New FDA Zika Rules Have IN Blood Centers Rushing To Comply

Indiana blood centers are rushing to comply with a federal rule that all blood donated in the United States be tested for the Zika virus.

Previously, Indiana blood donors have been screened through a questionnaire that asks if they have traveled to parts of the world where Zika transmission occurs.

No locally-transmitted cases of the virus have been recorded in Indiana, and the mosquito that carries the virus isn’t native to the state.

However, Justin Kreuter, Medical Director of the Mayo Clinic’s blood donor program, says the measure means public health officials are getting in front of the problem.

“Now that we are seeing vector-borne infections that go from mosquito to human, and also sexual transmission of Zika in the United States, at some point in places like Indiana, those travel history questions become less effective,” he says.

Indiana Blood Center Executive Vice President Dan Waxman says the test was only recently approved by the FDA, so most donation centers don’t yet have the equipment or the know-how to use it.

“That’s the other part of the challenge for this,” he says. “For blood centers who may have never used this equipment, they have to bring it in, they have to learn to use it, they have to validate it.”

Additionally, because the approval is “investigational,” that means centers will need to jump through more logistical hoops to obtain and run the tests, says Waxman.

Waxman says the new testing means it will cost more money for the blood donation centers to get the blood to needy hospitals.

“And then that charge will be added on to processing fees for blood products and ultimately this is paid by the hospital and the patient,” he says.

Because the new rule is so new, both Waxman and Kreuter say they can’t say for sure how much more the testing will cost centers. Kreuter simply says they can be sure it will be “more.”

The Red Cross, the state’s other major blood donation center, declined an interview, saying it preferred not to comment on Zika. However, in an email, a spokesman did say the Red Cross “will continue to work closely with the FDA regarding our timeline for implementing testing in all U.S. states as required by the revised Zika virus guidance.” He added, “it is too early to know the exact cost of this extensive expansion.”

Certain southern states and New York have four weeks to comply with the new testing rules. Other states, including Indiana, have only until November before they must start the additional testing.