Our advocacy for federal guidelines related to gender-diverse (transgender, non-binary, gender non-conforming, and other non-cisgender identities) blood donors are included here. To read our research brief submitted to the FDA, click here. 

To read all of this information in one file- open our public version of the brief with additional background information supporting our research argument here

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Overview - Blood Donation - Blood Products - Sex/Gender/Gender-Diversity - Transitioning - Legal Recognition - Hemoglobin -  FDA Language - Pregnancy - Immune System - Respiratory System - TRALIs - Transfusion Mortality - Therapeutic Phlebotomy - Donor History Questionnaire - Governing Bodies - Recommendations 

Overview

• Gender-Diverse blood donors include, but are not limited to: transgender, nonbinary, gender non-conforming, gender-fluid, and other non cisgender individuals
  
• Although slightly affirming language (targeting men/women) was included in 2015 and 2020 FDA guidances, it did not include gender identities outside of male/female and was not included in the 2023 update to blood donor eligibility.
  
• The FDA has failed to provide any guidance or recommendation related to the screening and testing of gender-diverse blood donors. This oversight, in assuming that all blood donors are cisgender, has not only potentially created unwelcoming environments for much needed donors, but potentially created undue risk to recipients of blood transfusions
  

Blood Donation

• Blood Donation is the process of removing blood products (platelets, plasma, red blood cells) from a donor and transfusing them into a recipient. 
• ​The 4 main steps include screening (questionnaire and eligibility determination), donation (removal of blood products from the donor), testing (detection of any transfusible infectious agents, blood type), and transfusion (administration to a recipient in need). 
• When ready to donate, you can find the closest blood bank you here.

Blood Products

• Blood can be either donated as is (whole blood), or can be broken up into specific components for transfusion. The donation of specific components may utilize machinery and a process called "apheresis", where the additional blood products are returned to the donor's body
• Whole blood is comprised of red blood cells (oxygen carrying), white blood cells (immune cells), platelets (clotting), and plasma (fluid)
• ​Different blood products have different lifespans, with Red blood cells lasting for up to 42 days, plasma lasting for up to a year, and platelets expiring after just 5 days. 
• Cryoprecipitate (aka "cryo") is a blood product comprised of clotting factors which is derived from plasma and administered to individuals bleeding or with clotting deficiencies or diagnoses. 
  

Sex, Gender & Gender-Diversity

• Gender identity is someone's sense of self as male, female, both, neither, or something else. 
• ​Transgender is an umbrella term that represents individuals whose gender identity does not match the sex assigned at birth
• Non-binary is an identity for those whose gender does not align with either end of the gender binary scale (male, female)
• Intersex: a range of conditions associated with atypical sex characteristics, which may be caused by chromosomes other than xx or xy
• Transitioning: the process that some gender-diverse individuals participate in that helps align their external presentation with their internal sense of self and gender. 
  

Transitioning

• Transitioning is a highly unique and individual process of aligning one's internal sense of gender and self, with one's external presentation. 
• This can be accomplished in a variety of ways including but not limited to internal transition, social transition, utilizing medical and surgical assistance, and pursuing legal changes to one's name, gender markers, and identification. 

Legal Recognition

• Unfortunately, gender-diverse individuals do not have the same rights and ease of transition in all parts of the country. Legal recognition means the ability to change one's name and gender marker
• ​Most states allow individuals to change their name, which may require a court order, and then allows an individual to update their social security, state ID, and other personal documents. 
• ​The requirements to change one's gender marker on legal documents varies greatly from state to state. Some allow you to change your state ID, some allow only your birth certificate, and some allow both. 

Hemoglobin

• Hemoglobin (hgb) s the protein in red blood cells that binds to oxygen and ensures that it reaches your body's tissues via the circulatory system
• There are two typical hemoglobin ranges, one for cis-men and one for cis-women. If a donor's hgb level is too low, it is unsafe for them to donate blood and they will be deferred until a later date. 
• There is no good alternative to the existing hgb ranges for gender-diverse individuals. Although hgb levels alter with hormone replacement therapy (HRT), not all gender-diverse individuals undergo HRT. 
  
• The FDA has failed to consider the needs of gender-diverse donors, leaving blood centers in the dark when attempting to maintain donor safety when giving blood. 
  

FDA Language

• Starting in 2015, the FDA included affirming language for male and female donors (regardless of sex assigned at birth), supporting donor self-identification.
• However, the FDA failed to provide any guidance on how to implement affirming practices, and failed to include any language for donors who are not male or female. 
• The 2023 update that introduced the Individual Risk Assessment also removed all gendered language from the FDA document, but it also removed the language supporting donor self-identification for gender.

Pregnancy

• During pregnancy, a pregnant person's immune system produced antibodies to the growing fetus, specifically "Human Leukocyte Antigen Antibodies" or "HLA Antibodies"
• These antibodies may continue to remain in the previously pregnant person's bloodstream after the end of a pregnancy, and can cause transfusion reactions in recipients
• To mitigate risk, any donors with a history of pregnancy, miscarriage, or abortion are not permitted to donate plasma or platelets, since there may be increased odds of HLA Antibody presence
• However, if blood centers only ask female-identifying patients about a risk of pregnancy (not asking trans men, nonbinary, and other gender-diverse donors), donors at a higher risk for HLA-antibody production may not be screened, and may be permitted to donate plasma or platelets. To mitigate this- all donors should be asked about a history of pregnancy, miscarriage, or abortion

Immune System & HLA Antibodies

• The immune system is composed of cells, tissues, and organs and works to fight infection and other threats. 
• Antibodies are proteins of the immune system that bind to non-self antigens (markers on cells that identify the cell as a part of the body) and alert the immune system to attack. 
• HLA Antibodies: Produced by a pregnant person's immune system in response to non-self antigens (from the growing fetus). These may respond to another person's immune system and trigger a transfusion reaction after receiving a blood product

Respiratory System

• The Respiratory system is a group of organs, tissues, and cells that works to provide oxygen and nutrients to your blood. 
• The respiratory system is comprised of the lungs, bronchi (tubes that connect to the lungs), trachea, and mouth/nose. The circulatory system works in tandem and is comprised of the vasculature (veins, arteries, capillaries), heart, and blood. 
• Pulmonary edema is a condition where fluid builds up in the lungs and can be caused by heart failure, pneumonia, trauma, allergic reactions or other causes. This can require supplemental oxygen, diuretics, and steroids. 

Transfusion-Related Acute Lung

​Injuries (TRALIs)

• TRALIs are an adverse effect of blood product administration, where white blood cells from the immune system accumulate in the lungs' air sacs along with fluid.
• TRALIs are the second leading cause of transfusion-related mortality and blood centers try to prevent them by deferring donors who were previously pregnant from donating plasma and platelets. 
• TRALIs present as shortness of breath, increased oxygen demand, fever, hypotension, and tachycardia. When paired with an x-ray, a diagnosis can be made. Treatment includes stopping the blood product, administration of oxygen, and other supportive therapies. 
  
• Some severe cases will require ventilation (the use of a breathing machine) for a period of time, as well as potential escalation to an intensive care unit. 
  

Transfusion-Related Mortality

• In rare cases, blood transfusions result in adverse reactions, and potentially death. The CDC and federal government release data on transfusion-related mortality each year. 
• TRALIs are classified as TRALIs or pTRALIs (possible trallies) and then defined as definite, probable, or possible. 
  • ​Possible TRALIs are cases with a pre-existing risk factor for a reaction. 
• ​TRALIs have been the second leading cause of transfusion related mortality for the previous few years, while holding the #1 spot from 2009-2015. 

Therapeutic Phlebotomy

• Exogenous (from outside of the body) testosterone administration is a treatment for low testosterone, gender affirming care, to grow hair, alter body mass, and many other diagnoses. For cisgender men this is referred to as "testosterone replacement therapy" or "TRT"
• TRT results in some side effects such as hair growth, altered body mass, and increased red blood cell production. 
• Some individuals are prescribed "therapeutic phlebotomy" or to donate blood at intervals to mitigate this increase in red blood cells to a safe/typical range. Most blood centers require 8 weeks between donations to ensure that a donor's levels don't drop too low, but some individuals on TRT are prescribed to donate more frequently than every 8 weeks. 
• Trans & gender-diverse individuals on HRT testosterone see the same side effects and may be some of the safest donors to donate red blood cells, despite most therapeutic phlebotomy programs targeting cis men.
  

Regulatory Organizations

• The FDA is the federal agency tasked with overseeing the nation's blood supply and ensuring safety for both blood donors and recipients. 
• The FDA is divided into Centers- specialized units that oversee topics and issues. The Center for Biologics Evaluation and Research (CBER) oversees blood and tissue donation
• Within CBER is the Blood Products Advisory Committee (BPAC), which provides opportunities for stakeholders, experts, and members of the public to voice concerns and address issues related to blood, plasma, and platelets. 
  
• The Association for Advancement of Blood and Biotherapies (AABB) is the nation's voice in blood banking and transfusion medicine. AABB translates the FDA's eligibility criteria into a donor history questionnaire. 

The Donor History Questionnaire 

• The Donor History Questionnaire (created by the Association for Advancement of Blood & Biotherapies) is a FDA-approved tool for assessing blood donor eligibility
• ​The DHQ is updated with revisions to blood donor eligibility criteria by the FDA, the current DHQ is version 4.0 and was last revised in May of 2023. 
• ​The current DHQ does not have any gendered language and does ask about pregnancy (history or current)
• The DHQ fails to provide any guidance for gender-diverse donors and is implemented differently based upon a facility's computer system and interface adaptability. 

Recommendations

We've broken our recommendations into 3 topic areas and multiple steps:

1. ​​Pregnancy & TRALIs: screen all donors for a history of pregnancy regardless of gender or presentation. Report data on non-fatal TRALI diagnosis and incidence. 
2. Inclusivity & Screening: Promote Research for and by gender-diverse blood donors, identifying best practices and current shortfalls; if necessary, create and support new research studies. Draft federal recommendations including universal hemoglobin, hematocrit, and body mass scales for donor eligibility. Allow donors to alter and change their gender markers. Advocate for improved access of computer systems for blood banks. Utilize and engage with gender-diverse individuals, collect data on GD experiences, and communicate the intent behind changes. 
3.   Assess non-cisgender individuals taking exogenous testosterone for erythrocytosis and the potential need for therapeutic phlebotomy. Promote plasma and platelet donation amongst transgender women, nonbinary donors, and other gender-diverse donors assigned male at birth.