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Diversity, Equity, and Inclusion in Health Care

Absolute Neutrophil Count (ANC) by Duffy Status Project

The American Society of Hematology (ASH) is at the forefront of addressing a critical health equity concern through its groundbreaking initiative - the Reconsideration of Absolute Neutrophil Count (ANC) Reference Ranges by Duffy Status.

The initiative is funded by a grant from the Doris Duke Foundation and seeks to ensure that all individuals, especially those with Duffy-null Associated Neutrophil Count (DANC), receive optimal care by redefining ANC reference ranges based on Duffy status. The overarching effort is structured as a multifaceted approach targeting health care systems, health care professionals, clinical trialists and their funding sources, and patients. The proposed project would lead to a better understanding of the impact of Duffy-null status and its implications for clinical decision-making.

Join ASH in this important endeavor to redefine ANC reference ranges and improve health care equity for all. Together, we can make a lasting impact on the lives of individuals with DANC.




Approximately two of three people identifying as Black in the U.S. are expected to have the Duffy null phenotype. Of note, race and ethnicity are not biological facts but sociopolitical constructs. Genetic traits do not obey racial boundaries or geographic constructs, so using them as proxies requires extreme caution. While the Duffy null phenotype is not exclusive to African or Arabian Peninsula genetic ancestry, it is most commonly found among these populations.

Explore the latest publication in Blood Advances.






THREE AIMS IN ACTION




Aim 1: Empower Health Care Systems (HCS)

Collaborate with select Health Care Systems to validate new adult and pediatric ANC reference ranges based on Duffy status.

Aim 2: Educate Health Care Professionals

Raise awareness about Duffy-null Associated Neutrophil Count (DANC) among practicing physicians, clinicians, administrators, and educators.

Aim 3: Begin Interventions on a Systems Level

Directly impact the lives of individuals with DANC by advocating for the adoption of Duffy testing and supporting the application of new ANC threshold ranges in clinical trials.






CURRENT STAGE: EMPOWER HEALTH CARE SYSTEMS

ASH will work with select Health Care Systems (HCS) in validating new adult and pediatric ANC reference ranges. ASH will also work with selected HCS to unveil the clinical ramifications relevant for people with DANC. Solutions to this issue will be locally developed as individual hospitals have their own policies, needs, and preferences for developing or validating reference ranges. A commitment to the central Institutional Review Board (IRB) and data sharing will facilitate development of replicable approaches and broader implementation. It is expected that this work will lead to a gathering consensus that would influence the adoption of the new reference ranges by other health care systems.


Requirements for Participating HCS:

  • Participate in a 16-month project.
  • Commit to centralized IRB and data sharing.
  • Attend in-person collaborative meetings.
  • Engage in ongoing teleconference meetings.
  • Develop a data-informed understanding of DANC's clinical ramifications.
  • Provide replicable approaches, lessons learned, and themes for dissemination.

Benefits for Participating HCS:

  • Improved health outcomes for individuals in their care.
  • Access to resources and support for project success.
  • Collaboration with other participating systems facilitated by ASH.
  • Participation in data sharing.
  • Stipends for validation and development of reference ranges.
  • Opportunity to influence the adoption of new reference ranges more broadly.

Key Dates

December, 2023  Health Care System RFP and Selection Process
 December 15, 2023  Application Deadline
 December, 2023 - January, 2024  Review and Selection
 February, 2024 - April, 2024  Notification, Terms and Conditions, Contracting, IRB

Request For Proposals

We are no longer accepting proposals from Health Care Systems interested in participating in the project. 

Submitted proposals are undergoing a competitive review based on institutional support, resources, commitment to diversity and equity, and representation of impacted populations. The review process considers how HCS include affiliated community-based care providers and minority serving institutions to broaden the reach of their proposal and fostering a more inclusive and impactful proposal.

Application Instructions

  1. Health Care System (HSC) Details: Name of Institution, ASH ID, etc.
  2. Multi-PI Details: Hematology/Oncology Project PI and Pathology Project PI details.
  3. Primary Contact: Administrative Staff Responsible for Application.
  4. Project Description: Detailed plan to achieve project goals.
  5. HCS Description and Demographics: Overview of the HCS, patient demographics, etc.
  6. HCS Support and Resources: Leadership Letter of Support, resources committed, etc.
  7. Hematology and Pathology Letter of Engagement: Collaborative leaders' commitment and approach.
  8. Resources: Enumerate committed resources.
  9. Project Funds and Budget Narrative: Budget details for stipends and associated expenses.
  10. Institutional Commitment to Matching and Supplemental Funding: Narrative on uncovered costs to be covered by the institution.

Frequently Asked Questions

Reference ranges are intended to identify the central 95% of healthy populations. However, some laboratory values can vary among different populations like von Willebrand factor by blood type.

Another example is found the Duffy null phenotype and absolute neutrophil counts (ANC). Approximately two in three people in the United States who have African or Middle Eastern genetic ancestry have the Duffy-null phenotype. This results in a clinically insignificant lower ANC compared to the commonly used reference population which is often established from individuals of Asian or European descent of whom nearly 100% are Duffy non-null.

Thus, individuals with the Duffy null phenotype have no increased risk of infection but are often incorrectly labeled as having neutropenia. This can result in unnecessary, expensive, and invasive testing, delayed or discontinued chemotherapy or other critical medications, exclusion from clinical trials, and other negative consequences.

 

ASH has partnered with the Doris Duke Charitable Foundation and has funding available to help with the development and dissemination of Duffy-null specific reference ranges. This funding is intended to cover the costs of Duffy typing and ANC testing and patient recruitment as well as some support for the time from physicians, laboratory techs, and/or research assistants required to complete this project.

This project will attempt to validate adult reference ranges from previously published values which requires approximately 40-60 Duffy null samples. It will also attempt to establish new pediatric reference ranges which require 120 Duffy null samples per age category.

Health Care systems can opt to participate in adults only, pediatrics only, or both.

There are multiple possible methods to obtain samples from healthy populations that are outlined in the draft protocols in order to match preferences and realities of each individual institution. Samples must be collected from healthy participants. However, residual blood or fresh blood can be used. Any setting where there is a density of healthy participants is acceptable. Duffy phenotyping or genotyping are both acceptable, and institutions can type samples in-house or through send-out. All institutions involved must participate in a central IRB. De-identified limited demographic data, Duffy typing, and ANC values will be submitted at regular intervals to RedCap Cloud throughout the project.

For additional frequently asked questions, please click to download the PDF.

Related Documents

Please be aware that ASH is actively negotiating central IRB through Western Copernicus Group (WCG). The working draft copies of the templated documents for the project are linked below. Final versions will be updated once the contract is executed.

Terms and Definitions

FAQ

Reference Application

Reference IRB Materials

  Consent Form

Questions

If you have questions or require additional information regarding the ANC by Duffy Status project, please contact [email protected].