ASBP: Donor Center Passes FDA Inspection with Zero Deficiencies
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Donor Center Passes FDA Inspection with Zero Deficiencies

04/14/2017
By Carl Norman, ASBP Blood Donor Recruiter, Fort Leonard Wood, Mo.
Donor Center Passes FDA Inspection with Zero Deficiencies
The Fort Leonard Wood Blood Donor Center received the Food and Drug Administration’s green light to continue collecting blood for another two years after passing their biennial compliance inspection March 28.

During the one-day, no-notice inspection, an FDA inspector reviewed the donor center’s training, quality control and equipment maintenance records as well as corrective action records and all standard operating procedures. The inspector also observed a mobile blood drive in progress.

When all was said and done, the inspector had only two non-binding recommendations and found zero deficiencies, extending the Missouri donor center’s blood collection license until 2019.

“This is a tremendous accomplishment for our donor center,” said Army Capt. Patrick Kaer, donor center deputy director. “Passing this inspection tells the FDA, Armed Services Blood Program and everyone at Fort Leonard Wood that we’re complying with all federal regulations governing blood collection and we’re doing so in grand fashion. Not passing this inspection has serious consequences for us and the people who depend on us for life-saving blood, so we take its compliance very seriously.”

“The FDA’s role is regulating and protecting the nation’s blood supply,” said Felix Ortiz-Plaza, Fort Leonard Wood Blood Donor Center quality assurance officer. “I see our team as the guardians of that blood supply for our troops and their families. These inspections are based on what is known as the ‘Five Layers of Safety,’ which consist of donor screening, donor deferral, product testing, product quarantine and investigating problems. The key to a successful inspection is always being ready and I’m proud to say our staff passing this inspection was a team effort, and we’re prepared for them every single day.”

FDA inspects entities that manufacture or process FDA-regulated products to verify that they comply with relevant regulations. Those inspected include vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, animal feed processors and compounding pharmacies. The FDA also inspects facilities that conduct studies in people (clinical trials), laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product, foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States and imported regulated products at the border.

The Fort Leonard Wood Blood Donor Center collects blood for the Armed Services Blood Program, the official blood collection agency for the Department of Defense. Collected blood goes to medical facilities in Afghanistan and other Overseas Contingency areas around the world and to military hospitals around the DOD.

According to Marty Ricker, ASBP donor recruiter director, the Military Healthcare System requires about 400 units of blood every day.

“It's the ASBP's mission to provide that blood, so we need all the donors we can get,” Ricker said. “If you have your health, celebrate it by donating a unit of blood to those who are not as fortunate.”

For more information about donating at the Fort Leonard Wood Blood Donor Center, call 573-596-5385 or e-mail Carl.A.Norman2.civ@mail.mil.

About the Armed Services Blood Program
Since 1962, the Armed Services Blood Program has served as the sole provider of blood for the United States military. As a tri-service organization, the ASBP collects, processes, stores and distributes blood and blood products to Soldiers, Sailors, Airmen, Marines and their families worldwide. As one of four national blood collection organizations trusted to ensure the nation has a safe, potent blood supply, the ASBP works closely with our civilian counterparts by sharing donors on military installations where there are no military blood collection centers and by sharing blood products in times of need to maximize availability of this national treasure. To find out more about the ASBP or to schedule an appointment to donate, please visit www.militaryblood.dod.mil. To interact directly with ASBP staff members, see more photos or get the latest news, follow @militaryblood on Facebook, Twitter, Flickr, YouTube and Pinterest. Find the drop. Donate.

The Armed Services Blood Program is a proud recipient of the Army Maj. Gen. Keith L. Ware Public Affairs award for journalism.