024, and rotations must occur by June 30, 2026. Interested applicants can apply here.

Through this unique opportunity, medical students and pathology residents are matched with a participating partner Medical Examiner-Coroner Office (10 sites available) across the country, for a 1-month on-site rotation. Awardees are provided with a $6,000 stipend to support travel and lodging during the rotation.

Past awardees have overwhelmingly reported rotations to be well-mentored, transformative experiences that have opened their eyes to the vital and fascinating role forensic pathology plays in modern society. Following her award rotation as a pathology resident, Anna Garcia MD said, “My ASCP/NIJ forensic pathology scholarship rotation was one of the best experiences in medicine thus far. I worked with forensic pathologists who were supportive, committed to my learning, and down-to-earth, fun people. The advice they have given me is invaluable. I would recommend this scholarship to anyone who wants the opportunity to be immersed in the field of forensic pathology while learning about underserved/underrepresented communities and their unique needs.”

To apply for this rotation experience, visit the full application here.

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

 

 

ASCP 2024 Effective Test Utilization Best Practice Recommendations Now Available

October 03, 2024

ASCP is pleased to announce that its 2024 Effective Test Utilization (ETU) Best Practice Recommendations are now available. 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 our 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. For more information and resources, please visit the ASCP Effective Test Utilization 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.

 

 

President’s Cancer Panel Invites ASCP to Workforce Meeting

October 03, 2024

ASCP Chief Medical Officer, Ali Brown, MD, FASCP was invited to a meeting of President Biden’s National Cancer Panel. The meeting on Developing and Retaining a Robust and Diverse Cancer Workforce was held on September 12th. The Panel, which is housed at the National Institutes of Health (NIH), is responsible for overseeing implementation of the National Cancer Plan. The National Cancer Plan - Everyone Has a Role provides a framework for collaboration to guide the nation’s efforts against cancer. It establishes eight goals that we must achieve to prevent cancer, reduce the cancer mortality rate, and maximize the quality of life for people living with cancer.

ASCP was proud to represent the field of pathology and laboratory medicine at this meeting, and to highlight our efforts to help end cancer. These efforts all center around initiatives that support our members in providing high-quality, equitable diagnostic laboratory services to our patients. At the meeting, Dr. Brown emphasized the importance of the pathology and laboratory medicine workforce and highlighted many of the efforts and challenges we face to retain a robust and diverse laboratory medicine workforce that serves our nation’s patients.

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.

 

 

President Biden Signs Bill Blocking Laboratory Payment Rate Cuts

September 27, 2024


 ASCP is pleased to announce that President Biden has signed a key temporary funding bill. Importantly, the measure blocks a series of massive cuts in the Medicare Clinical Laboratory Fee Schedule (CLFS) for 2025. Under the Protecting Access to Medicare Act (PAMA) of 2016, Congress tasked the Centers for Medicare and Medicaid Services (CMS) with revising the CLFS.  When CMS did so, it created a new fee schedule that massively undervalued payment rates.  Under that scheme, CMS was planning to cut payment rates in 2025 by up to 15 percent for approximately 800 laboratory tests—approximately one-third of the laboratory services reimbursed under the Medicare CLFS. 

Blocking cuts in laboratory payment rates for 2025 is a significant legislative victory for the laboratory community as the cuts would have wreaked havoc with laboratories wrestling with the dire shortage of laboratory professionals, the upcoming implementation of the flawed U.S. Food and Drug Administration’s Final Rule on Laboratory Developed Tests, among other challenges.

ASCP has been actively lobbying Congress to fix the flaws with PAMA by enacting the Saving Access to Laboratory Services Act and blocking cuts to the CLFS. As part of our goal of attaining a sustainable CLFS, ASCP will be working with our partners in the pathology and laboratory community to secure long-term PAMA reform as part of an end-of-year legislative package that Congress is expected to consider after the election. 

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

 

 



 

ePolicy News September 2024

September 11, 2024

ASCP Supports Legal Challenges to the FDA’s LDT Rule

The Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs) continues to be the object of criticism from the medical laboratory community. In addition to the lawsuit filed by the American Clinical Laboratory Association (ALCA) in May, a new lawsuit against the FDA has emerged, this time from the Association for Molecular Pathology (AMP).  ASCP strongly supports the two cases challenging FDA’s legal authority to regulate LDTs. Read more.

Gregory N. Sossaman, MD, MASCP, Installed as 2024-2025 President of the American Society for Clinical Pathology

Gregory N. Sossaman, MD, MASCP, was installed Sept. 6 as 2024-2025 President of the American Society for Clinical Pathology (ASCP) during the Society’s Annual Meeting, Sept. 4-6, in Chicago, IL. Learn more about his leadership experience and background here. 

Applications Open for ASCP Forensic Pathology Rotation Scholarship Award Program

The ASCP Forensic Pathology Rotation Scholarship Award Program is now accepting applications! This initiative addresses the critical shortage of forensic pathologists in the U.S., where only 500-600 pathologists practice—far below the 1,200 needed to meet medicolegal death investigation standards. As a result, there is an unprecedented demand for forensic pathologists, driving attractive compensation, loan repayment options, and flexible career opportunities. Read more.

ASCP Seeks Changes to How CMS Pays for Pathology, Laboratory Services

ASCP recently submitted formal comments on the Centers for Medicare and Medicaid Services (CMS) CY 2025 Medicare Physician Fee Schedule (PFS) Notice of Proposed Rulemaking. In it, ASCP raised concerns about the sustainability of CMS's proposals to ensure patient access to quality patient services. ASCP also noted that this year's rule marks the fifth straight year of the agency proposing to cut payment rates overall. Read more.

ASCP Global Health Fellowship Application Opens

Applications are now being accepted for the 2024 ASCP Resident Global Health Fellowship, which allows pathology residents and fellows to engage in pathology practice in a low- to middle-income country. Eligible applicants must be Resident or Fellow-in-Training members of ASCP, currently training in pathology in the U.S. or Canada. The application deadline for this opportunity is November 1, 2024. Read more.

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

ASCP Global Health Fellowship Application Opens

September 11, 2024

ASCP is excited to announce the opening of applications for the 2024 ASCP Resident Global Health Fellowship. This prestigious opportunity allows pathology residents and fellows to expand their experience by engaging in pathology practice in a low- to middle-income country. Eligible applicants must be Resident or Fellow-in-Training members of ASCP, currently training in pathology in the U.S. or Canada. The application deadline for this opportunity is November 1, 2024.

The fellowship offers $5,000 in travel and stipend support for one resident to travel to the Kilimanjaro Christian Medical Centre (KCMC) in Moshi, Tanzania, and participate in the Coalition for Implementation Research in Global Oncology (CIRGO) grant research. Under the guidance of Dr. Alex Mremi, MD, PhD, Head of the Department of Pathology at KCMC and principal investigator, the selected fellow will contribute to the ongoing research project on prostate cancer awareness, barriers to screening, and correlations with PSA levels among men in Northern Tanzania.

The fellowship includes a one-month in-country stay in Moshi, to take place between January and June 2025, as well as virtual collaboration on the project before and after the visit.

To access the full application, eligibility criteria, expectations for the resident, and more information about the project, click here.

Don’t miss this unique chance to enhance your global health experience!

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 Supports Legal Challenges to the FDA’s LDT Rule

September 11, 2024

The Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs) continues to be the object of significant criticism from the medical laboratory community. In addition to the lawsuit filed by the American Clinical Laboratory Association in May, a new lawsuit against the FDA has emerged, this time from the Association for Molecular Pathology (AMP). The AMP lawsuit was filed on August 19.

The two lawsuits are very similar. Both challenge the FDA’s May 6, 2024, Final Rule, claiming the authority to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetics Act (FDCA). In both cases, the parties seek summary judgment, meaning they urge the court to decide in their favor on the basis of the record and legal argument, without the need for a trial. This should help speed up a decision in the cases.

ASCP strongly supports plaintiffs ACLA and AMP in their cases challenging FDA’s legal authority to regulate LDTs. As a result, ASCP is working with several other concerned pathology and laboratory medicine organizations to jointly seek leave to submit an amicus brief supporting ACLA and AMP’s challenges to the FDA’s statutory authority.

ASCP has retained Jane Pine Wood from the law firm McDonald Hopkins to assist with its efforts. Ms. Wood has significant expertise as an attorney focused on legal issues facing the pathology and laboratory medicine community. ASCP has worked with Ms. Wood on many occasions.

In the amicus brief, ASCP as one of several amici curiae argues that the FDA’s rule is already undermining the ability of clinical laboratories to develop and use LDTs and that this is negatively impacting patient care. ASCP notes that FDA’s grant of enforcement discretion for certain tests creates significant uncertainty for laboratories and that this will create a powerful disincentive to innovate and create new tests to address patient care needs. ASCP also argues that FDA’s oversight is unnecessary and redundant as LDTs are already regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which provide the flexibility necessary for laboratories to adjust tests to the needs of individual patients. Under the FDA’s approach, such flexibility would not be possible.

ASCP Seeks Changes to How CMS Pays for Pathology, Laboratory Services

September 11, 2024

ASCP recently submitted formal comments on the Centers for Medicare and Medicaid Services (CMS) CY 2025 Medicare Physician Fee Schedule (PFS) Notice of Proposed Rulemaking (NPRM). In it, ASCP raised concerns about the sustainability of CMS’s proposals to ensure patient access to quality pathology services. ASCP noted that this year’s rule marks the fifth straight year of the agency proposing to cut payment rates overall. ASCP raised concern that physician payment rates have fallen significantly since 2001—approximately 26%—because the PFS lacks an inflationary adjustment.

As a result, ASCP urged CMS to work with Congress to address Medicare sustainability. ASCP outlined several bills Congress should enact to address the Medicare payment issues, such as the Strengthening Medicare for Patients and Providers Act (H.R. 2474,) to provide an annual inflationary adjustment for physician service; and the Saving Access to Laboratory Services Act (S. 1000/H.R.1835), to reform how the federal government sets laboratory fees.

ASCP’s comments also addressed CMS’s recent updates to its clinical labor costs. CMS recently updated the PFS direct expenses for technical services performed by non-physician laboratory personnel—including histotechnologists and cytologists. In doing so, CMS adopted data from ASCP’s 2021 Wage Survey, a policy change that significantly reduced cuts CMS had proposed for pathology and independent laboratories.

ASCP’s comments also address the inability of the Medicare Quality Payment Program and the Merit-based Incentive Payment System to adequately recognize the critical contributions of pathologists. 

ASCP will continue working with AMA and other medical specialty societies to advocate for appropriate payment reform from Congress.

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.

 

Applications Open for ASCP Forensic Pathology Rotation Scholarship Award Program

September 09, 2024

The ASCP Forensic Pathology Rotation Scholarship Award Program is now accepting applications! This initiative addresses the critical shortage of forensic pathologists in the U.S., where only 500-600 pathologists practice—far below the 1,200 needed to meet medicolegal death investigation standards. As a result, there is an unprecedented demand for forensic pathologists, driving attractive compensation, loan repayment options, and flexible career opportunities.

In collaboration with George Mason University and the National Institute of Justice, the ASCP has already awarded 19 scholarships to pathology residents, enabling them to gain hands-on experience in Medical Examiner-Coroner (ME-C) offices across the country, including in rural and underserved regions. These one-month forensic pathology rotations have provided invaluable exposure to the medico-legal system and career incentives, including hybrid models and multi-jurisdiction coverage.

For the final round of this scholarship program, ASCP is expanding eligibility to include medical students alongside pathology residents. Applications are due by October 11, 2024, and rotations must occur by June 30, 2026. Interested applicants can apply at https://forms.gle/4UmRWgaNoVE6gSzi6.

ASCP will continue to follow up with scholarship recipients to assess the program’s impact on entry into the forensic pathology workforce. Don't miss this exciting opportunity to jumpstart your career in this high-demand specialty!

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.

Gregory N. Sossaman, MD, MASCP, Installed as 2024-2025 President of the American Society for Clinical Pathology

September 05, 2024

Chair of Pathology at Ochsner Health takes reins of premier medical association serving pathologists and laboratory professionals

Gregory N. Sossaman, MD, MASCP, was installed Friday as 2024-2025 President of the American Society for Clinical Pathology (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.

After fellowship, he entered private practice in New Orleans until Hurricane Katrina in 2005 led to the closure of multiple area hospitals. In December 2005, he joined Ochsner Clinic Foundation, practicing anatomic pathology. In 2006, Dr. Sossaman was named section head of clinical pathology and became department chair in 2010. His professional practice is primarily in clinical pathology (including pathology informatics) along with leadership and management responsibilities.

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, he has been very active in Louisiana medical societies, serving on numerous committees and the governance boards of both the state and local medical societies. Currently, he serves  on the ASCP Board of Directors and as a member of the ASCP Commission on Science Technology and Policy. 

“I am honored to have been elected as an officer of ASCP, a society that represents the entire medical laboratory team and impacts health care around the globe,” he says. “ASCP has a strong cadre of dedicated volunteers and staff whose vision and commitment ensure the Society will remain at the forefront of laboratory medicine and pathology in the future.”

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 2024 Session Showcases Effective Test Utilization Best Practices

August 26, 2024

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)CMSHCM 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.

 

Renowned Speakers to Broaden Your Perspectives, Challenge Your Assumptions

August 23, 2024

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)SBBCM 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

ASCP 40 Under Forty Top Five Recognizes a New Generation of Leaders

August 23, 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, MBCM

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, QBRSCM

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, PACM, MBCM 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. 

ADVERTISEMENT