Community Blood Center is waiting for the U.S. Food and Drug Administration to sign off on one portion of a recently installed software system designed to streamline donor and collection information.
The blood bank went live with the new system, manufactured by IT Synergistics, on June 5. Donors became aware of the upgrade when they got new donor ID cards.
One piece of the new system — a computer-assisted questionnaire that every donor fills out about their health history and other personal information — hasn’t been implemented yet because the FDA, which regulates blood and tissue banks, hasn’t approved it yet.
The agency wants to know that the questionnaire technology, which relies on wireless technology, won’t interfere with other wireless systems in locations where blood drives are taking place, said Cyndi Condrey, IT blood systems project manager for Community Blood Center. CBC did its own security testing of the software and found it safe, but IT Synergistics is also testing it to make sure it complies with federal standards, she said.
There’s no time frame on when the FDA might sign off on the technology, said Mark Pompilio, a CBC spokesman.
In the meantime, blood and plasma donors who visit the blood bank’s brick-and-mortar donation centers will be filling out paper questionnaires.
Most donors won’t notice any changes, Condrey said, because 60 to 70 percent of CBC’s donors give blood at mobile blood drives, and have always filled out paper questionnaires. Once the FDA signs off on the questionnaire module, it will be used for all donors, including those at mobile blood drives, Pompilio said.
When CBC officials became aware of the issue with the computer-assisted questionnaire, they decided to move ahead with installing the rest of the system, and go back to paper forms while waiting for FDA approval.
Finding the right software system and then installing and implementing it was a 17-month process, Pompilio said. The system tracks everything from recruiting donors to blood collections to shipping blood products to hospitals served by the blood bank. The database includes information on 400,000 people who’ve donated blood.