Bloodworks Northwest says American Red Cross declining to fully comply with Zika virus testing

The American Red Cross is dedicated to providing the safest, most reliable blood products possible to patients in need. We take strong exception with the safety allegations made by Bloodworks Northwest that irresponsibly and erroneously stokes public health fears. The Red Cross is working aggressively to implement the U.S. Food and Drug Administration’s guidance released August 26, 2016, recommending universal investigational Zika virus nucleic acid testing of donated blood and blood products in the U.S. 

The FDA gave blood centers the opportunity to review their implementation plans and timelines with the FDA. The Red Cross has discussed our phased implementation plan with the FDA. The FDA understands our approach and has expressed no concern with our timeline. Claims that we are not in full compliance with FDA regulations are categorically untrue. 

It is significant to note that the Red Cross initiated Zika virus testing in June, ahead of most blood centers in the U.S. and prior to the FDA required testing guidance. Currently, the Red Cross conducts individual donation testing (ID-NAT) for Zika virus under an investigational study in ten U.S. states in which our collections occur that are believed to be at greatest risk of local mosquito transmission of Zika virus. Those states include Alabama, Arizona, California, Florida, Georgia, Mississippi, New York, Oklahoma, South Carolina and Texas. (The Red Cross does not collect blood in Hawaii, Louisiana or New Mexico.) Again, this is in full compliance with FDA guidance. The Red Cross began individual donation testing in Florida on July 25 – Florida is the only state in the continental U.S. designated by the CDC as active for local Zika virus transmission.

In the remaining states including those in the Pacific Northwest, the Red Cross will implement mini-pool donation testing (MP-NAT) for Zika virus under an investigational study by November 14. We will then migrate these states from mini-pool to individual testing before the end of the year. As an added layer of safety, we are retaining the health history question regarding travel to areas at risk for Zika virus and deferring accordingly. In addition, the Red Cross continues to provide donors with information regarding other Zika virus risks including travel, sexual contact, symptoms and/or diagnosis, and ask donors who are at risk to self-defer, or postpone their blood donation.

The Red Cross has a strong history of implementing safety initiatives including investigational blood donation screening tests, for example dengue viruses in the Caribbean. This was followed by the implementation of pathogen inactivation in response to the epidemic of dengue and chikungunya viruses in the Caribbean. We also introduced investigational testing for the parasite babesia that is common in New England and the upper Midwest. The Red Cross is now implementing pathogen inactivation in the continental U.S. The highest priority for the Red Cross is the safety of our donors and the recipients of blood.