By Carl Norman
Special to GUIDON
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 26.
During the two-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 and in-house blood drive in progress.
When all was said and done, the inspector found zero deficiencies, extending the Missouri donor center’s blood collection license until 2021.
“Blood is a drug and facilities that collect and process it must be inspected every two years, according to federal law,” said John Iwen, FDA inspector conducting the donor center’s inspection. “FDA inspections give everyone confidence that the facility is adhering to blood banking regulations, with the intent of assuring a safe blood supply as well as donor safety.”
“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 email email@example.com. For more about the Armed Services Blood Program, visit www.militaryblood.dod.mil.
(Editor’s note: Norman is the ASBP blood donor recruiter for Fort Leonard Wood.)