September 19, 2016

Dear Medical Director:
On August 26, 2016 the FDA released Revised Recommendations for Reducing the Risk of Zika Virus
Transmission by Blood and Blood Components. The Guidance for Industry identifies Zika Virus as a “relevant
transfusion transmission infection” and recommends that all blood collected in the United States be tested for Zika
Virus. This guidance replaces the prior recommendations for donor screening and deferrals with universal
individual donation testing (ID-NAT) using an investigational test.
The American Red Cross has been actively working to meet these requirements and has discussed our
implementation plan with the FDA. The FDA guidance recommends a three-phased geographic implementation
based on relative risk:
1. Collections in Florida and Puerto Rico must be tested immediately.
 Red Cross is performing ID-NAT on all collections in Florida. The Red Cross does not
collect in Puerto Rico.
2. Collections in high-risk states (Alabama, Arizona, California, Georgia, Hawaii, Louisiana,
Mississippi, New Mexico, New York, South Carolina, Texas) must implement testing within four
weeks.
 Red Cross is currently performing MP-NAT testing in all high-risk states except New
York. On September 26, 2016, Red Cross will implement MP-NAT in New York.
 Red Cross is also performing MP-NAT in Oklahoma.
 Red Cross will implement ID-NAT in all high-risk states by October 3, 2016.
3. For all other states, implement within 12 weeks.
 Red Cross is finalizing the plans to implement Zika testing on all donations, system wide,
later this year. Red Cross will implement MP-NAT in all other states by November 14,
2016.
The Red Cross is participating in the Hologic investigational new drug (IND) study, allowed by the FDA.
The test is a qualitative nucleic acid screening test that detects Zika virus RNA. All blood components tested and
found to be non-reactive for Zika virus by the investigational test will be labeled as "Neg for Zika by an
investigational NAT." This investigational verbiage will be contained on the ISBT label.

 The Red Cross will recover the costs associated with testing for ZIKA virus as allowed by the FDA. Approved cost
recovery fees will take effect later this year pursuant to the notice of your supply agreement.
The American Red Cross is committed to the safety and availability of the blood supply. Your local Account
Manager and Medical Director are available to answer any questions you may have.
Sincerely,

Susan Stramer, PhD
Vice President, Scientific Affairs
American Red Cross Biomedical Services