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College of American Pathologists Supports Gender-Neutral Blood Donor Screening

In April 2020, the U.S. Food and Drug Administration (FDA)—the regulatory body that oversees the U.S. blood supply and blood centers—shortened donor deferral periods from 12 months to 3 months for male donors who would have been deferred for having sex with another man (MSM); female donors who would have been deferred for having sex with a man who had sex with another man; and for those with recent tattoos and piercings. An update from the December 2015 FDA recommendations, this measure was in response to the impact of the COVID-19 pandemic on the blood supply shortage.

“As a physician who has previous experience leading a blood bank, I understand how a nationwide blood shortage can impact the quality of care at hospitals and emergency rooms across the country for cancer patients, patients who suffer acute injuries, and others who need blood,” says CAP President Emily E. Volk, MD, FCAP, chief medical officer for Baptist Health Floyd, and an associate professor of pathology at the University of Louisville School of Medicine.

The College of American Pathologists (CAP) strives for inclusivity and diversity in all our endeavors, and strongly supports gender-neutral blood donor screening based on individualized risk assessment for human immunodeficiency virus (HIV) infection instead of sexual orientation.

Despite these updates, the US still faces a severe national blood shortage crisis—particularly with O negative and O positive type red blood cells.

“More objective donor screening criteria can increase the safety and availability of the country’s blood supply, which can greatly benefit patient care,” Volk says.

Blood banks in several European countries and Israel already have instituted gender-neutral blood donor screening measures, and HealthCanada is currently reviewing a similar recommendation from the Canadian Blood Services.

“Lifting the gender barriers in the blood donor screening measure, while still maintaining the highest safety protocols, is critical to making the blood donation process more inclusive, objective and approachable,” says Glenn Ramsey, MD, FCAP, chair of the CAP’s Transfusion, Apheresis, and Cellular Therapy (TACT) committee, medical director of Northwestern Memorial Hospital’s blood bank, and professor of pathology at Northwestern University’s Feinberg School of Medicine. “This may broaden the pool of eligible donors, which is essential to help alleviate the severe nationwide blood shortage crisis.”

Currently, the FDA and leading blood collection organizations are sponsoring the pilot ADVANCE (Assessing Donor Variability And New Concepts in Eligibility) Study to evaluate alternatives to its current deferral policy for MSM to examine if different questions could be used in the donor history questionnaire. Local blood centers are partnering with LGBTQ+ community centers in eight metropolitan cities across the country to help recruit study participants.

“When complete, the ADVANCE study results will be crucial in determining how best to assess individual risk behaviors in US blood donors,” Ramsey explains.

Blood donors take considerable pride in making irreplaceable contributions to the health of their communities. The CAP supports participation in the ADVANCE Study, and the ability of safe and eligible individuals, regardless of sexual orientation, to give life-saving blood donations needed every day.

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